Scholten T, Gatz G, Hole U
University of Witten-Herdecke, General Hospital Hagen, Germany; and ALTANA Pharma, Konstanz, Germany.
Aliment Pharmacol Ther. 2003 Sep 15;18(6):587-94. doi: 10.1046/j.1365-2036.2003.01745.x.
To compare the efficacy of pantoprazole and esomeprazole for the treatment of gastro-oesophageal reflux disease- (GERD-) related symptoms.
In this multicentre, randomized, double-blind study 217 patients [intention-to-treat (ITT) population] diagnosed with endoscopically proven GERD grade B/C received pantoprazole (40 mg once daily (o.d.), n = 112] or esomeprazole (40 mg o.d/, n = 105) for 4 weeks. Patients recorded GERD-related symptoms (daytime and night-time) using diaries (daily), and/or by telephone interviews (every third day) and completed the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. The area under the time curve (AUC) for the sum score of GERD-related symptoms (symptom load of each patient during the treatment) and the time to reach adequate relief from GERD-related symptoms were calculated.
Patients reported first adequate relief from daytime GERD-related symptoms after a mean of 3.7 (pantoprazole) and 5.9 days (esomeprazole) (P = 0.034); the values for the night-time were 1.7 and 3.5 days, respectively (P = 0.012, ITT). The AUCs for the single symptoms and the sum scores were comparable.
Treatment with pantoprazole resulted in significantly faster first-time relief from daytime and night-time GERD-related symptoms than esomeprazole. Pantoprazole and esomeprazole were similar with respect to reduction of load of GERD-related symptoms.
比较泮托拉唑和埃索美拉唑治疗胃食管反流病(GERD)相关症状的疗效。
在这项多中心、随机、双盲研究中,217例经内镜证实为B/C级GERD的患者[意向性治疗(ITT)人群]接受泮托拉唑(40mg每日一次,n = 112)或埃索美拉唑(40mg每日一次,n = 105)治疗4周。患者通过日记(每日)和/或电话访谈(每三天一次)记录GERD相关症状(白天和夜间),并完成胃肠道症状评分量表(GSRS)问卷。计算GERD相关症状总分的时间曲线下面积(AUC)(每位患者治疗期间的症状负荷)以及达到GERD相关症状充分缓解的时间。
患者报告白天GERD相关症状首次充分缓解的平均时间分别为3.7天(泮托拉唑)和5.9天(埃索美拉唑)(P = 0.034);夜间分别为1.7天和3.5天(P = 0.012,ITT)。单个症状和总分的AUC具有可比性。
与埃索美拉唑相比,泮托拉唑治疗能显著更快地首次缓解白天和夜间GERD相关症状。泮托拉唑和埃索美拉唑在减轻GERD相关症状负荷方面相似。