Kim Eun Jin, Lee Oh Young, Lee Kang Nyeong, Lee Sung Joon, Jang Jae-Young, Cho Jin Woong, Kim Tae-Oh
Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
Department of Internal Medicine, Kangwon National University College of Medicine, Seoul, Korea.
J Neurogastroenterol Motil. 2019 Jul 1;25(3):403-412. doi: 10.5056/jnm18185.
BACKGROUND/AIMS: Proton pump inhibitors (PPIs) are frequently used to treat non-erosive reflux disease (NERD), but their effect is limited. It is not known whether a potential alternative, AlbisD, containing ranitidine hydrochloride, sucralfate hydrate, and tripotassium dicitrato bismuthate, is effective and safe in treating NERD. The aim of the study is to evaluate the efficacy and safety of AlbisD compared with omperazole in patients with NERD.
This was a multicenter, randomized, open-label, parallel-group, non-inferiority comparative study. A total of 126 patients with NERD were randomly allocated to either AlbisD twice daily or omeprazole 20 mg once daily for 4 weeks from February 2016 to August 2016. The study patients had histories of heartburn or regurgitation of moderate severity (> score 2) and a frequency of at least 2 episodes per week, and had no mucosal breaks of the esophagus on endoscopy. The primary efficacy variable was complete cure of heartburn at week 4. Secondary efficacy variables evaluating symptoms of heartburn and acid reflux as well as safety profiles were compared in the 2 groups at week 2 and 4 after treatment.
A total of 113 patients completed the study (57 and 56 in AlbisD and omeprazole groups, respectively). The proportion of patients with complete cure of heartburn at week 4 was not significantly different between the AlbisD and omeprazole groups (35.1% vs 32.1% respectively, = 0.740). There were no significant differences between the 2 groups in the any secondary variables including proportions of days without heartburn or acid reflux over 4 weeks (including daytime and nighttime). Adverse events were similarly reported in the 2 groups (7 [12.3%] vs 6 [10.7%]), and there were no serious adverse events.
The efficacy and safety of AlibsD in treating NERD patients are not inferior to those of omeprazole. Therefore, AlbisD can be an alternative to PPIs for NERD.
背景/目的：质子泵抑制剂（PPIs）常用于治疗非糜烂性反流病（NERD），但其效果有限。目前尚不清楚一种潜在的替代药物AlbisD（含盐酸雷尼替丁、水合硫糖铝和三钾二枸橼酸铋）治疗NERD是否有效且安全。本研究的目的是评估AlbisD与奥美拉唑相比治疗NERD患者的疗效和安全性。
这是一项多中心、随机、开放标签、平行组、非劣效性对照研究。2016年2月至2016年8月，共126例NERD患者被随机分为两组，分别接受每日两次AlbisD治疗或每日一次20mg奥美拉唑治疗，疗程4周。研究患者有中度严重程度（>2分）的烧心或反流病史，且每周发作频率至少2次，内镜检查食管无黏膜破损。主要疗效变量为第4周烧心完全治愈。在治疗后第2周和第4周，比较两组评估烧心和酸反流症状以及安全性的次要疗效变量。
共有113例患者完成研究（AlbisD组和奥美拉唑组分别为57例和56例）。第4周时，AlbisD组和奥美拉唑组烧心完全治愈的患者比例无显著差异（分别为35.1%和32.1%，P = 0.740）。两组在任何次要变量上均无显著差异，包括4周内（包括白天和夜间）无烧心或酸反流天数的比例。两组报告的不良事件相似（分别为7例[12.3%]和6例[10.7%]），且无严重不良事件。
AlbisD治疗NERD患者的疗效和安全性不劣于奥美拉唑。因此，AlbisD可作为治疗NERD的PPIs替代药物。
