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生物疗法治疗炎症性肠病的疗效:系统评价和荟萃分析。

Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis.

机构信息

Leeds Gastroenterology Institute, Leeds General Infirmary, Leeds, UK.

出版信息

Am J Gastroenterol. 2011 Apr;106(4):644-59, quiz 660. doi: 10.1038/ajg.2011.73. Epub 2011 Mar 15.

DOI:10.1038/ajg.2011.73
PMID:21407183
Abstract

OBJECTIVES

Crohn's disease (CD) and ulcerative colitis (UC) are inflammatory disorders of the gastrointestinal tract of unknown etiology. Evidence for treatment of the condition with biological therapies exists, but no systematic review and meta-analysis has examined this issue in its entirety.

METHODS

MEDLINE, EMBASE, and the Cochrane central register of controlled trials were searched (through to December 2010). Trials recruiting adults with active or quiescent CD or UC and comparing biological therapies (anti-tumor necrosis factor-α (TNFα) antibodies or natalizumab) with placebo were eligible. Dichotomous symptom data were pooled to obtain relative risk (RR) of failure to achieve remission in active disease and RR of relapse of activity in quiescent disease once remission had occurred, with a 95% confidence interval (CI).

RESULTS

The search strategy identified 3,061 citations, 27 of which were eligible. Anti-TNFα antibodies and natalizumab were both superior to placebo in inducing remission of luminal CD (RR of no remission=0.87; 95% CI 0.80-0.94 and RR=0.88; 95% CI 0.83-0.94, respectively). Anti-TNFα antibodies were also superior to placebo in preventing relapse of luminal CD (RR of relapse=0.71; 95% CI 0.65-0.76). Infliximab was superior to placebo in inducing remission of moderate to severely active UC (RR=0.72; 95% CI 0.57-0.91).

CONCLUSIONS

Biological therapies were superior to placebo in inducing remission of active CD and UC, and in preventing relapse of quiescent CD.

摘要

目的

克罗恩病(CD)和溃疡性结肠炎(UC)是病因不明的胃肠道炎症性疾病。有证据表明生物疗法可用于治疗这些疾病,但目前尚无系统评价和荟萃分析对此进行全面研究。

方法

检索 MEDLINE、EMBASE 和 Cochrane 对照试验中心注册库(截至 2010 年 12 月)。符合条件的试验应招募患有活动期或缓解期 CD 或 UC 的成年人,并比较生物疗法(抗肿瘤坏死因子-α(TNFα)抗体或那他珠单抗)与安慰剂的疗效。采用二项分类症状数据汇总分析,计算活动期疾病缓解失败和缓解后疾病复发的相对风险(RR),95%置信区间(CI)。

结果

检索策略共检出 3061 篇文献,其中 27 篇符合纳入标准。抗 TNFα 抗体和那他珠单抗均优于安慰剂诱导 CD 肠腔缓解(无缓解 RR=0.87;95%CI 0.80-0.94 和 RR=0.88;95%CI 0.83-0.94)。抗 TNFα 抗体也能更好地预防 CD 肠腔复发(复发 RR=0.71;95%CI 0.65-0.76)。英夫利昔单抗在诱导中重度活动期 UC 缓解方面优于安慰剂(RR=0.72;95%CI 0.57-0.91)。

结论

生物疗法在诱导活动期 CD 和 UC 缓解,预防缓解期 CD 复发方面优于安慰剂。

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