Sirinawasatien Apichet, Kantathavorn Nontapat
Division of Gastroenterology, Department of Medicine, Rajavithi Hospital, College of Medicine, Rangsit University, Bangkok 10400, Thailand.
Clin Exp Gastroenterol. 2019 Jul 26;12:337-347. doi: 10.2147/CEG.S214677. eCollection 2019.
The aim of this study was to compare the effect of omeprazole plus mosapride combination therapy with that of omeprazole monotherapy in proton pump inhibitor (PPI) refractory gastroesophageal reflux disease (GERD) patients.
Patients were eligible to participate in this study if they had experienced symptoms of heartburn and/or regurgitation more than twice weekly and were unresponsive to at least 8 weeks of a standard dose of PPI. A total of 44 consecutive patients were randomized to receive omeprazole 20 mg once daily plus either mosapride 5 mg or placebo three times daily for 4 weeks. We evaluated their clinical symptoms by means of frequency scale for symptoms of GERD (FSSG) questionnaires completed at the beginning and the end of the study. The primary outcome was to compare changes in FSSG scores between treatment groups during the study period.
Most of the study population had non-erosive reflux disease (91.0% in the combination group and 81.8% in the control group). The minority of patients had Los Angeles grade A or B erosive esophagitis (9% in the combination group and 18.2% in the control group). None of the patients had Los Angeles grade C or D erosive esophagitis. FSSG total scores significantly decreased both in the combination group and the control group, with no significant differences in improvement between the groups (-8.00±7.18 for the combination group versus -5.68±6.29 for the control group, =0.129). As a secondary outcome, our data showed that the effect of combination therapy on a number of symptom-free days (heartburn-free days, regurgitation-free days, and night-time heartburn-free days) was not superior to PPI monotherapy.
Combining mosapride for four weeks with a standard dose of PPI is not more effective than PPI alone in patients with PPI-refractory GERD.
本研究旨在比较奥美拉唑联合莫沙必利与奥美拉唑单药治疗质子泵抑制剂（PPI）难治性胃食管反流病（GERD）患者的疗效。
若患者每周出现烧心和/或反流症状超过两次，且对至少8周的标准剂量PPI无反应，则有资格参与本研究。共有44例连续患者被随机分为两组，一组每天一次服用20mg奥美拉唑加5mg莫沙必利，另一组每天三次服用安慰剂，为期4周。我们通过在研究开始和结束时完成的胃食管反流病症状频率量表（FSSG）问卷来评估他们的临床症状。主要结局是比较研究期间各治疗组FSSG评分的变化。
大多数研究对象患有非糜烂性反流病（联合治疗组为91.0%，对照组为81.8%）。少数患者患有洛杉矶分级A或B级糜烂性食管炎（联合治疗组为9%，对照组为18.2%）。没有患者患有洛杉矶分级C或D级糜烂性食管炎。联合治疗组和对照组的FSSG总分均显著下降，两组之间的改善情况无显著差异（联合治疗组为-8.00±7.18，对照组为-5.68±6.29，P = 0.129）。作为次要结局，我们的数据显示联合治疗对无症状天数（无烧心天数、无反流天数和无夜间烧心天数）的影响并不优于PPI单药治疗。
对于PPI难治性GERD患者，将莫沙必利与标准剂量的PPI联合使用4周并不比单独使用PPI更有效。
