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5-氨基水杨酸对Crohn病的维持缓解作用素有争议。此研究的目的是对静止期Crohn病结肠炎和/或回结肠炎患者预防性应用奥沙拉嗪是否具有维持缓解作用作一评价。 方法:此研究为一个随机、双盲、平行、安慰剂对照试验。从1992年2月～1996年1月328例完全缓解的Crohn病结肠炎和/或回结肠炎患者入选,奥沙拉嗪治疗组(n=167)和安慰剂组(n=161)分别给予奥沙拉嗪或安慰剂每日2克,共52周。在治疗前4周(-4)、0、4、13、26、39和52周进行Crohn病活动指数(CDAI)评价。治疗终点为复发(指CDAI积分>150或比治疗开始时积分增加60以上),临床复发指需要其他的治疗或手术。所有患者在0、13、26、52周及治疗终点进行安全性评价,统计学分析用UNIX SAS(6.09版)软件。 结果:两组之间的基础资料无显著性差异,治疗组与安慰剂组复发率相似(奥沙拉嗪48.5％比安慰剂45％),无论是结肠炎和/或回结肠炎,复发终止的时间两组没有差异。终止治疗的三个主要原因为CDAI复发(25％)、临床复发(10％)和不能耐受的副反应(13％)。治疗组比安慰剂组有更多患者不能完成52周全程治疗(奥沙拉嗪6.9％比安慰
The effect of 5-aminosalicylic acid on the maintenance of Crohn’s disease is controversial. The aim of this study was to evaluate whether prophylactic use of olsalazine in patients with quiescent Crohn’s disease and / or colitis has a maintenance response. METHODS: This study was a randomized, double-blind, parallel, placebo-controlled trial. From February 1992 to January 1996 328 patients with Crohn’s disease and / or colitis with complete remission were enrolled. Ozalizine (n = 167) and placebo (n = 161) Shalazine or placebo daily 2 grams, a total of 52 weeks. Crohn’s Disease Activity Index (CDAI) was evaluated at 4 weeks (-4), 0,4,13,26,39 and 52 weeks prior to treatment. The end of treatment was relapsed (CDAI score> 150 or more than 60 points above the start of therapy), and clinical relapse may require additional treatment or surgery. All patients were evaluated for safety at 0, 13, 26, 52 weeks and at the end of treatment, using statistical software such as UNIX SAS (version 6.09). Results: There was no significant difference in the underlying data between the two groups, with a similar relapse rate in the treated and placebo groups (olsalazine 48.5% versus placebo 45%), whether colitis and / or colitis, and relapse termination There was no difference in time between the two groups. The three primary causes of termination were CDAI recurrence (25%), clinical relapse (10%) and intolerable side effects (13%). More patients in the treatment group than in the placebo group were unable to complete the 52 weeks of treatment (olsalazine 6.9% more than comfort