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学科主题: 药理学
题名:
单次口服高剂量盐酸安妥沙星片在健康人体的耐受性研究
其他题名: Tolerance of antofloxacin hydrochloride tablet after high single oral dose in Chinese healthy subjects
作者: 赵彩芸; 吕媛; 王进; 夏亚红; 马雁; 田继红; 刘燕; 张煜昕
关键词: 盐酸安妥沙星 ; 高剂量 ; 单次口服 ; 耐受性 ; antofloxacin hydrochloride ; high dose ; single oral dose ; tolerance
刊名: 中国临床药理学杂志
发表日期: 2015
DOI: 10.13699/j.cnki.1001-6821.2015.14.016
期: 14, 页:1407-1410
收录类别: 中国科技核心期刊 ; 中文核心期刊 ; CSCD
文章类型: Journal Article
摘要: 目的:评价健康受试者单次口服高剂量盐酸安妥沙星的耐受性和安全性。方法30例受试者分为600mg组、800mg组、1000mg组,每组8名,分别予以单次口服盐酸安妥沙星600,800,1000 mg,以及安慰剂组6名。用药后,定时进行实验室检查、心电图和脑电图检查。结果30名受试者全部完成了研究。600mg组未见不良事件。800 mg组有3例受试者出现5件不良事件,主要为恶心、呕吐,考虑与研究药物有关。1000 mg组6例受试者出现10件不良事件,主要为恶心、呕吐、头晕、双足点状红斑,考虑与研究药物有关或很可能有关。安慰剂组未见不良事件。结论盐酸安妥沙星片600 mg为本次试验用药的最大安全耐受剂量。 Objective To evaluate the safety and tolerance of antofloxa-cin after high single oral dose in Chinese healthy subjects. Methods Thirty subjects were randomized into three dose groups (600, 800 and 1000 mg ) , each dose groups of eight subjects received study drug, otherwise two subjects in each group received placebo.Safety and tolerability were evaluated by monitoring adverse events, laboratory parameters, electrocardiography ( ECG ) and electroencephalogram ( EEG) .Results Totally 30 subjects finished study.No adverse event in 600 mg group.There were three subjects had 5 adverse events in 800 mg group, complained nausea and vomiting, considered related to study drug.In 1000 mg group, six subjects had 10 adverse events, including nausea, vomiting, dizziness and dot erythema of feet, related or probably related to study drug.There was no adverse event in placebo group. Conclusion After high single oral administration of antofloxacin hydrochloride, 600 mg was safe clinical maximum dose.
语种: 中文
原文出处: 查看原文
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内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/44675
Appears in Collections:北京大学第一临床医学院_临床药理研究所_期刊论文

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作者单位: 北京大学 第一医院 临床药理研究所,北京,100034

Recommended Citation:
赵彩芸,吕媛,王进,等. 单次口服高剂量盐酸安妥沙星片在健康人体的耐受性研究[J]. 中国临床药理学杂志,2015(14):1407-1410.
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