盐酸索西沙星片在健康人体单次给药的耐受性  

Tolerance of soxifloxacin hydrochloride tablet after ascending single dose in Chinese healthy subjects

作　　者：赵彩芸[1] 吕媛[1] 侯芳[1] 王进[1] 夏亚红[1] 马雁[1] 田继红[1] 刘燕[1] 张煜昕[1] 毛伟[2] 黄雅琴[2] 

机构地区：[1]北京大学第一医院临床药理研究所,北京100034 [2]浙江医药股份有限公司新昌制药厂,浙江绍兴312500

出　　处：《中国临床药理学杂志》2015年第16期1606-1609,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价健康受试者单次口服不同剂量盐酸索西沙星的安全性和耐受性。方法 72名受试者随机进入7个递增剂量组,50 mg剂量组8人（受试制剂与安慰剂比为3∶1）,予以盐酸索西沙星50 mg;100,200,300 mg剂量组各10人（受试制剂与安慰剂比为4∶1）,分别予以盐酸索西沙星100,200,300 mg;400,600 mg剂量组各12人（受试制剂与安慰剂比为2∶1）,分别予以盐酸索西沙星400,600 mg;800 mg剂量组10人（受试制剂与安慰剂比为3∶2）,予以盐酸索西沙星800 mg。用药后观察受试者的生命体征,定时进行实验室检查、心电图和脑电图描记。结果 72名受试者全部完成了研究,400 mg剂量组1例受试者在服药第3天左踝部碰伤,伴肌酸激酶升高,与研究药物无关;600 mg剂量组出现1例轻度头晕,800 mg剂量组2例受试者出现轻度恶心,与研究药物可能有关。其他受试者无不良事件。结论在50-800 mg剂量范围内单次口服盐酸索西沙星耐受性良好。Objective To evaluate the safety and tolerance of single oral dose of soxifloxacin hydrochloride in Chinese healthy subjects. Methods Seventy- two eligible subjects were randomized into 7 escalation dose groups. Eight subjects in 50 mg group were randomized to receive either study drug or placebo in the ratio of 3 to 1; each ten subjects in 100 mg,200 mg and 300 mg group received study drug to placebo was 4 ∶ 1,respectively. Twelve subjects in 400 mg and 600 mg group,the ratio of study drug to placebo was 2 ∶ 1,and ten subjects in 800 mg group was3∶ 2,respectively. Safety and tolerability were evaluated by monitoring adverse events,laboratory parameters,electrocardiography and electroencephalogram. Results A total of 72 subjects finished study. One subject in 400 mg group had bruise on the left ankle with creatine kinase elevated,considered not related to study drug,the other one in 600 mg group complained mild dizziness and two subjects in 800 mg group complained mild nausea. All of these symptoms were assessed as related to study drug. Conclusion Soxifloxacin hydrochloride was safe and well tolerated after single oral administration at dose range of 50 to 800 mg.

关 键 词：盐酸索西沙星 单次口服 耐受性 

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