伏诺拉生联合阿莫西林二联方案初次根除幽门螺杆菌的疗效分析  

Dual Therapy With Vonoprazan and Amoxicillin for Initial Treatment of Helicobacter pylori Infection

作　　者：杨秋霞 侯灼 周秋烨 张蓉 贾红萍[1] 尧颖[1] YANG Qiuxia;HOU Zhuo;ZHOU Qiuye;ZHANG Rong;JIA Hongping;YAO Ying(Department of Gastroenterology,Yan'an Hospital Affiliated to Kunming Medical University,Kunming,650051)

机构地区：[1]昆明医科大学附属延安医院消化内科,650051

出　　处：《胃肠病学》2024年第8期486-489,共4页Chinese Journal of Gastroenterology

摘　　要：背景:大量研究证实质子泵抑制剂联合阿莫西林高剂量二联疗法在幽门螺杆菌(Hp)根除治疗中具有良好的疗效。伏诺拉生作为一种高效的新型抑酸剂,有望进一步提高Hp根除率。目的:比较伏诺拉生联合阿莫西林二联方案与铋剂四联方案初次根除Hp感染的有效性和安全性。方法:本研究为单中心、前瞻性、随机对照临床试验。于2022年4月—2023年8月在昆明医科大学附属延安医院连续招募初治Hp感染患者,随机接受二联方案(伏诺拉生20 mg bid+阿莫西林1 g tid)和铋剂四联方案(雷贝拉唑20 mg bid+枸橼酸铋钾600 mg bid+克拉霉素500 mg bid+阿莫西林1 g bid)治疗,疗程均为14 d。主要结局指标为Hp根除率(14C⁃尿素呼气试验),次要结局指标为安全性和依从性。结果:210例符合标准的患者纳入研究,二联方案组106例,1例因药物不良反应出组;四联方案组104例,2例因未按要求服药出组。二联和四联方案组Hp根除率按意向治疗分析分别为89.6%(95/106)和92.3%(96/104),按方案分析分别为90.5%(95/105)和94.1%(96/102),组间差异均无统计学意义(P均>0.05)。二联方案组不良反应发生率显著低于四联方案组(4.7%对20.2%,P<0.05),两组依从性无明显差异。结论:14 d伏诺拉生联合阿莫西林二联方案用于Hp感染的初始治疗与铋剂四联方案疗效相当且用药简单、不良反应更少,可考虑作为Hp感染经验性治疗的一线方案。Background:A large number of studies have confirmed that high⁃dose dual therapy with proton pump inhibitor and amoxicillin has a good efficacy for eradication of Helicobacter pylori(Hp)infection.As a novel efficient acid suppressant,vonoprazan is expected to further improve the Hp eradication rate.Aims:To compare the efficacy and safety of vonoprazan⁃amoxicillin dual therapy and bismuth⁃containing quadruple therapy for initial treatment of Hp infection.Methods:This is a single⁃center,prospective,randomized controlled clinical trial.Patients positive for Hp infection and naive to eradication therapy were recruited consecutively from April 2022 to August 2023 at the Yan′an Hospital Affiliated to Kunming Medical University,and randomly allocated into two groups.One group received dual therapy with vonoprazan 20 mg bid and amoxicillin 1 g tid for 14 days;the other group received bismuth⁃containing quadruple therapy(rabeprazole 20 mg bid,bismuth potassium citrate 600 mg bid,clarithromycin 500 mg bid,and amoxicillin 1 g bid)for 14 days.The primary outcome was Hp eradication rate evaluated by 14C⁃urea breath test,and the secondary outcomes included safety and compliance.Results:A total of 210 patients who fulfilled the criteria were enrolled in this study,106 in dual therapy group and 104 in quadruple therapy group.One patient in dual therapy group was discontinued from the trial due to adverse drug reaction,and 2 patients in quadruple therapy group were withdrawn for failure to adhere to the treatment protocol.In intention⁃to⁃treat analysis,the Hp eradication rate of dual therapy was 89.6%(95/106),and that of quadruple therapy was 92.3%(96/104);while in per⁃protocol analysis,the eradication rates of these two groups were 90.5%(95/105)and 94.1%(96/102),respectively(all P>0.05).The adverse events rate of the dual therapy was significantly lower than that of the quadruple therapy(4.7%vs.20.2%,P<0.05).There was no significant difference in medication adherence between the two groups.Conclusions:The effi

关 键 词：二联疗法 伏诺拉生 阿莫西林 幽门螺杆菌 随机对照试验 

分 类 号：R57[医药卫生—消化系统]