某院近3年中药注射剂不良事件与超说明书用药相关性分析

目的：研究超说明书用药与中药注射剂不良事件的关系，促进中药注射剂合理应用。方法：回顾性分析某三级甲等综合性医院2013-2015年近3年期间中药注射剂不良事件及超说明书用药情况，考察中药注射剂不良事件与超说明书用药的相关性。结果：21种中药注射剂的59例不良事件中，存在超说明书用药28例（47.46%），涉及中药注射剂15种，其中，参麦、丹红和舒血宁等8种中药注射剂100.00%存在超说明书用药，超适应证（50.00%）和超溶媒类型（36.84%）最多见。经χ²检验，是否超说明书对不良事件类型（P=0.044）与发生时间（P=0.024）均有影响。与按说明书使用相比，超说明书用药时不良事件发生时间较迟，累及皮肤及附件系统的比例较大。结论：超说明书用药会影响中药注射剂不良事件的发生，临床应用应严格按照说明书要求。

Correlation analysis of off-label use and adverse drug events of Chinese herb injection in a hospital in recent 3 years

OBJECTIVE To investigate correlation between off-label drug use and adverse drug events (ADEs) of Chinese herb injection.METHODS ADEs of Chinese herb injection were investigated in a comprehensive grade 3A hospital from 2013 to 2015,and correlation between off-label use and ADE was analyzed.RESULTS The results showed 59 ADEs in total,28 ADEs presented off-label drug use (47.46%),involving 15 Chinese herb injections.Off-label use rate of 8 injections reached up to 100.00%,off indication (50.00%) and off solvent (36.84%) were very common.The chi-square test results showed that there was a strong correlation between the off-label use and ADE time (P=0.024) or ADE type (P=0.044).Compared to rational medication,the off-label use presented later ADE occurrence and higher proportion of skin allergic reaction.CONCLUSION The research hints that ADEs of Chinese herb injection are related to off-label use.