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Treatment of functional dyspepsia in Chinese adult patients with domperidone: A multicenter, randomized, double-blind, placebo-controlled, pilot study

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单位: [1]Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [2]Department of Gastroenterology, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, China. [3]Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing, China. [4]Department of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [5]Department of Gastroenterology, Union Hospital, Tongji medical college, Huazhong University of Science and Technology, Wuhan, China. [6]Janssen China R&D, Shanghai, China. [7]OTC Medical Affairs, Xian Janssen Pharmaceutical Ltd, Beijing, China.
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关键词: Functional dyspepsia Domperidone Nepean dyspepsia index Postprandial distress syndrome

摘要:
This pilot study aimed to evaluate domperidone in the treatment of Chinese patients with functional dyspepsia (FD) diagnosed according to Rome IV criteria, including identification of FD subtypes that potentially respond better to domperidone.This study was conducted at hospitals in China from Aug 2018 to Jul 2020. The study consisted of a 1-week screening phase and a 2-week double-blind treatment phase. Participants were randomized to domperidone 10 mg or matching placebo tablets three times daily for 14 days. The primary endpoint was overall treatment effect (OTE) response rate after 2 weeks of therapy.The study enrolled 160 patients, 80 in each group. The OTE response rate after 2 weeks therapy was numerically higher for domperidone (60.7%) compared with placebo (46.0%) (relative risk [RR], 1.318; 95% confidence interval [CI], 0.972-1.787). The OTE response rates after 2 weeks by FD subtype for domperidone and placebo were 60.3% vs 54.9% for postprandial distress syndrome (PDS) (RR, 1.098; 95% CI, 0.750-1.607) and 60.6% vs 35.2% for overlapping PDS-epigastric pain syndrome (EPS) (RR, 1.722; 95% CI, 0.995-2.980). Adverse events were reported by seven patients in the domperidone group and twelve patients in the placebo group. None of the adverse events in the domperidone group were serious or unexpected.Domperidone showed a positive pattern on OTE response rates after 2 weeks therapy compared to placebo in patients with FD as well as in subtypes of PDS and overlapping PDS-EPS. No new safety signal was observed. This article is protected by copyright. All rights reserved.This article is protected by copyright. All rights reserved.

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出版当年[2022]版:
大类 | 3 区 医学
小类 | 3 区 胃肠肝病学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 胃肠肝病学
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出版当年[2021]版:
Q3 GASTROENTEROLOGY & HEPATOLOGY
最新[2023]版:
Q3 GASTROENTEROLOGY & HEPATOLOGY

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第一作者单位: [1]Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [*1]Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shuaifuyuan, Wangfujing, Dongcheng District, Beijing 100730, China
通讯作者:
通讯机构: [1]Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [*1]Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shuaifuyuan, Wangfujing, Dongcheng District, Beijing 100730, China
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