枯草二联活菌防治抗生素相关性腹泻的系统评价

Systematic evaluation of combined bacillus subtilis and enterococcus faecium in prevention and treatment of antibiotic associated diarrhea

目的系统评价枯草二联活菌防治抗生素相关性腹泻(AAD)的疗效及安全性。方法计算机检索Cochrane图书馆(2011年第3期)、EMBase、PubMed、CNKI、CBM、VIP(各数据库检索时间均从创建至2011年10月)中关于枯草二联活菌防治ADD的随机对照试验(RCT),用RevMan5.10软件对数据进行Meta分析。结果共纳入16篇RCT,包括2879例患者。Meta分析结果显示,枯草二联活菌预防婴幼儿ADD效果优于对照组[RR=0.38,95%CI(0.32～45),P<0.01],用于辅助治疗婴幼儿ADD总有效率优于空白对照组[RR=1.34,95%CI(1.18～1.52),P<0.01],且优于其他微生态制剂[RR=1.14,95%CI(1.04～1.24),P<0.01];枯草二联活菌制剂治疗成人ADD总有效率优于空白对照组[RR=1.28,95%CI(1.11～1.48),P<0.01],内镜下复查结果与不良反应发生率与对照组间无统计学差异。结论基于现有临床证据,枯草二联活菌制剂防治ADD有效,安全性好。但由于纳入研究数量较少,研究质量不统一,本结论尚需要更多大样本、高质量临床RCT予以证实。

Objective To systematically evaluate the curative effects and safety of combimed bacillus subtilis and enterococcus faecium in the prevention and treatment of antibiotic associated diarrhea （AAD）. Methods Randomized controlled trials （RCT） of prevention and treatment of AAD with combimed bacillus subtilis and enterococcus faecium were searched out by computer in the Cochrane Library （Issue 3, 2011 ） , EMbase, PubMed, CNKI, CBM, and VIP （from their inception to October, 2011）. Meta analysis of the data was carried out by RevMan 5.10 software. Results Sixteen RCTs were chosen, which included 2879 patients. The Meta analyses showed that the effects of combined bacillus subtilis and enterococcus faecium on the prevention of ADD in infants were superior to those of the control group [ RR = 0. 38, 95 % CI （0. 32, 0.45 ）, P 〈 0. 01 ]. The total effective rate of this adjunctive treatment on ADD in infants was better than that of the blank control group [RR = 1.34, 95% CI （ 1.18, 1.52）, P 〈 0. 01 ] and that of other microbial ecological agents [ RR = 1. 14, 95% CI （ 1.04, 1.24）, P 〈 0. 01 ]. The total effective rate of combined bacillus subtilis and enterococcus faeeium in the treatment of ADD in adults was superior to that of the blank control group [RR = 1.28, 95% CI （1.11, 1.48）, P 〈0. 01 ], and there was no significant difference in the endoscopic reexamination Results and the incidence of side effects between the two groups. Conclusion Based on the present clinical evidences, the prevention and treatment of ADD with combined bacillus subtilis and enterococcus faecium are effective and safe. Howerver, due to the small amount of included studies, this Conclusion needs to be identified by more and larger samples and high - quality RCTs.