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

Wei Shen, Xiaoyan Zhao, Zhen Han, Yinglei Miao, Hua Huang, Zhenyu Zhang, Lei Dong, Yuqiang Nie, Huimei Li, RunZhou Ni

Journal: Medical engineering & physics 2023;110():103860

PMID: 35999163

Full Text on Elsevier Science View on PubMed

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.

Address: Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China.; Department of Gastroenterology, The Second Affiliated Hospital of Third Military Medical University, Chongqing 400037, China.; Department of Gastroenterology, The First Affiliated Hospital of Wannan Medical College, Wuhu 241001, China.; Department of Gastroenterology, The First Affiliated Hospital of Kunming Medical University, Kunming 650032, China.; Department of Gastroenterology, The Second Affiliated Hospital of Kunming Medical University, Kunming 650101, China.; Department of Gastroenterology, Nanjing First Hospital, Nanjing 210029, China. Electronic address: [email protected].; Department of Gastroenterology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710004, China.; Department of Gastroenterology, Guangzhou First People's Hospital, Guangzhou 510180, China.; Department of Gastroenterology, Daqing Oilfield General Hospital, Daqing 163316, China.; Department of Gastroenterology, Affiliated Nantong Hospital of Nantong University, Nantong 226001, China.

DOI: 10.1016/j.medengphy.2022.103860

Link outs

Subscription / membership required

Full Text Sources:

MeSH Terms: Humans, Anti-Ulcer Agents, Carnosine, Gastroscopy, Stomach Ulcer, Treatment Outcome, Organometallic Compounds, Zinc Compounds