Objective To evaluate the efficacy and the safety of recombinant human activated protein C (rhAPC) in treating sepsis. Methods The literature of sepsis therapy in Cochrane Library, MEDLINE, Embase, CBM disc for WINDOWS (CBM), CNKI, Wanfang data and VIP data up to the year 2011 have been searched by the randomized controlled trials (RCTs). After evaluating the qualities of RCTs, the accordant data were analvzed by Meta. Results A total of 6 pieces of RCTs literatures about rhAPC in treating sepsis were discovered. Meta analyses of the three primary outcome measures showed that fatality rate of trerapy group on the 28th day were different compared with that of control group ( Z = 3. 16, P = 0.002). The incidence of serious bleeding of control group were compared with that of therapy group during the rhAPC infusion on 28' day (Z=5.36, P < 0.00001; Z=2.76, P=0.006). Conclusion Recombinant human activated protein C in treating sepsis can significantly reduce fatality rate in patients with sever sepsis but it has an increased incidence rate of serious bleeding complications. The evaluation of safety and efficacy needs further research of large sample and high quality RCTs.%目的 综合性分析重组人活化蛋白C (recombinant human activated protein C,rhAPC)治疗脓毒症的有效性和安全性.方法 通过计算机检索Cochrane图书馆、Medline、EMbase、中国生物医学文献数据库(CBM)、中国知网(CNKI)、万方数据库和维普数据库中建库至2011年12月关于rhAPC治疗脓毒症研究中采用随机对照试验(RCT)的文献,对纳入文献进行质量评价和资料提取,并对符合质量标准的文献进行Meta分析.结果 本研究共纳入6篇RCT文献.Meta分析3个主要结局指标的结果显示,应用rhAPC治疗脓毒症的干预组总28 d病死率与对照组比较差异有统计学意义(Z=3.16,P=0.002)；干预组应用rhAPC期间及28 d严重出血事件的发生率与对照组比较差异均有统计学意义(Z=5.36,P＜0.00001；Z=2.76,P=0.006).结论 rhAPC可降低高风险成人脓毒症患者的病死率,但同时也带来了较高的出血风险,其有效性和安全性的评估还有待更多设计更合理的大样本RCT研究来进一步论证.
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