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Effectiveness of post-exposition prophylaxis with oseltamivir in nursing homes: a randomised controlled trial over four seasons

机译:oseltamivir预防暴露后在疗养院中的有效性:四个季节的随机对照试验

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Background Oseltamivir has been registered for use as post-exposition prophylaxis (PEP) following exposure to influenza, based on studies among healthy adults. Effectiveness among frail elderly nursing home populations still needs to be properly assessed. Methods We conducted a randomised double-blind placebo-controlled trial of PEP with either oseltamivir (75 mg once daily) or placebo among nursing home units where influenza virus was detected; analysis was unblinded. The primary outcome was laboratory-confirmed influenza among residents in units on PEP; the secondary outcome was clinical diagnosis of influenza-like illness (ILI). Results 42 nursing homes were recruited, in which 17 outbreaks occurred from 2009 through 2013, two caused by influenza virus B, the others caused by influenza virus A(H3N2). Randomisation was successful in 15 outbreaks, with a few chance differences in baseline indicators. Six outbreaks were assigned to oseltamivir and nine to placebo. Influenza virus positive secondary ILI cases were detected in 2/6 and 2/9 units respectively (ns); secondary ILI cases occurred in 2/6 units on oseltamivir, and 5/9 units on placebo (ns). Logistical challenges in ensuring timely administration were considerable. Conclusion We did not find statistical evidence that PEP with oseltamivir given to nursing home residents in routine operational settings exposed to influenza reduced the risk of new influenza infections within a unit nor that of developing ILI. Power however was limited due to far fewer outbreaks in nursing homes than expected since the 2009 pandemic. (RCT nr NL92738)
机译:背景根据健康成年人的研究,奥塞他韦已被注册为暴露于流感后的暴露后预防(PEP)。仍然需要适当评估脆弱的养老院人口的有效性。方法我们在发现流感病毒的疗养院单位中,使用奥司他韦(每天一次75毫克)或安慰剂,对PEP进行了一项随机双盲安慰剂对照试验。分析是盲目的。主要结果是PEP单位居民中实验室确诊的流感。次要结果是流感样疾病(ILI)的临床诊断。结果招募了42家疗养院,其中2009年至2013年爆发了17次暴发,其中两次是由B型流感病毒引起的,其他是由A3型流感病毒引起的。随机化在15次暴发中获得成功,基线指标的几率差异很大。奥司他韦有6次暴发,安慰剂有9次。分别以2/6和2/9单位检测出流感病毒阳性继发性ILI病例(ns);继发性ILI病例在奥司他韦上占2/6单位,在安慰剂上占5/9单位(ns)。确保及时管理的后勤挑战是巨大的。结论我们没有发现统计证据表明,在常规操作环境中,向患有流感的常规手术场所的疗养院居民给予PEP含奥司他韦可以降低单位内新流感感染的风险,也不会降低ILI的风险。但是,由于自2009年大流行以来养老院爆发的次数比预期的要少得多,因此电力供应受到限制。 (RCT编号NL92738)

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