莫西沙星序贯疗法与镶嵌疗法根除幽门螺旋杆菌临床有效性的比较研究

Comparison of clinical efficacy of moxifloxacin-based sequential and hybrid therapy for the Helicobacter pylori eradication

目的:比较莫西沙星序贯疗法与镶嵌疗法根除幽门螺旋杆菌(Helicobacter pylori,Hp)的临床有效性。方法:选取2012年5月至2015年11月于我院治疗的144例Hp感染患者为研究对象,随机分为A、B两组,每组72例,分别接受14日莫西沙星序贯疗法和14日镶嵌疗法。治疗后4周^(13)C-urea呼气试验结果为阴性者定义为Hp根除成功;患者的药物摄入率超过85%定义为依从性良好。记录患者的Hp根除率、治疗依从率及不良反应发生率。结果:A组患者意向治疗(intention-to-treat,ITT)分析根除率为91.7%(66/72,95%CI 90.1%~92.8%),高于B组的79.2%(57/72,95%CI 77.2%~80.6%),且组间差异具有统计学意义(P=0.02)。A组患者方案(per protocol,PP)分析根除率为94.3%(66/70,95%CI 92.8%~95.5%),明显高于B组的83.8%(57/68,95%CI 80.5%~84.0%,P=0.005)。另外,A组的不良反应发生率低于B组(11.4%vs 20.6%,P=0.03)。结论:作为Hp一线治疗方案,14日莫西沙星序贯疗法与14日镶嵌疗法相比具有更高的Hp根除率、治疗依从性及更低的不良反应发生率。

Objective： To compare the clinical efficacy of moxifloxacin-based sequential and hybrid therapy for the Helicobacter pylori（ Hp） eradication. Methods： 144 patients with Hp infection from May 2012 to December2015 treared in our hospital were chosen,they were randomly divided into group A and B with 72 patients in each group,and received the 14-day course of moxifloxacin-based sequential therapy and 14-day course of hybrid therapy,respectively. Successful eradication of Hp infection was defined as a negative^13C-urea breath test 4 weeks after the treatment. Patient compliance was defined as good if drug intake was larger than 85%. Hp eradication rate,compliance with treatment and adverse event rate were evaluated. Results： The eradication rate in the intention-to-treat（ ITT） analysis in group A was 91. 7%（ 66/72,95% CI 90. 1% - 92. 8%）,higher than 79. 2%（ 57/72,95% CI 77. 2% - 80. 6%） in group B,with statistically significant difference（ P = 0. 02）. The eradication rate in per-protocol（ PP） analysis in group A was 94. 3%（ 66/70,95% CI 92. 8% - 95. 5%）,significantly higher than 83. 8%（ 57/68,95% CI 80. 5% - 84. 0%,P = 0. 005） in group B. Additionally,the adverse event rate in group A was lower than that in group B（ 11. 4% vs 20. 6%,P = 0. 03）. Conclusion： As the first-line treatment of Hp,14-day moxifloxacin-based sequential therapy has the higher eradication rate,compliance with treatment and lower adverse event rate compared with 14-day course of hybrid therapy.