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目的探讨胺碘酮致严重不良反应的临床特点。方法选取开封市第一人民医院2009年1月至2013年6月胺碘酮不良反应报告360例患者,共390例次不良反应,对比2种剂型胺碘酮导致不良反应的临床表现和转归。结果胺碘酮片剂导致不良反应92例次,注射剂导致不良反应298例次。片剂导致不良反应的主要临床表现有肝功能损伤、甲状腺功能亢进或减低、咳嗽、咳痰、呼吸困难、皮疹等。注射剂产生不良反应的临床表现有肝功能损伤、静脉炎、皮疹、过敏等。两种剂型所致不良反应转归比较差异无统计学意义(P>0.05)。结论胺碘酮片剂与注射剂引发的不良反应存在差异性,所以在进行不良反应监测时需有侧重点,胺碘酮应用过程中需提高用药健康指导及指标监测。
Objective To investigate the clinical characteristics of serious side effects caused by amiodarone. Methods A total of 390 adverse reactions were reported in 360 cases of amiodarone adverse reactions reported by the First People’s Hospital of Kaifeng from January 2009 to June 2013. The clinical manifestations and outcomes of ADRs . Results Amiodarone tablets resulted in 92 adverse reactions and 298 adverse reactions caused by injection. The main clinical manifestations of tablet-induced adverse reactions are liver damage, hyperthyroidism or hypothyroidism, cough, sputum, dyspnea, rashes and the like. Clinical manifestations of adverse reactions caused by injection of liver damage, phlebitis, rash, allergies and so on. There was no significant difference in adverse reactions between the two dosage forms (P> 0.05). Conclusion Amiodarone tablets and injection caused adverse reactions, there are differences in the adverse reaction monitoring need to focus on the application process of amiodarone need to improve drug health guidance and monitoring indicators.