Labenz J, Rühl G H, Bertrams J, Börsch G
Department of Internal Medicine, Elisabeth Hospital, Essen, Germany.
Dig Dis Sci. 1994 Jul;39(7):1483-7. doi: 10.1007/BF02088052.
The purpose of the present study was to investigate the Helicobacter pylori eradication potency of combined amoxicillin-omeprazole treatment in patients with duodenal ulcer disease and to compare the efficacy of two omeprazole and amoxicillin doses concerning H. pylori eradication, ulcer healing, pain relief, and safety. Ninety patients with active H. pylori-positive (culture and/or histology) duodenal ulcer disease were randomly treated with either omeprazole 20 mg twice a day plus amoxicillin 1 g twice a day (group I, N = 30), omeprazole 40 mg twice a day plus amoxicillin 1 g twice a day (group II, N = 30), or omeprazole 40 mg twice a day plus amoxicillin 1 g three times a day (group III, N = 30) over two weeks, followed by ranitidine at bedtime for another four weeks. The overall proportion of H. pylori eradication was 83% and of ulcer healing 92% without statistically significant differences between the study groups. Complete pain relief occurred after a median of one day in all groups. Six patients complained of side effects during the therapy phase, which led to therapy discontinuation in one female patient. In conclusion, omeprazole plus amoxicillin is a highly effective and well-tolerated therapy regimen to eradicate H. pylori in duodenal ulcer disease. In addition, the results suggest that there is no clear dose-response relation between the dosages of omeprazole and amoxicillin used in this study on the one hand and the H. pylori eradication rates on the other.
本研究的目的是调查阿莫西林联合奥美拉唑治疗十二指肠溃疡疾病患者时根除幽门螺杆菌的效力,并比较两种奥美拉唑和阿莫西林剂量在根除幽门螺杆菌、溃疡愈合、疼痛缓解及安全性方面的疗效。90例活动性幽门螺杆菌阳性(培养和/或组织学检查)的十二指肠溃疡疾病患者被随机分为三组,分别接受以下治疗:每日两次,每次20毫克奥美拉唑加每日两次,每次1克阿莫西林(第一组,N = 30);每日两次,每次40毫克奥美拉唑加每日两次,每次1克阿莫西林(第二组,N = 30);或每日两次,每次40毫克奥美拉唑加每日三次,每次1克阿莫西林(第三组,N = 30),为期两周,随后在睡前服用雷尼替丁,持续四周。幽门螺杆菌的总体根除率为83%,溃疡愈合率为92%,各研究组之间无统计学显著差异。所有组中,疼痛在中位数一天后完全缓解。6例患者在治疗阶段出现副作用,其中一名女性患者因此停止治疗。总之,奥美拉唑加阿莫西林是根除十二指肠溃疡疾病中幽门螺杆菌的一种高效且耐受性良好的治疗方案。此外,结果表明,本研究中使用的奥美拉唑和阿莫西林剂量一方面与幽门螺杆菌根除率之间没有明确的剂量反应关系。