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

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。

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.