Jefferson T, Demicheli V, Deeks J, Rivetti D
Cochrane Vaccines Field, Cochrane Centre, Summertown Pavillion, Middle Way, Oxford, Oxfordshire, UK, OX2 7LG.
Cochrane Database Syst Rev. 2000(2):CD001265. doi: 10.1002/14651858.CD001265.
Influenza is an acute respiratory infection associated with raised temperature, headache, muscle ache and cough. The objective of this review was to assess the effects of neuraminidase inhibitors (NIs) in preventing cases of influenza and shortening or reducing the severity of influenza in healthy adults. A further objective was to estimate the frequency of adverse effects associated with NI administration.
We searched Medline, the Cochrane Acute Respiratory Infections Group trials register, the Cochrane Controlled Trials Register (CCTR), manufacturers' databases, Embase (1991 to 1998) and reference lists of articles in May 1999. We also contacted manufacturers, researchers in the field, and authors of studies evaluated in the review.
Randomised or quasi-randomised placebo-controlled studies of NIs in healthy adults. Studies assessing protection or treatment from exposure to naturally occurring and experimental influenza were considered. The main outcomes were numbers and/or severity of influenza cases and the number and seriousness of adverse effects.
Two reviewers applied the inclusion criteria to the retrieved studies, assessed trial quality and extracted data.
Eight trials with 1180 adults were included. Overall the methodological quality of the studies appeared to be good. As a preventive measure, NIs when compared to placebo were 74% effective (95% confidence interval 50% to 87%) in preventing naturally occurring cases of clinically defined influenza, and 60% effective (95% confidence interval 76% to 33%) in preventing cases of laboratory confirmed influenza. As a treatment, NIs shorten the duration of symptoms by one day - weighted mean difference 1 (95% confidence interval -1.3 to -0.6). The time gained in returning to normal activities is half a day - weighted mean difference -0.5 ( 95% confidence interval -1.1 to -0.1) for laboratory cases of influenza. The adverse event profile (local nasal irritation) of Zanamivir appears no better than placebo - odds ratio 1.19 ( 95% confidence interval 0.39 to 3.62). Compared with rimantadine in a preventive role, Oseltamivir has a significantly lower incidence of adverse effects and significantly higher incidence of nausea. For treatment, the adverse event profile shows that gastrointestinal symptoms are significantly worse in NIs than placebo - Peto odds ratio 2.32 ( 95% confidence interval 1.55 to 3.47).
REVIEWER'S CONCLUSIONS: NIs are effective for the prevention and treatment of influenza. Overall NIs are safe, although Oseltamivir causes significant nausea.
流感是一种与体温升高、头痛、肌肉疼痛和咳嗽相关的急性呼吸道感染。本综述的目的是评估神经氨酸酶抑制剂(NIs)在预防健康成年人流感病例以及缩短或减轻流感严重程度方面的效果。另一个目的是估计与服用NIs相关的不良反应发生频率。
我们检索了医学数据库(Medline)、Cochrane急性呼吸道感染组试验注册库、Cochrane对照试验注册库(CCTR)、制造商数据库、Embase(1991年至1998年)以及1999年5月文章的参考文献列表。我们还联系了制造商、该领域的研究人员以及本综述中所评估研究的作者。
针对健康成年人使用NIs的随机或半随机安慰剂对照研究。考虑评估从自然发生和实验性流感暴露中获得的保护或治疗效果的研究。主要结局是流感病例的数量和/或严重程度以及不良反应的数量和严重程度。
两名评审员将纳入标准应用于检索到的研究,评估试验质量并提取数据。
纳入了八项涉及1180名成年人的试验。总体而言,这些研究的方法学质量似乎良好。作为一种预防措施,与安慰剂相比,NIs预防临床确诊流感自然病例的有效率为74%(95%置信区间50%至87%),预防实验室确诊流感病例的有效率为60%(95%置信区间76%至33%)。作为一种治疗方法,NIs可使症状持续时间缩短一天——加权平均差为1(95%置信区间-1.3至-0.6)。对于实验室确诊的流感病例,恢复正常活动所节省的时间为半天——加权平均差为-0.5(95%置信区间-1.1至-0.1)。扎那米韦的不良事件谱(局部鼻部刺激)似乎并不比安慰剂好——优势比为1.19(95%置信区间0.39至3.62)。在预防作用方面,与金刚烷胺相比,奥司他韦的不良反应发生率显著更低,但恶心发生率显著更高。对于治疗,不良事件谱显示NIs组的胃肠道症状比安慰剂组明显更严重——Peto优势比为2.32(95%置信区间1.55至3.47)。
NIs对流感的预防和治疗有效。总体而言,NIs是安全的,尽管奥司他韦会引起明显的恶心。