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中国临床药理学与治疗学 ›› 2022, Vol. 27 ›› Issue (7): 785-792.doi: 10.12092/j.issn.1009-2501.2022.07.009

• 药物治疗学 • 上一篇    下一篇

基于真实世界的阿托伐他汀仿制药和原研药防治缺血性脑卒中/短暂性脑缺血发作的有效性和安全性比较

梁美芳1,2,陈庆状2,杨沛群3,王勇1   

  1. 1南方医科大学珠江医院药学部,广州 510282,广东;2广州市中西医结合医院药学部,广州 510800,广东;3广州市中西医结合医院脑病科,广州 510800,广东

  • 收稿日期:2022-03-11 修回日期:2022-07-19 出版日期:2022-07-26 发布日期:2022-08-11
  • 通讯作者: 王勇,男,博士,主任药师,研究方向:临床药学、药理学。 Tel: 020-61643888 E-mail: yongwh2005@163.com
  • 作者简介:梁美芳,女,硕士研究生,主管药师,研究方向:临床药学。 Tel: 020-86888565-2028 E-mail: lmf1312230904@163.com
  • 基金资助:
    广州市花都区科技工业商务和信息化局医疗卫生一般科研专项(21-HDWS-085);广东省“十三五”中医重点专科(临床药学)建设项目

Efficacy and safety of generic and branded atorvastatin in patients with ischemic stroke/transient ischemic attack: A real-world study

LIANG Meifang 1,2, CHEN Qingzhuang 2, YANG Peiqun 3, WANG Yong   

  1. 1 Pharmacy Department, Zhujiang Hospital of Southern Medical University, Guangzhou 510282, Guangdong, China; 2 Pharmacy Department, Guangzhou Hospital of Integrated Traditional and West Medicine, Guangzhou 510800, Guangdong, China; 3 Neurology Department, Guangzhou Hospital of Integrated Traditional and West Medicine, Guangzhou 510800, Guangdong, China
  • Received:2022-03-11 Revised:2022-07-19 Online:2022-07-26 Published:2022-08-11

摘要: 目的:采用真实世界临床数据,对阿托伐他汀原研药和国产仿制药防治缺血性脑卒中/短暂性脑缺血发作的有效性和安全性进行比较。方法:纳入2018年1月1日至2021年3月31日期间因缺血性脑卒中/短暂性脑缺血发作入院且诊断明确后规律服用阿托伐他汀至少6个月的成年患者,根据患者长期使用的阿托伐他汀的厂家分为原研组和仿制组,通过倾向匹配评分方法平衡混杂因素,对治疗结局进行对比分析。结果:本研究最终纳入665名患者,原研组302例,仿制组363例,倾向匹配评分调整前后,两组在有效性指标缺血性脑卒中/短暂性脑缺血发作复发率、美国国立卫生院卒中量表(NIHSS)评分和改良Rankin评分量表(mRS)评分变化、新发冠状动脉粥样硬化性心脏病发生率,以及安全性指标AST/ALT升高发生率、复合的不良事件发生率(包含肌酸肌酶(CK)升高、颅内出血和AST/ALT升高)方面的差异均无统计学意义。结论:基于本研究的真实世界数据,阿托伐他汀原研药和国产仿制药在防治缺血性脑卒中/短暂性脑缺血发作的有效性和安全性无显著差异。

关键词: 阿托伐他汀, 缺血性脑卒中, 短暂性脑缺血发作, 有效性, 安全性

Abstract: AIM: In this study, we assessed the safety and efficacy of generic and branded atorvastatin in patients with ischemic stroke/transient ischemic attack in real-world practice.  METHODS: Patients admitted for ischemic stroke/transient ischemic attack between January 1, 2018 and March 31, 2021 who continually received atorvastatin for ≥6 months after diagnosis were included. Safety and efficacy endpoints in patients receiving the generic atorvastatin were compared with those of patients receiving the branded medication. Propensity score matching was applied to control confounders. RESULTS: There were 665 patients in our final analysis, 302 in the branded group and 363 in the generic group. After propensity score matching, patients who received generic atorvastatin did not show a greater incidence of Ischemic Stroke/transient ischemic attack recurrence or onset of coronary heart disease. Similar changes in NIHSS and mRS scores were observed between the generic and branded groups. Consistent results were found in rates of hepatobiliary laboratory abnormalities and the compound adverse event profile of an elevated creatine kinase level, elevated aspartate aminotransferase/alanine aminotransferase levels, and intracranial hemorrhage. Results were consistent before and after propensity score matching. CONCLUSION: Both generic and branded atorvastatin are equally effective in preventing stroke recurrence and improving neurological deficits in patients with ischemic stroke/transient ischemic attack. Both treatments are generally well tolerated by patients.

Key words: atorvastatin, ischemic stroke, transient ischemic attack, efficacy, safety

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