Ison Michael G, Hui David S, Clezy Kate, O'Neil Brian J, Flynt Amy, Collis Philip J, Simon Thomas J, Alexander W James
Divisions of Infectious Diseases and Organ Transplantation, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Antivir Ther. 2013;18(5):651-61. doi: 10.3851/IMP2442. Epub 2012 Oct 30.
Seasonal interpandemic influenza causes >200,000 annual hospitalizations in the United States. Optimal antiviral treatment in hospitalized patients is not established.
During three interpandemic influenza seasons, 137 patients hospitalized with suspected acute influenza were randomized to 5-day treatment with intravenous peramivir 400 mg or 200 mg once daily or oral oseltamivir 75 mg twice daily. Time to clinical stability and quantitative changes in viral titres from nasopharyngeal specimens were primary and key secondary end points, respectively.
Infection was confirmed in 122 patients with influenza A (H1N1), influenza A (H3N2) or influenza B. Median times (95% CI) to clinical stability were 37.0 h (22.0, 48.7) with peramivir 400 mg, 23.7 h (16.0, 38.9) with peramivir 200 mg and 28.1 h (22.0, 37.0) with oseltamivir (P=0.306). Patients (n=97) who were clinically unstable at enrolment had median times (95% CI) to clinical stability of 24.3 h (21.2, 47.5) with peramivir 400 mg, 31.0 h (17.2, 47.7) with peramivir 200 mg and 35.5 h (23.3, 37.9) with oseltamivir (P=0.541). Titres of influenza A viruses in nasopharyngeal specimens decreased similarly across treatments, but more rapid decreases in titres of influenza B occurred with peramivir treatment. There were no deaths among patients with confirmed influenza and the incidence of adverse events was low and generally similar among treatment groups.
Treatment of acute seasonal influenza in hospitalized adults with either peramivir or oseltamivir resulted in generally similar clinical outcomes. Treatment with peramivir was generally safe and well tolerated and could be of benefit in this population.
在美国,季节性流感大流行间期每年导致超过20万例住院病例。住院患者的最佳抗病毒治疗方案尚未确定。
在三个流感大流行间期季节,137例因疑似急性流感住院的患者被随机分为三组,分别接受为期5天的治疗,其中一组静脉注射帕拉米韦400mg,每日1次;另一组静脉注射帕拉米韦200mg,每日1次;第三组口服奥司他韦75mg,每日2次。达到临床稳定的时间以及鼻咽部标本中病毒滴度的定量变化分别为主要终点和关键次要终点。
122例患者确诊感染甲型流感(H1N1)、甲型流感(H3N2)或乙型流感。帕拉米韦400mg组达到临床稳定的中位时间(95%CI)为37.0小时(22.0,48.7),帕拉米韦200mg组为23.7小时(16.0,38.9),奥司他韦组为28.1小时(22.0,37.0)(P=0.306)。入组时临床不稳定的患者(n=97)中,帕拉米韦400mg组达到临床稳定的中位时间(95%CI)为24.3小时(21.2,47.5),帕拉米韦200mg组为31.0小时(17.2,47.7),奥司他韦组为35.5小时(23.3,37.9)(P=0.541)。各治疗组中,鼻咽部标本中甲型流感病毒的滴度下降情况相似,但帕拉米韦治疗使乙型流感病毒滴度下降更快。确诊流感的患者中无死亡病例,不良事件发生率较低,且各治疗组间总体相似。
住院成人急性季节性流感患者使用帕拉米韦或奥司他韦治疗的临床结局总体相似。帕拉米韦治疗总体安全且耐受性良好,可能对该人群有益。