仿制药与原研药对急性冠脉综合征患者的疗效和经济性影响研究  

Study on the Efficacy and Economic Effects of Generic Drugs and Original Drugs on Patients with Acute Coronary Syndrome

作　　者：张惠君 刘惠强[1] 劳淑贞 李伟杰 黄洁 李嘉聆 王衍洪[1] ZHANG Huijun;LIU Huiqiang;LAO Shuzhen;LI Weijie;HUANG Jie;LI Jialing;WANG Yanhong(Department of Pharmacy,Dongguan Tungwah Hospital,Dongguan,Guangdong 523110,China;Binhaiwan Central Hospital of Dongguan,Dongguan,Guangdong 523900,China;Department of Pharmacy,Dongguan Songshan Lake Tungwah Hospital,Dongguan,Guangdong 523808,China;Department of Cardiovascular Medicine,Dongguan Tungwah Hospital,Dongguan,Guangdong 523110,China)

机构地区：[1]东莞东华医院药学部,广东东莞523110 [2]东莞市滨海湾中心医院,广东东莞523000 [3]东莞东华医院心血管内科,广东东莞523110 [4]东莞松山湖东华医院药学部,广东东莞523808

出　　处：《今日药学》2025年第2期118-122,共5页Pharmacy Today

基　　金：东莞市社会发展科技面上项目(20221800903012)。

摘　　要：目的通过对急性冠脉综合征患者使用仿制药与原研药情况进行对比分析,旨在探讨ACS患者使用仿制药与原研药的有效性和经济性影响。方法回顾性收集2019年1月~2023年10月于某院心内科门诊就诊的ACS患者的临床资料,共筛选出135例患者,按ACS二级预防用药分类分为3组,血压组(n=56)、心率组(n=49)和血脂组(n=30),统计患者使用原研药6个月与换用仿制药后6个月的临床治疗效果、有效率、药物经济学评价等指标。结果对血压组、血脂组和心率组分别使用原研药和仿制药后所得的治疗效果进行比较,仿制药治疗效果与原研药接近,差异均无统计学意义(P>0.05)。血压组与心率组在换药前后临床有效率结果一致,血脂组在使用原研药期间有效率为96.67%(29/30),换用仿制药后有效率为93.33%(28/30),差异无统计学意义(P>0.05)。3组患者由原研药转用仿制药后C、C/E均明显低于换药前,△C/△E为正数,换药后的用药方案更具经济性。敏感性分析结果显示转用仿制药后的用药方案依然更具经济性。结论ACS二级预防用药中降压药物、调脂药物、控制心率药物在原研药和仿制药的比较中显示出有效性相当,而在药物经济性上仿制药显示出绝对的优势。OBJECTIVE To compare and analyze the use of generic drugs and original drugs in patients with acute coronary syndrome,in order to explore the effectiveness and economic impact of generic drugs and original drugs in patients with ACS.METHODS Clinical data of ACS patients treated in the cardiology outpatient department of a hospital from January 2019 to October 2023 were retrospectively collected.A total of 135 patients were screened out and divided into 3 groups based on the secondary preventive drugs for ACS,blood pressure group(n=56),heart rate group(n=49),and blood lipid group(n=30).The clinical therapeutic effect,effective rate,and pharmacoeconomic evaluation of patients using the original drug for 6 months and the generic drug for 6 months were analyzed.RESULTS Blood pressure group,blood lipid group,and heart rate group were compared after using the original drug and generic drug,the therapeutic effect of the generic drug was close to that of the original drug,and the difference was not statistically significant(P>0.05).The clinical effective rate of blood pressure group and heart rate group before and after drug change was consistent,the effective rate of blood lipid group was 96.67%(29/30)during the use of the original drug,and 93.33%(28/30)after the change to generic drug,the difference was not statistically significant(P>0.05).C and C/E in three groups were significantly lower than before drug change after switching from original drug to generic drug,and△C/△E was positive,indicating that the drug use regimen after the drug change was more economical.Sensitivity analysis showed that the drug regimen was still more economical after switching to generic drugs.CONCLUSION The effectiveness of antihypertensive drugs,lipid-regulating drugs and heart rate control drugs in the secondary prevention of ACS was comparable between the original drugs and generic drugs,and the generic drugs showed absolute advantages in drug economy.

关 键 词：急性冠脉综合征 仿制药 原研药 降压 调脂 心率 有效性 经济性 

分 类 号：R969[医药卫生—药理学]