Becker U, Faurschou P, Jensen J, Lindorff K, Pedersen P B, Ranløv P J
Scand J Gastroenterol. 1984 May;19(3):405-10.
In a double-blind study 83 patients with duodenal ulcers, initially healed after treatment with either 1 g cimetidine daily or 50 mg trimipramine daily, were allocated by randomization to maintenance treatment with either 400 mg cimetidine daily, 25 mg trimipramine daily, or placebo for 6 months. Monthly clinical interviews were carried out and endoscopy performed whenever the symptoms suggested ulcer relapse. After 6 months the treatment was discontinued, and the patients were observed similarly for another 6-month period. After 6 months of maintenance treatment 88% in the cimetidine group versus 55% in the trimipramine group and 53% in the placebo group remained in symptomatic remission, yielding a significant difference between the cimetidine-treated patients and the two other groups (P less than 0.05). After a further 6 months of drug-free follow-up study, the percentages were 48% versus 29% and 29% in the cimetidine, trimipramine, and placebo groups, respectively (P less than 0.05). Thus maintenance treatment with trimipramine proved no better than placebo in preventing relapses of duodenal ulcers. Second, maintenance treatment with 400 mg cimetidine daily did prevent ulcer relapse, and, third, maintenance treatment with cimetidine for 6 months did not alter the long-term course of the duodenal ulcer disease.
在一项双盲研究中，83例十二指肠溃疡患者最初分别接受每日1克西咪替丁或每日50毫克曲米帕明治疗后痊愈，然后通过随机分组接受每日400毫克西咪替丁、每日25毫克曲米帕明或安慰剂维持治疗6个月。每月进行临床访谈，每当出现症状提示溃疡复发时进行内镜检查。6个月后停止治疗，对患者进行类似观察，为期6个月。维持治疗6个月后，西咪替丁组88%的患者、曲米帕明组55%的患者和安慰剂组53%的患者仍处于症状缓解状态，西咪替丁治疗的患者与其他两组之间存在显著差异（P<0.05）。在进一步6个月的停药随访研究后，西咪替丁组、曲米帕明组和安慰剂组的百分比分别为48%、29%和29%（P<0.05）。因此，曲米帕明维持治疗在预防十二指肠溃疡复发方面并不比安慰剂更好。其次，每日400毫克西咪替丁维持治疗确实可预防溃疡复发，第三，西咪替丁维持治疗6个月并未改变十二指肠溃疡疾病的长期病程。
