Cooper Nicola J, Sutton Alexander J, Abrams Keith R, Wailoo Allan, Turner David, Nicholson Karl G
Department of Epidemiology and Public Health, University of Leicester, Leicester LE1 6TP.
BMJ. 2003 Jun 7;326(7401):1235. doi: 10.1136/bmj.326.7401.1235.
To review the clinical effectiveness of oseltamivir and zanamivir for the treatment and prevention of influenza A and B.
Systematic review and meta-analyses of randomised controlled trials.
Published studies were retrieved from electronic bibliographic databases; supplementary data were obtained from the manufacturers.
Randomised controlled, double blind trials that were published in English, had data available before 31 December 2001, evaluated treatment or prevention of naturally occurring influenza with zanamivir or oseltamivir (if given using the formulation and dosage licensed for clinical use), and reported at least one end point of relevance.
The main outcome measures were the median time to the alleviation of symptoms (for treatment trials) and number of flu episodes avoided (for prevention trials). Three population groups were defined: children aged 12 years and under; otherwise healthy individuals aged 12 to 65 years; and "high risk" individuals (those with certain chronic medical conditions or aged 65 years and older).
Seventeen treatment trials and seven prevention trials identified met the inclusion criteria. All trials included compared one of the drugs against placebo or standard care. Treatment of children, otherwise healthy individuals, and high risk populations with zanamivir reduced the median duration of symptoms in days respectively by 1.0 (95% confidence interval 0.5 to 1.5), 0.8 (0.3 to 1.3), and 0.9 (-0.1 to 1.9) for the intention to treat population. The corresponding results, in days, for oseltamivir were 0.9 (0.3 to 1.5), 0.9 (0.3 to 1.4), and 0.4 (-0.7 to 1.4). The effect of giving zanamivir and oseltamivir prophylactically resulted in a relative reduction of 70-90% in the odds of developing flu, depending on the strategy adopted and the population studied.
Evidence from randomised controlled trials consistently supports the view that both oseltamivir and zanamivir are clinically effective for treating and preventing flu. However, evidence is limited for the treatment of certain populations and for all prevention strategies.
综述奥司他韦和扎那米韦治疗及预防甲型和乙型流感的临床疗效。
随机对照试验的系统评价和荟萃分析。
从电子文献数据库检索已发表的研究；补充数据从制造商处获得。
以英文发表、在2001年12月31日前有可用数据、评估扎那米韦或奥司他韦（若使用临床许可的剂型和剂量）对自然发生的流感的治疗或预防效果且报告了至少一项相关终点的随机对照双盲试验。
主要结局指标为症状缓解的中位时间（用于治疗试验）和避免的流感发作次数（用于预防试验）。定义了三类人群：12岁及以下儿童；12至65岁的健康个体；“高危”个体（患有某些慢性疾病或65岁及以上的人群）。
确定的17项治疗试验和7项预防试验符合纳入标准。所有纳入试验均将其中一种药物与安慰剂或标准治疗进行了比较。对于意向性治疗人群，用扎那米韦治疗儿童、健康个体和高危人群，症状持续时间的中位数分别缩短了1.0天（95%置信区间0.5至1.5）、0.8天（0.3至1.3）和0.9天（-0.1至1.9）。奥司他韦相应的结果分别为0.9天（0.3至1.5）、0.9天（0.3至1.4）和0.4天（-0.7至1.4）。预防性使用扎那米韦和奥司他韦的效果使患流感几率相对降低70%至90%，这取决于所采用的策略和所研究的人群。
随机对照试验的证据一致支持奥司他韦和扎那米韦在治疗和预防流感方面均具有临床疗效的观点。然而，针对某些人群的治疗和所有预防策略的证据有限。
