Euler A R, Tytgat G, Berenguer J, Brunner H, Wood D R, Lookabaugh J L, Phan T D
Gastroenterology. 1987 Mar;92(3):604-7. doi: 10.1016/0016-5085(87)90007-2.
Previous therapeutic trials with prostaglandins have shown them to be effective in healing duodenal ulcers when used at doses that are highly effective suppressors of gastric acid secretion. We undertook this trial to determine if a cytoprotective dose of arbaprostil (10 micrograms q.i.d. for 4 wk) would also be efficacious in this disease state. Eighty-two patients between the ages of 19 and 72 yr with endoscopically documented duodenal ulcers were entered into this randomized double-blind placebo-controlled trial. The patients were monitored with biweekly endoscopies and laboratory examinations, weekly interviews during the period when drug was administered, and a follow-up interview plus laboratory examinations 1 wk after drug administration was completed. No statistically significant differences between the arbaprostil and placebo treatment groups were found for ulcer healing rates, pain relief, antacid consumption, side effects, or laboratory examinations. It is presumed that this prostaglandin may not have sufficient duodenal cytoprotective capacity to effectively heal duodenal ulcers, or that some suppression of gastric acid secretion may be required to achieve significant clinical efficacy.
以往使用前列腺素的治疗试验表明，当以能高效抑制胃酸分泌的剂量使用时，它们对十二指肠溃疡的愈合有效。我们进行这项试验是为了确定细胞保护剂量的阿巴前列素（每日4次，每次10微克，共4周）在这种疾病状态下是否也有效。82名年龄在19岁至72岁之间、经内镜检查证实患有十二指肠溃疡的患者进入了这项随机双盲安慰剂对照试验。对患者进行每两周一次的内镜检查和实验室检查、给药期间每周一次的访谈，以及在给药结束后1周进行一次随访访谈和实验室检查。在溃疡愈合率、疼痛缓解、抗酸剂消耗量、副作用或实验室检查方面，未发现阿巴前列素治疗组和安慰剂治疗组之间存在统计学上的显著差异。据推测，这种前列腺素可能没有足够的十二指肠细胞保护能力来有效治愈十二指肠溃疡，或者可能需要抑制胃酸分泌才能取得显著的临床疗效。
