Archambault A P, Pare P, Bailey R J, Navert H, Williams C N, Freeman H J, Baker S J, Marcon N E, Hunt R H, Sutherland L
Centre de Gastro-enterologie et d'Endoscopie de Montreal, Canada.
Gastroenterology. 1988 May;94(5 Pt 1):1130-4. doi: 10.1016/0016-5085(88)90003-0.
We conducted a double-blind, randomized, parallel group study in 169 patients with acute duodenal ulcers to compare omeprazole, 20 mg daily, with cimetidine, 600 mg twice daily. After 2 wk, 58% of the omeprazole-treated patients and 46% of the cimetidine-treated patients were completely healed (p = 0.056). After 4 and 6 wk 84% and 88% healed with omeprazole, and 80% and 89% healed with cimetidine (p = NS). After 2 wk, pain was completely gone in 62% of the omeprazole-treated patients versus 46% of the cimetidine-treated patients (p = 0.04). Clinical or laboratory adverse events were reported in 6 (7%) of the omeprazole-treated patients and 11 (13%) of the cimetidine-treated patients (p = NS). An adverse event caused withdrawal of 1 patient on omeprazole (anxiety and depression) and 2 patients on cimetidine (diarrhea and fall in hemoglobin). We conclude that omeprazole (20 mg daily) resulted in a trend toward more rapid ulcer healing compared with a relatively high dose of cimetidine (600 mg b.i.d.), and was preferred by patients for relief of ulcer pain.
我们对169例急性十二指肠溃疡患者进行了一项双盲、随机、平行组研究,以比较每日20毫克的奥美拉唑与每日两次600毫克的西咪替丁。2周后,接受奥美拉唑治疗的患者中有58%完全愈合,接受西咪替丁治疗的患者中有46%完全愈合(p = 0.056)。4周和6周后,接受奥美拉唑治疗的患者愈合率分别为84%和88%,接受西咪替丁治疗的患者愈合率分别为80%和89%(p = 无显著差异)。2周后,接受奥美拉唑治疗的患者中有62%疼痛完全消失,而接受西咪替丁治疗的患者中这一比例为46%(p = 0.04)。接受奥美拉唑治疗的患者中有6例(7%)报告了临床或实验室不良事件,接受西咪替丁治疗的患者中有11例(13%)报告了此类事件(p = 无显著差异)。1例接受奥美拉唑治疗的患者(焦虑和抑郁)以及2例接受西咪替丁治疗的患者(腹泻和血红蛋白下降)因不良事件退出研究。我们得出结论,与相对高剂量的西咪替丁(每日两次600毫克)相比,奥美拉唑(每日20毫克)有使溃疡愈合更快的趋势,并且在缓解溃疡疼痛方面更受患者青睐。