Clinical observation of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori infection
- VernacularTitle:伏诺拉生三联疗法用于幽门螺杆菌感染初治患者的临床观察
- Author:
Shaowei HAN
1
;
Zijie DENG
2
;
Tao LYU
2
;
Nansong WANG
1
;
Jiajing ZENG
2
Author Information
1. Dept. of Pharmacy，the University of Hong Kong-Shenzhen Hospital，Guangdong Shenzhen 518053，China
2. Dept. of Gastroenterology，the University of Hong Kong-Shenzhen Hospital，Guangdong Shenzhen 518053，China
- Publication Type:Journal Article
- Keywords:
Helicobacter pylori;
vonoprazan;
bismuth-based quadruple therapy;
treatment-naive;
therapeutic efficacy;
safety
- From:
China Pharmacy
2024;35(22):2789-2792
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To evaluate the therapeutic efficacy and safety of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori （Hp） infection. METHODS From March 2022 to August 2023， 198 treatment-naive patients with Hp infection treated at the outpatient service of department of gastroenterology in our hospital were assigned to the vonoprazan- based triple therapy group （VAC group， n＝98） and the bismuth-based quadruple therapy group （BQT group， n＝100） using the random number table method. Patients in VAC group were given Vonoprazan fumarate tablets （20 mg） + Amoxicillin capsules （1 g） + Clarithromycin tablets （0.5 g）， all twice daily. Patients in BQT group were given Esomeprazole magnesium enteric-coated tablets （20 mg， twice daily） + Metronidazole tablets （0.4 g， four times daily） + Tetracycline tablets （0.5 g， three times daily） + Bismuth potassium citrate capsules （0.6 g， twice daily）. The treatment course for both groups was 14 days. The Hp eradication rates were compared between the two groups in intention-to-treat （ITT）， modified intention-to-treat （MITT）， and per-protocol （PP） analysis sets， while adverse reaction occurrence and medication compliance of two groups were recorded. RESULTS In the ITT， MITT and PP analyses sets， the Hp eradication rates in VAC group were non-inferior to those in BQT group. The incidences of grades 1-2 nausea， vomiting， and loss of appetite in VAC group were significantly lower than in BQT group， and the proportion of patients with good compliance was significantly higher in VAC group （P＜0.05）. Regardless of whether the body mass index （BMI） ≤25 kg/m2 or ＞25 kg/m2， no statistically significant difference was observed in the Hp eradication rates between the two groups （P＞0.05）. CONCLUSIONS Vonoprazan-based triple therapy is non-inferior to bismuth-based quadruple therapy in the treatment of treatment-naive patients with Hp infection， with higher safety and good patient medication compliance. BMI has no significant impact on the Hp eradication rate.
