Linezolid for the treatment of multidrug-resistant, gram-positive infections: Experience from a compassionate-use program
Linezolid for the treatment of multidrug-resistant, gram-positive infections: Experience from a compassionate-use program
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DOI：
10.1086/345744
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发表时间：
2003-01-15
影响因子：
11.8
通讯作者：
Schentag, JJ
中科院分区：
文献类型：
--
作者：
Birmingham, MC;Rayner, CR;Schentag, JJ
利奈唑胺通过同情使用计划用于治疗多重耐药革兰氏阳性菌感染。患者（n = 796）接受600 mg利奈唑胺静脉注射或口服，每12 It（828个疗程）。46%的感染存在菌血症，10.6%存在心内膜炎，31.1%存在线路相关感染。其他感染包括腹腔内感染（15.1%）、复杂性皮肤和皮肤结构感染（13.3%）和骨髓炎（10.7%）。耐万古霉素肠球菌占66.3%，耐甲氧西林葡萄球菌占22.1%。可评价人群的临床意向治疗（ITT）结局如下：治愈，73.3%;失败，6.8%;不确定，19.9%。可评估患者的微生物学ITT结局如下：治愈，82.4%;失败，14.1%;不确定，3.5%。在治愈评估测试中，临床治愈率和微生物学成功率分别为91.5%和85.8%。可能与利奈唑胺使用相关的最常见不良事件为胃肠道紊乱（9.8%的病例）、血小板减少症（7.4%的病例）、血红蛋白/红细胞压积水平降低（4.1%的病例）和皮肤反应（4.0%的病例）。利奈唑胺在该复杂患者人群中提供了高临床治愈率和微生物学成功率，总体耐受性非常好。
Linezolid was provided for treatment of multidrug-resistant, gram-positive infections through a compassionate-use program. Patients (n = 796) received 600 mg of linezolid intravenously or orally every 12 It (828 treatment courses). Bacteremia was present in 46% of infections, endocarditis was present in 10.6%, and line-related infections were present in 31.1%. Other infections included intraabdominal infections (15.1%), complicated skin and skin-structure infections (13.3%), and osteomyelitis (10.7%). Causative pathogens included vancomycin-resistant enterococci (66.3%) and methicillin-resistant staphylococci (22.1%). Clinical intent-to-treat (ITT) outcomes in the evaluable population were as follows: cure, 73.3%; failure, 6.8%; and indeterminate, 19.9%. Microbiological ITT outcomes in evaluable patients were as follows: cure, 82.4%; failure, 14.1%; and indeterminate, 3.5%. At the test of cure assessment, the clinical cure and microbiological success rates were 91.5% and 85.8%, respectively. The most common adverse events possibly related to linezolid use were gastrointestinal disturbances (9.8% of cases), thrombocytopenia (7.4% of cases), decreased hemoglobin/hematocrit levels (4.1% of cases), and cutaneous reactions (4.0% of cases). Linezolid provided high rates of clinical cure and microbiological success in this complicated patient population, with very good overall tolerance.