广东省2009年407例炎琥宁注射剂不良反应报告分析

目的:为临床安全、合理使用炎琥宁注射剂提供参考。方法:对407例炎琥宁注射剂引起的不良反应的临床资料进行统计分析。结果:炎琥宁注射剂引起的407例不良反应中,儿童(0～14岁)最多见,占59.2%,尤以0～3岁的婴幼儿发生率最高,为27.5%;严重的、新的、一般的不良反应构成比分别为6.1%、12.3%、81.6%;临床表现以皮肤及其附件损害多见,占54.5%,其次为全身性损害,占18.4%。结论:炎琥宁注射剂引起的不良反应不容忽视,临床使用时应注意用药的浓度、滴速,婴幼儿应禁用;加强用药后的监护和上市后的再评价,防止和减少不良反应的发生。

Analysis of 407 ADR Cases Caused by Yanhuning Injection in Guangdong Province

OBJECTIVE：To provide reference for safe and rational use of Yanhuning injection in the clinic.METHODS：The clinical information for 407 ADR cases caused by Yanhuning injection were analyzed statistically.RESULTS：Among 407 ADR cases induced by Yanhuning injection,59.2% ADR cases occurred in young children under 14 years old,27.5% cases occurred in children under 3 years old.There were 6.1% severe ADR cases,12.3% new ADR cases and 81.6% general cases.54.5% clinical symptoms were injury of skin and its appendants and 18.4% clinical symptoms were impairment of body.CONCLUSION：ADR caused by Yanhuning injection could not be ignored.For that reason,clinical medication,including control of drug concentration and injection speed,should be implemented very reasonably and carefully.It is not recommended to giving children under 3 years old Yanhuning injection.Post-medication monitoring and re-evaluation should be strongly enforced to avoid or reduce the occurrence of ADR cases.