189例静脉注射胺碘酮不良反应分析

Analysis of 189 Reports of Adverse Drug Reaction Caused by Intravenous Amiodarone

目的分析静脉注射胺碘酮致药品不良反应(ADR)发生的特点,相关因素及预防措施。方法筛选有效ADR报告表,用统计学方法分析患者的性别、年龄、胺碘酮给药方式、剂量对胺碘酮所致ADR严重程度的影响,分析静脉注射胺碘酮ADR的临床表现,同时分析对ADR的处理情况和预后转归。结果共收集ADR报告189例,其中男性116例,平均年龄(67±15)岁;女性73例,平均年龄(60±15)岁。原患疾病主要为循环系统疾病174例,呼吸系统疾病4例,肿瘤4例,外科疾病2例,其他5例。给药方式包括负荷给药37例,无负荷给药152例。严重不良反应共30例,肝损害最多,占74.19%,其次为过敏性休克和血压下降,分别占6.45%,尖端扭转型室速、肾功能不全、心悸、神经系统损害分别占3.23%。对ADR的治疗方法包括药物减量、停用、积极临床治疗。共对183例进行随访(6例未能随访),其中67例治愈,106例好转,7例有后遗症,3例死亡(原有疾病死亡)。静脉应用胺碘酮的严重ADR比例为15.87%,ADR的发生与性别(P=0.061,>0.05)、年龄(P=0.140,>0.05)、剂量(P=0.857,>0.05)、有无使用负荷剂量(P=0.572,>0.05)无明显相关性。结论胺碘酮在临床应用中是相对比较安全的抗心律失常药,但其ADR多样,但经及早对症处理,均获得良好转归,在临床工作中应加强临床医生对药品ADR的重视,注意个体化应用,严密监测ADR情况,减少严重不良事件发生。

Objective To analyze the features related factors, prevention and treatment methods of amiodarone induced adverse drug reaction （ADR）. Methods Acquiring ADR case information from Beijing Adverse Drug Reaction Monitoring Center during 2005-2012 to observe the clinical manifestations of amiodarone ADR. And using statistical methods to analyze the relationship between amiodarone ADR severity and the impacts from the patient＇s gender, age, method of administration, dose.Also the processing of ADRand prognosis outcome were evaluated. Results A total of 189 cases of ADR reports were collected, 116 cases were male, mean age 67±15 years old, 73 cases were female, mean age 60±15 years old. There are 174 cases of circulatory system diseases, 4 cases of respiratory diseases, 4 cases of cancer, 2 cases of surgical diseases and 5 other cases. Administration includes load administered 37 cases, no load administered 152 cases. A total of 30 cases of serious adverse reactions were observed. Among them, liver damage is the most, accounting for 74.19%, and followed by anaphylactic shock and blood pressure drop, 6.45%respectively. Torsades de pointes ventricular tachycardia, renal insufficiency, palpitations, hypotension, respectively, accounted for 3.23%. ADR treatments include medication reduction, discontinuation and active clinical treatment. A total of 183 cases were followed up （6 cases failed to follow-up）, of which 67 cases were cured, 106 cases were improved, 7 cases with sequelae, 3 deaths （original disease deaths）.Serious ADRs induced by intravenous amiodarone account for 15.87%.There was no significant correlation between ADR occurrence and gender （P=0.061,〉0.05）, age （P=0.140,〉0.05）, dose （P=0.857,〉0.05）, with or without use of a loading dose （P=0.572,〉0.05）. Conclusion In clinical applications, amiodarone is a relatively safe antiarrhythmic drug, but its ADRs diverse. Early symptomatic treatment will lead to good outcomes. In clinical work, clinicians should pay attention to individual amiodarone application, monitor ADR and reduce serious adverse events.