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目的评价双歧杆菌三联活菌制剂治疗功能性便秘的临床疗效。方法检索中国知网、万方、维普、Pubmed、EMbase、Web of Science数据库,收集2005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功能性便秘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。结果无RCT入选,纳入18个前瞻性non-RCT,共1397例患者。治疗组(对照组常规治疗措施+双歧杆菌三联活菌胶囊或散剂)718例,对照组679例。治疗组的总体疗效优于对照组(OR 3.98,95%CI:2.46~6.43,P<0.01);治疗组功能性便秘复发率低于对照组(OR 0.23,95%CI:0.14~0.36,P<0.01);治疗组不良反应发生率与对照组比较,差异无统计学意义(OR 0.70,95%CI:0.37~1.34,P=0.29)。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功能性便秘的总体疗效,同时可以有效降低功能性便秘的复发率。
Objective To evaluate the clinical efficacy of Bifidobacterium triple viable agents in the treatment of functional constipation. METHODS: All the randomized controlled trials of functional Bifidobacterium (Bifidobacterium trifoliatum) preparations for the treatment of functional constipation were collected at home and abroad from January 2005 to December 2013 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 There were 13 RCTs enrolled in 18 prospective non-RCT patients without RCT. The treatment group (control group conventional treatment + Bifidobacterium triple viable capsule or powder) 718 cases, 679 cases of the control group. The overall efficacy of the treatment group was better than that of the control group (OR 3.98,95% CI: 2.46-6.33, P <0.01). The recurrence rate of functional constipation in the treatment group was lower than that in the control group (OR 0.23, 95% CI: 0.14-0.36, P <0.01). The incidence of adverse reactions in the treatment group was not significantly different from that in the control group (OR 0.70, 95% CI: 0.37-1.34, P = 0.29). Conclusion Bifidobacterium triple viable preparations can improve the overall curative effect of functional constipation, and reduce the recurrence rate of functional constipation effectively.