Carling L, Unge P, Almström C, Cronstedt J, Ekström P, Hägg S, Hansson B
Scand J Gastroenterol. 1987 Apr;22(3):325-31. doi: 10.3109/00365528709078599.
The safety and efficacy of enprostil, 35 micrograms twice daily, and of cimetidine, 400 mg twice daily, in the treatment of duodenal ulcers were compared in a randomized, double-blind, parallel, multiclinic study. Endoscopy was performed before treatment and at 2-week intervals for 6 weeks or until the ulcer healed. Patients recorded their drug compliance, antacid use, ulcer symptoms, and adverse experiences daily. One hundred and six patients entered the trial, of which 104 were eligible for the initial endoscopy analysis. Base-line characteristics were similar in the two treatment groups. The cumulative healing rates in the enprostil group were 56%, 86%, and 92% at 2, 4, and 6 weeks, respectively, and those in the cimetidine group were 53%, 84%, and 90% (NS). The healing rates for nonsmokers at 6 weeks were 96% in the enprostil group and 97% in the cimetidine group, which were significantly greater than those for smokers--88% and 81%, respectively. There were no significant differences in the duration, severity, or frequency of daytime or nighttime pain between the groups. Seventeen of the enprostil patients (32%) reported 21 adverse experiences during the trial, and 20 of the cimetidine patients (39%) reported 23 adverse experiences. No patients withdrew because of adverse experiences. The two drugs were similarly safe and effective in the treatment of duodenal ulcer.
在一项随机、双盲、平行、多中心研究中，比较了每天两次服用35微克恩前列素和每天两次服用400毫克西咪替丁治疗十二指肠溃疡的安全性和有效性。治疗前及治疗后每2周进行一次内镜检查，持续6周或直至溃疡愈合。患者每天记录其药物依从性、抗酸剂使用情况、溃疡症状及不良反应。106例患者进入试验，其中104例符合初始内镜分析条件。两个治疗组的基线特征相似。恩前列素组在2周、4周和6周时的累积愈合率分别为56%、86%和92%，西咪替丁组分别为53%、84%和90%（无显著性差异）。6周时，恩前列素组非吸烟者的愈合率为96%，西咪替丁组为97%，均显著高于吸烟者，吸烟者的愈合率分别为88%和81%。两组间白天或夜间疼痛的持续时间、严重程度或频率无显著差异。恩前列素组有17例患者（32%）在试验期间报告了21次不良反应，西咪替丁组有20例患者（39%）报告了23次不良反应。无患者因不良反应退出试验。两种药物在治疗十二指肠溃疡方面安全性和有效性相似。
