Ilaprazole-amoxicillin dual therapy at high dose as a first-line treatment for helicobacter pylori infection in Hainan: a single-center, open-label, noninferiority, randomized controlled trial

BMC Gastroenterology

Research

Fei-Hu Bai¹  Shi-Mei Huang²  Da-Ya Zhang²  Xiao-Dong Zhang²  Chen Chen²  Da Li²  Run-Xiang Chen²  Fan Zeng²  Shi-Ju Chen² 

[1] Department of Gastroenterology, The Second Affiliated Hospital of Hainan Medical University, Yehai Avenue, #368, Longhua District, Haikou, Hainan Province, China;The Gastroenterology Clinical Medical Center of Hainan Province, Haikou, China;Graduate School, Hainan Medical University, Haikou, China;

关键词: Helicobacter pylori;    Dual therapy;    Quadruple therapy;    Ilaprazole;    Eradication rate;    Noninferiority;   

DOI  :  10.1186/s12876-023-02890-5

 received in 2023-03-26, accepted in 2023-07-17,  发布年份 2023

来源: Springer

【 摘 要 】

ObjectivesThis study aimed to evaluate the efficacy, adverse events, patient compliance, and cost of dual therapy with Ilaprazole-amoxicillin (IA) at high dose versus Ilaprazole-amoxicillin-furazolidone-bismuth (IAFB) quadruple therapy for the Helicobacter pylori (H.pylori) infection among Chinese patients.Methods200 patients who had tested positive for H. pylori and undergoing upper gastrointestinal endoscopy after being diagnosed with chronic gastritis participated in this open-label randomized controlled clinical trial. Patients were randomized to Group A and Group B: the 14-day IA dual treatment group (101) and IAFB quadruple treatment group (99). The 13 C urea breath test was conducted to determine whether H. pylori had been eliminated 4–6 weeks after the treatment. Eradication rates, drug-related adverse events, patient compliance, and drug costs were compared between the two treatment groups.ResultsEradication rates in group A were 92.1% and 94.9%, depending on the intention-to-treat (ITT), per-protocol (PP), respectively, which was similar to group B (91.9% and 93.6%). There was no significant difference observed in adverse events between the two groups (P = 0.518). Interestingly, compliance was significantly higher in group A compared to the group B (P = 0.031). In addition, drug costs were significantly lower for group A in comparison to the group B.ConclusionsIA dual therapy was found to be equally effective, safer and less costly than IAFB quadruple therapy. Therefore, these therapies can be potentially considered as first-line regimens for empirical treatment.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 1