含芦氟沙星四联疗法和含大剂量阿莫西林二联疗法用于幽门螺杆菌根除失败后补救治疗的疗效分析

背景:一线三联疗法根除幽门螺杆菌(Hp)的失败率日益增高。如何选用有效的抗菌药物进行Hp根除失败的补救治疗是临床亟待解决的问题。目的:评估含芦氟沙星四联疗法和含大剂量阿莫西林二联疗法补救根除Hp的有效性和安全性。方法:93例Hp根除失败的患者随机进入含芦氟沙星四联疗法(RBRF)组(雷贝拉唑10 mg bid+枸橼酸铋雷尼替丁220 mg bid+芦氟沙星200 mg qm+呋喃唑酮100 mg bid,疗程14 d)和含大剂量阿莫西林二联疗法(RA)组(雷贝拉唑20 mg bid+阿莫西林1000 mg tid,疗程14 d),治疗结束4周后复查13C-尿素呼气试验,评估Hp根除疗效。结果:共85例患者完成试验,RBRF组按意向治疗(ITT)和按方案(PP)分析根除率分别为83.3%和90.9%,RA组分别为80.0%和87.8%,两组ITT和PP根除率差异均无统计学意义(P>0.05)。按PP分析,RBRF组不良反应发生率显著高于RA组(15.9%对2.4%,P<0.05),所有不良反应均在停药后消失。结论:对Hp根除失败的患者,含芦氟沙星四联疗法和含大剂量阿莫西林二联疗法均可作为安全、有效的补救治疗方案。

Efficacy of Quadruple Therapy with Rufloxacin and Dual Therapy with High Dose Amoxicillin as Rescue Regimens for Failure of Helicobacter pylori Eradication

Background： The failure rate of first-line triple eradication therapy for Helicobacter pylori （Hp） infection is increasing. Therefore, selecting effective antibiotics for rescue therapy in patients with failure of Hp eradication has been an eager task. Aims： To assess the efficacy and safety of quadruple therapy with rufloxacin and dual therapy with high dose amoxicillin as rescue regimens for Hp eradication. Methods： Ninety-three patients who had failed in Hp eradication were randomly assigned into quadruple therapy with rufloxacin （RBRF） group （rabeprazole 10 mg bid ＋ ranitidine bismuth citrate 220 mg bid ＋ rufloxacin 200 mg qm ＋ furazolidone 100 mg bid for 14 days ） and dual therapy with high dose amoxicillin （RA） group （rabeprazole 20 mg bid ＋ amoxicillin lO00 mg tid for 14 days）. Four weeks after the treatment course, 13 C-urea breath test was reexamined to assess the Hp eradication rate. Results： A total of 85 patients completed the trial. Hp eradication rates by intention-to-treat （ITT） and per-protocol （PP） analysis in RBRF group were 83.3% and 90.9%, respectively; and those in RA group were 80.0% and 87.8%, respectively. No significant difference in Hp eradication rates by ITr and PP analysis was found between the two groups （P 〉 0.05）. The incidence of adverse effect by PP analysis in RBRF group was significantly higher than that in RA group （ 15.9% vs. 2.4% , P 〈 0.05）. All the adverse effects disappeared spontaneously after the stopping of drug. Conclusions ： Both quadruple therapy with rufloxacin and dual therapy with high dose amoxicillin can be used as effective and safety rescue therapy for patients with failure of Hp eradication.