预约演示
更新于：2026-02-27
Artesunate
青蒿琥酯
更新于：2026-02-27
概要
基本信息
原研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (1988-01-01), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、孤儿药 (英国)、突破性疗法 (美国) |
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结构/序列
分子式C19H28O8 |
InChIKeyFIHJKUPKCHIPAT-AHIGJZGOSA-N |
CAS号88495-63-0 |
关联
203
项与 青蒿琥酯 相关的临床试验NCT06872112
Phase I Study: A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension
This is a 20-week, Phase 1, single-center, open-label, dose-escalation study evaluating the safety and tolerability of daily oral artesunate in patients with PAH.
开始日期2026-01-01 |
申办/合作机构 |
ChiCTR2500113111
Artesunate in the treatment of steroid-refractory chronic graft-versus-host disease: A single-arm, open-label clinical study
开始日期2025-11-28 |
申办/合作机构 |
NCT07095309
Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer
TThis study evaluates the safety and effectiveness of pre-operative artesunate, given orally once a day for 14 days prior to surgery, in patients with Stage II/III colorectal cancer.
Artesunate is an established antimalarial drug with an excellent safety profile. It is well tolerated, affordable, and widely available. Several laboratory studies and one small pilot clinical study in patients with colorectal cancer have shown that artesunate can reduce the proliferation and growth of cancer cells.
One hundred patients diagnosed with Stage II/III operable colorectal cancer will be randomly allocated to receive oral artesunate 200 mg daily or a matching placebo for 14 days prior to surgery. Patients will then be followed closely for 5 years to determine whether pre-operative artesunate reduces the risk of cancer recurrence after surgery.
Artesunate is an established antimalarial drug with an excellent safety profile. It is well tolerated, affordable, and widely available. Several laboratory studies and one small pilot clinical study in patients with colorectal cancer have shown that artesunate can reduce the proliferation and growth of cancer cells.
One hundred patients diagnosed with Stage II/III operable colorectal cancer will be randomly allocated to receive oral artesunate 200 mg daily or a matching placebo for 14 days prior to surgery. Patients will then be followed closely for 5 years to determine whether pre-operative artesunate reduces the risk of cancer recurrence after surgery.
开始日期2025-08-15 |
申办/合作机构 |
100 项与 青蒿琥酯 相关的临床结果
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100 项与 青蒿琥酯 相关的转化医学
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100 项与 青蒿琥酯 相关的专利（医药）
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3,760
项与 青蒿琥酯 相关的文献（医药）2026-12-31·REDOX REPORT
Artesunate ameliorates experimental autoimmune uveitis by inhibiting the LCN2-STAT3 axis and suppressing microglial activation
Article
作者: Hua, Dihao ; Gu, Jingsai ; Xia, Qinyun ; Yuan, Yilin ; Chen, Zhen ; Huang, Pingping ; Ren, He
OBJECTIVE:
To evaluate the efficacy and underlying molecular mechanisms of artesunate (ART) in experimental autoimmune uveitis (EAU).
METHODS:
An EAU mouse model was established and treated with ART via oral gavage. Disease severity was assessed by clinical scoring and retinal histology. SPR analysis examined ART binding to LCN2 and STAT3. Immunofluorescence co-staining was conducted to evaluate the expression and co-localization of LCN2 with microglia in retinal tissues. Western blot analysis was performed to measure protein levels of STAT3, LCN2, SLC7A11, FTH1, GPX4, IL-6, IL-1β, IL17A and TNF-α. In vitro, BV2 microglial cells were used, and LCN2 was knocked down with siRNA. Inflammatory cytokine concentrations in retina and BV2 cell culture supernatants were assessed through ELISA.
RESULTS:
ART treatment significantly improved clinical and histopathological scores in EAU mice and exhibited moderate binding affinity for LCN2 and STAT3. It suppressed microglial activation and downregulated the expression of LCN2 and STAT3, along with the release of IL-6, IL-1β, IL17A and TNF-α. In BV2 microglial cells, ART decreased LCN2 expression and attenuated proinflammatory cytokine secretion.
CONCLUSIONS:
Artesunate attenuates EAU by inhibiting the LCN2-STAT3 axis and suppressing the activation of microglial and Th17 cells.
2026-03-01·Journal of Infection and Public Health
Suboptimal primaquine adherence in Plasmodium vivax malaria: Evidence from high-burden tribal districts in Odisha
Article
作者: Thiruvengadam, Kannan ; Rahi, Manju ; Sharma, Rohit ; Perumalsamy, Nandhini ; K, Anju Viswan ; Rahul, Arya ; Srirama, Srikanth ; Arumugam, Renuka Devi
BACKGROUND:
Eliminating Plasmodium vivax malaria in India's tribal regions is challenging, mainly due to poor adherence to primaquine, the only hypnozoiticidal drug for radical cure under national policy. Incomplete adherence to the 14-day primaquine regimen leads to relapse, treatment failure, ongoing transmission, and may contribute to antimalarial resistance. This study quantified primaquine adherence, and explored behavioral factors influencing non-adherence in high-burden tribal districts of Odisha.
METHODS:
This prospective cohort study conducted from January to December 2024 in two high-burden tribal districts (Malkangiri, Koraput) enrolled 269 laboratory-confirmed P. vivax patients aged over one year. Structured questionnaires collected demographic, clinical, and treatment data. Adherence to the 14-day primaquine regimen was assessed on days 7 and 14 via self-report, pill counts, and blister pack inspection. Uni- and multivariable analyses identified predictors of non-adherence.
RESULTS:
Adherence to chloroquine (3 days) and artesunate-SP (mixed infections) exceeded 93 %, while only 58.7 % (95 % CI: 52.6-64.9) completed the 14-day primaquine course. Healthcare workers dispensed drugs according to guidelines. Treatment discontinuation was mainly due to symptom resolution (61.9 %) and forgetfulness (21.4 %); only one patient discontinued primaquine due to an adverse event. Older age and household malaria history were associated with better adherence.
CONCLUSION:
Suboptimal primaquine adherence delays P. vivax elimination despite adequate drug supply and correct dosing. Addressing behavioral drivers of early treatment cessation is critical to interrupt relapse transmission. Programmatic focus should include intensified social behavior change communication, targeted directly observed therapy, and evaluation of shorter primaquine or single-dose tafenoquine treatments with G6PD testing to enhance radical cure and accelerate India's 2030 malaria elimination goal.
2026-03-01·JOURNAL OF DENTISTRY
Artesunate-loaded hydrogel promotes osteogenic differentiation and bone regeneration under inflammation: An in vitro and in vivo study
Article
作者: Nie, Rongrong ; Zhao, Cuicui ; Zhu, Han ; Tong, Enkang ; Dong, Xiaofei ; Meng, Xiangfeng ; Gong, Lingxue
OBJECTIVE:
This study aimed to prepare an artesunate (AS)-loaded gelatin methacryloyl (AS/GelMA) composite hydrogel and systematically evaluate its anti-inflammatory and pro-osteogenic effects in a lipopolysaccharide (LPS)-induced inflammatory microenvironment.
METHODS:
The AS/GelMA hydrogel was prepared, and its physicochemical properties were characterized by scanning electron microscopy, Fourier-transform infrared spectroscopy, X-ray photoelectron spectroscopy, degradation, rheology, and compression tests. Biocompatibility was assessed by Cell Counting Kit-8, Live/Dead, and cytoskeleton staining, and anti-inflammatory and osteogenic activities were evaluated by quantitative real-time polymerase chain reaction, western blot, immunofluorescence, and Alizarin Red S staining of rat bone marrow mesenchymal stem cells (rBMSCs) under LPS-induced inflammation. In vivo rat mandibular inflammatory defect models were constructed and assessed at two and four weeks post-surgery using micro-computed tomography and histological staining.
RESULTS:
The addition of AS enhanced the hydrogel's mechanical strength while maintaining its biocompatibility, interconnected porous structure, and injectability. In vitro, the AS/GelMA hydrogel significantly inhibited the expression of pro-inflammatory factors and significantly promoted osteogenic differentiation and mineralization under inflammation. In vivo, the AS/GelMA group showed no obvious visceral toxicity and accelerated higher-quality new bone formation at two and four weeks compared to controls.
CONCLUSIONS:
The AS/GelMA composite hydrogel effectively coordinated dual anti-inflammatory and pro-osteogenic bioactivities, significantly promoting the repair of inflammatory bone defects. Therefore, AS/GelMA represents a promising biomaterial strategy to improve regenerative outcomes under inflammation-compromised conditions.
CLINICAL SIGNIFICANCE:
The AS/GelMA hydrogel promoted the repair of mandibular inflammatory bone defects in rats by coordinating anti-inflammatory and pro-osteogenic activities. This offers a promising biomaterial strategy for addressing residual inflammation-related bone loss in oral and maxillofacial surgery.
141
项与 青蒿琥酯 相关的新闻（医药）2026-02-26
THE LANCET Infectious Diseases. Volume 26Number 1
柳叶刀传染病学 26卷 1期
https://www.thelancet.com/journals/laninf/issue/current
EDITORIAL(社论)
1
Urgent need for infection prevention and control in prisons
监狱中感染预防和控制的迫切需求
The Lancet Infectious Diseases
The Lancet Infectious Diseases Vol 26(1):p1
COMMENT（述评）
2
Now is the time to integrate serology into routine infectious disease surveillance
现在是时候将血清学纳入常规传染病监测了
Simon Cauchemez
The Lancet Infectious Diseases Vol 26(1):p2
3
Reassessing sotrovimab's role in COVID-19: insights and implications
重新评估索托维单抗在新冠肺炎治疗中的作用：见解与启示
Daniele Focosi,Fabrizio Maggi
The Lancet Infectious Diseases Vol 26(1):p3
4
Shaping opportunities for future clinical trials in tuberculosis
为未来结核病临床试验创造机会
Ivan Noreña,Beno Mbeya,Joanitah Nalunjogi,Ombeni Chimbe,Norbert Heinrich
The Lancet Infectious Diseases Vol 26(1):p5
5
Diversifying antimalarial treatment for uncomplicated Plasmodium falciparum malaria in Uganda
乌干达针对无并发症恶性疟原虫疟疾的抗疟治疗多样化
Arjen M Dondorp
The Lancet Infectious Diseases Vol 26(1):p6
6
A safe start for PfSPZ Vaccine, but efficacy in children remains elusive
PfSPZ疫苗安全起步，但在儿童中的疗效仍难以捉摸
Nicholas Aderinto,Temitomi Jane Oyedele
The Lancet Infectious Diseases Vol 26(1):p8
7
Rifasutenizol-based triple therapy for Helicobacter pylori infection
以利法苏替尼唑为基础的三联疗法治疗幽门螺杆菌感染
Jinnan Chen,Hong Lu
The Lancet Infectious Diseases Vol 26(1):p9
8
The smallest faith
最渺小的信念
Steven A Pergam
The Lancet Infectious Diseases Vol 26(1):p11
9
Negative results in long COVID clinical trials: choosing outcome measures for a heterogeneous disease
新冠肺炎长期症状临床试验的阴性结果：为异质性疾病选择预后指标
Lara Goxhaj,Lisa McCorkell,Femke van Rhijn-Brouwer,Letícia Soares,Julia Moore Vogel,Chloé de Canson
The Lancet Infectious Diseases Vol 26(1):p13
10
Strengthening global preparedness and response to arboviral disease threats: a call to action
加强全球应对虫媒病毒疾病威胁的准备和响应：行动呼吁
WHO Global Arbovirus Initiative Technical Advisory Group
世界卫生组织全球虫媒病毒倡议技术咨询小组
The Lancet Infectious Diseases Vol 26(1):p15
11
Introducing our cover artist for 2026: Daria Lada
介绍我们2026年的封面艺术家：达里亚·拉达
Marco De Ambrogi
The Lancet Infectious Diseases Vol 26(1):p17
Correspondence（读者来信）
12
Epidemiological and virological update on the emerging SARS-CoV-2 variant BA.3.2
新兴新冠病毒变异株BA.3.2的流行病学和病毒学最新情况
Lu Zhang,Nianzhen Chen,Amy Eichmann,Inga Nehlmeier,Anna-Sophie Moldenhauer,Metodi V Stankov,Christine Happle,Alexandra Dopfer-Jablonka,Georg M N Behrens,Markus Hoffmann,Stefan Pöhlmann
The Lancet Infectious Diseases Vol 26(1):e1
13
Effects of LP.8.1-adapted mRNA vaccination on SARS-CoV-2 variant neutralisation
Christine Happle,Markus Hoffmann,Metodi V Stankov,Inga Nehlmeier,Amy Eichmann,Torsten LP.8.1适应性mRNA疫苗接种对新冠病毒变异株中和作用的影响
Witte,Luis Manthey,Stefan Pöhlmann,Alexandra Dopfer-Jablonka,Georg M N Behrens
The Lancet Infectious Diseases Vol 26(1):e3
14
Artificial intelligence and spillover prediction: aligning innovation with empirical reality in One Health surveillance
人工智能与溢出预测：在“同一健康”监测中使创新与经验现实保持一致
Nader Ebrahimi,Amir Ghaemi
The Lancet Infectious Diseases Vol 26(1):e6
15
Artificial intelligence and spillover prediction: aligning innovation with empirical reality in One Health surveillance – Authors' reply
人工智能与溢出预测：在“同一健康”监测中使创新与经验现实保持一致——作者回复
Frank Aarestrup,Marion Koopmans
The Lancet Infectious Diseases Vol 26(1):e7
16
Time to tackle vaccine–HLA associations with artificial intelligence
是时候用人工智能解决疫苗-人类白细胞抗原关联问题了
Alexander J Mentzer,George Davey Smith,Teresa Lambe,Julian C Knight,Mary Carrington
The Lancet Infectious Diseases Vol 26(1):e8
Corrections（更正）
17
Correction to Lancet Infect Dis 2025; published online Oct 29.
《柳叶刀-传染病》2025年更正；在线发表于10月29日
https://doi.org/10.1016/S1473-3099(25)00466-9
The Lancet Infectious Diseases Vol 26(1):e9
18
Correction to Lancet Infect Dis 2025; published online Oct 27.
《柳叶刀-传染病》2025年更正；在线发表于10月27日
https://doi.org/10.1016/S1473-3099(25)00546-8
The Lancet Infectious Diseases Vol 26(1):e9
19
Correction to Lancet Infect Dis 2025; 25: 1084–96
《柳叶刀-传染病》2025年更正；25卷：1084-1096页
The Lancet Infectious Diseases Vol 26(1):e9
20
Correction to Lancet Infect Dis 2025; published online Nov 10.
《柳叶刀-传染病》2025年更正；在线发表于11月10日
https://doi.org/10.1016/S1473-3099(25)00550-X
The Lancet Infectious Diseases Vol 26(1):e9
Newsdesk（新闻台）
21
Highlights of IDWeek 2025
2025年IDWeek亮点
Phoebe Hall
The Lancet Infectious Diseases Vol 26(1):e10
22
WHO publishes update on global antibiotic resistance
世界卫生组织发布全球抗生素耐药性最新情况
Timothy Jesudason
The Lancet Infectious Diseases Vol 26(1):e11
23
European Commission to fund new medicines for dengue
欧盟委员会资助登革热新药研发
Sanjeet Bagcchi
The Lancet Infectious Diseases Vol 26(1):e12
24
Second report from the UK Covid-19 Inquiry
英国新冠肺炎调查第二次报告
Talha Burki
The Lancet Infectious Diseases Vol 26(1):e13
25
Infectious disease surveillance update
传染病监测最新情况
Cahal McQuillan
The Lancet Infectious Diseases Vol 26(1):e14
26
Research in brief
研究简讯
Priya Venkatesan
The Lancet Infectious Diseases Vol 26(1):e15
Obituary（讣告）
27
Jean Louis Abdourahim Ndiaye
让·路易斯·阿卜杜拉希姆·恩迪亚耶
Sanjeet Bagcchi
The Lancet Infectious Diseases Vol 26(1):p19
Profile（人物介绍）
28
Fortunate Machingura—tackling climate change and disease
福图纳特·马辛古拉——应对气候变化与疾病
Tony Kirby
The Lancet Infectious Diseases Vol 26(1):p20
Media Watch（媒体观察）
Book（书籍）
29
The social and political drivers behind pandemics
大流行背后的社会和政治驱动因素
Emma Louise Fabiani
The Lancet Infectious Diseases Vol 26(1):p21
Articles（论著）
30
Dynamics of endemic virus re-emergence in children in the USA following the COVID-19 pandemic (2022–23): a prospective, multicentre, longitudinal, immunoepidemiological surveillance study
新冠肺炎疫情后美国儿童地方性病毒重新出现的动态（2022-23年）：一项前瞻性、多中心、纵向、免疫流行病学监测研究
Hai Nguyen-Tran,Sang Woo Park,Matthew R Vogt,Perdita Permaul,Alicen B Spaulding,Michelle L Hernandez,Jennifer A Bohl,Sucheta Godbole,Tracy J Ruckwardt,Peter W Krug,Daniel L Moss,Alexandrine Derrien-Colemyn,Ananda Chowdhury,Gabrielle Dziubla,Lu Wang,Mike Castro,Sandeep R Narpala,Elizabeth R Longtine,Amy R Henry,Teri-T B Ngo,Leonid Dzantiev,George B Sigal,C Jessica Metcalf,David W Kimberlin,Samuel R Dominguez,Abraham Mittelman,Adrian B McDermott,Leonid A Serebryannyy,Bryan Grenfell,Kevin Messacar,Daniel C Douek
The Lancet Infectious Diseases Vol 26(1):p22
31
Sotrovimab versus usual care in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
索托维单抗与常规治疗对住院新冠肺炎患者的疗效对比（RECOVERY）：一项随机、对照、开放标签、平台试验
RECOVERY Collaborative Group
RECOVERY协作组
The Lancet Infectious Diseases Vol 26(1):p34
32
A 3-month clofazimine–rifapentine-containing regimen for drug-susceptible tuberculosis versus standard of care (Clo-Fast): a randomised, open-label, phase 2c clinical trial
含氯法齐明-利福喷丁的3个月方案与标准治疗方案治疗药物敏感性结核病的对比（Clo-Fast）：一项随机、开放标签、2c期临床试验
John Z Metcalfe,Isabelle R Weir,Kimberly K Scarsi,Alberto Mendoza-Ticona,Samuel Pierre,Luke Hall,Jorge Leon-Cruz,Elin M Svensson,Simon E Koele,Wadzanai Samaneka,Cecilia Kanyama,Maxwell Yohane,Neetal Nevrekar,Busisiwe Ntsalaze,Jean Bernard Marc,Melanie Goth,Gary Maartens,Richard Chaissonon behalf of the ACTG A5362 study team
The Lancet Infectious Diseases Vol 26(1):p46
33
Global policy responses to antimicrobial resistance, 2021–22: a systematic governance analysis of 161 countries and territories
2021-22年全球应对抗菌药物耐药性的政策反应：对161个国家和地区进行的系统性治理分析
Jay Patel,Sahar Saeedi Moghaddam,Sruthi Ranganathan,Neil Vezeau,Emily O'Neill,Anne Harant,Michael Stolpe,Lothar H Wieler,Tim Eckmanns,Devi Sridhar
The Lancet Infectious Diseases Vol 26(1):p55
34
Efficacies of artemether–lumefantrine, artesunate–amodiaquine, dihydroartemisinin–piperaquine, and artesunate–pyronaridine for the treatment of uncomplicated Plasmodium falciparum malaria in children aged 6 months to 10 years in Uganda: a randomised, open-label, phase 4 clinical trial
乌干达6个月至10岁儿童使用蒿甲醚-本芴醇、青蒿琥酯-阿莫地喹、双氢青蒿素-哌喹和青蒿琥酯-吡喃隆治疗无并发症恶性疟原虫疟疾的疗效：一项随机、开放标签、4期临床试验
Moses R Kamya,Joaniter I Nankabirwa,Chris Ebong,Victor Asua,Moses Kiggundu,Stephen Orena,Martin Okitwi,Stephen Tukwasibwe,Bosco Agaba,Daniel Kyabayinze,Jimmy Opigo,Damian Rutazana,Benjamin Binagwa,Edward Mugwanya,Shakira Babirye,Gloria Sebikaari,Patrick M Condo,Grace Appiah,Sam L Nsobya,Melissa D Conrad,Philip J Rosenthal,Leah F Moriarty,Adoke Yeka
The Lancet Infectious Diseases Vol 26(1):p67
35
Safety, tolerability, and protective efficacy of a radiation-attenuated, whole sporozoite malaria vaccine in children in Gabon: a randomised, double-blind, placebo-controlled, phase 2 trial
加蓬儿童使用辐射减毒全孢子虫疟疾疫苗的安全性、耐受性和保护效力：一项随机、双盲、安慰剂对照、2期试验
Selidji T Agnandji,Jeroen Bok,Ayodele Alabi,Anita L Kabwende,Armel Mbouna,Juste Bie,Eleonne Moukiti,Albert Lalremruata,Meral Esen,Andrea Kreidenweiss,Natasha KC,B Kim Lee Sim,Thomas L Richie,L W Preston Church,Matthew B B McCall,Stephen L Hoffman,Peter G Kremsner,Benjamin Mordmüller
The Lancet Infectious Diseases Vol 26(1):p79
36
Effectiveness of the TAK-003 dengue vaccine in adolescents during the 2024 outbreak in São Paulo, Brazil: a test-negative, case–control study
TAK-003登革热疫苗在2024年圣保罗暴发期间对青少年的有效性：一项测试阴性病例对照研究
Otavio T Ranzani,Felippe Lazar Neto,Lisany Krug Mareto,Thiago Sanches Brumatti,Roberto Dias de Oliveira,Patricia Vieira da Silva,Edinéia Ribeiro dos Santos,Tatiana Lang D' Agostini,Regiane A Cardoso De Paula,Natalie E Dean,Albert I Ko,Derek A T Cummings,Jason R Andrews,Matt D T Hitchings,Julio Croda
The Lancet Infectious Diseases Vol 26(1):p91
37
Rifasutenizol-based triple therapy versus bismuth plus clarithromycin-based triple therapy for first-line treatment of Helicobacter pylori infection in China (EVEREST-HP): a phase 3, multicentre, randomised, triple-dummy, double-blind, controlled, non-inferiority trial
以利法苏替尼唑为基础的三联疗法与铋剂加克拉霉素为基础的三联疗法作为中国幽门螺杆菌感染一线治疗的对比（EVEREST-HP）：一项3期、多中心、随机、三模拟、双盲、对照、非劣效性试验
Zhiqiang Song,Liya Zhou,Weihong Wang,Cheng Lan,Tongyu Tang,Jun Xie,Huizhen Fan,Xuehong Wang,Xiuli Zuo,Yin Zhu,Chengxia Liu,Yongsong Gu,Huang Feng,Xiang Gao,Qing Zhang,Hong Zhang,Jing Chen,Guozhu Geng,Zhenkun Maon behalf of the EVEREST-HP Study Group
The Lancet Infectious Diseases Vol 26(1):p101
Series（专题研讨会）
38
Prevention and Management of Infections in People who are Immunocompromised
免疫功能低下人群感染的预防和治疗
Innovation in active and passive immunisation of people who are immunocompromised: a call to action
免疫功能低下人群主动和被动免疫接种的创新：行动呼吁
Joshua A Hill,Jim Boonyaratanakornkit,Malgorzata Mikulska,Benjamin W Teh,William O Hahn,Ghady Haidar,Catherine Liu,Deepali Kumar,Michael G Ison,Natasha Halasa
The Lancet Infectious Diseases Vol 26(1):e16
39
Prevention and Management of Infections in People who are Immunocompromised
免疫功能低下人群感染的预防和治疗
Tackling antimicrobial resistance in people who are immunocompromised: leveraging diagnostic and antimicrobial stewardship
应对免疫功能低下人群的抗菌药物耐药性：利用诊断和抗菌药物管理
Catherine Liu,Emily A Rosen,Erica J Stohs,Hannah Imlay,Masayuki Nigo,Lee S Gottesdiener,Miranda So,Frank Tverdek,Sanjeet Dadwal,Carlota Gudiol,Michael J Satlin,Susan K Seo,Jason A Trubiano,Ritu Banerjee,Kimberly E Hanson,Lilian M Abbo
The Lancet Infectious Diseases Vol 26(1):e30
Review（综述）
40
Unveiling the incidences and trends of alveolar echinococcosis in Europe: a systematic review from the KNOW-PATH project
揭示欧洲肺泡棘球蚴病的发病率和趋势：来自KNOW-PATH项目的系统综述
Adriano Casulli,Bernadette Abela,Daniele Petrone,Barbara Šoba,Balázs Dezsényi,Jacek Karamon,Laurence Millon,Urmas Saarma,Daniela Antolová,François Chappuis,Severin Gloor,Marcel Stoeckle,Beat Müllhaupt,Relja Beck,Heimo Lagler,Felix Lötsch,Herbert Auer,Marie-Pierre Hayette,Libuše Kolářová,Sniedze Laivacuma,Mindaugas Šarkūnas,Vitalijus Sokolovas,Audronė Marcinkutė,Karin Troell,Ansgar Deibel,Pikka Jokelainen,Małgorzata Sulima,Dagny Krankowska,Stillhard Roman,Gaëtan-Romain Joliat,Nermin Halkic,Solange Bresson-Hadni,Joanna Halina Bednarek,Andrzej Załęski,Małgorzata Paul,Sheraz Yaqub,Mogens Jensenius,Joke van der Giessen,Laura Nabarro,Peter Chiodini,Florent Demonmerot,Jenny Knapp,Beate Grüner,Peter Kern,Lynn Peters,Federica Santolamazza,Azzurra Santoro
The Lancet Infectious Diseases Vol 26(1):e49
Personal View（个人观点）
41
Azithromycin mass drug administration: balancing survival benefits and risks in children
阿奇霉素大规模药物给药：平衡儿童生存益处与风险
Nubwa Medugu,Ian C Michelow,Claudette Poole,Stephen K Obaro
The Lancet Infectious Diseases Vol 26(1):e62
Clinical Picture（临床影像）
42
Unexpected finding in a 17-year-old female undergoing screening colonoscopy
17岁女性接受筛查结肠镜检查时的意外发现
Ziheng Calvin Xu,Ethan Tan,Mayur Garg
The Lancet Infectious Diseases Vol 26(1):e75
THE LANCET Infectious Diseases. Volume 26Number 2
柳叶刀传染病学 26卷 2期
https://www.thelancet.com/journals/laninf/issue/current
EDITORIAL(社论)
1
Call for letters
征稿启事
The Lancet Infectious Diseases
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p111
Comment（述评）
2
Long COVID is here to stay—even in children
长期新冠症状将持续存在——即使在儿童中亦是如此
Danilo Buonsenso
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p112
3
Beyond ritonavir-boosted nirmatrelvir: the case for ensitrelvir in COVID-19 treatment
利托那韦强化版奈玛特韦之外的选择：恩赛特韦在新冠肺炎治疗中的应用
Ming Hong Choi,Ivan Fan Ngai Hung
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p113
4
A new monoclonal in the arMAMentarium against malaria
抗疟“武器库”中的新型单克隆抗体
Freia-Raphaella Lorenz,Matthew B B McCall
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p115
5
Household transmission of mpox in Africa: limited in adults but more prevalent in children
非洲猴痘家庭传播情况：在成人中传播有限，但在儿童中更为普遍
Oriol Mitjà,Michael Marks
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p117
6
The lasting lessons of mpox: infection, vaccination, and immune memory
猴痘带来的持久教训：感染、疫苗接种和免疫记忆
Raianna Fantin,Camila H Coelho
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p118
7
Xpert-Ultra for diagnosing asymptomatic tuberculosis
Xpert-Ultra用于诊断无症状结核病
Xia Yu,Hairong Huang
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p120
8
The genomic surveillance gap: averting the antimicrobial resistance pandemic requires global equity and action
基因组监测的差距：避免抗菌药物耐药性大流行需要全球公平与行动
David M Aanensen,Iruka N Okeke,Pilar Donado-Godoy,Beverly Egyir,Ravikumar K Lingegowda,Sonia Siaon behalf of the NIHR Global Health Research Unit on Genomic Surveillance of AMR
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p122
Correspondence（读者来信）
9
Spillover in dengue trials
登革热试验中的溢出效应
Thomas A Smith,Samuel I Watson
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e77
10
Spillover in dengue trials – Author's reply
登革热试验中的溢出效应——作者回复
Fernando Abad-Franch
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e78
11
Updating the traditional voriconazole trough concentration range
传统的伏立康唑谷浓度范围更新
Rongqiang Liao,Xiaoyuan Zheng
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e79
12
Updating the traditional voriconazole trough concentration range – Authors' reply
传统的伏立康唑谷浓度范围更新——作者回复
Inderpaul Singh Sehgal,Ritesh Agarwal,Valliappan Muthu
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e80
13
Clinical course and neurological profile of Kyasanur Forest disease
基萨努尔森林病的临床病程和神经特征
Nitin Gupta,Tirlangi Praveen Kumar
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e82
Corrections（更正）
14
Correction to Lancet Infect Dis 2025; published online Oct 10. https://doi.org/10.1016/S1473-3099(25)00482-7
对《柳叶刀-传染病》2025年发表内容的更正；10月10日在线发表。https://doi.org/10.1016/S1473-3099(25)00482-7
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e83
15
Correction to Lancet Infect Dis 2025; published online Dec 1. https://doi.org/10.1016/S1473-3099(25)00681-4
对《柳叶刀-传染病》2025年发表内容的更正；12月1日在线发表。https://doi.org/10.1016/S1473-3099(25)00681-4
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e83
Newsdesk（新闻台）
16
Promising early data for sorfequiline
索氟维林早期数据令人鼓舞
Ed Holt
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e84
17
Highlights from ASTMH 2025
2025年美国热带医学与卫生学会年会亮点
Marco De Ambrogi
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e85
18
Brazil approves domestic single-shot dengue vaccine
巴西批准国产单剂登革热疫苗
Marcia Triunfol
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e86
19
CDC cuts to childhood vaccine recommendations
美国疾控中心削减儿童疫苗接种建议
Priya Venkatesan
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e87
20
WHO launches unified plan for coronaviruses
世界卫生组织启动冠状病毒统一计划
Talha Burki
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e88
21
Infectious disease surveillance update
传染病监测更新
Cahal McQuillan
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e89
22
Research in brief
研究简讯
Priya Venkatesan
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e90
Obituary（讣告）
23
Walter Dowdle
沃尔特·道德尔
Sanjeet Bagcchi
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p124
Profile（人物简介）
24
Katie Anders—improving global dengue control
凯蒂·安德斯——改善全球登革热防控
Tony Kirby
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p125
Media Watch（媒体观察）
Film（电影）
25
Eliminating Guinea worm
根除麦地那龙线虫
Sanjeet Bagcchi
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p126
Articles（论著）
26
Long COVID associated with SARS-CoV-2 reinfection among children and adolescents in the omicron era (RECOVER-EHR): a retrospective cohort study
奥密克戎时代儿童与青少年长期新冠症状与SARS-CoV-2再感染的关联（RECOVER-EHR）：一项回顾性队列研究
Bingyu Zhang,Qiong Wu,Ravi Jhaveri,Ting Zhou,Michael J Becich,Yuriy Bisyuk,Frank Blanceró,Elizabeth A Chrischilles,Cynthia H Chuang,Lindsay G Cowell,Daniel Fort,Carol R Horowitz,Susan Kim,Nathalia Ladino,David M Liebovitz,Mei Liu,Abu S M Mosa,Hayden T Schwenk,Srinivasan Suresh,Bradley W Taylor,David A Williams,Jeffrey S Morris,Christopher B Forrest,Yong Chenon behalf of the RECOVER Consortium
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p127
27
Antiviral efficacy of oral ensitrelvir versus oral ritonavir-boosted nirmatrelvir in COVID-19 (PLATCOV): an open-label, phase 2, randomised, controlled, adaptive trial
口服恩赛特韦与口服利托那韦强化版奈玛特韦在新冠肺炎治疗中的抗病毒疗效（PLATCOV）：一项开放标签、2期、随机、对照、适应性试验
William H K Schilling,Podjanee Jittamala,Phrutsamon Wongnak,James A Watson,Simon Boyd,Viravarn Luvira,Tanaya Siripoon,Thundon Ngamprasertchai,Elizabeth M Batty,Ellen Beer,Shivani Singh,Tanatchakorn Asawasriworanan,Timothy Seers,Koukeo Phommasone,Terry John Evans,Varaporn Kruabkontho,Thatsanun Ngernseng,Jaruwan Tubprasert,Mohammad Yazid Abdad,Wanassanan Madmanee,Jindarat Kouhathong,Kanokon Suwannasin,Watcharee Pagornrat,Tianrat Piteekan,Borimas Hanboonkunupakarn,Kittiyod Poovorawan,Manus Potaporn,Attasit Srisubat,Bootsakorn Loharjun,Kesinee Chotivanich,Mallika Imwong,Sasithon Pukrittayakamee,Arjen M Dondorp,Nicholas P J Day,Watcharapong Piyaphanee,Weerapong Phumratanaprapin,Nicholas J Whiteon behalf of the PLATCOV Collaborative Group
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p139
28
Cefiderocol versus standard therapy for hospital-acquired and health-care-associated Gram-negative bacterial bloodstream infection (the GAME CHANGER trial): an open-label, parallel-group, randomised trial
头孢地尔与标准疗法治疗医院获得性和医疗保健相关性革兰氏阴性菌血流感染（GAME CHANGER试验）：一项开放标签、平行分组、随机试验
David L Paterson,Helmi Sulaiman,Po-Yu Liu,Mark D Chatfield,Mesut Yilmaz,Zeti Norfidiyati Salmuna,Mohd Zulfakar Mazlan,Siriluck Anunnatsiri,Rujipas Sirijatuphat,Darunee Chotiprasitsakul,David C Lye,Jyoti Somani,Shirin Kalimuddin,Abdullah T Aslan,Visanu Thamlikitkul,Yi-Tzu Lee,Ya-Sung Yang,Yi-Tsung Lin,Wan Nurliyana Wan Ramli,Chien-Hao Tseng,Sophia Archuleta,Yvonne Fu Zi Chan,Brian M Forde,Hugh Wright,Adam G Stewart,Kay A Ramsay,Weiping Ling,Vicki Rossi,Tiffany M Harris-Brown,Patrick N A Harrison behalf of the GAME CHANGER Trial Investigators
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p148
29
Efficacy and safety of ascending doses of orodispersible ivermectin co-administered with albendazole for Trichuris trichiura infections in preschool-aged children in Tanzania: a 坦桑尼亚学龄前儿童感染毛首鞭形线虫时，递增剂量口服分散片伊维菌素与阿苯达唑联合用药的疗效和安全性：一项单盲、随机、对照、剂量递增、2期试验
single-blind, randomised, controlled, dose-ranging, phase 2 trial
Viviane P Sprecher,Annina Schnoz,Stefan Biendl,Halima S Hussein,Sarah O Najim,Mohammed N Ali,Ibrahim S Mohammed,Said M Ali,Jan Hattendorf,Jennifer Keiser
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p160
30
Human monoclonal antibody MAM01 for protection against malaria in adults in the USA: a first-in-human, phase 1, dose-escalation, double-blind, placebo-controlled, adaptive trial
人源单克隆抗体MAM01保护美国成年人免受疟疾侵害：一项首次人体、1期、剂量递增、双盲、安慰剂对照、适应性试验
Kirsten E Lyke,Andrea A Berry,Matthew B Laurens,Jennifer Winkler,Sudhaunshu Joshi,Abra Rachida Koudjra,Lauryn Butler,Peter F Billingsley,Tales Pascini,Asha Patil,B Kim Lee Sim,Grace Fitzgerald,Julie Riegel,Kayla Andrews,Micha Levi,Aparna B Anderson,Charles D Wells,Hong Liu,James Huleatt,R Scott Miller
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p170
31
Characterising household transmission dynamics of clade Ib mpox in Burundi: a prospective cohort study
布隆迪Ib分支猴痘家庭传播动力学特征：一项前瞻性队列研究
Raoul Kamadjeu,Ferdinand Nsengimana,Manassé Nimpagaritse,Edna Moturi,Eric Kezakarayagwa,Rose Nkiko,Jonas Ngendakumana,Rémy Nimubona,Liliane Nkengurutse,Hamady Ba,Dionis Nizigiyimana,Paul Ngwakum,Mame Selbee Diouf,France Bégin,Joseph Nyandwi,Douglas James Noble
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p182
32
Long-term consequences of monkeypox virus infection or modified vaccinia virus Ankara vaccination in Belgium (MPX-COHORT and POQS-FU-PLUS): a 24-month prospective and retrospective cohort study
比利时猴痘病毒感染或改良痘苗病毒安卡拉株疫苗接种的长期后果（MPX-COHORT和POQS-FU-PLUS）：一项为期24个月的前瞻性和回顾性队列研究
Christophe Van Dijck,Nicole Berens-Riha,Luca M Zaeck,Cécile Kremer,Jacob Verschueren,Jasmine Coppens,Fien Vanroye,Elisabeth Willems,Evi Bosman,Natalie De Cock,Bart Smekens,Leen Vandenhove,Odin Goovaerts,Anke Van Hul,Janne Wouters,Bart K M Jacobs,Stefanie Bracke,Matilde Hens,Isabel Brosius,Elise De Vos,Eugene Bangwen,Sarah Houben,Achilleas Tsoumanis,Pedro Henrique Lopes Ferreira Dantas,Jojanneke Rutgers,Amber Lipman,Koen Wijnans,Patrick Soentjens,Emmanuel Bottieau,Chris Kenyon,Johan van Griensven,Thijs Reyniers,Niels Horst,Kevin K Ariën,Marjan Van Esbroeck,Andrea Torneri,Koen Vercauteren,Wim Adriaensen,Rory D de Vries,Joachim Mariën,Laurens Liesenborghs
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p190
33
Long-term risk of tuberculosis among individuals with Xpert Ultra trace screening results in Uganda: a longitudinal follow-up study
乌干达Xpert Ultra微量筛查结果阳性个体患结核病的长期风险：一项纵向随访研究
Joowhan Sung,Mariam Nantale,Annet Nalutaaya,Patrick Biché,James Mukiibi,Joab Akampurira,Rogers Kiyonga,Francis Kayondo,Michael Mukiibi,Caitlin Visek,Caleb E Kamoga,David W Dowdy,Achilles Katamba,Emily A Kendall
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：p203
Review（综述）
34
Invasive group A streptococcal infections: lessons learned from the 2022–23 upsurge
侵袭性A组链球菌感染：从2022-23年激增中吸取的教训
Alix Flamant,Alicia Demirjian,Theresa Lamagni,Julie Toubiana,Pierre R Smeesters,Jérémie F Cohen
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e91
35
A clinical practice guideline for tuberculous meningitis
结核性脑膜炎临床实践指南
Joseph Donovan,Fiona V Cresswell,Elizabeth W Tucker,Angharad G Davis,Ursula K Rohlwink,Julie Huynh,Regan Solomons,James A Seddon,Nathan C Bahr,Arjan van Laarhoven,Suzanne T Anderson,Sanjay K Jain,Felicia C Chow,Sophie Pattison,James E Scriven,Gabriela Singh,Rob E Aarnoutse,Jan-Willem C Alffenaar,Sofiati Dian,Abi Manesh,Robin Basu Roy,Varinder Singh,Ronald van Toorn,Caryn M Upton,Reinout van Crevel,Kelly E Dooley,Diana Gibb,David Meya,Robert J Wilkinson,Ewelina Rogozińska,Usha K Misra,Anthony Figaji,Guy E Thwaites
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e96
36
Towards shorter therapy for candidaemia: defining uncomplicated candidaemia in adults
缩短念珠菌血症疗程：界定成人非复杂性念珠菌血症
Ilana Reinhold,Susanne Picardi,Blasius Liss,Danila Seidel,Jannik Stemler,Philipp Koehler,Tamara Ruegamer,Rosanne Sprute,Oliver A Cornely
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e112
Personal View（个人观点）
37
A transformation in cholera surveillance
霍乱监测的变革
Amanda K Debes,Erin T Baumgartner,Kendra N Williams,David A Sack
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e124
Clinical Picture（临床图像）
38
Paediatric ocular toxocariasis with relentless progression despite negative metagenomic testing
尽管宏基因组检测呈阴性，但儿科眼弓蛔虫病仍持续进展
Diya Shah,Shiama Balendra,Harry Petrushkin,Anamika Patel
The Lancet Infectious Diseases. Feb 2026，Vol 26(2)：e130
THE LANCET Infectious Diseases. Volume 26Number 3
柳叶刀传染病学 26卷 3期
https://www.thelancet.com/journals/laninf/issue/current
EDITORIAL（社论）
1
Promises and challenges of AI in infectious diseases
人工智能在传染病领域的承诺与挑战
The Lancet Infectious Diseases
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p213
COMMENT（述评）
2
More real-world evidence for RSV vaccines in the global community
全球范围社区呼吸道合胞病毒（RSV）疫苗的更广泛的现实证据
Kristina L Bajema,Wesley H Self
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p214
3
Rapid diagnostic antigen tests for mpox and the need for decentralised testing—not quite there yet
猴痘快速诊断抗原检测及分散检测的必要性——尚待完善
Daniel Mukadi-Bamuleka,Kevin K Ariën
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p215
4
Solving the data bottleneck for artificial intelligence in infectious diseases
解决传染病人工智能领域的数据瓶颈问题
Cesar de la Fuente-Nunez
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p217
5
Artificial intelligence and One Health: potential for spillover prediction?
人工智能与“同一健康”理念：能否预测病原体外溢？
Marion Koopmans,Istvan Csabai,Daniel Remondini,Emma Snary,Frank Aarestrup
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p219
6
Artificial intelligence in the development of vaccines for infectious diseases
人工智能在传染病疫苗研发中的应用
Steve Black,Shabir A Madhi,Rino Rappuoli
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p221
7
Peer review at The Lancet Infectious Diseases in 2025
2025年《柳叶刀-传染病学》期刊专家评审
Ursula Hofer
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p223
8
Thank you to The Lancet Infectious Diseases statistical and peer reviewers in 2025
感谢2025年《柳叶刀-传染病学》期刊的统计学及评审专家
The Lancet Infectious Diseases Editors
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e132
CORRESPONDENCE（读者来信）
9
Methodological considerations in the attribution of long COVID to first or second infection
首次或二次感染导致长期新冠症状的方法学考量
Sara Carazo,Danuta M Skowronski,Manale Ouakki,Gaston De Serres
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e139
10
Methodological considerations in the attribution of long COVID to first or second infection – Authors' reply
首次或二次感染导致长期新冠症状的方法学考量——作者回复
Bingyu Zhang,Qiong Wu,Ravi Jhaveri,Christopher B Forrest,Yong Chen
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e141
11
Humoral immunity after LP.8.1 monovalent vaccines against a broad range of SARS-CoV-2 variants including XEC, LP.8.1, NB.1.8.1, XFG, and BA.3.2
LP.8.1单价疫苗针对包括XEC、LP.8.1、NB.1.8.1、XFG和BA.3.2在内的多种SARS-CoV-2变异株的体液免疫应答
Yu Kaku,Mizuka Fujiwara,Keiya Uriu,Maximilian Stanley Yo,Shusuke Kawakubo,Jumpei Ito,Naoya Itoh,Yoshifumi Uwamino,Fumitake Saito,Hironori Satoh,The Genotype to Phenotype Japan (G2P-Japan) Consortium,Kei Sato
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e142
12
Precision diagnostics for MBLs: the true game changer in treating antimicrobial resistance
金属β-内酰胺酶精准诊断：治疗抗菌药物耐药性的真正变革者
Brenda A Warecki,María F Mojica,Alejandro J Vila,Robert A Bonomo
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e144
13
Precision diagnostics for MBLs: the true game changer in treating antimicrobial resistance – Authors' reply
金属β-内酰胺酶精准诊断：治疗抗菌药物耐药性的真正变革者——作者回复
David L Paterson,Abdullah T Aslan,Patrick N A Harris
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e145
CORRECTIONS（更正）
14
Correction to Lancet Infect Dis 2025; published online Dec 9. https://doi.org/10.1016/S1473-3099(25)00659-0
《柳叶刀-传染病学》2025年发表文章勘误；在线发表于12月9日。https://doi.org/10.1016/S1473-3099(25)00659-0
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e146
15
Correction to Lancet Infectious Diseases 2026; published online Jan 20. https://doi.org/10.1016/S1473-3099(25)00773-X
《柳叶刀-传染病学》2026年发表文章勘误；在线发表于1月20日。https://doi.org/10.1016/S1473-3099(25)00773-X
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e146
NEWSDESK（新闻台）
16
Rabies an increasing threat in Ukraine
乌克兰狂犬病威胁日益加剧
Ed Holt
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e147
17
People needing trachoma interventions at record low
需要沙眼干预措施的人数创历史新低
Timothy Jesudason
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e148
18
Uneven STI response in EU/EEA countries
欧盟/欧洲经济区国家性传播感染应对措施不均衡
Sanjeet Bagcchi
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e149
19
Controversial HBV vaccine trial in Guinea-Bissau halted
几内亚比绍有争议的乙型肝炎病毒疫苗试验被叫停
Talha Burki
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e150
20
Research in brief
研究简讯
Priya Venkatesan
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e151
OBITUARY（讣告）
21
Ivan Hirsch
伊万·赫希
Sanjeet Bagcchi
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p224
PROFILE（人物介绍）
22
Reem Abu Shomar— championing water safety in Gaza
里姆·阿布·舒马尔——加沙地带水安全倡导者
Tony Kirby
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p225
MEDIA WATCH（媒体观察）
Book（书籍）
23
A prescription for public health literacy
提升公众健康素养的良方
Vijay Shankar Balakrishnan
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p226
Book（书籍）
24
Imagining the inevitable
想象不可避免之事
Cahal McQuillan
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p227
Film（电影）
25
Women's autonomy, safe sex and HIV prevention
女性自主权、安全性行为与艾滋病预防
Sanjeet Bagcchi
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p228
ARTICLES（论著）
26
Vaccine effectiveness of a bivalent respiratory syncytial virus (RSV) pre-F vaccine against RSV-associated hospital admission among adults aged 75–79 years in England: a multicentre, test-negative, case–control study
英国75-79岁成年人中双价呼吸道合胞病毒（RSV）预融合F蛋白疫苗对RSV相关住院的有效性：一项多中心、检测阴性、病例对照研究
Rebecca Symes,Heather J Whitaker,Shazaad Ahmad,David Arnold,Suryabrata Banerjee,Cariad M Evans,Robin Gore,Jennifer Hart,Katy Heaney,Onn Min Kon,Anne Melhuish,Munira Ortale Zogaib,Emanuela Pelosi,Najib M Rahman,Gerrit Woltmann,Tricia McKeever,Maria Zambon,Conall H Watson,Wei Shen Lim,Jamie Lopez Bernalon behalf of the HARISS network collaborators
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p229
27
Oral itraconazole versus oral voriconazole for treatment-naive patients with chronic pulmonary aspergillosis in India (VICTOR-CPA trial): a single-centre, open-label, randomised, controlled, superiority trial
印度治疗初治慢性肺曲霉病患者口服伊曲康唑与口服伏立康唑的对比研究（VICTOR-CPA试验）：一项单中心、开放标签、随机、对照、优效性试验
Inderpaul Singh Sehgal,Ritesh Agarwal,Sahajal Dhooria,Kuruswamy Thurai Prasad,Valliappan Muthu,Ashutosh Nath Aggarwal,Shivaprakash M Rudramurthy,Mandeep Garg,Arunaloke Chakrabarti
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p239
28
Accounting for non-adherence to assigned antibiotic treatment duration for bloodstream infection (BALANCE): a post-hoc analysis of a randomised clinical trial
血流感染抗生素治疗疗程依从性考量（BALANCE）：一项随机临床试验的事后分析
Sean W X Ong,Ruxandra Pinto,Robert K Mahar,Asgar Rishu,Joshua S Davis,Robert A Fowler,Steven Y C Tong,Nick Danemanfor the BALANCE trial consortium
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p250
29
Field evaluation of a rapid antigen test for mpox in the Democratic Republic of the Congo and Uganda: a multicentre, prospective, diagnostic accuracy study
刚果民主共和国和乌干达猴痘快速抗原检测的现场评估：一项多中心、前瞻性、诊断准确性研究
Barnabas Bakamutumaho,David Lupande Mwenebitu,Winters Muttamba,Ingrid Ampeire,Henry Kyobe Bosa,Esto Bahizire,Bertin Casinga Bisimwa,Andrew Obuku,Misaki Wayengera,Alison Sandeman,Matthew T G Holden,Patrick D M C Katoto,Bruce Kirenga,Deborah A Williamson,Wilber Sabiiti
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p260
30
Complications and mortality of typhoid fever: an updated global systematic review and meta-analysis
伤寒热的并发症与死亡率：一项更新的全球系统综述与荟萃分析
Shruti Murthy,Nienke N Hagedoorn,Suzanne Faigan,Meera D Rathan,Christian S Marchello,John A Crump
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p270
31
Global, regional, and national burden of Chagas disease, 1990–2023: a systematic analysis for the Global Burden of Disease Study 2023
1990-2023年全球、区域和国家层面查加斯病负担：2023年全球疾病负担研究的系统分析
GBD 2023 Chagas Disease and RAISE Study Collaborators
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p284
32
Safety, tolerability, and immunogenicity of the ChAdOx1 RVF vaccine against Rift Valley fever among healthy adults in Uganda: a single-centre, single-blind, randomised, placebo-controlled, dose-escalation, phase 1 trial
乌干达健康成年人中ChAdOx1裂谷热疫苗的安全性、耐受性和免疫原性：一项单中心、单盲、随机、安慰剂对照、剂量递增的1期试验
Zacchaeus Anywaine,Jennifer Serwanga,Abu-Baker Mustapher Ggayi,Andrew Max Abaasa,Daniel Wright,Ben Gombe,Peter Ejou,Tamara Namata,Antony Kigozi,Naboth Tukamwesiga,Vincent Basajja,Violet Ankunda,Dora Jocelyn Mulondo,Florence Nambaziira,Ayoub Kakande,Wilson Kakeeto,Phiona Nabaggala,Daniel Jenkin,Alison Lawrie,Pedro Folegatti,Nguyen Tran,Christian Hansen,Alison M Elliott,Adrian V S Hill,George M Warimwe,Pontiano Kaleebu
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p302
33
Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in children, adolescents, and adults in the USA: a randomised, observer-blind, placebo-controlled, phase 2 trial
美国儿童、青少年和成人基础免疫后18个月VLA15莱姆病疫苗候选物的加强免疫接种的免疫原性和安全性：一项随机、观察者盲法、安慰剂对照的2期试验
Laura Wagner,Michaela Obersriebnig,Romana Hochreiter,Vera Kadlecek,Julian Larcher-Senn,Lisa Hegele,Jason D Maguire,Timothy Murphy,Ulla Derhaschnig,Nicole Bézay,Juan Carlos Jaramillo,Susanne Eder-Lingelbach,Marc Messier
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：p314
SERIES（研讨会）
Artificial Intelligence and Infectious Diseases
人工智能与传染病
34
Artificial intelligence and infectious diseases: an evidence-driven conceptual framework for research, public health, and clinical practice
人工智能与传染病：基于证据的研究、公共卫生和临床实践概念框架
Anna Odone,Chiara Barbati,Silvia Amadasi,Tanja Schultz,David B Resnik
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e152
35
Artificial intelligence and infectious disease diagnostics: state of the art and future perspectives
人工智能与传染病诊断：现状与未来展望
Luca Miglietta,Timothy M Rawson,Ronald Galiwango,Alex Tasker,Damien K Ming,Darlington Akogo,Cecilia Ferreyra,Eric O Aboagye,N Claire Gordon,Carolina Garcia-Vidal,Jesus Rodriguez-Manzano,Alison H Holmes
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e168
36
Artificial intelligence and infectious diseases: tackling antimicrobial resistance, from personalised care to antibiotic discovery
人工智能与传染病：应对抗菌药物耐药性，从个性化治疗到抗生素发现
Alex Howard,Nada Reza,Peter L Green,Mo Yin,Erin Duffy,Henry C Mwandumba,Alessandro Gerada,William Hope
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e181
REVIEW（综述）
37
Community-acquired respiratory virus infections in patients with haematological malignancies or undergoing haematopoietic cell transplantation: updated recommendations from the 10th European Conference on Infections in Leukaemia
血液系统恶性肿瘤患者或接受造血细胞移植患者社区获得性呼吸道病毒感染：第10届欧洲白血病感染会议更新建议
Marie von Lilienfeld-Toal,Fareed Khawaja,Francesca Compagno,Christine Robin,José-Luis Piñana,Simone Cesaro,Hermann Einsele,Per Ljungman,David Navarro,Michael Boeckh,Roy F Chemaly,Hans H Hirsch
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e193
CLINICAL PICTURE（临床图像）
38
Mycoplasma hominis toe osteomyelitis: a rare and unusual bone infection
人型支原体足趾骨髓炎：一种罕见且不寻常的骨感染
Cheryl Keel,Pauleen McSherry,Rebecca Thombre,Sendurann Nadarajah,Rediat Tewolde,Owen B
Spiller,Baharak Afshar
The Lancet Infectious Diseases. Mar 2026，Vol 26(3)：e207
疫苗信使RNA临床1期临床研究
2026-02-24
摘要
重症肌无力、视神经脊髓炎谱系疾病（NMOSD）以及髓鞘少突胶质细胞糖蛋白抗体相关疾病（MOGAD）是一组抗体介导的神经免疫性疾病，常累及育龄期女性，因此在规划妊娠时需要审慎制定治疗方案。疾病恶化（针对重症肌无力）或发作（针对NMOSD和MOGAD）可能发生在妊娠期间，且在产后较为常见，可能导致本可预防的、长期的母体残疾。许多药品说明书持保守态度，或建议进行不必要的长时间药物洗脱或避免母乳喂养，这给医生和患者带来了不确定性。本观点整合了关于传统免疫抑制剂和生物疗法（包括补体抑制、B细胞耗竭和新生儿Fc受体阻断）的现有证据。尽管关于新型疗法在妊娠期安全性的数据很少，但初步数据表明，部分精选疗法可在妊娠期间继续使用以维持疾病稳定，并且可与母乳喂养兼容。我们就重症肌无力、NMOSD和MOGAD的疗法选择、婴儿疫苗接种以及胎儿和婴儿监测提供专家建议。
引言
数十年来，围绕妊娠的临床决策优先考虑胎儿安全而非母体健康，导致治疗犹豫不决，并将孕妇排除在临床研究之外。相比之下，临床指南通常强调在炎症性疾病患者中，产后尽早开始治疗并避免母乳喂养，同时未能充分考虑到新生儿可能接触到的、可能极小的影响，以及母乳喂养对母婴双方的益处。如今，正逐渐转向基于科学和共同知情决策，权衡治疗干预措施的风险与获益，旨在优化整个妊娠期和哺乳期母亲和孩子的结局。在本观点中，我们重点关注重症肌无力、水通道蛋白4（AQP4）抗体阳性的视神经脊髓炎谱系疾病（NMOSD）以及髓鞘少突胶质细胞糖蛋白（MOG）抗体相关疾病（MOGAD）。选择这些罕见的、抗体介导的神经免疫性疾病，是因为它们与育龄期女性密切相关，常常需要长期免疫治疗，新的药物选择迅速增加，已有相关的生殖安全性数据，并且存在产后疾病加重的趋势。尽管新兴证据已帮助指导多发性硬化——育龄期女性最常见的神经免疫性疾病——在计划生育各阶段的治疗决策，但对于其他神经免疫性疾病尚无类似的指导。重症肌无力、NMOSD和MOGAD在病理生理学、妊娠结局风险和治疗风险方面与多发性硬化不同，尽管某些治疗干预措施有所重叠。鉴于临床经验有限且新批准药物的安全性数据不足，对希望计划生育的患者进行常规神经科咨询颇具挑战。过去5年的证据表明，在妊娠期间维持免疫治疗不仅可能减少母体疾病活动和残疾，还可能减轻NMOSD的不良妊娠结局，尽管重症肌无力和MOGAD的数据仍然很少。
我们提供了一种实用的专家方法，用于在世界各地对患者从备孕期到产后进行咨询和管理。我们按时间顺序构建本观点，从这些疾病在妊娠期的历程开始，接着讨论分娩注意事项和产后阶段，包括母乳喂养。我们始终关注治疗方面的考量，包括与传统免疫抑制剂相关的考量，但尤其关注与新型疗法相关的考量，包括补体抑制剂、新生儿Fc受体（FcRn）阻断剂、IL-6抑制剂和B细胞耗竭剂。我们旨在支持个体化的治疗决策，以期在最大限度降低后代风险的同时优化母体结局。
计划生育期间及妊娠期的疾病病程
在下一节中，我们回顾妊娠如何影响重症肌无力、NMOSD和MOGAD的疾病活动。在为希望避免或推迟妊娠的患者提供咨询时，尽管关于避孕的文献很少，但没有证据表明外源性激素或避孕药会对这些疾病的疾病活动产生积极或消极的影响。关于辅助生殖技术的证据较少，但基于其在多发性硬化中的应用（在继续免疫治疗的情况下复发风险较低），这些技术在这些疾病中的安全性似乎是合理的。
重症肌无力
两项分别报告了734例和824例重症肌无力患者妊娠情况的大型荟萃分析（有一定重叠）发现，34%-36%的妊娠与重症肌无力恶化相关，20%-29%的妊娠与重症肌无力改善相关。妊娠期间重症肌无力相关恶化的风险在孕晚期增加，妊娠期间重症肌无力危象的风险为6.4%，尽管恶化的定义存在异质性，且可能仅能定义为增加吡啶斯的明的剂量。重症肌无力恶化的最高风险出现在产后（两篇文献分别为11.0%和8.2%）。与重症肌无力相关的临床因素，如抗体状态（ACh受体抗体阳性、MuSK抗体阳性或血清抗体阴性）、眼肌型对比非眼肌型重症肌无力、皮质类固醇激素的使用、使用抗胆碱酯酶药控制症状以及妊娠前重症肌无力完全缓解（对比未缓解），并不能显著预测妊娠期间重症肌无力的恶化。妊娠前或妊娠期间进行胸腺切除术与妊娠期间重症肌无力恶化风险降低相关（相比未行胸腺切除术）。关于妊娠期和产后使用的免疫治疗的记录普遍质量较低，因此仍然难以将重症肌无力加重或危象与妊娠期间的重症肌无力管理联系起来。值得注意的是，在一项针对48例重症肌无力患者妊娠的单中心研究中，由于频繁使用免疫治疗，在妊娠期或产后未观察到危象发作。产后是重症肌无力发病的高危时期，包括ACh受体抗体阳性、MuSK抗体阳性和血清抗体阴性的重症肌无力。
NMOSD
荟萃分析收集了近1000例NMOSD患者妊娠的数据，报告了产后期间复发和残疾风险增加（附件材料第20-23页）。2010年代的一些早期研究报告称，与妊娠前相比，妊娠早期的年化复发率有所增加，并报告妊娠期间年化复发率在数值上有所增加。过去5年发表的研究表明，妊娠期间的年化复发率与妊娠前相似或更低。几项小型NMOSD队列研究和一项荟萃分析报告了妊娠期间与发作相关的扩展残疾状态量表（EDSS）评分增加，但需要注意的是，残疾程度主要使用EDSS测量，而EDSS是为多发性硬化开发的，对NMOSD的变化敏感性较低。一项包含15项队列研究（639例妊娠）的荟萃分析显示，妊娠前与产后第一个三月期之间的年化复发率（平均差异+1.28，p<0.001）以及EDSS评分（平均差异+0.44，p<0.001）存在显著差异。在这项研究中，妊娠期间接受免疫抑制治疗和受孕年龄较大与妊娠相关发作风险降低相关。在不同研究中观察到的差异的可能解释包括受孕前或妊娠期间停止治疗的频率，以及纳入了血清阴性或误诊的NMOSD患者。关于妊娠期间充分免疫抑制治疗的定义存在显著差异，且在几项研究中此类治疗的使用率较低。
MOGAD
对于MOGAD，来自小型队列和病例系列的数据表明，妊娠期间年化复发率下降，产后上升，但需要注意的是可能纳入了单相病程的疾病（附件材料第23页）。在两个MOGAD患者队列中（一项研究25例，另一项19例），所有妊娠均未出现发作。在其中一项研究——一项评估确诊MOGAD病例（n=25）的法国队列中，产后的年化复发率低于妊娠前。然而，在另外两项研究中，产后和妊娠前的年化复发率相似。只有一项回顾性单中心研究评估了EDSS评分，结果显示在妊娠期间因发作导致EDSS恶化的大多数情况下，恢复良好。
产后时期可能增加MOGAD的发病易感性。在法国多中心队列研究中，144例患者中有13例（9%）在产后首次出现MOGAD发作；而在仅纳入有妊娠史的MOGAD女性患者的队列中，37%-60%的患者在妊娠期间或产后1年内发病。
关于这三种疾病围产期疾病活动，仍存在重要的知识空白（框1）。这些空白包括特定免疫疗法在预防妊娠期和产后恶化或发作风险以及残疾累积方面的效果。还需要进行研究以探讨妊娠期和产后恶化或发作的可能可改变的危险因素，例如妊娠前疾病稳定持续时间、受孕年龄以及既往胸腺切除术史。
框1：重症肌无力、NMOSD和MOGAD围产期管理的证据空白与未来研究方向
（1）围产期管理证据的需求与空白
避免恶化（重症肌无力）或发作（水通道蛋白4抗体阳性视神经脊髓炎谱系疾病[AQP4-NMOSD]和髓鞘少突胶质细胞糖蛋白抗体相关疾病[MOGAD]）及其相关的残疾增加：
研究妊娠期免疫治疗对妊娠期和产后恶化（重症肌无力）或发作（NMOSD和MOGAD）风险的影响，包括收集前瞻性和标准化数据
研究妊娠期和产后恶化（重症肌无力）或发作（NMOSD和MOGAD）的可改变危险因素
避免对胎儿和婴儿的伤害：
研究急性加重或发作治疗以及持续免疫治疗对妊娠结局（例如，出生体重降低和早产）的影响
研究妊娠期和哺乳期的疾病活动、急性发作治疗以及持续免疫治疗对后代短期和长期结局的影响，如产后第一年的感染、疫苗接种反应和发育障碍
（2）加速和加强未来围产期管理研究的建议
建立重症肌无力、NMOSD和MOGAD的国际和国家妊娠登记系统，包括医疗中心之间以及与监管机构和行业伙伴的合作
推广由MOGAD Eugène Devic European Network建议的最小妊娠变量数据集：一项旨在促进国际登记系统之间链接和研究的欧洲倡议
与健康保险数据库链接，以收集关于重症肌无力、NMOSD和MOGAD女性所生子代的数据
产科考量与妊娠结局
尽管存在一些混杂的证据，但在为患有重症肌无力、NMOSD和MOGAD的女性提供咨询时，可以告知她们，没有证据表明这些疾病会显著增加产科并发症的风险。一项针对重症肌无力患者妊娠的系统评价报告称，早产（<37周）发生率为11.9%（579例妊娠中69例），胎膜早破发生率为6.7%（404例妊娠中27例），高于已知的一般人群率（早产约10%，胎膜早破2-3%），尽管该研究未将重症肌无力患者的妊娠与对照组进行直接比较。美国2020年发表的一项研究将974名重症肌无力女性的分娩与无重症肌无力的女性进行比较，也发现早产风险较高（比值比1.4，95% CI 1.2–1.8），尽管胎膜早破的发生率并未增加。一项基于瑞典全国人口登记、历时30年的妊娠审计报告显示，在443名重症肌无力患者与4000多例对照妊娠中，任何妊娠并发症均无差异。在一个包含10名MuSK抗体阳性重症肌无力女性共14次妊娠的病例系列中，未观察到产科并发症。早期研究曾提出NMOSD孕妇的流产和子痫前期风险可能增加。然而，过去4年的荟萃分析显示，流产风险（8.1%）和子痫前期发生率（3-5%）与一般人群相似（流产率10-20%，视研究而定；子痫前期占妊娠的3-8%）。任何增加的子痫前期风险可能归因于与NMOSD同时存在的自身免疫性疾病，如系统性红斑狼疮。
在NMOSD孕妇中，循环中的AQP4-IgG可能靶向结合胎盘中的AQP4。已有报告称，在受NMOSD影响的妊娠中，胎盘出现AQP4免疫反应性丧失和补体负载的膜攻击复合物沉积；在一例病例报告中，一名在妊娠期间出现横贯性脊髓炎的妇女，其胎盘AQP4免疫反应性丧失与自然流产相关。在一项小鼠模型中，在子宫内暴露于AQP4抗体的雄性小鼠表现出皮质血管异常和记忆任务表现不佳。因此，尽管未经证实，但通过治疗控制AQP4阳性疾病可能对胎儿和婴儿结局有益。目前没有证据表明MOGAD孕妇与健康对照者的妊娠结局存在差异。
对于控制良好、轻度或中度的重症肌无力，以及NMOSD和MOGAD，推荐阴道分娩。在这三种疾病中，剖宫产通常仅出于产科指征。在重症肌无力中，偶尔可能因产程延长和母体耗竭而需要剖宫产。在NMOSD和MOGAD中，极少数情况下，如果因横贯性脊髓炎导致严重无力和感觉障碍，特别是累及脊髓圆锥时，可能需要剖宫产。
硬膜外麻醉和脊髓麻醉通常在NMOSD孕妇中耐受良好，且无不良事件证据。关于MOGAD孕妇的数据很少。重症肌无力孕妇首选硬膜外麻醉，但那些有严重延髓肌和呼吸肌无力的患者可能需要全身麻醉。除非必要，应避免使用神经肌肉阻滞剂。分娩期间应谨慎使用硫酸镁，因为它可能加重骨骼肌无力。
妊娠期疾病管理
对于患有重症肌无力、NMOSD或MOGAD的育龄期女性患者，初次专科会诊应包含计划生育的讨论。有证据表明，在疾病预先得到稳定的女性中，妊娠期和产后的疾病活动得到改善。那些计划生育的患者应被引导至被认为对妊娠安全的疗法（表1）。根据世界不同地区，可选方案可能仅限于皮质类固醇激素、经典免疫抑制剂和利妥昔单抗（rituximab，RTX）（框2）。具有致畸性的疗法，如传统的免疫抑制剂霉酚酸酯、甲氨蝶呤和环磷酰胺，应从一开始就避免使用，或者如果正在使用，应在尝试受孕前停用，并转换为对妊娠安全的替代免疫抑制剂。我们在附件材料中提供了说明性临床案例（第24-28页），以强调为计划妊娠或已妊娠的重症肌无力、NMOSD或MOGAD女性选择疗法时的关键考虑因素。
表-重症肌无力、NMOSD和MOGAD患者在计划生育和妊娠期间的现有证据与知识空白.pdf
框2：地区性考量
许多用于重症肌无力、水通道蛋白4抗体阳性视神经脊髓炎谱系疾病（AQP4-NMOSD）和髓鞘少突胶质细胞糖蛋白抗体相关疾病（MOGAD）的新型单克隆抗体——无论是已批准还是正在研究中——都价格高昂。即使在北美、欧洲以及日本和澳大利亚等国家，获取途径也部分受到保险状况或国家谈判的限制（未发表数据）。在世界其他地区，如拉丁美洲、非洲和亚洲，在获取单克隆抗体和其他疗法、专科医生、诊断测试（包括抗体检测和肌电图）以及母婴产科照护方面存在更显著的差距。这些地区获得长期经典免疫抑制剂和利妥昔单抗的机会各不相同。在世界所有地区，就计划生育进行咨询都很重要，并应侧重于当地条件。世界卫生组织认可的基本药物包括皮质类固醇激素、吡啶斯的明、硫唑嘌呤、甲氨蝶呤和利妥昔单抗，尽管重症肌无力、NMOSD和MOGAD不在列出的适应症之列。
结核病、HIV和乙型肝炎是许多地区重要的感染性疾病，建议在开始免疫治疗前进行常规筛查。如果在妊娠期间继续免疫治疗，尤其是单克隆抗体，应推迟新生儿的卡介苗接种，直到出生后6个月或直到血液学异常得到解决。
HIV感染者在接受免疫抑制治疗前应接受抗逆转录病毒药物治疗。登革热在热带和亚热带地区流行，已被报告为NMOSD的可能诱因。在这些地区，用奎宁治疗疟疾可能加重重症肌无力，可改用青蒿琥酯。
免疫疗法
人们对免疫疗法的生殖安全性特征了解得越来越深入。较老的药物基于稀缺的历史数据，带有过时的标签，而较新的疗法则缺乏来自妊娠期暴露的、充分的系统性证据。这种组合使得不确定性持续存在，并促使治疗上趋于谨慎。随着临床知识和经验不断扩展，并纳入了来自其他适应症（如多发性硬化和血液系统疾病）的安全性数据，有必要更新当前的推荐，并使实践与新兴证据保持一致。
在表1中，我们总结了当前关于妊娠期治疗暴露的可用安全性数据、现行实践以及关于特定疗法的专家建议。在妊娠期间，对于重症肌无力、NMOSD和MOGAD，可以继续使用长期低剂量口服皮质类固醇激素（仅限非氟化的泼尼松、泼尼松龙和甲泼尼龙），尤其是在疾病活动期或获取其他治疗途径受限的情况下。由于存在剂量相关的潜在风险，剂量应逐渐减至维持病情所需的最低有效剂量。在重症肌无力中，使用硫唑嘌呤、依库珠单抗（eculizumab，ECU）或瑞利珠单抗（ravulizumab，RAV）病情稳定的女性，在与主治的神经科医生权衡风险和获益后，可在妊娠期间继续治疗。关于FcRn阻断剂的数据仍然很少，但对于活动性重症肌无力的女性，尤其是在妊娠前两个三月期（即孕早期[第1-3个月]和孕中期[第4-6个月]），可以考虑使用。口服吡啶斯的明可用于对症治疗。
在NMOSD中，目前的实践是在妊娠前稳定疾病，选择与妊娠兼容的免疫治疗，并根据治疗的作用方式和持续时间，在妊娠期间维持治疗。诸如硫唑嘌呤、环孢素、依库珠单抗或瑞利珠单抗以及托珠单抗（tocilizumab，TCZ）或萨特利珠单抗（satralizumab，SAT）等药物应在妊娠期间继续使用，因为停药可能增加复发风险。单克隆抗体的妊娠暴露数据主要来自NMOSD中的利妥昔单抗，其次是依库珠单抗（来自阵发性睡眠性血红蛋白尿）和托珠单抗（来自风湿免疫病和COVID-19大流行期间）。来自较新队列的数据表明，如果在妊娠前使用利妥昔单抗治疗，许多NMOSD女性可以保持无复发。妊娠前治疗的持续时间和时间点似乎很重要。对于AQP4阳性NMOSD患者，若在妊娠前2年内有疾病活动、治疗持续时间不足2年或两者兼有，且末次利妥昔单抗治疗在妊娠前3个月以上，可考虑在孕早期末再次使用利妥昔单抗，但关于新生儿感染风险、低丙种球蛋白血症和血细胞减少症的数据仍然很少。在MOGAD中，除了经典的免疫抑制疗法、利妥昔单抗和抗IL-6受体抑制剂疗法（主要是托珠单抗），静脉注射免疫球蛋白可用于长期治疗，并且在少数活动性疾病的情况下可在妊娠期间继续使用。
急性疾病活动期的治疗
急性恶化——加重或发作——的治疗策略在这些疾病之间是相似的；妊娠期间可以使用高剂量和低剂量皮质类固醇激素（重症肌无力）、静脉注射免疫球蛋白（主要用于重症肌无力）以及血浆置换疗法。使用静脉注射免疫球蛋白治疗未观察到母体或新生儿并发症增加，数据主要来自其他疾病。尚无对照研究检验急性发作治疗和持续免疫治疗对妊娠结局（例如，出生体重降低和早产）的影响；这一空白应在未来的研究中加以解决（框1）。
与药物暴露相关的胎儿和新生儿健康问题
在妊娠期间，胎盘充当母体和胎儿循环之间的屏障和过滤器（图）。妊娠期间抗体经胎盘转运的变化对妊娠期间单克隆抗体的给药时机具有重要影响。尽管大多数大分子蛋白质无法穿过胎盘，但IgG抗体介导的母体免疫力向胎儿的传递，是通过胎盘上的药物转运体和自妊娠第17周开始表达的新生儿Fc受体促进的。抗体转运在妊娠最后4周达到高峰，而到妊娠第22周仅转运5-10%。因此，在某些情况下，对于NMOSD孕妇，孕早期末可能是给予B细胞耗竭疗法的合适时机。致病性抗体，如AChR-IgG、AQP4-IgG、MOG-IgG和MuSK-IgG，也能穿过胎盘，尤其是在妊娠后半期，导致在此期间胎儿并发症（如胎儿ACh受体抗体相关疾病）的风险更高。生理性抗体（如针对常见病毒或疫苗反应的母体抗体）会发生被动转移，其在孕晚期达到峰值；在妊娠期间，特别是在孕晚期使用某些疗法（例如，FcRn阻断剂），可减少妊娠最后几周保护性抗体向胎儿的转移。
图：重症肌无力、NMOSD和MOGAD中的抗体通过经胎盘转运传递给胎儿或新生儿，并通过母乳传递给婴儿。生理性转移包括致病性抗体、治疗性单克隆抗体和疫苗抗体。IgG亚类抗体可以通过胎盘从母体循环主动转运到胎儿循环。新生儿Fc受体是IgG经胎盘转运的驱动因素之一。在重症肌无力中，ACh受体抗体和MuSK抗体可穿过胎盘，进入胎儿循环，并诱发新生儿重症肌无力。在罕见情况下，特定的ACh受体抗体（可与胎儿ACh受体特异性γ亚基结合）转移给胎儿，可能与胎儿ACh受体抗体相关疾病有关，包括新生儿多发性关节挛缩。在NMOSD和MOGAD中，AQP4-IgG和MOG-IgG可穿过胎盘并进入胎儿循环，尽管这些IgG对胎儿的影响尚不清楚。所有治疗性单克隆抗体都可随着孕周增加而更多地穿过胎盘（在孕晚期达到高峰），并到达胎儿循环。抗CD19和抗CD20单克隆抗体引起的B细胞耗竭可增加孕妇和新生儿的感染风险（通过降低疫苗反应、B细胞耗竭或其他血液学异常）。具体而言，抗CD19和抗CD20单克隆抗体——如利妥昔单抗（用于超适应症治疗重症肌无力、NMOSD和MOGAD）和伊奈利珠单抗（用于治疗重症肌无力和AQP4阳性NMOSD）——以及FcRn阻断剂，如罗泽利昔珠单抗（rozanolixizumab）、艾加莫德（efgartigimod）和尼卡利单抗（nipocalimab）——用于治疗重症肌无力——可诱导低丙种球蛋白血症，从而减少生理性和保护性母体抗体的转移。萨特利珠单抗和托珠单抗是人源化单克隆抗体，靶向IL-6受体，萨特利珠单抗用于治疗AQP4阳性NMOSD（和超适应症治疗MOGAD），托珠单抗用于超适应症治疗NMOSD和MOGAD。在整个妊娠期间暴露于这些药物的新生儿可能出现血液学异常，感染风险增加，这可能会影响疫苗接种计划。依库珠单抗和瑞利珠单抗是补体C5抑制剂，用于治疗重症肌无力和AQP4阳性NMOSD。在整个妊娠期间暴露于这些药物的新生儿可能补体水平降低，并可能出现血液学异常，感染风险增加。泽卢克布仑钠（zilucoplan）是一种用于治疗重症肌无力的C5抑制剂，在整个妊娠期间可能进入胎儿循环，但离体模型提示其转移率较低（尚无人类可用数据）。致病性抗体、治疗性单克隆抗体和生理性抗体分泌到初乳和母乳中，因此可在哺乳期间转移给婴儿，但据认为大部分在婴儿肠道中被降解，不产生任何全身性生物学效应。AQP4=水通道蛋白4；FcRn=新生儿Fc受体；MOG=髓鞘少突胶质细胞糖蛋白；MOGAD=MOG抗体相关疾病；NMOSD=视神经脊髓炎谱系疾病。
关于重症肌无力、NMOSD和MOGAD常用疗法对胎儿的宫内影响的安全性数据很少，特别是对于新型疗法。关于FcRn阻断剂的数据很少，但FcRn阻断剂尼卡利单抗（nipocalimab，NIP）已显示出治疗重症肌无力的疗效，并且在一项针对13例患有早发性严重胎儿和新生儿溶血病的孕妇的单臂研究中，未发现与胎儿或新生儿并发症增加相关。补体抑制剂依库珠单抗在超过300例妊娠中未显示与不良妊娠结局相关，这些妊娠大多来自患有阵发性睡眠性血红蛋白尿的母亲。关于瑞利珠单抗，仅发表了一例在孕中期和孕晚期接受治疗的NMOSD母亲病例，记录到药物经胎盘转运但婴儿未出现不良事件。鉴于依库珠单抗有更丰富的安全性数据，使用瑞利珠单抗的患者可在妊娠期间转换为依库珠单抗。对于泽卢克布仑钠（zilucoplan，ZIL），一种大环肽类补体抑制剂，在离体人体胎盘灌注模型中观察到胎儿暴露的转移率较低（0.5%）。尽管关于使用萨特利珠单抗的孕妇数据很少，但我们可以从托珠单抗的数据以及妊娠期间使用它而未出现并发症的个别病例中推断其相对安全性。伊奈利珠单抗（inebilizumab，INE）是一种用于治疗NMOSD的抗CD19单克隆抗体；尚无已发表数据，但其安全性可能与其他B细胞耗竭剂相似，后者与感染风险增加相关。对于另一种B细胞耗竭剂利妥昔单抗，关于新生儿感染风险、低丙种球蛋白血症和血细胞减少症的数据仍然很少。有研究表明，妊娠期间使用高剂量急性或长期皮质类固醇激素治疗可能与唇裂和腭裂、出生体重降低或早产风险罕见增加有关。这些风险增加并未导致在妊娠期间接受过高剂量皮质类固醇激素的多发性硬化母亲的子代出现认知功能低下。
新生儿考量
母乳喂养与免疫疗法
母体抗体在母乳喂养期间转移给婴儿，以提供被动免疫力。母乳喂养对母亲和孩子还有许多其他健康益处，应支持母亲努力进行母乳喂养，除非有证据表明其特定的免疫疗法存在安全问题。母乳中IgA浓度最高，但也存在其他免疫球蛋白，包括IgG，其中IgG1是初乳、过渡乳和成熟乳中最主要的亚型。然而，母乳中IgG的浓度远低于血清，且由于IgG不能被全身吸收，致病性抗体的任何临床意义很可能极小。
重症肌无力和NMOSD，以及很可能MOGAD，都与产后病情恶化风险相关，不应因母乳喂养而推迟有效治疗。经典免疫抑制剂，如硫唑嘌呤、皮质类固醇激素、环孢素和他克莫司，与母乳喂养兼容，尽管在某些情况下（即硫唑嘌呤和皮质类固醇激素），有时建议在母乳喂养后暂停2-4小时（表2）。使用环磷酰胺、甲氨蝶呤或霉酚酸酯时不建议母乳喂养。单克隆抗体是大分子蛋白质，可在母乳中检测到，但与其他IgG一样，会在足月新生儿肠道中被降解，因此与母乳喂养兼容。对于用于其他自身免疫性疾病的较新单克隆抗体（如奥瑞利珠单抗和奥法妥木单抗），欧洲药品管理局的药品特征概要批准了母乳喂养。
表-重症肌无力、NMOSD和MOGAD患者在计划生育和妊娠期间的现有证据与知识空白.pdf
疫苗接种
新生儿暴露于患有自身免疫性疾病的母亲所使用的免疫疗法，引发了关于新生儿疫苗接种时机和安全性的问题。根据母亲所用药物的半衰期和药代动力学，新生儿体内药物浓度可持续长达6个月。过去3年发表的对暴露于生物制剂（主要是肿瘤坏死因子抑制剂）后接受轮状病毒减毒活疫苗的婴儿的研究显示出良好的安全性结果。对于宫内暴露于免疫治疗的婴儿，应评估其血液学参数，包括全血细胞计数、CD19和CD20细胞计数，以及对于暴露于B细胞耗竭疗法的婴儿，还应检测血清免疫球蛋白浓度。当白细胞或B细胞计数低于标准阈值时，应推迟接种减毒活疫苗。对于在妊娠期间给予单克隆抗体的婴儿，应推迟卡介苗（BCG）接种，因为已有少数病例报告，母亲在妊娠期间暴露于英夫利西单抗或阿达木单抗的婴儿出生后接种疫苗后发生了致命的播散性结核病。仅在母乳喂养期间而非妊娠期间暴露于单克隆抗体的情况，应遵循一般国家疫苗接种指南。
抗体血清学状态及相关后遗症
致病性IgG抗体，包括针对AChR和MuSK的抗体，可穿过胎盘，导致5-20%的血清抗体阳性和血清抗体阴性母亲所生的婴儿出现一过性新生儿重症肌无力。婴儿可能出现肌张力减退、吸吮力差、哭声弱、眼外肌无力，以及更罕见的呼吸困难，其中30%的病例需要重症监护支持。一过性新生儿肌无力通常在2-8周内缓解。强烈建议在配备新生儿重症监护室的三级医院分娩，并对重症肌无力母亲所生的婴儿进行密切监测。吡啶斯的明和新斯的明可用于治疗新生儿重症肌无力，严重病例可考虑使用静脉注射免疫球蛋白和血浆置换。
针对胎儿型ACh受体的抗体经胎盘转运可导致一种极为罕见但严重的并发症，伴有重大畸形：胎儿ACh受体抗体相关疾病，其中约半数病例表现为多发性关节挛缩。多发性关节挛缩的特征是由胎动减少引起的多发性挛缩，并可导致产前死亡。胎儿ACh受体抗体相关疾病还包括较轻的疾病，表现为永久性肌病，主要累及面部和延髓肌肉。可能存在其他异常，如听力丧失、膈肌麻痹、中枢神经系统受累和幽门狭窄。胎儿ACh受体抗体相关疾病可发生于无症状母亲所生的婴儿。在2023年发表的一项收集自不同国家的46例病例的队列研究中，50%患有这些疾病的新生儿母亲既往未诊断为重症肌无力。有效的孕早期母体免疫抑制、孕前胸腺切除术以及从妊娠早期开始的抗体清除疗法（即皮质类固醇激素、静脉注射免疫球蛋白和血浆置换）可能有助于降低新生儿重症肌无力、多发性关节挛缩和胎儿ACh受体抗体相关疾病对胎儿和婴儿的风险。目前尚不清楚FcRn阻断剂是否能降低这些疾病的风险，但此类治疗确实能减少IgG通过胎盘的转运。建议进行频繁的超声监测以寻找胎儿ACh受体抗体相关疾病的迹象，并就治疗获益和未来妊娠风险提供咨询。
小型病例系列记录了血清AQP4抗体阳性母亲所生婴儿的血清AQP4抗体呈阳性。正如根据抗体半衰期所预期的那样，新生儿在3个月时血清抗体转阴，未出现可识别的神经系统表现，尽管AQP4在妊娠14周时已在胎儿中枢神经系统中表达。据我们所知，MOGAD母亲所生的婴儿中尚未报告过MOG抗体的影响。
结论与未来方向
重症肌无力、NMOSD和MOGAD的围产期管理必须考虑到新的观察性证据的传播以及有效治疗的新型单克隆抗体的批准。通过在孕前和妊娠期间进行规划并实现最佳的疾病控制，可以改善母亲和孩子的结局。尽管在全球许多地区获取途径仍受限或根本不存在，但新型免疫疗法正越来越多地用于这些疾病。根据疾病的活动性和严重程度，可以在妊娠期和哺乳期考虑使用此类治疗。多学科团队的参与以及胎儿和婴儿监测至关重要。对于重症肌无力患者，抗体经胎盘转运可导致胎儿和婴儿并发症；而接受免疫抑制疗法治疗的母亲所生的婴儿可能出现免疫学和血液学副作用。应推迟接种活疫苗，尤其是卡介苗。母乳喂养可与部分经典免疫疗法以及任何单克隆抗体治疗结合进行，但并非所有疗法均可。国际协作数据收集和登记工作正在进行中，这对于制定未来关于这些罕见疾病围产期管理最佳实践的指南是必要的。神经科医生应基于所有可用证据，就计划生育和妊娠问题提供咨询，并鼓励所有患有重症肌无力、NMOSD或MOGAD的育龄期女性共同决策。
附件材料Current evidence and knowledge gaps in family planning and pregnancy in myasthenia gravis, NMOSD, and MOGAD.pdf
[参考文献]
Rotstein DL, Alroughani R, Arrambide G, Contentti EC, Chomba M, Fujihara K, Gilhus NE, Gouider R, Heckmann JM, Kim HJ, Li HF, Leite MI, Monif M, Siritho S, Thiel S, Vishnevetsky A, Viswanathan S, Vukusic S, Yamout B, Kümpfel T, Hellwig K. Current evidence and knowledge gaps in family planning and pregnancy in myasthenia gravis, NMOSD, and MOGAD. Lancet Neurol. 2026 Mar;25(3):308-324.
2026-02-24
The BRAFTOVI combination regimen is the only approved targeted regimen for first-line BRAF-V600E mutant metastatic colorectal cancer Pivotal results from the Phase 3 portion with mFOLFOX6 of the BREAKWATER trial demonstrated a clinically meaningful and statistically significant 51% risk reduction in death and a 47% risk reduction in disease progression or death compared to chemotherapy treatment with or without bevacizumab Expanded indication enables flexibility to use BRAFTOVI in combination with cetuximab and different fluorouracil-based chemotherapy regimens
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation based on results from the global Phase 3 BREAKWATER trial (NCT04607421).
BRAFTOVI in combination with cetuximab and mFOLFOX6 was granted accelerated approval by the FDA in December 2024 based on objective response rate (ORR) results, one of the BREAKWATER trial’s dual primary endpoints. The conversion from accelerated approval to full approval is based on significant benefit in outcomes for both progression-free survival (PFS), the trial’s other primary endpoint, and overall survival (OS), a key secondary endpoint, from the Phase 3 portion of the study that evaluated BRAFTOVIin combination with cetuximab and mFOLFOX6, as well as the ORR results from the Cohort 3 portion of the study, which evaluated BRAFTOVIin combination with cetuximab and FOLFIRI.
“This landmark approval, achieved through the robust clinical benefit demonstrated in the BREAKWATER trial, validates that this targeted therapy can impact outcomes for people living with an aggressive, hard-to-treat cancer,” said Aamir Malik, Executive Vice President, Chief U.S. Commercial Officer, Pfizer. “As the only targeted combination regimen shown to deliver a significant improvement in certain outcomes for patients with BRAF V600E‑mutant metastatic colorectal cancer, BRAFTOVI is uniquely positioned to redefine first‑line treatment and establish a new standard of care. This approval reinforces our leadership in bringing differentiated, potentially practice‑changing cancer therapies to patients and healthcare providers who urgently need improved options.”
“This approval gives oncologists confidence to use encorafenib plus cetuximab in combination with fluorouracil-based chemotherapy as a first-line standard of care for patients with BRAF V600E-mutant metastatic colorectal cancer,” said Scott Kopetz, M.D., Ph.D., FACP, Professor and Deputy Chair of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center and co-principal investigator of the BREAKWATER trial. “The BREAKWATER study demonstrated that these targeted combination regimens provided statistically significant benefit, providing the robust evidence we need to make treatment decisions that can meaningfully impact patient outcomes.”
In the BREAKWATER study, the safety profile of both combination regimens continued to be consistent with the known safety profile of each respective agent in the regimen. No new safety signals were identified. The most common side effects (≥25%) in the mFOLFOX6 regimen were peripheral neuropathy, nausea, fatigue, diarrhea, decreased appetite, rash, vomiting, hemorrhage, abdominal pain, arthralgia, pyrexia, and constipation. The most common side effects (≥25%) in the FOLFIRI regimen were nausea, diarrhea, fatigue, vomiting, alopecia, constipation, abdominal pain, decreased appetite, and rash.
Among patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6, 14% experienced an adverse reaction that resulted in permanent discontinuation of BRAFTOVI. There was no substantial difference in chemotherapy discontinuation due to side effects in the BRAFTOVI in combination with cetuximab and mFOLFOX6 arm compared with the chemotherapy, with or without bevacizumab arm. Among patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, 9% experienced an adverse reaction that resulted in permanent discontinuation of BRAFTOVI.
The BRAFTOVI combination regimen with mFOLFOX6 is also under regulatory review in Europe, where Pierre Fabre Laboratories has exclusive commercialization rights, and was recently approved for use in several other countries.
About BREAKWATER BREAKWATER is a Phase 3, randomized, active-controlled, open-label, multicenter trial of BRAFTOVI with cetuximab, alone or in combination with mFOLFOX6 or FOLFIRI (both fluorouracil-based chemotherapies) in participants with previously untreated BRAF V600E-mutant mCRC.
Phase 3 Analysis: BRAFTOVI in combination with cetuximab and mFOLFOX6: Patients were randomized to receive BRAFTOVI 300 mg orally once daily in combination with cetuximab (discontinued after randomization of 158 patients), BRAFTOVI 300 mg orally once daily in combination with cetuximab and mFOLFOX6 (n=236) or mFOLFOX6, FOLFOXIRI, or CAPOX, with or without bevacizumab (control arm) (n=243). The dual primary endpoints for these study groups are ORR and PFS as assessed by BICR. OS is a key secondary endpoint.
At the time of the PFS primary analysis, BRAFTOVI in combination with cetuximab and mFOLFOX6 significantly reduced the risk of disease progression or death by 47% compared to chemotherapy with or without bevacizumab (hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.41, 0.68; p<0.0001) as assessed by blinded independent central review (BICR). Median PFS was 12.8 months (95% CI, 11.2, 15.9) with the BRAFTOVI combination regimen compared to 7.1 months (95% CI, 6.8, 8.5) with chemotherapy with or without bevacizumab. In a second interim analysis of median OS, BRAFTOVI plus cetuximab and mFOLFOX6 significantly reduced the risk of death by 51% compared to chemotherapy, with or without bevacizumab (HR 0.49; 95% CI, 0.38, 0.63; p<0.0001). Median OS doubled from 15.1 months with chemotherapy, with or without bevacizumab (95% CI, 13.7, 17.7) to 30.3 months (95% CI, 21.7, Not Estimated) with the BRAFTOVI combination regimen. These data were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine.
Cohort 3 Analysis: BRAFTOVI in combination with cetuximab and FOLFIRI: In Cohort 3, patients were randomized to receive BRAFTOVI 300 mg orally once daily in combination with cetuximab and FOLFIRI (n=73) or FOLFIRI, with or without bevacizumab (control arm) (n=74). The primary endpoint of Cohort 3 is ORR as assessed by BICR. PFS is a key secondary endpoint; OS is a secondary endpoint summarized descriptively.
BRAFTOVI plus cetuximab and FOLFIRI demonstrated a clinically meaningful and statistically significant improvement in confirmed ORR assessed by BICR compared to patients receiving FOLFIRI with or without bevacizumab (64% vs 39%, odds ratio =2.76, p=0.0011). These data were presented at the 2026 American Society of Clinical Oncology Gastrointestinal (ASCO GI®) Cancers Symposium. Detailed PFS results from Cohort 3 will be submitted for presentation at an upcoming medical meeting.
About Colorectal Cancer (CRC) CRC is the third most common type of cancer in the world, with approximately 1.8 million new diagnoses in 2022.1 It is the second leading cause of cancer-related deaths.2 Overall, the lifetime risk of developing CRC is about 1 in 24 for men and 1 in 26 for women.2 In the U.S. alone, an estimated 158,850 people will be diagnosed with cancer of the colon or rectum in 2026, and approximately 55,000 are estimated to die from the disease each year.3 For 20% of those diagnosed with CRC, the disease has metastasized, or spread, making it harder to treat, and up to 50% of patients with localized disease eventually develop metastases.4
BRAF mutations are estimated to occur in 8-12% of people with mCRC and are associated with a poor prognosis for these patients.5 The BRAF V600E mutation is the most common BRAF mutation, and the risk of mortality in CRC patients with the BRAF V600E mutation is more than double that of patients with no known mutation present.5-7 Despite the high unmet need in BRAF V600E-mutant mCRC, prior to the BRAFTOVI accelerated FDA approval in this indication on December 20, 2024, there were no approved biomarker-driven therapies specifically indicated for people with previously untreated BRAF V600E-mutant mCRC.8,9
About BRAFTOVI® (encorafenib) BRAFTOVI is an oral small molecule kinase inhibitor that targets BRAF V600E. Inappropriate activation of proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK) has been shown to occur in certain cancers, including CRC.
Pfizer has exclusive rights to BRAFTOVI in the U.S., Canada, Latin America, Middle East, and Africa. Ono Pharmaceutical Co., Ltd. has exclusive rights to commercialize the product in Japan and South Korea, Medison has exclusive rights to commercialize the product in Israel and Pierre Fabre Laboratories has exclusive rights to commercialize the product in all other countries, including Europe and Asia (excluding Japan and South Korea).
INDICATION AND USAGE
BRAFTOVI® (encorafenib) is indicated, in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-authorized test.
Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC.
IMPORTANT SAFETY INFORMATION
Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 and FOLFIRI for recommended dosing and additional safety information.
WARNINGS AND PRECAUTIONS
New Primary Malignancies: New primary malignancies, cutaneous and noncutaneous, can occur. In the BREAKWATER trial, the following cutaneous malignancies occurred in patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6: melanocytic nevus in 5.6%, skin papilloma in 3%, basal cell carcinoma in 1.3%, squamous cell carcinoma of skin in 0.9%, keratoacanthoma in 0.4% and malignant melanoma in situ in 0.4%. In patients who received BRAFTOVI in combination with cetuximab and FOLFIRI, skin papilloma occurred in 2.8% and keratoacanthoma in 1.4% of patients. Perform dermatologic evaluations prior to initiating treatment, every 2 months during treatment, and for up to 6 months following discontinuation of treatment. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Dose modification is not recommended for new primary cutaneous malignancies. Based on its mechanism of action, BRAFTOVI may promote malignancies associated with activation of RAS through mutation or other mechanisms. Monitor patients receiving BRAFTOVI for signs and symptoms of noncutaneous malignancies. Discontinue BRAFTOVI for RAS mutation-positive noncutaneous malignancies. Monitor patients for new malignancies prior to initiation of treatment, while on treatment, and after discontinuation of treatment.
Tumor Promotion in BRAF Wild-Type Tumors: In vitro experiments have demonstrated paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells exposed to BRAF inhibitors. Confirm evidence of BRAF V600E or V600K mutation using an FDA-authorized test prior to initiating BRAFTOVI.
Cardiomyopathy: Cardiomyopathy manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in ejection fraction, has been reported in patients. Assess left ventricular ejection fraction (LVEF) by echocardiogram or multigated acquisition (MUGA) scan prior to initiating treatment, 1 month after initiating treatment, and then every 2 to 3 months during treatment. The safety has not been established in patients with a baseline ejection fraction that is either below 50% or below the institutional lower limit of normal (LLN). Patients with cardiovascular risk factors should be monitored closely. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.
Hepatotoxicity: Hepatotoxicity can occur. In the BREAKWATER trial, the incidence of Grade 3 or 4 increases in liver function laboratory tests in patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6 was 2.6% for alkaline phosphatase, 1.3% each for ALT and AST. In patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, the incidence of Grade 3 or 4 increases in liver function laboratory tests was 1.5% each for ALT and AST. Monitor liver laboratory tests before initiation of BRAFTOVI, monthly during treatment, and as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.
Hemorrhage: Hemorrhage can occur. In the BREAKWATER trial, hemorrhage occurred in 34% of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6; Grade 3 or 4 hemorrhage occurred in 3% of patients. In patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, hemorrhage occurred in 21% of patients. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.
Uveitis: Uveitis, including iritis and iridocyclitis, has been reported in patients treated with BRAFTOVI. In BREAKWATER, the incidence of uveitis among patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6 was 0.4%. Assess for visual symptoms at each visit. Perform an ophthalmological evaluation at regular intervals and for new or worsening visual disturbances, and to follow new or persistent ophthalmologic findings. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.
QT Prolongation: BRAFTOVI is associated with dose-dependent QTc interval prolongation in some patients. In the BREAKWATER trial, an increase of QTcF >500 ms was measured in 4% (9/226) of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6. In patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, an increase of QTcF >500 ms was measured in 1.5% (1/65) of patients. Monitor patients who already have or who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure and those taking other medicinal products associated with QT prolongation. Correct hypokalemia and hypomagnesemia prior to and during BRAFTOVI administration. Withhold, reduce dose, or permanently discontinue for QTc >500 ms.
Embryo-Fetal Toxicity: BRAFTOVI can cause fetal harm when administered to pregnant women. BRAFTOVI can render hormonal contraceptives ineffective. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with BRAFTOVI and for 2 weeks after the final dose.
Risks Associated with Combination Treatment: BRAFTOVI is indicated for use as part of a regimen in combination with cetuximab and mFOLFOX6 or FOLFIRI. Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 and FOLFIRI for additional risk information.
Lactation: Advise women not to breastfeed during treatment with BRAFTOVI and for 2 weeks after the final dose.
Infertility: Advise males of reproductive potential that BRAFTOVI may impair fertility.
ADVERSE REACTIONS BRAF V600Emutation-positive mCRC, in combination with cetuximab and mFOLFOX6
Serious adverse reactions occurred in 46% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6. Serious adverse reactions in >3% of patients included intestinal obstruction (4.7%), pyrexia (3.9%), sepsis (3.4%), and abdominal pain (3.4%) Fatal intestinal obstruction occurred in 0.9%, and fatal large intestinal perforation andgastrointestinal perforation occurred in 0.4% (each) in patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6 Most common adverse reactions (≥25%, all grades) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab), and a subset of the control arm (mFOLFOX6 ± bevacizumab), respectively were: peripheral neuropathy (64% vs 53% and 57%), nausea (54% vs 50% and 44%), fatigue (53% vs 41% and 45%), diarrhea (42% vs 50% and 44%), decreased appetite (38% vs 27% and 30%), rash (36% vs 6% and 5%), vomiting (36% vs 22% and 17%), hemorrhage (34% vs 21% and 15%), abdominal pain (32% vs 31% and 30%), arthralgia (32% vs 6% and 7%), pyrexia (29% vs 16% and 17%), and constipation (27% vs 23% and 25%) Most common laboratory abnormalities(≥10%, grade 3 or 4) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab), and a subset of the control arm (mFOLFOX6 ± bevacizumab), respectively were: increased lipase (53% vs 28% and 23%), decreased neutrophil count (37% vs 35% and 33%), decreased hemoglobin (19% vs 6% and 7%), decreased white blood cell count (12% vs 8% and 6%), and increased glucose (11% vs 2% and 1%)
BRAF V600E mutation-positive mCRC, in combination with cetuximab and FOLFIRI
Serious adverse reactions occurred in 39% of patients who received BRAFTOVI in combination with cetuximab and FOLFIRI. Serious adverse reactions in >3% of patients included febrile neutropenia (5.6%) and infusion related reaction (4.2%) Fatal gastrointestinal perforation occurred in 1.4% of patients who received BRAFTOVI in combination with cetuximab and FOLFIRI Most common adverse reactions (>25%, all grades) in the BRAFTOVI with cetuximab and FOLFIRI arm compared to the control arm (FOLFIRI ± bevacizumab) were nausea (61% vs 57%), diarrhea (55% vs 49%), fatigue (47% vs 50%), vomiting (47% vs 31%), alopecia (35% vs 22%), constipation (31% vs 29%), abdominal pain (30% vs 22%), decreased appetite (30% vs 32%), and rash (27% vs 1.5%) Most common laboratory abnormalities (≥10%, grade 3 or 4) in the BRAFTOVI with cetuximab and FOLFIRI arm compared to the control arm (FOLFIRI ± bevacizumab) were: decreased neutrophil count (30% vs 32%), increased lipase (22% vs 12%), decreased white blood cell count (20% vs 6%), and decreased hemoglobin (10% vs 3%)
DRUG INTERACTIONS
Strong or moderate CYP3A4 inhibitors: Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors, including grapefruit juice. If coadministration is unavoidable, reduce the BRAFTOVI dose.
Strong CYP3A4 inducers: Avoid coadministration of BRAFTOVI with strong CYP3A4 inducers.
Sensitive CYP3A4 substrates: Avoid the coadministration of BRAFTOVI with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. If the coadministration cannot be avoided, see the CYP3A4 substrate product labeling for recommendations.
Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI.
Avoid coadministration of BRAFTOVI with drugs known to prolong QT/QTc interval.
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About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Disclosure Notice The information contained in this release is as of February 24, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about BRAFTOVI® (encorafenib) and an approval in the U.S. for BRAFTOVI in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BRAFTOVI plus cetuximab and fluorouracil-based chemotherapy; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications may be filed in any additional jurisdictions for BRAFTOVI plus cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic CRC with a BRAF V600E mutation or in any jurisdictions for any other potential indications for BRAFTOVI; whether and when any such other applications may be approved by other regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether BRAFTOVI plus cetuximab and fluorouracil-based chemotherapy will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of BRAFTOVI or BRAFTOVI plus cetuximab and fluorouracil-based chemotherapy; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
ERBITUX® is a registered trademark of Eli Lilly and Company its subsidiaries, or affiliates.
References
Media Contact: PfizerMediaRelations@Pfizer.com Investor Contact: IR@Pfizer.com
Source: Pfizer Inc.
临床结果临床3期上市批准ASCO会议引进/卖出
100 项与 青蒿琥酯 相关的药物交易
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 疟疾 | 中国 | 1988-01-01 |
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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 | 肯尼亚 | 2025-01-22 | |
| 宫颈癌 | 临床2期 | 肯尼亚 | 2025-01-22 | |
| 原位癌 | 临床2期 | 美国 | 2023-12-06 | |
| 发育不良 | 临床2期 | 美国 | 2023-12-06 | |
| 外阴疾病 | 临床2期 | 美国 | 2023-12-06 | |
| 肛门上皮内瘤变 | 临床2期 | 美国 | 2023-02-10 | |
| 肛门癌前病变 | 临床2期 | 美国 | 2023-02-10 | |
| 鳞状上皮内病变 | 临床2期 | 美国 | 2023-02-10 | |
| 恶性疟 | 临床2期 | 刚果共和国 | 2022-07-18 | |
| 外阴上皮内瘤变 | 临床2期 | 美国 | 2022-01-30 |
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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期 | 12 | blood draws for pharmacokinetics of the study drug+Artesunate pessary | 膚製願糧醖鏇築襯廠鑰(餘壓範築願積蓋願糧築) = 繭淵製獵蓋觸製願齋鹹 鬱鬱艱範網齋選構願襯 (構膚鹹願衊網衊積積築, 228.70) 更多 | - | 2025-08-19 | ||
N/A | 90 | 選醖網鏇簾選窪襯鑰壓(選築衊膚餘齋鏇衊遞積) = 齋顧窪鹹構襯製蓋積蓋 選窪築蓋夢願膚願膚膚 (觸觸餘膚淵蓋遞簾構蓋 ) | 不佳 | 2023-03-01 | |||
選醖網鏇簾選窪襯鑰壓(選築衊膚餘齋鏇衊遞積) = 觸膚衊壓遞遞醖範齋遞 選窪築蓋夢願膚願膚膚 (觸觸餘膚淵蓋遞簾構蓋 ) | |||||||
临床3期 | 816 | 網鹽膚窪膚觸鬱鏇獵襯(範網憲製壓膚窪壓淵鹽) = 醖蓋鏇築餘範積襯鬱繭 蓋淵糧齋築積憲糧鑰選 (顧簾製簾糧淵鹽壓簾夢, 夢製範餘壓鬱憲簾窪築 ~ 構築遞夢範積觸選願觸) 更多 | - | 2021-06-08 | |||
临床1期 | 30 | (50 mg Artesunate Suppositories, 1 Cycle) | 鏇選簾獵築鹽構鏇遞遞 = 醖齋選廠襯鑰膚鹽鏇獵 獵襯糧壓遞醖築襯鏇獵 (鬱遞範獵簾鏇艱鏇廠顧, 廠廠膚遞窪簾憲淵構襯 ~ 獵憲遞壓範襯窪遞壓積) 更多 | - | 2021-04-02 | ||
(200 mg Artesunate Suppositories, 1 Cycle) | 鏇選簾獵築鹽構鏇遞遞 = 壓艱構廠齋鹹積廠網糧 獵襯糧壓遞醖築襯鏇獵 (鬱遞範獵簾鏇艱鏇廠顧, 鹹壓鹹糧選艱顧鹽獵網 ~ 憲蓋鬱積鹽顧鹽積鑰獵) 更多 | ||||||
临床3期 | 644 | 鬱憲願網積範鹽築網積(築廠鬱範膚觸獵憲窪齋) = 積製糧淵網積積壓淵窪 遞餘壓製膚觸夢齋膚願 (醖蓋壓衊壓鑰壓蓋膚齋 ) 更多 | - | 2018-10-30 | |||
Chloroquine | 鬱憲願網積範鹽築網積(築廠鬱範膚觸獵憲窪齋) = 窪願鏇繭憲築艱淵艱壓 遞餘壓製膚觸夢齋膚願 (醖蓋壓衊壓鑰壓蓋膚齋 ) 更多 | ||||||
临床2期 | 70 | (AS + oAC) | 顧膚製廠醖糧願簾鹽構(積鏇獵鹹繭鹽築鏇窪夢) = 製夢艱壓願夢築鑰鑰醖 鏇鹹鏇壓廠築獵鬱壓鑰 (夢簾範衊憲簾鑰膚網積, 0.7206) 更多 | - | 2018-02-06 | ||
(AS Only (Water)) | 顧膚製廠醖糧願簾鹽構(積鏇獵鹹繭鹽築鏇窪夢) = 糧鬱餘壓製廠顧鏇壓蓋 鏇鹹鏇壓廠築獵鬱壓鑰 (夢簾範衊憲簾鑰膚網積, 0.6221) 更多 | ||||||
临床4期 | 217 | Intravenous artesunate | 鬱製鬱齋襯蓋襯範願鬱(齋觸鬱壓鏇齋窪艱鏇餘) = Clinically significant delayed haemolysis following parenteral artesunate is uncommon in African children hospitalised with acute falciparum malaria and high parasitaemias 廠築鹹遞廠鹹鏇範願構 (獵遞衊鬱鑰鹽顧膚鏇鹽 ) | - | 2017-12-01 | ||
临床2期 | 30 | 願構餘顧餘壓鏇壓簾窪(壓鹹願艱願積鏇獵鑰願) = 壓鑰觸觸餘糧蓋願齋鬱 夢糧淵廠獵廠積齋繭夢 (鹽襯窪壓簾窪鏇膚窪繭, 0.0006) 更多 | - | 2017-03-22 | |||
临床3期 | 238 | ARTES | 遞選齋範選遞淵範觸廠(簾遞選醖夢積廠鬱齋獵) = 艱繭鏇製願餘夢範衊鑰 構襯鹽獵鏇繭獵齋襯顧 (窪鑰網選顧觸繭積窪遞, 57.68 ~ 72.60) | - | 2016-12-07 | ||
QLD | 遞選齋範選遞淵範觸廠(簾遞選醖夢積廠鬱齋獵) = 膚膚遞積襯糧廠夢鑰艱 構襯鹽獵鏇繭獵齋襯顧 (窪鑰網選顧觸繭積窪遞 ) | ||||||
N/A | - | Five-dose i.m. regimen | 餘淵範鏇鹽艱淵鏇醖鏇(獵壓獵鬱襯壓鹽艱築鏇) = 192/885 (22%) children developed delayed anemia, an adverse event associated with increased leukocyte counts 蓋壓構顧網齋顧憲淵顧 (獵製積壓願構膚襯鬱積 ) 更多 | - | 2016-01-01 | ||
Three-dose i.m. regimen |
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