利奈唑胺与万古霉素治疗儿童耐革兰氏阳性菌感染的比较
Linezolid versus vancomycin for treatment of resistant Gram-positive infections in children.
作者信息
Kaplan Sheldon L, Deville Jaime G, Yogev Ram, Morfin Ma Rayo, Wu Elba, Adler Stuart, Edge-Padbury Barbara, Naberhuis-Stehouwer Sharon, Bruss Jon B
机构信息
Baylor College of Medicine and Texas Children's Hospital, 6621 Fannin Street, MC3-2371, Feigin Center No. 1150, Houston, TX 77030, USA.
出版信息
Pediatr Infect Dis J. 2003 Aug;22(8):677-86. doi: 10.1097/01.inf.0000078160.29072.42.
BACKGROUND
Pediatric infections caused by resistant Gram-positive infections are an increasing concern with limited treatment options. Linezolid, a new oxazolidinone, is active against staphylococci, streptococci and enterococci.
OBJECTIVE
To assess clinical efficacy and safety of linezolid vs.vancomycin in antibiotic-resistant Gram-positive infections in children. DESIGN Hospitalized children (birth to 12 years of age) with nosocomial pneumonia, complicated skin/skin structure infections, catheter-related bacteremia, bacteremia of unknown source or other infections caused by Gram-positive bacteria were randomized 2:1 to receive linezolid intravenously followed by oral linezolid or vancomycin and then by an appropriate oral agent. Treatment duration was 10 to 28 days.
RESULTS
There were 321 patients enrolled (linezolid 219, vancomycin 102). Clinical cure rates were 79% vs.74% (P = 0.36) and 89% vs.85% (P = 0.31) for linezolid and vancomycin in intent-to-treat and clinically evaluable patients, respectively. Cure rates were similar by age and infection diagnosis. Pathogen eradication rates in microbiologically evaluable patients were high for linezolid and vancomycin, respectively, for methicillin-susceptible S. aureus (95% vs.94%; P = 0.82), methicillin-resistant S. aureus (88% vs.90%; P = 0.89) and methicillin-resistant coagulase-negative staphylococci (85% vs.83%, P = 0.87). In clinically evaluable patients, linezolid-treated patients required significantly fewer days of intravenous therapy compared with vancomycin-treated patients (8.0 +/- 4.8; 10.9 +/- 5.8 days, respectively; P < 0.001). In addition significantly fewer linezolid-treated patients had drug-related adverse events than did vancomycin-treated patients (19% vs.34%, respectively; P = 0.003). Hematologic events were uncommon and similar between treatment groups.
CONCLUSIONS
Linezolid was well-tolerated and as effective as vancomycin in treating serious Gram-positive infections in children.
背景
由耐革兰氏阳性菌引起的儿科感染日益受到关注，而治疗选择有限。利奈唑胺是一种新型恶唑烷酮类药物，对葡萄球菌、链球菌和肠球菌具有活性。
目的
评估利奈唑胺与万古霉素治疗儿童耐抗生素革兰氏阳性菌感染的临床疗效和安全性。
设计
将患有医院获得性肺炎、复杂性皮肤/皮肤结构感染、导管相关菌血症、不明来源菌血症或其他由革兰氏阳性菌引起感染的住院儿童（出生至12岁）按2:1随机分组，分别接受静脉注射利奈唑胺继以口服利奈唑胺或万古霉素，然后再给予适当的口服药物。治疗疗程为10至28天。
结果
共纳入321例患者（利奈唑胺组219例，万古霉素组102例）。在意向性治疗患者和临床可评估患者中，利奈唑胺和万古霉素的临床治愈率分别为79%对74%（P = 0.36）和89%对85%（P = 0.31）。按年龄和感染诊断，治愈率相似。在微生物学可评估患者中，利奈唑胺和万古霉素对甲氧西林敏感金黄色葡萄球菌的病原体清除率分别为95%对94%（P = 0.82），对甲氧西林耐药金黄色葡萄球菌为88%对90%（P = 0.89），对甲氧西林耐药凝固酶阴性葡萄球菌为85%对83%（P = 0.87）。在临床可评估患者中，与万古霉素治疗的患者相比，利奈唑胺治疗的患者静脉治疗天数显著更少（分别为8.0±4.8天；10.9±5.8天；P < 0.001）。此外，利奈唑胺治疗的患者发生药物相关不良事件的比例显著低于万古霉素治疗的患者（分别为19%对34%；P = 0.003）。血液学事件并不常见，且两组间相似。
结论
利奈唑胺耐受性良好，在治疗儿童严重革兰氏阳性菌感染方面与万古霉素疗效相当。
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