利伐沙班致出血风险因素分析及预测  

Analyzing and predicting the risk of hemorrhage induced by rivaroxaban

作　　者：梁婷 黄溯源 吴建博 龚皓鸣 沈杰 宋钟娟 LIANG Ting;HUANG Su-yuan;WU Jian-bo;GONG Hao-ming;SHEN Jie;SONG Zhong-juan(Department of Pharmacy,Affiliated Huadong Hospital,Fudan University,Shanghai 200040,China)

机构地区：[1]复旦大学附属华东医院药剂科,上海200040

出　　处：《中国医院药学杂志》2021年第3期277-281,共5页Chinese Journal of Hospital Pharmacy

基　　金：上海医院药学科研基金资助(编号:2015-YY-01-04)。

摘　　要：目的:分析服用利伐沙班后的出血不良反应与凝血指标和出血风险因素的相关性,以提高其临床用药的安全性。方法:回顾性分析2018年12月至2019年12月复旦大学附属华东医院服用利伐沙班的176例住院患者资料,对可能引起出血不良反应的危险因素进行单因素及Logistic回归分析,并在此基础上建立出血风险预测模型。结果:85例(48.30%)存在出血不良反应,其中实际观察到的出血不良反应39例,隐匿性出血不良反应46例。Logistic回归分析结果显示,凝血酶原时间(prothombin time,PT)、性别、联用非甾体抗炎药(NSAIDs)/抗血小板药物等4个影响因素对利伐沙班致出血不良反应有显著性影响(P<0.05)。进一步得到出血风险联合预测因子Y=-15.087+1.115×XPT-1.468×X性别+1.645×X联合NSAIDs+1.395×X联合抗血小板药物,其ROC曲线的AUC值为0.880,表明具有较好的预测能力。约登指数计算结果显示PT值超过12.75 s (灵敏度为0.762,特异度为0.725)易出现出血不良反应事件。结论:在服用利伐沙班时应加强患者出血风险因素的评估,以保证临床用药的安全性。OBJECTIVE To explore the relationship between risk factors, coagulation parameters and hemorrhage induced by rivaroxaban for boosting the safety of clinical medications.METHODS Clinical data were analyzed retrospectively for 176 inpatients receiving rivaroxaban from December 2018 to December. The risk factors correlated with hemorrhage were examined by single-factor and Logistic regression analysis. On this basis, the prediction model of bleeding risk was thus established.RESULTS A total of 85 cases(48.30%) had bleeding adverse reactions, including actually observed(n=39) and occult hemorrhage(n=46). Logistic regression analysis revealed that prothrombin time(PT), gender, combined usage of NSAIDs/antiplatelet drugs had significant impact on the adverse effects of rivaroxaban(P<0.05). Combining predictor Y was obtained(Y=-15.087+1.115×Xpt-1.468×Xgender+1.645×Xcombined with NSAIDs + 1.395×X combined with antiplatelet drugs). ROC curve indicated that combining predictor Y(AUC=0.880) had a better predictive capability. And Youden index indicated that the risk of bleeding became elevated when PT value exceeded 12.75 s(sensitivity 0.762, specificity 0.725).CONCLUSION For boosting the safety of clinical medications, clinicians should strengthen the evaluations of bleeding risk factors after taking rivaroxaban.

关 键 词：利伐沙班 出血 凝血酶原时间 

分 类 号：R969[医药卫生—药理学]