Vonoprazan-based triple and dual therapy versus bismuth-based quadruple therapy for Helicobacter pylori infection in China: a three-arm, randomised clinical trial protocol

Han, ShaoWei1,2; Deng, ZiJie3; Cheung, KaShing3,4; Lyu, Tao3; Chan, PuiLing2; Li, Ying2; Ni, Li3; Luo, XiaPeng3; Li, Kuan5

2023-07-07

10.1186/s12876-023-02872-7

BMC GASTROENTEROLOGY   影响因子和分区

1471-230X

Background Helicobacter pylori infection and associated diseases are a growing global public health issue. H. pylori infection is the major cause of gastric cancer, over 90% of duodenal ulcers, and over 70% of gastric ulcers. The infection rate of H. pylori is approximately 50%, and approximately 50% of new cases of gastric cancer worldwide occur in China. Bismuth (BI)-based quadruple therapy is recommended as the first-line treatment for H. pylori in China. Vonoprazan (VPZ), a new potassium-competitive acid blocker that can inhibit gastric acid secretion more effectively than proton pump inhibitors (PPIs), has been combined with antibiotics to effectively eradicate H. pylori. In this study, we compared the efficacy and safety of two VPZ-based therapies with that of BI-based therapy for H. pylori treatment.Methods A three-armed randomised controlled trial (RCT) is being conducted in Shenzhen, with 327 participants recruited from the Gastroenterology Clinic of the University of Hong Kong-Shenzhen Hospital. Patients were diagnosed with H. pylori infection based on a positive C-13-urea breath test (UBT). Patients are kept naive to their treatment and are randomly assigned in a 1:1:1 ratio to either VPZ-based triple, VPZ-based dual, or BI-based quadruple therapy for 14 days. All groups are subjected to follow-up evaluations of safety, adverse drug reactions, and clinical variables in the first, second, and fourth weeks after treatment. Successful eradication is confirmed by a negative C-13-UBT six weeks after treatment. If initial treatment fails, (1) those patients are turned to another regimen, or (2) a drug resistance test is conducted, after which an individualised treatment regimen shall be prescribed according to antimicrobial susceptibility testing. The resulting data will be evaluated using intention-treat and a per-protocol analysis.Discussion This study is the a RCT aims to evaluate the efficacy and safety of 14-day VPZ-based triple and dual therapies in comparison with BI-based quadruple therapy. The outcomes of this study may allow treatment recommendations and update drug instructions in China.

Helicobacter pylori C-13-urea breath test Vonoprazan Proton pump inhibitor-based regimen

SCI

英语

通讯

National Natural Science Foundation of China[81903581] ; Shenzhen Science and Technology Program["JCYJ20190807150005699","RCBS20200714115000009"] ; Shenzhen Key Medical Discipline Construction[SZXK059] ; Shenzhen Key Laboratory of Prevention and Treatment of Severe Infections[ZDSYS20200811142804014] ; Health Commission Grant of Guangdong Province, China[B2021239]

Gastroenterology & Hepatology

Gastroenterology & Hepatology

WOS:001026070800001

BMC

CLINICAL MEDICINE

2-s2.0-85164265059

Web of Science

1.Shantou Univ Med Coll, Shantou, Peoples R China
2.Univ Hong Kong, Shenzhen Hosp, Dept Pharm, Shenzhen, Peoples R China
3.Univ Hong Kong, Shenzhen Hosp, Dept Med, Shenzhen, Peoples R China
4.Univ Hong Kong, Li Ka Shing Fac Med, Sch Clin Med, Dept Med, Hong Kong, Peoples R China
5.Jinan Univ, Southern Univ Sci & Technol, Shenzhen Peoples Hosp, Affiliated Hosp 1,Dept Pharm,Clin Med Coll 2, Shenzhen, Peoples R China

Han, ShaoWei,Deng, ZiJie,Cheung, KaShing,et al. Vonoprazan-based triple and dual therapy versus bismuth-based quadruple therapy for Helicobacter pylori infection in China: a three-arm, randomised clinical trial protocol[J]. BMC GASTROENTEROLOGY,2023,23(1).

Han, ShaoWei.,Deng, ZiJie.,Cheung, KaShing.,Lyu, Tao.,Chan, PuiLing.,...&Li, Kuan.(2023).Vonoprazan-based triple and dual therapy versus bismuth-based quadruple therapy for Helicobacter pylori infection in China: a three-arm, randomised clinical trial protocol.BMC GASTROENTEROLOGY,23(1).

Han, ShaoWei,et al."Vonoprazan-based triple and dual therapy versus bismuth-based quadruple therapy for Helicobacter pylori infection in China: a three-arm, randomised clinical trial protocol".BMC GASTROENTEROLOGY 23.1(2023).