利奈唑胺相关血小板降低
MRSA
VRE
VRSA
BACKGROUND
万古霉素 vancomycin
利奈唑胺 linezolid
Antimicrobial resistance in China has become a serious healthcare problem, with high resistance rates of most common bacteria to clinically important antimicrobial agents. Methicillin-resistant S. aureus, ESBL-producing Enterobacteriaceae and carbapenem-resistant Acinetobacter baumannii represent more than 50% of microbial isolates.
Linezolid
oxazolidinone antibiotics
FDA
SFDA
unique mechanism of the antibacterial action
inhibition of protein synthesis in bacterial liposomes
approved indications for linezolid use
vancomycin-resistant Enterococcus infection and comorbid with bacteremia
hospital -acquired pneumonia
complicated skin and skin structure infections
community-acquired pneumonia and comorbid with bacteremia
uncomplicated skin and soft tissue infections
superiority
all ages
liver disease
poor kidney function
with or without bacterial invasion of the bloodstream
Efficacy of linezolid on HAP and VAP caused by MRSA is better than vancomycin
ATS/IDSA. Am J Respir Crit Care Med. ;171:388-416.
ATS/IDSA( ) guidelines for the management of adults with HAP/VAP/HCAP
血小板降低症 -来自临床 声音
上市前临床试验
——说明书
腹泻/头痛/恶心/呕吐/味觉异常
骨髓抑制
血小板降低 %(%-%)
/白细胞降低/贫血/全血细胞降低
乳酸酸中毒
视神经病变
周围神经病变
安全性&耐受性
上市后监测
——文件
关键 SAE是血小板降低
其她国家
高发生率 (-%)
中国
个案报道
没有大样本人群 发生率
研究目
临床实际发生率及严重程度
危险原因
风险特征 估量指标
住院患者使用利奈唑胺致相关血小板降低
资料&方法
数据起源
解放军总医院 (4,000 beds)
使用利奈唑胺/口服/静注/序贯
电子医疗统计
512 Patients were screened
7 Patients were excluded due to
younger than 18 years old
血小板降低症评价
505
85 were excluded due to diagnosis and drugs
Hematological disorders
Chemotherapy on tumor
Severe pancreatitis
Hepatoblastoma
Systemic Lupus Erythmatosus
antiplatelet agent
425 were eligible and consented
171 were excluded due to platelet count
baseline platelet anomalies
(less than 100×109/L or more than 400×109/L)
initial platelets were not recor
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