Chan-Tack Kirk M, Kim Christine, Moruf Alicia, Birnkrant Debra B
Division of Antiviral Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Antivir Ther. 2015;20(5):561-4. doi: 10.3851/IMP2944. Epub 2015 Feb 10.
Since the emergence of 2009 H1N1 virus, intravenous (IV) zanamivir has been authorized as an investigational treatment for patients with serious and life-threatening influenza through an Emergency Investigational New Drug application (EIND). This review encompasses the FDA's EIND database from May 2011 to June 2014.
This is a retrospective descriptive review of patient clinical data in the FDA's IV zanamivir EIND database from May 2011 to June 2014.
Of 364 IV zanamivir EIND requests, most (83%) patients were aged 18-64 years, 8 (2%) were pregnant, and 29 (8%) were children. 234 (64%) patients had ≥1 comorbidity reported. The majority (87%) were receiving oseltamivir when IV zanamivir was requested, and 33% had suspected (n=120; no improvement or worsening on oseltamivir) H275Y oseltamivir resistance. Influenza A was reported for 300 patients: confirmed 2009 H1N1 (n=163), suspected 2009 H1N1 (n=8), confirmed H3N2 (n=4) and not subtyped (n=125). Influenza B was reported for 25 patients. Many patients (87%) required invasive mechanical ventilation, 23 (6%) received high frequency oscillatory ventilation, and 74 (20%) received extracorporeal membrane oxygenation (ECMO). 289 (79%) patients had ≥1 complication such as renal failure (n=124; 77/124 required dialysis), bacteraemia (n=18), shock (n=95) or pneumonia (n=159). Of 134 (37%) patients with available outcome data, 83 died and 51 survived.
IV zanamivir EIND authorizations were for treatment of critically ill adult patients with 2009 H1N1, including a substantial number with suspected oseltamivir resistance. Data from prospective, randomized controlled trials are needed and are ongoing to assess the safety and efficacy of IV zanamivir for treatment of hospitalized patients with severe influenza.
自2009年甲型H1N1流感病毒出现以来，静脉注射扎那米韦已通过紧急研究性新药申请（EIND）被批准作为治疗严重及危及生命的流感患者的试验性治疗药物。本综述涵盖了2011年5月至2014年6月期间美国食品药品监督管理局（FDA）的EIND数据库。
这是一项对2011年5月至2014年6月期间FDA的静脉注射扎那米韦EIND数据库中患者临床数据的回顾性描述性综述。
在364份静脉注射扎那米韦的EIND申请中，大多数（83%）患者年龄在18至64岁之间，8名（2%）为孕妇，29名（8%）为儿童。234名（64%）患者报告有≥1种合并症。在申请静脉注射扎那米韦时，大多数（87%）患者正在接受奥司他韦治疗，33%的患者怀疑（n = 120；使用奥司他韦后无改善或病情恶化）存在H275Y奥司他韦耐药。300名患者报告感染甲型流感：确诊2009年甲型H1N1流感（n = 163）、疑似2009年甲型H1N1流感（n = 8）、确诊H3N2（n = 4）以及未分型（n = 125）。25名患者报告感染乙型流感。许多患者（87%）需要有创机械通气，23名（6%）接受高频振荡通气，74名（20%）接受体外膜肺氧合（ECMO）。289名（79%）患者出现≥1种并发症，如肾衰竭（n = 124；77/124需要透析）、菌血症（n = 18）、休克（n = 95）或肺炎（n = 159）。在134名（37%）有可用结局数据的患者中，83人死亡，5
