Wu Justin C Y, Sheu Bor-Shyang, Wu Ming-Shiang, Lee Yong Chan, Choi Myung-Gyu
Department of Medicine and Therapeutics, Prince of Wales Hospital, Shatin, Hong Kong, China.
Department of Internal Medicine, National Cheng Kung University Hospital, Tainan City, Taiwan.
J Neurogastroenterol Motil. 2020 Jan 30;26(1):85-95. doi: 10.5056/jnm19031.
BACKGROUND/AIMS: Since the use of dexlansoprazole in Asian subjects with gastroesophageal reflux disease (GERD) has not been adequately characterized, this study was conducted to evaluate the efficacy and safety of dexlansoprazole modified-release in Asian subjects with non-erosive reflux disease (NERD) and erosive esophagitis (EE).
In this phase 4, open-label, non-randomized, uncontrolled, multicenter, multi-country study sponsored by Takeda, subjects aged ≥ 20 years with persistent typical GERD symptoms for at least 6 months underwent endoscopy. Based on endoscopic findings, they were assigned to either dexlansoprazole modified-release 30 mg once-daily for 4 weeks (NERD group) or dexlansoprazole modified-release 60 mg once-daily for 8 weeks (EE group). The primary endpoint was the percentage of days that subjects did not experience any 24hour heartburn or acid regurgitation.
Of the 445 subjects screened from Hong Kong, South Korea, and Taiwan, 208 were enrolled in the NERD group (mean age: 53.6 years, male: 34.6%) and 88 in the EE group (mean age: 51.7 years, male: 55.7%). Over the treatment period, the median percentage of days that subjects did not experience any 24-hour heartburn or acid regurgitation was 26.9% and 65.5% in the NERD and EE groups, respectively; for nighttime heartburn or acid regurgitation the proportions were 59.3% and 83.3%, respectively. The treatment was well tolerated with low incidence of treatment-related adverse events in NERD and EE groups (6.7% and 5.7%, respectively).
In Asian patients with GERD, treatment with dexlansoprazole modified-release indicates a favorable efficacy and safety profile in relieving heartburn and acid regurgitation symptoms.
背景/目的：由于亚洲胃食管反流病（GERD）患者使用右兰索拉唑的情况尚未得到充分描述，本研究旨在评估右兰索拉唑缓释制剂在亚洲非糜烂性反流病（NERD）和糜烂性食管炎（EE）患者中的疗效和安全性。
在这项由武田制药赞助的4期、开放标签、非随机、非对照、多中心、多国研究中，年龄≥20岁且持续典型GERD症状至少6个月的受试者接受了内镜检查。根据内镜检查结果，他们被分配接受为期4周、每日一次30mg右兰索拉唑缓释制剂治疗（NERD组）或为期8周、每日一次60mg右兰索拉唑缓释制剂治疗（EE组）。主要终点是受试者无24小时烧心或反酸症状的天数百分比。
在从中国香港、韩国和台湾地区筛选的445名受试者中，208名被纳入NERD组（平均年龄：53.6岁，男性：34.6%），88名被纳入EE组（平均年龄：51.7岁，男性：55.7%）。在治疗期间，NERD组和EE组受试者无24小时烧心或反酸症状的天数中位数分别为26.9%和65.5%；夜间烧心或反酸症状的比例分别为59.3%和83.3%。治疗耐受性良好，NERD组和EE组与治疗相关的不良事件发生率较低（分别为6.7%和5.7%）。
在亚洲GERD患者中，右兰索拉唑缓释制剂治疗在缓解烧心和反酸症状方面显示出良好的疗效和安全性。
