Soares-Weiser K, Goldberg E, Tamimi G, Pitan O C, Leibovici L
Department of Social Work, Bar Ilan University, 82 Jerusalem Street, Kfar-Saba, Israel.
Cochrane Database Syst Rev. 2004;2004(1):CD002848. doi: 10.1002/14651858.CD002848.pub2.
Rotaviruses cause viral gastroenteritis and result in more deaths from diarrhoea in children under 5 years of age than any other single agent, particularly in low- and middle-income countries.
To assess rotavirus vaccines in relation to preventing rotavirus diarrhoea, death, and adverse events.
We searched the Cochrane Infectious Diseases Group's trial register (October 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2003), MEDLINE (1966 to October 2003), EMBASE (January 1980 to October 2003), LILACS (1982 to October 2003), Biological Abstracts (January 1982 to October 2003), reference lists of articles, and contacted researchers and rotavirus vaccine manufacturers.
Randomized controlled trials comparing rotavirus vaccines to placebo, no intervention, or other rotavirus vaccines in children and adults.
Two reviewers independently extracted data and assessed trial methodological quality, and contacted trial authors for additional information.
Sixty-four trials provided information on efficacy and safety of three main types of rotavirus vaccine (bovine, human, and rhesus) for 21,070 children. Different levels of efficacy were demonstrated with different vaccines varying from 22 to 89% to prevent one episode of rotavirus diarrhoea, 11 to 44% to prevent one episode of all-cause diarrhoea, and 43 to 90% to prevent one episode of severe rotavirus diarrhoea. Rhesus vaccine demonstrated a similar efficacy against one episode of rotavirus diarrhoea (37 and 44% respectively), and one episode of all-cause diarrhoea (around 15%) for trials performed in high and middle-income countries. Results on mortality and safety of the vaccines were scarce and incomplete. We noticed important heterogeneity among the pooled studies and were unable to discard a biased estimation of effect.
REVIEWER'S CONCLUSIONS: Current evidence shows that rhesus rotavirus vaccines (particularly RRV-TV) and the human rotavirus vaccine 89-12 are efficacious in preventing diarrhoea caused by rotavirus and all-cause diarrhoea. Evidence about safety, and about mortality or prevention of severe outcomes, is scarce and inconclusive. Bovine rotavirus vaccines were also efficacious, but safety data are not available. Trials of new rotavirus vaccines will hopefully improve the evidence base. Randomized controlled trials should be performed simultaneously in high-, middle-, and low-income countries.
轮状病毒可引发病毒性肠胃炎，在5岁以下儿童中，由腹泻导致的死亡病例里，轮状病毒比其他任何单一因素造成的死亡更多，在低收入和中等收入国家尤其如此。
评估轮状病毒疫苗在预防轮状病毒腹泻、死亡及不良事件方面的效果。
我们检索了Cochrane传染病小组的试验注册库（2003年10月）、Cochrane对照试验中央注册库（《Cochrane图书馆》2003年第3期）、MEDLINE（1966年至2003年10月）、EMBASE（1980年1月至2003年10月）、LILACS（1982年至2003年10月）、生物学文摘数据库（1982年1月至2003年10月）、文章的参考文献列表，并联系了研究人员和轮状病毒疫苗制造商。
比较轮状病毒疫苗与安慰剂、无干预措施或其他轮状病毒疫苗在儿童和成人中效果的随机对照试验。
两名评价员独立提取数据并评估试验方法学质量，若有需要，会联系试验作者获取更多信息。
64项试验提供了关于三种主要类型轮状病毒疫苗（牛源性、人源性和恒河猴源性）对21,070名儿童的疗效和安全性信息。不同疫苗显示出不同水平的疗效，预防一次轮状病毒腹泻的疗效从22%至89%不等，预防一次全因性腹泻的疗效从11%至44%不等，预防一次严重轮状病毒腹泻的疗效从43%至90%不等。在高收入和中等收入国家进行的试验中，恒河猴疫苗对一次轮状病毒腹泻（分别为37%和44%）以及一次全因性腹泻（约15%）显示出相似的疗效。关于疫苗死亡率和安全性的结果较少且不完整。我们注意到汇总研究之间存在重要的异质性，无法排除效应估计存在偏差的可能性。
目前的证据表明，恒河猴轮状病毒疫苗（特别是RRV-TV）和人轮状病毒疫苗89-12在预防轮状病毒引起的腹泻和全因性腹泻方面有效。关于安全性以及死亡率或严重后果预防方面的证据较少且尚无定论。牛源性轮状病毒疫苗也有效，但缺乏安全性数据。新的轮状病毒疫苗试验有望改善证据基础。应在高收入、中等收入和低收入国家同时开展随机对照试验。
