Lin Dong-Fang, Zhang Ying-Yuan, Wu Ju-Fang, Wang Fu, Zheng Jing-Chuan, Miao Jing-Zhi, Zheng Li-Ye, Sheng Rui-Yuan, Zhou Xin, Shen Hua-Hao, Ijzerman Margaret Marian, Croos-Dabrera Rodney Victor, Sheng Wei
Institute of Antibiotics, Huashan Hospital, Fudan University, 12 Wulumuqi Zhong Road, Shanghai 200040, China.
Int J Antimicrob Agents. 2008 Sep;32(3):241-9. doi: 10.1016/j.ijantimicag.2008.04.004. Epub 2008 Jul 16.
In this randomised, double-blind, comparator-controlled, multicentre study conducted in China, 142 hospitalised patients aged 18-75 years with pneumonia (n=80) or complicated skin and soft-tissue infection (cSSTI) (n=62) due to suspected or known Gram-positive pathogens were randomised (1:1) to receive either linezolid 600mg (n=71) or vancomycin 1g in patients aged < or =60 years or 0.75g in patients aged >60 years (n=71) intravenously every 12h. The duration of treatment was 10-21 days for patients with pneumonia and 7-21 days for patients with cSSTI. Clinical outcomes were assessed at end-of-treatment (EOT) visit and follow-up (FU) visit 7-28 days post therapy. Staphylococcus aureus was the most common pathogen at baseline and most of these isolates were resistant to meticillin. All isolates were susceptible to linezolid and vancomycin. For the evaluable patients, the effective treatment rate for linezolid was higher than that for vancomycin at EOT (86.9% (53/61) vs. 61.7% (37/60)) and at FU (83.1% (49/59) vs. 64.9% (37/57)). Pathogen eradication rates for the microbiologically evaluable patients at FU were 79.2% (42/53) for linezolid and 61.5% (32/52) for vancomycin. The incidence of drug-related adverse events (AEs) was 25.4% (18/71) for linezolid and 16.9% (12/71) for vancomycin. Four (5.6%) linezolid-treated and eight (11.3%) vancomycin-treated patients discontinued the study drug because of an AE. Linezolid was well tolerated and effective for the treatment of infections caused by Gram-positive pathogens, including meticillin-resistant S. aureus.
在中国进行的这项随机、双盲、对照、多中心研究中，142例年龄在18至75岁之间因疑似或已知革兰氏阳性病原体导致肺炎（n = 80）或复杂性皮肤及软组织感染（cSSTI）（n = 62）的住院患者被随机（1:1）分组，年龄≤60岁的患者接受利奈唑胺600mg（n = 71），年龄＞60岁的患者接受万古霉素1g（年龄≤60岁）或0.75g（年龄＞60岁）（n = 71），每12小时静脉注射一次。肺炎患者的治疗疗程为10至21天，cSSTI患者为7至21天。在治疗结束（EOT）访视以及治疗后7至28天的随访（FU）访视时评估临床结局。金黄色葡萄球菌是基线时最常见的病原体，且这些分离株大多对甲氧西林耐药。所有分离株对利奈唑胺和万古霉素均敏感。对于可评估患者，利奈唑胺在EOT时的有效治疗率高于万古霉素（86.9%（53/61）对61.7%（37/60）），在FU时也是如此（83.1%（49/59）对64.9%（37/57））。微生物学可评估患者在FU时利奈唑胺的病原体清除率为79.2%（42/53），万古霉素为61.5%（32/52）。利奈唑胺相关药物不良事件（AE）的发生率为25.4%（18/71），万古霉素为16.9%（12/71）。4例（5.6%）接受利奈唑胺治疗和8例（11.3%）接受万古霉素治疗的患者因AE而停用研究药物。利奈唑胺耐受性良好，对革兰氏阳性病原体包括耐甲氧西林金黄色葡萄球菌引起的感染有效。
