仿制与原研注射用头孢呋辛钠治疗儿童支气管肺炎疗效、安全性及经济性比较
Comparison of Efficacy,Safety and Economy Between Generic and Original-Patented Cefuroxime Sodium for Injection in the Treatment of Pediatric Bronchopneumonia
李明芳 1李承铖 2赵营莉 1单亮 1左东泽 1刘建军1
作者信息
- 1. 安徽省合肥市第二人民医院·安徽医科大学附属合肥医院,安徽 合肥 230011
- 2. 安徽省合肥市蜀山区疾病预防控制中心,安徽 合肥 230031
- 折叠
摘要
目的 比较注射用头孢呋辛钠的仿制药与原研药治疗支气管肺炎患儿的疗效、安全性及经济性.方法 通过医院信息系统档案数据库提取合肥市第二人民医院 2019 年 1 月至 2022 年 12 月收治的使用注射用头孢呋辛钠的支气管肺炎患儿的基本信息及临床资料,按用药的不同分为仿制组和原研组,以临床有效率和细菌清除情况评估疗效,以不良反应发生率评估安全性,将头孢呋辛钠费用视为药物治疗费以计算成本,并计算成本-效果比.结果 采用倾向性评分匹配法按 1∶2 匹配后仿制组和原研组分别纳入 104 例和208 例,两组的临床有效率、细菌清除情况及不良反应发生率均无显著差异(P>0.05);仿制组成本-效果比为 2.26,远低于原研组的 11.41.结论 注射用头孢呋辛钠仿制药和原研药的疗效与安全性具有临床一致性,仿制药经济性更具优势.
Abstract
Objective To compare the efficacy,safety and economy of generic and original-patented Cefuroxime Sodium for Injection in the treatment of pediatric bronchopneumonia.Methods Basic information and clinical data of children with bronchopneumonia treated with Cefuroxime Sodium for Injection at the Second People's Hospital of Hefei from January 2019 to December 2022 were extracted from the hospital information system archive database.The above children were divided into the generic group and the original-patented group according to different drugs.The efficacy was evaluated based on clinical effective rate and cases of bacterial clearance.The safety was evaluated based on the incidence of adverse reactions.The cefuroxime sodium fees was taken as the drug costs to calculate the costs and cost-effectiveness ratio.Results After matching at a ratio of 1∶2 by the propensity score matching,104 cases and 208 cases were included in the generic group and the original-patented group respectively.There was no significant difference in the clinical effective rate,cases of bacterial clearance and incidence of adverse reactions between the two groups(P>0.05).The cost-effectiveness ratio in the generic group was 2.26,which was significantly lower than 11.41 in the original-patented group.Conclusion The efficacy and safety of generic and original-patented Cefuroxime Sodium for Injection is consistent in clinical practice,while generic drugs are more economical.
关键词
真实世界研究/注射用头孢呋辛钠/仿制药/原研药/有效性/安全性/经济性Key words
real world study/Cefuroxime Sodium for Injection/generic drug/original-patented drug/clinical efficacy/safety/economy引用本文复制引用
基金项目
安徽省卫生健康委员会项目(AHWJ2023BAc20099)
蚌埠医学院自然科学类项目(BYKY2019304ZD)
出版年
2024
国家科技期刊平台
NSTL
万方数据