中国临床药学杂志2024，Vol.33Issue(8)：583-587,5.DOI:10.19577/j.1007-4406.2024.08.005
基于报告比值比法挖掘活血化瘀中药注射剂的不良反应信号
Vigilance signals of adverse reaction events on traditional Chinese medicine injection for activating blood and resolving stasis:a study of mining base on reporting odds ratio method
摘要
Abstract
AIM To explore the adverse drug reaction(ADR)signals of 6 kinds of traditional Chinese medicine injections for activating blood and resolving stasis(Xuesaitong,Xueshuantong,Shuxuetong,breviscapine,Erigeron breviscapus and Salvia miltiorrhiza),so as to provide reference for safe medication use in clinical practice.METHODS By inquiring the national adverse drug reaction detection system,the adverse reaction report data of 6 kinds of traditional Chinese medicine injections for activating blood and resolving stasis by Foshan medical institutions from January 2012 to December 2022 were mined and analyzed using the reporting odds ratio method(ROR).RESULTS There were 960 cases of adverse reactions with 6 kinds of traditional Chinese medicine injections for activating blood and resolving stasis.The signal involved system organs including skin and its accessories,systemic reaction,blood vessel and lymphatic system.ROR analysis showed that Xuesaitong had stronger signals in rash,pruritus and urticaria,Xueshuantong had stronger signals in vomiting,Shuxuetong had stronger signals in dyspnea,cough and edema,and Erigeron breviscapus and breviscapine had stronger signals in palpitations and fever.No significant safety alerts had been issued for Salvia miltiorrhiza injection so far.It was found by comparing the drug instructions that adverse reactions such as eye abnormalities,periorbital edema,and sneezing caused by Shuxuetong were not recorded in the drug instructions.CONCLUSION Different varieties of injection for activating blood and resolving stasis showed different intensity of adverse reactions in system organs.Some adverse reactions were not recorded in drug instructions.It is recommended to improve the revision of drug instructions.In the course of medication,varieties that have an impact on underlying diseases should be avoided as much as possible.关键词
活血化瘀/中药注射剂,报告比值比法/不良反应Key words
activating blood and resolving stasis/traditional Chinese medicine injection/reporting odds ratio/adverse reaction引用本文复制引用
杨惠霞,任剑雄,黄小梅,蔡权周..基于报告比值比法挖掘活血化瘀中药注射剂的不良反应信号[J].中国临床药学杂志,2024,33(8):583-587,5.基金项目
佛山市科学技术局科技创新项目(编号2220001005371) （编号2220001005371）
