仿制与原研注射用头孢曲松钠治疗社区获得性肺炎患儿药物经济学比较  

Pharmacoeconomic Comparison of Generic and Original-Patented Ceftriaxone Sodium for Injection in the Treatment of Community-Acquired Pneumonia in Children

作　　者：李雨萱 尹东锋 李倩 LI Yuxuan;YIN Dongfeng;LI Qian(School of Pharmacy,Shihezi University,Shihezi,Xinjiang,China 832003;General Hospital of Xinjiang Military Region,Urumqi,Xinjiang,China 832002)

机构地区：[1]石河子大学药学院,新疆石河子832003 [2]中国人民解放军新疆军区总医院,新疆乌鲁木齐832002

出　　处：《中国药业》2024年第2期113-116,共4页China Pharmaceuticals

基　　金：军队后勤科研项目[ZLJ22J022]。

摘　　要：目的对比注射用头孢曲松钠的国家组织药品集中带量采购(简称国家集采)中选品规(仿制药)与其原研药对应品规治疗社区获得性肺炎(CAP)患儿的药物经济学情况。方法调取新疆军区总医院电子病历系统中2020年1月至2022年8月该院儿科收治的非重症CAP患儿(年龄3个月至14岁)资料292份,根据治疗药物的不同分为A组(140份)和B组(152份),两组分别予注射用头孢曲松钠的仿制药和原研药品规(规格均为每支1.0 g)静脉滴注方案。查阅两组患儿的临床疗效、不良反应发生情况并计算治疗成本;采用成本-效果分析法进行药物经济学比较,并以敏感性分析验证。结果A组与B组患儿的有效率相当(87.14%比89.47%,P>0.05)。A组各项治疗成本(除住院成本外)均显著低于B组(P<0.01);A组体温好转时间显著长于B组,不良反应发生率显著高于B组(P<0.05);B组增量成本-效果比为471.36;敏感性分析结果显示,在总成本降低10%和有效率取95%置信区间下限的前提下,B组增量成本-效果比分别为424.23,364.88。结论注射用头孢曲松钠的仿制药比原研对应品规更具经济学优势。Objective To compare the pharmacoeconomics of bid-wining Ceftriaxone Sodium for Injection in the National Centralized-Drug Procurement(generic drug)and corresponding original-patented drug in the treatment of community-acquired pneumonia(CAP)in children.Methods A total of 292 children(three months to fourteen years)with non-severe CAP admitted to the Department of Pediatrics in the General Hospital of Xinjiang Military Region from January 2020 to August 2022 were selected by the hospital electronic medical-record system and divided into the group A(140 cases)and group B(152 cases)based on the different therapeutic drugs.The children in the groups A and B were given the intravenous drip of generic and original-patented drug(both with a specification of 1.0 g each)respectively.The clinical efficacy and incidence of adverse reactions in the two groups were obtained,and the treatment costs were calculated.The cost-effectiveness analysis was used to compare the pharmacoeconomics,and the sensitivity analysis was used for verification.Results The effective rates in the groups A and B were similar(87.14%vs.89.47%,P>0.05).The treatment costs(excluding hospitalization costs)in the group A were significantly lower than those in the group B(P<0.01).The time to temperature improvement in the group A was significantly longer than that in the group B,and the incidence of adverse reactions was significantly higher than that in the group B(P<0.05).The incremental cost-effectiveness ratio(ICER)in the group B was 471.36.The sensitivity analysis showed that the ICER in the group B was 424.23 when the total costs decreased by 10%,and that was 364.88 when the effective rate was at the lower limit of the 95%CI.Conclusion The generic Ceftriaxone Sodium for Injection is more economical than original patented drug.

关 键 词：儿童 社区获得性肺炎 注射用头孢曲松钠 原研药 仿制药 药物经济学 成本-效果 

分 类 号：R969.3[医药卫生—药理学] R978.1[医药卫生—药学]