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一项关于 5-氨基水杨酸、免疫调节剂和生物制剂预防克罗恩病术后复发疗效的网状荟萃分析。

A network meta-analysis on the efficacy of 5-aminosalicylates, immunomodulators and biologics for the prevention of postoperative recurrence in Crohn's disease.

机构信息

Xijing Hospital of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, 127 West Changle Road, Xi'an 710032, China.

Department of Health Statistics, Second Military Medical University, Shanghai 200433, China.

出版信息

Int J Surg. 2014;12(5):516-22. doi: 10.1016/j.ijsu.2014.02.010. Epub 2014 Feb 25.

Abstract

BACKGROUND AND AIMS

A number of agents have been evaluated in clinical trials to reduce the risk of postoperative recurrence in Crohn's disease (CD). The aim of this study was to compare the efficacy of 5-aminosalicylates, immunomodulators and biologics for postoperative prophylaxis of CD recurrence by using a network meta-analytical approach.

METHODS

PubMed, Embase, and Cochrane Library were searched (update to November 2013) to identify randomized placebo-controlled, or head-to-head trials among the three drug classes for prevention of postoperative CD relapse. The primary endpoint for efficacy was endoscopic recurrence, and the secondary outcomes were clinical recurrence and adverse events. We conducted a Bayesian network meta-analysis with a mixed treatment comparisons to combine both direct and indirect evidences.

RESULTS

Fifteen trials involving 1507 patients were included in this analysis. Biological agents were associated with a large and significant reduction of both endoscopic and clinical recurrence compared with placebo, 5-aminosalicylates, or immunomodulators. Immunomodulators showed greater efficacy in terms of endoscopic and clinical recurrence prophylaxis compared with 5-aminosalicylates or placebo, but with higher incidence of adverse events. 5-aminosalicylates were superior to placebo for prevention of clinical recurrence, without increasing the rate of side effect.

CONCLUSIONS

5-aminosalicylates, immunomodulators, and biologics are more efficacious than placebo for postoperative CD prevention. Biologics are found to be the most effective medications to prevent CD recurrence.

摘要

背景与目的

在临床试验中,已有多种药物被评估用于降低克罗恩病(CD)术后复发的风险。本研究旨在通过网状meta 分析方法比较 5-氨基水杨酸类、免疫调节剂和生物制剂在预防 CD 术后复发中的疗效。

方法

检索 PubMed、Embase 和 Cochrane Library(更新至 2013 年 11 月),以确定这三种药物类别中用于预防术后 CD 复发的随机安慰剂对照或头对头试验。疗效的主要终点为内镜复发,次要终点为临床复发和不良事件。我们进行了贝叶斯网状meta 分析,采用混合治疗比较法综合直接和间接证据。

结果

本分析共纳入 15 项涉及 1507 例患者的试验。与安慰剂、5-氨基水杨酸类或免疫调节剂相比,生物制剂可显著降低内镜和临床复发的风险。免疫调节剂在预防内镜和临床复发方面比 5-氨基水杨酸类或安慰剂更有效,但不良反应发生率更高。5-氨基水杨酸类在预防临床复发方面优于安慰剂,且不增加不良反应发生率。

结论

5-氨基水杨酸类、免疫调节剂和生物制剂在预防 CD 术后复发方面比安慰剂更有效。生物制剂是预防 CD 复发最有效的药物。

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