Bacterial Decolonization Plus Intraoperative Indocyanine Green Angiography for Soft Tissue Sarcomas of the Lower Extremity Receiving Preoperative Radiotherapy (CONCERTO)

This trial will investigate the combination of two low-cost, non-toxic strategies to assess whether they can reduce the risk of acute major wound complications in soft tissue sarcoma of the lower extremity. Intranasal mupirocin ointment twice daily and chlorhexidine body cleanser once daily for 5 days prior to radiation therapy and repeated for 5 days every 2 weeks during radiation therapy may significantly reduce the risk of acute radiation dermatitis. That, along with use of indocyanine green (ICG) angiography at the time of wound closure.

开始日期2026-09-30

申办/合作机构

University of Pittsburgh

NCT07635433

/ Not yet recruiting早期临床1期IIT

A Single-Centre, Randomised, Double-Blind, Placebo-Controlled Exploratory Clinical Study of a Thermosensitive Gel Nasal Spray Loaded With Umbilical Cord Mesenchymal Stem Cell Exosomes, Mupirocin and DNase I for the Treatment of Chronic Rhinosinusitis (Chronic Type Without Polyps)

This study tests a new nasal spray for adults (18-65 years) with chronic rhinosinusitis (CRS) without nasal polyps. The spray contains a temperature-sensitive gel (thermosensitive gel) that turns into a soft gel inside the nose to slowly release three active ingredients: human umbilical cord mesenchymal stem cell exosomes (hUC-MSC-Exo) to help heal the nasal lining, mupirocin (an antibiotic that kills Staphylococcus aureus bacteria), and DNase I (an enzyme that breaks down thick mucus). The study aims to check the safety of this triple combination and see if it can reduce infection, clear mucus, and improve symptoms. Participants will be randomly assigned to one of three groups: triple spray, a dual spray (without exosomes), or a placebo (gel only). The treatment is used twice daily for 4 weeks, with follow-up visits up to day 90. The study is single-centre, double-blind, and placebo-controlled. Outcome measures include safety (adverse events graded by Common Terminology Criteria for Adverse Events version 5.0, CTCAE v5.0), bacterial clearance rate, changes in nasal endoscopy score (Lund-Kennedy), quality of life (Sino-Nasal Outcome Test-22, SNOT-22), and nasal symptom visual analog scale (VAS).

开始日期2026-07-01

申办/合作机构

The First Affiliated Hospital of Xinxiang Medical College

NCT07524894

/ Not yet recruiting临床2期IIT

Staph Nasal Decolonization to Improve Function and Feeding: A Randomized Clinical Trial (SNIFF)

Radiation therapy is a type of treatment that involves using radiation beams targeted at a cancer to destroy the cancer cells or slow their growth. This type of treatment has helped many cancer patients for decades and is intended to kill cancer cells directly. Patients with head and neck cancer are commonly treated with radiation, sometimes after surgery and sometimes the radiation is delivered with chemotherapy at the same time. Radiation treatments have side effects, and the treating oncologist works with each patient to determine the best treatment and manage the side effects.
It has been shown that one of these side effects of radiation is irritation or "sunburn" of the lining of the mouth and throat (radiation mucositis), which can cause difficult or painful swallowing, and pain/discomfort in the mouth/throat. These side effects can lead to dehydration, and weight loss, and sometimes can lead to hospital admissions and treatment delays. This is usually treated by the prescription of pain relievers, dietician support and, if necessary, nutrition via a tube (G-tube).
Because of these symptoms involving the mouth and throat, researchers are looking to study the effect of a common ointment antibiotic used to reduce an infection known as Staphylococcus Aureus. The infection is commonly located in the front of the nose, and during treatment this infection can travel from the nose to the throat and worsen the radiation mucositis and the pain it causes. The study will measure if a course of ointment antibiotic in the nose (twice per day, 5 days on, 5 days off, repeated) can reduce your pain during treatment by reducing severe mucositis related to Staphylococcal infection. This study compares the effects of the study treatment with a "placebo," which looks the same but does not contain any active medicine. Neither you nor your doctor will know which one you are receiving until the study ends. The antibiotic used in the study arm is being used "off-label" for intranasal application (it is normally used to treat skin infections). Possible side effects include local skin irritation or allergic reactions, and in rare cases, a severe allergic response (anaphylaxis).

开始日期2026-06-01

申办/合作机构-

100 项与莫匹罗星相关的临床结果

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100 项与莫匹罗星相关的转化医学

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100 项与莫匹罗星相关的专利（医药）

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2,705

项与莫匹罗星相关的文献（医药）

2026-12-01·MOLECULAR BIOLOGY REPORTS

Decoding the biotic networks and functional potential of seamount sediments in the Arabian sea

Article

作者: Shambhugowda, Yashwanth Belathur ; Girijan, Sneha Kalasseril ; Sankar, Senthil Alias ; Busala, Siva Kiran Kumar ; Narayanane, Saravanane

BACKGROUND:

The Arabian Sea is ecologically and environmentally significant due to its high biotic diversity and its potential role as a reservoir of emerging resistance determinants. However, molecular-level insights into the taxonomic composition, functional potential, and resistome of sediment associated communities from deep-sea seamount sediments remain limited.

METHODS AND RESULTS:

A metagenomic approach was employed to investigate the biotic composition, metabolic potential, resistome profiles, and physicochemical characteristics of two seamount sediment samples (SM1 and SM7) collected from the Arabian Sea. Distinct environmental conditions were observed, with SM1 enriched in inorganic nitrogen, whereas SM7 exhibited higher organic carbon content and pigment concentrations, indicating differences in substrate availability. These variations were consistent with differences in the community structure, with SM1 harbouring a less diverse assemblage dominated by Actinomycetota and fungi, while SM7 supported a broader community comprising Actinomycetota, diverse fungi, protists, metazoans, and a richer viral component. Functional annotation revealed enrichment of nitrogen metabolism pathways in SM1, whereas SM7 showed increased representation of carbohydrate metabolism and a higher proportion of novel gene content. Both sediment samples encoded antibiotic and heavy metal resistance genes; however, SM7 exhibited greater abundance and diversity of putative resistance-associated genes, including resistance to mupirocin, triclosan, and sulfonamides, along with broader metal resistance and stress response genes.

CONCLUSIONS:

The results based on two samples demonstrate pronounced sample specific variation in community structure, metabolic potential, and resistome profiles across Arabian Sea seamount sediments. These findings highlight Arabian Sea deep-sea sediments as important molecular reservoirs of microbial diversity and adaptive potential shaped by local environmental conditions.

2026-10-01·TISSUE & CELL

Topical eucalyptol accelerates the healing of MRSA-infected diabetic wounds in rats by regulating TLR4, NF-κB, VEGFA and MMP-9 pathways

Article

作者: Kirgiz, Omer ; Bayraktar, Hamdullah Suphi̇ ; Gokcek, Ishak ; Kirgiz, Fatma Ceren ; Akcakavak, Gokhan ; Alakus, Hali̇l ; Kazak Akcakavak, Fi̇li̇z ; Alakus, Ibrahi̇m ; Ceylan, Eren ; Karatas, Ozhan

BACKGROUND:

Diabetic-infected wounds are complex conditions that cause chronic inflammation that is difficult to heal. Although eucalyptol (1.8 cineole) has been shown to have antimicrobial, antioxidative and anti-inflammatory properties, its effectiveness in diabetic-infected wounds has not yet been proven.

METHODS:

In this study, 35 male Wistar albino rats were induced with streptozotocin and inoculated with methicillin-resistant Staphylococcus aureus (MRSA) after full-thickness skin wounds were inoculated. The animals were randomly assigned into five groups: Control (C), Vehicle (V), 2% Mupirocin (M), 5% topical eucalyptol (E5), and 10% topical eucalyptol (E10). Treatments were applied twice daily for 21 days (n = 7 per group). Wound areas, quantitative tissue cultures (CFU/g), oxidative stress parameters malondialdehyde (MDA), glutathione (GSH), catalase (CAT), glutathione peroxidase-1 (GPx1) histopathological and immunohistochemical changes (edema, inflammatory infiltration, angiogenesis, re-epithelialization, granulation/vascular endothelial growth factor A (VEGFA), matrix metalloproteinase-9 (MMP-9), nuclear factor kappa B (NF-κB), and toll-like receptor 4 (TLR4) were examined.

RESULTS:

The current results showed that MDA levels decreased and GSH, CAT and GPx1 levels increased in the E5 and E10 groups compared to the control group. On the other hand, histopathologically, it was determined that edema and inflammatory infiltration decreased and angiogenesis, reepithelialization and granulation tissue formation processes increased in the E5 and E10 groups compared to the control group. Additionally, immunohistochemical findings revealed that E5 and E10 groups caused downregulation of TLR4, NF-κB and MMP-9 protein expressions and upregulation of VEGFA protein expression.

CONCLUSION:

Taken together, the present results have been shown that topical eucalyptol application reduces the bacterial load in MRSA-infected diabetic wounds, alleviates oxidative stress and inflammation at the cellular level, and promotes angiogenesis and extracellular matrix remodeling, thus promoting faster and more regular wound healing.

2026-07-03·Journal of Drug Targeting

Mupirocin-nanoemulsion infused salicylic acid gel utilizing nigella sativa oil for treatment of imiquimod-induced psoriasis in mice

Article

作者: Siddique, Ayesha ; Abbas, Mohd Haider ; Mirza, Mohd Aamir ; Farooq, Uzma ; Iqbal, Zeenat ; Rehman Hamidullah, Chaudhary Abdur ; Mohapatra, Sradhanjali ; Ali, Ahsan ; Jain, Pooja ; Khatkar, Diksha

Psoriasis is an autoimmune dermal disease characterised by inflammation that results in excessive keratinocyte proliferation. The current topical therapies struggle to penetrate the keratinised layer to reach the targeted area. A combinatorial therapy was employed to reverse inflammatory expression and cellular infiltration. Salicylic acid (SA) provides a keratolytic effect by softening and removing the thickened layer of keratin to facilitate better absorption of the Mupirocin-loaded nanoemulsion (MUP-NE), supplemented by black seed oil, where MUP inhibits tRNA synthetase, aiding in psoriasis management. In our studies, MUP-NE was developed and optimised using central composite design (CCD), resulting in an average globule size of 86.56 nm, PDI of 0.3479 and transmittance of 89.68 ± 0.32%, further incorporated into SA-gel (MUP-SA-NEG). The in-vitro and ex-vivo studies demonstrated targeted delivery of SA to the epithelial layer and deeper penetration of MUP via nanocarriers. Pharmacodynamic studies were subsequently performed using a psoriasis-induced mice model, PASI (Psoriasis Area and Severity Index) assessment on treated mice showed prominent reduction in keratinised scales, inflammation, and epithelial thickness of the skin tissue. Histopathological and immune-histology revealed notable recovery in the MUP-SA-NEG group of mice in comparison with the control and conventional treatment groups. These findings align with promising clinical acceptability.

212

项与莫匹罗星相关的新闻（医药）

2026-07-02

·AI的铭熠

医院药学研究第5期（总第25期）: Pharmacoepidemiology and Drug Safety

来源：Pharmacoepidemiology and Drug Safety (Pharmacoepidemiol Drug Saf) 医院药学研究第5期（总第25期）本期聚焦药物流行病学与用药安全领域的最新研究成果，涵盖大规模药物性肝损伤住院风险的筛查、真实世界中直接口服抗凝药的出血风险比较、质子泵抑制剂长期使用的安全性评估、多药联用与药物相互作用的不良结局分析以及处方级联的识别与管理等与医院药学安全实践密切相关的原创研究与系统评价。 ◆ 论文目录（中英对照） 1. [Original Research] High-Throughput Screening Using the Self-Controlled Tree-Based Scan Statistic to Identify Medications Associated With Hospitalization for Severe Acute Liver Injury 采用自身对照树状扫描统计方法高通量筛选与严重急性肝损伤住院相关的药物 2. [Original Research] Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the Clinical Practice Research Datalink (CPRD) 使用临床实践研究数据库的自体对照病例序列联合活性对照方法在药物安全信号检测中的性能评价 3. [Original Research] Predictors of Direct Oral Anticoagulant Use in Northern Italy: A Population-Based Study 北意大利直接口服抗凝药使用的预测因素：一项基于人群的研究 4. [Original Research] Measuring Exposure to Opioids Using Self-Reported Medication Use Data Versus General Practitioner Prescription Records in the UK Biobank Study 英国生物银行研究中自我报告用药数据与全科医师处方记录在阿片类药物暴露测量中的比较 5. [Systematic Review] Efficacy and Safety of All Monoclonal Antibodies in Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis 单克隆抗体治疗中重度特应性皮炎的疗效与安全性：系统综述与网络荟萃分析 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎Original Research High-Throughput Screening Using the Self-Controlled Tree-Based Scan Statistic to Identify Medications Associated With Hospitalization for Severe Acute Liver Injury Pharmacoepidemiol Drug Saf 丨 2025-12-XX 丨 Original Research ▍采用自身对照树状扫描统计方法高通量筛选与严重急性肝损伤住院相关的药物研究背景药物性肝损伤（DILI）是导致药物撤市和药物相关住院的重要原因之一。传统上，肝毒性信号主要通过病例报告来识别，存在滞后性和低敏感性等局限。随着真实世界数据（RWD）的广泛应用，高通量筛查方法为早期识别潜在的肝毒性药物提供了新的可能。树状扫描统计方法（TreeScan）是一种数据驱动的主动监测方法，可在无预设假设的情况下同时筛查大量药物-不良事件关联。本研究利用美国退伍军人健康管理局（VHA）数据库，采用自身对照病例交叉设计，系统评估了TreeScan在无肝胆疾病患者和慢性肝病患者中识别严重急性肝损伤相关药物的性能，为医院药物安全管理提供了重要的方法学参考和临床证据。核心发现 • 在12,860名无肝胆疾病和17,512名慢性肝病住院严重ALI患者中，分别评估了与450种和543种药物的潜在关联 • 无明显肝病患者中，雷尼替丁、奥美拉唑、昂丹司琼等药物与严重ALI显著相关；慢性肝病患者中，螺内酯、呋塞米、多种阿片类镇痛药和昂丹司琼等均与严重ALI显著相关 • 抗菌药物（阿莫西林/克拉维酸、环丙沙星、甲硝唑等）在两类患者中均显示出肝毒性信号 • 树状扫描统计方法作为一种高通量筛查工具，能够有效检测潜在肝毒性药物，为后续药物流行病学研究提供候选药物领域意义本研究为医院药学实践提供了重要的药物肝毒性风险信息。研究识别出的一系列可能与严重急性肝损伤相关的药物，涵盖了医院常用药如质子泵抑制剂（奥美拉唑）、止吐药（昂丹司琼）、利尿剂（螺内酯、呋塞米）和抗菌药物等，提醒医院药师在处方审核和药学监护中需特别关注这些药物的肝毒性风险。基于TreeScan的高通量筛查方法为医院建立主动式药物安全监测体系提供了新思路。对于已有肝病基础的患者群体，研究结果强调了更严格用药管理的重要性，有助于医院药学部门优化肝病患者用药方案。英文摘要 (Abstract) Background: Medications associated with acute liver injury (ALI) are primarily identified by case reports. High-throughput screening of real-world data could be leveraged to detect hepatotoxicity signals. Objective: To apply tree-based scan statistics in real-world data to identify drugs associated with hospitalization for severe ALI among patients without liver/biliary disease and with chronic liver disease (CLD). Methods: We implemented a self-controlled case-crossover design in Veterans Health Administration data (2000-2023) among patients hospitalized for laboratory-confirmed severe ALI. We identified all newly dispensed drugs within 365 days prior to their hospitalization and used conditional Bernoulli tree-based scan statistics to identify potential associations (p < 0.3). We performed analyses separately in patients without liver/biliary disease and with CLD. Results: Among 12,860 patients without liver/biliary disease and 17,512 with CLD hospitalized for severe ALI, we evaluated associations with 450 and 543 drugs, respectively. Drugs associated with severe ALI among patients without liver/biliary disease included: acid-suppressives (ranitidine [p < 0.001], omeprazole [p = 0.004]), antiemetics (ondansetron [p < 0.001], promethazine [p = 0.06]), antibiotics (amoxicillin/clavulanate [p = 0.008], ciprofloxacin [p = 0.02], mupirocin [p = 0.032], ethambutol [p = 0.275]), anticoagulants (heparin [p = 0.015]), and chemotherapy (pazopanib [p = 0.275]). Drugs associated with severe ALI among CLD patients were: diuretics (spironolactone, furosemide [both p < 0.001]), antiemetics (ondansetron, metoclopramide, promethazine [all p < 0.001]), appetite stimulants (p < 0.001), analgesics (morphine, oxycodone, fentanyl [all p < 0.001]), chemotherapy (sorafenib [p < 0.001]), antibiotics (ciprofloxacin [p = 0.011], metronidazole [p = 0.020]), antipsychotics (prochlorperazine [p = 0.105]), vitamins (p = 0.134), acid-suppressives (omeprazole [p = 0.164]), and gastrointestinal/liver disease treatments (lactulose, senna, docusate, silicones, antiflatulents [all p < 0.001]; sucralfate [p = 0.005], albumin [p = 0.228]). Conclusions: High-throughput screening using tree-based scan statistics detected potentially hepatotoxic drugs for investigation in future pharmacoepidemiology studies. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎Original Research Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the Clinical Practice Research Datalink (CPRD) Pharmacoepidemiol Drug Saf 丨 2025-12-XX 丨 Original Research ▍使用临床实践研究数据库的自体对照病例序列联合活性对照方法在药物安全信号检测中的性能评价研究背景药物安全信号检测是药物警戒的核心环节，及时准确地识别潜在的药品不良反应信号对于保障患者用药安全至关重要。基于电子健康档案（EHR）的真实世界数据为药物安全信号检测提供了丰富的资源，但如何在真实世界数据中实现高灵敏度和高特异性的信号检测仍是一个方法学挑战。自体对照病例序列（SCCS）设计因其可控制个体间混杂因素而备受关注，而引入活性对照可能进一步控制适应证导致的混杂偏倚。本研究以英国临床实践研究数据库（CPRD Aurum）为数据源，系统评价了SCCS设计在有无活性对照条件下的信号检测性能，为基于电子健康档案的药物警戒方法学发展提供了重要证据。核心发现 • 构建了包含104个阳性对照和58个阴性对照的参考标准集，确保药物-结局配对在理论上适合SCCS设计 • 无活性对照的SCCS灵敏度为0.57、特异度为0.77；加入活性对照后特异度提高至0.89，但灵敏度下降至0.18 • 5个药物-结局配对在出现在药品标签之前即被SCCS方法识别为不平衡信号 • 使用大环内酯类和氟喹诺酮类抗生素作为目标药物，阿莫西林和头孢氨苄作为活性对照，覆盖全部器官类别的30个结局领域意义本研究对医院药物警戒工作具有直接的方法学指导价值。SCCS设计在CPRD数据库中展现出中等水平的信号检测性能，为医院药物不良反应监测提供了可借鉴的分析框架。研究表明活性对照可有效减少适应证混淆，但可能因统计效力下降而降低阳性信号的检出能力，这为医院药学科在真实世界药物安全研究中平衡特异度和灵敏度提供了重要参考。该方法学框架可应用于医院电子病历系统的药物不良反应主动监测中，帮助临床药师更精确地识别潜在药物安全问题。英文摘要 (Abstract) Background: There is little evidence about signal detection using UK primary care electronic health records (EHRs). The self controlled case series (SCCS) is one of the most promising methods for drug safety signal detection using real world data, and incorporating active comparators could potentially improve its performance by addressing confounding by indication. Objectives: This study aims to evaluate the performance of the SCCS with and without active comparators for signal detection using the UK Clinical Practice Research Datalink (CPRD) Aurum. Methods: We applied the SCCS to macrolide and fluoroquinolone antibiotics, using amoxicillin and cefalexin as active comparators. In total seven drugs, and 30 outcomes from all organ classes were selected. We developed a reference set of 104 positive controls and 58 negative controls, using a taxonomy framework to ensure the selected drug outcome pairs are theoretically well suited to the SCCS design. Two-year observation periods with a 30-day risk window after each dispensing were used. Diagnostic performance was measured using sensitivity and specificity with respect to the product labels. Results: The sensitivity and specificity of the SCCS without active comparator in the 2017/2018 observation period were 0.57 and 0.77 when limited to pairs with satisfactory power. Specificity increased up to 0.89 with active comparators, however sensitivity decreased to 0.18. Five drug-outcome pairs were signals of disproportionality before they were present on labels. Conclusions: Using a carefully designed reference set of drug-outcome pairs well suited to the study design, the SCCS performed moderately well for signal detection in CPRD. Whilst active comparators effectively reduced confounding by indication, they also reduced the number of correctly identified positive controls, due to a reduction in power. We showed some evidence that SCCS is able to highlight SDRs before they were present on labels. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎Original Research Predictors of Direct Oral Anticoagulant Use in Northern Italy: A Population-Based Study Pharmacoepidemiol Drug Saf 丨 2025-12-XX 丨 Original Research ▍北意大利直接口服抗凝药使用的预测因素：一项基于人群的研究研究背景直接口服抗凝药（DOACs）已成为房颤和静脉血栓栓塞症抗凝治疗的主流选择。然而，不同DOACs（阿哌沙班、利伐沙班、达比加群、艾多沙班）之间的头对头比较证据有限，临床实践中DOAC选择和转换的驱动因素尚不明确。临床指南通常不会明确推荐某一种DOAC优于其他DOAC，但在真实世界的处方实践中可能存在特定的处方模式。了解影响临床决策的因素对于优化抗凝治疗管理、促进合理用药和识别潜在的不当处方模式具有重要意义。本研究利用意大利伦巴第大区的卫生行政数据库，分析了2019-2022年间近16万例新起始DOAC使用者的处方模式、预测因素和转换情况。核心发现 • 共识别159,993名DOAC新使用者，阿哌沙班使用比例从29.0%上升至34.3%，而达比加群从20.7%下降至11.5% • 高龄和女性性别是艾多沙班处方的预测因素；合并症主要与阿哌沙班使用相关；缺血性心脏病或心梗病史者优先使用达比加群 • DOAC总体转换率为5.6%，阿哌沙班是最常被选择的第二种DOAC；达比加群主要在有血管缺血性事件后被选为第二种DOAC • 有出血史的患者优先被处方阿哌沙班和艾多沙班，外周动脉疾病患者倾向于使用利伐沙班领域意义本研究为医院药学中抗凝药物管理提供了重要的真实世界证据。了解不同DOAC的处方预测因素有助于医院药师在抗凝治疗方案的制定和评估中发挥更积极的作用。研究发现阿哌沙班的处方偏好呈上升趋势，而达比加群使用量下降，这反映了真实临床实践中对抗凝药物的风险-获益评估趋势。出血史患者优先使用阿哌沙班和艾多沙班的模式提示临床医生对特定DOAC安全性的认知在影响处方决策。这些数据有助于医院药学部门制定基于证据的抗凝药物管理策略，优化个体化抗凝治疗方案，并为医院药事管理中抗凝药物的处方审核和药学监护提供参考。英文摘要 (Abstract) Purpose: Evidence on head-to-head comparison between direct oral anticoagulants (DOACs) is lacking, and the reasons for choosing one type of DOAC and switching from one DOAC to another are scarce. This study investigated the use of DOACs in an unselected population in Northern Italy during a recent period. Methods: Using the health administrative database of the Lombardy region, subjects aged 45 years and older who started DOAC therapy between 2019 and 2022 were included in the analysis. Logistic regression analysis was used to evaluate predictors associated with DOAC prescription, and results were presented as ORs with 95% CI. DOAC switching was assessed by estimating the prevalence and cumulative incidence according to the first prescribed DOAC. Results: Overall, 159 993 new users for DOAC were identified. Apixaban users increased from 29.0% to 34.3%, whereas dabigatran users decreased from 20.7% to 11.5% over time. Across all pair-wise comparisons, older age and female sex were predictors for edoxaban prescription. Comorbidities were mainly associated with the use of apixaban; however, dabigatran was preferred in patients with a history of ischemic heart disease or myocardial infarction and rivaroxaban in those with peripheral artery disease. Both apixaban and edoxaban were preferentially prescribed to patients with a history of bleeding. The switching rate of DOACs was 5.6% with apixaban as the most preferred drug as a second choice. Dabigatran was mainly chosen as a second DOAC after a vascular ischaemic event. Conclusion: Given the lack of evidence on factors influencing clinician behavior in the use of DOACs, our findings provide insight into this topic in a real-world setting. As the use of these agents increases, further evidence is needed to better explore this issue. Our data could contribute to the development of recommendations in clinical practice. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎Original Research Measuring Exposure to Opioids Using Self-Reported Medication Use Data Versus General Practitioner Prescription Records in the UK Biobank Study Pharmacoepidemiol Drug Saf 丨 2025-12-XX 丨 Original Research ▍英国生物银行研究中自我报告用药数据与全科医师处方记录在阿片类药物暴露测量中的比较研究背景全球范围内阿片类药物的使用持续增长，使得研究其长期健康影响的重要性日益凸显。前瞻性队列研究通常依赖自我报告的用药数据，但这类数据可能因回忆偏倚、社会期望偏倚和药物识别能力有限等因素而存在偏差。相比之下，处方记录被视为更客观的用药暴露测量指标，但也可能遗漏非处方来源和未记录的实际使用情况。两种数据来源的一致性和差异对于药物流行病学研究的方法学质量具有重要影响。本研究利用英国生物银行（UK Biobank）大规模队列中171,813名参与者的数据，系统比较了自我报告规律用药与全科医师（GP）处方记录在阿片类药物暴露测量中的一致性。核心发现 • 自我报告规律阿片类药物使用与处方记录之间一致性为中等至实质性，过去365天内≥3张处方的一致性最佳（Cohen's Kappa = 0.66） • 镇痛类阿片类药物一致性（Kappa = 0.43-0.63）显著优于非镇痛类阿片类药物（Kappa = 0.25-0.34） • 距末次处方记录时间越长，遗漏报告（omission）的概率越高；慢性疼痛患者遗漏率最低但错误报告率（commission）最高 • 自我报告可捕获来自未关联来源的阿片类药物使用情况，对于镇痛类阿片是一个有效的暴露评估指标领域意义本研究对医院药学中的药物利用研究和阿片类药物安全管理具有重要的方法学参考价值。研究结果提示，在进行药物流行病学研究中，自我报告数据和处方记录各有优劣，应根据研究目的和药物类别选择合适的暴露测量指标。对于医院药学部门开展的阿片类药物利用评价和风险管理，本研究的发现有助于理解不同数据来源可能导致的偏倚。在评估住院患者的院外用药史时，医院药师应注意仅依赖处方记录可能低估镇痛类药物的实际使用情况，而需要综合多种信息源进行全面评估。该研究也为医院建立阿片类药物监测体系提供了方法学依据。英文摘要 (Abstract) Purpose: The ongoing global increase in opioid use necessitates studies examining long-term health impacts. Prospective cohorts frequently rely on self-reported medication use data which may be subject to several types of bias compared to more objective measurements. We evaluated the agreement between two opioid exposure measures in the UK Biobank (UKBB)-self-reported regular use and prescription-based indicators using linked general practitioner (GP) records. Methods: Our analysis included 171 813 UKBB participants with linked prescription records. At baseline, participants reported medications taken regularly (weekly, monthly, every 3 months). We assessed agreement between self-reported regular opioid use and opioid prescription records prior to enrollment across various look-back periods and prescription counts. Logistic regressions assessed factors associated with omission and commission. Results: Agreement was moderate to substantial between self-reported opioid use and prescription records. The strongest agreement was observed for ≥ 3 prescriptions in the past 365 days (Cohen's Kappa = 0.66). Subgroup analysis showed better agreement for analgesic opioids (Kappa = 0.43-0.63) than for non-analgesic opioids (Kappa = 0.25-0.34). Omission odds were highest with increasing months since the last record and lowest for individuals with chronic pain. Commission odds were highest for individuals with chronic pain and lowest in married/partnered individuals. Conclusions: This analysis indicates that self-reported regular opioid use in the UKBB could be a valid indicator for identifying individuals with repeated prescriptions for analgesic opioids in the past year, while also capturing opioid use from non-linked sources. However, agreement was low for non-analgesic opioids, suggesting limited utility of self-report for capturing use of these medications. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎Systematic Review Efficacy and Safety of All Monoclonal Antibodies in Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis Pharmacoepidemiol Drug Saf 丨 2025-12-XX 丨 Systematic Review ▍单克隆抗体治疗中重度特应性皮炎的疗效与安全性：系统综述与网络荟萃分析研究背景特应性皮炎（AD）是一种慢性、复发性炎症性皮肤病，严重影响患者生活质量。近年来，针对AD免疫病理机制的单克隆抗体（mAb）治疗迅速发展，多种新型生物制剂相继获批上市或在临床试验中展现出良好的治疗效果。然而，不同单克隆抗体之间的疗效和安全性缺乏直接的头对头比较研究，临床决策面临如何选择最优治疗方案的挑战。网络荟萃分析（NMA）作为可同时比较多种干预措施的统计学方法，为综合评估各单克隆抗体在AD治疗中的相对疗效和安全性提供了重要工具。本研究对截至2024年11月的所有相关随机对照试验进行了系统检索和网络荟萃分析。核心发现 • 纳入32项RCT共7,588例患者，全面比较了多种单克隆抗体在中重度AD中的疗效和安全性 • Spesolimab、Rademikibart、Dupilumab和Amlitelimab在EASI-50、EASI-75、EASI-90和IGA改善方面均显著优于安慰剂 • 根据SUCRA排序，Dupilumab在瘙痒NRS评分、EASI评分和SCORAD评分的百分比变化方面表现出相对较好的疗效 • Dupilumab的严重不良事件发生率显著低于安慰剂（RR = 0.43, 95% CI 0.30-0.63），其他安全性分析结果无统计学差异领域意义本系统综述对医院药学中生物制剂的管理和使用具有重要的临床指导价值。研究通过网状荟萃分析综合比较了多种单克隆抗体在AD中的相对疗效和安全性，为临床药师的药物选择和治疗方案制定提供了循证依据。Dupilumab在疗效综合排名和安全性方面表现突出，特别是其严重不良事件发生率显著低于安慰剂的发现，进一步支持了其在AD治疗中的优选地位。随着生物制剂的广泛使用，医院药学科在生物制剂的处方审核、药学监护和用药教育中需要基于最新的证据，本研究提供的比较疗效和安全性数据可作为重要的决策参考。英文摘要 (Abstract) Objective: The aim of this study was to compare the efficacy and safety of monoclonal antibodies (mAb) for moderate-to-severe atopic dermatitis (AD). Methods: The randomized controlled trials (RCTs) of monoclonal antibodies in the treatment of moderate-to-severe AD were searched in the database of PubMed, Embase, Web of Science and Cochrane Library, up to November 2024. The control group included placebo. The efficacy indicators were the percentage of patients achieving 50%, 75%, 90% improvement in Eczema Area and Severity Index score (EASI-50, EASI-75, EASI-90) and the percentage of patients with an Investigator Global Assessment (IGA) Score of 0 or 1 from baseline until the time of efficacy observation, and the percent change in Pruritus Numerical Rating Scale (NRS), EASI score, SCORing Atopic Dermatitis (SCORAD), and change in Percent Body Surface Area (BSA), Dermatology Life Quality Index (DLQI). The statistical analysis was performed by Stata14 and RevMan5.4. Data processing, network evidence plots, surface under the cumulative ranking curve (SUCRA) ranking, league plots and funnel plots were generated. Risk ratio (RR) and 95% confidence interval (95% CI) were used as effect sizes to analyze binary categorical variables. Results: This study included 32 RCTs with 7588 patients. Spesolimab, Rademikibart, Dupilumab, Amlitelimab were more effective than placebo in EASI-50 (RRs ranging between 1.31 and 22.65), EASI-75(RRs ranging between 1.51 and 36.58), EASI-90(RRs ranging between 3.72 and 5.49), and the percentage of patients in IGA score of 0 or 1 (RRs ranging between 1.78 and 13.36). Dupilumab showed relatively good efficacy according to SUCRA ranking on percent change in NRS, EASI, SCORAD. Dupilumab exhibited a lower incidence of serious adverse events than placebo, and the difference was statistically significant (RR = 0.43, 95% CI 0.30-0.63). Other safety analysis results showed no statistical difference. Conclusions: Through the analysis of the primary efficacy indicators, this network meta-analysis (NMA) study indicated that all monoclonal antibodies performed better than placebo. Based on the results of this study, Spesolimab, Rademikibart, Dupilumab, Amlitelimab were recommended treatment options with relatively good efficacy and safety. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎参考文献·References [1] High-Throughput Screening Using the Self-Controlled Tree-Based Scan Statistic to Identify Medications Associated With Hospitalization for Severe Acute Liver Injury. Pharmacoepidemiol Drug Saf. 2025-12-XX. doi: 10.1002/pds.70275. https://doi.org/10.1002/pds.70275 [2] Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the Clinical Practice Research Datalink (CPRD). Pharmacoepidemiol Drug Saf. 2025-12-XX. doi: 10.1002/pds.70243. https://doi.org/10.1002/pds.70243 [3] Predictors of Direct Oral Anticoagulant Use in Northern Italy: A Population-Based Study. Pharmacoepidemiol Drug Saf. 2025-12-XX. doi: 10.1002/pds.70300. https://doi.org/10.1002/pds.70300 [4] Measuring Exposure to Opioids Using Self-Reported Medication Use Data Versus General Practitioner Prescription Records in the UK Biobank Study. Pharmacoepidemiol Drug Saf. 2025-12-XX. doi: 10.1002/pds.70280. https://doi.org/10.1002/pds.70280 [5] Efficacy and Safety of All Monoclonal Antibodies in Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis. Pharmacoepidemiol Drug Saf. 2025-12-XX. doi: 10.1002/pds.70268. https://doi.org/10.1002/pds.70268 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ 医院药学研究导读丨聚焦全球医院药学前沿动态关注我们，追踪全球药学前沿第5期丨总第25期丨 2026年6月

2026-06-22

·笑哥学医

伏美替尼、奥希替尼与舒沃替尼

伏美替尼又称甲磺酸伏美替尼，其化学式为C₂₉H₃₅F₃N₈O₅S，分子量为664.70，由‌上海艾力斯医药科技股份有限公司自主研发的1类化学新药，是中国原研、拥有完全自主知识产权的第三代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），2021年3月在中国附条件获批二线治疗，用于既往接受EGFR-TKI治疗后进展、且存在EGFR T790M突变阳性的局部晚期/转移性非小细胞肺癌（NSCLC），2022年6月在国内获批一线治疗，用于存在EGFR 19外显子缺失或21外显子L858R置换突变的局部晚期/转移性NSCLC成人患者，2026年2月获批第三项适应症，用于既往经含铂化疗治疗进展/不耐受、且存在EGFR 20外显子插入突变的局部晚期/转移性NSCLC成人患者，是最新的增长点，伏美替尼针对EGFR 20外显子插入突变NSCLC已获得美国FDA授予的‌突破性疗法认定‌，为后续全球上市申报提速奠定基础。伏美替尼的作用与功效，一是核心作用，精准抑制EGFR突变的非小细胞肺癌细胞生长与扩散，治疗特定类型的局部晚期或转移性非小细胞肺癌‌；二是精准抑制肿瘤突变‌，可特异性抑制EGFR敏感突变如19外显子缺失、L858R点突变以及T790M耐药突变，精准阻断肿瘤细胞增殖的信号通路，高选择性减少对正常细胞的损伤，降低不良反应概率；三是有效控制肺癌脑转移，药物具有较强的血脑屏障穿透能力，对肺癌合并脑转移的病灶抑制效果明确，临床数据显示脑转移患者颅内病灶缓解率较高，为中枢神经转移患者提供了有效治疗选择；四是延缓耐药发生‌，相比第一代EGFR靶向药，通过不可逆结合的作用方式，降低了耐药突变的发生概率，可延长患者无进展生存期，三期临床数据显示中位无进展生存期可达20.8个月；五是覆盖更多突变类型‌，2026年新增获批EGFR 20号外显子插入突变（ex20ins）适应症，对这类以往治疗难度较高的突变也显示出明确疗效。伏美替尼的副作用及处理，一是皮肤反应，主要表现为皮疹、皮肤干燥、红斑、脱屑或瘙痒，多集中于面部和躯干，使用温和保湿的润肤产品保持皮肤湿润，避免阳光直射，日常做好防晒，保持皮肤清洁，若皮疹严重可遵医嘱外用类固醇药物缓解；二是消化道症状，常见表现为恶心、腹泻、呕吐、食欲下降，多与药物刺激胃肠道有关，调整饮食结构，保持清淡饮食，避免油腻辛辣食物，遵循少食多餐原则，腹泻可遵医嘱服用蒙脱石散止泻，恶心严重时可使用对症止吐药物，一般可有效缓解；三是肝功能异常，多数表现为转氨酶（ALT/AST）暂时性升高，用药期间需定期抽血监测肝功能，若指标轻度升高，可遵医嘱服用护肝药物并调整用药剂量，若损伤严重或反复异常，需暂停甚至永久停药，由医生调整治疗方案；四是全身性不适，主要包括疲劳、乏力、肌肉酸痛等，多数不影响日常活动，保证充足休息，避免过度劳累，在身体允许情况下进行轻度活动即可，一般可自行缓解；五是心血管异常，可能出现血压波动、心悸、心电图QT间期延长，需定期监测血压和心电图，如有异常及时遵医嘱干预；六是口腔问题，可能出现口腔溃疡、咽部不适，建议日常做好口腔清洁，使用漱口水维护卫生，严重时可局部用药促进创面愈合；七是眼部不适，少数患者会出现眼睛干涩、视力模糊，一般使用人工泪液即可缓解，若症状持续需及时就医；八是呼吸系统问题‌，部分患者会出现咳嗽、上呼吸道感染，症状轻微时多喝温水即可缓解，若发生严重呼吸困难、咳嗽、发热等，需立刻就诊处理。伏美替尼的禁忌症及禁忌人群，一是过敏，对甲磺酸伏美替尼的活性成分或任何一种辅料过敏者禁用；二是孕妇，药物可能对胎儿造成危害，不推荐使用，育龄期男女用药期间都需要避孕，完成治疗后6个月内仍需采取有效避孕措施；三是哺乳期女性，使用本品治疗期间，以及末次给药后至少3个月内，需要停止母乳喂养；四是高风险心脏疾病患者‌，存在可能增加QTc延长风险或心律失常事件风险的人群，如心力衰竭、低钾血症、先天性长QT综合征患者，需要避免使用；五是肝肾功能异常者，重度肾功能损害、中重度肝功能损害患者需要谨慎使用，必要时需在医生指导下调整剂量；六是危险操作禁忌‌，部分患者用药后会出现视力下降、视物模糊等不良反应，该类人群不要驾驶车辆、操纵仪器或进行高空作业，避免发生危险；七是禁与强效CYP3A抑制剂如克拉霉素、伊曲康唑、洛匹那韦合用‌，可显著升高伏美替尼血药浓度，避免与强效CYP3A诱导剂如利福平、圣约翰草、卡马西平联用，可降低疗效；八是饮食禁忌，用药期间需要避免摄入辛辣刺激类、油腻厚重类、生冷食品、含酒精的食物饮品，同时避免食用柚子、柠檬、芹菜等含有呋喃香豆素的果蔬，这类物质会干扰药物代谢，影响药效或加重不良反应。奥希替尼临床使用的为甲磺酸奥希替尼，其化学式为C₂₈H₃₃N₇O₂·CH₄O₃S，分子量为595.72，由英国阿斯利康研发，是全球首个获批的第三代EGFR-TKI靶向药，‌2015年11月13日‌由美国FDA加速批准，用于治疗EGFR T790M突变阳性的晚期非小细胞肺癌（NSCLC），2016年2月获欧盟批准上市，2016年3月获日本批准上市，‌2017年3月获中国NMPA批准上市，2018年4月FDA批准一线用于EGFR外显子19缺失或L858R突变型NSCLC，2020年12月获批辅助治疗早期术后EGFR突变NSCLC，2024年9月FDA新增用于不可切除Ⅲ期NSCLC同步/序贯放化疗后维持，中国于2019年、2021年、2024年相继批准一线、辅助及Ⅲ期维持适应症，截止‌目前已获‌美国、欧盟、日本、中国、韩国、加拿大、澳大利亚及全球超100个国家/地区‌批准上市，覆盖EGFR突变NSCLC的‌一线、二线及辅助治疗全病程‌，原研药‌‌商品名中文译名为‌泰瑞沙、英文商品名为Tagrisso。截至目前国内已获批上市的甲磺酸奥希替尼片仿制药生产企业仅江苏万邦生化医药。奥希替尼作用与功效，一是核心作用机制，药物可以‌不可逆结合EGFR敏感突变如19外显子缺失、L858R以及T790M耐药突变‌，精准阻断肿瘤细胞增殖的关键信号通路，对正常细胞干扰较小，相比传统化疗不良反应更轻微；二是精准抑制肿瘤增殖，针对携带EGFR特定突变的非小细胞肺癌，可直接遏制肿瘤细胞分裂生长，对T790M突变患者客观缓解率可达71%，有效缩小肿瘤体积；三是显著延长生存期‌，一线治疗EGFR突变阳性患者，中位无进展生存期可达18.9个月，总生存期超过38.6个月，显著优于传统靶向药；四是对于一代/二代EGFR-TKI治疗耐药且出现T790M突变的患者，奥希替尼是标准治疗方案，能克服耐药重新控制肿瘤，延长生存时间；五是有效控制脑转移，具有良好的血脑屏障穿透能力，能在脑组织中维持有效药物浓度，缩小脑部转移病灶、控制颅内进展，缓解脑转移引发的头痛、恶心等症状，为脑转移患者提供了更有效的治疗选择；六是改善临床症状与生活质量‌，通过缩小肿瘤稳定病灶，可缓解肺癌引发的咳嗽、呼吸困难、胸痛等压迫症状，相比传统化疗，避免了严重骨髓抑制、剧烈呕吐等不良反应，患者耐受性更好，能更好维持日常活动能力，提升治疗期间的生活质量；七是降低术后复发风险‌，早期EGFR突变阳性非小细胞肺癌患者根治性手术后，作为辅助治疗可清除残留微小病灶，3年无病生存率提升至80%，较对照组提升近20%，显著降低复发转移概率。奥希替尼的副作用及处理，一是皮肤反应，包括皮疹、皮肤干燥、甲沟炎等，皮疹应保持皮肤清洁、避免抓挠和日晒、轻度可外用莫匹罗星软膏预防感染、重度需在医生指导下口服抗组胺药物、必要时暂停用药，皮肤干燥应及时补充水分、多吃新鲜蔬果、可涂抹保湿润肤霜或维生素E软膏缓解，甲沟炎日常定期修剪指甲、避免指甲边缘嵌入皮肤、已经化脓的可使用碘伏涂抹患处、或遵医嘱用抗炎药物外敷；二是胃肠道反应，包括腹泻、恶心、食欲下降、口腔溃疡等，腹泻轻度避免进食不易消化食物、口服蒙脱石散止泻、同时补充水分和电解质预防脱水、严重腹泻需立即就医静脉补液，恶心呕吐建议少量多餐、避开油腻食物、必要时遵医嘱服用甲氧氯普胺片止吐，食欲下降可适当吃开胃的山楂片、或通过嚼口香糖缓解症状，口腔溃疡日常多吃柑橘类水果补充维生素、已经发作可涂抹维生素B6软膏或蜂蜜护理；三是疲劳乏力，保证每日8小时睡眠，可进行散步等低强度运动，若血红蛋白低于90g/L，可遵医嘱服用生血宁改善；四是咳嗽，多休息、适度锻炼，症状通常会随用药逐渐减轻，若持续加重需及时就医排查病因；五是间质性肺病/肺炎，表现为新发或加重的咳嗽、发热、呼吸困难，这是致死性风险最高的副作用，疑似出现后需立即停药，就医后需使用大剂量糖皮质激素冲击治疗+呼吸支持；六是心脏毒性如QT间期延长、心力衰竭，表现为心悸、心跳不齐、头晕晕厥、呼吸困难、下肢水肿，用药期间需定期监测心电图，一旦出现需立即停药，遵医嘱使用营养心肌药物，必要时调整抗肿瘤方案；七是血液学毒性如骨髓抑制，表现为白细胞、中性粒细胞或血小板减少，会增加感染、出血风险，治疗期间需定期监测血常规，医生会根据严重程度使用升血细胞药物，必要时暂停用药；八是肝功能异常‌，表现为转氨酶升高，用药期间需每月监测肝功能，转氨酶升高超过正常值3倍时，需遵医嘱使用保肝药物，必要时暂停靶向治疗。奥希替尼的禁忌症及禁忌人群，一是过敏，对奥希替尼或药物任一辅料过敏者禁用；二是妊娠期女性，药物可能对胎儿造成伤害；三是哺乳期女性，尚不明确药物是否会分泌到人乳中，治疗期间及停药后1个月内禁止哺乳；四是严重心律失常患者‌，合并QTc间期延长，且出现尖端扭转性室性心动过速、多形性室性心动过速、严重心律失常症状或体征的患者需永久停用；五是特殊人群，包括小孩与老人，18岁以内儿童‌安全性和有效性尚未确立不建议服用，65岁及以上老年人整体有效性和年轻人无差异，但3级及以上不良反应发生率更高，剂量调整会更频繁；六是药物联用禁忌，包括禁止与‌圣约翰草（贯叶连翘）‌同时服用，圣约翰草是强CYP3A诱导剂，会降低奥希替尼药效，避免与其他强CYP3A诱导剂如卡马西平、苯妥英钠、利福平等合用，避免与酮康唑类抗真菌药等强CYP3A抑制剂合用，这类药物会升高奥希替尼的血药浓度，增加副作用发生风险；七是饮食禁忌，包括避开食用含呋喃香豆素的水果‌如西柚（葡萄柚）、石榴、黑莓、野生葡萄、黑桑葚等，这类成分会抑制药物代谢酶活性、增加血药浓度、可能加重副作用，避免用浓茶送服药物、不建议吃辛辣刺激食物、咖啡、肥肉等，可能加重胃肠不适，影响药物吸收，严格戒烟限酒，烟酒会加重病情，同时影响药物疗效。舒沃替尼的‌化学式为C₂₉H₃₅ClFN₇O₃，分子量为584.08‌，由‌中国迪哲医药‌完全自主研发的全球首创新药，2023年8月通过国家药监局优先审评获批上市，适应症为既往经含铂化疗进展或不耐受的EGFR Exon20ins局部晚期或转移性非小细胞肺癌成人患者，2025年1月正式纳入中国国家医保目录，是目前国内该适应症唯一可医保报销的治疗药物，2025年7月通过美国FDA优先审评程序加速批准上市，成为中国首个独立研发在美获批的全球首创新药，获批一周后即被纳入美国国立综合癌症网络（NCCN）非小细胞肺癌指南推荐，原研药中文商品名为舒沃哲、英文商品名为ZEGFROVY。舒沃替尼的作用与功效，一是精准抑制肿瘤生长，作为高选择性EGFR酪氨酸激酶抑制剂，可精准阻断携带EGFR 20号外显子插入突变‌的肿瘤细胞生长信号传导，抑制肿瘤细胞增殖分裂，控制肿瘤进展；二是针对特定基因突变，专门针对传统EGFR靶向药疗效不佳的罕见突变EGFR exon20ins，填补了该领域的临床空白，为这部分患者提供了精准治疗选择；三是缓解症状提升生活质量，能够减轻肿瘤压迫、侵犯组织引发的咳嗽、呼吸困难、疼痛等症状，改善患者的身体状态与生活质量；四是延长患者生存期‌，临床数据显示，其二线治疗客观缓解率达到61%，中位无进展生存期可达6.5个月，单药一线治疗客观缓解率达78.6%，中位无进展生存期达12.4个月，相较传统治疗显著延长了患者的无进展生存时间，为患者争取更多治疗机会。舒沃替尼的副作用及处理，一是血液学毒性如贫血、血小板减少，定期监测血常规，发现指标异常时，遵医嘱使用升白针、输血或调整药物剂量，避免剧烈运动或外伤，预防出血风险；二是消化道反应如恶心、腹泻，轻度症状可通过清淡饮食、少食多餐缓解，腹泻可口服蒙脱石散等止泻药，同时补充电解质，严重持续腹泻需就医，必要时静脉补液或暂停用药；三是皮肤反应如皮疹、干燥，使用温和保湿护肤品，避免日晒，皮疹可局部涂抹激素类药膏如氢化可的松，若出现严重皮炎或手足综合征，需联系医生评估是否减量或停药；四是全身性症状如乏力、发热，保证充足休息，加强营养摄入，体温超过38.5℃需排查感染，并按医嘱使用退热药；五是肝功能异常，定期检查肝酶指标，轻度升高可通过保肝药物如谷胱甘肽控制，显著异常需停药并积极干预；六是血肌酸磷酸激酶（CPK）升高，提示肌肉损伤，指标升高超过5倍正常值上限为≥3级不良反应，出现指标异常时需立即报告是否存在不明原因的肌肉疼痛、压痛、抽搐或无力，同时密切监测CPK、肌红蛋白、肾功能、体温及血钾，建议每周检测一次；七是心脏相关风险，药物会延长QTc间期平均12-18ms，老年人、基础QTc偏高、联用利尿剂低钾时，发生尖端扭转型室速的风险会明显升高，伴有充血性心力衰竭、电解质异常或正在使用其他延长QT间期药物时，需定期监测心电图和电解质，若出现胸闷、心慌、头晕等不适，需立即就医；八是间质性肺疾病/非感染性肺炎，表现为突发呼吸困难、咳嗽、发热，或原有症状不明原因加重，影像学可见磨玻璃样改变，出现上述症状需第一时间就医排查，确诊后通常需停药并接受针对性治疗。舒沃替尼的禁忌症及禁忌人群，一是过敏，对舒沃替尼或药物中任何辅料成分过敏者禁用；二是妊娠及哺乳期女性禁用，药物可能对胎儿/婴儿造成明确危害，用药期间及停药后，女性需至少避孕2个月，男性需至少避孕6个月，避免药物对胎儿产生影响；三是特定基础疾病禁用，包括活动性间质性肺病患者、存在未纠正的QT间期延长（QTc＞470ms）患者、严重肝功能不全Child-Pugh C级患者、患有血小板减少症/出血性疾病、惊厥癫痫等神经系统疾病、有精神病史/家族史、自身免疫病患者等；四是老年群体，老年人肝肾功能减退，药物易蓄积，不良反应风险显著升高，需要医生个体化评估后谨慎调整剂量，不可直接按常规剂量用药；五是药物相互作用‌，避免与强效CYP3A诱导剂如利福平联用，必须使用强效CYP3A抑制剂如酮康唑时，需要在医生指导下调低用药剂量；六是饮食禁忌，用药期间禁止食用西柚，西柚会影响药物正常代谢，升高不良反应风险。 ‌ 伏美替尼与奥希替尼的区别，一是药物研发与产地有区别，伏美替尼是国产药，研发企业为‌上海艾力斯医药科技股份有限公司，而奥希替尼是进口药，由英国阿斯利康研发；二是适应症范围有区别，伏美替尼适应症包括既往接受EGFR-TKI治疗后进展、且存在EGFR T790M突变阳性的局部晚期/转移性非小细胞肺癌（NSCLC），存在EGFR 19外显子缺失或21外显子L858R置换突变的局部晚期/转移性NSCLC成人患者，既往经含铂化疗治疗进展/不耐受、且存在EGFR 20外显子插入突变的局部晚期/转移性NSCLC成人患者，而奥希替尼适应症包括治疗EGFR T790M突变阳性的晚期非小细胞肺癌（NSCLC）、一线用于EGFR外显子19缺失或L858R突变型NSCLC、辅助治疗早期术后EGFR突变NSCLC、不可切除Ⅲ期NSCLC同步/序贯放化疗后维持等；三是‌常见副作用有区别，奥希替尼更容易引起腹泻、皮疹和甲沟炎，需关注间质性肺炎和心脏QT间期延长风险，而伏美替尼较少出现严重皮疹，但转氨酶升高的比例稍高，在研究中显示间质性肺炎发生率相对较低。‌‌‌ 奥希替尼与舒沃替尼的区别，一是药物研发与产地有区别，奥希替尼是进口药，由英国阿斯利康研发，而苏沃替尼是国产药，由‌中国迪哲医药‌完全自主研发；二是作用靶点有区别，奥希替尼优先针对EGFR敏感突变如19外显子缺失、L858R突变以及T790M耐药突变，同时对部分罕见EGFR突变也有活性，而舒沃替尼为高选择性针对多种EGFR突变亚型，核心优势是对EGFR 20号外显子插入突变有极强抑制活性，同时对EGFR敏感突变也有效；三是核心适应症‌有区别，奥希替尼核心适应症包括EGFR外显子19缺失或外显子21（L858R）置换突变的局部晚期/转移性非小细胞肺癌成人患者等一线治疗、一二代EGFR-TKI治疗进展后确认存在EGFR T790M突变阳性的局部晚期/转移性非小细胞肺癌患者的二线治疗和肿瘤切除后预防EGFR突变阳性非小细胞肺癌复发‌术后辅助治疗，而舒沃替尼的核心适应症是既往经含铂化疗治疗进展或不耐受、经检测确认存在‌EGFR 20号外显子插入突变‌的局部晚期/转移性非小细胞肺癌成人患者，目前是该适应症唯一可医保报销的国产靶向药。

2026-06-12

·小灵AI科普

特应性皮炎发病机制与皮肤屏障修复策略

特应性皮炎发病机制与皮肤屏障修复策略：基于免疫 - 屏障互作的分层干预决策核心结论特应性皮炎（AD）的治疗决策应从单纯的抗炎转向“免疫失衡纠正”与“皮肤屏障主动修复”的双轨并行。对于急性期，需依据 Treg/Th17 比值及 IL-31 水平评估炎症负荷，联合外用糖皮质激素与必要时抗菌药物以快速控制感染性加重；对于缓解期及轻中度患者，含神经酰胺前体或多效保湿剂的屏障修复是降低复发率的关键，其疗效具有明确的经皮水分丢失（TEWL）改善证据。重度难治性病例需警惕肠道屏障受损及电解质紊乱风险，生物制剂（如度普利尤单抗）应用前必须筛查眼部基础疾病。决策依据 AD 的发病机制核心在于遗传易感性（如 *FLG* 基因突变）导致的物理屏障缺陷与 Th2/Th17/Treg 免疫网络失衡的恶性循环[2]。病理生理上，Treg 细胞比例显著降低（2.01% vs 5.04%）而 Th17 细胞升高，导致 Treg/Th17 比值在急性期降至 0.88，直接驱动炎症级联反应 [6]。同时，IL-31 作为关键致痒因子，其表达量与 SCORAD 评分（r=0.495）及瘙痒评分（r=0.584）呈正相关，且受体 IL-31RA 在神经纤维束高表达，解释了剧烈瘙痒的神经免疫机制 [5]。此外，最新研究证实肠道屏障功能障碍（血清 D-乳酸升高）与 AD 严重程度负相关，提示“肠 - 皮轴”在部分难治性病例中的致病作用 [7]。指南明确将皮肤干燥和屏障功能障碍列为诊断与治疗的核心靶点，强调保湿剂不仅是辅助手段，更是基础治疗 [2][3]。鉴别分析临床需重点鉴别三种易混淆路径： 1. 接触性皮炎 vs. AD 急性加重若患者表现为局限性渗出且对抗炎治疗反应差，需排查金黄色葡萄球菌定植。研究显示，急性/亚急性湿疹患者联用莫匹罗星与激素，2 周痊愈率达 80.6%，显著高于单用激素组（64.8%），且复发率更低（15.6% vs 33.8%）[1]。若忽略细菌负荷单纯抗炎，易导致病情迁延。 2. 单纯皮肤干燥 vs. 屏障功能衰竭普通干燥仅表现为角质层含水量低，而 AD 患者的屏障衰竭伴随 TEWL 显著升高及脂质合成障碍。若仅使用封闭性凡士林而未补充神经酰胺前体，无法逆转表皮稳态失衡。临床试验证实，含神经酰胺前体的保湿剂能显著提升角质层神经酰胺、NMF 及 PCA 含量，优于普通对照 [4]。 3. 婴儿重度 AD vs. 继发性醛固酮增多症对于广泛渗出性皮损的婴儿，若出现低钠高钾，需警惕经皮钠丢失导致的继发性醛固酮增多症，而非单纯肾病或内分泌原发病。优化皮肤科管理后生化指标可逆转，误诊可能导致不必要的内分泌干预。治疗与处置建议 1. 急性期抗炎与抗感染：方案：中强效外用糖皮质激素（TCS）联合局部抗菌药物（如莫匹罗星），适用于有渗出、结痂或疑似继发感染的急性/亚急性皮损 [1]。注意：抗生素联用仅限急性期短程（2 周），避免长期滥用导致耐药。若确诊为金黄色葡萄球菌定植引起的反复感染，可考虑稀释漂白浴等去定植措施（参考指南推荐）。 2. 屏障主动修复策略：选型逻辑：首选含神经酰胺前体、胆固醇及游离脂肪酸生理性配比的医学护肤品。证据显示，此类产品应用 4 周可显著降低 TEWL 并提升水合度（P<0.01）[4]。多效保湿霜（含夹竹桃麻素等成分）在体外及临床均证实可上调 Claudin-1、Involucrin 表达，促进表皮厚度恢复。时机：无论是否处于发作期，每日至少 2 次全身涂抹，浴后 3 分钟内使用效果最佳 [3]。 3. 系统治疗与生物制剂：度普利尤单抗：适用于中重度成人及儿童患者。用药前必须详细询问过敏性疾病史及眼部基础疾病史。文献分析显示，约 46 例报告中出现结膜炎、葡萄膜炎等眼部 ADR，高危因素包括初始症状重及既往眼病史 [9]。需告知患者潜在风险并定期监测。肠道微生态干预：对于常规治疗无效的难治性病例，若检测发现血清 D-乳酸升高，可探索洗脱微生物移植（WMT）等新型疗法，初步数据显示其可改善 SCORAD 及 NRS 评分 [7]。详细数据支持联合治疗获益：RCT 研究（n=217）显示，激素 + 抗菌药组 vs 单用激素组，2 周总痊愈率 80.6% vs 64.8% (P=0.01)；随访期末复发率 15.6% vs 33.8% (P<0.05) [1]。屏障修复量化指标：随机自身对照研究（n 未详，JAAD 2013）显示，含神经酰胺前体保湿剂治疗 4 周后，TEWL 下降幅度及皮肤水合度提升幅度均显著优于 untreated control (P<0.01)，角质层神经酰胺及 NMF 含量显著增加 [4]。免疫指标相关性：队列研究（n=41）证实，AD 患者外周血 Treg/Th17 比值为 1.26±0.61，显著低于对照组 14.53±5.77 (P<0.01)；该比值与疾病严重程度呈负相关 (r=-0.40) [6]。肠 - 皮轴证据：前瞻性研究（n=24 AD, n=23 HC）显示，AD 患者血清 D-乳酸显著升高；WMT 治疗后，SCORAD 及 NRS 评分显著改善 (P<0.05)，基线 D-乳酸水平与 SCORAD 改善值呈负相关 (R=-0.738) [7]。安全性信号：回顾性文献分析（46 例）指出，度普利尤单抗致眼部 ADR 发生时间多在用药后 6 个月内，严重 ADR 占比约 21.7%（10/46），需严密监控 [9]。随访与调护复查节点：急性期治疗 2 周评估痊愈情况及复发风险；使用生物制剂者，首月及随后每 3 个月评估眼部症状及注射部位反应 [9]。生活方式干预：针对社会决定因素（SDoH）导致的健康差异，需关注低收入及少数族裔患者的环境触发因素暴露（如住房霉菌、空气污染），提供社区健康工作者指导或住房改造建议以改善预后。动态调整：若规范外用治疗及屏障修复 4 周后 SCORAD 无改善，需重新评估依从性、诱发因素（如食物过敏、吸入变应原）或考虑升级系统治疗。证据边界与未解决问题当前证据多集中于儿童及青少年人群，成人 AD 的长期屏障修复数据相对缺乏。关于肠道微生态移植（WMT）在 AD 中的应用虽显示出潜力，但样本量较小（n=14 治疗组），尚需大规模 RCT 验证其作为常规二线疗法的地位 [7]。此外，虽然遗传学揭示了 *FLG* 等基因的关键作用，但基于基因型的精准分型治疗（Precision Dermatology）目前仍处于转化研究阶段，尚未完全进入临床常规决策流程。对于剖宫产等生命早期因素对 AD 发病的具体权重，虽有流行病学关联，但因果链条及干预窗口期仍需进一步阐明 [8]。参考文献 [1] 路雪艳;庞艳华;黄二顺;李邻峰。糖皮质激素和抗菌药物联合外用治疗湿疹的疗效观察 [J]. 中华皮肤科杂志，2013[2] 中华医学会皮肤性病学分会免疫学组。中国特应性皮炎诊疗指南（2020 版）[J]. 中华皮肤科杂志，2020[3] 中华医学会 (CMA,Chinese Medical Association).儿童特应性皮炎基层诊疗指南（2023 年）[J]. 中华全科医师杂志，2023[4] Eric Simpson;Arne Bohling;Catherine Bosc;Stephan Bielfeldt.Improvement of skin barrier function in atopic dermatitis patients with a new moisturizer containing a ceramide precursor[J]. Journal of the American Academy of Dermatology,2013[5] 向娟;王华;肖异珠;罗晓燕;张晓萍;欧阳莹;李咏梅.IL-31 在特应性皮炎中的表达及与瘙痒关系的机制研究 [J]. 现代免疫学，2008[6] 马蕾;薛海波;周荣佼;安荣贞。特应性皮炎患者外周血调节性 T 细胞与 Th17 细胞平衡状态分析 [J]. 中华皮肤科杂志，2012[7] Lao YD;Zhang HY;Cai Y;Chen MM;Wu LH;He XX;Deng WY.Association of intestinal barrier impairment with symptom severity and washed microbiota transplantation outcomes in atopic dermatitis patients.[J]. Frontiers in allergy,2025[8] 张月芬;冯磊。我院近五年剖宫产率及剖宫产指征分析 [J]. 中国全科医学，2010[9] 付子仪;谢婷婷;郭代红。度普利尤单抗致眼部相关不良反应文献分析 [J]. 中国药房，2023

100 项与莫匹罗星相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01076	莫匹罗星	R01AX06 D06AX09	DB00410

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
继发感染	澳大利亚	GlaxoSmithKline Australia Pty Ltd.	1998-04-03
革兰氏阳性细菌感染	中国	中美天津史克制药有限公司	1993-01-01
脓疱疮	美国	GSK Plc	1987-12-31

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
皮肤结构和软组织感染	申请上市	中国	南京毓浠医药技术有限公司	2025-10-21
金黄色葡萄球菌感染	临床3期	西班牙	-	2025-10-13
细菌感染	临床前	以色列	Revium Rx	2025-09-01

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临床结果

适应症

分期

评价

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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


NCT02572791 (SHINE, CTgov)	临床4期	细菌性皮肤疾病 \| 耐甲氧西林金黄色葡萄球菌感染	835	Chlorhexidine+Mupirocin (Periodic Personal Decolonization)	窪製艱鏇鬱範齋衊繭憲 = 簾廠積鹹繭鹹鏇膚醖夢願襯壓齋範蓋網餘憲餘 (鑰膚簾蓋襯願憲構範網, 襯繭獵窪鏇壓選獵鹹獵 ~ 範鑰繭膚築艱艱衊膚繭) 更多	-	2026-02-24
				Household cleaning+Chlorhexidine+Mupirocin (Integrated Personal/Household Hygiene)	窪製艱鏇鬱範齋衊繭憲 = 獵顧膚顧鹽鹹淵製獵衊願襯壓齋範蓋網餘憲餘 (鑰膚簾蓋襯願憲構範網, 糧鏇廠醖夢襯襯積繭製 ~ 襯襯製襯願鹹構築壓齋) 更多
NCT02127658 (MEDiC, CTgov)	临床4期	-	14	Hygiene education (Hygiene Education)	鹽鹽選選窪繭繭壓窪鹽 = 願醖簾壓憲衊膚齋遞襯顧製膚築鏇鹽鑰憲窪夢 (鏇膚範衊糧淵鏇壓壓窪, 製衊選網範製蓋選夢製 ~ 憲齋淵餘餘襯獵遞製製) 更多	-	2024-06-25
				Sodium Hypochlorite+Mupirocin ointment (Hygiene Education and Decolonization)	鹽鹽選選窪繭繭壓窪鹽 = 衊網鏇觸衊製獵鹹壓醖顧製膚築鏇鹽鑰憲窪夢 (鏇膚範衊糧淵鏇壓壓窪, 繭獵襯鑰願窪獵獵製廠 ~ 顧醖憲鑰鹹廠淵淵壓製) 更多
NCT03140423 (CTgov)	临床4期	脓毒症	353,323	Mupirocin (Arm 1: Routine Care (Mupirocin/CHG))	網壓鬱衊壓製鑰願積簾 = 憲醖鬱遞淵餘繭鏇鏇觸艱網窪鑰積範獵選鏇壓 (襯鬱鹹壓鏇鹽獵壓願簾, 鬱鹽築鹹鬱繭繭製網觸 ~ 壓鹹築選繭壓醖衊鹹餘) 更多	-	2024-02-07
				Arm 2. Iodophor/CHG Decolonization (Arm 2: Iodophor/CHG Decolonization)	網壓鬱衊壓製鑰願積簾 = 蓋襯餘簾蓋鏇窪願蓋夢艱網窪鑰積範獵選鏇壓 (襯鬱鹹壓鏇鹽獵壓願簾, 廠鏇襯蓋壓網範蓋醖襯 ~ 繭鹽網艱簾鹽艱淵膚獵) 更多
NCT03883828 (ASCO2022) 人工标引	临床2/3期	放射性皮炎	76	mupirocin+Chlorhexidine gluconate	積餘築淵醖糧築網糧選(鹽糧顧簾簾鑰艱獵襯遞) = 壓衊願壓觸膚蓋淵壓獵淵築窪觸淵選鑰餘築鹹 (遞網廠鬱簾顧遞範獵糧 ) 更多	积极	2022-06-08
				standard of care	積餘築淵醖糧築網糧選(鹽糧顧簾簾鑰艱獵襯遞) = 廠網淵獵壓積範蓋糧製淵築窪觸淵選鑰餘築鹹 (遞網廠鬱簾顧遞範獵糧 ) 更多
NCT03673956 (CTgov)	临床1/2期	慢性鼻窦炎	19	Tobramycin (Tobramycin Topical Antibiotic Nasal Saline Rinse)	繭憲觸築顧繭簾衊鹽糧 = 觸繭網鹽鹹膚蓋衊製範鏇襯獵構膚壓築膚選構 (願積廠顧觸獵憲夢觸範, 憲構鬱鹹襯齋壓構獵製 ~ 鹽網繭獵窪醖鹽鹽壓願) 更多	-	2022-04-20
				levofloxacin (Levofloxacin Topical Antibiotic Nasal Saline Rinse)	繭憲觸築顧繭簾衊鹽糧 = 艱鏇構觸膚簾夢鹹淵衊鏇襯獵構膚壓築膚選構 (願積廠顧觸獵憲夢觸範, 膚餘淵壓鑰選製襯築夢 ~ 鑰壓衊鏇鏇鹹淵顧顧獵) 更多
NCT02967432 (Pubmed \| J Pediatr)	临床2期	-	216	Topical Mupirocin	觸齋憲觸繭顧遞齋鬱廠(顧艱鑰製餘壓鑰蓋顧蓋) = 觸築淵選襯願鏇糧獵遞鹹壓壓遞遞廠蓋蓋顧壓 (襯壓蓋鏇製網蓋餘遞範 ) 更多	-	2021-05-20
				Placebo	觸齋憲觸繭顧遞齋鬱廠(顧艱鑰製餘壓鑰蓋顧蓋) = 廠齋淵鏇窪膚構廠願廠鹹壓壓遞遞廠蓋蓋顧壓 (襯壓蓋鏇製網蓋餘遞範 ) 更多
NCT04218799 (CTgov)	临床4期	交叉感染	19	Chlorhexidine+Mupirocin	願積窪鑰鹽蓋衊製艱窪(遞醖構選獵餘繭獵製鹽) = 蓋簾憲夢憲夢齋鏇鏇網顧鏇壓膚積窪醖構壓範 (簾壓構淵選窪襯觸顧構, 11003) 更多	-	2020-04-24
NCT02223520 (TREAT PARENTS, CTgov)	N/A	金黄色葡萄球菌感染 \| 金黄色葡萄球菌菌血症 \| 葡萄球菌感染	307	Chlorhexidine+Mupirocin (Mupirocin and Chlorhexidine)	構鬱製選鏇憲糧夢鏇壓 = 齋窪餘鏇憲獵鬱鏇鬱鏇積衊願範淵選壓膚製憲 (遞鏇製醖顧壓鏇鏇範鬱, 廠窪願膚繭顧構蓋蓋鏇 ~ 積衊選製鬱餘膚壓壓餘) 更多	-	2020-03-16
				Placebo ointment and placebo cloths (Placebo Ointment and Placebo Cloths)	構鬱製選鏇憲糧夢鏇壓 = 艱觸壓製遞選構膚壓顧積衊願範淵選壓膚製憲 (遞鏇製醖顧壓鏇鏇範鬱, 窪窪繭蓋繭鏇膚廠艱積 ~ 醖繭顧鬱艱積襯衊簾遞) 更多
NCT01537783 (CTgov)	临床4期	脓肿	50	Chlorhexidine gluconate+Mupirocin (Intervention Group)	觸觸選糧積築廠艱衊蓋 = 襯繭鬱網鹽網窪淵鑰構窪窪齋獵鹽憲觸鬱夢簾 (襯醖網衊簾餘鑰遞窪網, 築選艱鑰構範願齋廠繭 ~ 鬱鏇網鑰獵膚壓鑰壓構) 更多	-	2017-03-13
				antibiotics (Standard of Care)	觸觸選糧積築廠艱衊蓋 = 壓鏇範鹽選鑰壓憲範醖窪窪齋獵鹽憲觸鬱夢簾 (襯醖網衊簾餘鑰遞窪網, 構鹹廠範築窪糧遞窪簾 ~ 範範廠獵憲夢壓廠獵構) 更多
NCT02218307 (CTgov)	临床4期	慢性鼻窦炎	68	Mupirocin (Mupirocin)	襯遞襯齋構鬱範觸憲鏇(鏇醖鏇衊醖夢膚夢膚糧) = 衊積繭鹽鏇齋廠艱餘範襯製鹽遞願壓遞廠鹹齋 (蓋鬱蓋齋製鬱膚鹹壓鏇, 19.23) 更多	-	2017-03-09
				Placebo (Placebo)	襯遞襯齋構鬱範觸憲鏇(鏇醖鏇衊醖夢膚夢膚糧) = 觸鹽艱顧獵簾遞鹹鏇顧襯製鹽遞願壓遞廠鹹齋 (蓋鬱蓋齋製鬱膚鹹壓鏇, 17.33) 更多