首页|阿托伐他汀仿制药治疗高脂血症疗效与安全性的多中心回顾性队列研究

阿托伐他汀仿制药治疗高脂血症疗效与安全性的多中心回顾性队列研究

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目的:比较阿托伐他汀仿制药与原研药的临床疗效和安全性差异,为国家组织药品集采中选仿制药的临床合理使用、集采政策的落地执行提供真实世界的证据.方法:本研究为多中心、回顾性、队列研究,数据来源于国内10家医疗机构的门诊电子信息系统.纳入2020年4月1日至2023年3月31日门诊首次处方阿托伐他汀仿制药(美达信)或原研药(立普妥)的患者,采用倾向性评分匹配法均衡两组患者基线特征,对两组患者用药后的血脂相关指标的改善情况、药物性肝损伤和肌肉症状发生率进行比较.结果:与原研药组相比,入组后6个月内仿制药组的LDL-C、非HDL-C、TC和TG水平较基线水平的降低值和降低百分比均无统计学差异,仿制药组出现药物性肝损伤诊断的患者比例少于原研药组,出现新增肌肉症状相关诊断患者比例无统计学差异.结论:在本研究中,阿托伐他汀仿制药与原研药在临床降脂效果和安全性方面基本相当.用阿托伐他汀仿制药替代原研药在真实诊疗环境中具有可行性.
Efficacy and Safety of Generic Atorvastatin in Patients with Hyperlipidemia:A Multicenter Retrospective Cohort Study
Objective:The paper compares the clinical efficacy and safety differences between generic and original atorvastatin to provide real-world evidence for the rational use of selected generic drugs in clinical practice and the implementation of national volume-based procurement policy.Methods:This is a multicenter retrospective cohort study.The data was collected from the outpatient electronic information systems of 10 medical institutions in China.Patients prescribed with atorvastatin,either original or generic,for the first time between April 1,2020 and March 31,2023 were included.Propensity score matching was used to adjust the baseline characteristics of the generic drug group and original drug group.The improvement of blood lipid tests,the occurrence of drug-induced liver injury and muscle symptoms were compared between the groups.Results:No significant differences were observed between the generic drug group and the original drug group in terms of reduction in LDL-C,non HDL-C,TC and TG levels from baseline within 6 months after enrollment.Compared to the original drug group,the generic drug group exhibited significantly lower occurrence of drug-induced liver injury and the the proportions of patients diagnosed with new muscle symptoms were not significantly different.Conclusion:In this study,the generic and the original atorvastatin were basically equivalent in terms of clinical lipid-lowering efficacy and safety.They are replaceable in clinical practice.

atorvastatingeneric drugreal-world studyefficacysafety

邢晓璇、刘雪莹、王之舟、张晓彤、王可、董宪喆、张兰

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首都医科大学宣武医院药学部 北京 100053

阿托伐他汀 仿制药 真实世界研究 疗效 安全性

2024

中国医疗保险
中国医疗保险研究会

中国医疗保险

影响因子:0.492
ISSN:1674-3830
年,卷(期):2024.(9)