目的:了解福建医科大学附属三明第一医院(以下简称"我院")新的、严重的药品不良反应(adverse drug reaction,ADR)发生的特点,为临床安全用药提供参考.方法:对2013—2016年我院545例新的、严重的ADR报告的类型及联合用药情况、患者年龄及性别、引发ADR的给药途径及药物种类、ADR累及器官和(或)系统及主要临床表现、转归等进行回顾性分析.结果:545例新的、严重的ADR,新的ADR 371例(占68.07％),严重的ADR 174例(占31.93％);22例存在联合用药情况.女性患者略多于男性,年龄≥70岁者最多.对症处理后,大部分ADR均痊愈或好转.静脉滴注致ADR病例数最多,其次为口服给药.抗感染药、心血管系统用药引发的ADR病例数最多;在抗感染药引起的131例ADR中,氟喹诺酮类所致ADR病例数最多,其次为头孢菌素类.ADR主要累及皮肤及其附件、呼吸系统及全身.结论:应不断完善ADR监测,尤其是新的、严重的ADR,并应加强抗感染药的安全性监测,进一步促进临床安全用药.%OBJECTIVE:To investigate the features of new/severe adverse drug reactions ( ADR) in Sanming the First Hospital Affiliated to Fujian Medical University ( hereinafter referred to as "our hospital") , so as to provide reference for the rational drug application in clinic .METHODS:Retrospective analysis was conducted on 545 cases of ADR during 2013-2016 in our hospital including types of reports , drug combination, patients' age and gender, ADR-inducing route of administration and drug categories , ADR involved organs and ( or ) systems and major clinical manifestations and prognosis , etc.RESULTS: Of the 545 new/severe ADR cases, 371 cases (68.07％) were new ADR, 174 cases(31.93％) were severe ADR;22 cases had drug combination.In addition, the number of female cases were more than male cases , and patients aged ≥70 years old took the lead .After symptomatic treatment , most ADR had been improved .And the number of ADR cases induced by intravenous drip took the lead , followed by oral administration .The highest number of ADR cases were induced by anti-infectious drugs and cardiovascular system drugs.Of the 131 cases of ADR induced by anti-infectious drugs, quinolone drugs took the lead , followed by cephalosporin drugs . ADR mainly involved skins and its accessories , respiratory system and the body . CONCLUSIONS: It is necessary to improve the ADR monitoring , especially for the new/severe ADR, and to strengthen the safety monitoring on anti-infectious drugs , so as to further promote the drug safety in clinic .
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