Glise H, Martinson J, Solhaug J H, Carling L, Unge P, Engström G, Hallerbäck B
Dept. of Surgery, Trollhättan Hospital, Sweden.
Scand J Gastroenterol. 1991 Feb;26(2):137-45. doi: 10.3109/00365529109025023.
In a Swedish-Norwegian multicentre study patients with endoscopically verified duodenal ulcers (greater than 5 mm) were randomized to 2 or 4 weeks of treatment with either 20 mg omeprazole once daily or 300 mg ranitidine once daily. The aim was to evaluate 2 and 4 weeks' treatment with regard to symptomatic improvement during treatment, relapse after treatment, and safety of the two drugs. Endoscopy was not performed to check healing at the end of treatment. Instead the patients were instructed to contact the investigator in the event of recurrence of symptoms for renewed endoscopy. Follow-up was ended 10 weeks after stopping active treatment. Altogether 450 patients were evaluated at 17 centres. The symptomatic improvement during treatment was good in all groups, with significantly better reductions of daytime pain and heartburn in omeprazole-treated patients. Symptomatic relapse was commonest in the 2-week ranitidine group (57%), significantly more than in the 2-week omeprazole group (31%) (p less than 0.003). In the 4-week groups relapse rates were 34% (ranitidine) and 39% (omeprazole) (NS). It is suggested that in the short-term treatment of acute duodenal ulcer 20 mg omeprazole once daily is most rationally used in a 2- to 4-week regimen, whereas 300 mg ranitidine once daily should not be used for less than 4 weeks.
在一项瑞典 - 挪威多中心研究中，经内镜证实患有十二指肠溃疡（大于5毫米）的患者被随机分为两组，分别接受为期2周或4周的治疗，治疗方案为每日一次服用20毫克奥美拉唑或每日一次服用300毫克雷尼替丁。目的是评估这两种药物在治疗期间的症状改善情况、治疗后的复发情况以及安全性。治疗结束时未进行内镜检查以确认溃疡愈合情况。相反，患者被要求在症状复发时联系研究者以便重新进行内镜检查。在停止积极治疗10周后结束随访。共有450名患者在17个中心接受评估。所有组在治疗期间的症状改善情况都较好，奥美拉唑治疗的患者白天疼痛和烧心症状的减轻明显更显著。症状复发在2周雷尼替丁组最为常见（57%），显著高于2周奥美拉唑组（31%）（p < 0.003）。在4周治疗组中，复发率分别为34%（雷尼替丁）和39%（奥美拉唑）（无显著性差异）。建议在急性十二指肠溃疡的短期治疗中，每日一次服用20毫克奥美拉唑最合理的疗程为2至4周，而每日一次服用300毫克雷尼替丁的疗程不应少于4周。
