连续口服甲磺酸加替沙星片的人体耐受性研究

Tolerability of gatifloxacin mehanesulfanae orally for 10 days in Chinese health volunteers

目的 :在中国健康成年志愿者中 ,评估连续口服甲磺酸加替沙星片的耐受性。方法 :根据GCP原则设计试验方案 ,选择 10名 18～ 4 0岁健康男性受试者参加连续口服甲磺酸加替沙星片耐受性试验 ,口服甲磺酸加替沙星片每次 4 0 0mg ,每日 1次 ,连续10d。观察临床症状、体征 ,包括体温、脉搏、呼吸频率、血压等指标 ;实验室指标包括心电图、脑电图、血常规、凝血功能、尿常规、肝功能、肾功能、电解质等。结果 :入选受试者给药后及给药期间症状、体征及实验室检查均未见有临床意义的改变。试验中未见严重的临床不良反应 ,有 2例受试者出现GPT、GOT轻度升高 ,可能与药物有关 ,停药 1wk后恢复正常。结论 :10名健康受试者连续口服甲磺酸加替沙星片10d ,每日 4 0 0mg 。

AIM: To evaluate the tolerance of gatifloxacin mehanesulfanae after taking orlly multi dose in Chinese healthy volunteers. METHODS: The protocol was designed according to GCP principle. After physical examination and laboratory tests, 10 volunteers (18-40 yr) were invited to attend the clinical trial to evaluate the tolerance of gatifloxacin mehanesulfanae in 400 mg qd in continuous 10 days. Clinical symptoms, vital signs, routine blood tests, clotting function, routine urine tests, hepatic function, renal function, blood electrolytes, electrocardiogram, and electroencephalogram were observed or examined before and after administration. RESULTS: There was no significant clinical change in the 10 volunteers before and after administration. There was no serious ADRs during the trial, and only 2 volunteers were found the slightly increase of GPT and GOT which maybe associated with the tested drug. CONCLUSION: It is safe and tolerable that Chinese healthy volunteers were treated by gatifloxacin mehanesulfanae in 400 mg qd. in continuous 10 days.