阿托伐他汀钙片仿制药与原研药治疗高脂血症的疗效与经济学评价  

Efficacy and Economic Evaluation of Atorvastatin Calcium Tablets Generics and Original Drugs in the Treatment of Hyperlipidemia

作　　者：谢欠 李娜 龚敏 易吉秀 陈正萍 XIE Qian;LI Na;GONG Min;YI Jixiu;CHEN Zhengping(Dept.of Pharmacy,Qianjiang Central Hospital of Chongqing,Chongqing 409000,China;Dept.of Endocrinology,Qianjiang Central Hospital of Chongqing,Chongqing 409000,China)

机构地区：[1]重庆市黔江中心医院药学部,重庆409000 [2]重庆市黔江中心医院内分泌科,重庆409000

出　　处：《中国医院用药评价与分析》2021年第1期34-37,共4页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：重庆市黔江区科技计划项目(No.黔科技2019012)。

摘　　要：目的:比较阿托伐他汀钙片仿制药(阿乐)与原研药(立普妥)治疗高脂血症的临床疗效和经济学评价。方法:选取2017年1月至2019年12月重庆市黔江中心医院收治的高脂血症患者150例,采用随机数字表法将患者分为观察组(75例)和对照组(75例)。对照组患者给予阿托伐他汀钙片原研药(立普妥)20 mg/d;观察组患者给予阿托伐他汀钙片仿制药(阿乐)20 mg/d;两组患者的给药时间均为连续给药24周。检测两组患者的血脂指标[甘油三酯(TG)、总胆固醇(TC)、低密度脂蛋白胆固醇(LDLC)及高密度脂蛋白胆固醇(HDL-C)]水平,比较两组患者药物治疗的临床疗效和安全性,并进行药物经济学评价。结果:与治疗前相比,两组患者治疗后的血浆TC、TG及LDL-C水平明显降低,血浆HDL-C水平明显升高,差异均有统计学意义(P<0.05);治疗后,两组患者组间比较,TG、TC、LDL-C及HDL-C水平的差异均无统计学意义(P>0.05)。观察组、对照组患者的调脂总有效率分别为92.00%(69/75)、94.67%(71/75);观察组、对照组患者的不良反应发生率分别为10.67%(8/75)、12.00%(9/75),上述差异均无统计学意义(P>0.05)。观察组、对照组患者的总成本分别为92.40、1026.48元,成本-效果比分别为1.01、10.84;以观察组作为参考,对照组的增量成本-效果比为正数,提示对照组方案(立普妥)成本降低,其药物疗效也随之降低,故观察组方案(阿乐)更具有经济学价值。敏感度分析(药物成本费用减少10%)结果与成本-效果分析的结果具有一致性。结论:阿托伐他汀钙片仿制药(阿乐)与原研药(立普妥)均能有效治疗高脂血症,且安全性较高,但仿制药(阿乐)更具有药物经济学优势。OBJECTIVE:To compare the clinical efficacy and economic effects of Atorvastatin calcium tablets generics(Ale)and original drugs(Lipitor)in the treatment of hyperlipidemia.METHODS:Totally 150 patients with hyperlipidemia admitted into Qianjiang Central Hospital of Chongqing from Jan.2017 to Dec.2019 were extracted to be divided into the observation group and the control group via the random number table,with 75 cases in each group.The control group was given Atorvastatin calcium tablets original drugs(Lipitor)20 mg/d,while the observation group received Atorvastatin calcium tablets generics(Ale)20 mg/d.Both groups were treated for 24 weeks.Blood lipids[triglycerides(TG),total cholesterol(TC),low density lipoprotein cholesterol(LDL-C)and high density lipoprotein cholesterol(HDL-C)levels]of two groups were detected.The clinical efficacy and safety of drug treatment between two groups were compared,and the drug economy was evaluated.RESULTS:Compared with before treatment,the plasma TC,TG and LDL-C levels of two groups decreased significantly after treatment,while the plasma HDL-C levels increased significantly,with statistically significant differences(P<0.05).After treatment,there was no significant difference in TG,TC,LDL-C and HDL-C levels between two groups(P>0.05).The total effective rates of lipid regulation in the observation group and control group were 92.00%(69/75)and 94.67%(71/75),respectively.The incidence of adverse drug reactions in the observation group and the control group were respectively 10.67%(8/75)and 12.00%(9/75),the difference was not statistically significant(P>0.05).The total costs of the observation group and the control group were respectively 92.40 and 1026.48 yuan,and the cost-effectiveness ratios were respectively 1.01 and 10.84.Taking observe group as the reference,the incremental cost-effectiveness ratio was positive number,indicating that the cost of the control group(Lipitor group)decreased,and its drug efficacy also decreased,therefore,the observation group(Ale group)was the most e

关 键 词：阿托伐他汀钙片 阿乐 立普妥 高脂血症 有效性 安全性 经济性 

分 类 号：R972.6[医药卫生—药品]