Jantausch Barbara A, Deville Jaime, Adler Stuart, Morfin Maria Rayo, Lopez Pio, Edge-Padbury Barbara, Naberhuis-Stehouwer Sharon, Bruss Jon B
Children's National Medical Center, Washington, DC, USA.
Pediatr Infect Dis J. 2003 Sep;22(9 Suppl):S164-71. doi: 10.1097/01.inf.0000086956.45566.55.
Nosocomial infections, particularly hospital-acquired pneumonia (HAP) and bacteremia, are an increasing concern in pediatric hospitals and pediatric intensive care units. Gram-positive pathogens are a leading cause of these infections in children. Linezolid is well-tolerated and as effective as vancomycin in the treatment of these infections in adults.
To evaluate the clinical effectiveness and safety of iv/oral linezolid and iv vancomycin in children with resistant Gram-positive HAP or bacteremia.
Hospitalized children <12 years of age were randomized 2:1 to linezolid or vancomycin. Patients received linezolid 10 mg/kg iv every 8 h with the option to change treatment to oral linezolid suspension 10 mg/kg every 8 h or iv vancomycin 10 to 15 mg/kg every 6 to 24 h. Clinical response was evaluated at follow-up. Results from an analysis of patients with HAP or bacteremia are presented.
Thirty-nine patients (linezolid, 23; vancomycin, 16) with HAP and 113 patients with bacteremia (linezolid, 81; vancomycin, 32) were included in the intent-to-treat group. Clinical cure rates for clinically evaluable patients with HAP did not differ between treatment groups (linezolid, 90.0% and vancomycin, 100%; P = 0.305). No significant difference was seen in clinical cure rates in the clinically evaluable population between the linezolid and vancomycin groups for patients with catheter-related bacteremia (84.8 and 80.0%, respectively; P = 0.716) or patients with bacteremia of unknown source (79.2 and 69.2%, respectively; P = 0.501). In this subset fewer linezolid-treated patients had drug-related adverse events than did vancomycin-treated patients (19.4% vs. 28.3%; P = 0.230). Similar percentages of patients with laboratory abnormalities, including selected hematologic parameters, were seen in both treatment groups.
Intravenous/oral linezolid was well-tolerated and as effective as vancomycin in treating children with resistant Gram-positive HAP or bacteremia.
医院感染，尤其是医院获得性肺炎（HAP）和菌血症，在儿科医院和儿科重症监护病房中日益受到关注。革兰氏阳性病原体是儿童这些感染的主要原因。利奈唑胺耐受性良好，在治疗成人这些感染方面与万古霉素效果相当。
评估静脉注射/口服利奈唑胺和静脉注射万古霉素治疗耐革兰氏阳性HAP或菌血症儿童的临床有效性和安全性。
将12岁以下住院儿童按2:1随机分为利奈唑胺组或万古霉素组。患者接受每8小时静脉注射10mg/kg利奈唑胺，可选择改为每8小时口服10mg/kg利奈唑胺混悬液，或每6至24小时静脉注射10至15mg/kg万古霉素。随访时评估临床反应。呈现了HAP或菌血症患者分析结果。
意向性治疗组纳入39例HAP患者（利奈唑胺组23例，万古霉素组16例）和113例菌血症患者（利奈唑胺组81例，万古霉素组32例）。治疗组中临床可评估的HAP患者临床治愈率无差异（利奈唑胺组90.0%，万古霉素组100%；P = 0.305）。利奈唑胺组和万古霉素组中导管相关菌血症患者（分别为84.8%和80.0%；P = 0.716）或不明来源菌血症患者（分别为79.2%和69.2%；P = 0.501）的临床可评估人群临床治愈率无显著差异。在该亚组中，接受利奈唑胺治疗出现药物相关不良事件的患者少于接受万古霉素治疗的患者（19.4%对28.3%；P = 0.230）。两个治疗组中出现实验室异常（包括选定血液学参数）的患者百分比相似。
静脉注射/口服利奈唑胺耐受性良好，在治疗耐革兰氏阳性HAP或菌血症儿童方面与万古霉素效果相当。
