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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 analyze the characteristics of adverse drug reactions (ADRs) of amiodarone tablets and injections and provide reference for clinical safety medication. Methods From January 2006 to February 2012, the adverse drug reaction reports received by Beijing Center for Adverse Drug Reactions (ADRs) and related to amiodarone were highly likely to be related to and possibly related to ADRs. Clinical manifestations, the ratio of serious ADRs and prognosis. Results A total of 180 ADRs related to amiodarone were collected, involving 180 patients and 195 ADRs. Among 180 patients, there were 119 males and 76 females, ranging in age from 2 months to 97 years with a mean age of 64 years. Twenty-one patients had previous history of ADRs. Of the 195 ADRs, 151 were ADRs (77.4%) and 44 (22.6%) were severe ADRs. There were 46 cases of amiodarone tablet-related ADRs, of which 13 cases were serious ADRs (28.3%). Amiodarone injection-related ADRs were 149 cases, of which 31 cases were serious ADRs (20.8%). The proportion of serious ADRs caused by amiodarone tablets was slightly higher than that of injection, but the difference was not statistically significant (χ2 = 1.12, P = 0.29). The main clinical manifestations of ADRs caused by amiodarone tablets were liver damage (34.7%), hyperthyroidism or depression (17.3%), cough, expectoration, dyspnea (10.9% Headache dizziness (4.3%), rhabdomyolysis (4.3%), allergies (2.2%) and so on. The main clinical manifestations of ADRs induced by amiodarone injections were hepatic impairment (25.5%), phlebitis (27.5%), rash (14.1%), allergy (8.1%), arrhythmia (6.0%), headache and dizziness %), Blood pressure (4.7) and so on. There was no significant difference in the outcome of ADRs between two dosage forms (χ2 = 8.18, P = 0.09). Conclusion Amiodarone tablets and injections caused by ADRs are different, so its ADR monitoring should be focused. The use of amiodarone tablets in patients with intensive medication guidance and related indicators should be strengthened.