新型催醒药莫达芬尼片单次口服耐受性研究  

The tolerance of a oral single dose of new wakefulness-promoting agent-Modafinil in Chinese Health Volunteers

作　　者：王睿[1] 周筱青 方翼 王林[2] 金义光[2] 王中孝 裴斐 柴栋 朱曼 彭涛[2] 

机构地区：[1]中国人民解放军总医院,药材处北京100853 [2]中国人民解放军军事医学科学院,放射医学研究所北京100850

出　　处：《解放军药学学报》2004年第5期321-324,共4页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：军队"十五"攻关重点课题项目;No .0 1L0 2 1-2

摘　　要：目的　在中国健康成年男性志愿者中 ,评估单次口服新型催醒药莫达芬尼片的安全性、耐受性。方法　选择 30名 18岁～ 5 0岁健康成人 ,用区组随机化设计方法 ,将受试者随机分配至 5 0、10 0、2 0 0、30 0、4 0 0mg组 ,每组 6名受试者。观察指标为临床症状体征 ,实验室指标包括心电图、脑电图、血常规、尿常规、肝功能、肾功能、电解质等。严密观察并记录试验期间发生的不良反应事件。同时 ,观察药物对受试者睡眠的影响。结果　各组入选受试者各项指标测定值均在正常范围 ,条件均衡 ,具较好可比性。给药后体温、呼吸频率、脉搏、血压、实验室检查肾功能、电解质等未见有临床意义的改变。各剂量组受试者在给药后 ,均发现有不同程度的睡眠减少现象。试验中 ,未见严重的临床不良反应 ,仅发现三例轻度一过性不良反应 ,其中 2 0 0mg组一例 ,表现为GPT升高 ,4 0 0mg组二例 ,表现为体温升高。结论　 30名健康受试者分组单次口服莫达芬尼片 ,最大剂量至4 0 0mg,比较安全、耐受性较好。Aim To evaluate the safety and tolerance of oral single-dose of wakefulness-promoting agent-modafinil in Chinese healthy volunteers.Methods After physical examination and laboratory tests were performed,30 healthy volunteers in 18～50 years old were devided into 50,100,200,300,400mg groups randomly with 6 subjects in each group.Clinical symptoms,vital signs,electrocardiogram,electroencephalogram,routine blood tests,clotting function,routine urine tests,renal function,blood electrolytes were observed or examined before and after oral single-dose of modafinil.Results It was shown that after volunteers were taken single-dose of modafinil from 50mg to 400mg,the vital signs,clinical symptoms and laboratory tests were mainly in the normal range.The subjects in every groups were found that their sleeping time became short.Only three cases of ADRs were found that was involved in the drug,such as GPT of one case in 200mg group increased,temperature of two cases in 400mg groups increased slightly.Conclusion Chinese healthy volunteers treated by single-dose of modafinil up to 400mg were safe and tolerable.

关 键 词：莫达芬尼 耐受性 健康志愿者 安全性 

分 类 号：R971.3[医药卫生—药品]