315例天麻素临床不良反应/事件分析

以患者一般情况、用药情况、不良反应/事件(ADR/ADE)发生时间、临床表现及转归等作为考查项,对重庆市2008年1月—2014年6月天麻素所致的315例ADR/ADE进行回顾性研究,以分析其ADR/ADE发生的特点,为临床合理用药提供参考。结果发现在315例发生ADR/ADE的患者中,男性143例(45.4%),女性172例(54.6%),主要发生于45岁以上年龄段患者(74.9%);60例ADE(19.0%)为超适应证用药引起,66例ADE(21.0%)为超剂量用药引起;静脉滴注致ADR/ADE多发生于30 min内(85.5%),口服给药致ADR/ADE多发生于口服后2 h内(74.4%),肌内注射致ADR/ADE均发生于10 min内。共发生ADR/ADE 593例次,以胃肠系统(30.9%)、皮肤及其附件(26.5%)损害为主,61.9%为新的ADR/ADE。提示医务人员应了解天麻素所致ADR/ADE的规律和特点,临床上规范化应用,并密切关注患者变化,重视ADR/ADE的监测工作,提高用药安全性。

Analysis on 315 cases of clinical adverse drug reaction/event induced by gastrodin

With patients' general situation, medication use, occurrence time of adverse drug reaction/event (ADR/ADE), clinical manifestations and prognosis as reference items, a retrospective study was made for 315 cases with ADR/ADE induced by Gastrodin in Chongqing from January 2008 to June 2014, in order to analyze the characteristics of ADR/ADE and provide reference for rational clinical medication. The results showed that among the 315 cases with ADR/ADE, 143 cases (45.4%) were males and 172 cases (54.6%) were females, most of them (74.9%) were aged above 45; 60 cases (19.0%) with ADE were caused by off-label indications and 66 cases (21.0%) with ADE were caused by over dosage; ADR/ADE cases induced by intravenous drip mainly happened within 30 min (85.5%), ADR/ADE cases induced by oral administration mainly happened within 2 h (74.4%), and all of ADR/ADE cases induced by intramuscular injection happened within 10 min. Totally 593 ADR/ADE cases were reported, which were mainly damages in gastrointestinal system, skin and its adnexa; And 61.9% of ADR/ADE cases were newly reported. It is suggested that medical workers shall learn about the regularity and characteristics of ADR/ADE induced by gastrodin, apply it in clinic with standards, pay close attention to changes of patients' situations and attach importance to the monitoring of ADR/ADE, so as to enhance the safety of medication.