摘要
目的比较标准三联疗法、四联疗法及序贯疗法根除幽门螺杆菌(Hp)的疗效及安全性。方法300例非溃疡性消化不良者随机入选三联、四联及序贯疗法组,三联疗法组予兰索拉唑+阿莫西林+克拉霉素治疗10d。四联疗法组予兰索拉唑+胶体次枸橼酸铋+阿莫西林+克拉霉素治疗10d。序贯疗法组前5d予兰索拉唑+阿莫西林治疗,后5d予兰索拉唑+克拉霉素+甲硝唑治疗。治疗结束至少停药4周后复查14 C尿素呼气试验,结果阴性表示根除成功。同时评估疗效及安全性。对Hp根除率进行意向性分析和符合方案分析比较。结果意向性分析显示三联疗法组、四联疗法组及序贯疗法组的Hp根除率分别是66%(66/100)、82%(82/100)及84%(84/100)。符合方案分析显示三联疗法组、四联疗法组及序贯疗法组的Hp根除率分别是72%(66/92)、91%(82/90)及89%(84/94)。意向性分析及符合方案分析均表明三联疗法组Hp根除率明显低于四联疗法组或序贯疗法组,差异有统计学意义(P均<0.05),而四联疗法组与序贯疗法组间差异无统计学意义(P>0.05)。结论四联疗法或序贯疗法可作为临床根治Hp的一线治疗方案。
Objective To compare the efficacy and safety of triple therapy ,therapy ,quadruple therapy and sequential therapy in Helicobacter pylori （Hp） eradication .Methods A total of 300 Hp positive patients with non-ulcer dyspepsia were recruited and randomly assigned into triple therapy ,therapy ,quadruple therapy and se-quential therapy group .The patients in tripietriple therapy group received lansoprazole ,amoxicillin and clarithro-mycin forclarithromycin for 10 days .The patients in quadruple therapy group received lansoprazole ,colloidal bis-muth subcitrate ,amoxicillin and clarithromycin forclarithromycin for 10 days .The patients in sequential therapy group received lansoprazole with amoxicillin for 5 days ,and then lansoprazole with clarithromycin and metron-idazole for another five days .The 14C-urea breathe test was re-examined at least 4 weeks after the completion of treatment ,the result with Hp negative indicated the success of Hp eradication .The efficacy and safety were also evaluated .Hp eradication rates were compared with the intention-to-treat（ITT） and per protocol （PP） analysis . Results According to ITT analysis ,the eradication rates of Hp in triple therapy group ,quadruple therapy group , and sequential therapy group were 66% （66/100） ,82% （82/100） and 84% （84/100） respectively .According to PP analysis ,the eradication rates of Hp in triple therapy group ,quadruple therapy group ,and sequential therapy group were 72% （66/92） ,91% （82/90） and 89% （84/94） respectively .Whether with ITT analysis or with ITT analysis ,the Hp eradication rate in the triple therapy group was lower than that of the quadruple therapy group or that of the sequential therapy group .There was significant difference .However ,there was no significant differ-ence of the Hp eradication betweentbetween the quadruple therapy group and the sequential therapy group .Con-clusion The quadruple therapy and the sequential therapy should be considered as the first line choice .
基金
广东省清远市科技信息局计划项目(2012B011204024)
关键词
螺杆菌
幽门
药物疗法
治疗结果
Helicobacter pylori
Drug therapy
T reatment outcome
