深圳地区中药制剂不良反应报告分析

摘要

目的:分析深圳地区2009年中药制剂不良反应(ADRs)报告,提出解决问题的对策,促进中药制剂的合理应用.方法:筛选出973份中药制剂ADRs报告,分别从患者年龄、性别、给药途径、临床表现、药品种类等方面进行统计分析.结果:中青年(19～39岁)ADRs发生率较高；女性患者ADRs发生率明显高于男性.发生ADRs的给药途径主要为口服和静脉注射,ADRs涉及的中药制剂共341个品种,其中口服制剂66种(19.35％),其次为注射剂.ADRs主要表现为皮肤及其附件损害(35.74％).结论:应加强对口服和注射类中药制剂ADRs的监测以保障患者用药安全.%Objective; To analyze adverse drug reactions ( ADRs) associated with Traditional Chinese Medicine (TCM) preparation reported in Shenzhen, 2009 and propose countermeasures to promote the rational use of TCM preparation. Methods; Totally 973 cases of ADRs were analyzed in respects of the age distribution of patients, gender, route of administration, clinical representation and the variety of drugs. Results; The ADRs incidence rate of young adults (19 ~ 39 years old) was higher, while female patients were significantly higher than male. The main routes of administration related to ADRs were oral administration and intravenous administration. There were 341 varieties of TCM preparation involved in ADRs, which include 66 species of oral preparation( 19. 35% ) , followed by injection. ADRs mainly were the damage of skin and its appendages(35. 74% ). Conclusion; Monitoring of ADRs associated with oral and injectable TCM preparation should be strengthened to protect patients' medicinal safety.