摘要
目的：评价健康人体对左奥硝唑片的耐受性。方法：采用随机、盲法、安慰剂对照的单中心临床研究。48名健康受试者经筛选进入临床试验,其中38名健康受试者随机分为4组参加了单次给药耐受性试验,各组剂量分别为250、500、1000、1500 mg。10名健康受试者参与了为期7 d的连续给药耐受性试验,剂量为1000 mg。各组均设2例安慰剂。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：在单次和多次给药耐受性试验中,受试者用药前后生命体征、心电图及实验室检查均没有临床意义的改变。20名受试者发生轻度不良事件,表现为头晕、乏力、困倦、恶心等。结论：健康受试者服用左奥硝唑片日剂量250~1000 mg,可安全耐受。
AIM： To evaluate the tolerability of（S）-ornidazole in healthy volunteers. METHODS： It is a randomized,blinded,placebo-controlled single-center clinical study.Fowrty-eight healthy volunteers enrolled the study.Thirty-eight healthy volunteers were randomly divided into four groups to attend single-dose tolerability trial（250,500,1000,1500 mg,respectively）.Ten healthy volunteers entered multi-dose tolerability trial for 7 days [1000 mg（S）-ornidazole,Qd].Two healthy volunteers of each group were given placebo.Vital signs,electrocardiogram and serum biochemical indicators were observed before and after（S）-ornidazole administration and adverse effects were recorded.RESULTS：In the study,there were no abnormal findings in vital signs,electrocardiogram and serum biochemical indicators.20 healthy volunteers experienced mild adverse effects of dizziness,fatigue,drowsiness nausea and so on.CONCLUSION：（S）-ornidazole tablet is safe for healthy volunteers at daily dose of 250 to 1000 mg.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2011年第4期412-416,共5页
Chinese Journal of Clinical Pharmacology and Therapeutics
