治疗用卡介苗上市后的安全性监测  

Post-marketing safety surveillance of BCG for therapeutic use

作　　者：周扬[1] 严龙[1] 屈戈 赵薇[1] 王俊峰 李军[1] 石小容 张磊[1] ZHOU Yang;YAN Long;QU Ge;ZHAO Wei;WANG Jun-feng;LI Jun;SHI Xiao-rong;ZHANG Lei(Chengdu Institute of Biological Products Co.,Ltd.,Chengdu 610023,Sichuan Province,China)

机构地区：[1]成都生物制品研究所有限责任公司

出　　处：《中国生物制品学杂志》2019年第11期1252-1256,共5页Chinese Journal of Biologicals

摘　　要：目的分析治疗用卡介苗(BCG for therapeutic use,tBCG)上市后不良反应(adverse drug reaction,ADR),监测其安全性。方法通过主动临床研究和被动自发报告途径收集2016~2017年期间使用tBCG进行膀胱癌灌注治疗患者的ADR信息,对ADR的类型、严重程度及转归情况进行分析。结果经tBCG灌注治疗后,主动临床研究和被动自发报告中ADR发生率分别为31.9%和1.6%。最常见的ADR为尿频、排尿困难、膀胱炎、发热等,均属于与灌注治疗方式和治疗机理相关的反应或损伤。多数反应为非严重ADR,转归情况较好。结论tBCG上市后显示出良好的安全性,本研究为修订产品说明书的安全信息提供了依据。Objective To analyze the adverse drug reactions(ADRs)and monitor the safety of BCG for therapeutic use(tBCG)reported after the vaccine comes onto the market.Methods The information on ADRs in patients with bladder cancer,who underwent intravesical instillation therapy with tBCG in 2016~2017,were collected from active clinical research and passive spontaneous reports,and analyzed for the type,seriousness and outcome.Results After treatment with tBCG,the reported incidence rates of ADRs from active clinical study and passive spontaneous reports were 31.9%and 1.6%respectively.The most common ADRs were frequent micturition,dysuria,cystitis and fever,which were associated with the intravesical instillation mode and treatment mechanism.Most of the reactions were non-serious,of which the outcome was satisfied.Conclusion The tBCG showed high post-marketing safety,which provided a basis for revision of the information on safety in instruction.

关 键 词：治疗用卡介苗 膀胱癌 安全性 不良反应 

分 类 号：R737.14[医药卫生—肿瘤]