【摘要】 目的分析某院上报的严重药品不良反应/事件的发生特点,为临床安全用药提供参考。方法回顾性分析某院上报的182例严重药品不良反应/事件报告,对涉及药物种类、给药途径、转归、累及系统-器官以及临床表现进行分析。结果 182例报告中男性90例,女性92例;15～44岁占比最大(35.71%);涉及药品种类中抗感染药物占比最高(28.04%),其次为中成药制剂及中枢神经系统用药;累及系统-器官以肝胆损害、全身性损害、皮肤及其附件损害最多;临床表现以肝功能异常、肝酶升高、过敏性休克最为常见。结论抗感染药物、中成药制剂仍是严重药品不良反应/事件的监测重点;加强对45岁以上中老年患者长期联合用药的肝肾功能监测,确保患者用药安全。更多还原

【Abstract】 Objective To analyze the characteristics of serious adverse drug reactions/events(ADR/AE) reported in one hospital so as to provide reference for rational drug use in clinical practice. Methods One hundred and eighty-two reports of serious ADR/AE in one hospital were retrospectively analyzed, while drug categories, routes of administration, prognosis, systems or organs involved and clinical manifestations were studied. Results Among the 182 cases, 90 were males and 92 were females, and the group aged 15 to 44 accounted for 35.71%. According to categories, antimicrobial drugs ranked first(28.04%), followed by Chinese patent medicines and central nervous system drugs. Hepatobiliary disorders, general disorders, skin and appendages disorders were the most common involved systems organ classes(SOCs). The main clinical manifestations were abnormal hepatic function, increased hepatic enzymes, and anaphylactic shock. Conclusion Antimicrobial drugs and Chinese patent medicines remain the focus of monitoring of serious ADR/AE. Patients over 45 years old who have taken more than one drug for a long time should be monitored for liver and kidney function to ensure medication safety.更多还原