益生菌治疗溃疡性结肠炎有效性及安全性的meta分析

Meta-analysis of the efficacy and safety of probiotics in treatment of ulcerative colitis

目的:评价益生菌治疗溃疡性结肠炎(ulcerative colitis,UC)的有效性及安全性。方法:计算机检索Pubmed、Cochrane图书馆、Embase、中国期刊全文数据库、中国生物医学文献数据库、万方数据库,纳入研究数据采用Rev Man 5.3软件处理。结果:共纳入22项随机对照试验(randomized controlled trial,RCT),14项RCT关于益生菌治疗活动期UC,12篇RCT关于益生菌治疗缓解期UC(4项同时观察两个时期)。其中11项显示了不良反应数目。系统评价结果:①益生菌组较安慰剂组治疗活动期UC诱导缓解率显著增高(OR=2.21,95%CI:1.31~3.71,P=0.003);益生菌合剂(VSL#3)对活动期UC诱导缓解率明显高于对照组(OR=2.31,95%CI:1.44~3.70,P=0.000 5);②益生菌组治疗活动期UC诱导缓解率与5-氨基水杨酸(5-aminosalicylic acid,5-ASA)组差异无统计学意义(OR=0.82,95%CI:0.49~1.36,P=0.44);③益生菌对缓解期UC复发率低于安慰剂组(OR=0.41,95%CI:0.21~0.78,P=0.007),与美沙拉嗪组相比差异无统计学意义(P=0.78);④益生菌组与对照组的不良反应发生率差异无统计学意义(P=0.13)。结论:联合传统治疗基础上,益生菌治疗活动期UC较安慰剂可提高临床缓解率;其中VSL#3对活动期UC有效;对于缓解期UC,益生菌较安慰剂降低临床复发率,与美沙拉嗪效果相当;益生菌不良反应少,安全可信。

Objective：To evaluate the effect and safety of probiotics in treatment of ulcerative colitis（UC）. Methods：Pubmed, Cochrane library, Embase and CNKI, CBM, and Wanfang database were searched, and meta-analysis was performed with Rev Man 5.3 software. Twenty-two randomized controlled trials（RCT） were included, among which 14 RCTs were on probiotics for active UC, 12 RCTs were onprobiotics for quiescent UC, and 4 RCTs investigated both. Eleven of the 22 articles provided the numbers of adverse reactions. Results： For active UC, the induction remission rate of probiotic group was obviously higher than the placebo group（OR=2.45, 95%CI： 1.27-4.71, P=0.007）.The remission rate of VSL#3 group was significantly higher than that in the control group（OR=2.31, 95%CI： 1.44-3.70, P=0.000 5）.There had no statistical difference in clinical remission rate between probiotic and 5-ASA（OR=0.82, 95%CI： 0.49-1.36, P=0.44）. For quiescent UC,the relapse rate of the probiotic group was obviously lower than placebo（OR=0.41, 95%CI： 0.21-0.78, P=0.007）, and no significant difference was observed between probiotics and masalazine（OR=1.05, 95%CI： 0.76-1.43, P=0.78）. There were no statistical differences between probiotics and control in adverse reactions（OR=1.26, 95%CI： 0.94-1.70, P=0.13）. Conclusion：On the basis of combined traditional treatment, probiotics can significantly increase the remission rate of active UC than placebo. VSL#3 may be effective for active UC.For quiescent UC, probiotics can significantly decrease the relapse rate, and may be as effective as mesalazine. Probiotics has good safety and less adverse reactions.