生物等效性试验中口服托吡酯致中性粒细胞减少1例  

Topiramate-induced decrease of neutrophils in a healthy volunteer in a bioequivalence trial:a case report

作　　者：汪旻晖[1] 黄伟 沈杰[1] WANG Min-hui;HUANG Wei;SHEN Jie(Center of Drug Clinical Evaluation,Yijishan Hospital,Wannan Medical College,Wuhu 241001,Anhui Province,China;Hefei Cosource Pharmaceuticals Incorporated,Hefei 230088,Anhui Province,China)

机构地区：[1]皖南医学院弋矶山医院药物临床评价中心,芜湖241001 [2]合肥合源药业有限公司,合肥230088

出　　处：《复旦学报（医学版）》2021年第5期707-710,共4页Fudan University Journal of Medical Sciences

基　　金：皖南医学院弋矶山医院药物临床试验项目(2019Y003);皖南医学院教学质量与教学改革工程项目(2019jyxm33)。

摘　　要：托吡酯临床常用于癫痫和偏头痛的治疗,中性粒细胞减少是其罕见的不良反应,在中国或健康人中未见报告。本文报道了1例中国成年男性健康志愿者在参加托吡酯片生物等效性(bioequivalence,BE)试验过程中发生中性粒细胞减少的病例,并讨论了该病例的处理及转归,以期引起对托吡酯相关血液系统不良反应及临床试验中健康志愿者安全性保护的关注,为特异性药物诱导的中性粒细胞减少症(idiosyncratic drug-induced neutropenia,IDIN)的早期诊疗提供一些参考。Topiramate is often used clinically in the treatment of epilepsy and migraine.Decrease of neutrophils is a very rare adverse reaction of topiramate,and no case has been reported in Chinese people or in healthy people.We presented a case with decrease of neutrophils induced by topiramate in a Chinese adult male healthy participant in a bioequivalence(BE)study of topiramate tablets,and discussed the treatment and outcome of this case.It reminds us to pay attention to hematopoietic system related adverse reactions associated with topiramate and the safety of healthy volunteers in clinical trials.It may provide some referential ideas for the early diagnosis and treatment of idiosyncratic drug-induced neutropenia(IDIN).

关 键 词：托吡酯 中性粒细胞减少 中性粒细胞减少症 生物等效性(BE) 不良反应 

分 类 号：R915[医药卫生—微生物与生化药学]