来氟米特人体耐受性试验研究  

The study of the tolerance of Leflunomide in human being

作　　者：姚宏伟[1] 金涌[1] 李常玉[1] 汤晓林[1] 张运芳[1] 李俊[1] 

机构地区：[1]安徽医科大学临床药理研究所,合肥230032

出　　处：《安徽医药》2001年第2期93-95,共3页Anhui Medical and Pharmaceutical Journal

摘　　要：目的　研究正常国人对来氟米特 (Leflunomide ,Lef)的耐受程度。方法　选择 2 2名健康志愿者 ,男 11人 ,女 11人 ,按男女随机分成 4组 ,每组男女各半 ,每组人数分别为 4、6、6、6人 ,按从低到高递增的顺序 10、2 0、40、80mg ,单次口服Lef,观察给药前、给药后 1h、2 4h和 48h各种不良反应和试验前后的血尿常规及肝肾功能。结果　Lef(10～ 80mg)各剂量组试验中 ,志愿者均无明显不良反应 ,试验前后血尿常规及肝肾功能无显著性变化。结论　 2 2名健康志愿者口服Lef(10～ 80mg)均能很好地耐受 ,Ⅱ期临床试验可以参考此剂量范围选择临床试验剂量。AIM To study the tolerance of Leflunomide (Lef) in normal Chinese. METHODS 22 healthy volunteers, male 11, female 11, were selected for study of tolerance of Lef in human being. They were randomly divided into 4 groups, which took 10, 20, 40, 80 mg respectively by the stratified method. Each group had 4,6,6,6 people respectively and half of men and women. We observed all kinds of adverse reactions, blood routine, hepatic and renal functions before and after test. RESULTS In each group, every volunteer had not obvious adverse reactions and HR, R, BP ECG were in normal range. Before and after test, blood routine, hepatic and renal functions had not significant change. CONCLUSION 22 healthy volunteers had a good tolerance when they took Lef from 10 to 80 mg. Furthermore, the phase Ⅱ clinical test can refer to the aboved dosage ranges.

关 键 词：来氟米特 耐受性 药理学 

分 类 号：R965[医药卫生—药理学]