251例药源性甲状腺功能损害不良反应报告分析

Analysis of 251 Cases of Adverse Reaction of Drug-induced Thyroid Dysfunction

目的:探讨引起药源性甲状腺功能损害的药物种类及其不良反应表现特点,为临床合理用药提供依据。方法:收集2010年1月~2017年6月国家药品不良反应监测数据库中浙江省平台上报的不良反应为药源性甲状腺损害的病例,利用Excel软件统计分析患者性别、年龄、原患疾病、可疑药品种类、不良反应类型、发生时间、临床表现、转归等相关因素。结果:共收集甲状腺损害病例251例252例次。多种药物可引起不同类型的甲状腺功能异常,主要为抗精神病类药物(54.18%)、抗心律失常药物(17.93%)和抗躁狂药物(12.35%),共占83.46%,其中抗精神病药富马酸喹硫平片发生不良反应例次占总例次的46.83%,绝大多数的不良反应表现为甲状腺功能降低;盐酸胺碘酮片发生不良反应例次占总例次的17.86%,其严重不良反应报告占其ADR报告数的62.22%,不良反应表现为甲状腺功能减退和甲状腺功能亢进,比例约为4.5∶1。碳酸锂片发生不良反应例次占总例次的12.70%,但国内生产的碳酸锂片说明书中不良反应项下均未提及甲状腺功能损害。结论:多种药物可引起药源性甲状腺功能损害,应引起临床应重视,提高用药安全性。

Objective： To investigate the drugs leading to drug-induced thyroid dysfunction and discuss their clinical characteristics,so as to provide reference for rational drug use in the clinic. Methods： Collected reports of Adverse Reaction of Drug-induced thyroid dysfunction in Zhejiang province from January 2010 to June 2017 and analyzed patients＇ gender and age,primary diseases,categories of suspected drugs,types of ADRs,organs and systems involved,clinical manifestation and outcomes by using Excel software. Results： A total of 251 cases were collected,a variety of drugs can cause different types of thyroid dysfunction,mainly for antipsychotic drugs（ 54. 18%）,antiarrhythmic drugs（ 17. 93%）and anti-manic drugs（ 12. 35%）. Among them,the ADRs of Quetiapine Fumarate Tablets accounted for 46. 83% of the total cases,the majority of adverse reactions showed hypothyroidism. Amiodarone hydrochloride tablets accounted for17. 86% and the serious ADRs accounted for 62. 22%. The adverse reactions were hypothyroidism and hyperthyroidism and the ratio was about 4. 5∶ 1. The Lithium carbonate tablets＇ adverse reactions accounted for 12. 70%,but the thyroid dysfunction were not mentioned in drug instructions. Conclusion： A variety of drugs can induce drug-related thyroid disease. It should cause clinical attention and improve drug safety.