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奥美拉唑(Omeprazole,OME)是壁细胞质子泵强效抑制剂。本研究以安慰剂为对照,比较间歇OME(每周末每日口服20mg连续三天)与维持OME治疗(每日10mg)6个月以预防十二指肠溃疡(DU)复发的疗效。方法:195例经内镜证实DU直径大于5mm和曾接受OME治疗2~8周后溃疡获得愈合的18~80岁门诊病人随机被分为每日口服OME 20mg每周末连续三天、每日口服OME 10mg和安慰剂治疗三组,疗程为6个月。病人在本研究期间反复作血清胃泌素、内镜和胃泌酸区粘膜活组织检查。研究结束时内镜检查发现溃疡复发或某周内出现三天或三天以上中、重度溃疡样疼痛则判为复发。结果:安慰剂组病人缓解率显著低于OME组,OME 10mg组缓解率低于OME 20mg组,但差异无统计学意义。各组吸烟者复发率都较高,但也无显著差异。多数复发性溃疡均有症状,安慰剂组有较多病人出现溃疡症状而内镜检查未发现溃疡。3、6月时内镜证实溃疡复发率在OME 20mg组分别为16%、23%,OME 10mg组为21%、27%安慰剂组为50%、67%。
Omeprazole (OME) is a potent inhibitor of parietal proton pump. In this study, placebo was used as a control to compare the efficacy of intermittent OME (oral administration of 20 mg daily for three consecutive days each weekend) with maintenance OME (10 mg daily) for 6 months to prevent recurrence of duodenal ulcer (DU). METHODS: A total of 195 outpatients 18 to 80 years of age with ulcer healing greater than 5 mm in diameter and 2 to 8 weeks after having undergone OME were randomized to receive OME 20 mg orally daily for 3 consecutive days daily for oral administration orally OME 10mg and placebo treatment of three groups, treatment for 6 months. Patients were repeatedly treated with serum gastrin, endoscopic and gastrocampal mucosal biopsies during the study. End of the study endoscopy found ulcer recurrence or within a week or three days more than three days, severe ulcer-like pain is judged as recurrence. Results: The response rate in placebo group was significantly lower than that in OME group. The response rate in OME 10 mg group was lower than that in OME 20 mg group, but the difference was not statistically significant. The recurrence rate of smokers in each group was higher, but no significant difference. Most recurrent ulcers have symptoms, placebo group, there are more patients with ulcer symptoms and no ulcers detected by endoscopy. Endoscopy at 3 and 6 months confirmed that ulcer recurrence rates were 16% and 23% in the 20 mg OME group, 21% in the OME 10 mg group and 50% and 67% in the 27% placebo group.