Kaplan Sheldon L, Afghani Behnoosh, Lopez Pio, Wu Elba, Fleishaker Dona, Edge-Padbury Barbara, Naberhuis-Stehouwer Sharon, Bruss Jon B
Texas Children's Hospital MC 3-2371, 6621 Fannin Street, Suite 1150, Houston, TX 77030, USA.
Pediatr Infect Dis J. 2003 Sep;22(9 Suppl):S178-85. doi: 10.1097/01.inf.0000087020.75886.93.
Infections caused by methicillin-resistant Staphylococcus aureus (MRSA) are becoming increasingly prevalent. Linezolid is effective and well-tolerated in the treatment of adults with MRSA infections.
To evaluate the clinical efficacy and safety of iv/oral linezolid in children with MRSA infections.
Data were obtained from two independent clinical trials. In an outpatient trial children (5 to 17 years of age) with uncomplicated skin and skin structure infections (SSSIs) were treated with linezolid or cefadroxil. In an inpatient trial hospitalized children (0 to 11 years of age) with pneumonia, bacteremia or complicated SSSI caused by resistant Gram-positive pathogens were administered iv linezolid with the option to switch to oral suspension (patients >90 days of age) or iv vancomycin. A subset of patients with MRSA infections from the two clinical trials is analyzed herein.
In the outpatient trial children with skin infections caused by MRSA were treated with linezolid (15 patients) and cefadroxil (10 patients). In the microbiologically evaluable population, the clinical cure rate was 92.3% in the linezolid group and 85.7% in the cefadroxil group (P = 0.64). The pathogen eradication rate for MRSA was 92.3 and 85.7% in the linezolid and cefadroxil groups, respectively (P = 0.64). There were very few adverse events or drug-related adverse events and no serious adverse events in the outpatient trial. In the inpatient trial 20 children treated with linezolid and 14 treated with vancomycin had infections caused by MRSA. In the microbiologically evaluable population, the clinical cure rate was 94.1% in the linezolid group and 90.0% in the vancomycin group (P = 0.69). Pathogen eradication rates were 88.2 and 90.0% for the linezolid and vancomycin groups, respectively (P = 0.89). Susceptibility patterns of the MRSA isolates showed distinct patterns between the outpatient and inpatient trials. In the inpatient trial fewer patients in the linezolid group had drug-related adverse events than did those in the vancomycin group (20% vs. 43%; P = 0.15).
Intravenous/oral linezolid is effective and well-tolerated in children with MRSA infections.
耐甲氧西林金黄色葡萄球菌(MRSA)引起的感染日益普遍。利奈唑胺在治疗成人MRSA感染方面有效且耐受性良好。
评估静脉注射/口服利奈唑胺治疗儿童MRSA感染的临床疗效和安全性。
数据来自两项独立的临床试验。在一项门诊试验中,对患有单纯性皮肤和皮肤结构感染(SSSI)的儿童(5至17岁)用利奈唑胺或头孢羟氨苄进行治疗。在一项住院试验中,对患有由耐药革兰氏阳性病原体引起的肺炎、菌血症或复杂性SSSI的住院儿童(0至11岁)静脉注射利奈唑胺,并可选择改用口服混悬液(年龄>90天的患者)或静脉注射万古霉素。本文分析了来自这两项临床试验的一部分MRSA感染患者。
在门诊试验中,患有MRSA引起的皮肤感染的儿童用利奈唑胺治疗(15例患者)和头孢羟氨苄治疗(10例患者)。在微生物学可评估人群中,利奈唑胺组的临床治愈率为92.3%,头孢羟氨苄组为85.7%(P = 0.64)。利奈唑胺组和头孢羟氨苄组MRSA的病原体清除率分别为92.3%和85.7%(P = 0.64)。门诊试验中不良事件或药物相关不良事件极少,且无严重不良事件。在住院试验中,20例接受利奈唑胺治疗的儿童和14例接受万古霉素治疗的儿童感染由MRSA引起。在微生物学可评估人群中,利奈唑胺组的临床治愈率为94.1%,万古霉素组为90.0%(P = 0.69)。利奈唑胺组和万古霉素组的病原体清除率分别为88.2%和90.0%(P = 0.89)。MRSA分离株的药敏模式在门诊和住院试验之间显示出不同的模式。在住院试验中,利奈唑胺组药物相关不良事件的患者少于万古霉素组(20%对43%;P = 0.15)。
静脉注射/口服利奈唑胺治疗儿童MRSA感染有效且耐受性良好。