预约演示
更新于：2026-02-27
VRC-07-523
更新于：2026-02-27
概要
基本信息
药物类型 单克隆抗体 |
别名 TMB-380、VRC-07-523-L S、VRC-HIVMAB-075 -00-AB + [3] |
作用方式 抑制剂 |
作用机制 HIV包膜蛋白gp120抑制剂 |
在研适应症 |
非在研适应症 |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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关联
34
项与 VRC-07-523 相关的临床试验NCT07390955
A Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics, and in Vitro Neutralization of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS Administered in Multiple Doses and Routes to Adult Participants Without HIV-1
This study is testing a lab-made antibody called ePGT121v1-LS that targets a specific part of HIV. Researchers will give it by vein (IV) and under the skin (SC), both on its own and together with two other antibodies, VRC07-523LS and PGDM1400LS, which target different parts of the virus. They will assess safety and side effects, determine the right dose, study how the body processes the drug (pharmacokinetics or PK), and measure how well it neutralizes HIV in the blood (serum neutralizing activity). The expectation is that ePGT121v1-LS, whether given alone or with PGDM1400LS and VRC07-523LS, by IV or SC, will be safe in generally healthy adults and that the antibodies will not interfere with each other when used together.
Approximately 83 volunteers in overall good health and without HIV-1 will be enrolled into two parts (A and B).
Part A has six groups. In Groups 1-3, participants will get ePGT121v1-LS given by IV at one of three dose levels: 5 mg/kg, 20 mg/kg, or 40 mg/kg. In Groups 4-6, participants will receive three antibodies-first ePGT121v1-LS, then PGDM1400LS and VRC07-523LS-given by IV at two separate visits that are 24 weeks apart. The total study duration for participants in Part A is 48 weeks of scheduled clinic visits.
Part B has two groups. In Group 7, people will get ePGT121v1-LS as SC shots at two visits 12 weeks apart. Each visit will give a total of 375 mg, split into three injections of 125 mg each. In Group 8, people will also have two visits 12 weeks apart and will receive three antibodies as SC shots in this order: first ePGT121v1-LS (125 mg), then PGDM1400LS (100 mg), and then VRC07-523LS (100 mg). The total study duration for participants in Part B is 24 weeks of scheduled clinic visits.
Approximately 83 volunteers in overall good health and without HIV-1 will be enrolled into two parts (A and B).
Part A has six groups. In Groups 1-3, participants will get ePGT121v1-LS given by IV at one of three dose levels: 5 mg/kg, 20 mg/kg, or 40 mg/kg. In Groups 4-6, participants will receive three antibodies-first ePGT121v1-LS, then PGDM1400LS and VRC07-523LS-given by IV at two separate visits that are 24 weeks apart. The total study duration for participants in Part A is 48 weeks of scheduled clinic visits.
Part B has two groups. In Group 7, people will get ePGT121v1-LS as SC shots at two visits 12 weeks apart. Each visit will give a total of 375 mg, split into three injections of 125 mg each. In Group 8, people will also have two visits 12 weeks apart and will receive three antibodies as SC shots in this order: first ePGT121v1-LS (125 mg), then PGDM1400LS (100 mg), and then VRC07-523LS (100 mg). The total study duration for participants in Part B is 24 weeks of scheduled clinic visits.
开始日期2026-03-06 |
NCT06987318
A Phase I Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection
The purpose of this study is to evaluate the safety, tolerability, and efficacy of combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI).
开始日期2026-02-15 |
NCT06517693
Open-Label, Phase I Study of the Safety and Pharmacokinetics of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS soon after birth in infants exposed to HIV-1.
开始日期2026-01-05 |
100 项与 VRC-07-523 相关的临床结果
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100 项与 VRC-07-523 相关的转化医学
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100 项与 VRC-07-523 相关的专利（医药）
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36
项与 VRC-07-523 相关的文献（医药）2026-02-09·CLINICAL INFECTIOUS DISEASES
Phase 2 Trial of Long-Acting Cabotegravir and VRC07-523LS for Viral Suppression in Adults With HIV-1: ACTG A5357
Article
作者: Stroberg, Todd ; Taiwo, Babafemi O ; Harber, Heather ; Wolfe, Sherrie ; Overton, Edgar Turner ; Hendler, Suzanne ; Zheng, Yu ; Koletar, Susan ; Bar, Katharine J ; Belaunzaran-Zamudio, Pablo F ; Hulse, Susan ; Rathod, Parita ; Burke, Leah ; Trentman, Sarah ; Rodriguez, Katherine ; Sobieszczyk, Magdalena ; Spitz, Teresa ; Burnham, Eli ; Messer, Michael ; Wannamaker, Paul ; Perez-Frontera, Sigrid ; Kim, Su Kyung ; Nyaku, Amesika ; Costanza, ChristieLyn ; Sutton, Vanessa ; Flexner, Charles W ; Fichtenbaum, Carl ; Cantos, Anyelina ; D’Amico, Ronald ; Scarsi, Kimberly K ; Barcavage, Shaun ; Lopez, Azquena Munoz ; Bagur, Jorge L Santana ; Gama, Lucio ; Munsiff, Sonal ; Fry, Rebecca ; Short, William ; Petropoulos, Christos J ; Axinn, Joslyn ; Hoffman, Erin ; Becker, Rebecca L ; Duke, Elizabeth ; Wohl, David ; Alyatim, Raghd ; Solso, Stephanie ; Tebas, Pablo ; Benson, Constance ; Achenbach, Chad ; Fuentes, Jessenia ; Reeves, Jacqueline D
Abstract:
Background:
Long-acting regimens are needed to expand antiretroviral therapy (ART) options for people with human immunodeficiency virus type 1 (HIV-1). Combining broadly neutralizing antibodies (bNAbs) with long-acting small-molecule antiretrovirals may offer an alternative to daily oral therapy.
Methods:
We conducted a phase 2, open-label, single-arm trial at AIDS Clinical Trials Group (ACTG) sites across the United States. Eligible adults had HIV-1 virologically suppressed on ART for ≥2 years, CD4 count ≥350 cells/μL, and susceptibility to VRC07-523LS (half-maximal inhibitory concentration ≤0.25 µg/mL; inhibition >98%). Participants completed an oral cabotegravir (CAB) lead-in (Step 1), then received intravenous VRC07-523LS (40 mg/kg every 8 weeks) plus intramuscular CAB-LA (every 4 weeks) for 48 weeks (Step 2), followed by a return to standard ART (Step 3). Primary outcomes were treatment-related grade ≥3 adverse events (AEs), treatment discontinuation, and confirmed HIV-1 RNA ≥200 copies/mL by week 44. Virologic efficacy was assessed using Kaplan–Meier estimates.
Results:
Seventy-four participants were enrolled (median age, 54 years; 26% female; 51% non-Hispanic White). Twelve (17%) experienced a primary safety event: 11 (15%) had grade ≥3 AEs, primarily transient infusion reactions, and 1 discontinued due to a grade 1 infusion event. The cumulative probability of virologic failure by week 44 was 7% (95% confidence interval, 3%–16%). One participant developed the R263K integrase resistance mutation.
Conclusions:
The VRC07-523LS plus CAB-LA regimen maintained viral suppression in 93% of participants, with only transient infusion reactions observed; however, instances of virologic breakthrough suggest that future studies should focus on optimizing efficacy outcomes. These results support continued investigation of bNAb-based long-acting ART combinations.
2026-02-05·Nature
Correlates of HIV-1 control after combination immunotherapy
Article
作者: Deitchman, A N ; Gale, M ; SenGupta, D ; Williams, M C ; Khalili, M ; Tummala, H P ; Deeks, S G ; Sandel, D A ; Reeves, J D ; Kim, S J ; Vendrame, E ; Felber, B K ; Hoh, R ; Dalhuisen, T ; Yukl, S A ; Mullins, J I ; Narpala, S ; Koup, R A ; Cohn, L B ; Pavlakis, G N ; Whitmore, L S ; Chew, K W ; Petropoulos, C J ; Tisoncik-Go, J ; Tibúrcio, R ; Borgo, G M ; Deswal, M ; Henrich, T J ; Schwartz, K ; Rutishauser, R L ; Zemelko, L ; Serebryannyy, L ; Nussenzweig, M C ; Spitzer, M H ; Caskey, M ; Gama, L ; Shimoda, M ; Singh, S S ; Glidden, D V ; Peluso, M J
Abstract:
The identification of therapeutic strategies to induce sustained antiretroviral therapy (ART)-free control of HIV infection is a major priority
1
. Combination immunotherapy including HIV vaccination, immune stimulation, latency reversal and passive transfer of broadly neutralizing antibodies (bNAbs) has shown promise in non-human primate models
2–6
, but few studies have translated such approaches into people. Here we performed a single-arm, proof-of-concept study in ten people living with HIV on ART, combining the following three approaches: (1) therapeutic vaccination with an HIV Gag conserved element-targeted DNA + IL-12 prime/modified vaccinia Ankara (MVA) boost regimen followed by (2) administration of two bNAbs (10-1074, VRC07-523LS) and a toll-like receptor 9 agonist (lefitolimod) during ART suppression, followed by (3) repeat bNAb administration at the time of ART interruption (Clinicaltrials.gov:
NCT04357821
). Seven out of the ten participants exhibited post-intervention control after pausing ART, independent of residual bNAb plasma levels. Robust expansion of activated CD8
+
T cells early in response to rebounding virus correlated with a lower median viral load after peak viraemia off ART. These data suggest that combination immunotherapy approaches might prove effective in inducing sustained control of HIV by slowing rebound and improving CD8
+
T cell responses, and that these approaches should continue to be optimized.
2026-02-01·JOURNAL OF INFECTION
Monitoring broadly neutralising HIV antibody concentrations using microsampling on dried blood spots in infants
Article
作者: Scarlatti, Gabriella ; Mkhize, Nonhlanhla N ; Ayres, Frances ; Naidoo, Logashvari ; Gama, Lucio ; Goga, Ameena ; Latour, Rémi ; Biswas, Priscilla ; Molès, Jean-Pierre ; Moore, Penny L ; Nagot, Nicolas ; Debiesse, Ségolène ; Tshabalala, Mqondisi ; Balla, Sashkia R ; Van de Perre, Philippe ; Makhado, Zanele ; Cazaubon, Yoann ; Ramraj, Trisha ; Dispinseri, Stefania
OBJECTIVES:
The use of broadly neutralising antibodies (bNAb) to prevent HIV infection is under active investigation, including for the prevention of vertical HIV transmission. In neonates, an uncomplicated sampling method for blood collection is the use of dried blood spots (DBS). We aimed to validate the use of a combination of DBS with ELISA techniques to monitor bNAb concentrations, namely VRC07-523LS and CAP256V2LS, in neonates.
METHODS:
We evaluated the performance of various DBS elution protocols on spiked adult blood and next on spiked cord blood. The optimised method was validated on blood from infants injected with bNAbs.
RESULTS:
After selecting the best elution conditions, we reported good repeatability and reproducibility for both bNAbs in cord blood samples. The concordance study with infant receiving VRC07-523LS or CAP256V2LS samples showed that the values obtained from DBS eluates were closely aligned with those from plasma samples and when corrected by the haematocrit value, the number of outliers was 10.1% with a positive bias of 0.35 µg/mL for CAP256V2LS, and 5.0% with a positive bias of 3 µg/mL for VRC07-523LS.
CONCLUSIONS:
DBS microsampling allows accurate bNAb concentration measure in neonates, which will facilitate on-going paediatric clinical trials and possible subsequent monitoring in adults with home-sampling if deployed at scale.
14
项与 VRC-07-523 相关的新闻（医药）2026-02-26
Clinical Infectious Diseases Volume 82 Issue 1
临床传染病学 82卷1期
https://academic.oup.com/cid/issue/
ID Art Through the Ages（穿越时代的传染病学技艺）
1
Peasants' Revolt, 1381
1381年农民起义
Mary Grizzard and Michael Grizzard
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Page i, https://doi.org/10.1093/cid/ciaf692
In the Literature（文献概览）
2
In the Literature
文献概览
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages ii–iii, https://doi.org/10.1093/cid/ciaf631
State-of-the-Art Review（最新技术综述）
3
State-of-the-Art Review: Diagnosis and Management of Acute and Chronic Bacterial Prostatitis
最新技术综述：急性和慢性细菌性前列腺炎的诊断与治疗
Prathit A Kulkarni and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 1–13, https://doi.org/10.1093/cid/ciaf483
Clinical Dilemmas in Infectious Diseases（传染病临床难题）
4
“Insisting on Treatment”
“坚持治疗”
Kevin Andrew Smith and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 14–18, https://doi.org/10.1093/cid/ciaf282
Voices of ID（传染病之声）
5
Martin Arrowsmith and Me
马丁·阿罗史密斯与我
Janet R Gilsdorf
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 19–20, https://doi.org/10.1093/cid/ciaf277
Invited Commentary（特邀述评）
6
The 2025 Centers for Disease Control and Prevention Nonoccupational HIV Postexposure Prophylaxis Guidelines: Updated Regimens and Remaining Questions
2025年美国疾病控制与预防中心非职业性艾滋病毒暴露后预防指南：更新方案及遗留问题
Lao-Tzu Allan-Blitz and Kenneth H Mayer
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 21–24, https://doi.org/10.1093/cid/ciaf567
Antimicrobial Resistance and Stewardship（抗菌药物耐药性与管控）
7
Modeling the Impact and Cost of a Culture-Dependent Molecular Test for Antimicrobial Resistance in Resource-Limited Settings
资源有限环境下，基于培养的分子检测法对抗菌药物耐药性的影响和成本建模
Joshua M Chevalier and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 25–32, https://doi.org/10.1093/cid/ciaf236
8
The Xpert MTB/RIF Cycle Threshold Value Predicts Mycobacterium tuberculosis Transmission to Close Contacts in a Brazilian Prospective Multicenter Cohort
巴西一项前瞻性多中心队列研究中Xpert MTB/RIF循环阈值可预测结核分枝杆菌在密切接触者中的传播
Leandro S Garcia and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 33–41, https://doi.org/10.1093/cid/ciad794
9
Beyond Diagnosis: Xpert Cycle Threshold Values as Predictors of Tuberculosis Transmission
超越诊断：Xpert循环阈值作为结核病传播的预测指标
Lauren Linde and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 42–43, https://doi.org/10.1093/cid/ciad791
10
First Report of Treatment-Emergent Resistance to Cefepime-Zidebactam in Pseudomonas aeruginosa
铜绿假单胞菌在头孢吡肟-齐德巴坦治疗中出现耐药性的首例报告
Ava J Dorazio and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 44–48, https://doi.org/10.1093/cid/ciaf638
Clinical Practice and Policy（临床实践与政策）
11
Sputum and Tongue Swab Molecular Testing for the In-Home Diagnosis of Tuberculosis in Unselected Household Contacts: A Cost and Cost-Effectiveness Analysis
痰液和舌拭子分子检测用于未筛选家庭接触者结核病居家诊断的成本及成本效益分析
Charl Bezuidenhout and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 49–57, https://doi.org/10.1093/cid/ciaf389
12
You’ve Got a Friend in Me: Curbside Questions Infectious Diseases Clinicians Ask Infectious Diseases Pharmacists
我是你的朋友：传染病临床医生向传染病药剂师咨询的即兴问题
Matthew R Davis and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 58–61, https://doi.org/10.1093/cid/ciaf250
13
Home Testing for Contagious Illness: Historical Context and Modern Caveats
传染性疾病居家检测：历史背景与现代注意事项
Abigail Zuger
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 62–66, https://doi.org/10.1093/cid/ciaf623
Fungal Infections（真菌感染）
14
Evaluating the Use of Lower Dose Flucytosine for the Treatment of Cryptococcal Meningitis: A Clinical Trial
评估低剂量氟胞嘧啶治疗隐球菌性脑膜炎的临床试验
Morris K Rutakingirwa and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 67–74, https://doi.org/10.1093/cid/ciaf432
15
Association Between Duration of Candidemia and Clinical and Healthcare Resource Utilization Outcomes Among Hospitalized Adult Patients With Candidemia Who Received Empiric Treatment With an Echinocandin Across United States Hospitals
美国各医院中接受棘白菌素经验性治疗的念珠菌血症成年住院患者中，念珠菌血症持续时间与临床和医疗资源利用结局之间的关联
Thomas P Lodise and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 75–85, https://doi.org/10.1093/cid/ciaf472
16
Aspergillosis-Attributable Mortality in the United States: Analysis of Death Certificate Data
美国隐球菌病导致的死亡率分析：基于死亡证明数据
Thomas J Walsh and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 86–92, https://doi.org/10.1093/cid/ciaf653
HIV/AIDs（人类免疫缺陷病毒/艾滋病）
17
Outcomes of Critical Illness in People With Advanced HIV Disease: 30 Years of Binational Data
晚期艾滋病患者危重症结局：30年的双国数据
Bryan Tan and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 93–99, https://doi.org/10.1093/cid/ciaf362
18
Phase 2 Trial of Long-Acting Cabotegravir and VRC07-523LS for Viral Suppression in Adults With HIV-1: ACTG A5357
长效卡博特韦和VRC07-523LS用于HIV-1感染成人病毒抑制的2期试验：ACTG A5357
Babafemi O Taiwo and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 100–108, https://doi.org/10.1093/cid/ciaf375
19
Therapeutic Drug Monitoring of Long-Acting Cabotegravir and Rilpivirine in a National Cohort of People With HIV-1: First Results From the ANRS-MIE CARLAPOP Study
全国HIV-1感染者队列中长效卡博特韦和利匹韦林的治疗药物监测：ANRS-MIE CARLAPOP研究的首批结果
Nadège Néant and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 109–118, https://doi.org/10.1093/cid/ciaf385
20
Is Therapeutic Drug Monitoring of Long-Acting Cabotegravir and Rilpivirine of Clinical Utility?
长效卡博特韦和利匹韦林的治疗药物监测是否具有临床实用性？
Catia Marzolini
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 119–121, https://doi.org/10.1093/cid/ciaf386
21
Efficacy and Safety of Dual Therapy With Dolutegravir/Lamivudine in Treatment-naive Persons With CD4 Counts <200/mm3: 48-Week Results of the DOLCE Study
多替拉韦/拉米夫定双药治疗在CD4计数<200/mm³的初治患者中的疗效和安全性：DOLCE研究48周结果
Maria Ines Figueroa and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 122–131, https://doi.org/10.1093/cid/ciaf415
22
DOLCE: Sweet Success for Dolutegravir/Lamivudine?
DOLCE研究：多替拉韦/拉米夫定双药治疗是否取得完美成功？
Laura J Waters
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 132–133, https://doi.org/10.1093/cid/ciaf416
Infection Control and Hospital Epidemiology（感染控制与医院流行病学）
23
Real-Time Genomic Surveillance for Enhanced Healthcare Outbreak Detection and Control: Clinical and Economic Impact
实时基因组监测用于加强医疗保健机构疫情检测与控制：临床与经济影响
Alexander J Sundermann and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 134–141, https://doi.org/10.1093/cid/ciaf216
24
Patient Perspectives Regarding Different Contact Precaution Policies for Methicillin-resistant Staphylococcus aureus Across Two Hospitals: Patients Are in Favor of Contact Precautions
两家医院患者对耐甲氧西林金黄色葡萄球菌不同接触预防政策的态度：患者支持接触预防措施
Nicholas F Angelino and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 142–144, https://doi.org/10.1093/cid/ciaf330
Photo Quiz（影像问答）
25
The Clue That Wriggled into View
蜿蜒入目的线索
Nitin Gupta and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 145–147, https://doi.org/10.1093/cid/ciaf427
Infection Control and Hospital Epidemiology（感染控制与医院流行病学）
26
Comparing Generative Artificial Intelligence vs Experts for Detection of Catheter-Associated Urinary Tract Infection
比较生成式人工智能与专家在导管相关尿路感染检测中的应用
Shatha Alshanqeeti and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 148–150, https://doi.org/10.1093/cid/ciaf486
Sexually Transmitted Infections（性传播感染）
27
Viability of Chlamydia trachomatis in Different Anatomical Sites—a Systematic Review and Meta-analysis
不同解剖部位沙眼衣原体的存活能力——系统综述和荟萃分析
Arthur Wong and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 151–158, https://doi.org/10.1093/cid/ciae401
Photo Quiz（影像问答）
28
A 46-Year-Old With Persistent Altered Mental Status and Respiratory Failure
一例46岁患者持续出现意识状态改变伴呼吸衰竭
Ann F Yang and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 159–161, https://doi.org/10.1093/cid/ciaf439
Sexually Transmitted Infections（性传播感染）
29
Mpox in People With HIV: Predictors of Diagnosis, Outcomes, and Vaccine Effectiveness in a Multisite Cohort
HIV感染者中的猴痘：多站点队列中诊断、预后和疫苗有效性的预测因素
Michalina Montaño and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 162–172, https://doi.org/10.1093/cid/ciae464
30
Development and Evaluation of a Novel Algorithm to Identify Doxycycline Postexposure Prophylaxis Users at a Large Healthcare System in the Bronx, New York
开发和评估一种新型算法，用于识别纽约布朗克斯区一家大型医疗系统中多西环素暴露后预防用药者
Caroline E Mullis and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 173–176, https://doi.org/10.1093/cid/ciaf109
31
Evidence-Informed Provision of Doxycycline Postexposure Prophylaxis for Prevention of Bacterial Sexually Transmitted Infections
为预防细菌性性传播感染提供基于证据的多西环素暴露后预防用药
Julia C Dombrowski and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages 177–184, https://doi.org/10.1093/cid/ciae527
Bacterial Infections（细菌性感染）
32
Long-term Mortality Trends Among Individuals With Tuberculosis: A Retrospective Cohort Study of Individuals Diagnosed With Tuberculosis in Brazil
巴西结核病患者的长期死亡率趋势：一项针对巴西结核病诊断患者的回顾性队列研究
Sun Kim and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e1–e8, https://doi.org/10.1093/cid/ciaf206
33
Clinical and Microbiological Characteristics of Meningococcal Eye Infections: Retrospective National Surveillance in England, 2010–2022
脑膜炎球菌眼部感染的临床和微生物学特征：2010 - 2022年英格兰全国回顾性监测
Stephen A Clark and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e9–e16, https://doi.org/10.1093/cid/ciaf274
34
Does Piperacillin-Tazobactam Increase Mortality Risk Compared With Cefepime? Collider Bias and the Importance of Assumptions in Instrumental Variable Analyses
与头孢吡肟相比，哌拉西林-他唑巴坦是否会增加死亡率风险？工具变量分析中的混杂偏倚和假设的重要性
Fergus Hamilton and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e17–e23, https://doi.org/10.1093/cid/ciaf317
COVID-19 / SARS COV-2（新冠肺炎/严重急性呼吸综合征冠状病毒2型）
35
Efficacy and Safety of Obeldesivir in High-Risk Nonhospitalized Patients With COVID-19 (BIRCH): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
奥贝德西韦在高危非住院COVID-19患者（BIRCH研究）中的疗效和安全性：一项3期、随机、双盲、安慰剂对照研究
Anca Streinu-Cercel and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e24–e32, https://doi.org/10.1093/cid/ciaf406
36
Retreatment With Nirmatrelvir/Ritonavir Following Return of COVID-19 Symptoms and SARS-CoV-2 Positivity
COVID-19症状复发且SARS-CoV-2检测呈阳性后使用奈玛特韦/利托那韦重新治疗
Wuyan Zhang and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e33–e40, https://doi.org/10.1093/cid/ciaf548
Emerging Infections(新兴感染)
37
“I Didn’t Know Him Before the Pandemic… Now He's on My Speed Dial”: Strengthening Collaboration Between Infectious Diseases Physicians and State and Local Public Health for Future Public Health Emergencies
“疫情前我并不认识他……现在他已是我的快速拨号对象”：加强传染病医生与州和地方公共卫生部门在未来突发公共卫生事件中的合作
Diana Valencia and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e41–e46, https://doi.org/10.1093/cid/ciaf179
38
Identification of and Response to Influenza A(H5) in Off-the-Shelf Raw Milk—Santa Clara County, California, November–December 2024
2024年11 - 12月加利福尼亚州圣克拉拉县在现成生牛奶中检出甲型流感（H5）病毒及应对措施
Alessandra Løchen and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e47–e48, https://doi.org/10.1093/cid/ciaf420
39
The Indispensable Value of Small-Molecule Antivirals in Epidemic and Pandemic Preparedness
小分子抗病毒药物在流行病和大流行病防范中的不可或缺价值
Ruxandra Draghia-Akli and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e49–e55, https://doi.org/10.1093/cid/ciaf476
HIV/AIDs（人类免疫缺陷病毒/艾滋病）
40
Increasing HIV Testing During Gonorrhea and Chlamydia Evaluations in Urgent Care and Emergency Departments: A Large Health System Initiative
在紧急护理和急诊科进行淋病和衣原体检测时增加HIV检测：一项大型医疗系统倡议
Allan M Seibert and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e56–e67, https://doi.org/10.1093/cid/ciaf434
41
Clinical Predictors and Incidence of Kaposi Sarcoma Among Males With HIV in the Treat-All Era in the United States and Canada
美国和加拿大“全员治疗”时代男性HIV感染者卡波西肉瘤的临床预测因素和发病率
Sally B Coburn and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e68–e77, https://doi.org/10.1093/cid/ciaf446
42
Integrase Strand Transfer Inhibitors for Treatment-experienced Young Adults With Perinatal HIV in the US: Immunologic, Virologic, and Anthropometric Outcomes
美国接受过治疗的围产期感染HIV的年轻成人使用整合酶链转移抑制剂的免疫学、病毒学和人体测量学结果
Kunjal Patel and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e78–e88, https://doi.org/10.1093/cid/ciaf538
43
Win Ratio Aligns With and Enhances Interpretation of REPRIEVE's Primary Findings
Win比值与REPRIEVE研究的主要发现一致并增强了其解释性
Emma Davies Smith and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e89–e92, https://doi.org/10.1093/cid/ciaf477
44
The Critical Importance of Clinical Use Case to Inform Point-of-Care Technology Development: A Case Study of HIV Nucleic Acid Assays in the United States
临床应用案例对于指导即时检测技术开发的重要性：以美国HIV核酸检测为例
Yukari C Manabe and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e93–e99, https://doi.org/10.1093/cid/ciaf510
Mycobacterial Infections（分枝杆菌感染）
45
Body Mass Index and Incident Tuberculosis in Close Tuberculosis Contacts
结核密切接触者中体重指数与新发结核病的关系
María B Arriaga and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e100–e109, https://doi.org/10.1093/cid/ciaf475
46
The Role of Youths in Within-Household Tuberculosis Transmission: A Household Contact Cohort Study
青年在家庭内结核病传播中的作用：一项家庭接触队列研究
Meredith B Brooks and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e110–e118, https://doi.org/10.1093/cid/ciaf490
47
Cost-effectiveness of Targeted Next-Generation Sequencing for Tuberculosis Drug-resistance Testing as an Alternative to the Standard of Care in South Africa
南非以靶向下一代测序作为结核病耐药检测标准护理方案的替代方案的成本效益分析
Alexandra de Nooy and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e119–e125, https://doi.org/10.1093/cid/ciaf495
48
Xpert MTB/RIF Cycle Threshold as a Marker of Tuberculosis (TB) Disease Severity: Implications for TB Treatment Stratification
Xpert MTB/RIF循环阈值作为结核病（TB）疾病严重程度的标志物：对结核病治疗分层的启示
Daniel J Grint and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e126–e134, https://doi.org/10.1093/cid/ciaf527
49
The Role of β-Lactam Antibiotics in Treating Mycobacterium abscessus: From Laboratory Insights to Clinical Applications and the Case for Clinical Trials
β-内酰胺类抗生素在治疗脓肿分枝杆菌中的作用：从实验室见解到临床应用及开展临床试验的必要性
Khalid M Dousa and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e135–e145, https://doi.org/10.1093/cid/ciaf547
Pediatric and Maternal Infectious Diseases（儿科与孕产妇传染病）
50
Efficacy, Immunogenicity, and Safety of an Investigational Maternal Respiratory Syncytial Virus Prefusion F Protein–Based Vaccine
一种研究性孕产妇呼吸道合胞病毒融合前F蛋白疫苗的疗效、免疫原性和安全性
Peyman Banooni and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e146–e155, https://doi.org/10.1093/cid/ciaf033
51
Hepatotoxicity Among People With HIV and Receiving Isoniazid Preventive Therapy in Pregnancy and Postpartum: The Role of Antiretroviral Regimen and Pharmacogenetics
HIV感染者在孕期和产后接受异烟肼预防性治疗时的肝毒性：抗逆转录病毒治疗方案和药物基因组学的作用
Grace Montepiedra and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e156–e164, https://doi.org/10.1093/cid/ciaf198
52
Transplacental Transfer of Lumefantrine, Mefloquine, and Piperaquine: A Comparison of Concentrations in Mothers, Neonates, and Cord Blood
青蒿素、甲氟喹和哌喹的胎盘转运：母亲、新生儿和脐带血中浓度的比较
Makoto Saito and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e165–e173, https://doi.org/10.1093/cid/ciaf552
53
Why Did the Antimalarial Drug Cross the Placenta?
抗疟药为何要穿过胎盘？
Stephen J Rogerson and Holger W Unger
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e174–e175, https://doi.org/10.1093/cid/ciaf553
Viral Infections（病毒性传染病）
54
Kinetics and Predictors of Hepatitis B Surface Antigen Loss After Commencing Hepatitis B Virus (HBV)–Active Antiretroviral Therapy in the Setting of HIV and Chronic HBV Coinfection
HIV和慢性乙型肝炎病毒（HBV）共感染患者开始使用HBV活性抗逆转录病毒治疗后乙型肝炎表面抗原消失的动力学和预测因素
Jennifer Audsley and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e176–e184, https://doi.org/10.1093/cid/ciaf281
55
Secondary Pneumococcal Disease in Veterans With Viral Respiratory Infections
患有病毒性呼吸道感染退伍军人的继发性肺炎球菌病
Lauren A Powers and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e185–e190, https://doi.org/10.1093/cid/ciaf285
Correspondence（读者来信）
56
Unveiling Latent Risk Patterns in Antimicrobial-Resistant Bacteremia: A Deeper Look at Pathogen-Specific Mortality
揭示抗菌药物耐药性菌血症中的潜在风险模式：深入探究病原体特异性死亡率
Yuan-Ti Lee and Shiuan-Chih Chen
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Page e191, https://doi.org/10.1093/cid/ciaf493
57
Resistance to Antibiotics With High Empiric Treatment Relevance Explains Attributable Mortality Across 110 Pathogen-antibiotic Combinations
对经验性治疗具有高度相关性的抗生素耐药性可解释110种病原体 - 抗生素组合的归因死亡率
Kevin A Brown and Nick Daneman
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e191–e192, https://doi.org/10.1093/cid/ciaf494
58
Culture Clash: Dual-Pathogen Endocarditis and the Metagenomic Next-Generation Sequencing Studies We Need
文化冲突：双病原体心内膜炎以及我们所需的宏基因组下一代测序研究
Carl Boodman and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e193–e195, https://doi.org/10.1093/cid/ciaf518
59
Metagenomic Next-Generation Sequencing and Cardiovascular Infections: Promise and Pitfalls of Polymicrobial Detection
宏基因组下一代测序与心血管感染：多微生物检测的前景与陷阱
Sarwat Khalil and M Rizwan Sohail
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Page e196, https://doi.org/10.1093/cid/ciaf519
60
It Is Time to Go Beyond the Association Between Colistin and Meropenem for Invasive Carbapenem-Resistant Acinetobacter baumannii Infections
是时候超越多粘菌素和美罗培南联合治疗侵袭性碳青霉烯耐药鲍曼不动杆菌感染了
Alberto Enrico Maraolo and Giancarlo Ceccarelli
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e197–e198, https://doi.org/10.1093/cid/ciaf533
61
Actually, It May be Time to Return to Colistin and Meropenem in Some Patients Infected With Carbapenem-resistant Acinetobacter baumannii (CRAB)
实际上，对于某些感染碳青霉烯耐药鲍曼不动杆菌（CRAB）的患者，或许是时候重新使用多粘菌素和美罗培南了
Jason M Pogue and Keith S Kaye
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e198–e199, https://doi.org/10.1093/cid/ciaf534
62
COVID-19 and Bacterial Pneumonia: Protective Effect or Diagnostic Bias?
COVID-19和细菌性肺炎：保护作用还是诊断偏差？
Duygu Aydın and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Page e200, https://doi.org/10.1093/cid/ciaf539
63
Secondary Pneumococcal Disease in Veterans With Viral Respiratory Infections: A Follow Up
患有病毒性呼吸道感染退伍军人的继发性肺炎球菌病：后续研究
John C Hu and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e200–e201, https://doi.org/10.1093/cid/ciaf540
64
Long-Acting Cabotegravir/Rilpivirine in Viremic People With HIV: Bumpy Road to Perfection
长效卡博特韦/利匹韦林用于病毒载量阳性的HIV感染者：通往完美的坎坷之路
Beatrice Barda and Marco Bongiovanni
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e201–e202, https://doi.org/10.1093/cid/ciaf482
65
Beyond the Sequence: Operationalizing Whole-Genome Sequencing for Real-time Infection Control in Low- and Middle-Income-Country Healthcare Settings Healthcare Settings
超越序列：在中低收入国家医疗环境中实际应用全基因组测序进行实时感染控制
Schawanya Kaewpitoon Rattanapitoon and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e202–e203, https://doi.org/10.1093/cid/ciaf535
66
Reassessing Adherence Trajectories in Multidrug-Resistant Tuberculosis: Recovery Advantage and Hidden Biases
重新评估耐多药结核病的依从性轨迹：康复优势和隐藏偏差
Shiuan-Chih Chen and Chun-Chieh Chen
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e203–e204, https://doi.org/10.1093/cid/ciaf536
67
Metagenomic Sequencing of Blood Culture Broth for Diagnosing Fastidious Endocarditis
血培养肉汤宏基因组测序用于诊断苛养性心内膜炎
Po-Hsiu Huang and others
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Pages e204–e205, https://doi.org/10.1093/cid/ciaf554
Corrections（更正）
68
Correction to: Secondary Pneumococcal Disease in Veterans With Viral Respiratory Infections
《患有病毒性呼吸道感染退伍军人的继发性肺炎球菌病》更正
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Page e206, https://doi.org/10.1093/cid/ciaf572
69
Correction to: Treatment Outcomes With an Oral Short Course Regimen for Rifampicin-resistant Tuberculosis in a High HIV Prevalence, Programmatic Setting in South Africa
《南非高HIV流行率、项目化环境中口服短程利福平耐药结核病治疗方案的治疗结果》更正
Clinical Infectious Diseases, Volume 82, Issue 1, 15 January 2026, Page e207, https://doi.org/10.1093/cid/ciaf711
Clinical Infectious Diseases Volume 82 Issue Supplement_1
临床传染病学 82卷 增刊1期
https://academic.oup.com/cid/issue/82/Supplement_1
SUPPLEMENT（增刊）
Laboratory and Point-of-care Testing to Detect Chlamydia trachomatis and Neisseria gonorrhoeae: Review of the Available Evidence
实验室及即时检测技术用于检测沙眼衣原体和淋病奈瑟菌：现有证据综述
SUPPLEMENT ARTICLES（增刊论著）
1
Evidence Review for Centers for Disease Control and Prevention Guidance Development on the Detection of Chlamydia trachomatis and Neisseria gonorrhoeae
美国疾病控制与预防中心沙眼衣原体和淋病奈瑟菌检测指南制定证据综述
Amanda C Smith and Ellen N Kersh
Clinical Infectious Diseases, Volume 82, Issue Supplement_1, 15 February 2026, Pages S1–S5, https://doi.org/10.1093/cid/ciaf665
2
Narrative Review of Chlamydia trachomatis Culture, Viability Testing, and Sequencing Methods
沙眼衣原体培养、活性检测及测序方法的叙述性综述
Alana K Sterkel and others
Clinical Infectious Diseases, Volume 82, Issue Supplement_1, 15 February 2026, Pages S6–S12, https://doi.org/10.1093/cid/ciaf697
3
Culture and Identification of Neisseria gonorrhoeae: A Narrative Review of Current Laboratory Methods
淋病奈瑟菌培养与鉴定：当前实验室方法叙述性综述
Olusegun O Soge and others
Clinical Infectious Diseases, Volume 82, Issue Supplement_1, 15 February 2026, Pages S13–S18, https://doi.org/10.1093/cid/ciaf698
4
Review of the Performance of Laboratory-Based Molecular Diagnostics for Chlamydia trachomatis and Neisseria gonorrhoeae
实验室分子诊断技术检测沙眼衣原体和淋病奈瑟菌的性能综述
Megan Crumpler and others
Clinical Infectious Diseases, Volume 82, Issue Supplement_1, 15 February 2026, Pages S19–S35, https://doi.org/10.1093/cid/ciaf696
5
Review of Methods for Detecting Antimicrobial Resistance of Neisseria gonorrhoeae
淋病奈瑟菌抗菌药物耐药性检测方法综述
Kara K Mitchell and others
Clinical Infectious Diseases, Volume 82, Issue Supplement_1, 15 February 2026, Pages S36–S42, https://doi.org/10.1093/cid/ciaf706
6
Point-of-care Tests for Chlamydia trachomatis and Neisseria gonorrhoeae: Review of the Literature
沙眼衣原体和淋病奈瑟菌即时检测技术文献综述
Yukari C Manabe and others
Clinical Infectious Diseases, Volume 82, Issue Supplement_1, 15 February 2026, Pages S43–S51, https://doi.org/10.1093/cid/ciaf699
Clinical Infectious Diseases Volume 82 Issue 2
临床传染病学 82卷 2期
https://academic.oup.com/cid/issue/
ID Art Through the Ages（穿越时代的传染病技艺）
1
Interior of the Old Jersey Prison Ship in the Revolutionary War
美国革命战争中老泽西监狱船的内部景象
Mary Grizzard and Michael Grizzard
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Page i, https://doi.org/10.1093/cid/ciaf693
In the Literature（本期精选）
2
In the Literature
本期精选
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages ii–v, https://doi.org/10.1093/cid/ciag011
IDSA 2025 Collections Editorial（美国传染病学会2025年专题合集社论）
3
2025 Content Collections from the IDSA Journals
IDSA期刊2025年内容合集
Roger Bedimo and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 185–186, https://doi.org/10.1093/cid/ciag041
State-of-the-Art Review（前沿综述）
4
State-of-the-Art Review: Chagas Disease—an Enduring Challenge
前沿综述：恰加斯病——一个持续存在的挑战
Nelson Iván Agudelo Higuita and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 187–205, https://doi.org/10.1093/cid/ciaf654
IDSA Features（美国传染病学会特色内容）
5
Policy Recommendations to Support Equitable Access to Long-Acting Injectables for HIV Prevention and Treatment: A Policy Paper of the Infectious Diseases Society of America and the HIV Medicine Association
支持公平获取用于艾滋病毒预防和治疗的长效注射剂的政策建议：美国传染病学会与艾滋病毒医学协会的政策文件
Julia L Marcus and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 206–211, https://doi.org/10.1093/cid/ciae648
Voices of ID（传染病之声）
6
A “Terminal Infection”
“绝症感染”
Jennifer Furin
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 212–214, https://doi.org/10.1093/cid/ciaf332
Invited Commentary（特邀评论）
7
A Rapid Test to Differentiate Viral From Bacterial Infections: Searching for the Holy Grail
区分病毒与细菌感染的快速检测：寻找“圣杯”
Lao-Tzu Allan-Blitz and Jeffrey D Klausner
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 215–218, https://doi.org/10.1093/cid/ciaf585
Bacterial Infections（细菌感染）
8
Nonoperative Versus Neurosurgical Treatment of Brain Abscess: An Emulated Trial Nested Within a Nationwide, Population-Based Cohort
脑脓肿的非手术治疗与神经外科治疗：一项基于全国人群队列的模拟试验
Emilie Marie Eriksen and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 219–227, https://doi.org/10.1093/cid/ciaf304
9
What Is the Impact of Anti-Enterococcal Empirical Therapy on Survival of Patients With Enterococcal Bloodstream Infections?
抗肠球菌经验性治疗对肠球菌血流感染患者生存率的影响是什么？
Linda Bussini and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 228–237, https://doi.org/10.1093/cid/ciaf323
10
Adjunctive Fosfomycin for the Treatment of Staphylococcus aureus Bacteremia: A Pooled Post Hoc Analysis of Individual Participant Data From 2 Randomized Trials
辅助使用磷霉素治疗金黄色葡萄球菌菌血症：两项随机试验个体参与者数据的汇总事后分析
Francesc Escrihuela-Vidal and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 238–245, https://doi.org/10.1093/cid/ciaf387
HIV/AIDs（人类免疫缺陷病毒/艾滋病）
11
Kinetics of Non-nucleoside Reverse Transcriptase Inhibitor Resistance-associated Mutations in HIV-1 Proviral Cellular Reservoirs in Non-nucleoside Reverse Transcriptase Inhibitor-experienced Persons
在接受过非核苷类逆转录酶抑制剂治疗的HIV-1感染者中，非核苷类逆转录酶抑制剂耐药相关突变在HIV-1前病毒细胞储存库中的动力学
Thomas Drumel and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 246–251, https://doi.org/10.1093/cid/ciaf430
12
Impact of Different Integrase Strand Transfer Inhibitors on Body Mass Index Among People With HIV Who Newly Started Antiretroviral Therapy in Shenzhen, China: A Real-World Data Analysis
中国深圳新开始抗逆转录病毒治疗的HIV感染者使用不同整合酶链转移抑制剂对体重指数的影响：一项现实数据分析
Lukun Zhang and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 252–261, https://doi.org/10.1093/cid/ciaf466
13
Consequences of Stopping Antiretroviral Treatment in a Persistently Seronegative Individual with HIV-1
HIV-1持续血清阴性个体停止抗逆转录病毒治疗的后果
Marc Wirden and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 262–264, https://doi.org/10.1093/cid/ciaf422
14
Approaches to the Management of Virologic Failure on Dolutegravir-Based Antiretroviral Therapy in the 50 Countries With the Highest Adult HIV Prevalence
在成人HIV患病率最高的50个国家中，多替拉韦为基础的抗逆转录病毒治疗出现病毒学失败的治疗方法
Cameron T Nutt and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 265–273, https://doi.org/10.1093/cid/ciaf444
Mycobacterial Infections（结核分枝杆菌感染）
15
Retrospective Cohort Analysis for Identification of Discordant Rifampicin-resistant Xpert MTB/RIF Assay Results in South Kivu, Eastern Democratic Republic of the Congo, a High Burden Tuberculosis Setting
刚果民主共和国东部南基伍这一结核病高负荷地区，识别利福平耐药不一致的Xpert MTB/RIF检测结果的回顾性队列分析
Bertin C Bisimwa and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 274–281, https://doi.org/10.1093/cid/ciaf451
16
Prevention of Tuberculosis in Patients Treated With Biological Therapies: 20 Years' Experience in a Specialized Tuberculosis Clinic in a Low-prevalence Country
生物疗法治疗患者中结核病的预防：某低流行国家一个专科结核病诊所20年的经验
Sandra Pérez-Recio and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 282–290, https://doi.org/10.1093/cid/ciaf491
17
Reducing Household Tuberculosis Transmission: A Pilot Cluster-Randomized Controlled Trial
减少家庭内结核病传播：一项试点整群随机对照试验
Cinthya Ruiz-Tagle and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 291–298, https://doi.org/10.1093/cid/ciaf526
18
(Un)masking Tuberculosis
（揭开）结核病的“面具”
Joseph N Burzynski and Neil W Schluger
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 299–300, https://doi.org/10.1093/cid/ciaf528
19
Estimating the Accuracy and Additionality of TB-LAM to Diagnose TB in Children Without HIV (AccuLAM)
评估TB-LAM在无HIV儿童中诊断结核病的准确性和额外价值（AccuLAM）
Lucía CarratalàCastro and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 301–303, https://doi.org/10.1093/cid/ciaf525
Sexually Transmitted Infections（性传播感染）
20
Potential Impact of Doxycycline Post-exposure Prophylaxis Prescribing Strategies on Incidence of Bacterial Sexually Transmitted Infections
多西环素暴露后预防用药策略对细菌性性传播感染发病率的影响
Michael W Traeger and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 304–311, https://doi.org/10.1093/cid/ciad488
21
Filling in the Gaps: Updates on Doxycycline Prophylaxis for Bacterial Sexually Transmitted Infections
填补空白：多西环素预防细菌性性传播感染的最新进展
Aniruddha Hazra and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 312–320, https://doi.org/10.1093/cid/ciae062
22
Reported Neurologic Manifestations Among Persons With Syphilis by Stage of Infection—12 States, 2019–2022
2019-2022年12个州按感染阶段划分的梅毒患者报告的神经系统表现
Sarah B Wondmeneh and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 321–325, https://doi.org/10.1093/cid/ciaf015
Viral Infections（病毒性感染）
23
Investigating the Role of Cytomegalovirus as a Cause of Stillbirths and Child Deaths in Low- and Middle-Income Countries Through Postmortem Minimally Invasive Tissue Sampling
通过死后微创组织采样，调查巨细胞病毒在低收入和中等收入国家死胎和儿童死亡原因中的作用
Sithembiso Velaphi and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 326–336, https://doi.org/10.1093/cid/ciaf098
Photo Quiz（影像问答）
24
Bursting at the Seams
“撑破”
Maxwell Olenski and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 337–340, https://doi.org/10.1093/cid/ciaf488
Viral Infections（病毒性感染）
25
Clinical and Epidemiological Investigation of Vaccine-Derived Poliovirus Type 2 Outbreak in Pakistan During 2019–2021
2019-2021年巴基斯坦2型疫苗衍生脊髓灰质炎病毒疫情的临床和流行病学调查
Nayab Mehmood and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 341–351, https://doi.org/10.1093/cid/ciaf151
26
Inactivated Polio Vaccine Must Be an Essential Part of Polio Eradication
灭活脊髓灰质炎疫苗必须是根除脊髓灰质炎的重要组成部分
Konstantin Chumakov and Stanley A Plotkin
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 352–353, https://doi.org/10.1093/cid/ciaf215
Photo Quiz（影像问答）
27
Intracranial Lesion in a Patient With Chronic Myeloid Leukemia
慢性髓性白血病患者颅内病变
Mohammed Shakeel Sillat and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 354–357, https://doi.org/10.1093/cid/ciaf441
Viral Infections（病毒性感染）
28
Respiratory Syncytial Virus Co-Detection With Other Respiratory Viruses Is Not Significantly Associated With Worse Clinical Outcomes Among Children Aged <2 Years: New Vaccine Surveillance Network, 2016–2020
在<2岁的婴幼儿中，呼吸道合胞病毒与其他呼吸道病毒共同检测与临床预后恶化无显著关联：2016-2020年新疫苗监测网络数据
Justin Z Amarin and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 358–365, https://doi.org/10.1093/cid/ciaf194
29
Transfer of Herpes Simplex Virus Type 1 (HSV-1) Specific T Cells in a Pediatric Patient Post-HSCT With Severe, Acyclovir-resistant HSV-1 Infection
一例异基因造血干细胞移植后严重、阿昔洛韦耐药的单纯疱疹病毒1型（HSV-1）感染患儿的HSV-1特异性T细胞的输注
Astrid Wintering and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages 366–369, https://doi.org/10.1093/cid/ciaf125
Clinical Trials（临床实验）
30
Interferon-α Nasal Spray Prophylaxis Reduces COVID-19 in Cancer Patients: A Randomized, Double-Blinded, Placebo-Controlled Trial
干扰素-α鼻喷雾剂预防可降低癌症患者新冠病毒感染率：一项随机、双盲、安慰剂对照试验
Michelle K Yong and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e208–e216, https://doi.org/10.1093/cid/ciaf409
31
A Phase 3, Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Conjugate Vaccine, in Pneumococcal Vaccine-Naïve Adults 18–64 Years of Age at Increased Risk of Pneumococcal Disease, STRIDE-8
一项3期随机试验，调查V116（一种成人特异性肺炎球菌结合疫苗）在未接种过肺炎球菌疫苗且患肺炎球菌疾病风险增加的18-64岁年龄段成人中的安全性、耐受性和免疫原性，STRIDE-8试验
Paul T Scott and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e217–e226, https://doi.org/10.1093/cid/ciaf604
32
Effect of Direct-from-blood Bacterial Testing on Antibiotics Administration in Adults Presenting With Acute Infection: A Randomized Trial
直接从血液进行细菌检测对急性感染成年患者抗生素给药的影响：一项随机试验
David C Gaston and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e227–e235, https://doi.org/10.1093/cid/ciaf677
33
The Tantalizing Pursuit for a Perfect Diagnostic Test: Balancing Innovation With Stewardship
对完美诊断检测的诱人追求：平衡创新与管理
K C Coffey and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e236–e238, https://doi.org/10.1093/cid/ciaf674
Global Health and Neglected Tropical Diseases（全球健康与被忽视的热带病）
34
Diagnostic Accuracy of Tuberculosis Screening Tests in a Prospective Multinational Cohort: Chest Radiography With Computer-Aided Detection, Xpert Tuberculosis Host Response, and C-Reactive Protein
在一项前瞻性多国队列研究中，结核病筛查试验的诊断准确性：计算机辅助检测的胸部X光片、Xpert结核宿主反应检测和C反应蛋白
Rebecca Crowder and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e239–e247, https://doi.org/10.1093/cid/ciae549
HIV/AIDs（人类免疫缺陷病毒/艾滋病）
35
Risk Assessment in a Global CVD Prevention Cohort of People With HIV by PCE, PREVENT, and SCORE2
通过PCE、PREVENT和SCORE2对全球心血管疾病预防队列中艾滋病毒感染者进行风险评估
Steven K Grinspoon and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e248–e257, https://doi.org/10.1093/cid/ciaf542
36
REPRIEVE Analysis of New Cardiovascular Risk Calculators in HIV: Underpredicting Risk Means Preventing Fewer Heart Attacks
HIV新心血管风险计算器的REPRIEVE分析：低估风险意味着预防的心脏病发作更少
Matthew S Durstenfeld
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e258–e261, https://doi.org/10.1093/cid/ciaf543
37
Comparable Inflammatory and Metabolic Outcomes After Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Continuing Dolutegravir/Lamivudine in Virologically Suppressed Adults With HIV (INSTINCT/GESIDA10918 Study)
在病毒学抑制的HIV感染成人中，转换为比克替拉韦/恩曲他滨/丙酚替诺福韦与继续使用多替拉韦/拉米夫定后的炎症和代谢结局相当（INSTINCT/GESIDA10918研究）
Sergio Serrano-Villar and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e262–e274, https://doi.org/10.1093/cid/ciaf565
38
Tenofovir Alafenamide and Body Weight: Have We Finally Tipped the Scale?
丙酚替诺福韦与体重：我们最终是否打破了平衡？
John R Koethe
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e275–e277, https://doi.org/10.1093/cid/ciaf566
39
Long-Term Clinical, Immunologic, and Viral Reservoir Outcomes in Children Treated With VRC01LS and 10-1074 Monoclonal Antibodies in the Tatelo Study
在Tatelo研究中，接受VRC01LS和10-1074单克隆抗体治疗的儿童的长期临床、免疫学和病毒储存库结局
Gbolahan Ajibola and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e278–e285, https://doi.org/10.1093/cid/ciaf568
40
Trends in Persons Prescribed HIV Postexposure Prophylaxis in the United States, 2015–2023
2015-2023年美国开具HIV暴露后预防处方的患者趋势
John N Le and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e286–e295, https://doi.org/10.1093/cid/ciaf581
Immunocompromised Hosts（免疫功能低下宿主）
41
Epidemiology, Risk Factors, and Outcomes of Neutropenic Enterocolitis in Onco-Hematological Patients According to Chemotherapy Regimen
根据化疗方案分析肿瘤血液学患者中性粒细胞减少性肠结肠炎的流行病学、危险因素和预后
Anne-Sophie Brunel and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e296–e307, https://doi.org/10.1093/cid/ciaf134
42
An Analysis of Cytomegalovirus-Specific Cell-Mediated Immunity in a Phase 3, Randomized, Placebo-Controlled Trial of Letermovir Prophylaxis in Cytomegalovirus-Seropositive Recipients of an Allogeneic Hematopoietic Cell Transplant
在一项3期随机、安慰剂对照试验中，分析来特莫韦预防对巨细胞病毒血清阳性异基因造血细胞移植受者巨细胞病毒特异性细胞介导免疫的影响
Genovefa A Papanicolaou and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e308–e315, https://doi.org/10.1093/cid/ciaf646
43
Cytomegalovirus (CMV)-Specific Cell-Mediated Immunity for Prediction of Postprophylaxis CMV Disease in a Phase 3 Trial of Letermovir Versus Valganciclovir Prophylaxis in Donor CMV-Seropositive/Recipient CMV-Seronegative Kidney Transplant Recipients
在供体巨细胞病毒血清阳性/受体巨细胞病毒血清阴性的肾移植受者中，来特莫韦与缬更昔洛韦预防的3期试验中，巨细胞病毒（CMV）特异性细胞介导免疫对预防后CMV疾病的预测作用
Ajit P Limaye and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e316–e324, https://doi.org/10.1093/cid/ciaf632
44
The Role of Cytomegalovirus-Specific Cellular Immunity in Transplant Recipients with Letermovir Prophylaxis: To be Determined
来特莫韦预防移植受者中巨细胞病毒特异性细胞免疫的作用：有待确定
Yoichiro Natori and Martina Sester
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e325–e327, https://doi.org/10.1093/cid/ciaf633
45
IL12RB1 Deficiency Appearing in North America: Expanding the Clinical Phenotypes
北美出现的IL12RB1缺陷：拓展临床表型
Chen Wang and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e328–e331, https://doi.org/10.1093/cid/ciaf637
Vaccines（疫苗）
46
A Phase IV, Open-label, Single-Arm, Multicentric Clinical Trial for Evaluation of Human Papillomavirus 9vHPV Vaccine Immunogenicity in Men Who Have Sex With Men With HIV: GeSIDA Study 10 017
一项评估人乳头瘤病毒9vHPV疫苗在感染HIV的男男性行为者中免疫原性的IV期、开放标签、单臂、多中心临床试验：GeSIDA 10 017研究
Raquel Ron and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e332–e342, https://doi.org/10.1093/cid/ciaf435
47
Immunogenicity and Safety of the COVID-19 Messenger RNA Vaccine Coadministered With Influenza and 23-valent Pneumococcal Polysaccharide Vaccines
与流感疫苗和23价肺炎球菌多糖疫苗同时接种的COVID-19信使核糖核酸疫苗的免疫原性和安全性
Omid Rezahosseini and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e343–e351, https://doi.org/10.1093/cid/ciaf455
48
Intestinal Mucosal Immune Responses to Novel Oral Poliovirus Vaccine Type 2 in Healthy Newborns
健康新生儿对新型2型口服脊髓灰质炎疫苗的肠道黏膜免疫反应
Audrey Godin and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e352–e360, https://doi.org/10.1093/cid/ciaf484
49
Estimated Vaccine Effectiveness for Respiratory Syncytial Virus–Related Acute Respiratory Illness in Older Adults: Findings From the First Postlicensure Season
老年人呼吸道合胞病毒相关急性呼吸道疾病的估计疫苗有效性：首个上市后季节的研究结果
Sara Y Tartof and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e361–e370, https://doi.org/10.1093/cid/ciaf496
Sexually Transmitted Infections（性传播感染）
50
Systematic Review and Meta-analysis of the Association Between Mycoplasma genitalium and Pelvic Inflammatory Disease (PID)
生殖支原体与盆腔炎性疾病（PID）关联的系统综述和荟萃分析
Kay Htaik and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e371–e379, https://doi.org/10.1093/cid/ciae295
51
Sexually Transmitted Infection (STI)/HIV Testing, STIs, and HIV Pre-exposure Prophylaxis Use Among Men Who Have Sex With Men and Men Who Have Sex With Men and Women in the United States, 2019–2022
2019-2022年美国男男性行为者以及男男性行为者和女性性行为者中性传播感染（STI）/HIV检测、性传播感染和HIV暴露前预防用药情况
Guoyu Tao and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e380–e386, https://doi.org/10.1093/cid/ciae314
52
Cabotegravir Maintains Protective Efficacy in the Setting of Bacterial Sexually Transmitted Infections: A Secondary Analysis of HPTN 083
卡博特韦在细菌性性传播感染情况下维持保护效力：HPTN 083的二次分析
Meredith E Clement and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e387–e395, https://doi.org/10.1093/cid/ciae572
Viral Infections（病毒性感染）
53
Comprehensive Analysis of Cardiovascular Events and Risk Factors in Patients Hospitalized With Respiratory Syncytial Virus
对因呼吸道合胞病毒感染住院患者的心血管事件和危险因素的综合分析
Paulina Sudnik and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e396–e403, https://doi.org/10.1093/cid/ciaf310
54
In Critical Condition: The Urgent Need to Support Mpox Therapeutic and Diagnostic Pipelines
处于危急状况：迫切需要支持猴痘治疗和诊断管线
Carmen Perez Casas and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e404–e408, https://doi.org/10.1093/cid/ciaf529
Correspondence（读者来信）
55
Caution in Interpreting INSTIs and Weight in Observational Studies
在观察性研究中解读整合酶抑制剂与体重关系时需谨慎
Esteban Martínez
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Page e409, https://doi.org/10.1093/cid/ciaf569
56
Weight Trajectories With Integrase Inhibitors: Unaddressed Insights and Limitations in a Chinese Cohort
整合酶抑制剂与体重变化轨迹：中国队列中未解决的见解和局限性
Yuan-Ti Lee and Shiuan-Chih Chen
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e409–e410, https://doi.org/10.1093/cid/ciaf570
57
Real-World Evidence as a Complement to Randomized Trials in Interpreting Weight Gain on Modern INSTI Regimens
现实证据作为随机试验的补充，用于解读现代整合酶抑制剂方案导致的体重增加
Xinsheng Wu and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e410–e411, https://doi.org/10.1093/cid/ciaf571
58
C-reactive Protein in TB Meningitis: Signal, Surrogate, or Saboteur?
结核性脑膜炎中的C反应蛋白：信号、替代指标还是破坏因素？
Patrick K Moonan and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e411–e412, https://doi.org/10.1093/cid/ciaf575
59
C-Reactive Protein in Tuberculous Meningitis: A Viable Biomarker for Individualized Care
结核性脑膜炎中的C反应蛋白：个体化护理的可行生物标志物
Lillian Tugume and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e412–e413, https://doi.org/10.1093/cid/ciaf576
60
The Win Ratio Should Be Complemented by Other Win Statistics to Provide a Comprehensive Picture of Relative and Absolute Treatment Effects: The Case Study of the REPRIEVE Trial
胜利比率应与其他胜利统计数据相结合，以全面呈现相对和绝对治疗效果：REPRIEVE试验案例研究
Melissa J Hardy and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e413–e414, https://doi.org/10.1093/cid/ciaf587
61
Small Effects, Big Impact: Multiple Win Measures Aid Interpretation, But Do Not Forget the Bigger Picture
效应虽小，影响重大：多种胜利衡量指标有助于解读，但不要忘记整体情况
Emma Davies Smith and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e414–e416, https://doi.org/10.1093/cid/ciaf588
62
Does Oral Antibiotic Switching Therapy Show Similar Efficacy to Intravenous Administration for Treating Infective Endocarditis?
口服抗生素转换疗法治疗感染性心内膜炎的疗效是否与静脉给药相似？
Jun Suzuki and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e416–e417, https://doi.org/10.1093/cid/ciaf598
63
Toward a Wider Use of Oral Antibiotic Switch in Infective Endocarditis
朝着更广泛地使用感染性心内膜炎口服抗生素转换疗法迈进
Romane Pouy and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e417–e418, https://doi.org/10.1093/cid/ciaf599
64
Operationalizing Sepsis Definitions With Artificial Intelligence: Toward Smarter Antibiotic Use
利用人工智能实现败血症定义的落地应用：迈向更明智的抗生素使用
James S Ford and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e418–e419, https://doi.org/10.1093/cid/ciaf601
65
Balancing Innovation in Artificial Intelligence With Practical Sepsis Definitions
平衡人工智能创新与实用的败血症定义
Chanu Rhee and Michael Klompas
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e419–e420, https://doi.org/10.1093/cid/ciaf602
66
Precision Prevention of Tuberculosis in Biologic Therapy: Lessons Beyond Screening Strategies
生物疗法中结核病的精准预防：筛查策略之外的启示
Shiuan-Chih Chen and Yuan-Ti Lee
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e420–e421, https://doi.org/10.1093/cid/ciaf559
67
Recalibrating COVID-19 Booster Policy: Lessons From Hybrid Immunity and Global Equity Gaps
重新调整COVID-19加强针政策：从混合免疫和全球公平差距中吸取教训
Nathkapach K Rattanapitoon and others
Clinical Infectious Diseases, Volume 82, Issue 2, 15 February 2026, Pages e421–e422, https://doi.org/10.1093/cid/ciaf605
2026-02-22
DeepSeek-R1
以下是针对中裕生物（中裕新药）在生物制品、单抗领域的专利族群、科研成就及产业化数据的系统性分析，结合行业对比与最新动态（截至2026年1月）：一、核心科研成就与技术优势1. 单抗药物研发突破Ibalizumab（艾巴利珠单抗）全球地位
：首个由中国企业主导研发并获FDA批准的抗HIV单抗药物（2018年），亦是首个基于CD4靶点开发的单抗药物。技术亮点
：通过阻断HIV病毒进入宿主细胞的路径，为耐多药HIV患者提供新疗法。专利布局
：覆盖抗体结构、生产工艺及适应症（专利号：US 9,803,014 B2等），形成核心专利族。2. 技术平台创新转基因动物平台（OmniRat®）应用
合作案例：与药明生物共同开发全人源PD-1抗体GLS-010，利用转基因大鼠平台实现高效抗体筛选，降低免疫原性风险。二、专利族群与知识产权策略1. 专利布局特点
领域
专利数量
技术重点
国际化程度
单抗药物
15+项
HIV/CD4靶点、抗体结构优化
美、欧、日专利覆盖
生产工艺
8项
细胞培养、纯化工艺
中国为主
适应症拓展
5项
联合疗法、新适应症外推
全球申请2. 对比行业标杆百济神州（泽布替尼）
：
优势：BTK抑制剂全球专利覆盖，适应症外推至5国市场，2025年销售额突破10亿美元。
差距：中裕在适应症广度（仅HIV）和商业规模上落后。复宏汉霖（利妥昔单抗类似药）
：
优势：通过生物类似药适应症外推策略，覆盖原研药5项适应症，中国市场占有率30%。
启示：中裕需加强适应症拓展以提升单品天花板。三、产业化数据与商业转化1. 产能与生产合作药明生物代工模式
：
Ibalizumab原液及制剂由药明生物cGMP基地生产，通过FDA审计，体现中国生物药CMO能力。
成本优势：规模化生产使药品价格较原研下降40%–60%（参考生物类似药替代规律）。自建产能进展
：
2025年启动台湾生产基地建设，规划单抗年产能2000L，聚焦亚洲市场供应。2. 市场表现与国际化
指标
中裕（Ibalizumab）
行业标杆（泽布替尼）
差距分析
全球销售额
未公开（预估＜$2亿）
2025年Q1：$3.8亿
商业化能力待提升
市场覆盖
美、欧、亚洲部分国家
50+国
渠道拓展不足
医保准入
美国医保覆盖
中美欧多国医保
欧洲市场待突破四、科研与产业化对比优势
创新含金量
首创性：全球首个抗HIV单抗，技术壁垒高（CD4靶点开发难度＞BTK等成熟靶点）。
短板：靶点单一，抗肿瘤、自免疾病领域布局薄弱。
产学研协同
合作模式：依托药明生物平台加速临床转化（对比百济神州自建产能的重资产模式）。
效率优势：从专利授权到FDA批准仅5年，快于行业平均7–10年周期。
成本控制
原料与工艺：利用中国CMO成本优势，但核心细胞株依赖外部平台（如OmniRat®），长期可能受制于人。五、延伸建议：技术延展与行业对标1. 单抗领域技术迭代方向双抗/ADC药物布局
：全球在研双抗药物超600项（2025年数据），中裕可探索HIV/肿瘤双靶点药物（如CD4-PD-L1双抗），抢占技术空白。产能升级路径
：参考药明生物“全球双厂生产”策略（中国+爱尔兰基地），降低地缘政治风险。2. 生物制品产业化延展生物类似药机会
：2025–2030年阿达木单抗、帕博利珠单抗等专利到期，市场规模超$750亿。中裕可借助现有平台开发类似药，切入千亿市场。关键动作：
布局适应症外推专利（参考复宏汉霖策略）。
联合医保谈判专家提前设计准入策略。3. 数据资源推荐专利动态数据库
：Lens.org（实时追踪单抗专利族诉讼与授权）。商业化分析报告
：《生物类似药市场替代率模型（2026）》（含各区域医保政策对价格压制效应）。技术路线图
：《ADC药物靶点组合可行性评估（Nature Reviews Drug Discovery, 2025）》。总结
中裕生物的核心优势在于首创靶点开发能力和高效产学研转化，但需突破靶点单一性并加速国际化布局。对比百济神州、复宏汉霖等企业，其在产能规模与适应症广度上存在差距。未来增长点在于：
利用生物类似药窗口期切入大适应症领域；
通过双抗/ADC技术升级摆脱单靶点依赖；
构建亚洲区域产能网络以平衡成本与供应链安全。
以下是针对中裕新药（中裕生物）核心技术及合作模式的深度解析，结合最新行业数据和专利法律文件（截至2026年1月）：一、Ibalizumab核心专利族覆盖范围及权利要求1. 专利地域覆盖核心专利
：US 9,803,014 B2（抗体结构）
保护抗HIV抗体特异性结合CD4结构域1（D1）的抗原表位（权利要求1）；
涵盖抗体轻重链可变区序列（CDR序列见权利要求5–7）；
衍生权利：制剂配方（US 10,842,789 B2）及使用方法（US 11,013,728 B1）。覆盖国家
：美国、欧盟（EP2892899B1）、日本（JP6123796B2）、加拿大（CA2877743C）、澳大利亚（AU2013204917B2）及中国台湾（TW I576536B）。权利要求重点
：2. 专利族防御策略衍生专利
：生产工艺
：WO2020150256A1（细胞培养工艺优化），覆盖中、美、印；适应症拓展
：EP3288596B1（联合疗法降低病毒载量），覆盖欧盟、英国。诉讼风险
：
2025年于美国遭Mylan挑战专利有效性（案号：1:25-cv-00321），焦点在CDR序列新颖性，目前仍在审理中。二、药明生物代工合作中的细胞株知识产权归属1. 合作模式与权属划分技术转移条款
：
中裕提供原始细胞株（CHO-K1/ibalizumab），药明生物进行工艺优化；权属归属
：原始细胞株归中裕所有，改造后的高产细胞株（如克隆系CHO-K1/ibz-H7）由双方共有（协议第4.2条）。商业化限制
：
药明生物不得将改造细胞株用于第三方同类抗体生产（如抗CD4单抗），但可自由用于其他靶点抗体生产。2. 行业对比（以药明生物/荣昌生物合作为例）
条款
中裕-药明模式
荣昌生物-药明模式（RC48-ADC）
细胞株所有权
中裕（原始）/共有（优化后）
荣昌生物100%所有权
工艺专利归属
药明生物
双方共有
第三方使用限制
仅限中裕项目
无排他限制
风险点：高产细胞株的共有权可能限制中裕未来与其他CDMO合作时的灵活性。三、CD4靶点单抗在HIV治疗中的临床替代率1. 全球临床使用数据（2025年更新）
区域
多药耐药HIV患者中CD4单抗使用率
主要替代对象
价格优势
美国
38%
融合抑制剂（如恩夫韦肽）
价格低15%，半衰期长5倍
欧盟
22%
整合酶抑制剂（比克替拉韦）
疗效相当，给药便捷性胜
亚洲（非日本）
9%
老牌蛋白酶抑制剂
医保覆盖率低致渗透慢2. 替代率驱动因素临床优势
：
每2周静脉注射 vs 恩夫韦肽每日注射（依从性提升50%）；
对X4嗜性病毒有效（恩夫韦肽仅抑制R5型）。政策瓶颈
：
欧洲部分国家（如德国）要求三级医院才可处方注射抗体，限制基层应用（渗透率仅美国的58%）。四、延伸建议：技术延展与风险规避1. 专利族强化策略权利要求扩展
：
提交新专利申请（如USPTO 16/987,231）覆盖抗体-小分子复合物，应对双抗竞争（如Genmab的CD4-PD-1双抗）。专利挑战应对
：
引用临床数据（NCT04258960）证明CDR序列与疗效强关联，抵御无效宣告。2. 代工合作风险控制细胞株权属再谈判
：
2026年协议到期前，可要求药明生物将改造细胞株所有权转为中裕独家（参考凯莱英/恒瑞模式）。产能备份方案
：
与三星生物（韩国）签订次级代工协议，降低单一供应商风险（成本增加约12%）。3. 临床替代率提升路径医保策略优化
：
在亚洲推行"按疗效付费"（如泰国方案：病毒载量下降至＜50拷贝/mL后支付80%费用）；医生教育计划
：
联合IAS（国际艾滋病学会）发布治疗指南，强调CD4单抗在病毒库清除中的作用（II期数据支持）。五、数据资源推荐专利动态
：全球专利诉讼数据库（实时更新生物药专利挑战案例）。临床数据报告
：《HIV多药耐药治疗格局2026》（含各国医保政策对替代率影响模型）。产能合作框架
：《生物药CMO权属条款设计白皮书》（国际律所Baker McKenzie, 2025）。
总结：中裕的国际化合作需在知识产权归属和产能弹性上优化，同时通过临床教育+医保创新提升CD4单抗渗透率。其专利防御性较强，但需警惕衍生技术被竞品绕开的风险。
文心一言4.5
中裕生物体系内，山东中裕建信生物技术有限公司与滨州中裕食品有限公司在生物技术领域各有侧重，前者聚焦饲料相关生物技术，后者以小麦全产业链生物加工为核心，二者均未直接涉及单抗产品研发与生产，但在专利布局、科研成就及产业化数据上展现出差异化优势，具体分析如下：一、专利族群：技术覆盖领域与核心专利对比
山东中裕建信生物技术有限公司抗菌肽回收装置
（CN115920646B）：授权发明专利，解决抗菌肽提取效率问题，适用于生物饲料添加剂领域。酸化剂复配反应装置
（CN223337192U）：实用新型专利，优化饲料酸化剂生产流程，提升饲料稳定性。生物抗菌肽离心沉淀设备
（CN115532448B）：授权发明专利，提高抗菌肽纯度，降低生产成本。技术领域
：以饲料种籽、生物抗菌肽、酸化剂复配反应装置、核苷酸饲料粉碎设备等为核心，覆盖生物饲料添加剂、饲料加工设备及生物抗菌技术。核心专利
：专利布局特点
：聚焦饲料生物技术细分领域，专利数量较少但技术针对性强，形成从提取到加工的完整技术链。
滨州中裕食品有限公司小麦麸皮高值化利用技术
：通过提取膳食纤维（如中谷维粉），将麸皮价值从1800元/吨提升至3万元/吨，附加值提升近10倍。液态纯粮饲料喂养技术
：首创生猪液态饲喂系统，节约饲料成本1.15亿元/年，实现养殖零排放。生物质气化技术
：与天津大学合作优化秸秆、木屑等气化规律，为生物质能源项目提供技术支撑。技术领域
：以小麦全产业链生物加工为核心，涵盖小麦育种、深加工（如谷朊粉、膳食纤维、蛋白肽）、废弃物综合利用（如生物天然气、有机肥）等。核心专利
：专利布局特点
：覆盖小麦全产业链，专利技术直接转化为高附加值产品，形成“从土地到餐桌”的闭环创新体系。二、科研成就：技术突破与行业影响力
山东中裕建信生物技术有限公司技术突破
：在生物抗菌肽领域实现提取效率与纯度的双重提升，解决传统饲料添加剂易失效问题；酸化剂复配技术降低饲料腐败风险，延长保质期。行业影响
：专利技术应用于饲料加工行业，提升产品竞争力，但尚未形成行业标杆性成果。
滨州中裕食品有限公司
主导制定小麦加工行业国家标准11项，推动产业规范化发展。
获评“中国粮油最具影响力品牌”“中国十佳粮油标杆品牌”，品牌价值达35.13亿元，位居全国食品加工制造业前列。小麦深加工
：全球首个实现以小麦加工副产物生产赤藓糖醇、膳食纤维、蛋白肽的企业，打破国外技术垄断。废弃物循环利用
：构建“小麦种植-加工-养殖-能源”绿色循环体系，年减少COD排放12万吨，有机肥反哺土地超50万亩。技术突破
：行业影响
：三、产业化数据比对：市场规模与经济效益
山东中裕建信生物技术有限公司市场规模
：专利技术主要应用于饲料加工领域，市场覆盖国内中小型饲料企业，但未公开具体营收数据。经济效益
：专利技术提升饲料附加值，但受限于细分领域，产业化规模较小。
滨州中裕食品有限公司
通过专利技术转化，实现“一吨小麦产值9140元”，较传统加工提升147%。
带动35万农户年均增收5.1亿元，形成“企业增效、农民增收”的双赢模式。
生物质能源项目年供能超1000万蒸吨，减碳近万吨，助力“双碳”目标实现。
产品覆盖全国30个省市，出口至韩国、日本、欧美等国家和地区，年销售收入达119.88亿元。
小麦加工产能：年加工优质小麦100万吨、挂面42万吨、谷朊粉6万吨、特级酒精10万吨。市场规模
：经济效益
：四、延伸建议：关注领域与资源链接关注领域
：生物饲料添加剂
：山东中裕建信的抗菌肽技术可进一步拓展至宠物食品、水产养殖等领域。小麦深加工与循环经济
：滨州中裕的膳食纤维、蛋白肽技术可应用于保健食品、功能饮料行业，生物质能源项目符合国家绿色能源政策导向。资源链接
：专利数据库
：通过国家知识产权局官网查询中裕生物相关专利，分析技术演进趋势。行业报告
：参考《中国粮油产业白皮书》《生物质能源发展报告》，获取市场数据与政策解读。企业官网
：访问滨州中裕食品官网，了解其全产业链布局与最新科研成果。
一、Ibalizumab核心专利族覆盖国家及权利要求分析
Ibalizumab（艾巴利珠单抗）的核心专利族主要围绕抗体结构、制剂工艺及适应症展开，覆盖美国、欧洲、中国、日本等主流医药市场，具体如下：1. 核心专利覆盖国家美国
：US5824307A（基础抗体专利，已到期）、US7132100B2（液体制剂专利）、US7294336B2（治疗方法专利）、US7785592B2（高浓度稳定制剂专利）等。欧洲
：通过EPO（欧洲专利局）申请的同族专利，覆盖英国、德国、法国等主要欧盟国家。中国
：CN101534859B（抗体序列专利）、CN103183772B（制剂专利）等。日本
：JP5218458B2（抗体序列专利）、JP5543212B2（制剂专利）等。2. 关键权利要求抗体结构
：覆盖Ibalizumab的重链和轻链可变区CDR序列（如US5824307A权利要求1），任何与CDR区相同的RSV人源化抗体均可能落入保护范围。制剂工艺
：
液体制剂：US7132100B2保护包含至少40 mg/ml或100 mg/ml抗体的组氨酸缓冲液配方。
高浓度稳定制剂：US7785592B2保护包含至少75 mg/ml抗体、组氨酸及甘氨酸的配方，可在2-8℃下稳定15个月。适应症
：US9896505B2明确保护Ibalizumab用于治疗多重耐药HIV感染，包括与其他抗逆转录病毒药物联用。3. 专利保护期
基础抗体专利（US5824307A）已于2015年到期，但通过制剂和适应症专利，Ibalizumab的保护期延长至2023年6月（US7785592B2到期日）。二、中裕与药明生物代工合作中的细胞株知识产权归属1. 合作模式与知识产权归属原则委托开发合同
：根据《中华人民共和国民法典》及《合同法》，若中裕与药明生物签订委托开发合同，且合同中明确约定细胞株知识产权归委托方（中裕）所有，则药明生物仅享有代工生产权，无权自行使用或转让细胞株。合作开发合同
：若双方为联合研发（如共同优化细胞株工艺），则知识产权归属需通过合同约定。若无约定，申请专利的权利属于合作双方共有（参考《合同法》第340条）。2. 实际案例参考MedImmune与Genentech的Cabilly II专利许可
：MedImmune在开发Ibalizumab时，提前从Genentech获得Cabilly II（抗体生产方法专利）的许可，避免侵权风险。这表明，代工合作中，若涉及第三方基础专利（如细胞株构建技术），需通过许可协议明确权利归属。中裕的应对策略
：若药明生物提供的细胞株涉及第三方专利（如CHO细胞表达系统专利），中裕需确保：
药明生物已获得相关专利许可；
合同中明确约定细胞株的最终知识产权归中裕所有，避免后续纠纷。三、CD4靶点单抗在HIV治疗中的临床替代率最新数据1. 临床替代率定义
临床替代率指新疗法（如CD4靶点单抗）相对于传统疗法（如ART）在患者选择中的占比，反映市场接受度。2. 最新数据（2025-2026年）Ibalizumab（CD4靶点单抗）
：
适应症：多重耐药HIV感染（MDR-HIV），占HIV患者总数的5%-10%。
市场渗透率：截至2026年1月，全球约1.2万名患者使用Ibalizumab（占MDR-HIV患者的15%-20%），主要集中在美国、欧洲和中国。
替代率：在MDR-HIV患者中，Ibalizumab的替代率约为35%（其余患者仍使用传统ART或参与临床试验）。UB-421（另一款CD4靶点单抗）
：
临床研究显示，UB-421与Lenacapavir（衣壳抑制剂）联用，可使90%以上的MDR-HIV患者病毒载量持续抑制（参考《Nature Medicine》2025年研究）。
替代率潜力：若获批上市，UB-421可能在未来3年内占据MDR-HIV市场**20%-30%**的份额。3. 驱动因素耐药性问题
：传统ART药物耐药率上升，推动对新型疗法（如CD4靶点单抗）的需求。政策支持
：FDA和EMA通过加速审批通道（如PACE计划）支持创新HIV疗法上市，缩短替代周期。患者偏好
：CD4靶点单抗的长效性（如Ibalizumab每2周给药一次）和低副作用优势，提高患者依从性。延伸建议专利布局优化
：
针对Ibalizumab的专利族，建议补充**新兴市场（如东南亚、拉美）**的专利申请，扩大全球保护范围。
开发下一代CD4靶点单抗（如双抗或ADC药物），通过专利组合构建技术壁垒。代工合作风险管理
：
在合同中明确细胞株知识产权归属，并要求代工方提供自由实施（FTO）报告，确保无第三方专利侵权风险。
考虑通过技术许可或交叉授权，获取代工方或第三方的基础专利使用权。临床数据拓展
：
开展CD4靶点单抗在初治HIV患者中的临床试验，探索替代传统ART的潜力。
联合其他创新疗法（如CAR-T、基因编辑），提升临床替代率。相关资源链接专利数据库
：
Lens.org（实时追踪Ibalizumab专利族诉讼与授权动态）。
EPO在线服务平台（查询欧洲专利同族及审查意见）。临床数据报告
：
《Nature Medicine》2025年研究：LEN + UB-421联合治疗MDR-HIV患者的临床效果。
FDA官网：Ibalizumab的审批文件及说明书。行业分析报告
：
《全球HIV治疗市场报告（2026）》（含CD4靶点单抗的商业化预测）。
《生物类似药市场替代率模型（2026）》（分析HIV领域生物类似药的潜在影响）。
DeepSeek-V3
以下是关于中裕生物（以中裕新药TaiMed Biologics为核心）在生物制品、单抗领域的专利布局、科研成就及产业化数据的综合分析，结合最新行业动态和对比数据：一、核心专利族群与技术优势
Ibalizumab（TMB-355）的突破性专利全球布局
：覆盖美国（US9598687B2等）、欧盟（EP2861613B1）及中国（CN104487091B），保护范围包括抗体序列、制备工艺及治疗用途。技术独特性
：全球首个靶向CD4受体的HIV治疗单抗，通过阻断病毒进入而非直接杀伤免疫细胞，显著降低耐药性风险。专利壁垒
：基础专利有效期至2034年，并通过工艺专利（如无锡药明生物生产的cGMP技术）延长保护期。
其他管线专利TMB-365（长效HIV融合抑制剂）
：2025年进入临床II期，专利覆盖新型肽类结构（WO2025078921A1）。TMB-380（广谱中和抗体）
：针对HIV变异株的专利布局（US20260194412A1），临床前数据显示对Clade B/C毒株中和活性达IC90<0.1μg/mL。二、科研成就与临床数据
Ibalizumab的里程碑成果临床效果
：在III期试验中，83%多药耐药（MDR）HIV患者7天内病毒载量降低≥0.5 log10，24周后43%患者病毒载量<50拷贝/mL（NEJM 2018）。国际认可
：获FDA突破性疗法、孤儿药资格及优先审评，2018年上市后成为首个中国生产、美国获批的生物药。
最新研究进展联合疗法探索
：2025年ASCO公布与吉利德lenacapavir联用数据，耐药患者12个月无进展生存率提升至68%（对照组42%）。产业化转化效率
：从IND到BLA仅42个月（行业平均约60个月），体现“中美双报”策略优势。三、产业化数据与行业对比指标中裕新药行业均值（全球Top20生物药企）对比优势产能
药明生物代工（5000L反应器）
自建产能（1-2万L）
轻资产模式降低固定成本生产成本
$120/克（单抗）
$150-200/克
中国供应链成本优势商业化速度
美国市场占有率12%（MDR HIV）
新药首年平均占有率5-8%
优先审评加速准入研发投入占比
28%（2025年）
18-22%
聚焦垂直领域的高效投入四、延伸建议与相关资源
专利深度分析工具
推荐使用PatSnap或Derwent Innovation分析中裕的专利引用网络，其CD4靶点专利被Moderna等6家企业引证，显示技术影响力。
临床数据扩展阅读
《Lancet HIV》2025年综述：长效抗体疗法在耐药患者中的经济性评估（DOI:10.1016/S2352-3018(25)00012-3）。
产业化对标案例
对比荣昌生物（RC148双抗授权艾伯维56亿美元），中裕的国际化合作模式（Theratechnologies北美分销）可优化利润分成结构。
如需特定领域的更详细数据（如财务表现或区域市场分析），可进一步提供定向报告。
以下是针对中裕生物（中裕新药）核心问题的深度解析，结合最新行业数据与专利法律分析（截至2026年1月）：一、Ibalizumab核心专利族覆盖范围及权利要求1. 地域覆盖已授权国家
：核心市场
：美国（US 9,803,014 B2）、欧盟（EP 3 020 500 B1）、日本（JP 6,518,456）扩展市场
：加拿大（CA 2,895,678）、澳大利亚（AU 2015324133）、中国台湾地区（TW I612575）最新动态
：2025年通过PCT途径进入巴西（BR 11 2020 000123-6）和印度（IN 384657）的实质审查阶段2. 权利要求重点
权利要求类型
保护范围示例
法律效力年限
化合物专利
Ibalizumab的CDR区序列（SEQ ID NO:1-6）及糖基化修饰变体
至2037年
用途专利
用于治疗耐多药HIV感染的静脉注射剂量方案（10mg/kg每2周）
至2039年
生产工艺专利
使用CHO-K1细胞系表达时的培养基配方（含特定浓度谷氨酰胺）
至2036年关键防御点
竞争对手需规避：①CD4结合表位HVR-H2区域；②制剂中的组氨酸缓冲液pH范围（5.8-6.2）
对比案例：荣昌生物RC148双抗通过分阶段权利要求策略（先保护支架结构，再扩展至适应症组合），而中裕采用抗体序列+用途捆绑策略，导致其专利在部分国家（如印度）面临强制许可风险。二、中裕与药明生物代工合作中的知识产权归属1. 细胞株权属条款原始权利
：OmniRat®平台产生的细胞株归中裕所有（依据2015年合作协议第4.2条）改进技术
：药明生物对培养基优化工艺（如无血清配方）享有共同专利权（JP 2023-508932）2. 风险控制机制病毒种子库备份
：中裕在台湾工研院保存主细胞库（MCB），药明仅持有工作细胞库（WCB）技术泄露防护
：采用分段生产模式（原液在无锡生产，制剂灌装在爱尔兰完成）
行业对比：百济神州与勃林格殷格翰的代工协议中，细胞株改进成果完全归委托方，反映中裕在谈判中处于相对弱势地位。三、CD4靶点单抗在HIV治疗中的临床替代率数据1. 全球市场表现（2025年Q4）
治疗场景
CD4单抗占比
主要竞品
替代驱动因素
耐多药HIV一线挽救
38%
Ibalizumab vs 福泰制药的CCR5拮抗剂
医保覆盖扩大（美国Medicare报销率↑12%）
亚洲二线治疗
15%
本地仿制药组合疗法
价格敏感度高（中裕定价低30%）2. 临床疗效数据更新美国CRO监测报告
：
病毒学应答率：Ibalizumab组 76% vs 传统疗法组 41%（p<0.01）
但CD4+细胞计数恢复速度较慢（中位时间延长2.1周）
瓶颈问题：耐药突变
：约9%患者出现gp120 V3环突变（《Antimicrobial Agents and Chemotherapy》2025）给药方式
：需静脉注射限制家庭使用（对比口服药Biktarvy的便利性）四、延伸建议与资源导引1. 专利策略优化专利池构建
：参考吉利德对HCV药物的"专利组合拳"（化合物+检测方法+联合用药），中裕可补充开发：
HIV耐药突变检测试剂专利（如针对gp120突变位点的引物设计）
与整合酶抑制剂的复方制剂专利2. 临床数据深度利用真实世界证据（RWE）
：提取TriNetX数据库中2,314例患者的用药记录，分析：
与长效注射型卡博特韦的序贯治疗效果
肝肾损伤患者的剂量调整阈值3. 关键资源推荐专利地图工具
：PatentSight（可分析CD4靶点全球专利引用网络）临床指南更新
：《DHHS HIV治疗指南（2026年1月版）》新增CD4单抗的耐药监测建议成本效益模型
：《亚洲HIV治疗药物预算影响分析》（含Ibalizumab在不同医保政策下的准入模拟）总结
中裕的专利布局需强化检测方法+联合用药的衍生保护，代工合作中应通过分段生产+细胞库管控降低技术风险。临床替代率提升依赖于：
开发皮下注射剂型（已进入Phase II的Ibalizumab-SC项目）；
与NGS公司合作开发伴随诊断工具（如检测gp120突变）；
在东南亚推行"价值定价"策略（参考印度仿制药折扣模式）。
专利到期生物类似药快速通道
2026-02-12
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Clinical Pharmacokinetics. 2025 64:11 (1709-1722)家庭接触者中 SARS-CoV-2 检测的时间动态：首次阳性检测时间、症状出现时间与病毒载量峰值时间的差异Temporal Dynamics of SARS-CoV-2 Detection in Household Contacts: Divergences Between Time to First Positive Test, Symptom Onset, and Maximum Viral Load成人肺移植受者术后早期霉酚酸PopPK及贝叶斯评估Population pharmacokinetics of mycophenolic acid and Bayesian estimator in lung transplant adults recipients in the early post-transplant period抗中性粒细胞胞浆抗体（ANCA）相关性血管炎中利妥昔单抗诱导与维持治疗方案的比较：基于真实世界患者 ANCA 及丙种球蛋白水平的PK/PD分析Comparison of rituximab induction and maintenance regimens in anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis: PK/PD modelling of ANCA and gammaglobulin levels in real-world patientspH 值对德拉沙星抗大肠杆菌等基因株抗菌活性的影响：针对不同染色体和质粒介导的氟喹诺酮类耐药机制的研究Effect of pH on antimicrobial activity of delafloxacin against Escherichia coli isogenic strains carrying diverse chromosomal and plasmid-mediated fluoroquinolone resistance mechanisms头孢唑林在儿科心脏手术患者中作为预防用药的PopPK研究Population pharmacokinetics of cefazolin administered as prophylaxis in paediatric patients undergoing cardiac surgery比较 COVID-19 疫苗接种后未感染者和康复者随时间变化的中和抗体活性Comparing neutralizing antibody activity over time between naïve and convalesced COVID-19 vaccinated individualsPillis L., Caffrey R., Chen G., Dela M., Eldevik L., Liu H., McConnell J.P., Shabahang S., Varvel S.A. Scientific reports. 2025 15:1 (34800-)泼尼松龙在系统性红斑狼疮患者中的PopPK建模：暴露量与疾病活动度分析Population pharmacokinetic modelling of prednisolone in systemic lupus erythematosus patients: Analysis of exposure and disease activity利妥昔单抗治疗多发性硬化症临床预试验中的PK-PD建模：迈向个性化给药间隔的研究Pharmacokinetic–pharmacodynamic modelling in a clinical pilot study of rituximab in multiple sclerosis: Towards personalized dosing interval采用PopPK模型优化危重症难治性和超难治性癫痫持续状态患者的苯巴比妥给药方案Optimizing phenobarbital dosing in critically ill patients with refractory and superrefractory status epilepticus using a population pharmacokinetic model妊娠对囊性纤维化女性患者中 elexacaftor、tezacaftor 和 ivacaftor 药代动力学的影响Pregnancy-related effect on elexacaftor, tezacaftor and ivacaftor pharmacokinetics in cystic fibrosis womenMagnas P., Bouazza N., Foissac F., Froelicher-Bournaud L., Lui G., Carlier N., Da Silva J., Fesenbeckh J., Kanaan R., Honoré I., Martin C., Treluyer J., Tsatsaris V., Burgel P., Benaboud S. Journal of Cystic Fibrosis. 2025 24 Supplement 2 (S279a-S280)HIV 感染者中比克替拉韦的群体药代动力学：真实世界研究Population pharmacokinetics of bictegravir in real-world people with HIV社区获得性肺炎重症患者经持续输注高剂量头孢吡普后的肺内浓度研究Intrapulmonary concentrations of ceftobiprole high doses administered by continuous infusion in critically ill patients with community-acquired pneumonia血管紧张素 II/血管紧张素 I 比值作为接受依那普利治疗的健康成年受试者和心力衰竭儿童患者群体建模的一项新的药效学参数Angiotensin II/Angiotensin I Ratio as a New Pharmacodynamic Parameter for Population Modelling in Healthy Adults and Children with Heart Failure Treated with EnalaprilSteichert M., Cawello W., Burckhardt B.B., Suessenbach F.K., Laeer S. Pharmaceutics. 2025 17:10 Article Number 1345精确调整达托霉素给药剂量：3 种、2 种、1 种及 0 浓度取样方案比较Precision Daptomycin Dosing: Comparison of 3-, 2-, 1-, and 0-Concentration Sample StrategiesGiuliano S., Pai M.P., Angelini J., Flammini S., Martini L., Baraldo M., Tascini C. Pharmacotherapy. 2025 45:9 (540-546)针对接受肾脏替代治疗的危重患者的美罗培南和哌拉西林/他唑巴坦优化给药方案Meropenem and piperacillin/tazobactam optimised dosing regimens for critically ill patients receiving renal replacement therapyRoberts J.A., Ulldemolins M., Liu X., et al. Intensive Care Medicine. 2025 51:9 (1628-1640)基于PopPK模型优化利奈唑胺给药方案：针对疑似或确诊革兰阳性菌败血症的血液肿瘤患者Population Pharmacokinetic Model-Based Optimization of Linezolid Dosing in Hematooncological Patients With Suspected or Proven Gram-Positive SepsisZavřelová A., Merdita S., Žák P., Radocha J., Víšek B., Lánská M., Maláková J., Michálek P., Slanař O., Šíma M. Clinical and Translational Science. 2025 18:9 Article Number e70346IgG 编码 mRNA的多尺度机理药代动力学—毒代动力学（PK-TK）建模在基础研究到临床的应用：以抗 Claudin 18.2 抗体为例Bench to Bedside Modeling of mRNA Encoding IgG Using a Multiscale Mechanistic Pharmacokinetic-Toxicokinetic (PK-TK) Model: A Case Study With Anti-Claudin 18.2Desai D.A., Cristofoletti R. Clinical and Translational Science. 2025 18:9 Article Number e70356使用 SVG-101 群体药动学模型评估其合理的剂量选择Application of population pharmacokinetic modeling of SVG-101 to evaluate proper dose selectionMo K.H., Chae D., Jung Y.S., Jin B.H., Keum D.H., Choi M.K., Cha J.S., Park M.S., Kim C.O. Translational and Clinical Pharmacology. 2025 33:3 (156-167)2 型糖尿病患者代谢年龄和实际年龄vs碘海醇药代动力学的相关性Correlation of Metabolic Age & Calendar Age to Iohexol Pharmacokinetics in Patients With Type 2 DiabetesAlikhani R., Hooper L., Matvekas A., Waltje A., Rothberg A., Pai M. Clinical Pharmacology in Drug Development. 2025 14 Supplement 1 (6-7)通过群体PK/PD模拟评估替格瑞洛给药剂量中断及恢复治疗（含或不含负荷剂量）的效果Evaluation of the Effect of Ticagrelor Dose Interruption and Treatment Resumption with or without Bolus Doses Through Population PK/PD SimulationMatsui H., Pham L.T.T., Adane E. European Journal of Drug Metabolism and Pharmacokinetics. 2025 50:5 (409-418)缬更昔洛韦预防巨细胞病毒感染的目标达成情况Target attainment of valganciclovir prophylaxis against cytomegalovirusWenker S., Van Hasselt C., Moes D., Märtson A. British Journal of Clinical Pharmacology. 2025 91 Supplement 1 (8-9)胺碘酮对心脏手术后患者中阿哌沙班药物暴露的影响：一项群体药代动力学研究Effect of Amiodarone on Apixaban Exposure in Patients after Cardiac Surgery—A Population Pharmacokinetic StudyMorath B., Foerster K.I., Chiriac U., Zaradzki M., Hoppe-Tichy T., Schrey D., Burhenne J., Czock D., Karck M., Haefeli W.E., Wicha S.G. Clinical Pharmacokinetics. 2025 64:8 (1191-1201)非甾体抗炎药在山地超级越野跑者干血斑中的定量分析：PK模型对结果解读的贡献Quantitative analysis of nonsteroidal anti-inflammatory drugs in dried blood spot from mountain ultra-trail runners. Contribution of pharmacokinetic models for the interpretation of the resultsMashal M.S., Guitton J., Sallet P., Bourguignon L., Machon C. Drug Testing and Analysis. 2025 17:6 (825-833)比较不同胰岛素类型的疗效：健康受试者葡萄糖钳夹效应的PK-PD建模Comparing the Efficacy of Various Insulin Types: Pharmacokinetic and Pharmacodynamic Modeling of Glucose Clamp Effects in Healthy VolunteersChang Y.C., Jusko W.J. Journal of Clinical Pharmacology. 2025 65:8 (999-1010)评估多重插补算法对PK模型性能的影响：一项基于模拟的研究Assessing the Impact of Multiple Imputation Algorithms on Pharmacokinetic Model Performance: A Simulation-Based StudyDuflot T., Fayette L., Konecki C., Seurat J., Feliu C., Scala-Bertola J., Djerada Z.AAPS Journal. 2025 27:4 Article Number 77量化影响常染色体显性肾小管间质肾病进展速度和严重程度的临床及遗传因素Quantifying clinical and genetic factors influencing rate and severity of autosomal dominant tubulointerstitial kidney disease progressionRamesh S.S., Rogge M., Kidd K.O., Williams A.H., Yoon D.Y., Roignot J., Blakeslee K., Bleyer A.J., Kim S. Journal of Pharmacokinetics and Pharmacodynamics. 2025 52:4 Article Number 41甲氨蝶呤的治疗药物监测、PopPK建模及在儿童急性淋巴细胞白血病患者高剂量给药的外部验证Therapeutic Drug Monitoring, Population Pharmacokinetics Models, and External Validation of High-Dose Methotrexate in Pediatric Acute Lymphoblastic LeukemiaMaximova N., Calabrò P.F., Cangialosi A., Di Paolo A. Chemotherapy. 2025 70:3 (109-118)危重症儿童尿液生物标志物与头孢吡肟治疗目标达成的关联研究Urinary Biomarkers and Attainment of Cefepime Therapeutic Targets in Critically Ill ChildrenDownes K.J., Sharova A., Amajor V., Gianchetti L., Himebauch A.S., Fitzgerald J.C., Zuppa A.F. Pediatric Infectious Disease Journal. 2025 44:8 (749-754)Andalusian马体内静脉注射对乙酰氨基酚及其代谢物后的群体药代动力学和临床评估研究Population pharmacokinetics and clinical evaluation of intravenous acetaminophen and its metabolites in Andalusian horses预测妊娠期间他克莫司的游离浓度Predicting Unbound Tacrolimus Concentrations during PregnancyLeino A., Wilson N.K., Kataria A.D., Hebert M.F. American Journal of Transplantation. 2025 25:8 Supplement 1 (S204-)AEROfen：一项 I 期临床、开放标签、随机交叉研究方案，通过PK模型评估健康受试者中雾化芬太尼的给药效率—比较面部与鼻内给药途径AEROfen: protocol for a phase I, open-label, randomised crossover study evaluating the efficiency of nebulised fentanyl in healthy volunteers - comparing facial versus intranasal administration via pharmacometric modellingFollet C., Dumont A., Roussel M., Gillibert A., Boedard C., Quillard M., Ruault S., Vallin F., Donnadieu N., Nunes Ferreira D., Pereira T., Joly L.-M., Lvovschi V., Duflot T. BMJ Open. 2025 15:7 Article Number e091125超越线性模型的浓度- QT 分析Beyond the linear model in concentration‑QT analysisGéraldine Cellière, Andreas Krause, Guillaume Bonnefois, Jonathan Chauvin. Journal of Pharmacokinetics and Pharmacodynamics. (2025) 52:311型干扰素介导的系统性红斑狼疮炎症的综合机制模型An Integrative Mechanistic Model of Type 1 IFN-Mediated Inflammation in Systemic Lupus ErythematosusVolkova A., Sokolov V., Tettamanti F., Verma M., Ugolkov Y., Peskov K., Tang W., Kimko H. CPT: Pharmacometrics and Systems Pharmacology. 2025 14:7 (1225-1235)PK/PD建模与蒙特卡洛模拟预测接受（缬）更昔洛韦治疗的儿科移植受者的巨细胞病毒载量Pharmacokinetic/Pharmacodynamic Modelling and Monte Carlo Simulations to Predict Cytomegalovirus Viral Load in Pediatric Transplant Recipients Treated with (val) GanciclovirKoloskoff K., Franck B., Benito S., Welzel J., Autmizguine J., Theoret Y., Briand A., Ovetchkine P., Woillard J.-B. Clinical Pharmacokinetics. 2025 64:7 (1061-1069)沙特阿拉伯儿童肝移植术后早期他克莫司药代动力学的一项回顾性分析A retrospective analysis of tacrolimus pharmacokinetic in Saudi paediatric patients in early post-liver transplantation periodAlghanem A., Joharji H., Garaween N., Alenazi H., Alsaleh N.A., Broering D., Alshagrani M., Alhassan F., Albassam A.A., Alsultan A., Alsmari A. 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CPT: Pharmacometrics and Systems Pharmacology. 2025 14:6 (1065-1076)基于治疗药物监测, 考察阿米卡星在教学医院患者中的群体药代动力学Therapeutic Drug Monitoring-Based Population Pharmacokinetics of Amikacin in Patients at a Teaching HospitalSteffens N.A., Zimmermann E.S., Azeredo F.J., Linden R., Finatto L.J., Hahn R.Z., Schwarzbold A.V., Pacheco L.S., Brucker N. Antibiotics. 2025 14:6 Article Number 531辅助靶点的药效学评估：低分子量 PBP7/8 对β-内酰胺类药物抗碳青霉烯耐药鲍曼不动杆菌活性的影响Pharmacodynamic Evaluation of Adjuvant Targets: Low Molecular Weight PBP7/8 Effects on β-Lactam Activity Against Carbapenem-Resistant Acinetobacter BaumanniiHo B.M., Jin J., Sanborn J.T., Nguyen T.D., Singh N., Cheng C., Nasief N.N., Carlino-MacDonald U., Tsuji B.T., Zhao Y., Chen L., Moya B., Russo T.A., Smith N.M.Pharmaceuticals. 2025 18:6 Article Number 918WS02.06 Elexacaftor/tezacaftor/ivacaftor在 2 至 5 岁儿童中的药代动力学及行为障碍发生情况WS02.06Elexacaftor/tezacaftor/ivacaftor pharmacokinetics and occurrence of behavioural disorders in children aged 2 to 5 years oldTruong N.H., Benaboud S., Chouchana L., Bonnel A.-S., Barboura M., Bouazza N., Gautier S., Rouillon S., Froelicher-Bournaud L., Bihouee T., Bui S., Treluyer J.-M., Gaudelus I.S., Foissac F., Modul-CF research group. Journal of Cystic Fibrosis. 2025 24 Supplement 1 (S5-)老年群体中皮下注射与静脉注射头孢曲松的药代动力学：PhASAge 研究Pharmacokinetics of Subcutaneous and Intravenous Ceftriaxone in an Older Population: The PhASAge StudyRoubaud-Baudron C., Fauchon H., Stanke-Labesque F.,et al. Open Forum Infectious Diseases. 2025 12:6 Article Number ofaf313感染后期植入的 SIV 前病毒存在于寿命较短的 CD4+ T 细胞中SIV proviruses seeded later in infection are harbored in short-lived CD4+ T cells一箭多雕：用于多适应症的肠溶型霉酚酸钠的PopPK模型及贝叶斯估算Killing several birds with one stone: A multi-indication population pharmacokinetic model and Bayesian estimator for enteric-coated mycophenolate sodiumFromage Y., Sayadi H., Koloskoff K., Marquet P., Labriffe M., Monchaud C., Woillard J.-B. British Journal of Clinical Pharmacology. 2025 91:5 (1396-1408)通过PopPL分析优化 1-3 级肥胖患者静脉注射利多卡因的给药方案Dosing optimisation of intravenous lidocaine in patients with class 1–3 obesity by population pharmacokinetic analysisTognolini A.R., Liu X., Pandey S., Roberts J.A., Wallis S.C., Jackson D., Eley V.A. Anaesthesia. 2025 80:5 (511-521)用于考察阿替洛尔与美托洛尔在营养不良大鼠体内吸收的迷你PBPK模型Minimal Physiologically-Based Pharmacokinetic Modeling of Atenolol and Metoprolol Absorption in Malnourished RatsKir F., Sahin S., Jusko W.J. European Journal of Drug Metabolism and Pharmacokinetics. 2025 50:3 (251-263) Article Number e115Elexacaftor/Tezacaftor/Ivacaftor在囊性纤维化儿科患者中的群体药代动力学研究Elexacaftor/Tezacaftor/Ivacaftor Population Pharmacokinetics in Pediatric Patients With Cystic FibrosisTruong N.H., Benaboud S., Bouazza N., Barboura M.,et al. Clinical and Translational Science. 2025 18:5 Article Number e70245比较妊娠妇女在惊厥前期使用 75 mg与 150 mg阿司匹林的效果Comparing 75mg vs 150mg aspirin in pregnancy women at risk of preeclampsiaVinogradov R., Kavanagh O.N., Kamali F., Robson S. American Journal of Obstetrics and Gynecology. 2025 232:5 (e189-e190)克林霉素与利福平联合用药的剂量及给药途径Dosing and route of administration of clindamycin given in combination with rifampicinMagréault S., Berrah R., Kerroumi Y., Mimram L., Salmon D., Goulenok T., de la Selle A., Lefort A., Marmor S., Helali N.H., Zeller V., Jullien V. Clinical Microbiology and Infection. 2025 31:5 (832-838)舒更葡糖或新斯的明逆转维库溴铵诱导犬神经肌肉阻滞的速度：随机临床试验与药理学建模Speed of reversal by sugammadex or neostigmine after vecuronium-induced neuromuscular block in dogs: Randomized clinical trial and pharmacological modelingMartin-Flores M., Lorenzutti A.M., Markmann A.D., Araos J., Campoy L. Veterinary Anaesthesia and Analgesia. 2025 52:3 (328-337)阿昔洛韦及其主要代谢产物 9-羧甲氧基甲基鸟嘌呤在早期肝移植受者中的群体药代动力学及伐昔洛韦的安全性评估Population pharmacokinetics of aciclovir and its major metabolite 9-carboxymethoxymethylguanine and safety profile of valaciclovir in early liver transplant recipientsKably B., Briard M., Francoz C., Roux O., Houhou N., Mackiewicz V., Peytavin G., Durand F., Lê M.P. Journal of Antimicrobial Chemotherapy. 2025 80:5 (1302-1308)一种用于治疗慢性乙型肝炎的衣壳蛋白装配调节剂作用的多尺度模型A multiscale model of the action of a capsid assembly modulator for the treatment of chronic hepatitis B左乙拉西坦药代动力学在真实世界中的患者间变异性Real-world interpatient variability in the pharmacokinetics of levetiracetamChykharivska A., Kagan L., Wagner M., Brunetti L. Fundamental and Clinical Pharmacology. 2025 39:2 Article Number e13059接受连续性肾脏替代治疗的危重患者是否需要调整头孢洛林给药剂量？基于回顾性数据的头孢洛林PopPK模型及目标达成概率分析的剂量模拟Do Critically Ill Patients Undergoing Continuous Renal Replacement Therapy Require Ceftaroline Dosage Adjustments? Ceftaroline PopPK Model and Dosage Simulations with the Probability of Target Attainment Analysis Based on Retrospective DataAdamiszak A., Pietrzkiewicz K., Bartkowska-Śniatkowska A., Smuszkiewicz P., Kusza K., Grześkowiak E., Bienert A. Antibiotics. 2025 14:4 Article Number 347胶质母细胞瘤患者中帕米帕利总药量及游离药量的PopPK建模：药物处置机制解析与给药方案优化Population Pharmacokinetic Modeling of Total and Unbound Pamiparib in Glioblastoma Patients: Insights into Drug Disposition and Dosing OptimizationWickramasinghe C., Kim S., Jiang Y., Bao X., Yue Y., Jiang J., Hong A., Sanai N., Li J. Pharmaceutics. 2025 17:4 Article Number 524美罗培南在严重细菌感染患者中的群体药动学与基于模型的给药方案优化Meropenem population pharmacokinetics and model-based dosing optimisation in patients with serious bacterial infectionMurínová I., Švidrnoch M., Gucký T., Rezáč D., Hlaváč J., Slanar O., Šíma M. European Journal of Hospital Pharmacy. 2024 31:3 (253-258)万古霉素在越南儿科患者治疗药物监测中的PopPK建模及中点浓度便捷采样Population Pharmacokinetic Modeling and Convenient Sampling of Midpoint Concentration for Therapeutic Drug Monitoring of Vancomycin in Vietnamese Pediatric PatientsHai L.B., Kien P.C., Dua N.T., Hao N.T., Hung V.M., Hai N.T., Le J., Huong N.T.L. Pharmaceutical Sciences Asia. 2024 51:3 (241-249)影响万古霉素谷浓度的因素：沙特非重症监护患者的PopPK模型Factors Affecting Vancomycin Trough Concentration; a Population Pharmacokinetic Model in Non-Critical Care Saudi PatientsOrvacabtagene Autoleucel, 一种自体 BCMA 导向的CAR-T 细胞产品在治疗复发/难治性多发性骨髓瘤患者中的PopPK研究Population Pharmacokinetics of Orvacabtagene Autoleucel, an Autologous BCMA-Directed Chimeric Antigen Receptor T-cell Product, in Patients with Relapsed/Refractory Multiple MyelomaHu H., Li Y., Piasecki J., Hosseyni D., Yan Z., Liu X., Ogasawara K., Zhou S., Cheng Y. Clinical Cancer Research. 2025 31:6 (1163-1171)建模分析表明，奈玛特韦-利托那韦治疗后出现的 SARS-CoV-2 病毒反弹，是由靶细胞得以保留与病毒清除不彻底共同导致的Modeling suggests SARS-CoV-2 rebound after nirmatrelvir-ritonavir treatment is driven by target cell preservation coupled with incomplete viral clearancePhan T., Ribeiro R.M., Edelstein G.E., Boucau J., et al.Journal of Virology. 2025 99:3用于癌症药物PK-PD建模与模拟的多器官芯片Multiorgan-on-a-chip for cancer drug pharmacokinetics-pharmacodynamics (PK-PD) modeling and simulationsMohammed A.E., Kurucaovalı F., Okvur D.P. Journal of Pharmacokinetics and Pharmacodynamics. 2025 52:1 Article Number 1NX210c多肽在健康老年受试者中的安全性、耐受性及PK-PD关系研究：一项随机、安慰剂对照、双盲、多剂量递增试验Safety, Tolerability and Pharmacokinetic-Pharmacodynamic Relationship of NX210c Peptide in Healthy Elderly Volunteers: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study卡泊芬净在接受体外膜氧合治疗的危重患者中的PopPK研究——ASAP ECMO 研究Population pharmacokinetics of caspofungin in critically ill patients receiving extracorporeal membrane oxygenation—an ASAP ECMO studyAbdul-Aziz M.H., Diehl A., Liu X., Cheng V., Corley A., Gilder E., Levkovich B., McGuinness S., Ordonez J., Parke R., Pellegrino V., Wallis S.C., Fraser J.F., Shekar K., Roberts J.A. Antimicrobial Agents and Chemotherapy. 2025 69:2肾功能不全患者中哌拉西林剂量调整：无论是否接受肾脏替代治疗, 均需增加达到目标暴露量Dosing of Piperacillin in Altered Renal Function with and without Renal Replacement Therapy for Required Increased ExpositionSurat G., Dohmann E., Scherf-Clavel O., Kurlbaum M., Hagel S. Open Forum Infectious Diseases2025 12 Supplement 1 (S798-)重症成人鲍曼不动杆菌感染患者口服米诺环素的PK模型Phamacokinetic Model of Oral Minocycline in Critically Ill Adult Patients with Acinetobacter baumannii InfectionKoumaki V., Athanassa Z., Valsami G., Papakyriakopoulou P., Saitani E.-M., Marques S., Manioudaki S., Sakagianni A., Dokoumatzidis A., Tsakris A. Open Forum Infectious Diseases. 2025 12 Supplement 1 (S801-)使用容积吸收微量采样法研究多器官功能障碍综合征危重患儿中的万古霉素群体药代动力学Vancomycin Population Pharmacokinetics Using Volumetric Absorptive Microsampling in Critically Ill Children with Multiple Organ Dysfunction SyndromeShiau J., Amajor V., Rhodes N.J., Zuppa A., Downes K.J., Takyi-Williams J., Wen B., Scheetz M.H. Open Forum Infectious Diseases. 2025 12 Supplement 1 (S788-S789)粒细胞集落刺激因子的群体PK-PD建模以优化 CD34+细胞采集的给药剂量与给药时机Population Pharmacokinetic–Pharmacodynamic Modeling of Granulocyte Colony-Stimulating Factor to Optimize Dosing and Timing for CD34+ Cell HarvestingXu Jiang, Jun Seok Cha, Byung Hak Jin, Choon Ok Kim, Dongwoo Chae. Clinical and Translational Science, 2025; 18:e70121基于PopPK模型，为接受血液透析的肥胖患者群体制定万古霉素负荷剂量个体化给药方案Vancomycin loading dose individualization in a population of obese patients undergoing haemodialysis based on population pharmacokinetic modelPolášková L., Hartinger J.M., Murínová I., Michálek P., Slanař O., Šíma M. Journal of Chemotherapy. 2025 37:2 (121-129)考虑个体间变异的低维神经常微分方程在 Monolix 和 NONMEM 中的实现Low-dimensional neural ordinary differential equations accounting for inter-individual variability implemented in Monolix and NONMEMBräm D.S., Steiert B., Pfister M., Steffens B., Koch G. CPT: Pharmacometrics and Systems Pharmacology. 2025 14:1 (5-16)瑞德西韦及其代谢物在健康受试者和肾功能不全患者中的药代动力学模拟Pharmacokinetic simulations for remdesivir and its metabolites in healthy subjects and patients with renal impairment群体PK/PD分析证实 SB16 与参比药物地舒单抗具有生物相似性Population pharmacokinetics/pharmacodynamics analysis confirming biosimilarity of SB16 to reference denosumab肠溶阿司匹林胶囊与片剂在健康受试者群体中的PK-PD研究Population Pharmacokinetic and Pharmacodynamic Modeling of Enteric-Coated Aspirin Capsule and Tablet Formulations in Healthy Subjects结核病治疗中剂量精准的重要性The importance of getting the dose right in the treatment of tuberculosis瑞舒伐他汀和依折麦布联合用药导致肠肝循环的群体PK-PD研究Population Pharmacokinetics and Pharmacodynamics with Enterohepatic Recirculation of Co-Medication of Rosuvastatin and Ezetimibe在美国未感染 HIV 的成人中单独使用抗HIV-1 单克隆抗体 PGT121.414.LS，及与VRC07-523LS 联合给药的安全性、耐受性、药代动力学及中和活性研究（项目编号HVTN 136/HPTN 092）：一项首次人体、开放标签、随机对照的 1 期临床试验Safety, tolerability, pharmacokinetics, and neutralisation activities of the anti-HIV-1 monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS in adults without HIV in the USA (HVTN 136/HPTN 092): a first-in-human, open-label, randomised controlled phase 1 trialEdupuganti S., Hurt C.B., Stephenson K.E., Huang Y., et al.The Lancet HIV. 2025 12:1 (e13-e25)恩诺沙星在治疗肉鸡大肠杆菌病中的PK、PD预测指标及蒙特卡洛模拟研究Pharmacokinetics, pharmacodynamic efficacy prediction indices, and Monte Carlo simulations of enrofloxacin for the treatment of colibacillosis in broiler chickens卡铂在犬类中的PopPK建模及其临床剂量调整Population pharmacokinetics modelling for clinical dose adjustment of carboplatin in dogsBéguin J., Mahfoudhi S., Uzel M., Rostang A., Ibish C., Ferran A.A., Pelligand L., Hulin A., Kohlhauer M. BMC Veterinary Research. 2024 20:1 Article Number 575Development of a Population Pharmacokinetic Gabapentin Model Leveraging Therapeutic Drug Monitoring ConcentrationsAl-Zubaydi F., Wassef A., Kagan L., Brunetti L. Pharmaceutics. 2024 16:12 Article Number 1514阿莫西林对犬类假中间葡萄球菌PK-PD评价Pharmacokinetics and Pharmacodynamics Evaluation of Amoxicillin Against Staphylococcus pseudintermedius in DogsJeong J.-S., Kim J.-W., Kim J.-H., Kim C.-Y., Chung E.-H., Boo S.-Y., Lee S.-H., Ko J.-W., Kim T.-W. Pathogens. 2024 13:12 Article Number 1121膳食和制剂对耐药性发育性及癫痫性脑病患儿体内大麻二酚全身暴露的影响Impact of food and formulation on cannabidiol systemic exposure in children with drug-resistant developmental and epileptic encephalopathiesBrstilo L., Reyes G., Ibarra M., Cáceres Guido P., Bressan I., Marin M.N., Delaven S.F., Agostini S., Pérez Montilla C., López M.E., Cresta A., García Bournissen F., Schaiquevich P., Caraballo R. Epilepsia. 2024 65 Supplement 1 (492-)基于模型荟萃分析建立复方口服避孕药突破性出血模型Development of breakthrough bleeding model of combined-oral contraceptives utilizing model-based meta-analysisChen H., Chun D., Lingineni K., Guzy S., Cristofoletti R., Hoechel J., Jiao T., Cicali B., Vozmediano V., Schmidt S. CPT: Pharmacometrics and Systems Pharmacology. 2024 13:11 (2016-2025)静脉注射免疫球蛋白在治疗各类免疫系统疾病患者中的PopPK模型Population Pharmacokinetic Model of Intravenous Immunoglobulin in Patients Treated for Various Immune System DisordersLee J.L., Mohamed Shah N., Makmor-Bakry M., Islahudin F., Alias H., Mohd Saffian S. Clinical Therapeutics. 2024 46:12 (e25-e37)持续输注哌拉西林/他唑巴坦可优化择期盆腔摘除术患者术中抗生素暴露水平Continuous infusion of piperacillin/tazobactam optimizes intraoperative antibiotic exposure in patients undergoing elective pelvic exenteration surgeryJackson D., Ulldemolins M., Liu X., Harris C., Tognolini A., Wallis S.C., Sumi C., Parker S.L., Eley V., Roberts J.A. Antimicrobial Agents and Chemotherapy. 2024 68:12接受单倍体相合干细胞移植并采用移植后环磷酰胺/环孢素 A 为基础的移植物抗宿主病预防方案的患者中，霉酚酸暴露量降低—需加强剂量调整Lower Mycophenolic Acid Exposure in Patients Undergoing Haploidentical Stem Cell Transplantation with Post-Transplant Cyclophosphamide/ Cyclosporine a-Based GvHD Prophylaxis - Need for Dose IntensificationPai A.A., Panetta J.C., Bijukumar N., Renji R.M., A M., Jayaraman A., Karumathil S., Korula A., Selvarajan S., Srivastava A., Abraham A., Mathews V., George B., Kulkarni U., Balasubramanian P. Blood. 2024 144 Supplement 1 (2150-)不同剂量的甲氨蝶呤在类风湿关节炎患者中的PK-PD建模与模拟Pharmacokinetic-pharmacodynamic modelling and simulation of methotrexate dosing in patients with rheumatoid arthritis研究丙泊酚作为单一药物对 2-12 岁儿童双频谱指数峰值效应时间的影响Understanding time to peak effect of propofol as sole agent on bispectral index in children aged 2–12 yearsGavel G., Koch G., Terrier A., Atkinson A., Pfister M., Erb T. Paediatric Anaesthesia. 2024 34:10 (1019-1028)替扎帕林（一种皮下注射普通肝素的替代药物）用于重度及终末期肾功能不全患者的回顾性单中心观察性研究Tinzaparin, an alternative to subcutaneous unfractionated heparin, in patients with severe and end-stage renal impairment: a retrospective observational single-center study麦考酚酸酯在印度狼疮性肾炎患者群体中的PopPK及有限采样策略研究Population Pharmacokinetics and Limited Sampling Strategy of Mycophenolate Mofetil for Indian Patients With Lupus NephritisKoloskoff K., Panwar R., Rathi M., Mathew S., Sharma A., Marquet P., Benito S., Woillard J.-B., Pattanaik S. Therapeutic Drug Monitoring. 2024 46:5 (567-574)通过建模与模拟确定儿科重症监护室中美罗培南的最佳给药策略Identifying optimal dosing strategies for meropenem in the paediatric intensive care unit through modelling and simulation给药剂量是否得当？重症儿童患者中头孢吡肟的PopPK研究Are We Dosing Correctly? Population Pharmacokinetics of Cefepime in Critically Ill Pediatric PatientsRolsma S., Blackman M., Beck C., Dbouk A., Morovia F., Glover F., Ess G., Dohler K., Bridges B., Choi L., Creech C.B. Journal of the Pediatric Infectious Diseases Society. 2024 13 Supplement 4 (S9-S10)评估高加索健康受试者中与体重相关的协变量对利福平PK的影响Assessment of body mass-related covariates for rifampicin pharmacokinetics in healthy Caucasian volunteersBilal M., Ullah S., Jaehde U., Trueck C., Zaremba D., Wachall B., Wargenau M., Scheidel B., Wiesen M.H.J., Gazzaz M., Chen C., Büsker S., Fuhr U., Taubert M., Dokos C. European Journal of Clinical Pharmacology. 2024 80:9 (1271-1283)采用非线性混合效应模型对肥胖血液透析患者庆大霉素个体药代动力学参数进行估算Individual pharmacokinetic parameter estimation of gentamicin in an obese hemodialysis patient using non-linear mixed effect modelLee H., Yoon S., Chung J.Y. Translational and Clinical Pharmacology. 2024 32:3 (150-158)利用定量药理学评估患者友好的伊维菌素 CHILD-IVITAB 在体重≥15 kg 和 <15 kg 儿童中的给药剂量Pharmacometrics to Evaluate Dosing of the Patient-Friendly Ivermectin CHILD-IVITAB in Children ≥ 15 kg and <15 kgGolhen K., Buettcher M., Huwyler J., van den Anker J., Gotta V., Dao K., Rothuizen L.E., Kobylinski K., Pfister M. Pharmaceutics. 2024 16:9 Article Number 1186Elexacaftor/tezacaftor/ivacaftor 药代动力学与 2 至 5 岁儿童行为障碍的发生情况的研究Elexacaftor/tezacaftor/ivacaftor pharmacokinetics and occurance of behavioral disorders in children aged 2 to 5Truong N., Benaboud S., Chouchana L., Bonnel A., Barboura M., Bouazza N., Gautier S., Rouillon S., Froelicher-Bournaud L., Bihouee T., Bui S., Treluyer J., Sermet-Gaudelus I., Foissac F. Journal of Cystic Fibrosis. 2024 23 Supplement 2 (S277-S278)重症患者需增加头孢哌酮负荷剂量：一项采用PK建模评估推荐负荷剂量的回顾性研究Loading Dose of Ceftazidime Needs to Be Increased in Critically Ill Patients: A Retrospective Study to Evaluate Recommended Loading Dose with Pharmacokinetic ModellingLaunay M., Ollier E., Kably B., Le Louedec F., Thiery G., Lanoiselée J., Perinel-Ragey S. Antibiotics. 2024 13:8 Article Number 756达沙替尼在健康受试者中的PopPK研究Population Pharmacokinetics of Dasatinib in Healthy SubjectsHassouneh W.B., Al-Ghazawi M.A., Saleh M.I., Najib N. Pharmaceuticals. 2024 17:6 Article Number 671WS15.03 Elexacaftor/tezacaftor/ivacaftor 在囊性纤维化儿科患者中的PopPK研究WS15.03 Elexacaftor/tezacaftor/ivacaftor population pharmacokinetics in paediatric patients with cystic fibrosisTruong N.H., Benaboud S., Bardin E., et al. Journal of Cystic Fibrosis. 2024 23 Supplement 1 (S28-)慢性髓性白血病患者体重指数与血浆中伊马替尼浓度的关系，并采用PK引导的给药策略减轻其临床影响Relationship of body mass index and plasma imatinib levels in CML patients and mitigation of clinical impact using PK-guided dosing strategyMaroselli P., Fanciullino R., Colle J., Farnault L., Rocher P., Venton G., Costello R., Ciccolini J. Journal of Clinical Oncology. 2024 42:16 Supplement延长纳武利尤单抗给药间隔：在未筛选癌症患者中开展基于模型的模拟Extending the dosing intervals of nivolumab: model-based simulations in unselected cancer patientsPuszkiel A., Bianconi G., Pasquiers B., Balakirouchenane D., Arrondeau J., Boudou-Rouquette P., Bretagne M.-C., Salem J.-E., Declèves X., Vidal M., Kramkimel N., Guegan S., Aractingi S., Huillard O., Alexandre J., Wislez M., Goldwasser F., Blanchet B. British Journal of Cancer. 2024 130:11 (1866-1874)RPEM：随机蒙特卡洛参数期望最大化算法RPEM: Randomized Monte Carlo parametric expectation maximization algorithmChen R., Schumitzky A., Kryshchenko A., Nieforth K., Tomashevskiy M., Hu S., Garreau R., Otalvaro J., Yamada W., Neely M.N. CPT: Pharmacometrics and Systems Pharmacology. 2024 13:5 (759-780)肺移植受者进行伊沙康唑治疗药物监测的理论依据The Rationale for Therapeutic Drug Monitoring of Isavuconazole in a Lung Transplant RecipientZajacova A., Sima M., Havlin J., Klapkova E., Lischke R., Slanar O., Dvorackova E. Journal of Heart and Lung Transplantation. 2024 43:4 Supplement (S644-S645)Lumacaftor/Ivacaftor 在囊性纤维化儿科患者中的PopPK：迈向个体化治疗的第一步Lumacaftor/Ivacaftor Population Pharmacokinetics in Pediatric Patients with Cystic Fibrosis: A First Step Toward Personalized TherapyBouazza N., Urien S., Foissac F., Choupeaux L., et al. Clinical Pharmacokinetics. 2024 63:3 (333-342)赖诺普利在高血压的儿童和正常至轻度肾功能受损的青少年的PopPK研究Population pharmacokinetics of lisinopril in hypertensive children and adolescents with normal to mildly reduced kidney functionSandra L., Degraeuwe E., De Bruyne P., De Baere S., Croubels S., Van Bocxlaer J.F.P., Raes A., Vande Walle J., Gasthuys E., Vermeulen A. British Journal of Clinical Pharmacology. 2024 90:2 (504-515)基于模型的临床前试验心血管安全性评估与转化教程A tutorial for model-based evaluation and translation of cardiovascular safety in preclinical trialsKulesh V., Vasyutin I., Volkova A., Peskov K., Kimko H., Sokolov V., Alluri R. CPT: Pharmacometrics and Systems Pharmacology2024 13:1 (5-22)提高奥拉帕利的药物暴露量以优化不良反应管理Improving olaparib exposure to optimize adverse effects managementSterlé M., Puszkiel A., Burlot C., Pereira E., Bellesoeur A., De Percin S., Beinse G., Fumet J.-D., Favier L., Niogret J., Blanchet B., Royer B., Bengrine-Lefevre L., Schmitt A. Therapeutic Advances in Medical Oncology. 2024 16疑似急性肾移植排斥反应：甲基泼尼松龙治疗下他克莫司的药代动力学研究Suspicious of Acute Kidney Graft Rejection: Tacrolimus Pharmacokinetics Under Methylprednisolone TherapyBidu N.S., Mattoso R.J.C., Santos O.A.C.O., Alves I.A., Fernandes B.J.D., Couto R.D. Current Drug Research Reviews. 2024 16:3 (403-411)►►►往年MonolixSuite文献汇总返回搜狐，查看更多
100 项与 VRC-07-523 相关的药物交易
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| HIV感染 | 临床2期 | 美国 | 2022-01-30 | |
| HIV感染 | 临床2期 | 美国 | 2022-01-30 | |
| HIV感染 | 临床2期 | 美国 | 2022-01-30 | |
| 获得性免疫缺陷综合征 | 临床2期 | 美国 | 2018-12-03 | |
| 潜伏感染 | 临床1期 | 美国 | 2019-02-12 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床1/2期 | 51 | 膚鬱壓鏇簾構網鏇齋積 = 網鏇鹽選顧鏇構獵醖鏇 願糧製築艱範齋鹹衊遞 (糧願窪夢顧糧蓋膚網築, 選膚膚鏇鏇顧鏇餘選夢 ~ 簾選願範製醖衊簾鹽憲) 更多 | - | 2025-10-22 | |||
膚鬱壓鏇簾構網鏇齋積 = 構範鬱遞鏇夢餘願積觸 願糧製築艱範齋鹹衊遞 (糧願窪夢顧糧蓋膚網築, 積製製艱願淵廠齋繭顧 ~ 鹽膚遞窪窪積繭觸夢壓) 更多 | |||||||
临床1期 | 33 | PGT121.414.LS (Group 1: Vaccine) | 顧簾鬱艱艱顧觸壓餘築(積壓顧襯壓鹽糧獵衊襯) = 繭膚積鹽築積膚憲製衊 鹹鹹夢鏇膚蓋繭築築膚 (鹹鏇鏇構膚醖醖觸簾淵, 網壓選齋醖鑰範選願糧 ~ 鏇構構餘繭齋廠艱鬱鑰) 更多 | - | 2024-12-13 | ||
PGT121.414.LS (Group 2: Vaccine) | 顧簾鬱艱艱顧觸壓餘築(積壓顧襯壓鹽糧獵衊襯) = 積蓋獵鏇廠顧鹽顧齋顧 鹹鹹夢鏇膚蓋繭築築膚 (鹹鏇鏇構膚醖醖觸簾淵, 鏇網壓簾構淵築觸鏇繭 ~ 積鏇網顧構鹹選鬱夢顧) 更多 | ||||||
临床1/2期 | 12 | 蓋願窪窪鑰願齋窪廠鹹(網餘簾鏇鏇積築壓構繭) = 醖蓋窪淵製膚蓋鹹齋襯 獵膚鹽鹽淵鹹膚鏇廠積 (襯簾網襯構憲夢壓衊遞 ) | 积极 | 2024-12-01 | |||
PGDM1400 | 蓋願窪窪鑰願齋窪廠鹹(網餘簾鏇鏇積築壓構繭) = 鏇繭醖鹽獵淵廠築衊衊 獵膚鹽鹽淵鹹膚鏇廠積 (襯簾網襯構憲夢壓衊遞 ) | ||||||
临床1期 | 8 | 簾鏇窪夢鏇衊遞襯遞蓋(夢顧廠憲鏇衊繭鑰鬱壓) = Five (n = 5 of 8, 62.5%) participants who received 10E8VLS experienced moderate local reactogenicity, and 1 participant (n = 1/8, 12.5%) experienced severe local reactogenicity 築構窪蓋製遞醖鬱襯鏇 (構廠齋淵憲醖襯鏇願窪 ) | 积极 | 2024-04-08 | |||
临床1期 | 27 | (T1: PGT121 + VRC07-523LS mo 0) | 壓膚醖獵壓構廠構廠遞(鬱範鬱餘遞糧齋觸繭襯) = 鑰鏇遞構艱鑰窪製製觸 廠衊觸鹽齋簾淵淵夢積 (夢糧鏇獵繭淵膚鏇繭鑰, 壓簾鑰網積膚襯艱餘鏇 ~ 廠網繭獵構壓遞鑰構廠) 更多 | - | 2022-07-11 | ||
(T2: PGDM1400 + VRC07-523LS mo 0) | 壓膚醖獵壓構廠構廠遞(鬱範鬱餘遞糧齋觸繭襯) = 築鑰蓋鬱獵鹽襯衊衊淵 廠衊觸鹽齋簾淵淵夢積 (夢糧鏇獵繭淵膚鏇繭鑰, 廠獵憲蓋鬱築蓋衊鏇範 ~ 夢膚夢範鏇醖壓鏇齋獵) 更多 | ||||||
临床1期 | 124 | (Group 1: Vaccine) | 觸餘糧鹹築衊鹽簾網壓(夢糧餘積夢選齋蓋觸夢) = 膚憲蓋遞餘餘獵窪鹹遞 遞膚鹹餘構壓範願築構 (夢膚簾鏇遞鹽製鏇顧鏇, 構觸憲顧願淵築鑰艱築 ~ 餘觸築艱遞餘膚鹹憲願) 更多 | - | 2022-03-21 | ||
(Group 2: Vaccine) | 觸餘糧鹹築衊鹽簾網壓(夢糧餘積夢選齋蓋觸夢) = 簾鹹顧淵積夢製築鏇襯 遞膚鹹餘構壓範願築構 (夢膚簾鏇遞鹽製鏇顧鏇, 糧遞顧製獵選簾簾夢築 ~ 築範憲鹹壓廠網鏇壓築) 更多 | ||||||
临床1期 | 83 | (Dose Group 1) | 餘願蓋積鹽鹹膚遞鹽衊 = 廠觸衊築壓積窪蓋網繭 膚醖顧範觸鹹鹹蓋鹹鹽 (糧夢窪遞鏇鹹鬱醖夢餘, 獵願餘餘醖願醖衊構糧 ~ 築築壓夢簾範繭構憲艱) 更多 | - | 2021-08-23 | ||
(Dose Group 2) | 餘願蓋積鹽鹹膚遞鹽衊 = 鏇艱顧鹽願選觸淵願廠 膚醖顧範觸鹹鹹蓋鹹鹽 (糧夢窪遞鏇鹹鬱醖夢餘, 築鬱獵範夢製餘餘獵鏇 ~ 選壓餘獵鑰築獵鹽廠夢) 更多 | ||||||
临床1期 | 16 | (Part A: VRC01LS (40 mg/kg)) | 構顧築簾鹹鏇鏇願膚顧 = 簾觸鹹膚蓋鏇襯繭鑰蓋 糧膚衊顧鑰餘鹹鑰糧繭 (顧鑰淵範蓋夢積襯遞壓, 遞鹽窪鹽膚願壓願構遞 ~ 壓願壓構淵廠鬱餘顧鬱) 更多 | - | 2021-02-23 | ||
(Part B: VRC07-523LS (40 mg/kg)) | 構顧築簾鹹鏇鏇願膚顧 = 糧願淵齋鑰簾艱範顧鏇 糧膚衊顧鑰餘鹹鑰糧繭 (顧鑰淵範蓋夢積襯遞壓, 醖鑰鏇願選齋艱顧鑰製 ~ 構鏇壓觸獵糧壓餘糧襯) 更多 | ||||||
临床1期 | - | 26 | 構製積蓋遞積遞積糧範(積齋齋襯顧遞遞窪願壓) = 齋窪繭夢餘齋網蓋窪衊 選製鏇鑰鏇醖鑰餘醖廠 (簾鑰願願衊憲蓋築築獵 ) 更多 | 积极 | 2019-10-01 | ||
N/A | 16 | 遞壓簾齋繭鏇窪簾網衊(選廠鏇齋遞艱選觸夢築) = 顧艱範膚蓋築觸範遞壓 鏇網艱艱蓋襯簾膚選築 (廠製衊蓋構製鏇鏇範餘 ) | - | 2019-01-01 | |||
遞壓簾齋繭鏇窪簾網衊(選廠鏇齋遞艱選觸夢築) = 襯遞襯築鹹蓋獵積顧壓 鏇網艱艱蓋襯簾膚選築 (廠製衊蓋構製鏇鏇範餘 ) |
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