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生物治疗时代的手术率:上升、下降还是不变?

Surgical rates in the era of biological therapy: up, down or unchanged?

作者信息

Olivera Pablo, Spinelli Antonino, Gower-Rousseau Corinne, Danese Silvio, Peyrin-Biroulet Laurent

机构信息

aDepartment of Internal Medicine, Gastroenterology Section, Centro de Educación Médica e Investigaciones Clínicas (CEMIC), Buenos Aires, Argentina bColon and Rectal Surgery Unit, Humanitas Clinical and Research Center, Rozzano Milan, Italy cDepartment of Biomedical Science, Humanitas University, Rozzano Milan, Italy dPublic Health Unit, Epimad Registry and LIRIC-UMR 995 Inserm, Lille University Hospital, Université Lille 2, Lille, France eDepartment of Gastroenterology, IBD Center, Humanitas Research Hospital, Rozzano Milano, Italy fINSERM U954 and Department of Hepatogastroenterology, Nancy University Hospital, Université de Lorraine, Vandoeuvre-lès-Nancy, France.

出版信息

Curr Opin Gastroenterol. 2017 Jul;33(4):246-253. doi: 10.1097/MOG.0000000000000361.

Abstract

PURPOSE OF REVIEW

The aim of this review is to summarize data regarding surgical trends in inflammatory bowel disease in the prebiologic and biologic era, with a focus on population-based studies and randomized controlled trials (RCTs).

RECENT FINDINGS

There is paucity of data in RCTs regarding surgical rates, with only a few clinical trials reporting them. From the available data, meta-analyses of RCTs have concluded that antitumor necrosis α agents (anti-TNF) reduce surgical rates in ulcerative colitis and Crohn's disease. A large body of evidence from population-based studies from different regions of the world is available to evaluate surgical trends before and after the introduction of anti-TNF agents. The risk of surgery decreased significantly over the past six decades; these decreasing trends continued in the biologic era, which might indicate a potential beneficial disease-modifying effect of biologics. There is lack of data with nonanti-TNF biologics (i.e. anti-integrins and ustekinumab) regarding the risk of surgery.

SUMMARY

Although data from population-based studies and available RCTs suggest a protective effect from surgery of anti-TNF agents, definitive conclusions should be drawn only when more disease-modifying trials with different biologics and treatment strategies become available.

摘要

综述目的

本综述旨在总结在使用生物制剂之前和使用生物制剂时代炎症性肠病的手术趋势数据,重点关注基于人群的研究和随机对照试验(RCT)。

最新发现

RCT中关于手术率的数据很少,只有少数临床试验报告了这些数据。根据现有数据,RCT的荟萃分析得出结论,抗肿瘤坏死因子α制剂(抗TNF)可降低溃疡性结肠炎和克罗恩病的手术率。来自世界不同地区基于人群研究的大量证据可用于评估抗TNF制剂引入前后的手术趋势。在过去六十年中手术风险显著降低;这些下降趋势在生物制剂时代仍在持续,这可能表明生物制剂具有潜在的有益疾病改善作用。关于非抗TNF生物制剂(即抗整合素和优特克单抗)的手术风险缺乏数据。

总结

尽管基于人群的研究和现有RCT的数据表明抗TNF制剂对手术有保护作用,但只有当有更多针对不同生物制剂和治疗策略的疾病改善试验时,才能得出明确结论。

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