阿奇霉素药物不良反应/事件报告相关因素的分析

目的通过对我院阿奇霉素药物不良反应/事件(ADR/ADE)报告相关因素分析,了解阿奇霉素药物ADR/ADE发生特点及规律,为促进临床安全、有效、合理用药提供参考。方法对我院2004年1月1日至2011年3月20日收集到的198例阿奇霉素药物ADR/ADE报告,从患者情况、不良反应的临床表现、给药途径、原患疾病及因果关系的评价等方面进行回顾性统计分析。结果 198例阿奇霉素药品ADR/ADE报告中,女性多于男性;0~15岁的儿童57例占28.79%,50~81岁的患者109例占55.05%;给药途径主要是静脉点滴192例占96.97%;累及的系统-器官主要是皮肤及其附件69例34.85%,消化系统56例28.29%和呼吸系统42例21.22%等;主要发生在用药后10~35min。结论不合理使用阿奇霉素是ADR/ADE发生的主要因素之一,临床应重视阿奇霉素引起的ADR/ADE,减少或者避免严重的ADR/ADE的发生,确保用药安全。

Analysis on 198 cases adverse drug reaction/event reports of azithromycin

Objective In order to promote the rational use of azithromycins in clinic,the 198 azithromycins ADR/ADEs(adverse drug reactions/events) reports were analyzed.Methods 198 azithromycins ADR/ADEs Reports were statistical analyzed from 2004 to 2011 in our hospital.The potential characteristics and rules of the reports included the condition of patients,clinical manifestations of adverse reaction,route of administration,types of antibacterials and assessment were analyzed.Results In the 198 cases of azithromycins ADR/ADEs,females was slightly more than males;children between 0 to 15 years old age were accounted for the majority(57cases,28.79%);patients between 50 to 81 years old age were accounted for the majority(109cases,55.05%);administered intravenously were accounted for the majority(192cases,96.97%).The most three vulnerable system/organ were skin and its appendages(69case,34.85%),digestive-system(56case,28.29%),respiratory-system(42case,21.22%).ADR/ADEs were usually occurred between 10 to 35 min after administration.Conclusion It is necessary to strengthen the azithromycins ADR/ADE monitoring to decrease the occurrence of serious ADR /ADE and ensure clinical safety,effective,rational use of it.