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Abstract：
OBJECTIVE: To compare the efficacy and safety of omeprazole-domperidone combination vs omeprazole monotherapy in gastroesophageal reflux disease (GERD).
METHODS: In a comparative, randomized controlled, phase 4 study, outpatients with GERD were randomly allocated to either group 1 (omeprazole 20 mg + domperidone 30 mg) or group 2 (omeprazole 20 mg) in an equal ratio; 2 capsules daily in the morning were administered for 8 weeks.
RESULTS: Sixty patients were enrolled. Esophagitis reversal was observed in 92% patients in group 1 vs 65.2% in group 2. Approximately, 83.3% patients in group 1 vs 43.3% patients in group 2 demonstrated full cupping of reflux symptoms at 8 weeks. Combined therapy resulted in significantly longer period of heartburn-free days (23 vs 12 days on omeprazole). There were no safety concerns.
CONCLUSIONS: Omeprazole-domperidone combination was more effective than omeprazole alone in providing complete cupping of reflux symptoms and healing of esophagitis in patients with GERD. Both the treatments were well tolerated with few reports of adverse events.
BACKGROUND: This trial is registered with http://clinicaltrials.gov, number NCT02140073.
METHODS: In a comparative, randomized controlled, phase 4 study, outpatients with GERD were randomly allocated to either group 1 (omeprazole 20 mg + domperidone 30 mg) or group 2 (omeprazole 20 mg) in an equal ratio; 2 capsules daily in the morning were administered for 8 weeks.
RESULTS: Sixty patients were enrolled. Esophagitis reversal was observed in 92% patients in group 1 vs 65.2% in group 2. Approximately, 83.3% patients in group 1 vs 43.3% patients in group 2 demonstrated full cupping of reflux symptoms at 8 weeks. Combined therapy resulted in significantly longer period of heartburn-free days (23 vs 12 days on omeprazole). There were no safety concerns.
CONCLUSIONS: Omeprazole-domperidone combination was more effective than omeprazole alone in providing complete cupping of reflux symptoms and healing of esophagitis in patients with GERD. Both the treatments were well tolerated with few reports of adverse events.
BACKGROUND: This trial is registered with http://clinicaltrials.gov, number NCT02140073.
摘要：
目的：比较奥美拉唑联合多潘立酮与奥美拉唑单药治疗胃食管反流病（GERD）的疗效和安全性。
方法：在比较中，随机对照,第四阶段研究，GERD门诊患者按等比例随机分为第1组(奥美拉唑20mg+多潘立酮30mg)或第2组(奥美拉唑20mg);每天早晨给药2粒,共8周.
结果：纳入60例患者。在第1组92％的患者中观察到食管炎逆转，在第2组中观察到65.2％。大约,第1组83.3%的患者与第2组43.3%的患者在第8周时表现出完全拔罐的反流症状。联合治疗导致无胃灼热天数明显延长（奥美拉唑治疗23天vs12天）。没有安全问题。
结论：奥美拉唑-多潘立酮联合用药在GERD患者的反流症状完全拔罐和食管炎愈合方面比奥美拉唑单独用药更有效。两种治疗均具有良好的耐受性，很少有不良事件报告。
背景：此试验已在http://clinicaltrials.gov注册，编号NCT02140073。
方法：在比较中，随机对照,第四阶段研究，GERD门诊患者按等比例随机分为第1组(奥美拉唑20mg+多潘立酮30mg)或第2组(奥美拉唑20mg);每天早晨给药2粒,共8周.
结果：纳入60例患者。在第1组92％的患者中观察到食管炎逆转，在第2组中观察到65.2％。大约,第1组83.3%的患者与第2组43.3%的患者在第8周时表现出完全拔罐的反流症状。联合治疗导致无胃灼热天数明显延长（奥美拉唑治疗23天vs12天）。没有安全问题。
结论：奥美拉唑-多潘立酮联合用药在GERD患者的反流症状完全拔罐和食管炎愈合方面比奥美拉唑单独用药更有效。两种治疗均具有良好的耐受性，很少有不良事件报告。
背景：此试验已在http://clinicaltrials.gov注册，编号NCT02140073。
