郴州市2015年生产经营企业上报的药品不良反应1329例分析

发布时间：2018-05-16 19:15

本文选题：药品不良反应 + 药品生产经营企业　；参考：《湘南学院学报(医学版)》2016年04期

【摘要】：目的了解郴州市药品生产经营企业上报的药品不良反应(ADR)的特点,加强企业对ADR监测工作的认识,为药物安全监管及合理用药提供参考依据。方法收集郴州市药品经营企业2015年上报的1 329例ADR报告,按患者年龄、性别、给药途径、临床表现、所涉及的药品种类、因果关系评价、报告人职业等进行汇总分类。结果郴州市2015年药品生产经营企业上报的药品不良反应有1 329例,其中,患者以30~50岁为主,女性多于男性;给药途径以口服为主,占88.04%;临床表现以胃肠系统损害最常见,占40.20%;ADR涉及的药品有465种,中成药引发的ADR最多,占32.28%;报告人职业主要是职业药师,占80.59%;因果关系评价以"可能"居多,占56.88%;ADR结局主要为治愈,占57.03%;ADR级别以"一般"居多,占76.00%。结论药品生产经营企业在ADR的监测工作中有作用,应该加强ADR知识的宣传,避免其重复发生,提高合理用药水平。
[Abstract]:Objective to understand the characteristics of adverse drug reactions (ADR) reported by pharmaceutical production and marketing enterprises in Chenzhou, and to strengthen the understanding of ADR monitoring in enterprises, and to provide reference for drug safety supervision and rational drug use. Methods A total of 1 329 cases of ADR reported by drug trading enterprises in Chenzhou in 2015 were collected and classified according to patients' age, sex, route of administration, clinical manifestation, kinds of drugs involved, evaluation of causality, occupation of the speaker, etc. Results in 2015, there were 1 329 cases of adverse drug reactions reported by pharmaceutical production and marketing enterprises in Chenzhou, in which the majority of patients were 30 to 50 years old, more women than men, oral administration was the main way of administration, accounting for 88.04. The most common clinical manifestation was gastrointestinal system damage. There were 465 kinds of drugs involved in 40.20 and 40.20% of them, the most of which was caused by proprietary Chinese medicine (32.28%); the main profession of the speaker was professional pharmacist (80.59%); the causality evaluation was mainly "possible", accounting for 56.88% of the outcome of ADR was mainly cure, accounting for 57.03% of ADRs in the "average" level, accounting for 76.00%. Conclusion Drug production and marketing enterprises play an important role in the monitoring of ADR. We should strengthen the propaganda of ADR knowledge, avoid its recurrence and improve the level of rational drug use.
【作者单位】：南华大学附属郴州市第一人民医院药学部;
【基金】：湖南省教育厅课题(15K114) 郴州市科技局资助项目(CZKJ2016039)
【分类号】：R954

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