摘要
目的:初步评价注射用比伐卢定在中国人群的安全性和耐受性。方法:筛选48名中国健康受试者,男女各半,随机分为四组,分别单次静脉推注注射用比伐卢定0.5,0.75,1.05 mg.kg-1,或以0.75 mg.kg-1静推后,立即接续以1.75 mg.kg-1.h-1的速度匀速静滴4 h,观察给药前后受试者的临床症状、体征,以及实验室检查指标变化。结果:受试者给药前后各项检查的差异无统计学意义。试验期间出现轻度不良事件5例,其中,可能与药物有关的不良反应3例,表现为轻度黏膜出血。结论:注射用比伐卢定在中国健康受试者中有良好的耐受性。
Objective： To evaluate the safety and tolerance of bivalirudin injection in Chinese healthy volunteers.Methods： Forty-eight Chinese healthy volunteers were selected and enrolled in 4 groups randomly.Each group was administrated bivalirudin by 0.5,0.75,1.05 mg·kg-1 i.v.bolus once respectively or 1.75 mg·kg-1·h-1 i.v.drip for 4 hours after 0.75 mg·kg-1 i.v.bolus.Clinical symptoms,signs and lab examinations were recorded during the clinical trial.Results： There was no significant difference of each index before and after administration.Five adverse events occurred during the clinical trial.Three of which were related to bivalirudin,mainly mild mucosal bleeding.Conclusion： Bivalirudin had good safety and tolerance in Chinese healthy volunteers.
出处
《中国药物应用与监测》
CAS
2011年第3期136-138,共3页
Chinese Journal of Drug Application and Monitoring
基金
国家新药创制科技重大专项课题(2008ZX09312-006)
