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目的评价双歧杆菌三联活菌制剂治疗急慢性腹泻的临床疗效。方法检索中国知网、万方、维普、Pubmed、EMbase、Web of Science数据库,收集2000年1月至2013年12月国内外应用双歧杆菌三联活菌制剂治疗急慢性腹泻的所有随机对照试验(randomized controlled trial,RCT)和前瞻性非随机对照试验(non-randomized controlled trial,non-RCT)。按照纳入与排除标准选择文献、提取资料和评价纳入研究的方法学质量后,采用Cochrane协作网提供的Rev Man5.2软件进行Meta分析。结果纳入10个前瞻性non-RCT,共822例患者,其中治疗组(对照组常规用药+双歧杆菌三联活菌制剂)413例,对照组409例。治疗组的总有效率高于对照组(OR 3.18,95%CI 2.07~4.89,P<0.01);治疗组与对照组治疗急慢性腹泻大便性状好转率差异无统计学意义(OR 1.63,95%CI 0.70~3.83,P=0.26);治疗组与对照组治疗急慢性腹泻消化道症状好转率差异无统计学意义(OR 1.68,95%CI 0.73~3.86,P=0.22)。结论双歧杆菌三联活菌制剂与常规治疗药物联用可以提高急慢性腹泻的总体疗效,相关症状改善情况有待进一步大样本多中心RCT研究进行验证。
Objective To evaluate the clinical efficacy of Bifidobacterium triple viable agents in the treatment of acute and chronic diarrhea. METHODS: All the randomized controlled trials of Bifidobacterium triple viable preparations for treating acute and chronic diarrhea at home and abroad from January 2000 to December 2013 were collected by searching CNKI, Wanfang, VIP, Pubmed, EMbase and Web of Science databases randomized controlled trial (RCT) and prospective non-randomized controlled trial (non-RCT). Meta-analysis was performed using RevMan5.2 software provided by the Cochrane Collaboration after selecting documents according to inclusion and exclusion criteria, extracting data and evaluating the quality of the included studies. Results A total of 822 patients were included in the prospective non-RCT. Among them, 413 patients in the treatment group (conventional drug + Bifidobacterium triple viable agent in the control group) and 409 in the control group. The total effective rate of the treatment group was higher than that of the control group (OR 3.18,95% CI 2.07-4.89, P <0.01). There was no significant difference in the improvement rate of stool consistency between the treatment group and the control group (OR 1.63, 95% CI 0.70 ~ 3.83, P = 0.26). There was no significant difference in improvement rate of digestive tract symptom between treatment group and control group (OR 1.68,95% CI 0.73 ~ 3.86, P = 0.22). Conclusions Bifidobacterium triple viable preparations can improve the overall curative effect of acute and chronic diarrhea in combination with conventional therapeutic agents. The improvement of related symptoms needs to be verified by the large sample multi-center RCT.