摘要
目的系统评价与其它药物比较,青蒿琥酯注射剂与栓剂治疗重症疟疾是否能降低患者病死率和改善其他临床结局。方法计算机检索Cochrane图书馆(2007年第3期)、MEDLINE(1966～2007.4)、EMbase(1988～2007.4)、CBMweb(1978～2007.4)、VIP(1989～2007.4)和CNKI(1994～2007.4)数据库,收集所有青蒿琥酯注射剂与栓剂治疗重症疟疾的随机对照试验(RCT),使用Cochrane系统评价方法,评价纳入研究的方法学质量并提取有效数据进行分析。结果共纳入11个RCT,共2269例患者。根据Cochrane图书馆推荐的RCT质量评价标准,各纳入研究的方法学质量均较高,6篇为A级,5篇为B级。其中6个RCT比较静脉注射用青蒿琥酯与静脉注射用奎宁的疗效,结果显示病死率差异有统计学意义[RR0.65,95%CI(0.52,0.80),P<0.0001],静脉注射用青蒿琥酯的疗效优于静脉注射用奎宁。3个RCT比较了静脉注射用青蒿琥酯与青蒿素栓的疗效,结果显示病死率差异无统计学意义,其RR及95%CI分别为0.94(0.35,2.56),0.58(0.19,1.74)和2.00(0.39,10.26)。2个RCT比较静脉注射和肌肉注射用青蒿琥酯的疗效,差异无统计学意义[RR1.50,95%CI(0.52,4.31),P=0.45]。静脉注射用青蒿琥酯与静脉注射用氯喹、蒿甲醚等其它药物比较,其病死率差异均无统计学意义。9个RCT报告了治疗后的不良反应,主要为轻微胃肠道反应,恶心、呕吐等。结论与奎宁比较,注射用青蒿琥酯更有效且副作用发生率明显降低;静脉用青蒿琥酯与肌肉用青蒿琥酯比较,以及静脉用青蒿琥酯与青蒿素栓比较,在病死率方面差异均无统计学意义。
Objective To investigate the effects of two formulations of artesunate, and to provide evidence for the WHO Model List of Essential Medicines. Methods We searched The Cochrane Library （2006, Issue 4）, MEDLINE （ 1966 to 2007）, EMbase （1988 to 2007）, CBM （1978 to 2007）, VIP （1989 to 2007） and CNKI （1994 to 2007）. Randomised trials comparing the two formulations of artesunate with other drugs were eligible for inclusion. We applied the methods of The Cochrane Collaboration to assess the effects of artesunate, compared to placebo and active controls. Results Eleven trials were included, of which 6 compared intravenous artesunate with intravenous quinine. The quality of each study was high, 6 out of the 11 studies were graded A according to the criteria of The Cochrane Collaboration. The other 5 were graded B. The meta-analysis suggested that the mortality rate was lower in the intravenous artesunate group than in the intravenous quinine group [RR 0.65, 95%CI （0.52, 0.80）, P〈0.0001]. Three trials compared intravenous artesunate with artemisinin suppositories. These trials generated similar estimates and confidence intervals for mortality rates, showing no significant difference between the two treatments [0.94 （0.35 to 2.56）, 0.58 （0.19 to 1.74） and 2.00 （0.39 to 10.26）]. Two trials compared intravenous artesunate and intramuscular artesunate, and no significant difference in mortality rate was identified between the two treatment groups [RR 1.50, 95%CI 0.52 to 4.31]. Mortality rates were not statistically significantly different for intravenous artesunate compared to alternative drugs. No significant adverse drug reactions were observed. Conclusions Artesunate is effective and safe in the treatment of severe malaria.
出处
《中国循证医学杂志》
CSCD
2007年第11期794-801,共8页
Chinese Journal of Evidence-based Medicine
关键词
重症疟疾
青蒿琥酯
奎宁
系统评价
随机对照试验
Severe malaria
Artesunate
Quinine
Systematic Review
Randomized controlled trial
