| 何柳,杜昕,王文化,马长生.原研他汀药及国产仿制他汀药的依从性及成本效果比较[J].Chinese journal of Epidemiology,2020,41(11):1900-1904 |
| 原研他汀药及国产仿制他汀药的依从性及成本效果比较 |
| Comparison of compliance and cost effectiveness between brand-name statins and generic statins |
| Received:November 14, 2019 |
| DOI：10.3760/cma.j.cn112338-20191114-00809 |
| KeyWord: 他汀药 原研药 仿制药 依从性 成本效果 |
| English Key Word: Statins Brand-name drug Generic drug Compliancy Cost effectiveness |
| FundProject:国家重点研发计划（2016YFC1301002，2020YFC2004803）；北京市科学技术委员会项目（D171100006817001） |
| Author Name | Affiliation | E-mail | | He Liu | Department of Cardiology Beijing Anzhen Hospital, Capital Medical University, National Clinical Research Center for Cardiovascular Diseases, Office of Beijing Cardiovascular Diseases Prevention, Beijing 100029, China | | | Du Xin | Department of Cardiology Beijing Anzhen Hospital, Capital Medical University, National Clinical Research Center for Cardiovascular Diseases, Office of Beijing Cardiovascular Diseases Prevention, Beijing 100029, China | duxinheart@sina.com | | Wang Wenhua | Department of Cardiology Beijing Anzhen Hospital, Capital Medical University, National Clinical Research Center for Cardiovascular Diseases, Office of Beijing Cardiovascular Diseases Prevention, Beijing 100029, China | | | Ma Changsheng | Department of Cardiology Beijing Anzhen Hospital, Capital Medical University, National Clinical Research Center for Cardiovascular Diseases, Office of Beijing Cardiovascular Diseases Prevention, Beijing 100029, China | |
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| Abstract: |
| 目的 探索原研他汀药和国产仿制他汀药在服药依从性、降胆固醇幅度和成本效果的差异。方法 从北京市朝阳区社区卫生服务中心信息系统中提取2015年1月至2017年12月首次处方他汀药的≥18岁患者处方记录，筛选出41 496条原研他汀药处方记录和60 491条国产仿制他汀药处方记录，比较首次处方后1年内的服药依从性，对服药依从性较好的患者比较服药1年后两组药物降低胆固醇的幅度，并采用成本-比值法进行成本效果分析。结果 国产仿制他汀药的服药依从性（28.2%）较原研药差（36.2%），差异有统计学意义（P<0.001）。在服药依从性较好且1年内未更换或调整药物剂量的患者中，调整个体年龄、性别、高血压、糖尿病病史及社区内相关性的影响后，199名一直服用国产仿制阿托伐他汀（20 mg/d）的患者1年后降低TC［降低幅度：（0.86±0.07）mmol/L vs.（0.40±0.10）mmol/L，P<0.001］和LDL-C［降低幅度：（0.67±0.07）mmol/L vs.（0.42±0.08）mmol/L，P=0.003］的幅度大于服用相同成分和剂量原研药的患者（232名），且降低相同幅度的胆固醇可以节省50%以上的医药费。结论 尽管国产仿制他汀药依从性较差，但有可能在降胆固醇效果上替代原研药并降低患者经济负担，但本研究证据级别有限且缺乏不良反应数据，有必要开展高质量的临床研究推动国产仿制药的发展。 |
| English Abstract: |
| Objective To explore the differences of adherence, lipid reduction and cost- effectiveness between brand-name and generic statins. Methods Statins prescription records of adult patients aged 18 years and above with the first prescription of statins between January 2015 to December 2017, were collected from community health information system of Chaoyang district of Beijing. Medication compliancy after first prescription was compared between group only taking brand-name statins (41 496 records) and group only taking generic statins (60 491 records). Lipid reduction and cost-effectiveness were also compared between two groups. Results The medication compliancy of generic statins was worse than brand-name statins (28.2% vs. 36.2%, P<0.001). After excluding the influence of age, sex, history of hypertension and diabetes, and community correlation, generic atorvastatin (20 mg/day) showed better total cholesterol reduction effect [(0.86±0.07) mmol/L] and better low density lipid-cholesterol reduction effect [(0.67±0.07) mmol/L] one year later in 199 patients who consistently used it compared with brand-name atorvastatin at same dosage in 232 patients [(0.40±0.10) mmol/L and (0.42±0.08) mmol/L] (P<0.001, P=0.003). From the perspective of cost effectiveness, generic atorvastatin (20 mg/day) can reduce more than 50% of medical expenses at the same cholesterol reduction level. Conclusions Generic statins might replace brand-name statins with similar treatment effect but lower medical expenses although its compliancy needs improvement. However, the data of adverse reactions of generic statins are lacking, it is necessary to carry out high-quality clinical research to improve and promote the development of generic statins. |
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