降血脂药品不良反应报告的调查分析

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降血脂药品不良反应报告的调查分析

秦丹,牛刚,张飘飘,宋海波,靳洪涛,李鹏

中国医学科学院药物研究所,北京中医药大学国医堂,中国医学科学院药物研究所,国家食品药品监督管理总局药品评价中心,中国医学科学院药物研究所,中国人民解放军军事医学科学院卫生勤务与医学情报研究所

收稿日期:2017-04-16 修回日期:2017-04-16 出版日期:2017-06-25 发布日期:2017-06-26
基金资助:
国家人口与健康科学数据共享平台

Investigation and Analysis of Antilipemic Agents ADR Reports

Institute of Materia Medica, Chinese Academy of Medical Sciences,Guoyitang TCM Clinic, Beijing University of Chinese Medicine,Institute of Materia Medica, Chinese Academy of Medical Sciences,Institute of Materia Medica, Chinese Academy of Medical Sciences

Received:2017-04-16 Revised:2017-04-16 Online:2017-06-25 Published:2017-06-26
Supported by:
National Scientific Data Sharing Platform for Population and Health

摘要/Abstract

摘要： 目的：调查分析降血脂药品不良反应（ADR）发生的特点及规律，为临床合理用药提供参考。方法：从国家食品药品监督管理总局信息中心提供的“药品不良反应数据库”和“降血脂药物数据库”提取患者服降血脂药过程中发生ADR的报告及降血脂药临床试验中发生的ADR，建立相应数据库并对其进行描述统计分析。结果：筛选符合要求的记录1141条，患者男女比例近乎1.02:1，年龄近似正态分布，部分患者有青霉素等过敏史记载，且病史多集中于循环系统和内分泌系统；ADR涉及的降血脂药以片剂和胶囊剂为主，涉及药理作用类型以他汀类（构成比48.66％）和中药饮片、植物油脂和提取物、中药制剂类降血脂药（构成比35.31％）为主；ADR最常见的临床表现为消化系统损害，但大部分经过相关处理后能够痊愈或者好转。结论：降血脂药ADR 的发生与多种因素有关相关，临床用药中需严格掌握药物的适应症、给药途径以及注射剂的滴速等，同时加强ADR的监测和报告工作，保障患者用药安全。

Abstract: Objective: Investigate and analyzed the regularity and characteristics of adverse drug reaction(ADR)of antilipemic agents to reduce the incidence of ADR and provide reference for clinical rational drug use. Methods: ADR cases reported by the “MDC_CLINIC_DRUG_JXZY”database and “MDC_ADVERSE_DRUG” database which provided by CFDA through the network system were selected to two new databases and analyzed statistically. Results: There were a total of 1141 ADR records, among which the ratio of male to female is close to 1.02:1, the patient"s age was in accord with the normal distribution, the age group of 40- 80 was more easily to get reaction ; A total kinds of 7 drugs were involved, Statins took the lead, the main route of administration was oral administration, and the clinical manifestations were mainly digestive system damage. Conclusion: The occurrence of antilipemic agents ADR is related to various factors. Great importance should be attached to ADR monitoring and reporting. We also should reduce the use of intravenous drugs,pay attention to the safety of drug use in elderly patients,promote clinical rational antilipemic agents use, and ensure the safety of patients.

秦丹,牛刚,张飘飘,宋海波,靳洪涛,李鹏. 降血脂药品不良反应报告的调查分析[J]. .