Labenz J, Wegener M, Adamek R J, Opferkuch W, Rühl G H, Börsch G
Elisabeth-Krankenhaus, Medizinische Klinik, Essen.
Leber Magen Darm. 1994 Mar;24(2):73-5.
Thirty-five consecutive patients (median age: 50 years, 17 men and 18 women) suffering from Helicobacter pylori associated peptic ulcer disease (duodenal ulcer: n = 15, gastric ulcer: n = 13) or severe functional dyspepsia (n = 7) were enrolled in a two-center clinical trial and treated with omeprazole 20 mg bid preprandially and roxithromycin 300 mg bid postprandially over two weeks. After cessation of the study medication, ulcer patients received a full dose H2-blocker treatment up to the final examination four weeks later. All patients completed the trial without contravening the protocol. Side effects were not recorded. The overall proportion of cure of Helicobacter pylori-infection was 29% (10 out of 35 patients) without statistically significant difference between the two participating centers (center I: 7 out of 20 patients [35%], center II: 3 out of 15 patients [20%]; p = 0.33). We conclude from our results that omeprazole plus roxithromycin is an ineffective treatment schedule with regard to cure of H.pylori-infection in patients with peptic ulcer disease or dyspepsia.
连续35例幽门螺杆菌相关性消化性溃疡疾病(十二指肠溃疡:n = 15,胃溃疡:n = 13)或重度功能性消化不良(n = 7)患者(中位年龄:50岁,男性17例,女性18例)被纳入一项双中心临床试验,并在两周内接受餐前口服20 mg奥美拉唑每日两次和餐后口服300 mg罗红霉素每日两次的治疗。在停止研究用药后,溃疡患者接受全剂量H2受体阻滞剂治疗直至四周后的最终检查。所有患者均完成试验且未违反方案。未记录到副作用。幽门螺杆菌感染的总体治愈率为29%(35例患者中的10例),两个参与中心之间无统计学显著差异(中心I:20例患者中的7例[35%],中心II:15例患者中的3例[20%];p = 0.33)。我们从结果中得出结论,对于消化性溃疡疾病或消化不良患者,奥美拉唑联合罗红霉素在治愈幽门螺杆菌感染方面是一种无效的治疗方案。