120例胺碘酮不良反应分析

Analysis of 120 amiodarone adverse reactions

目的探讨胺碘酮所致不良反应(ADR)的发生情况,为临床安全、合理用药提供参考。方法 120例胺碘酮所致不良反应患者,对其年龄、性别、基础疾病、用药途径、用药剂量、不良反应史、不良反应的临床表现等进行统计分析。结果 120例胺碘酮ADR患者中,男77例(64.17%),女43例(35.83%),发生在60岁以上病例83例(69.17%);原患疾病以循环系统疾病为主,共107例(89.17%);用药原因中心律失常101例(84.17%),以心房颤动(房颤)为多共56例(46.67%);共有2种给药途径,口服给药27例(22.50%),静脉给药93例(77.50%);120例ADR患者的报告中,一般ADR 100例(83.33%),严重ADR 20例(16.67%);主要临床表现为肝损害、静脉炎、过敏样反应、肺损害、低血压及心律失常、甲状腺功能异常;经减量、停药等处理后治愈35例(29.17%),好转76例(63.33%),有后遗症8例(6.67%),死亡1例(0.83%)。结论胺碘酮在临床应用中是比较安全的抗心律失常药,但其ADR表现多样,在临床工作中应严密监测ADR情况,减少严重不良事件发生。

Objective To investigate adverse drug reaction（ADR） caused by amiodarone, in order to provide reference for clinical safety and rational drug use. Methods There were 120 patients with adverse drug reaction cases caused by amiodarone. Statistical analysis was made on their age, gender, underlying disease, administration route, drug dosage, history and clinical manifestation of adverse reactions. Results Among 120 patients with amiodarone ADR, there were 77 male（64.17%） and 43 female（35.83%）. There were 83 cases over 60-year-old（69.17%）. 107 cases had circulation system disease as mainly underlying disease（89.17%）. 101 cases had arrhythmia as administration reason（84.17%）, among them atrial fibrillation was the main cause with 56 cases（46.67%）. There were 2 administration routes, as oral administration in 27 cases（22.50%） and intravenous administration in 93 cases（77.50%）. Among reports of 120 ADR cases, there were 100 cases with normal ADR（83.33%）, and 20 cases with severe ADR（16.67%）. Main clinical manifestations included hepatic damage, phlebitis, anaphylactoid reaction, lung damage, hypotension, arrhythmia, and thyroid dysfunction. After measures of dose decrease and drug withdrawal, there were 35 cured cases（29.17%）, 76 improved cases（63.33%）, 8 cases with sequelae（6.67%）, and 1 death case（0.83%）. Conclusion As a safe antiarrhythmic agent in clinical application, amiodarone still provides various ADR manifestations. Close monitoring on ADR in clinical work is necessary for reducing incidence of severe adverse reactions.