某眼科医院2016～2017年59例荧光素钠不良反应分析

Analysis of 59 Cases of Adverse Drug Reaction Induced by Sodium Fluorescein Injection in An Ophthalmic Center during 2016-2017

目的:分析某眼科医院59例荧光素钠不良反应(ADR)报告,了解其ADR发生特点,提高临床用药安全性。方法:收集2016年1月～2017年12月某眼科医院835例使用荧光素钠行眼底荧光血管造影患者中发生ADR的病历资料,对患者年龄、性别与疾病分布,ADR的发生时间、累及系统/器官及主要临床表现,ADR的处理及结果,国产与进口制剂ADR发生率等进行统计分析。结果:共收集到荧光素钠ADR有效报告59份,不良反应发生率7. 06%。进口与国产制剂ADR发生率分别为5. 73%及7. 68%,差异无统计学意义(P> 0. 05)。40岁以下年龄组ADR发生比例较高,其中18岁以下年龄组ADR发生比例25. 93%。ADR发生时间以用药后30 min以内为主;累及系统和器官以中枢及外周神经系统损害、皮肤及附件损害所占比例最大。3例重度ADR患者经急诊科紧急治疗后好转。结论:应加强对荧光素钠ADR的主动监测并对其用药风险进行评估,尽可能减少患者ADR的发生,保障患者用药安全。

Objective：To investigate the characteristics of 59 cases of adverse drug reaction （ADR） induced by Sodium Fluoreseein injection in an ophthalmic center, so as to improve the security of clinical drug application. Methods： ADR reports of Sodium Fluorescein injection used in 835 cases of fluorescence fundus angiography （FFA） during January 2016 to December 2017 in contrast room of an ophthalmic center were collected and analyzed. Results： There were 59 cases of ADRs induced by Sodium Fluoreseein injection, the incidence rate of ADR was 7.06% ; the incidence rate of ADR of domestic and imported Sodium Fluorescein injection was 5.73% and 7.68% respectively. The proportion of ADR of fluorescein sodium was significandy higher in the group below 40 years of age. Among them, the proportion of ADR of fluorescein sodium was 25.93% in the age group below 18 years old. The ADR manifested within 30 minutes after medication. The main presentation of ADR was lesion of central and peripheral nervous system, followed by damage of skin and its appendages. 3 cases of serious ADR lead to emergency department were out of danger after rescue. Conclusion： It was important for medical staff to strengthen ADRs monitoring of Sodium Fluorescein and assess medication risks in patients to reduce the occurrence of adverse reactions and ensure their medication safety.