Glatzel Dirk, Abdel-Qader Muwafeg, Gatz Gudrun, Pfaffenberger Bernd
Hanover, Germany.
Digestion. 2007;75 Suppl 1:69-78. doi: 10.1159/000101085. Epub 2007 May 4.
BACKGROUND/AIM: Little is known about the symptom course during and after treatment of gastroesophageal reflux disease (GERD). Here we address this question in patients with erosive GERD treated with pantoprazole or esomeprazole 40 mg once daily using the validated reflux questionnaire ReQuest.
Of 585 patients enrolled, 561 (intention-to-treat; ITT) patients with endoscopically confirmed GERD grades A-D (Los Angeles Classification) were randomized. To assess the GERD symptomatology, the patients completed the ReQuest daily, and analysis was done prior to (7 days), during (28 days), and after treatment (7 days). The mean scores (last 3 treatment days) of the subscale ReQuest(TM)-GI (gastrointestinal complaints) were compared between both groups. After the end of treatment, the number of symptom episodes and the rate of relapses were calculated.
Noninferiority of pantoprazole versus esomeprazole during treatment was shown (mean ReQuest-GI score). During the posttreatment period, the proportion of patients experiencing a symptomatic relapse (51 vs. 61%, p = 0.0216, ITT) and the number of symptom episodes (0.56 vs. 0.74, p = 0.0095, ITT) were significantly lower on pantoprazole than on esomeprazole.
Pantoprazole 40 mg was at least as effective as esomeprazole 40 mg for relieving GERD symptoms. During the posttreatment phase, patients on pantoprazole had a significantly lower risk to relapse and experienced significantly fewer symptom episodes.
背景/目的:关于胃食管反流病(GERD)治疗期间及治疗后的症状进程,人们了解甚少。在此,我们使用经过验证的反流问卷ReQuest,针对每日服用40mg泮托拉唑或埃索美拉唑治疗的糜烂性GERD患者解决这一问题。
在纳入的585例患者中,561例(意向性治疗;ITT)经内镜确诊为GERD A - D级(洛杉矶分类法)的患者被随机分组。为评估GERD症状,患者每日完成ReQuest问卷,在治疗前(7天)、治疗期间(28天)及治疗后(7天)进行分析。比较两组间ReQuest(TM)-GI(胃肠道不适)子量表的平均得分(治疗的最后3天)。治疗结束后,计算症状发作次数和复发率。
显示治疗期间泮托拉唑不劣于埃索美拉唑(平均ReQuest - GI得分)。在治疗后阶段,泮托拉唑组出现症状复发的患者比例(51%对61%,p = 0.0216,ITT)和症状发作次数(0.56对0.74,p = 0.0095,ITT)均显著低于埃索美拉唑组。
40mg泮托拉唑在缓解GERD症状方面至少与40mg埃索美拉唑一样有效。在治疗后阶段,服用泮托拉唑的患者复发风险显著更低,症状发作次数也显著更少。