Diaz de Rojas F, Berenguer J, Rodrigo L, Aran-Suau R, Da Silveira J C, Clerch L, Garcia Aparicio P, Caswell C
Schering-Plough, Madrid, Spain.
Dig Dis Sci. 1998 Sep;43(9):1964-9. doi: 10.1023/a:1018882425236.
In most patients duodenal ulcer is a chronic relapsing disease. If no active maintenance treatment or eradication therapy is given after healing, around 70-100% of patients have a relapse during the first year. We conducted a double-blind multicenter study in 472 patients with duodenal ulcer. They were treated with omeprazole 20 mg every morning for four or eight weeks and when healed were randomly allocated to maintenance treatment with either omeprazole 20 mg every morning or ranitidine 150 mg at bedtime for up to six months. The patients were assessed by endoscopy at monthly intervals until healing occurred. Thereafter scheduled endoscopy was carried out after 1, 3, and 6 months of maintenance treatment or immediately in the event of a suspected relapse. Healing status (intention to treat approach) was 87% at four weeks and 93% at eight weeks. At six months the estimated remission rate was 90% for omeprazole and 82% for ranitidine (P = 0.03, 95% CI 1-15%). The incidence of adverse events was similar during the two maintenance treatments. Treatment with omeprazole 20 mg every morning maintained significantly more patients in remission than treatment with ranitidine 150 mg at bedtime.
在大多数患者中，十二指肠溃疡是一种慢性复发性疾病。如果在愈合后不给予积极的维持治疗或根除治疗，约70 - 100%的患者在第一年就会复发。我们对472例十二指肠溃疡患者进行了一项双盲多中心研究。他们每天早晨服用20毫克奥美拉唑，疗程为四周或八周，愈合后被随机分配至维持治疗组，一组每天早晨服用20毫克奥美拉唑，另一组睡前服用150毫克雷尼替丁，为期最长六个月。每月通过内镜检查对患者进行评估，直至愈合。此后，在维持治疗1、3和6个月后或怀疑复发时立即进行定期内镜检查。四周时愈合率（意向性治疗分析）为87%，八周时为93%。六个月时，奥美拉唑的估计缓解率为90%，雷尼替丁为82%（P = 0.03，95%可信区间1 - 15%）。两种维持治疗期间不良事件的发生率相似。每天早晨服用20毫克奥美拉唑维持缓解的患者明显多于睡前服用150毫克雷尼替丁的患者。
