Efficacy and safety of polaprezinc in the treatment of gastric ulcer: A multicenter, randomized, double-blind, double-dummy, positive-controlled clinical trial. (December 2022)

• Record Type: Journal Article
• Authors: Shen, Wei; Zhao, Xiaoyan; Han, Zhen; Miao, Yinglei; Huang, Hua; Zhang, Zhenyu; Dong, Lei; Nie, Yuqiang; Li, Huimei; Ni, RunZhou
• Is Part Of: Medical engineering & physics. Volume 110(2022)
• Publication Date: 2022-12
• Subjects: Polaprezinc -- Granules -- Rebamipide -- Gastric ulcer -- Efficacy -- Safety -- Gastroscopy; Biomedical engineering -- Periodicals; Biomedical Engineering -- Periodicals; Physics -- Periodicals; Génie biomédical -- Périodiques; Biomedical engineering; Electronic journals; Periodicals; 610.28
• DOI: 10.1016/j.medengphy.2022.103860
• Languages: English
• ISSNs: 1350-4533

Abstract

Highlight: FAS analysis showed that the effective rates confirmed by gastroscopy after treatment in the test group and the control group were 81.48% and 74.31%, respectively. PPS revealed that the effective rates in the test group and the control group were 85.15% and 80.81%. Polaprezinc granules have the same therapeutic effect on GU as commonly used drugs in clinical practice. Abstract: 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.