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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

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目的 挖掘6种活血化瘀中药注射剂(血塞通、血栓通、疏血通、灯盏花素、灯盏细辛和丹参)的不良反应信号,为临床安全用药提供参考.方法 通过查询国家药品不良反应监测系统,佛山医疗机构自2012年1月至2022年12月收集的6种活血化瘀中药注射剂不良反应报告数据,采用报告比值比法进行挖掘并分析.结果 6种活血化瘀中药注射剂共计960例不良反应病例,信号累及系统器官包括皮肤及其附件、全身反应、血管及淋巴系统等.分析发现,血塞通引起皮疹、瘙痒、荨麻疹信号较强,血栓通引起呕吐信号较强,疏血通引起呼吸困难、咳嗽、水肿信号较强,灯盏细辛和灯盏花素引起心悸、发热等信号较强,丹参注射剂暂未获得有效警戒信号.通过对比药品说明书发现,疏血通引起眼异常、眶周水肿、喷嚏等不良反应未在药品说明书中记载.结论 不同品种活血化瘀中药注射剂在系统器官表现方面药物警戒信号强度不一.部分不良反应未在药品说明书中记载,建议完善药品说明书修订.在用药过程中,尽可能避免使用对基础疾病有影响的品种.
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

杨惠霞、任剑雄、黄小梅、蔡权周

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广东省佛山市中医院药学部,佛山 528000

广东省佛山市药品不良反应监测中心不良反应监测室,佛山 528000

活血化瘀 中药注射剂,报告比值比法 不良反应

佛山市科学技术局科技创新项目

2220001005371

2024

中国临床药学杂志
中国药学会

中国临床药学杂志

CSTPCD
影响因子:0.502
ISSN:1007-4406
年,卷(期):2024.33(8)
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