医学
埃索美拉唑
内科学
养生
随机对照试验
幽门螺杆菌
尿素呼气试验
胃肠病学
意向治疗分析
不利影响
阿莫西林
临床试验
联合疗法
抗生素
幽门螺杆菌感染
微生物学
生物
作者
Yong Xie,Yi Hu,Yin Zhu,Hong Wang,Qizhi Wang,Yanqing Li,Jiangbin Wang,Zhenyu Zhang,Dekui Zhang,Xiao‐Wei Liu,Nonghua Lv
摘要
Abstract Background Bismuth‐containing quadruple therapy is an effective regimen for Helicobacter pylori ( H. pylori ) treatment. No head‐to‐head comparison trials have been conducted to evaluate the efficacy of colloidal bismuth pectin (CBP) in quadruple therapy for eradicating H. pylori . We aimed to compare the efficacy and safety of CBP quadruple therapy and bismuth potassium citrate (BPC) quadruple therapy for 14 days in the first‐line treatment of H. pylori . Methods In this multicenter, randomized, double‐blind, non‐inferiority clinical trial, H. pylori ‐infected subjects without eradication history were randomized to receive amoxicillin 1 g twice daily, tetracycline 500 mg three time daily, esomeprazole 20 mg twice daily in combination with CBP 200 mg three time daily or BPC 240 mg twice daily for 14 days. 13 C‐urea breath tests were used to access the eradication rate at least 4 weeks after treatment. Results Between April 2021 and July 2022, 406 patients were assessed for eligibility and 339 subjects were randomized. The cure rates (primary outcome) of CBP and BPC quadruple therapy were 90.5% and 92.3% ( p = 0.56) by intention‐to‐treat analysis, respectively, and 96.1% and 96.2% ( p = 1.00) by per‐protocol analysis, respectively. CBP quadruple therapy was non‐inferior to BPC quadruple therapy in the intention‐to‐treat and per‐protocol analysis ( p < 0.025). The frequency of adverse events and compliance were not different among the two groups ( p > 0.05). Conclusions Both CBP and BPC quadruple therapy for 14 days provide high efficacy, good compliance, and safety in the first‐line treatment of H. pylori in China.
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