新功能、新界面、新体验,扫描即可下载生物谷APP!
首页 » JAMA » JAMA:ω-3脂肪酸对预防克罗恩病复发无效

JAMA:ω-3脂肪酸对预防克罗恩病复发无效

来源:JAMA 2008-04-24 18:36

加拿大西安大略大学Feagan等报告,他们进行的2项随机双盲安慰剂对照研究表明,ω-3游离脂肪酸对预防克罗恩病复发无效,相关论文发表于《美国医学协会期刊》(JAMA)。

克罗恩病的维持治疗主要使用免疫抑制剂,但免疫抑制增加感染的危险。因此,对于克罗恩病安全有效的维持治疗很关键。

研究者于2003年1月至2007年2月间在加拿大、欧洲、以色列和美国的98个中心进行了2项随机双盲安慰剂对照研究(Epanova方案克罗恩病研究,EPIC-1研究和EPIC-2研究)。评估口服ω-3游离脂肪酸预防克罗恩病复发是否比安慰剂更有效。

EPIC-1和EPIC-2研究分别纳入363与375例静止期克罗恩病患者。纳入者的克罗恩病活动指数(CDAI)评分<150分,被随机分成2组,分别接受ω-3游离脂肪酸(4 g/d)或安慰剂治疗(共58周),不允许接受其他治疗。

临床复发定义为CDAI评分≥150分和与基线值相比增加>70分,或开始接受抗活动期克罗恩病治疗。

结果显示,在EPIC-1研究中,ω-3游离脂肪酸组患者的1年复发率为31.6%,安慰剂组为35.7%(危险率比(HR)为0.82,P=0.30)。在EPIC-2研究中,ω-3游离脂肪酸组患者的1年复发率为47.8%,安慰剂组为48.8%(HR为0.90,P=0.48)。上述研究中严重不良事件不常见,且大部分与克罗恩病相关。(来源:中国医学论坛报 蒋文)

生物谷推荐原始出处:

JAMA),299(14):1690-1697,Brian G. Feagan,Paul Rutgeerts

Omega-3 Free Fatty Acids for the Maintenance of Remission in Crohn Disease

The EPIC Randomized Controlled Trials

Brian G. Feagan, MD; William J. Sandborn, MD; Ulrich Mittmann, MD; Simon Bar-Meir, MD; Geert D’Haens, MD, PhD; Marc Bradette, MD; Albert Cohen, MD; Chrystian Dallaire, MD; Terry P. Ponich, MD; John W. D. McDonald, MD, PhD; Xavier Hébuterne, MD, PhD; Pierre Paré, MD; Pavel Klvana, MD; Yaron Niv, MD; Sandro Ardizzone, MD; Olga Alexeeva, MD; Alaa Rostom, MD; Gediminas Kiudelis, MD; Johannes Spleiss, MSc; Denise Gilgen, PhD; Margaret K. Vandervoort, MSc; Cindy J. Wong, MSc; Guang Yong Zou, PhD; Allan Donner, PhD; Paul Rutgeerts, MD, PhD

Context  Maintenance therapy for Crohn disease features the use of immunosuppressive drugs, which are associated with an increased risk of infection. Identification of safe and effective maintenance strategies is a priority.

Objective  To determine whether the oral administration of omega-3 free fatty acids is more effective than placebo for prevention of relapse of Crohn disease.

Design, Setting, and Patients  Two randomized, double-blind, placebo-controlled studies (Epanova Program in Crohn's Study 1 [EPIC-1] and EPIC-2) conducted between January 2003 and February 2007 at 98 centers in Canada, Europe, Israel, and the United States. Data from 363 and 375 patients with quiescent Crohn disease were evaluated in EPIC-1 and EPIC-2, respectively.

Interventions  Patients with a Crohn's Disease Activity Index (CDAI) score of less than 150 were randomly assigned to receive either 4 g/d of omega-3 free fatty acids or placebo for up to 58 weeks. No other treatments for Crohn disease were permitted.

Main Outcome Measure  Clinical relapse, as defined by a CDAI score of 150 points or greater and an increase of more than 70 points from the baseline value, or initiation of treatment for active Crohn disease.

Results  For EPIC-1, 188 patients were assigned to receive omega-3 free fatty acids and 186 patients to receive placebo. Corresponding numbers for EPIC-2 were 189 and 190 patients, respectively. The rate of relapse at 1 year in EPIC-1 was 31.6% in patients who received omega-3 free fatty acids and 35.7% in those who received placebo (hazard ratio, 0.82; 95% confidence interval, 0.51-1.19; P = .30). Corresponding values for EPIC-2 were 47.8% and 48.8% (hazard ratio, 0.90; 95% confidence interval, 0.67-1.21; P = .48). Serious adverse events were uncommon and mostly related to Crohn disease.

Conclusion  In these trials, treatment with omega-3 free fatty acids was not effective for the prevention of relapse in Crohn disease.

温馨提示:87%用户都在生物谷APP上阅读,扫描立刻下载! 天天精彩!


相关标签

最新会议 培训班 期刊库