BACKGROUND:The purpose of this study was to investigate if the use of a higher night time dose of ranitidine (300 mg) could keep significantly more duodenal ulcer patients in remission than the usual maintenance dose (150 mg).

METHODS:Double-blind, multi-centre, parallel group study of patients with proven healed duodenal ulcer randomized to ranitidine 150 mg or 300 mg daily for 1 year. The primary study end-point was symptomatic, endoscopically proven ulcer relapse.

RESULTS:A total of 489 patients were recruited into the study. The endoscopically proven relapse rates were 6.1% of ranitidine 150 mg daily (n = 250) and 6.9% on 300 mg daily (n = 239). These differences were not statistically significant.

CONCLUSION:This study provides further evidence that maintenance therapy with ranitidine 150 mg daily is highly effective at preventing duodenal ulcer relapse. The use of the higher dose of 300 mg daily does not appear to keep significantly more patients in remission.

译文

背景 : 这项研究的目的是调查是否使用较高的夜间剂量的雷尼替丁 (300 mg) 可以使十二指肠溃疡患者的缓解比通常的维持剂量 (150 mg) 明显更多。
方法 : 双盲,多中心,平行组研究,已证实已治愈的十二指肠溃疡患者随机分配给雷尼替丁150 mg或300 mg,每天1年。主要研究终点是有症状的,经内镜证实的溃疡复发。
结果 : 总共招募了489名患者。经内镜证实的复发率是雷尼替丁每天150 mg (n = 250) 和6.9% 每天300 mg (n = 239) 6.1%。这些差异在统计学上并不显着。
结论 : 这项研究提供了进一步的证据,表明每天使用雷尼替丁150 mg维持治疗可有效预防十二指肠溃疡复发。每天使用较高剂量的300 mg似乎并不能使更多的患者缓解。

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