458例氨茶碱注射液不良反应/事件报告分析  

Analysis of 458 Reports of Adverse Drug Reactions/Events Induced by Aminophyiline Injection

作　　者：马雪皎[1] 刘超[1] 王长之[1] 杨雪[1] Ma Xuejiao Liu Chao Wang Changzhi Yang Xue(Henan Food and Drug Evaluation Center, Zhengzhou, Henan, China 450018)

机构地区：[1]河南省食品药品评价中心,河南郑州450018

出　　处：《中国药业》2017年第18期82-85,共4页China Pharmaceuticals

基　　金：河南省科技攻关项目[162102310379]

摘　　要：目的促进临床安全、合理用药。方法回顾性分析2012年至2016年河南省辖区内458例氨茶碱注射液不良反应/事件(ADR/ADE)的一般规律和特点。对比中美同类产品说明书,以期发现异同。结果报告中男性患者略多于女性,65岁及以上报告数最多(43.67%),30 min内发生的ADR/ADE占58.30%。最常见的ADR/ADE是恶心(26.80%),其次是呕吐(17.37%),累及器官主要是胃肠系统损害(49.13%)、心率及心律紊乱(11.29%)、精神紊乱(10.30%)。血清茶碱浓度越高,ADR/ADE程度越严重,特别是潜在的不可逆脑损伤、致死性的心律失常和惊厥性发作、死亡风险。结论应重视氨茶碱注射液引发的ADR/ADE,完善说明书安全性信息,增强预警、监测能力,提升临床安全、合理用药水平。Objective To promote clinical safety and rational use of drugs. Methods The general rules and characteristics of 458 cases of ADR/ADE related to the Aminophyiline Injection from 2012 to 2016 in Henan province were analyzed retrospectively. The instructions of similar products in China and America were compared in order to find similarities and differences. Results In the reports,men were slightly more likely than women,and over 65 years old patients were more than other ages（ 43. 67 %）,58. 30 % ADR/ADE oc curred within 30 min. The most common ADR/ADE was nausea（ 26. 80 %）,followed by vomiting（ 17. 37 %）,the main organs involved were gastrointestinal system damage（ 49. 13%）,heart rate and arrhythmia（ 11. 29%）,and mental disorder（ 10. 30%）. The higher the serum theophylline concentration,the serious the degree of ADR/ADE,particularly the potentially irreversible brain injury,lethality arrhythmia and convulsion,and the risk of death. Conclusion It is important to pay attention to the ADR/ADE induced by Aminophyiline Injection,improve the safety information of the instructions,strengthen the ability of early warning and monitoring,and improve the level of clinical safety and rational drug use.

关 键 词：氨茶碱注射液 药品不良反应 药品不良事件 合理用药 

分 类 号：R969.3[医药卫生—药理学] R974.3[医药卫生—药学]