达托霉素在日本获批用于治疗耐甲氧西林金黄色葡萄球菌。
Daptomycin approved in Japan for the treatment of methicillin-resistant Staphylococcus aureus.
机构信息
Department of Infection Control and Prevention, Aichi Medical University School of Medicine, Nagakute, Aichi, Japan.
出版信息
Ther Clin Risk Manag. 2012;8:79-86. doi: 10.2147/TCRM.S23875. Epub 2012 Feb 17.
Abstract
Daptomycin is a lipoglycopeptide antibacterial drug that is rapidly bactericidal for methicillin-resistant Staphylococcus aureus (MRSA) infection and has antibiotic activity against a wide range of Gram-positive organisms. It has been approved by the Ministry of Health, Labor and Welfare in Japan for the treatment for bacteremia, right-sided endocarditis, and skin and skin-structure infections, such as necrotizing fasciitis, due to MRSA on the basis of a Phase III trial conducted in Japan since July, 2011. In Japanese Phase I and III trials, daptomycin therapy given at 4 mg/kg and 6 mg/kg once per day was well tolerated and effective as standard therapy for the treatment of acute bacterial skin and skin-structure infections and bacteremia caused by MRSA, but side effects remain to be evaluated in large-scale trials.
摘要
达托霉素是一种糖肽类抗生素药物，对耐甲氧西林金黄色葡萄球菌（MRSA）感染具有快速杀菌作用，对多种革兰氏阳性菌具有抗菌活性。自 2011 年 7 月以来，在日本进行的 III 期临床试验的基础上，达托霉素已获日本厚生劳动省批准，用于治疗由 MRSA 引起的菌血症、右侧心内膜炎和皮肤及皮肤结构感染，如坏死性筋膜炎。在日本的 I 期和 III 期临床试验中，达托霉素 4mg/kg 和 6mg/kg 每日一次的治疗方案耐受性良好，且与标准疗法一样有效，可治疗由 MRSA 引起的急性细菌性皮肤和皮肤结构感染和菌血症，但仍需要在大规模试验中评估其副作用。
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