A Randomized, Comparative Trial of a Potassium-Competitive Acid blocker (AZD0865)and Esomeprazole for the Treatment of Patients With Nonerosive Reflux Disease
A Randomized, Comparative Trial of a Potassium-Competitive Acid blocker (AZD0865)and Esomeprazole for the Treatment of Patients With Nonerosive Reflux Disease
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DOI：
10.1111/j.1572-0241.2007.01544.x
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发表时间：
2008-01-01
影响因子：
9.8
通讯作者：
Lundborg, Per
中科院分区：
文献类型：
--
作者：
Dent, John;Kahrilas, Peter J.;Lundborg, Per
目的：AZD0865是一种起效快、作用时间长的胃酸抑制药。本研究采用双盲、随机、多中心研究，观察AZD0865治疗非糜烂性反流病(NERD)的有效性和安全性。方法：将胃灼热至少6个月且胃镜检查无糜烂的患者随机分为两组，分别给予AZD0865(25 mg/d、50 mg/d或75 mg/d)或埃索美拉唑20 mg/d治疗4wk。在整个治疗期间，患者使用电子日记每天两次报告胃灼热和其他书呆子症状的存在和强度。在第14天对部分患者进行24小时动态食道/胃内pH监测。结果：共1,469名患者被随机分为两组。对于所有治疗组，胃灼热持续消失(连续7天)的中位时间约为12天，在任何AZD0865剂量或与埃索美拉唑相比都没有显著差异。治疗4wk期间胃灼热持续消失的累积发生率在各治疗组之间无显著差异(即65-70%)。AZD0865 75 mg/d与埃索美拉唑20 mg/d相比，胃内pH>4的时间百分比显著增加(75%比60%，P<；0.05)。AZD0865一般耐受性良好，尽管在接受该药的一些患者中出现了可逆性转氨酶升高。结论：在治疗NERD患者方面，AZD0865没有提供比埃索美拉唑20 mg更好的临床益处。
OBJECTIVES: AZD0865 is a gastric acid-suppressing agent that has a rapid onset of action and long duration of effect. This double-blind, randomized, multicenter study investigated the efficacy and safety of AZD0865 in the treatment of patients with nonerosive reflux disease (NERD).METHODS: Patients with troublesome heartburn for at least 6 months and no evidence of erosions at endoscopy were randomized to receive AZD0865 (25, 50, or 75 mg/day) or esomeprazole 20 mg/day, for 4 wk. Throughout the treatment period, patients reported the presence and intensity of heartburn and other NERD symptoms twice daily using an electronic diary. Twenty-four-hour ambulatory intraesophageal/intragastric pH monitoring was performed in a subset of patients on day 14.RESULTS: A total of 1,469 patients were randomized. The median time to sustained absence of heartburn (for 7 consecutive days) was approximately 12 days for all treatment groups and did not differ significantly for any of the AZD0865 doses or compared with esomeprazole. There were no significant differences among treatment groups in the cumulative incidence of sustained absence of heartburn during 4 wk treatment (i.e., 65-70%). The percentage of time for which intragastric pH was greater than 4 was significantly greater for AZD0865 75 mg/day compared with esomeprazole 20 mg (75% vs 60%, P < 0.05). AZD0865 was generally well tolerated although reversible elevations of liver transaminases occurred in some patients receiving the agent.CONCLUSIONS: AZD0865 did not provide clinical benefit over esomeprazole 20 mg in the management of patients with NERD.