含左氧氟沙星5日伴同疗法根除幽门螺杆菌感染的疗效

Efficacy of 5-day levofloxacin-containing concomitant therapy in eradicating Helicobacter pylori infection

目的:观察含左氧氟沙星5日伴同疗法对幽门螺杆菌(Helicobacter pylori,H.pylori)的根除效果和安全性.方法:既往未接受过H.pylori根除治疗的H.pylori阳性感染患者160例,随机分为含左氧氟沙星5日伴同疗法组(病例组)和10日序贯疗法组(对照组).疗程结束4 wk后行14C-尿素呼气试验判断两组的H.pylori根除效果,同时比较两组不良反应.结果:按意向性治疗(intention-to-treat,ITT)分析,病例组根除率为90%,对照组为91.25%;按符合方案集(per-protocol,PP)分析,病例组92.31%,对照组为92.41%.病例组的ITT、PP根除率非劣效于对照组,P<0.05.两组间不良反应发生率分别为11.25%及13.75%,P>0.05.结论:含左氧氟沙星5日伴同疗法能达到与10日序贯疗法相近的根除率,能有效根除H.pylori,且安全性良好,有望作为一有效的初治方案.

AIM： To assess the efficacy and safety of 5-day levofloxacin-containing concomitant therapy in eradicating of Helicobacter pylori（H. pylori） infec-tion. METHODS： One hundred and sixty patients with H. pylori infection who did not receive eradication therapy were randomly assigned to two groups to receive 5-day levofloxacin-con-taining concomitant therapy and 10-day sequen-tial therapy, respectively. The eradication effect was assessed by the 14C-urea breath test at 4 wk after treatment. Adverse events were recorded. RESULTS： According to intention-to-treat（ITT） analysis, the eradication rates of H. pylori inthe concomitant therapy group and sequential therapy group were 90% and 91.25%, respec-tively. According to per-protocol（PP） analysis, the eradication rates were 92.31% and 92.41%, respectively. The ITT and PP eradication rates in the concomitant therapy group were not inferior to those in the sequential therapy group（P〈0.05）. The rates of adverse events were 11.25% and 13.757%, respectively（P〉0.05）. CONCLUSION： The 5-day levofloxacin-contain-ing concomitant therapy is as effective and safe in eradicating H. pylori infection as the 10-day levofloxacin-containing sequential therapy.