8564例注射用灯盏花素不良反应报告分析  

Analysis of 8564 Adverse Drug Reactions of Breviscapine for Injection

作　　者：赵成跟 张洪波 侯菲 ZHAO Cheng-gen;ZHANG Hong-bo;HOU Fei(Kunming Longjin Pharmaceutical Co.,Ltd,Kunming 650503,China)

机构地区：[1]昆明龙津药业股份有限公司,昆明650503

出　　处：《中国合理用药探索》2023年第3期106-115,共10页Chinese Journal of Rational Drug Use

摘　　要：目的:分析注射用灯盏花素的药品不良反应(ADR)发生规律及影响因素,挖掘潜在用药风险,指导临床合理用药。方法:回顾性分析8564例注射用灯盏花素致ADR病例报告,汇总分析患者性别与年龄分布情况、用药情况、ADR累及器官/系统损害及主要临床表现情况、ADR发生时间、持续时间和转归情况。结果:8564例注射用灯盏花素致ADR主要集中在45岁及以上患者(7309例,85.35%);女性多于男性;ADR累及多个器官/系统损害,主要为皮肤及皮肤附件疾病、全身整体疾病、胃肠疾病、神经系统疾病、心血管疾病和呼吸系统疾病等,其中75.86%的患者在首次用药后即发生不良反应,11.77%的患者存在联合用药情况。结论:注射用灯盏花素引起的ADR可能与患者年龄、性别、不合理用药、联合用药有关。Objective:To analyze the occurrence pattern and influence factors of adverse drug reactions(ADRs) of breviscapine for injection,to explore the potential risks of drug use,and to guide the rational use of drugs.Methods:A retrospective analysis was performed on 8564 ADRs caused by breviscapine for injection.The distribution of gender and age,drug use,damages to organs/systems involved in ADRs and major clinical manifestations,and the time of onset,duration and outcome of ADRs were summarized and analyzed.Results:8564 ADRs were mainly concentrated in patients aged 45 years and above(7309 patients,85.35%).The incidence was higher in women than that in men;the damages to multiple organs/systems involved in ADRs mainly included skin and skin appendage disorders,systemic disorders,gastrointestinal disorders,nervous system disorders,cardiovascular disorders and respiratory disorders.75.86% of patients experienced adverse drug reactions after the first dose,11.77% of the patients had co-medication.Conclusion:ADRs caused by breviscapine for injection may be related to the age,gender,irrational use of drug,and combination medication.

关 键 词：注射用灯盏花素 不良反应 药品安全性信息 合理用药 分析 

分 类 号：R259[医药卫生—中西医结合]