首页|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

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

扫码查看
目的 评价伏立康唑片剂原研药与两种仿制药(仿制A、仿制B)的安全性、有效性和经济性 3 个指标,为我国集采政策顺利推进和抗真菌药物合理使用提供数据支撑。方法 采用病历回顾性分析方法,通过医院信息系统(HIS)提取2022 年1-12 月广西医科大学第一附属医院使用原研、集采仿制伏立康唑片剂的全部住院患者资料。根据使用药品不同进行分组:Ⅰ组:只使用原研药品组;Ⅱ组:只使用仿制药品A组;Ⅲ组:只使用仿制药品B组。以伏立康唑血药浓度是否达标作为主要有效性指标,同时纳入对感染炎症指标的影响评价药物有效性;以伏立康唑对肝酶影响和不良反应上报情况评价药物安全性;采用成本-效果分析方法评价药物的经济性,并进行敏感性分析。结果 原研药与两种仿制药有效性指标比较均无统计学差异(P>0。05);原研药与仿制 B 谷氨酰转移酶(GGT)比较差异有统计学意义(P<0。05),原研药与两种仿制药其他安全性指标比较均无统计学差异(P>0。05);仿制A有效率最高,仿制B有效率最低,原研药品有效率居中。3 组成本-效果分析显示,原研药品成本-效果比为 711。99、仿制A为547。90、仿制B为463。34,原研药品成本-效果比最高,最不具有成本-效果优势。敏感性分析结果与成本-效果分析结果一致。结论 使用口服国产伏立康唑片剂可降低患者住院经济负担,在有效性方面不劣于原研口服药物,而在安全性方面则可能存在差异。
Establishing A Comprehensive Evaluation System for Voriconazole Original and Generic Drugs:An Analysis of Safety,Efficacy,and Economic Indicators
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.

VoriconazoleReal worldSafetyEfficacyEconomics

罗俊、戚志伟、韦坤璇、陈杰梅、王丹丹、刘国萍、刘滔滔、覃福礼

展开 >

广西医科大学第一附属医院药学部,南宁 530021

柳州市人民医院药学部,广西 柳州 545200

伏立康唑 真实世界 安全性 有效性 经济性

2024

中国药物经济学
中国中医药研究促进会

中国药物经济学

影响因子:0.712
ISSN:1673-5846
年,卷(期):2024.19(11)