基于真实世界数据的阿托伐他汀钙片集采品种短期降脂效果、安全性及经济性评价  

Evaluation of short-term lipid-lowering effect,safety,and economics of centralized procured atorvastatin calcium tablets based on real-world data

作　　者：吴义来 何银梅 余建国 栾家杰[1] Wu Yilai;He Yinmei;Yu Jianguo;Luan Jiajie(Department of Clinical Pharmacy,Yijishan Hospital of Wannan Medical College,Wuhu,Anhui 241000,China;Department of pharmacy,the Second Affiliated Hospital of Wannan Medical College,Wuhu,Anhui 241000,China)

机构地区：[1]皖南医学院弋矶山医院临床药学科,安徽芜湖241000 [2]皖南医学院第二附属医院药剂科,安徽芜湖241000

出　　处：《齐齐哈尔医学院学报》2024年第18期1707-1712,共6页Journal of Qiqihar Medical University

基　　金：中华医学会临床药学专项科研基金(Z-2021-46-2101)。

摘　　要：目的比较阿托伐他汀钙片集采品种与原研品种短期降脂效果和不良事件间的差异,并基于真实世界数据进行药物经济学评价,为临床实践提供依据。方法选择2023年5—12月本院首次确诊高脂血症的患者73例作为研究对象,根据服用的阿托伐他汀钙片品种分为对照组(29例)和观察组(44例)两组。对照组口服原研品种治疗,观察组口服集采品种治疗。比较服药前及服药后1个月血脂指标,并评估两组方案不良事件发生率及经济性。结果治疗后观察组与对照组TC、TG、LDL-C、非HDL-C均显著降低(P<0.05)。但两组间各血脂指标的降幅无统计学意义(P>0.05)。观察组肝酶异常发生率为9.1%,高于对照组的3.4%,但均属1级不良反应,不影响临床治疗。最小成本法显示集中采购品种阿托伐他汀片年药品费用为93.08元,显著低于原研品种。结论基于真实世界数据,阿托伐他汀钙片集采品种短期降脂效果、安全性与原研品种无显著区别,集采品种使得降脂治疗费用大幅度降低。Objective To compare the short-term lipid-lowering effects and adverse events between centralized procured generic atorvastatin calcium tablets and the original brand,and to perform a pharmacoeconomic evaluation using real-world data to provide evidence for clinical practice.Methods Between May and December 2023,73 patients newly diagnosed with hyperlipidemia at Yijishan Hospital of Wannan Medical College were selected as study subjects.They were divided into a control group(29 cases)and an observation group(44 cases)based on the type of atorvastatin calcium tablets they received.The control group was treated with the original brand,while the observation group received the centralized procurement generic.The blood lipid indexes of the two groups were compared before and one month after medication,and the incidence of adverse events and the economics of the two treatment schemes were evaluated.Results After treatment,both the observation group and the control group showed significant reductions in TC,TG,LDL-C,and non-HDL-C(P<0.05).However,there was no statistically significant difference in the reduction of lipid profiles between the two groups(P>0.05).The incidence of abnormal liver enzymes in the observation group was 9.1%,which was higher than the 3.4%in the control group,but both were Grade 1 mild adverse reactions that did not affect clinical treatment.The minimum cost analysis showed that the annual drug cost of centralized procured atorvastatin calcium tablets was 93.08 Yuan that significantly lower than original drug.Conclusions Based on real-world data,there was no significant difference in the short-term lipid-lowering effect and safety between the centralized procured atorvastatin calcium tablets and the original drug.The centralized procured drugs significantly reduced the cost of lipid-lowering treatment.

关 键 词：阿托伐他汀钙片 国家组织集中带量采购 真实世界数据 短期降脂 药物经济学 

分 类 号：R969.3[医药卫生—药理学]