多剂静滴甲磺酸加替沙星氯化钠注射液耐受性试验

Investigation on the tolerance of gatifloxacin mehanesulfanae by a multi-dose intravenous infusion

目的 :在中国健康志愿者中评价多剂静滴甲磺酸加替沙星氯化钠注射液的安全性和耐受性。方法 :选择健康成年男性志愿者 10名 ,恒速静脉滴注甲磺酸加替沙星氯化钠注射液 ,qd ,每次 4 0 0mg ,连续 14d。观察指标为临床症状、生命体征、心电图、血常规、尿常规、肝功能、肾功能、凝血功能、电解质等。结果 :试验结束后 ,健康志愿者体温、脉搏、呼吸频率、血压、心电图、血常规、肾功能、电解质等各项指标测定值均在正常范围内。本试验过程中仅发现 4例次可能与药物有关的不良反应 ,分别表现为AST ,ALT或γ 谷氨酰转移酶轻度升高 ,均为轻度一过性 ,可耐受 ,于停药后 1周内自行恢复。结论 :多剂静滴甲磺酸加替沙星氯化钠注射液 ,耐受性较好 。

Objective:To evaluate the safety and tolerance of gatifloxacin in Chinese healthy volunteers.Methods:After physical examination and laboratory tests were performed,10 healthy volunteers were administered with multi dose of 400mg gatifloxacin,qd for 14 days.Clinical symptoms,vital signs,routine blood tests, routine urine tests,hepatic function,renal function,clotting function,blood electrolytes,electrocardiogram,electroencephalogram were observed or examined before and after multi dose intravenous infusion of gatifloxacin.Results:It was shown that after multi dose intravenous infusion of 400mg gatifloxacin,the vital signs,clinical symptoms and laboratory tests were mainly in the normal range,but there were some slight ADRs that was concerned with the drug,such as ALT,AST or GGT increased,but the ADRs were found vanishing in one week.Conclusion:Multi dose intravenous infusion gatifloxacin in Chinese healthy volunteers is safe and tolerable.