摘要
目的评价高剂量艾司奥美拉唑-阿莫西林二联疗法(HDDT)与经典铋剂四联疗法(BQT)作为首次幽门螺杆菌感染一线治疗的有效性、安全性以及复发情况。方法此项单中心、前瞻性、随机临床对照试验于2022年2月至2023年2月从福州市第一总医院招募了367例Hp感染初治患者作为研究对象,根据数字随机表随机分为HDDT组(口服艾司奥美拉唑20 mg+阿莫西林750 mg,4次/d,疗程14 d)和BQT组(口服艾司奥美拉唑20 mg+胶体果胶铋250 mg+阿莫西林1.0 g+克拉霉素0.5 g,2次/d,疗程14 d)。经13C-尿素呼气试验或粪Hp抗原检测评估治疗后4周的根除成功率,统计用药期间的安全性、依从性以及1年的复发率。结果BQT、HDDT患者Hp根除率的意向性(ITT)分析结果(85.91%、57.65%)、符合方案集(PP)分析结果(94.57%、85.33%)比较,差异有统计学意义(P<0.05)。两组患者不良反应发生率、服药依从性比较,差异无统计学意义(P>0.05);HDDT组根除率较BQT组高(P<0.05)。HDDT组复发率稍低于BQT组(1.64%、4.69%),差异无统计学意义(P>0.05)。结论对于Hp感染初治患者而言,高剂量艾司奥美拉唑联合阿莫西林根除Hp感染的效果好,且具有良好的安全性,患者服药依从性较高。
Objective The aim of our study was to examine the efficacy,safety,and one-year recurrence rates of high-dose esomeprazole-amoxicillin dual therapy(HDDT)versus conventional bismuth quadruple therapy(BQT)as initial therapy for the Helicobacter pylori(H.pylori)infection.Methods In this randomized,prospective,single-center trial,we enrolled 367 individuals recently diagnosed with H.pylori infection from February 2022 to February 2023 in our hospital.Participants were allocated at random into two cohorts according to Digital Random Table:the HDDT cohort,where subjects received esomeprazole(Nexion)at a dose of 20 mg and amoxicillin at 750 mg,administered four times daily over a period of 14 days;and the BQT cohort,which involved administration of esomeprazole(Nexion)20 mg,bismuth subsalicylate 250 mg,amoxicillin 1.0 g,and clarithromycin 0.5 g,each twice daily for 14 days.The eradication of H.pylori was assessed using 13C-urea breath tests or stool tests for H.pylori antigens,carried out 4 to 8 weeks following the conclusion of treatment.Additionally,we documented any adverse reactions,medication adherence,and the incidence of recurrence after one year.Results The results of the intentionality(ITT)analysis of H.pylori eradication rate in HDDT patients(85.91%,57.65%)and the per protocol set(PP)analysis(94.57%,85.33%)showed significant differences(P<0.05).The incidence of adverse reactions and medication adherence in group 2 show no statistical significance(P>0.05).It showed high eradication rate in HDDT group(P<0.05).Compared with Hp recurrence rate in group 2 patients,HDDT group was slightly lower than BQT group(1.64%,4.69%),which was no statistically significant difference(P>0.05).Conclusions For H.pylori infected patients,the combination(esomeprazole combined with amoxicillin)had good eradication efficacy,good safety profile,comparable recurrence rate,and high medication compliance.
作者
蔡惠美
叶梓婕
马燕燕
阮贤妹
李晨辉
曹文瑜
CAI Huimei;YE Zijie;MA Yanyan;RUAN Xianmei;LI Chenhui;CAO Wenyu(Department of Gastroenterology,Fuzhou First Hospital Affiliated to Fujian Medical University,Fuzhou,Fujian 350000,China;Department of Pharmacy,Fuzhou First Hospital Affiliated to Fujian Medical University,Fuzhou,Fujian 350000,China;Department of Clinical Medicine,Fujian Medical University,Fuzhou,Fujian 350000,China)
出处
《中国医药指南》
2025年第20期19-23,共5页
Guide of China Medicine
基金
福州市市级科技计划项目(2021-S-254)
福建省临床重点专科建设项目经费资助(No.20230105)。
关键词
幽门螺杆菌
根除治疗
二联疗法
四联疗法
复发
Helicobacter pylori
Eradication therapy
Dual therapy
Quadruple therapy
Recurrence rate
