Retrospective Controlled Study on Clinical Efficacy and Safety of Domestic and Original Atorvastatin Calcium Tablets

ZHANG Feng; WANG Rui; LIN Zhanquan; CHEN Jinping; LI Xiurong; ZHANG Yan’e

doi:10.14009/j.issn.1672-2124.2021.11.018

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Retrospective Controlled Study on Clinical Efficacy and Safety of Domestic and Original Atorvastatin Calcium Tablets

更新时间：2022-10-08

- Retrospective Controlled Study on Clinical Efficacy and Safety of Domestic and Original Atorvastatin Calcium Tablets
- Vol. 21, Issue 11, Pages: 1358-1360(2021)
- 作者机构：
  
  首都医科大学石景山教学医院/北京市石景山医院药剂科
- 作者简介：
- 基金信息：
- DOI：10.14009/j.issn.1672-2124.2021.11.018
  CLC： R969.4
- Published：2021，
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ZHANG Feng, WANG Rui, LIN Zhanquan, et al. Retrospective Controlled Study on Clinical Efficacy and Safety of Domestic and Original Atorvastatin Calcium Tablets. [J]. 21(11):1358-1360(2021)
DOI：

ZHANG Feng, WANG Rui, LIN Zhanquan, et al. Retrospective Controlled Study on Clinical Efficacy and Safety of Domestic and Original Atorvastatin Calcium Tablets. [J]. 21(11):1358-1360(2021) DOI： 10.14009/j.issn.1672-2124.2021.11.018.

摘要

目的:比较国产阿托伐他汀钙片与原研阿托伐他汀钙片的临床有效性和安全性

为临床用药提供依据。方法:以2019年3月23日即北京市正式实施"4+7"带量采购政策第1日为时间节点

从北京市石景山医院(以下简称"我院")医院信息系统中调取该时间节点前后3个月(2018年12月23日至2019年6月23日)我院门诊或住院病房服用阿托伐他汀钙片的患者资料

分为对照组(一直服用原研阿托伐他汀钙片)、观察1组(一直服用国产阿托伐他汀钙片)和观察2组(该时间节点之前服用原研阿托伐他汀钙片

该时间节点之后服用国产阿托伐他汀钙片)。以总胆固醇、甘油三酯、低密度脂蛋白胆固醇和高密度脂蛋白胆固醇为有效性指标

以天冬氨酸转氨酶、丙氨酸转氨酶和肌酸激酶为安全性指标

对三组患者上述指标水平进行对比分析。2018年12月23日至2019年6月23日我院服用阿托伐他汀钙片的患者共22 829例

其中门诊18 183例

住院病房4 646例。经过人工筛选

符合有效性研究入组要求的患者共388例

符合安全性研究入组要求的患者共420例。结果:观察1组、观察2组患者的有效性指标水平分别与对照组比较

差异均无统计学意义(P> 0.05);观察1组、观察2组患者的安全性指标水平分别与对照组比较

差异均无统计学意义(P> 0.05)。结论:国产与原研阿托伐他汀钙片的有效性、安全性均相似;与原研阿托伐他汀钙片相比

国产阿托伐他汀钙片在价格方面更具优势

在保证疗效的前提下

可以减少患者的经济负担

临床可安全使用。

Abstract

OBJECTIVE: To compare the clinical efficacy and safety between domestic atorvastatin calcium tablets and original atorvastatin calcium tablets

so as to provide reference for clinical medication. METHODS: Mar. 23 rd

2019

which was the first day of the official implementation of the“4 + 7”quantity procurement policy in Beijing

was set as the time node

and the data of patients taking atorvastatin calcium tablets in outpatient or inpatient of Beijing Shijingshan Hospital（ hereinafter referred to as“our hospital”） for 3 months before and after the time node（ from Dec.23 rd

2018 to Jun. 23 rd

2019） were retrieved from HIS of our hospital. The data were divided into control group（ who had been taking original atorvastatin calcium tablets）

observation group 1（ who had been taking domestic atorvastatin calcium tablets） and observation group 2（ who had been taking original atorvastatin calcium tablets before the time point and domestic atorvastatin calcium tablets after the time point）. The total cholesterol

triglycerides

low density lipoprotein cholesterin and high density lipoprotein cholesterin were used as efficacy-related indicators

and the aspartate aminotransferase

alanine aminotransferase and creatine kinase were used as safety-related indicators

so that the levels of these indicators were compared and analyzed among three groups. Totally 22 829 patients took atorvastatin calcium tablets in our hospital from Dec. 23 rd

2018 to Jun. 23 rd

2019

including 18 183 cases were outpatients and 4 646 cases were inpatients. After manual screening

a total of 388 patients met the requirements for enrollment in the effectiveness study and420 patients met the requirements for enrollment in the safety study. RESULTS: There were no statistically significant differences in the efficacy-related indicators of between observation group 1/observation group 2 and the control group（ P >0. 05）; there was no statistically significant difference in the safety-related indicators between observation group 1/observation group 2 and the control group（ P > 0. 05）. CONCLUSIONS: The domestic atorvastatin calcium tablets have similar efficacy and safety with the original atorvastatin calcium tablets; compared with original atorvastatin calcium tablets

the domestic atorvastatin calcium tablets have more advantages in terms of price

which can reduce the economic burden of patients while ensuring the efficacy and can be used safely in clinical practice.

关键词

阿托伐他汀钙片原研阿托伐他汀钙片国产阿托伐他汀钙片有效性安全性

Keywords

Atorvastatin calcium tabletsOriginal atorvastatin calcium tabletsDomestic atorvastatin calcium tabletsEfficacySafety

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