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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 Epstein to healthy male volunteers in China. Methods: Thirty-six selected subjects participated in a single-dose tolerability trial. Eight subjects were enrolled in a continuous dosing tolerance test at 5 mg each for q12h for 8 days. The changes of clinical symptoms and laboratory test results of the subjects before and after administration in the single administration and the continuous administration were compared respectively. Results: In a single oral 2.5, 5, 10, 20 and 30 mg of Epsilon, 24h and 72h after taking the subjects physical examination and laboratory test results compared with no difference before administration. Continuous drug resistance results showed no difference in body test and laboratory test results between before and after administration of DHT on days 3 and 9. CONCLUSIONS: Subjects are well tolerated with Epsilon, and a recommended clinical dose of 5-10 mg is acceptable.