"Efficacy and safety of polaprezinc in the treatment of gastric ulcer: A multicenter, randomized, double-blind, double-dummy, positive-controlled clinical trial"

作者全名："Shen, Wei; Zhao, Xiaoyan; Han, Zhen; Miao, Yinglei; Huang, Hua; Zhang, Zhenyu; Dong, Lei; Nie, Yuqiang; Li, Huimei; Ni, RunZhou"

作者地址："[Shen, Wei] Chongqing Med Univ, Affiliated Hosp 2, Dept Gastroenterol, Chongqing 400010, Peoples R China; [Zhao, Xiaoyan] Third Mil Med Univ, Affiliated Hosp 2, Dept Gastroenterol, Chongqing 400037, Peoples R China; [Han, Zhen] Wannan Med Coll, Affiliated Hosp 1, Dept Gastroenterol, Wuhu 241001, Peoples R China; [Miao, Yinglei] Kunming Med Univ, Affiliated Hosp 1, Dept Gastroenterol, Kunming 650032, Yunnan, Peoples R China; [Huang, Hua] Kunming Med Univ, Affiliated Hosp 2, Dept Gastroenterol, Kunming 650101, Yunnan, Peoples R China; [Zhang, Zhenyu] Nanjing First Hosp, Dept Gastroenterol, Nanjing 210029, Peoples R China; [Dong, Lei] Xi An Jiao Tong Univ, Dept Gastroenterol, Affiliated Hosp 2, Xian 710004, Peoples R China; [Nie, Yuqiang] Guangzhou First Peoples Hosp, Dept Gastroenterol, Guangzhou 510180, Peoples R China; [Li, Huimei] Daqing Oilfield Gen Hosp, Dept Gastroenterol, Daqing 163316, Peoples R China; [Ni, RunZhou] Nantong Univ, Dept Gastroenterol, Affiliated Nantong Hosp, Nantong 226001, Peoples R China"

通信作者："Zhang, ZY (通讯作者)，Nanjing First Hosp, Dept Gastroenterol, Nanjing 210029, Peoples R China."

来源：MEDICAL ENGINEERING & PHYSICS

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000911958200001

JCR分区：Q3

影响因子：2.2

年份：2022

卷号：110

期号：　

开始页：　

结束页：　

文献类型：Article

关键词：Polaprezinc; Granules; Rebamipide; Gastric ulcer; Efficacy; Safety; Gastroscopy

摘要："Objective: To investigate the clinical efficacy and safety of polaprezinc compared with rebamipide in the treatment of gastric ulcers (GU). Methods: GU patients (n = 224) from 10 clinical centers were prospectively enrolled and randomly divided into a control (n = 113) or test (n = 111) group. The control group was treated with rebamipide tablets, while the test group was treated with polaprezinc. The primary endpoint was the effective treatment rate, which was confirmed by gastroscopy after 8 weeks of treatment. The secondary efficacy endpoint was the improvement rate of gastrointestinal symptoms after 4 and 8 weeks of treatment. Results: The basic characteristics of the two groups were well balanced. For the primary efficacy endpoint, the effective rates confirmed by gastroscopy, after treatment for the test and control groups were 81.48% and 74.31% (P = 0.1557), respectively. After 4 and 8 weeks of treatments, both treatment groups had comparable improvements rates in gastrointestinal symptoms (test vs. control: 44.44% vs. 39.45% [P = 0.4559] and 81.48% vs. 77.06% [P = 0.4223]). Further, the two groups had similar adverse events and reactions to the study drugs. Conclusion: These findings suggest that the efficacy and safety of polaprezinc were similar to those of rebamipide in the treatment of GU."

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