国内乌司他丁治疗脓毒症的疗效的系统评价

Systematic Review of Therapeutic Efficacy of Ulinastatin for Domestic Sepsis in China

目的:系统评价国内乌司他丁治疗脓毒症的疗效。方法:计算机检索中国期刊全文数据库、中国生物医学文献数据库、中文科技期刊全文数据库和万方数据库,收集国内乌司他丁治疗脓毒症的随机对照试验(RCT)或半随机对照试验(QRCT),并追溯纳入文献的参考文献。对检索出的文献进行质量评价,并采用Rev Man 5.0统计软件对提取的资料进行统计分析。结果:共纳入28项研究,合计1 615例患者。Meta分析结果显示,治疗组患者的28 d病死率[RR=0.55,95%CI(0.41,0.73),P<0.05]、观察期间病死率[RR=0.51,95%CI(0.37,0.70),P<0.05]、重症监护室住院天数[WMD=-5.75,95%CI(-6.59,-4.91),P<0.05]、平均住院天数[WMD=-5.00,95%CI(-10.24,0.24),P=0.06]及多器官衰竭发生率[RR=0.53,95%CI(0.31,0.90),P=0.02]均显著低于对照组,治疗后的急性生理学与慢性健康状况评分Ⅱ(APACHEⅡ)改善情况显著优于对照组[WMD=-5.19,95%CI(-5.71,-4.66),P<0.05]。结论:乌司他丁可以降低脓毒症患者的28 d病死率、观察期间病死率,缩短住院时间,降低多脏器功能不全的发生率,改善APACHEⅡ评分。由于本研究纳入的原始文献质量不高,故有待更多高质量的研究加以证实。

OBJECTIVE：To evaluate therapeutic efficacy of ulinastatin in the treatment of sepsis in china.METHODS：Retrieved from CNKI,CBM,VIP and Wanfang database,randomized controlled trials（RCT）and quasi-randomized controlled trials（quasi-RCT）of ulinastatin in the treatment of sepsis were searched.The references were also searched.The methodological quality of included studies was estimated,and Rev Man 5.0 software was used for data analysis.RESULTS：28 RCT were included,involving 1 615 patients.Meta-analysis showed 28-day mortality [RR=0.55,95%CI（0.41,0.73）,P0.05],mortality during observation period [RR=0.51,95%CI（0.37,0.70）,P0.05],hospitalization days in ICU [WMD=-5.75,95%CI（-6.59,-4.91）,P0.05],average hospitalization days [WMD=-5.00,95%CI（-10.24,0.24）,P=0.06] and the incidence of multiple organ dysfunction [RR= 0.53,95%CI（0.31,0.90）,P=0.02] of treatment group were all lower than control group.The improvement of acute physiology and chronic health evaluation Ⅱ（APACHE Ⅱ）score [WMD=-5.19,95%CI（-5.71,-4.66）,P0.05] in treatment group was better than in control group.CONCLUSIONS：Ulinastatin can decrease the 28-day mortality,the mortality during observation period,hospitalization days in hospital,the incidence of MODS,and improve APACHE Ⅱ score.However,because of the low methodological quality of included trials,high quality studies are needed to be performed to testify its therapeutic efficacy and safety.