安妥沙星铋剂四联疗法根除幽门螺杆菌疗效分析

Antofloxacin-based Bismuth Quadruple Therapy for Helicobacter pylori Eradication

背景:抗菌药物耐药是导致幽门螺杆菌(Hp)根除治疗失败的重要原因,因此探索新的Hp根除治疗方案成为研究热点。目的:探讨安妥沙星铋剂四联疗法在初治患者中根除Hp的疗效、安全性和最佳剂量。方法:纳入2019年1月—2019年12月在中国人民解放军联勤保障部队第900医院初次接受Hp根除治疗的患者400例,随机分为4组,每组100例。安妥沙星减量组、常规组和加量组根除治疗方案为安妥沙星100 mg/200 mg/300 mg,qd+泮托拉唑40 mg,bid+枸橼酸铋钾220 mg,bid+阿莫西林1000 mg,bid,口服14 d;对照组采用左氧氟沙星500 mg,qd,另三种药物剂量和用法与试验组相同。记录治疗过程中的不良反应。停药至少4周后行13C/14C-尿素呼气试验检测Hp。结果:384例患者完成治疗和随访。安妥沙星减量组、常规组、加量组和对照组Hp根除率按符合方案(PP)分析分别为88.7%、93.8%、96.8%和80.4%,按意向治疗(ITT)分析分别为86.0%、90.0%、91.0%和78.0%。常规组和加量组与对照组间PP、ITT根除率差异均有统计学意义(P均<0.05)。三组试验组与对照组间不良反应发生率无明显差异(P均>0.05),加量组不良反应发生率明显高于减量组和常规组,差异有统计学意义(31%对16.0%和22.0%,P均<0.05)。结论:安妥沙星铋剂四联疗法在初治患者中可有效、安全地根除Hp,安妥沙星推荐剂量为200 mg,qd。

Background:Resistance to antibiotics is the major cause for failure of Helicobacter pylori(Hp)eradication therapy.Therefore,exploring new eradication regimen has become a hotspot of research.Aims:To investigate the efficacy,safety and optimal dose of antofloxacin-based bismuth quadruple therapy for first-line Hp eradication.Methods:Four hundred patients with Hp infection and naive to eradication therapy were prospectively recruited from January 2019 to December 2019 at the 900th Hospital of Joint Logistics Support Force,PLA and were randomly divided into four groups:low-,normal-,and high-dose antofloxacin groups and control group,100 cases in each group.Patients in low-,normal-,and high-dose antofloxacin groups received antofloxacin 100 mg,200 mg,and 300 mg qd,respectively,pantoprazole 40 mg bid,bismuth potassium citrate 220 mg bid,and amoxicillin 1000 mg bid for 14 days;patients in control group received levofloxacin 500 mg qd and the other three drugs with same dose and frequency for 14 days.Adverse events during treatment were recorded.Hp eradication was confirmed by 13C/14C-urease breath test at least 4 weeks after end of treatment.Results:A total of 384 patients finished the treatment course and follow-up.The eradication rates for per-protocol(PP)analysis of low-,normal-,and high-dose antofloxacin groups and control group were 88.7%,93.8%,96.8%,and 80.4%,respectively;and those for intention-to-treat(ITT)analysis were 86.0%,90.0%,91.0%,and 78.0%,respectively.Both PP and ITT eradication rates were significantly higher in normal-and high-dose antofloxacin groups than in control group(P all<0.05).No statistical differences in adverse events were detected between the three antofloxacin groups and control group(all P>0.05),and the adverse events occurred more frequently in high-dose antofloxacin group than in normal-and low-dose groups(31.0%vs.22.0%and 16.0%,all P<0.05).Conclusions:Antofloxacin-based bismuth quadruple therapy was effective and safe for first-line Hp eradication.The optimal dose of antofloxacin is 200 mg,qd.