利奈唑胺相关血小板减少.ppt
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1、利奈唑胺相关性血小板减少,陈 超 解放军总医院 药品保障中心 临床药学室,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, ES
2、BL-producing Enterobacteriaceae and carbapenem-resistant Acinetobacter baumannii represent more than 50% of microbial isolates.,Linezolid,oxazolidinone antibiotics 2000 FDA 2007 SFDA unique mechanism of the antibacterial action inhibition of protein synthesis in bacterial liposomes approved indicati
3、ons 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 live
4、r 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. 2005;171:388-416. ATS/IDSA(2005) guidelines for the management of adults with HAP/VAP/HCAP,血小板减少症 -来
5、自临床的声音,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 血小板减少 2.4%(0.3%-10.0%) /白细胞减少/贫血/全血细胞减少 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 文献 主要的SAE是血小板减少 其他国家 高发生率 (15.1-38.7%) 中国 个案报道 没有大样本人群的发生率,研究目的,临床实际发生率及严重程度 危险因素 风险特征的预测指标,住院患者使用利奈唑胺致相关血小板减少,资料&方法,数据来源 解放军总医院 (4,000 beds) 使用利奈唑胺/口服/静注/序贯 电子医疗记录,512 Patients were scr
6、eened,7 Patients were excluded due to younger than 18 years old,血小板减少症评价,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 d
7、ue to platelet count baseline platelet anomalies (less than 100109/L or more than 400109/L) initial platelets were not recorded or less than three platelet observation points,254 were included in the analysis,回顾性研究,资料&方法,Thrombocytopenia in this study -lack of uniform diagnostic criteria,Variables G
8、ender Age Body weight Daily dose (mg/kg) duration of linezolid administration laboratory data (5 factors) Alanine aminotransferase Total bilirubin Creatinine Albumin Baseline platelet,标准 1严重,标准 2轻中度,platelet count less than 100 109/L,25% reduction from baseline platelet count or less than 100 109/L,
9、结 果,标准1 69/254 27.2% 标准 2 131/254 51.6% & IV 度血小板下降 27/254 10.6% 输血或输注血小板 17/254 6.7% WHO assessment of acute and subacute adverse performance and indexing standards grade , 26-49 109 / L grade , 25 109 / L,研究对象概况,血小板减少发生率,169 男性 /85 女性 平均年龄 59.0 17.7 (range 18-95) 岁 平均用药时间 9.43 5.63 (range 2-35.5)
10、天,结果与国外文献报道相近 显著高于产品资料所报道的期临床研究结果 轻中度血小板下降很常见(10%) 存在出血倾向,血小板下降常见,结果 差异性分析,Risk factors Analysis of Thrombocytopenia Criterion 1,+ chi-square test # t-test * Mann-Whitney U-test,结果 差异性分析,Risk factors Analysis of Thrombocytopenia Criterion 2,+ chi-square test # t-test * Mann-Whitney U-test,结果 单因素分析,R
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