美常安联合常规治疗对溃疡性结肠炎的系统评价

Systematic Evaluation on Medilac-S Combined Conventional Treatment for Ulcerative Colitis

目的系统评价美常安联合常规治疗对溃疡性结肠炎的疗效及安全性。方法计算机检索Cochrane图书馆(2012年第1期)、EM-Base、PubMed、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、中文科技期刊全文数据库(VIP)(各数据库检索时间均从创建之日起至2012年5月)关于美常安治疗溃疡性结肠炎的随机对照试验。用RevMan5.12软件对数据进行Meta分析。结果共纳入24篇RCT,包括1 358例患者。与对照组相比,美常安组总有效率优于对照组[RR=1.34,95%CI(1.25,1.42),P<0.000 01];缓解复发率优于对照组[RR=0.23,95%CI(0.12,0.45),P<0.001];症状缓解率(腹痛、腹泻、黏液血便、里急后重)优于对照组;评分改善(大便菌群积分比、Sutherland指数、肠镜分级积分)优于对照组,差异均有统计学意义。美常安组不良反应发生率[OR=0.74,95%CI(0.42,1.30),P=0.29]与对照组之间差异没有统计学意义。结论基于现有临床证据,美常安联合常规治疗对溃疡性结肠炎有效、安全性好,但由于纳入研究数量较少,研究质量不统一,此结论尚需要更多大样本、高质量临床随机对照试验予以证实。

Objective To systematically evaluate the effectiveness and safety of Medilac- S combined conventional treatment for ulcera- tive colitis（UC）.Methods The randomized controlled trials （RCTs） of Medilac- S combined conventional treatment for UC in the Cochrane Library （Issue 1,2012）, EMbase, PubMed, CBM, CNKI and VIP from their establishment to May 2012 were retrieved by com- puter. The retrieval data were performed the meta analysis by RevMan 5.12 software. Results Twenty-four RCTs involving 1 358 pa- tients were ultimately identified. The results of meta analysis showed that the total effective rate of the Medilac- S group was superior to the control group[ RR=1.34, 95% CI（1.25, 1.42）, P〈0. 000 01 ]; the remission and relapse rate in the Medilac- S group was supe- rior to the control group[ RR =0. 23, 95% CI（0. 12, 0. 45）, P 〈 0. 001 ]; the remission rate of symptoms （abdominal pain, diarrhea, mucous bloody stool, tenesmus） in the Medilac- S group was superior to the control group; the improvement of the scores （fecal microflora inte- gral ratio, Sutherland index, enteroscopic grading integral） in the Medilac-S group was superior to the control group, all differences showing statistical significance. There was no statistical difference in the incidence rate of adverse reactions between the two groups [ OR = 0. 74, 95% CI（0. 42, 1.30）, P = 0. 29]. Conclusion According to the present clinical evidence, Medilac - S combined conventional treatment is effective and safe for UC. However, due to the smaller number of RCTs and the non- uniform quality of the included stud- ies, this conclusion needs larger sample size and high- quality RCTs for verification.