中国药物经济学2024，Vol.19Issue(11)：16-21,6.DOI:10.12010/j.issn.1673-5846.2024.11.003
基于安全与有效以及经济学指标建立伏立康唑原研与仿制药综合评价体系
Establishing A Comprehensive Evaluation System for Voriconazole Original and Generic Drugs:An Analysis of Safety,Efficacy,and Economic Indicators
摘要
Abstract
Objective To evaluate the three indicators of safety,efficacy and economy of voriconazole tablets originator and two generics(generic A and generic B),to provide data support for the smooth promotion of China's pooled procurement policy and the rational use of antifungal drugs.Methods A retrospective analysis method was used to extract the data of all inpatients who used the original and pooled imitation voriconazole tablets in the First Affiliated Hospital of Guangxi Medical University from January to December 2022 through hospital information system(HIS).They were divided into groups according to the different drugs used:Group Ⅰ:only the original drugs were used;Group Ⅱ:only generic drugs were used in group A;Group Ⅲ:Only generic drugs were used in Group B.The main efficacy index was whether the Voriconazole concentration reached the standard in blood,and the effect on the indicators of infection and inflammation was included to evaluate the efficacy of the drug.The safety of voriconazole was evaluated by the effects of voriconazole on liver enzymes and the reporting of adverse reactions.Cost-effectiveness analysis was used to evaluate the economy and sensitivity of the drug.Results There was no significant difference in the effectiveness indexes between the original drug and two generic drugs(P＞0.05).There were statistically significant differences between the original and generic B glutamyltransferase(GGT)(P＜0.05),and no statistically significant differences in other safety indexes between the original and two generic drugs(P＞0.05).The effective rate of imitation A was the highest,the effective rate of imitation B was the lowest,and the effective rate of the original drug was in the middle.3 Component cost-effectiveness analysis showed that the cost-effectiveness ratio of the original drug was 711.99,that of generic A was 547.90,and that of generic B was 463.34.The cost-effectiveness ratio of the original drug was the highest and had the least cost-effectiveness advantage.The results of sensitivity analysis were consistent with those of cost-effectiveness analysis.Conclusion The use of oral home-made voriconazole tablets may reduce the economic burden of hospitalisation for patients and is not inferior to the originator oral drug in terms of effectiveness,while there may be differences in terms of safety.关键词
伏立康唑/真实世界/安全性/有效性/经济性Key words
Voriconazole/Real world/Safety/Efficacy/Economics分类
医药卫生引用本文复制引用
罗俊,戚志伟,韦坤璇,陈杰梅,王丹丹,刘国萍,刘滔滔,覃福礼..基于安全与有效以及经济学指标建立伏立康唑原研与仿制药综合评价体系[J].中国药物经济学,2024,19(11):16-21,6.基金项目
广西高校中青年教师科研基础能力提升项目(2022KY0089) （2022KY0089）
广西壮族自治区卫生健康委员会自筹经费科研课题项目(Z-A20220427) （Z-A20220427）
广西壮族自治区卫生健康委员会自筹经费科研课题项目(Z20201369) （Z20201369）
