Modigliani R, Pieddeloup C, Hecketsweiler P, Descos L, Lerebours E, Vernisse B, Costil V, Bitoun A, Lacroute J M, Maire P
Gastroenterol Clin Biol. 1983 Aug-Sep;7(8-9):683-92.
The prevention of relapse in quiescent Crohn's disease remains a major therapeutic challenge. The present study is a double blind placebo (P)-controlled, randomized, multicentre cooperative trial designed to test the effectiveness of levamisole (L) in the prophylaxis against flare up in patients with quiescent Crohn's disease. The trial included 2 successive phases: a) phase I:167 patients with inactive disease (but who had not had previous resection of all diseased tissue) were randomly and double blindly assigned to receive either L (150 mg orally once weekly) or P; patients were randomized in 2 strata: those having experienced a recent flare up (within the 3 months preceding their entry into the trial: red strata) versus others (blue strata). Patients were followed up at 3 monthly intervals during 2 years. Initially there was no significant difference between L and P groups as regard to age, sex ratio, duration of disease at the time of randomization, incidence of prior intestinal resection, Crohn's disease topography, clinical activity; biological activity was slightly but significantly higher (P less than 0.05) in the P group. Twelve patients were withdrawn from analysis (lost to follow-up: 2; inadequate respect of the protocol: 10), leaving 155 patients (78 L, 77 P) who completed the study. L did not significantly influence any of the following parameters: incidence of attacks (L: 37 p. 100; P: 35 p. 100), lag time between the entry into the trial and the occurrence of the attack (L: 32.7 +/- 5.2; P: 41.8 +/- 5.8; m +/- SEM; weeks), curves of maintenance in remission (Kaplan-Meier method), outcome rank, severity of attacks. Attempts to analyse separately certain subgroups--subjects with purely colonic (+/- anal) disease, subjects with small bowel localization (+/- anus), patients of the red or blue strata--did not show any statistical difference between L and P. Thirteen patients left the trial for minor intolerance (10 L, 3 P). b) Phase II lasted one further year and involved the patients still in remission and in the trial at the end of phase I (n = 57). Those who had received L during phase I were randomized between continuance of L (L leads to L) vs. a change to P (L leads to P); those who had been on P during phase I were randomized between continuance of P vs. a switch to L.(ABSTRACT TRUNCATED AT 400 WORDS)
静止期克罗恩病复发的预防仍是一项重大的治疗挑战。本研究是一项双盲安慰剂对照、随机、多中心合作试验，旨在测试左旋咪唑（L）预防静止期克罗恩病患者病情复发的有效性。该试验包括两个连续阶段：a）第一阶段：167例病情静止（但之前未切除所有病变组织）的患者被随机双盲分配接受L（每周口服150毫克）或安慰剂（P）；患者按两个层次随机分组：近期有病情复发者（在进入试验前3个月内：红色层次）与其他患者（蓝色层次）。在两年时间里，每3个月对患者进行一次随访。最初，L组和P组在年龄、性别比、随机分组时的病程、既往肠道切除发生率、克罗恩病病变部位、临床活动度方面无显著差异；P组的生物学活性略高但有显著差异（P<0.05）。12例患者退出分析（失访：2例；未充分遵守方案：10例），剩余155例患者（78例L组，77例P组）完成研究。L对以下任何参数均无显著影响：发作发生率（L组：37%；P组：35%）、进入试验至发作的间隔时间（L组：32.7±5.2；P组：41.8±5.8；均值±标准误；周）、缓解维持曲线（Kaplan-Meier法）、结局等级、发作严重程度。对某些亚组进行单独分析——单纯结肠（±肛门）疾病患者、小肠病变（±肛门）患者、红色或蓝色层次的患者——未显示L组和P组之间有任何统计学差异。13例患者因轻微不耐受退出试验（10例L组，3例P组）。b）第二阶段又持续了一年，纳入了在第一阶段结束时仍处于缓解期且仍在试验中的患者（n = 57）。在第一阶段接受L治疗的患者被随机分为继续接受L治疗（L组继续用L）与改为接受P治疗（L组改为P）；在第一阶段接受P治疗的患者被随机分为继续接受P治疗与改为接受L治疗。
