Azathioprine versus mesalazine for prevention of postoperative clinical recurrence in patients with Crohn's disease with endoscopic recurrence: efficacy and safety results of a randomised, double-blind, double-dummy, multicentre trial
Azathioprine versus mesalazine for prevention of postoperative clinical recurrence in patients with Crohn's disease with endoscopic recurrence: efficacy and safety results of a randomised, double-blind, double-dummy, multicentre trial
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DOI：
10.1136/gut.2009.194159
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发表时间：
2010-06-01
期刊：
影响因子：
24.5
通讯作者：
Herrlinger, Klaus R.
中科院分区：
文献类型：
--
作者：
Reinisch, Walter;Angelberger, Sieglinde;Herrlinger, Klaus R.
目的比较硫唑嘌呤和美沙拉嗪片预防克罗恩病（CD）术后中重度内镜下复发患者临床复发的效果。方法：在奥地利、捷克共和国、德国和以色列的21个胃肠病学中心进行为期1年的双盲、双假随机研究。研究参与者是78名成年CD患者，他们在过去6-24个月内接受了回肠结肠吻合术切除，没有随后的临床复发，克罗恩病活动性指数（CDAI）评分= 200，比基线增加>= 60分，或由于缺乏疗效或药物不良反应无法忍受而停药。结果硫唑嘌呤组治疗失败率为22.0%(9/41)，美萨拉嗪组为10.8%(4/37)，差异为11.1% （95% CI -5.0% ~ 27.3%, p=0.19）。硫唑嘌呤的临床复发率明显低于美萨拉嗪(0/41 (0%)vs 4/37 (10.8%), p=0.031)，而由于药物不良反应而停药仅发生在硫唑嘌呤治疗的患者中（9/41 (22.0%)vs 0%, p=0.002）。从基线到第12个月，硫唑嘌呤和美塞拉嗪组Rutgeerts评分下降>= 1分的患者比例分别为63.3%（19/30）和34.4%(11/32)，差异有统计学意义（p=0.023）。结论：在临床复发风险较高的CD术后患者中，硫唑嘌呤与美沙拉嗪的治疗失败并不能证明其优越性。
Objective The aim of the study was to compare azathioprine versus mesalazine tablets for the prevention of clinical recurrence in patients with postoperative Crohn's disease (CD) with moderate or severe endoscopic recurrence.Methods This was a 1 year, double-blind, double-dummy, randomised study which took place in 21 gastroenterology centres in Austria, the Czech Republic, Germany and Israel. The study participants were 78 adults with CD who had undergone resection with ileocolonic anastomosis in the preceding 6-24 months without subsequent clinical recurrence and with a Crohn's disease activity index (CDAI) score = 200 and an increase of >= 60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction.Results Treatment failure occurred in 22.0% (9/41) of azathioprine-treated patients and 10.8% (4/37) of mesalazine-treated patients, a difference of 11.1% (95% CI -5.0% to 27.3%, p=0.19). Clinical recurrence was significantly less frequent with azathioprine versus mesalazine (0/41 (0%) vs 4/37 (10.8%), p=0.031), whereas study drug discontinuation due to adverse drug reactions only occurred in azathioprine-treated patients (9/41 (22.0%) vs 0%, p=0.002). The proportion of patients showing >= 1 point reduction in Rutgeerts score between baseline and month 12 was 63.3% (19/30) and 34.4% (11/32) in the azathioprine and mesalazine groups, respectively (p=0.023).Conclusions In this population of patients with postoperative CD at high risk of clinical recurrence, superiority for azathioprine versus mesalazine could not be demonstrated for therapeutic failure.