Hawkey C J, Long R G, Bardhan K D, Wormsley K G, Cochran K M, Christian J, Moules I K
Department of Therapeutics, University Hospital, Nottingham.
Gut. 1993 Oct;34(10):1458-62. doi: 10.1136/gut.34.10.1458.
The purpose of this study was to compare duodenal ulcer healing, symptom relief, and safety of lansoprazole (a new proton pump inhibitor) given at doses of 30 mg and 60 mg, in the morning with ranitidine 300 mg at bedtime. Two hundred and eighty nine patients were enrolled over a 20 month period in a double blind randomised parallel group comparative study set in outpatient endoscopy units of six United Kingdom medical centres. Patients were randomised to receive lansoprazole 30 mg in the morning (n = 95), 60 mg in the morning (n = 96), or ranitidine 300 mg at bedtime (n = 98) for four weeks. Efficacy was assessed by gastroscopy at study entry and after two and four weeks of treatment. Symptom relief was monitored by patient diaries and physician review at two and four weeks. Both doses of lansoprazole resulted in significantly greater ulcer healing than ranitidine after two and four weeks. Respective healing rates on lansoprazole 30 mg, 60 mg, and ranitidine 300 mg were 78%, 80%, and 60% after two weeks and 93%, 97%, and 81% after four weeks. Patients on lansoprazole 30 mg (p = 0.002) and lansoprazole 60 mg (p = 0.026) also recorded greater relief of night time pain in the diary cards during the first seven days of treatment than those on ranitidine. Patients on lansoprazole 60 mg reported significantly better pain relief at their two week visit compared with those receiving ranitidine (p = 0.007). There were no differences between treatment groups in the occurrence or pattern of adverse drug reactions during the trial. It is concluded that for patients with duodenal ulcer, lansoprazole 30 mg or 60 mg is associated with faster ulcer healing and better symptom relief than ranitidine 300 mg at bedtime. There were no significant differences between lansoprazole 30 mg and 60 mg. These data indicate that lansoprazole should be used at a once daily dose of 30 mg for the treatment of duodenal ulcer.
本研究旨在比较晨起服用30毫克和60毫克剂量的兰索拉唑（一种新型质子泵抑制剂）与睡前服用300毫克雷尼替丁在十二指肠溃疡愈合、症状缓解及安全性方面的差异。在英国六个医疗中心的门诊内镜科室进行的一项为期20个月的双盲随机平行组对照研究中，共招募了289名患者。患者被随机分为三组，分别为晨起服用30毫克兰索拉唑（n = 95）、晨起服用60毫克兰索拉唑（n = 96）或睡前服用300毫克雷尼替丁（n = 98），疗程为四周。在研究开始时以及治疗两周和四周后通过胃镜评估疗效。在治疗两周和四周时通过患者日记及医生复查监测症状缓解情况。治疗两周和四周后，两种剂量的兰索拉唑导致的溃疡愈合均显著优于雷尼替丁。服用30毫克兰索拉唑、60毫克兰索拉唑和300毫克雷尼替丁的患者在两周后的愈合率分别为78%、80%和60%，四周后的愈合率分别为93%、97%和81%。在治疗的前七天，服用30毫克兰索拉唑（p = 0.002）和60毫克兰索拉唑（p = 0.026）的患者在日记卡上记录的夜间疼痛缓解程度也高于服用雷尼替丁的患者。在两周的复诊时，服用60毫克兰索拉唑的患者报告的疼痛缓解情况明显优于服用雷尼替丁的患者（p = 0.007）。试验期间，各治疗组在药物不良反应的发生情况或模式上没有差异。结论是，对于十二指肠溃疡患者，晨起服用30毫克或60毫克兰索拉唑比睡前服用300毫克雷尼替丁能更快促进溃疡愈合且症状缓解更好。30毫克和60毫克兰索拉唑之间没有显著差异。这些数据表明，兰索拉唑治疗十二指肠溃疡的每日剂量应为30毫克。
