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
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.
activating blood and resolving stasistraditional Chinese medicine injectionreporting odds ratioadverse reaction