6所医院414例利奈唑胺相关性血小板减少集中监测研究  

Analysis of Risk Factors Associated with the Development of Thrombocytopenia in 6 Hospital's 414 Case of Patients Who Received Linezolid Therapy

作　　者：郭代红[1] 陈超[1] 李罄[2] 何菊英[3] 吴涌[4] 任天舒[5] 黄进[6] 曹秀堂[1] 徐元杰[1] 金杨红[1] 

机构地区：[1]解放军总医院药品保障中心,北京100853 [2]广州军区武汉总医院 [3]第三军医大学西南医院 [4]南京军区福州总医院 [5]沈阳军区沈阳总医院 [6]空军总医院

出　　处：《药物流行病学杂志》2013年第3期109-113,共5页Chinese Journal of Pharmacoepidemiology

基　　金：军队十二五面上项目;军队药品风险防控关键技术研究(项目编号:CWS12J127)

摘　　要：目的:研究住院患者使用利奈唑胺致血小板减少的发生率、严重程度和危险因素。方法:采用前瞻性研究,以6家医院2011年1月～2011年6月使用利奈唑胺的住院患者为研究对象,开发专用监测采集软件与临床药师评估相结合,实施多中心医院集中监测,通过回归分析筛查利奈唑胺相关血小板减少的危险因素,使用接收者操作特性曲线预测其临床特征。结果:获得利奈唑胺用药病例648例,按本研究目的纳入有效病例414例,血小板减少低于正常值的发生率为20.05%,出现明显血小板减少(定义为低于基础值的75%)的发生率为6.3%,7.25%发生了Ⅲ度和Ⅳ度血小板下降,血小板减少最低值(59.41±25.94)×10~9·L^(-1),平均降幅(60.84±22.43)%。多因素分析显示基础血小板值、年龄和是否重症监护患者与血小板减少的发生密切相关,基础血小板值≤183×1~9·L^(-1),年龄≥76岁的患者易出现明显血小板减少甚至出血风险。结论:利奈唑胺致相关血小板减少的临床发生率远高于产品资料,且存在一定的出血倾向,尤其对于基础血小板计数偏低、肾功能不全、高龄、危重症等多个危险因素并存的患者应增加全血细胞计数的监测频率。Objective：To investigate the incidence,severity and risk factors of thrombocytopenia in patients undergoing their Iinezolid therapy.Methods;This was a prospective study of patients treated with linezolid by the oral or parenteral route,between January 2011 and June 2011 in six military sentinel surveillance hospitals.Data were extracted from the electronic medical records in hospital information system and evaluated by clinical pharmacists.Risk factors were determined using logistic regression analysis,and clinical features were predicted using receiver operating characteristic curves. Results：A total of 414 patients were included in the study.Thrombocytopenia occurred in 83 patients（20.05%）,and thrombocytopenia defined as a decrease in platelet count of≥75%at the baseline occurred in 26 patients（6.3%）.The multivariate analysis showed that the baseline platelet count≤183×10~9 ？ L^（-1）,age≥76 years,critical patients were independent risk factors associated with thrombocytopenia in patients who received linezolid therapy and the incidence even increased. Conclusion：The actual incidence of linezolid-related thrombocytopenia in patients was higher than that suggested in drug instructions.Several factors might influence the occurrence of linezolid-induced thrombocytopenia.Further studies are needed to determine which at-risk patients will be the candidates for concentration adjustment of linezolid.The frequency of clinical blood tests should be increased especially to critical patients with low pre-treatment platelet value and advanced age.

关 键 词：利奈唑胺 血小板减少 危险因素 基础血小板值 

分 类 号：R978.1[医药卫生—药品]