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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 study the incidence, severity and risk factors of in-hospital use of linezolid-induced thrombocytopenia. Methods: A prospective study was conducted to study the inline hospitalized patients for linezolid in 6 hospitals from January 2011 to June 2011. A dedicated monitoring software was developed to evaluate the efficacy of clinical pharmacists. Multicentre hospital centralized monitoring, Risk factors for linezolid-related thrombocytopenia were screened by regression analysis and the receiver operating characteristic curve was used to predict its clinical characteristics. RESULTS: Six hundred and eighty-eight patients receiving linezolid were enrolled, and 414 valid cases were included for this study. The incidence of suboptimal thrombocytopenia was 20.05% and significant thrombocytopenia (defined as 75% below baseline) The incidence of thrombocytopenia of grade Ⅲ and grade Ⅳ occurred at a rate of 6.3% and 7.25%, respectively. The lowest value of thrombocytopenia was 59.41 ± 25.94 × 10 ~ 9 · L -1, with an average decrease of 60.84 ± 22.43%. Multivariate analysis showed that basal platelet values, age, and intensive care patients were closely related to thrombocytopenia. The basal platelet value was ≤183 × 1 ~ 9 · L ~ (-1), and patients with age ≥76 years old had obvious thrombocytopenia Even bleeding risk. CONCLUSION: The clinical incidence of linezolid-related thrombocytopenia is much higher than that of the product data, and there is a certain tendency of bleeding, especially for patients with low risk of basal platelet count, renal insufficiency, advanced age, critical illness and so on The frequency of monitoring of whole blood counts should be increased.