循证医学证据提示益生菌对溃疡性结肠炎(UC)的诱导缓解无效,但对维持缓解有效,然而2009年发表的两项临床试验结果显示益生菌合剂VSL#3对UC的诱导缓解有效。目的:系统评价益生菌尤其是VSL#3诱导UC缓解的有效性和安全性。方法:联机检索MEDLINE、EMBASE、CochraneLibrary和中国生物医学文献数据、万方数据库,由两名分析人员独立选取与UC诱导缓解相关、比较益生菌治疗组与对照组(安慰剂或阳性对照)的随机对照试验(不限语种)并提取数据。应用RevMan5.2.10软件行meta分析,同时行亚组分析和敏感性分析。结果:共纳入9项随机对照试验,共557例UC患者,其中4项治疗组使用VSL#3。Meta分析显示益生菌组总体诱导缓解率显著优于对照组(OR=2.05,95%CI:1.14~3.70,P=0.02),亚组分析显示VSL#3亚组诱导缓解率显著优于对照组(OR:2.35,95%CI:1.45—3.80,P=0.0005),其他菌种与对照组间诱导缓解率无明显差异。益生菌组、VSL#3亚组与对照组间不良反应发生率均无明显差异。敏感性分析显示meta分析结果稳定。结论:VSL#3对UC的诱导缓解作用优于对照组且安全性高。
Evidence-based medicine suggested that probiotic treatment was more effective than placebo in maintaining remission in ulcerative colitis (UC), but did not provide additional benefit in inducing remission. However, two clinical trials published in 2009 showed that VSL#3, a probiotic mixture, was effective for the induction of remission in UC. Aims: To systematically evaluate the effectiveness and safety of probiotics, especially VSL#3 for induction of remission in UC. Methods: MEDLINE, EMBASE, Cochrane Library, CBM and Wanfang Data were searched for randomized controlled trials comparing the induction of remission in UC between probiotics treatment and non-probiotics treatment (placebo or positive control) without language limitation. Information was retrieved by two reviewers independently. RevMan 5. 2. 10 software was used to perform meta-analysis; subcategory analysis and sensitivity analysis were also performed. Results: Nine randomized controlled trials with a total of 557 UC patients met the inclusion criteria, of which g were VSL#3 treatment. From meta-analysis, the odds ratio of probiotics treatment for induction of remission was 2.05 (95% CI: 1.14-3.70, P =0. 02) when compared with non-probiotics treatment. Subcategory analysis showed that the odds ratio of VSL#3 treatment was 2.35 (95% CI : 1.45-3.80, P = 0.0005 ), while nonsignificant odds ratios were seen for other probiotics. The adverse effect rate was not significantly different between probiotics/VSL#3 treatment and non- probiotics treatment. Sensitivity analysis showed that the result of pooled analysis of the nine trials was stable. Conclusions: VSL#3 is safe and superior to non-probiotics treatment for induction of remission in UC.