Fock K M, Teo E K, Ang T L, Chua T S, Ng T M, Tan Y L
Division of Gastroenterology, Department of Medicine, Changi General Hospital, 2 Simei Street 3, 529889 Singapore.
World J Gastroenterol. 2005 May 28;11(20):3091-8. doi: 10.3748/wjg.v11.i20.3091.
Gastro-esophageal reflux disease (GERD) is becoming increasingly common in Asia. Data on the efficacy of proton pump inhibitors in patients with non-erosive GERD (NERD) in Asia is lacking. This double-blind study compared the efficacy and safety of rabeprazole with esomeprazole in relief of symptoms in patients with NERD.
One hundred and thirty-four patients with reflux symptoms of NERD and normal endoscopy were randomized to receive rabeprazole 10 mg or esomeprazole 20 mg once daily for 4 wk. Symptoms were recorded in a diary and changes in severity of symptoms noted.
At 4 wk of treatment, rabeprazole 10 mg and esomeprazole 20 mg were comparable with regards to the primary endpoint of time to achieve 24-h symptom-free interval for heartburn 8.5 d vs 9 d and regurgitation 6 d vs 7.5 d. Rabeprazole and esomeprazole were also similarly efficacious in term of patient's global evaluation with 96% of patients on rabeprazole and 87.9% of patients on esomeprazole, reporting that symptoms improved (P = NS). Satisfactory relief of day- and night-time symptoms was achieved in 98% of patients receiving rabeprazole and 81.4% of patients receiving esomeprazole. Adverse events were comparable in both groups (P = NS).
Rabeprazole 10 mg has a similar efficacy and safety profile in Asians with NERD as esomeprazole 20 mg. Further study is necessary to investigate whether the small differences between the two drugs seen in this study are related to the improved pharmacodynamic properties of rabeprazole. Both drugs were well tolerated.
胃食管反流病（GERD）在亚洲正变得越来越普遍。亚洲缺乏关于质子泵抑制剂对非糜烂性GERD（NERD）患者疗效的数据。这项双盲研究比较了雷贝拉唑和埃索美拉唑缓解NERD患者症状的疗效和安全性。
134例有反流症状且内镜检查正常的NERD患者被随机分为两组，分别每日一次服用10mg雷贝拉唑或20mg埃索美拉唑，疗程4周。症状记录在日记中，并记录症状严重程度的变化。
治疗4周时，就实现烧心24小时无症状间隔的主要终点而言，10mg雷贝拉唑和20mg埃索美拉唑相当（分别为8.5天和9天），反流方面也相当（分别为6天和7.5天）。在患者总体评估方面，雷贝拉唑和埃索美拉唑的疗效也相似，服用雷贝拉唑的患者中有96%、服用埃索美拉唑的患者中有87.9%报告症状改善（P=无显著性差异）。接受雷贝拉唑治疗的患者中有98%、接受埃索美拉唑治疗的患者中有81.4%的白天和夜间症状得到满意缓解。两组的不良事件相当（P=无显著性差异）。
10mg雷贝拉唑在亚洲NERD患者中的疗效和安全性与20mg埃索美拉唑相似。有必要进一步研究本研究中所见两种药物之间的微小差异是否与雷贝拉唑改善的药效学特性有关。两种药物耐受性均良好。
