Randomized controlled study of vonoprazan dual therapy and bismuth-containing quadruple therapy with low resistance antibiotics in the treatment of Helicobacter pylori infection
10.3760/cma.j.cn311367-20240514-00193
- VernacularTitle:伏诺拉生二联方案与含铋剂低耐药抗生素四联方案根除幽门螺杆菌的随机对照研究
- Author:
Zijie DENG
1
;
Shaowei HAN
;
Mingfeng XU
;
Xiaoyu LIU
;
Chun NING
;
Tao LYU
Author Information
1. 香港大学深圳医院消化及肝脏科，深圳 518053
- Publication Type:Journal Article
- Keywords:
Vonoprazan;
Low resistance antibiotic;
Helicobacter pylori;
Treatment
- From:
Chinese Journal of Digestion
2024;44(12):800-805
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy, adverse reactions and compliance of vonoprazan (VPZ) dual therapy and bismuth-containing quadruple therapy with low-resistance antibiotics in the initial treatment of primary Helicobacter pylori ( H. pylori) infection. Methods:From March 7, 2022 to August 25, 2023, a total of 200 patients with H. pylori infection who visited the Department of Gastroenterology and Hepatology of the University of Hong Kong-Shenzhen Hospital were selected. According to the random number table method, the patients were randomly divided into the VPZ combined with amoxicillin treatment group (hereinafter referred as VPZ dual therapy group) and the proton pump inhibitor (PPI), tetracycline, full-dose (1 600 mg/d) metronidazole and bismuth treatment group (hereinafter referred as PPI quadruple therapy group). The patients of VPZ dual therapy group were given VPZ 20 mg (twice a day) combined with amoxicillin 1 000 mg (3 times a day), and the patients of PPI quadruple therapy group were given esomeprazol 20 mg (2 times a day), bismuth 0.6 g (twice a day), metronidazole 400 mg (4 times a day), and tetracycline 500 mg (3 times a day). The patients of both groups were treated for 14 days. The H. pylori infection status was re-examined 4 weeks after drug withdrawal. The results were analyzed by intention-to-treat (ITT) analysis, modified ITT analysis and per-protocol analysis (PPA). One-sided μ test was used for non-inferiority evaluation, and two-sided 95% confidence interval (95% CI) was obtained. Chi-square test was used for statistical analysis. Results:In the ITT analysis, 92.0% (92/100) of patients in the VPZ dual therapy group and 77.0% (77/100) of patients in the PPI quadruple therapy group completed the 14-day treatment, and the difference was statistically significant ( χ2=8.59, P=0.003). In the ITT analysis, the H. pylori eradication rates in the VPZ dual therapy group and the PPI quadruple therapy group were 96.0% (96/100) and 92.0% (92/100), respectively, and the difference was statistically significant (difference=4.0%, 95% CI -2.9% to 11.5%, P<0.001). In the modified ITT analysis, the H. pylori eradication rates of the VPZ dual therapy group and the PPI quadruple therapy group were 97.0% (96/99) and 95.8% (92/96), respectively, and the difference was statistically significant (difference=1.1%, 95% CI -4.9% to 7.6%, P=0.002). In the PPA, the H. pylori eradication rates of the VPZ dual therapy group and the PPI quadruple therapy group were 96.7% (89/92) and 97.4% (75/77), respectively, and the difference was statistically significant (difference=-0.7%, 95% CI -6.9% to 6.1%, P=0.009). In the ITT analysis, the incidence of adverse reaction in the VPZ dual therapy group was lower than that in the PPI quadruple therapy group (39.0%, 39/100 vs. 71.0%, 71/100), and the difference was statistically significant ( χ2=20.69, P<0.001). Conclusion:In initial treatment of H. pylori infection, the eradication rate of VPZ dual therapy is non-inferior to that of PPI quadruple therapy, and VPZ dual therapy demonstrates higher safety.
