盐酸恩丹西酮注射剂Ⅰ期临床药物耐受性试验  

PhaseⅠClinical Trial of Ondansetron Hydrochloride

作　　者：梁德荣[1] 徐楠[1] 张辉明[1] 

机构地区：[1]华西医科大学临床药理研究所

出　　处：《华西医学》1995年第3期280-283,共4页West China Medical Journal

摘　　要：本文报道２０例成年健康自愿受试者随机纳入５组，分别静脉注射盐酸恩丹西酮２ｍｇ、４ｍｇ、８ｍｇ、１２ｍｇ和１６ｍｇ后观察４８小时，以研究健康成人对该药的耐受程度。结果表明，应用该药后一般耐受性良好，虽有１０例受试者分别出现头晕、腹痛、便秘、稀便、视力模糊等不良反应，但均轻微、短暂，勿需处理。未见锥体外系症状。不良反应可见于各剂量组，但剂量增至１６ｍｇ时，不良反应明显增加。本文提示，成年患者盐酸恩丹西酮注射剂用量每次低于１２ｍｇ时，一般不会出现严重不良反应。A phaseⅠclinical trial of domestic ondansetron hyd rochloride was conducted to investigate the safe and tolerable dosage of the new antiemetic drug in Chinese. Twenty healthy volunteers were selected and randomized into five dose groups. Each of them received an intraveous single dose of2 , 4, 8, 12 or 16 mg ondansetron respectively.They were observed for 48 hours. Results showed that mild and transeint dizziness.abdominalgia, diarrhea or constipation, blurred vision were observed in 10 of the 20 volunteers and no treatment was required. No extrapyramidal symptoms occurred.Although adverse effects were observed in all of the groups,it increased obviously in 16mg group.This study suggests that the domestic ondansetron is generally well tolerated in Chinese and no serious side-effects occurred over a wide range of doses.The maximum recommended dose on this schedule of ondansetron is 12 mg per time.

关 键 词：恩丹西酮 注射剂 抗药性 止吐药 

分 类 号：R975.4[医药卫生—药品]