Gendre J P, Mary J Y, Florent C, Modigliani R, Colombel J F, Soulé J C, Galmiche J P, Lerebours E, Descos L, Viteau J M
Hôpital Rothschild, Paris.
Ann Gastroenterol Hepatol (Paris). 1993 Oct;29(5):251-6.
Mesalamine provides a new therapeutic approach in treating Crohn's disease.
To assess the efficacy and safety of slow-release mesalamine (Pentasa) in maintaining remission in Crohn's disease, 161 patients with inactive disease were randomized to receive either Pentasa (2 g/day) or placebo in a 2-year double-blind, multicenter trial. Two strata were defined according to the duration of their remission: < 3 months (n = 64) or 3-24 months (n = 97), presumed to be high and low relapse risk strata, respectively.
The probability of relapse was higher in the short-remission placebo group than in the three other groups (p < 0.003), showing there was a significant benefit from Pentasa in the high relapse risk stratum. In this stratum, the 2-year on-going remission rate was of 29% +/- 9% and 45% +/- 11% (mean +/- SD) in the placebo and Pentasa groups, respectively. The incidences of side effects were similar in both groups.
Pentasa (2 g/day for 2 years) is a safe and effective maintenance treatment for Crohn's disease when given within 3 months of achieving remission.
美沙拉嗪为克罗恩病的治疗提供了一种新的治疗方法。
为评估缓释美沙拉嗪（颇得斯安）在维持克罗恩病缓解方面的疗效和安全性，161例病情缓解的患者在一项为期2年的双盲、多中心试验中被随机分为接受颇得斯安（2克/天）或安慰剂治疗。根据缓解持续时间定义了两个分层：<3个月（n = 64）或3 - 24个月（n = 97），分别假定为高复发风险分层和低复发风险分层。
短缓解期安慰剂组的复发概率高于其他三组（p < 0.003），表明在高复发风险分层中颇得斯安有显著益处。在该分层中，安慰剂组和颇得斯安组的2年持续缓解率分别为29%±9%和45%±11%（均值±标准差）。两组的副作用发生率相似。
在达到缓解后3个月内给予颇得斯安（2克/天，持续2年）是治疗克罗恩病安全有效的维持疗法。
