基于回顾性队列的阿托伐他汀钙仿制药与原研药安全性和经济性评价及危险因素评估

目的:比较真实世界患者人群使用阿托伐他汀钙仿制药与原研药的安全性和经济性,评估影响阿托伐他汀钙安全性的危险因素。方法:回顾性收集某三甲医院2020年5月至2021年4月在急诊药房使用阿托伐他汀钙的所有患者的病例数据及药品费用数据,根据所用阿托伐他汀钙药物品种分为原研药及仿制药组进行统计分析。结果:原研药组与仿制药组患者肌酸激酶升高(2.45%vs.2.91%),以及丙氨酸氨基转移酶和/或门冬氨酸氨基转移酶升高的不良反应发生率(3.67%vs.5.83%),差异均无统计学意义(P＞0.05)。多因素Logistic回归分析显示,高龄(OR=0.285,P=0.036)与肌酸激酶升高相关,感染(OR=0.366,P=0.026)、心梗(OR=0.303,P=0.048)与丙氨酸氨基转移酶和/或门冬氨酸氨基转移酶升高相关。仿制药的用药频度较原研药大幅提高(P＜0.01),使用成本仅为原研药的1/30。结论:阿托伐他汀钙仿制药比原研药经济性更好,且安全性无显著差异。高龄、感染、心梗可能是服用阿托伐他汀患者发生相关不良反应的重要危险因素。

Retrospective comparative study on safety,economy and risk assessment of the generic and branded atorvastatin calcium

OBJECTIVE To compare the safety and economy of atorvastatin calcium generic and original drugs in real-world patients,and to evaluate the risk factors affecting the safety of atorvastatin calcium.METHODS Data of patients taking atorvastatin calcium and the expense information from a Grade A tertiary hospital emergency pharmacy during May 2020 to April 2021 were retrospectively collected.The relevant data were divided into the branded and the generic groups by drug varieties.RESULTS There were no significant difference (P>0.05) in rates of increased creatine kinase (CK) (2.45% vs.2.91%),increased alanine aminotransferase (ALT) and/or aspartate transaminase (AST) (3.67% vs.5.83%) between the branded and generic groups.The multivariate analysis via logistic regression demonstrated that increased CK was related with advanced age(OR=0.285,P=0.036),and increased ALT and/or AST was related with infections (OR=0.366,P=0.026) and myocardial infarct (OR=0.303,P=0.048).The defined daily doses (DDDs) of generic atorvastatin was significantly increased compared with the branded atorvastatin (P<0.01),while the cost was only 1/30 of that of the branded atorvastatin.CONCLUSION The generic atorvastatin calcium cost less than that of the branded drug and there is no significant difference in drug safety between two groups.Advanced age,infection and myocardial infarct probably are the independent risk factors for related adverse reaction in atorvastatin calcium medication population.