摘要
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。
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 from2013 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 8injections 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.
作者
谭朝丹
陈伟成
刘娟
时扣荣
李洁
顾伟鹰
TAN Zhao-dan CHEN Wei-cheng LIU Juan SHI Kou-rong LI Jie GU Wei-ying(Pharmaceutical Department, Shanghai No. 7 People＇s Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200137, China)
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2016年第21期1900-1904,共5页
Chinese Journal of Hospital Pharmacy
基金
上海市进一步加快中医药事业发展三年行动计划(2014-2016年)
中医药专门人才计划(ZY3-RCPY-3-1037)
中医医院中药制剂能力提升项目(ZY3-JSFC-2-1011)
关键词
中药注射剂
超说明书用药
不良事件
Chinese herb injection
off-label use
adverse drug reactions
