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

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.

• Authors: Wei Shen, Xiaoyan Zhao, Zhen Han, Yinglei Miao, Hua Huang, Zhenyu Zhang, Lei Dong, Yuqiang Nie, Huimei Li, RunZhou Ni
• Journal: Medical engineering & physics (Med Eng Phys) Vol. 110 Pg. 103860 (12 2022) ISSN: 1873-4030 [Electronic] England
• PMID: 35999163 (Publication Type: Randomized Controlled Trial, Multicenter Study, Journal Article)
• Copyright: Copyright © 2022 Elsevier Ltd. All rights reserved.

Chemical References

• Anti-Ulcer Agents
• Carnosine
• polaprezinc
• Organometallic Compounds
• Zinc Compounds

Topics

• Humans
• Anti-Ulcer Agents (therapeutic use)
• Carnosine (therapeutic use)
• Gastroscopy
• Stomach Ulcer (drug therapy)
• Treatment Outcome
• Organometallic Compounds (therapeutic use)
• Zinc Compounds (therapeutic use)