不同剂型胺碘酮的不良反应分析  

Analysis of adverse reactions due to different dosage forms of amiodarone

作　　者：王冬雪[1] 刘玉清[1] 高冠男 林京玉[3] 张黎明[3] 李一石[1] 

机构地区：[1]中国医学科学院北京协和医学院阜外心血管病医院卫生部心血管药物临床研究重点实验室,北京100037 [2]黑龙江省罗北县宝全岭管理局中心医院心内科 [3]北京市药品不良反应监测中心

出　　处：《药物不良反应杂志》2012年第6期356-359,共4页Adverse Drug Reactions Journal

基　　金："十一五"国家科技支撑计划(2009ZXO9501-32);"重大新药创制"国家科技重大专项(2012ZX09303008-001)

摘　　要：目的分析胺碘酮片剂与注射剂的药物不良反应(ADRs)特点,为临床安全用药提供参考。方法收集2006年1月至2012年2月北京市药物不良反应监测中心收到的与胺碘酮肯定有关、很可能有关和可能有关的不良反应报告,比较2种剂型胺碘酮所致ADRs的临床表现、严重ADRs构成比及转归。结果共收集到胺碘酮相关ADRs报告180份,涉及180例患者、195例次ADRs。180例患者中男性119例,女性76例;年龄2个月～97岁,平均年龄64岁。21例患者既往有ADRs史。195例次ADRs中一般ADRs 151例次(77.4%),严重ADRs 44例次(22.6%)。胺碘酮片剂相关ADRs 46例次,其中严重ADRs 13例次(28.3%);胺碘酮注射剂相关ADRs 149例次,其中严重ADRs 31例次(20.8%)。胺碘酮片剂所致严重ADRs的比例稍高于注射剂,但差异无统计学意义(χ2=1.12,P=0.29)。胺碘酮片剂所致ADRs的主要临床表现为肝功能损伤(34.7%)、甲状腺功能亢进或减低(17.3%)、咳嗽、咳痰、呼吸困难(10.9%)、皮疹等(8.7%)、头痛头晕(4.3%)、横纹肌溶解(4.3%)、过敏(2.2%)等。胺碘酮注射剂所致ADRs的主要临床表现为肝功能损伤(25.5%)、静脉炎(27.5%)、皮疹(14.1%)、过敏(8.1%)、心律失常(6.0%)、头痛头晕(5.4%)、血压下降(4.7)等。2种剂型所致ADRs的转归差异无统计学意义(χ2=8.18,P=0.09)。结论胺碘酮片剂与注射剂所致ADRs有所不同,因此其ADR的监测应有所侧重。对使用胺碘酮片剂的患者尤应加强用药指导和相关指标监测。Objective To investigate the characteristics of adverse drug reactions （ADRs） caused by amiodarone tablets and injection in order to provide reference for safe drug use in clinical practice. Methods The reports of adverse reactions to amiodarone assessed as definite association, probable association and possible association in Center for ADR Monitoring of Beijing from January 2006 to February 2011 were collected. The clinical manifestations of ADRs, the ratio of servious adverse reactions, and outcome between the two dosage forms of amiodarone were compared. Results A total of 180 reports related to adverse reactions of amiodarone were collected, including 180 patients and 195 cases of adverse reactions. One hundred and eighty patients comprised 119 male and 76 female with average age of 64 years （2 months to 97 years）. Twenty one patients had a history of adverse drug reactions. One hundred and ninty-five cases of ADRs included 151 cases （77.4%） of common ADRs and 44 cases （22.6%） of serious ADRs. Forty-six cases of ADRsincluded 13 （28.3%） serious cases associated with anfiodarone tablets. One hundred and forty-nine cases of ADRs included 31 （20. 8% ） serious cases associated with amiodarone injeetion. The ratio of serious ADRs eaused by amiodarone tablets was slightly higher than by injection, but the difference was not statistically significant （X2 = 1.12 ,P = 0.29）. The clinical manifestations of ADRs eaused by amiodarone tablets included increased hepatic enzymes （34.7%）, hyperthyroidism or hypothyroidism （ 17.3% ）, cough, expeetoration or dyspnea （10. 9% ）, eruption （8.7%）, headache, dizziness （4.3%）, rhabdomyolysis （4.3%）, allergy （2. 2% ）, etc. The clinieal manifestations of ADRs caused by amiodarone injection included increased hepatic enzymes （25. 5% ）, phlebitis （27.5%）, eruption （ 14. 1% ）, allergy （8. 1% ）, arrhythmia （6.0%）, headaehe, dizziness （5.4%）, a drop in blood pressure （4.7%）, ere. There was not signifieant d

关 键 词：胺碘酮 剂型 

分 类 号：R972.2[医药卫生—药品]