序贯疗法和标准三联疗法对儿童幽门螺杆菌感染的根除效果和成本-效果评价

Cost-effectiveness evaluation of sequential therapy and standard triple therapy in eradication of Helicobacter pylori infection in children

目的:探讨序贯疗法和标准三联疗法对儿童幽门螺杆菌(Helicobacter pylori,Hp)的根除效果和药物经济学价值。方法:前瞻性选取90例Hp感染患儿(年龄4~14岁),按区组随机化方法分成Ⅰ组、Ⅱ组,每组各45例,分别采用标准三联和序贯疗法治疗。重点对两组患儿Hp根除效果和经济效益进行比较分析。结果:Ⅰ组、Ⅱ组分别有42例、43例完成治疗和复查,分别按意向性分析(intention-to-treat,ITT)和遵循研究方案分析(per-protocol,PP),Ⅱ组Hp根除率86.67%、90.70%均高于Ⅰ组66.67%、71.43%,差异有统计学意义(P<0.05);两组治疗后Hp感染临床症状评分均明显下降,且Ⅱ组治疗后"腹胀""厌食纳差"评分低于Ⅰ组,差异有统计学意义(P<0.05);组间治疗不良反应发生率和随访12个月复发率比较,差异无统计学意义(P>0.05);Ⅱ组疗程费用[(356.83±42.06)元]低于Ⅰ组[(457.08±55.19)元],分别按ITT和PP分析,Ⅱ组成本效果比(cost/effectiveness,C/E)为411.70、393.42均低于Ⅰ组的685.59、639.90。结论:序贯疗法对儿童Hp感染的根除率高于标准三联疗法,安全性好,药物经济学价值显著。

Objective:To explore the effects and pharmacoeconomic value of sequential therapy and standard triple therapy in eradication of Helicobacter pylori(Hp)infection in children.Methods:A total of 90 children with Hp infection(aged 4–14 years)were randomly divided into groupⅠand groupⅡ,with 45 cases in each group.Effectiveness and economic benefits of Hp eradication in the two groups of children were specially compared and analyzed.Results:Forty-two cases in groupⅠand 43 cases in groupⅡcompleted treatment and review respectively.According to intention to treat(ITT)and per protocol(PP),Hp eradication rates in groupⅡwere 86.67%and 90.70%,which were higher than 66.67%and 71.43%in groupⅠ(P<0.05).After treatment,the clinical symptom scores of Hp infection in the two groups decreased significantly,and the scores of"abdominal distension"and"anorexia"in groupⅡwere lower than those in groupⅠ(P<0.05).There was no significant difference in the incidence of adverse reactions and recurrence rate after 12 months of follow-up between the two groups(P>0.05).The treatment cost of groupⅡwas(356.83±42.06)yuan,which was lower than that of groupⅠ(457.08±55.19)yuan.According to ITT and PP analysis,the cost/effectiveness(C/E)of groupⅡwas 411.70 and 393.42,which were lower than that of groupⅠ(685.59 and 639.90).Conclusion:the eradication rate of sequential therapy for children with Hp infection is higher than that of standard triple therapy,with good safety,and the cost of treatment and C/E are significantly reduced,and the value of pharmacoeconomic is remarkable.