Hanauer S B, Krawitt E L, Robinson M, Rick G G, Safdi M A
University of Chicago, Illinois.
Am J Gastroenterol. 1993 Sep;88(9):1343-51.
Current long-term treatment of Crohn's disease is unsatisfactory. Based on the Crohn's Disease Activity Index (CDAI), this multicenter trial enrolled patients with either active Crohn's disease (CDAI > or = 150) or disease in remission (CDAI < 150). The primary measure of therapeutic response was mean change in CDAI from baseline to final visit. All patients began treatment with a dosage of < or = 4 g/day of mesalamine that ranged from 3.7 g at baseline to 3.4 g at final visit. Overall, 467 patients were enrolled: 333 (active disease) and 134 (remission). The median study participation time was 14 months. For patients entering with active disease, the mean reduction in CDAI was 77 points, with 42% (122/289) achieving remission by their final visit. For patients entering in remission, there was an increase in mean CDAI from 90 at baseline to 96 at final visit, with 79% (95/120) of patients in remission at final visit and 72% (31/43) in remission continuously after 12 months of therapy. From baseline to final visit, the mean prednisone dose decreased 5 mg/day in patients with active disease and 11 mg/day in patients in remission. Mesalamine was well tolerated and no adverse laboratory trends were observed. These results suggest that controlled-release mesalamine shows promise as a steroid-sparing agent and as a safe and effective long-term therapy for the induction of and maintenance of remission of mild-to-moderate Crohn's disease.
目前克罗恩病的长期治疗效果并不理想。基于克罗恩病活动指数（CDAI），这项多中心试验纳入了活动期克罗恩病（CDAI≥150）或缓解期疾病（CDAI＜150）的患者。治疗反应的主要衡量指标是从基线到末次访视时CDAI的平均变化。所有患者开始使用美沙拉嗪剂量≤4g/天进行治疗，基线时为3.7g，末次访视时为3.4g。总体而言，共纳入467例患者：333例（活动期疾病）和134例（缓解期）。研究参与的中位时间为14个月。对于活动期疾病患者，CDAI的平均降低值为77分，42%（122/289）的患者在末次访视时达到缓解。对于缓解期患者，CDAI的平均值从基线时的90增加到末次访视时的96，79%（95/120）的患者在末次访视时仍处于缓解期，72%（31/43）的患者在治疗12个月后持续缓解。从基线到末次访视，活动期疾病患者的泼尼松平均剂量每天降低5mg，缓解期患者每天降低11mg。美沙拉嗪耐受性良好，未观察到不良实验室指标变化趋势。这些结果表明，缓释美沙拉嗪有望作为一种类固醇节约剂，以及一种安全有效的长期疗法，用于诱导和维持轻至中度克罗恩病的缓解状态。
