奈莫沙星(泰格星®):一种新型无氟喹诺酮类药物

Li-wen Chang, M. Hsu, Ying-yuan Zhang
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引用次数: 3

摘要

Nemonoxacin (Taigexyn®)是一种新型的c -8-甲氧基无氟喹诺酮类药物,已在台湾(2014年)和中国大陆(2016年)获批用于社区获得性肺炎(CAP)。2013年12月,FDA授予nemonoxacin“合格传染病产品”和CAP和急性细菌性皮肤和皮肤结构感染的“快速通道”指定。它对典型和非典型呼吸道病原体具有广谱的杀菌活性。特别是,奈蒙沙星对耐药的革兰氏阳性球菌有活性,包括耐青霉素肺炎链球菌和耐甲氧西林金黄色葡萄球菌。在三个随机、双盲、对照的II-III期临床试验中,比较口服奈蒙沙星与口服左氧氟沙星治疗CAP的疗效和安全性。本文将回顾奈蒙沙星对呼吸道病原体(包括肺炎链球菌和金黄色葡萄球菌)的微生物学特征,以及三个II-III期研究的微生物学结局数据。
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Nemonoxacin (Taigexyn®): A New Non-Fluorinated Quinolone
Nemonoxacin (Taigexyn ® ), a novel C-8-methoxy non-fluorinated quinolone, has been approved for use in community-acquired pneumonia (CAP) in Taiwan (2014) and mainland China (2016). The FDA granted nemonoxacin ‘qualified infectious disease product’ and ‘fast-track’ designations for CAP and acute bacterial skin and skin structure infection in December 2013. It possesses a broad spectrum of bactericidal activity against typical and atypical respiratory pathogens. In particular, nemonoxacin has activity against resistant Gram-positive cocci, including penicillin-resistant Streptococcus pneumoniae and methicillin-resistant Staphylococcus aureus . Oral nemonoxacin was compared with oral levofloxacin for efficacy and safety in three randomized, double-blinded, controlled Phase II–III clinical trials for the treatment of CAP. This article will review the microbiological profile of nemonoxacin against respiratory pathogens including S. pneumoniae and S. aureus , and microbiological outcome data from the three Phase II–III studies.
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