12198例国家基本药物致不良反应/事件报告分析

目的：了解《国家基本药物目录》（2009版）中的药物发生药品不良反应/事件（ADR/ADE）的情况及特点,为基本药物的合理使用与安全警戒以及风险管理工作提供参考依据。方法：对2011年广西壮族自治区ADR/ADE监测中心收到的不良反应/事件报告12 198例进行统计与分析。结果：12 198例不良反应/事件报告中,男女比例为1.00∶1.04（5 982/6 216）,患者年龄主要集中于15～65岁;共涉及218个基本药物品种,以头孢菌素为主,其次为中成药;静脉滴注所致不良反应居首位,其次为口服;累及器官和（或）系统以皮肤及其附件、全身性损害为主;339例严重的不良反应报告中,过敏反应发生率最高,其次为过敏性休克;原患疾病排序居前5位的是：上呼吸道感染、支气管炎、急性支气管炎、肺结核和肺部感染。结论：临床工作中应密切关注国家基本药物所致的不良反应,迫切需要研究制定国家基本药物致不良反应的分级和风险评价标准,以确保临床安全、有效用药。

Adverse Drug Reactions/Adverse Drug Events Induced by National Essential Drugs: Analysis of 12198 Cases

OBJECTIVE：To study the status quo and characteristics of the adverse drug reaction（ADR）/adverse drug events（ADE） induced by national essential drugs（on the list of national essential drugs,2009 edition） for references of rational use,safety alert and risk management of the national essential drugs.METHODS： A total of 12 198 ADR/ADE cases induced by national essential drugs collected by Guangxi Zhuang Autonomous Region ADR/ADE Monitoring Center were analyzed statistically.RESULTS： Of the 12 198 cases,the ratio of male to female was 1.00∶1.04（5 982/6 216）,with patients aged 15-65 years showing the highest proportion.A total of 218 drugs were involved in the ADR/ADE,with cephalosporins showing the highest proportion followed by traditional Chinese medicine injections.The ADR was chiefly caused via intravenous administration followed by oral administration.The ADR/ADE appeared mainly as lesions of skin and accessories and systemic damage.There were 399 serious ADR cases,of which,allergic reaction were most frequent followed by allergic shock.The top five primary diseases included upper respiratory tract infection,bronchitis,acute bronchitis,tuberculosis and lung infections.CONCLUSION： Clinically,close attention should be paid to the ADR induced by national essential drugs.It is urgent to establish well-defined criteria for the grading and risk assessment of ADR induced by national essential drugs in order to ensure clinical safe,effective and rational drug use.