Effect and safety of anaprazole in the treatment of duodenal ulcers:a randomized,rabeprazole-controlled,phase Ⅲ non-inferiority study  被引量:3

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作  者:Huiyun Zhu Xue Pan Li Zhang Hongxin Sun Huizhen Fan Zhongwei Pan Caibin Huang Zhenwang Shi Jin Ding Qi Wang Yiqi Du Nonghua Lyu Zhaoshen Li 

机构地区:[1]Department of Gastroenterology,Changhai Hospital of Navy Military Medical University,Shanghai 200433,China [2]Drug Clinical Trial Institution,Changhai Hospital of Navy Military Medical University,Shanghai 200433,China [3]Department of Gastroenterology,Yichun People’s Hospital,Yichun,Jiangxi 336028,China [4]Department of Gastroenterology,Meihekou Central Hospital,Meihekou,Jilin 135099,China [5]Department of Gastroenterology,The First Affiliated Hospital of Gannan Medical College,Ganzhou,Jiangxi 341001,China [6]Department of Gastroenterology,Hefei Second People’s Hospital,Hefei,Anhui 230011,China [7]Department of Gastroenterology,Jinhua Central Hospital,Jinhua,Zhejiang 321099,China [8]Department of Gastroenterology,Anqing Municipal Hospital,Anqing,Anhui 246004,China [9]Department of Gastroenterology,The First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi 330006,China

出  处:《Chinese Medical Journal》2022年第24期2941-2949,共9页中华医学杂志(英文版)

摘  要:Background:The pharmacokinetic and clinical behaviors of many proton pump inhibitors(PPIs)in peptic ulcer treatment are altered by CYP2C19 genetic polymorphisms.This non-inferiority study evaluated the efficacy and safety of the novel PPI anaprazole compared with rabeprazole.We also explored the influence of Helicobacter pylori(H.pylori)infection status and CYP2C19 polymorphism on anaprazole.Methods:In this multicenter,randomized,double-blind,double-dummy,positive-drug parallel-controlled,phase Ⅲ study,Chinese patients with duodenal ulcers were randomized 1:1 to receive rabeprazole 10 mg+anaprazole placebo or rabeprazole placebo+anaprazole 20 mg once daily for 4 weeks.The primary efficacy endpoint was the 4-week ulcer healing rate assessed by blinded independent review.Secondary endpoints were the proportion of patients with improved overall and individual duodenal ulcer symptoms at 4 weeks.Furthermore,exploratory subgroup analysis of the primary endpoint by H.pylori status and CYP2C19 polymorphism was conducted.Adverse events were monitored for safety.Non-inferiority analysis was conducted for the primary endpoint.Results:The study enrolled 448 patients(anaprazole,n=225;rabeprazole,n=223).The 4-week healing rates were 90.9%and 93.7%for anaprazole and rabeprazole,respectively(difference,-2.8%[95%confidence interval,-7.7%,2.2%]),demonstrating non-inferiority of anaprazole to rabeprazole.Overall duodenal ulcer symptoms improved in 90.9%and 92.5%of patients,respectively.Improvement rates of individual symptoms were similar between the groups.Healing rates did not significantly differ by H.pylori status or CYP2C19 genotype for either treatment group.The incidence of treatment-emergent adverse events was similar for anaprazole(72/220,32.7%)and rabeprazole(84/219,38.4%).Conclusions:The efficacy of anaprazole is non-inferior to that of rabeprazole in Chinese patients with duodenal ulcers.Registration:ClinicalTrials.gov,NCT04215653.

关 键 词:Cytochrome P-450 CYP2C19 Non-inferiority trial Peptic ulcer POLYMORPHISM Genetic Proton pump inhibitors Anaprazole RABEPRAZOLE 

分 类 号:R574.51[医药卫生—消化系统]

 

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