Lartigue S, Corrion F, Bernades P, Bonfils S, Chevalier T, Laverdant C, Mignon M, Minaire Y, Pariente A, Vicari F
Hôpital G.-et-R.-Laennec, Nantes.
Gastroenterol Clin Biol. 1994;18(6-7):617-22.
Enprostil, a synthetic prostaglandin E2, has been shown to exert both antisecretory and mucoprotective activity. It is effective in duodenal ulcer healing. OBJECTIVE--This study was performed to compare the frequency and the delay of spontaneous duodenal ulcer relapse during a two-year follow up period after initial healing by enprostil (35 micrograms, twice a day) or ranitidine (300 mg per day). METHODS--This multicentric, double-blind, randomized study included 642 patients (324 in the enprostil group and 318 in the ranitidine group). Patients included in the follow up period were evaluated by an endoscopy at 6 months, one and two years after healing. RESULTS--After a 6 weeks treatment period, healing rate was 85% for ranitidine and 70% for enprostil, respectively (P < 0.001). Adverse effects, especially digestive ones, occurred more often with enprostil than with ranitidine (P < 0.001). After initial healing, there was no significant difference between the 2 groups concerning the cumulative rate of relapse, despite a non significant trend for a milder rate of relapse in the enprostil group (P = 0.08). Twenty-seven % of the patients randomized to treatment (intend-to-treat analysis) in the enprostil group and 29% in the ranitidine group had no ulcer recurrence 6 months after ulcer healing, and respectively 12% and 13% at 2 years (difference not statistically significant). CONCLUSIONS--It is concluded that a) ranitidine is more effective and has less adverse effects than enprostil for duodenal ulcer healing, b) after duodenal ulcer healing by enprostil, there is a non significant trend for a lower rate of relapse than after healing with ranitidine, c) there is the same proportion of patients without ulcer in the 2 groups after 6 months and 2 years.
恩前列素是一种合成前列腺素E2，已被证明具有抗分泌和黏膜保护活性。它对十二指肠溃疡愈合有效。目的——本研究旨在比较在使用恩前列素（35微克，每日两次）或雷尼替丁（每日300毫克）初步治愈后，两年随访期内十二指肠溃疡自发复发的频率和延迟情况。方法——这项多中心、双盲、随机研究纳入了642例患者（恩前列素组324例，雷尼替丁组318例）。纳入随访期的患者在愈合后6个月、1年和2年接受内镜检查评估。结果——经过6周治疗期后，雷尼替丁的愈合率为85%，恩前列素为70%，差异有统计学意义（P<0.001）。恩前列素的不良反应，尤其是消化系统不良反应，比雷尼替丁更常见（P<0.001）。初步愈合后，两组的累积复发率无显著差异，尽管恩前列素组的复发率有轻微降低的非显著趋势（P = 0.08）。恩前列素组随机接受治疗（意向性分析）的患者中，27%在溃疡愈合后6个月无溃疡复发，雷尼替丁组为29%；2年时分别为12%和13%（差异无统计学意义）。结论——得出以下结论：a）在十二指肠溃疡愈合方面，雷尼替丁比恩前列素更有效且不良反应更少；b）恩前列素治愈十二指肠溃疡后，复发率有低于雷尼替丁治愈后的非显著趋势；c）两组在6个月和2年后无溃疡患者的比例相同。
