注射用磷酸左奥硝唑酯二钠的Ⅰ期临床耐受性试验  

Phase Ⅰ tolerance clinical trail of intravenous injection of levornidazole in Chinese healthy volunteers

作　　者：曹江[1] 梅和坤[1] 江学维[1] 唐铭婧[1] 牛卉[1] 王凯[1] 汶柯[1] 王睿[1] 王瑾[1] 王培兰[2] 

机构地区：[1]中国人民解放军总医院药物临床研究中心,北京100853 [2]中国人民解放军总医院总医务室,北京100853

出　　处：《中国临床药理学杂志》2015年第23期2311-2313,共3页The Chinese Journal of Clinical Pharmacology

基　　金：十二五国家重大科技专项基金资助项目(2012ZX09303004-002)

摘　　要：目的研究注射用磷酸左奥硝唑酯二钠单次给药的耐受剂量。方法用单中心、随机、盲法、安慰剂对照试验设计。40例受试者随机分为5组,男女各半,分别静脉滴注磷酸左奥硝唑酯二钠1000,1500,2000,2500,3000 mg,其中每组随机选2例静脉滴注安慰剂。观察受试者用药前后生命体征、心电图及实验室检查的变化,并观察和记录不良事件。结果受试者用药前后生命体征、心电图无临床意义的改变。1例受试者白细胞计数降低,受试者无任何症状及体征,判断与药物可能有关。共发生7例次不良事件,但均较轻微,持续时间短,未经干预,均自行缓解和消失。结论注射用磷酸左奥硝唑酯二钠在1000~3000mg耐受性和安全性良好,单次给药最大耐受剂量为3000 mg,推荐给药方案为2000 mg·d-1。Objective To study the maximum tolerated dose of levornidazole with phosphate ester disodium in Chinese healthy volunteers. Methods This was a single- center,randomized,blinded,placebo- controlled trial. Healthy volunteers were accepted a single dose intravenous injection of levornidazole in each group with dose escalation design to determine the maximum tolerated dose of single dose. A total of40 healthy volunteers were screened and equally divided into five groups（ half were male and half female）,two cases（ one man and woman） of each group were randomly chosen to receive placebo. The dosage of each group were 1000,1500,2000,2500,3000 mg,separately. Changes in vital signs,electrocardiogram and laboratory tests were recorded,and adverse events were also observed and recorded. Results Changes of vital signs and eletrocariogram were without clinical significance before and after administration. White blood cell count were reduced in 1 patient without any symptoms and signs,which might be related to drugs. A total of 7 cases of adverse events occurred,which were mild,short- duration,and disappeared without intervention. Conclusion Good tolerability and safety was shown in single dose of levornidazole range from1000- 3000 mg,the maximum tolerated single dose was 3000 mg. Dosage recom-mended in phaseⅡclinical trial is 2000 mg·d- 1.

关 键 词：注射用磷酸左奥硝唑酯二钠 单次静滴 耐受性试验 

分 类 号：R472[医药卫生—护理学]