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低剂量抗酸剂或西咪替丁治疗良性胃溃疡。一项双盲、随机、安慰剂对照试验。

Healing of benign gastric ulcer with low-dose antacid or cimetidine. A double-blind, randomized, placebo-controlled trial.

作者信息

Isenberg J I, Peterson W L, Elashoff J D, Sandersfeld M A, Reedy T J, Ippoliti A F, Van Deventer G M, Frankl H, Longstreth G F, Anderson D S

出版信息

N Engl J Med. 1983 Jun 2;308(22):1319-24. doi: 10.1056/NEJM198306023082203.

Abstract

We conducted a 12-week, double-blind, randomized, placebo-controlled trial to determine whether cimetidine (300 mg with meals and at bedtime) or a convenient, liquid aluminum-magnesium antacid regimen (15 ml one hour after meals and at bedtime) would expedite healing or relief of symptoms in patients with benign gastric ulcer. Of the 101 patients who completed the trial according to protocol, 32 received the antacid, 36 cimetidine, and 33 placebo. At 4, 8, and 12 weeks after entry, ulcers had healed in a larger percentage of patients treated with cimetidine than of those treated with placebo: 53, 86, and 89 per cent of the cimetidine group versus 26, 58, and 70 per cent of the placebo group (P = 0.02, 0.01, 0.05), respectively. Healing at the three intervals had occurred in 38, 70, and 84 per cent, respectively, of the antacid-treated patients. Neither cimetidine nor antacid was more effective than placebo in relieving symptoms. The presence or absence of symptoms during the fourth and eighth treatment weeks was a poor predictor of the presence of absence of an ulcer crater. We conclude that cimetidine significantly hastens the healing of benign gastric ulcer.

摘要

我们进行了一项为期12周的双盲、随机、安慰剂对照试验,以确定西咪替丁(每餐及睡前服用300毫克)或方便的液体铝镁抗酸剂方案(餐后1小时及睡前服用15毫升)是否能加速良性胃溃疡患者的溃疡愈合或缓解症状。在按照方案完成试验的101例患者中,32例接受抗酸剂治疗,36例接受西咪替丁治疗,33例接受安慰剂治疗。在入组后的第4、8和12周,接受西咪替丁治疗的患者溃疡愈合的比例高于接受安慰剂治疗的患者:西咪替丁组分别为53%、86%和89%,而安慰剂组分别为26%、58%和70%(P值分别为0.02、0.01、0.05)。抗酸剂治疗的患者在这三个时间点的愈合率分别为38%、70%和84%。在缓解症状方面,西咪替丁和抗酸剂均不比安慰剂更有效。在治疗的第4周和第8周有无症状并不能很好地预测有无溃疡 crater。我们得出结论,西咪替丁能显著加速良性胃溃疡的愈合。

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