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目的:系统评价环孢素A(CsA)治疗再生障碍性贫血(AA)的临床疗效。方法:电子检索MEDLINE(1996年1月~2006年5月)、EMBASE(1984年1月~2006年5月)、Cochrane临床对照试验资料库(2006年第2期)、中国Cochrane中心临床对照实验资料数据库(2006年第2期)、中国生物医学文献数据库(1978年1月~2006年5月),手工检索纳入试验的所有中文及外文文献及相关文献,并逐个进行方法学质量评价,采用Rev-Man4.2.7软件进行Meta分析。结果:共纳入7个随机对照试验(513例患者)。Meta分析结果显示,①病死率:1个研究与左旋咪唑比较,发生病死率的差异无统计学意义[RR0.52,95%CI(0.25,1.05)],1个研究与ATG比较,发生病死率的差异有统计学意义[RR0.14,95%CI(0.03,0.61)];②总有效率:2个研究与左旋咪唑比较,其差异有统计学意义[RR2.24,95%CI(1.55,3.23)],3个研究与不使用CsA相比较,其差异有统计学意义[RR1.70,95%CI(1.35,2.14)],2个研究与ATG比较,其差异有统计学意义[RR1.77,95%CI(1.03,3.03)];③不良反应:CsA较其他药物不良反应少。结论:现有的有限证据表明,CsA与不使用CsA或使用其他药物相比较,部分或全部降低AA患者的病死率、总有效率和不良反应的发生率;需要更多设计良好的随机、双盲、安慰剂对照试验加以证实。
Objective: To evaluate the clinical efficacy of cyclosporin A (CsA) in the treatment of aplastic anemia (AA). METHODS: MEDLINE (January 1996 to May 2006), EMBASE (January 1984 to May 2006), Cochrane Central Register of Controlled Trials (2006 issue 2), Cochrane Central Register of Controlled Trials (2006 Issue 2), China Biomedical Literature Database (January 1978 to May 2006), manually search all the Chinese and foreign literature and related literature included in the trial, and conduct a methodological quality evaluation one by one using the Rev-Man 4.2.7 software for meta-analysis. Results: Seven randomized controlled trials (513 patients) were included. The results of Meta analysis showed that: (1) The case fatality rate: There was no significant difference in mortality between one study and levamisole [RR 0.52, 95% CI (0.25, 1.05)]. One study compared with ATG and died (RR 0.14,95% CI (0.03,0.61)]; ② The total effective rate: compared with levamisole in two studies, the difference was statistically significant [RR2.24, 95% CI ( 1.55,3.23)]. There was significant difference between the three studies and the non-use of CsA [RR1.70,95% CI (1.35,2.14)]. There was significant difference between the two studies [RR1.77,95% CI (1.03,3.03)]; adverse reactions: CsA adverse reactions than other drugs less. CONCLUSIONS: The available limited evidence suggests that CsA partially or completely reduces the overall mortality and the overall incidence of adverse events in patients with AA compared with no use of CsA or with other drugs; the need for more well-designed randomized, double Blind, placebo-controlled trials were confirmed.