利奈唑胺不同速度单次静滴在中国健康成年志愿者的耐受性  

Tolerance of single dosage of linezolid with different intravenous infusion speed in Chinese healthy volunteers

作　　者：尹红[1] 蔡芸[1] 白楠[1] 王睿[1] 梁蓓蓓[1] 

机构地区：[1]中国人民解放军总医院药品保障中心,北京100853

出　　处：《中国临床药理学杂志》2011年第2期107-109,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价不同速度单次静滴利奈唑胺(噁唑烷酮类抗菌药物)在中国健康成年志愿者的安全性、耐受性。方法筛选12名符合条件的健康成年受试者,男女各半。分别以600 mg/0.5 h,600 mg/2 h和600 mg/4 h的速度,单次静脉滴注利奈唑胺。在给药前1 d、给药后6 h和给药第3 d,测定心电图、血常规及尿常规、血生化,并对体征指标每日观测,进行单因素方差分析;观察不良事件。结果体征及实验室检查指标大多无明显改变。试验中未见严重不良事件,未见可能与药物有关的不良反应。结论 3种速度(600 mg/0.5 h,600 mg/2h和600 mg/4 h)静滴利奈唑胺均具有良好的安全性和耐受性。Objective To evaluate the safety and tolerance of single dosage of linezolid with different intravenous infusion speed in Chinese healthy volunteers.Method Twelve healthy volunteers（six males and six females） were chosen and crossover in three groups including 600 mg/0.5 h,600 mg/2 h and 600 mg/4 h.Subjects have electrocardiogram,urine and blood biochemical parameters and the routine blood test on the day before medication,6 hours after medication and the third day after medication.Subjects were observed and recorded vital sighs and adverse events during the trail.Clinical data should undertake one-factor analysis of variance.Results In any groups,the clinical symptoms,vital signs and index of laboratory examination were in normal range.There were no severe adverse events,and no adverse events related to the drug.The data of Hb,RBC and HCT in 6 hours after medication are significantly lower than the day before medication.Conclusion Single dosage of linezolid speed in 600 mg/0.5 h,600 mg/2 h and 600 mg/4 h are safe and tolerable in Chinese healthy volunteers.

关 键 词：利奈唑胺 单次静滴 安全性 耐受性 

分 类 号：R969.1[医药卫生—药理学] R978.19[医药卫生—药学]