口服美沙拉嗪（颇得斯安）用于克罗恩病维持治疗：一项多中心安慰剂对照研究。消化系炎症治疗研究组（GETAID）
Oral mesalamine (Pentasa) as maintenance treatment in Crohn's disease: a multicenter placebo-controlled study. The Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives (GETAID).
作者信息
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
机构信息
Hôpital Rothschid, Paris, France.
出版信息
Gastroenterology. 1993 Feb;104(2):435-9. doi: 10.1016/0016-5085(93)90411-5.
BACKGROUND
Mesalamine provides a new therapeutic approach in treating Crohn's disease.
METHODS
To assess the efficacy and safety of slow-release mesalamine (Pentasa; Ferring AS, Vanløse, Denmark) 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 a low relapse risk strata, respectively.
RESULTS
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 ongoing 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.
CONCLUSIONS
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.
背景
美沙拉嗪为克罗恩病的治疗提供了一种新的治疗方法。
方法
为评估缓释美沙拉嗪（颇得斯安；Ferring AS公司，丹麦范洛瑟）维持克罗恩病缓解的疗效和安全性，在一项为期2年的双盲、多中心试验中，将161例病情缓解的患者随机分为两组，分别接受颇得斯安（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。
结果
短期缓解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。
结论
在缓解后3个月内给予颇得斯安（2克/天，持续2年）是克罗恩病安全有效的维持治疗方法。
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