凝血指标监测预测利伐沙班抗凝治疗安全性的研究  

Study on monitoring coagulation index and predicting safety of rivaroxaban anticoagulant therapy

作　　者：章袁[1] 常斌鸽[2] 马景鑑[2] 拱忠影[3] 郭承承[3] 王园 牛宁宁[4] 陈启新 汪志云[3] ZHANG Yuan;CHANG Bin-ge;MA Jing-jian;CONG Zhong-ying;GUO Cheng-cheng;WANG Yuan;NIU Ning-ning;CHEN Qi-xin;WANG Zhi-yun(Department of Pharmacy,Tianjin First Central Hospital,TIANJIN 300192;Department of Neurosurgery,Tianjin First Central Hospital,TIANJIN 300192;Department of Neurology,Tianjin First Central Hospital,TIANJIN 300192;Department of Ultrasonography,Tianjin First Central Hospital,TIANJIN 300192;School of Pharmacy,Tianjin Medical University,TIANJIN 300070,China)

机构地区：[1]天津市第一中心医院药学部,天津300192 [2]天津市第一中心医院神经外科,天津300192 [3]天津市第一中心医院神经内科,天津300192 [4]天津市第一中心医院超声科,天津300192 [5]天津医科大学药学院,天津300070

出　　处：《中国新药与临床杂志》2023年第10期669-674,共6页Chinese Journal of New Drugs and Clinical Remedies

基　　金：天津市卫生健康科技项目(KJ20143)。

摘　　要：目的探讨凝血指标监测用于预测利伐沙班抗凝治疗安全性的可行性。方法纳入2021年3月至2022年3月天津市第一中心医院神经内科使用利伐沙班治疗的患者118例,收集所有患者的临床基线资料。于给药前(基础),以及给药3~5 d后再次给药2~4 h(峰值)和下次给药前(谷值)进行凝血指标监测,记录这三个时间点的凝血酶原时间(PT)和活化部分凝血活酶时间(APTT)值,进行3个月随访并记录出血事件。结果39例患者发生出血为出血组,79例患者为未出血组,出血组患者合并高血压、冠心病比例显著高于未出血组(P<0.05)。其余项目2组间比较无显著差异(P>0.05)。在出血事件中,消化道出血发生率最高(38%)。出血组PT_(谷值)、PT_(峰值)和APTT_(峰值)显著高于未出血组(P<0.05)。logistic回归分析显示,PT_(峰值)是预测出血的最佳指标,临界值为18.15 s(灵敏度为0.667,特异度为0.684)。结论临床使用利伐沙班应关注消化道出血。在监测利伐沙班出血风险方面,PT峰值是最敏感的预测指标,当PT_(峰值)≥18.15 s时,提示有出血风险。AIM To explore the feasibility of monitoring coagulation index to predict the safety of rivaroxaban anticoagulant therapy.METHODS A total of 118 patients treated with rivaroxaban were selected in the Department of Neurology of Tianjin First Central Hospital from March 2021 to March 2022,and clinical baseline data were collected.Coagulation indexes were monitored before administration(basic),2 to 4 hours after administration(peak value)and before next administration(trough value),after 3 to 5 days of steady state.Prothrombin time(PT)and activated partial thromboplastin time(APTT)values at these three time points were recorded.All patients were followed up for 3 months and bleeding events were recorded.RESULTS Thirty-nine patients with bleeding were in the bleeding group,and the other 79 patients were in the non-bleeding group.The proportion of hypertension and coronary heart disease in the bleeding group was significantly higher than that in the non-bleeding group(P 0.05).There were no significant difference in other items between the two groups(P 0.05).Among the bleeding events,the incidence of gastrointestinal bleeding was the highest(38%).The PT_(trough),PT_(peak) and APTT_(peak) in the bleeding group were significantly higher than those in the non-bleeding group(P 0.05).Logistic regression results showed that PT_(peak) was the best predictor of bleeding with a cut-off value of 18.15 s(sensitivity=0.667,specificity=0.684).CONCLUSION Gastrointestinal bleeding should be concerned with the clinical use of rivaroxaban.PT_(peak) is the most sensitive predictor for monitoring the bleeding risk of rivaroxaban.When PT_(peak)≥18.15 s,it indicates the risk of bleeding.

关 键 词：利伐沙班 凝血酶原时间 出血 因子Ⅹa 

分 类 号：R973.2[医药卫生—药品]