基于莫西沙星和铋剂的四联疗法对幽门螺杆菌根除失败后的补救治疗

Remedial Effect of Quadruple Therapy Based on Moxifloxacin and Bismuth on Eradication Failured of Helicobacter Pylori

【目的】评价基于莫西沙星和铋剂的四联疗法对幽门螺杆菌根除失败后进行补救治疗的有效性和安全性。【方法】应用前瞻性、随机、对照研究的方法,将符合入选标准的患者136例随机分为拓展四联方案组(66例)和经典四联方案组(70例),分别按照拓展四联方案(胶体果胶铋100 mg tid+兰索拉唑30 mg bid+阿莫西林1000 mg bid+莫西沙星400 mg qd联用)和经典铋剂四联方案(胶体果胶铋100 mg tid+兰索拉唑30 mg bid+四环素片750 mg bid+甲硝唑片400 mg bid联用),疗程均为14 d。在治疗结束1月后,分别对两组患者进行内镜检查、快速尿素酶试验和13碳/14碳尿素酶呼气试验进行疗效评价,并对药物不良反应和依从性进行监测。【结果】拓展四联方案组60例完成最后的治疗及随访,其中55例补救治疗获得成功,按照意向治疗(ITT)和符合方案(PP)补救治疗Hp根除率分别为83.3%(55/66)和91.7%(55/60)。经典四联方案组64例完成最后的治疗及随访,其中37例补救治疗获得成功,按照意向治疗(ITT)和符合方案(PP)补救治疗Hp根除率分别为52.9%(37/70)和57.8%(37/64),差异均有统计学意义(P<0.001)。药物不良反应和依从性方面的监测结果显示,两组患者差异无统计学意义(P>0.05)。【结论】基于莫西沙星和铋剂的四联疗法对初次幽门螺杆菌根除失败后进行补救治疗的根除率高于经典的铋剂四联方案,在安全性方面与经典铋剂四联方案无异,具备作为初次Hp根除失败后进行补救治疗方案的基本条件。

[Objective ] To evaluate the efficacy and safety of quadruple therapy based on moxifloxacin and bismuth in the treatment of Helicobacter pylori eradication failure. [ Methods ] A prospective, randomized, comparative study was conducted in which 136 eligible patients were randomly divided into the extended quadruple group （66 patients, and the quadruplex therapies are Pectin bismuth 100 mg tid ＋ lansoprazole 30 mg bid ＋ amoxicillin 1000 mg bid ＋ moxifloxacin 400 mg qd） and the classical quadruple group （70 patients, and the quadruple therapies are colloidal pectin bismuth 100 mg tid ＋ lansoprazole 30 mg bid ＋ tetracycline tablet 750 mg Bid ＋ metronidazole tablets 400 mg bid combination ） and were under treatment for 14 days. One month after the treatment, endoscopy, rapid urease test, and 13-carbon/ 14-carbon urease breath test were used to evaluate the adverse effects and adherence of the drugs in the two groups respectively. [ Results ] In the extended quadruple group, among 60 patients who had completed the final treatment and follow-up survey, 55 were successfully treated, with eradication rates of （83.3%, 55/66） and 91.7% （55/60） according to intention-to-treat （ITT） and Per-protocol （PP） respectively. In the classic quadruple group, 64 patients completed the final treatment and follow-up survey. Among them, 37 cases were successful, and the eradication rates according to ITT and PP remedy are 52.9% （37/70） and 57.8% （37/64） respectively. The difference was statistically significant （P 〈 0.001 ）. Adverse drug reactions and compliance monitoring showed no significant difference between the two groups （P 〉 0.05 ）. [ Conclusion ] The quadruple therapy based on moxifloxacin and bismuth displays a higher eradication rate than that of the classical bismuth quadruple therapy on the first-time elimination failure of Helicobacter pylori while shows no difference in safety consideration, thus can serve as remedial therapy for the primary lip eradication failure.