摘要
本文报道16例健康成年自愿受试者,随机分为5组,分别服氟康唑50、100、200、300和400mg后观察48小时。结果表明,50～300mg组无任何不良反应,400mg组可出现轻度头昏、思睡和稀便。全部受试者用药前后体检及实验室检查(血尿常规、肝肾功)均正常。本文提示成年患者氟康唑日剂量100～400mg耐受良好,一般不会产生严重不良反应。
A phase Ⅰ clinical trial of domestic fluconazole was conducted to investigate the safe and tolerable dosage of the new bistriazole antifungal drug in Chinese. Sixteen healthy volunteers were selected and randomized into five dose groups. Each of them received an oral single dose of 50, 100, 200, 300 or 400mg fluconazole respectively. They were observed for 48 hours. Results showed that no side-effect appeared in 50 to 300 mg groups. Only mild and transeint dizziness, drowsiness and diarrhea were observed in 2 of the 4 volunteers of 400 mg group and no treatment was required. Physical examination and laboratory analyses revealed no abnormalities in all of the groups. This study suggests that the domestic fluconazole is generally well tolerated in Chinese and no severe side-effects may be observed over a wide range of doses. The maximum recommended dose on this schedule of flucongazole is 400 mg per day.
出处
《华西医学》
CAS
北大核心
1993年第2期148-150,共3页
West China Medical Journal
关键词
氟康唑
耐受性试验
Fluconazole, Phase Ⅰ clinical trial
