典型文献
Effect and safety of anaprazole in the treatment of duodenal ulcers: a randomized, rabeprazole-controlled, phase III non-inferiority study
文献摘要：
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.
文献关键词：
Cytochrome P-450 CYP2C19;Non-inferiority trial;Peptic ulcer;Polymorphism;Genetic;Proton pump inhibitors;Anaprazole;Rabeprazole
中图分类号：
作者姓名：
Zhu Huiyun;Pan Xue;Zhang Li;Sun Hongxin;Fan Huizhen;Pan Zhongwei;Huang Caibin;Shi Zhenwang;Ding Jin;Wang Qi;Du Yiqi;Lyu Nonghua;Li Zhaoshen
作者机构：
Department of Gastroenterology, Changhai Hospital of Navy Military Medical University, Shanghai 200433, China;Drug Clinical Trial Institution, Changhai Hospital of Navy Military Medical University, Shanghai 200433, China;Department of Gastroenterology, Yichun People’s Hospital, Yichun, Jiangxi 336028, China;Department of Gastroenterology, Meihekou Central Hospital, Meihekou, Jilin 135099, China;Department of Gastroenterology, The First Affiliated Hospital of Gannan Medical College, Ganzhou, Jiangxi 341001, China;Department of Gastroenterology, Hefei Second People’s Hospital, Hefei, Anhui 230011, China;Department of Gastroenterology, Jinhua Central Hospital, Jinhua, Zhejiang 321099, China;Department of Gastroenterology, Anqing Municipal Hospital, Anqing, Anhui 246004, China;Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330006, China
文献出处：
引用格式：
[1]Zhu Huiyun;Pan Xue;Zhang Li;Sun Hongxin;Fan Huizhen;Pan Zhongwei;Huang Caibin;Shi Zhenwang;Ding Jin;Wang Qi;Du Yiqi;Lyu Nonghua;Li Zhaoshen-.Effect and safety of anaprazole in the treatment of duodenal ulcers: a randomized, rabeprazole-controlled, phase III non-inferiority study)[J].中华医学杂志（英文版）,2022(24):2941-2949
A类：
anaprazole,rabeprazole,NCT04215653,Anaprazole,Rabeprazole
B类：
Effect,safety,treatment,duodenal,ulcers,randomized,controlled,phase,III,inferiority,study,Background,pharmacokinetic,clinical,behaviors,many,proton,pump,inhibitors,PPIs,peptic,altered,by,CYP2C19,genetic,polymorphisms,This,evaluated,efficacy,novel,compared,We,also,explored,influence,Helicobacter,pylori,infection,status,Methods,In,this,multicenter,double,dummy,positive,drug,parallel,Chinese,patients,were,receive,placebo,once,daily,weeks,primary,was,healing,assessed,blinded,independent,review,Secondary,endpoints,proportion,improved,overall,individual,symptoms,Furthermore,exploratory,subgroup,analysis,conducted,Adverse,events,monitored,Non,Results,enrolled,rates,respectively,difference,confidence,interval,demonstrating,Overall,Improvement,similar,between,groups,Healing,did,significantly,genotype,either,incidence,emergent,adverse,Conclusions,that,Registration,ClinicalTrials,gov,Cytochrome,trial,Peptic,Polymorphism,Genetic,Proton
AB值：
0.408873
相似文献
机标中图分类号，由域田数据科技根据网络公开资料自动分析生成，仅供学习研究参考。
