微生态制剂治疗溃疡性结肠炎的系统评价

Probiotic Agents for Ulcerative Colitis: A Systematic Review

目的系统评价微生态制剂治疗溃疡性结肠炎的疗效和安全性。方法计算机检索Cochrane图书馆临床对照试验数据库(2007年第1期)、MEDLINE/PubMed(1978～2007)、EMbase(1978～2007)、Ovid(1978～2007)、中国生物医学文献数据库(1978～2007)、中文科技期刊全文数据库(1989～2007)、中国期刊全文数据库(1979～2007)和万方学位论文数据库(1978～2007),手工检索《中华消化杂志》等4种相关中文期刊、相关会议论文集及所有检索到文献的参考文献,纳入微生态制剂治疗溃疡性结肠炎的所有随机对照试验(RCT),并按Cochrane协作网推荐的方法进行系统评价。结果共纳入13个RCT,包括1146例患者。Meta分析结果显示:①临床缓解率:微生态制剂不优于氨基类制剂[OR=0.93,95%CI(0.53,1.66),P=0.82],但微生态制剂加氨基类制剂联合治疗优于氨基类制剂[OR=2.69,95%CI(1.57,4.61),P=0.0003]。②临床复发率:微生态制剂治疗优于安慰剂[OR=0.03,95%CI(0.00,0.15),P<0.0001];但不优于氨基类制剂[OR=0.95,95%CI(0.65,1.38),P=0.79];微生态制剂加氨基类制剂联合治疗也不优于单纯氨基类制剂治疗[OR=0.57,95%CI(0.24,1.32),P=0.19]。③不良反应发生率:微生态制剂不优于氨基类制剂[OR=0.85,95%CI(0.43,1.70),P=0.65];微生态制剂治疗加氨基类制剂联合治疗也不优于氨基类制剂[OR=0.30,95%CI(0.06,1.54),P=0.15]。结论现有的证据显示,在缓解溃疡性结肠炎临床症状方面,微生态制剂不优于氨基类制剂,但微生态制剂加氨基类制剂联合治疗优于单用氨基类制剂。在预防复发方面,微生态制剂优于安慰剂,但不优于氨基类制剂;微生态制剂加氨基类制剂联合治疗也不优于单用氨基类制剂治疗。微生态制剂不良反应发生较少。鉴于本系统评价纳入研究质量均不太高,因此对上述结果的应用应慎重,并期待进一步研究的证据。

Objective To evaluate the effectiveness and safety of probiotic agents for ulcerative colitis. Methods We searched electronically the Cochrane Central Register of Controlled Trials （Issue 1, 2007）, MEDLINE （1978 to 2007）, EMBASE （1978 to 2007）, OVID Database （1978 to 2007）, Chinese Biological Medicine Database （CBM Disc） （1978 to 2007）, CNKI （1979 to 2007）, Chinese VIP Database （i989 to 2007） and Wanfang Database （1978 to 2007）. We also checked the reference lists of retrieved articles and hand-searched 4 kinds of important journals to identify randomized controlled trials of probiotic agents for ulcerative colitis. Meta-analyses were conducted with The Cochrane Collaboration＇s RevMan 4.2 software. Results Thirteen trials involving 1146 patients were included. Meta-analyses showed that probiotic agents were not superior to aminosalicylates for the clinical remission rate （OR 0.93, 95% CI 0.53 to 1.66; P=0.82）; but the combination of probiotic agents and aminosalicylates were superior to aminosalicylates alone （OR 2.69, 95% CI 1.57 to 4.61; P=0.0003）. In terms of the clinical relapse, the rate for probiotic agents was superior to that for placebo （OR 0.03, 95% CI 0.00 to 0.15; P〈0.0001）; but not superior to aminosalicylates （OR 0.95, 95% CI 0.65 to 1.38; P=0.79）. The combination of probiotic agents and aminosalicylates was not superior to aminosalicylates alone （OR 0.57, 95% CI 0.24 to 1.32; P=0.19）. As for the incidence of adverse effects, probiotic agents were not superior to aminosalicylates （OR 0.85, 95% CI 0.43 to 1.70; P=0.65）; and the combination of probiotic agents and aminosalicylates was not superior to aminosalicylates alone （OR 0.30, 95% CI 0.06 to 1.54; P=0.15）. Conclusion Probiotic agents are not superior to aminosalicylates based on the evidence in this review, but the combination of probiotic agents and aminosalicylates is superior to aminosalicylates alone in maintaining remission. Probiotic agents are superior to placebo but not superior to aminosalicylates, and the combination of probiotic agents and aminosalicylates is not superior to aminosalicylates alone in preventing relapse. Probiotic agents have good tolerability. However, all these findings should be interpreted with caution and more clinical trials are needed.