某狂犬病人免疫球蛋白产品连续3年不良反应分析研究  

Analysis on Adverse Reactions of A Rabies Human Immunoglobulin Product in 3 Consecutive Years

作　　者：张念恒[1] 唐应萍 肖燕 曾乐 于霞[2] ZHANG Nianheng;TANG Yingping;XIAO Yan;ZENG Le;YU Xia(Guizhou Provincial Center for Disease Control and Prevention,Guizhou Guiyang 550004,China;Guizhou Provincial People′s Hospital,Guizhou Guiyang 550002,China)

机构地区：[1]贵州省疾病预防控制中心,贵州贵阳550004 [2]贵州省人民医院,贵州贵阳550002

出　　处：《中国医药导刊》2023年第2期210-213,共4页Chinese Journal of Medicinal Guide

摘　　要：目的:研究分析某狂犬病人免疫球蛋白产品上市后连续3年的不良反应情况,评估其安全性,确保接种者的接种安全。方法:收集分析该狂犬病人免疫球蛋白产品3年内(2017—2019年)的临床使用情况及不良反应情况,并与全国疫苗不良反应数据比较。结果:3年间该狂犬病人免疫球蛋白产品销售3073083瓶,全国共向国家药品不良反应监测中心提交32例因接种该产品引起的不良反应报告。其中异常反应5例、一般反应27例;愈后结果为15例痊愈,15例好转,2例不详;不良反应报告数与产品使用量比率约为0.0104‰,不良反应率低于同期疫苗不良反应发生率(χ^(2)=35.863,P<0.05)。结论:该狂犬病人免疫球蛋白产品不良反应发生率低,对人体相对安全,具有良好的接种适宜性和安全性。Objective:To analyze the adverse reactions of a rabies human immunoglobulin product in 3 consecutive years,evaluate its safety,and to ensure the safety of the inoculation.Methods:The clinical use and adverse reactions of a rabies human immunoglobulin product in three years(2017—2019)were collected and analyzed,and compared with the national vaccine adverse reaction data.Results:In the 3 years,3073083 bottles of this rabies immunoglobulin product were sold,and 32 cases of adverse reactions caused by inoculation were reported to the national adverse reaction monitoring center.Among them,5 cases were abnormal reactions and 27 cases were general reactions;15 cases recovered,15 cases improved and 2 cases were unknown.The ratio of reported adverse reactions to product usage was about 0.0104‰,and the adverse reaction rate was lower than that of vaccine adverse reactions in the same period(χ^(2)=35.86,P<0.05).Conclusion:This rabies immunoglobulin product has a low incidence of adverse reactions and is relatively safe and has good suitability and safety.

关 键 词：狂犬病人免疫球蛋白 安全性评价 不良反应 

分 类 号：R512.99[医药卫生—内科学]