单次静滴米卡芬净钠在健康成年志愿者的耐受性  

Tolerance of single intravenous injection micafungin in Chinese healthy volunteers

作　　者：白楠[1] 李晓娇[2] 蔡芸[1] 梁蓓蓓[1] 王睿[1] 

机构地区：[1]中国人民解放军总医院临床药理室,北京100853 [2]厦门大学医学院药学系,福建厦门361005

出　　处：《中国临床药理学杂志》2010年第10期743-745,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价中国健康受试者单次静脉滴注3种不同剂量注射用米卡芬净钠(抗真菌药)的安全性和耐受性。方法选择12名18～45岁健康受试者,男女各半,用自身三交叉试验设计,用分层随机法,依次接受静脉滴注3种不同剂量的米卡芬净钠,观察并记录受试者临床体征及各种生化指标结果,采用方差分析比较给药前后各项指标变化。结果单次静脉滴注米卡芬净钠50,100,150mg前后,受试者的体征及实验室检查指标变化,未见具有临床意义的差异。结论中国健康人群受试者恒速静滴3个剂量(50,100,150mg.h-1)米卡芬净均具有较好的耐受性。Objective To assess the safety and toleration of single intra- venous injection mieafungin in Chinese healthy volunteers. Methods This was a randomized, 3 -way cross over, single dose study in healthy Chinese adults. Twelve health subjects （6 males, 6 females ） were screened and randomized to three different dose. The tolerability was assessed by monitoring adverse events （AEs） and laboratory parameters. Results The vital signs, clinical symptoms and laboratory tests of three doses were mainly in the normal range. Conclusion The results suggested that the tolerance of micafungin is good,and 50, 100, 150 mg·h^-1 of micafungin at intravenous injection for clinical use is acceptable.

关 键 词：米卡芬净 安全耐受性 抗真菌 

分 类 号：R969.1[医药卫生—药理学] R978.5[医药卫生—药学]