泰利心胶囊Ⅰ期临床人体耐受性试验  

Phase Ⅰ clinical tolerance study of Tailixin Capsule in healthy volunteers

作　　者：刘松山[1] 何成诗[1] 张爽[1] 陈光宇[1] 

机构地区：[1]成都中医药大学附属医院,成都610072

出　　处：《中药药理与临床》2012年第3期108-110,共3页Pharmacology and Clinics of Chinese Materia Medica

摘　　要：目的:评价健康受试者对泰利心胶囊的耐受性和安全性,为Ⅱ期临床试验给药方案提供依据。方法:选择健康受试者44例,随机进入7个单次给药组和2个连续给药组。单次给药组分别口服泰利心胶囊100mg、200mg、300mg、500mg、700mg、900mg、1200mg,连续给药组口服泰利心胶囊1次200mg和300mg,1天2次,服药7天。观察生命体征、实验室检查指标、临床症状和不良反应。结果:单次给药无不良反应,连续给药剂量组有轻微头痛的不良反应。结论:健康人体对泰利心胶囊耐受性较好,临床应用较安全,仅见轻微头痛。推荐Ⅱ期临床试验给药剂量范围是1次100mg～200mg,1天2次。Objective ：To evaluate the tolerance and safety of Tailixin Capsules in healthy volunteers,and assess the safety range of clinical use of drugs and given - drug project in phase Ⅱ clinical trial. Methods： A total of 44 healthy volunteers were randomly divided into 7 single - dose groups（ 100mg,200mg,300 mg ,500 mg ,700 mg ,900 mg and 1200mg）and a multiple -dose group（200mg and 300 mg,2 times a day,for 7 days）. The safety profile and tolerance were evaluated by observing vital signs,laboratory tests clnical symptoms and adverse reaction. Re- suits ： No adverse reaction in single -dose groups but only mild adverse reaction appeared in successive dose such as slight headache. Con- clusion： Healthy body has a good tolerance for Tailixin capsule,and it is safe to use this drug except slight headache. The recommended dose is 100mg-200mg 2 times every day in phase Ⅱ clinical trial.

关 键 词：泰利心胶囊 Ⅰ期临床试验 耐受性 安全性 

分 类 号：R285[医药卫生—中药学]