基于帕累托图的荧光素钠注射液致ADR报告分析及影响因素评估

Analysis of ADR reports induced by sodium fluorescein injection based on Pareto diagram and evaluation of influencing factors

目的 分析临床使用荧光素钠注射液发生药品不良反应(ADR)的临床特点,为用药安全提供参考依据。方法 收集2012年1月至2022年12月该院上报至国家ADR监测系统的荧光素钠注射液致ADR 146例患者报告,采用帕累托图分析ADR累及的系统/器官,并对患者性别、年龄及荧光素钠注射液生产厂家等进行统计分析。结果 146例患者发生194例次ADR,消化系统最为多见(127例次,65.46%),其次为呼吸系统(40例次,20.62%)和皮肤及其附件(21例次,10.82%)。年龄(≥60岁)是荧光素钠注射液致ADR的危险因素(P<0.05)。结论 消化系统反应是荧光素钠注射液致ADR的主要表现,患者年龄是ADR的主要影响因素,对该类患者进行眼底血管荧光造影时要做好用药指导,确保临床用药安全。

Objective To analyze the clinical characteristics of adverse drug reactions(ADR)of sodium fluorescein injection in clinical use,and to provide reference for drug safety.Methods A total of 146 cases patients of ADR reports induced by sodium fluorescein injection reported to the national ADR monitoring system in our hospital from January 2012 to December 2022 were collected.Pareto diagram was used to analyze the ADR involving systems/organs,and the gender,age of patients and manufacturers of sodium fluorescein injection were statistically analyzed.Results There were 194 cases of ADR in 146 patients.The digestive system was the most common(127 cases,65.46%),followed by respiratory system(40 cases,20.62%)and skin and its accessories(21 cases,10.82%).Age(≥60 years old)was a risk factor for ADR of fluorescein sodium injection(P<0.05).Conclusion Digestive system reaction is the main manifestation of ADR induced by fluorescein sodium injection.The age of patients is the main influencing factor of ADR.It is necessary to provide medication guidance for patients with fundus fluorescein angiography to ensure the safety of clinical medication.