布南色林中国健康志愿者药代动力学研究不良事件分析

目的:分析布南色林片在健康志愿者药代动力学研究不良事件的原因及影响因素,反映布南色林在中国人群的安全性特征。方法:回顾了某院2011-2017年完成的8项布南色林片在中国健康受试者的药代动力学研究安全性数据,对不良事件类型、数量、持续时间、累及系统、关联性进行分析。结果:研究共纳入96名健康受试者(288次给药),共计发生不良事件108次。嗜睡是最常见的不良事件,最常累及的系统为精神神经系统。不良事件发生率随着日剂量增加而递增。女性健康受试者不良事件发生率是健康男性受试者的1.8倍。餐后组受试者出现不良事件比例是同等剂量下空腹组的1.6倍。结论:不良事件发生可能与布南色林体内暴露量有关。在后续研究中,应关注性别、进食状态及给药剂量对布南色林不良事件发生率的影响。

Analysis of adverse events in pharmacokinetic studies on blonanserin in healthy Chinese volunteers

OBJECTIVE To analyze the causes and influencing factors of adverse events in healthy volunteers,and to reflect the safety characteristics of Buchanserin in Chinese population.METHODS The safety data of 8 Nan Shi Lin Pian in healthy Chinese subjects completed in a hospital from 2011 to 2017 were reviewed,and the types,number,duration,involved systems,and relevance of adverse events were analyzed.RESULTS A total of 96 healthy subjects (288 doses) were included in the study,with a total of 108 adverse events.Somnolence was the most common adverse event,and the most frequently affected system was the psychoneurologic system.The incidence of adverse events increased with increasing daily dose.The incidence of adverse events was 1.8 times higher in female healthy subjects than in healthy male subjects.The proportion of subjects with adverse events was 1.6 times higher in the urea group than in the fasting group at the same dose.CONCLUSION The occurrence of adverse events may be related to the in vivo exposure of Buchanserin.In subsequent studies,attention should be paid to the effects of gender,feeding state,and dose administered on the incidence of adverse events in Brunsalin.