齐鲁儿童医院14例醒脑静注射液静脉滴注致药品不良反应分析

Analysis of Fourteen Cases of Adverse Drug Reactions Caused by Intravenous Infusion of Xingnaojing Injection in Qilu Children's Hospital

目的:探讨醒脑静注射液药物不良反应发生的特点及规律,指导临床合理用药。方法:收集山东大学齐鲁儿童医院2016年醒脑静注射液所致14例不良反应报告,对患儿年龄、用药原因、用法用量、使用溶媒、不良反应累及器官及不良反应严重程度等进行整理和统计,分析发生不良反应的原因和规律。结果:醒脑静注射液本身可能引起过敏反应;其所引起的不良反应病例中1~3岁儿童占57.14%;非说明书适应证用药患儿占80%;以5%葡萄糖为溶媒所致的ADR达78.57%;儿童使用醒脑静注射液发生严重不良反应达71.43%。结论:醒脑静注射液使用过程中应明确其功能主治,禁止超功能主治用药;使用0.9%氯化钠注射液作为溶媒更安全;减少超药品说明书用药;3岁以下患儿在有替代药物的情况下,不使用醒脑静注射液;生产厂家应加强醒脑静注射液用于儿童的安全性研究。

Objective： To explore the characteristics and regularity of adverse drug reactions（ADR） caused by Xingnaojing injection and to guide the clinical rational drug use. Methods： 14 reports of ADR caused by Xingnaojing injection in Qilu Children＇s Hospital of Shandong University in 2016 were collected. Age of children, medication reasons, usage and dosage, vehicle used, organs involved in ADR, and the severity of ADR etc. were sorted out and statistically analyzed in order to find out the reasons and regularity of the ADR. Results： Xingnaojing injection itself may cause allergic reactions. Among these cases of ADR, children aged 1-3 years accounted for 57.14%, medication without manual indications accounted for 80% of the patients, ADR with 5% glucose as the vehicle accounted for 78.57%, serious ADR caused by Xingnaojing injection accounted for 71.43%. Conclusion： In the process of using Xingnaojing injection, its function and indication should be known clearly and hyperfunctional use should be prohibited. It is safer to use 0.9% sodium chloride injection as solvent. Furthermore, off-label drug use should be reduced. If alternative drugs were available, Xingnaojing injections shuld not be used in the treatment of children under 3 years of age. In addition, manufacturers should strengthen the safety evaluation of Xingnaojing injection for children.