爱普列特正常人体耐受性研究  

Tolerance of Epristeride in Normal Male Volunteers

作　　者：李家泰[1] 郑直 金杰[2] 李天云[1] 李华[1] 王婉青 

机构地区：[1]北京大学临床药理研究所,北京100083 [2]北京大学泌尿研究所,北京100034

出　　处：《中国临床药理学杂志》2000年第6期419-423,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的：观察中国健康男性志愿者对爱普列特的耐受性。方法：３６名入选受试者参加了单剂量耐受性试验。８名受试者入选参加每次５ｍｇ，ｑ１２ｈ，持续８ｄ的连续给药耐受性试验。分别比较单次给药和连续给药试验中给药前与给药后受试者的临床症状和实验室化验结果的变化。结果：在单次口服２．５，５，１０，２０和３０ｍｇ爱普列特时，服药后２４ｈ，７２ｈ时受试者的体证及试验室检查结果与给药前比较没有区别。连续给药耐受性结果显示除双氢睾酮服药后第３ｄ和第９ｄ受试者的体证及试验室检查结果与给药前比较也没有区别。结论：受试者对爱普列特具有很好的耐受性，推荐临床一次５—１０ｍｇ的应用剂量是可以接受的。OBJECTIVE: To observe the tolerance of epristeride, a steroid 5a - reductase inhibitor, in Chinese healthy male volunteers. METHODS:Thirty-six volunteers were enrolled in single-dose ascending trial, eight volunteers were enrolled in multiple-dose trial. Comparisons were made on the clinical symptoms and lab examinations acquired pre dosing and after dosing in the single-dose and multiple-dose regimens respectively. RESULTS: Single oral taking 2.5mg, 5mg, 10mg, 20mg or 30mg of espristeride did not affect the vital signs of the subjects. There were no abnormal changes in the lab examinations pre dosing and 24hr and 72hr after dosing.. When subject was giving 5mg of espristeride, Q12h, for 8 days, no significant change was found in the clinical symptoms and lab examinations, except DHT. CONCLUSIONS:The results suggested that the tolerance of epristeride is good, and 5 to 10mg of epristeride at a time recommended for clinical use is acceptable.

关 键 词：爱普列特 前列腺增生 耐受性 试验 

分 类 号：R983[医药卫生—药品] R697.320.5[医药卫生—药学]