利伐沙班在缺血性脑卒中合并小腿肌间静脉血栓形成患者中的疗效与安全性影响因素分析  

Influencing factors analysis of the efficacy and safety of rivaroxaban in ischemic stroke patients with calf muscular vein thrombosis

作　　者：章袁[1] 巩欣媛 刘国萍[3] 刘鑫鑫 金小杰 张容绮 汪志云[3] ZHANG Yuan;GONG Xin-yuan;LIU Guo-ping;LIU Xin-xin;JIN Xiao-jie;ZHANG Rong-qi;WANG Zhi-yun(Department of Pharmacy,Tianjin First Central Hospital,Tianjin 300192,China;Department of Science and Education,Tianjin First Central Hospital,Tianjin 300192,China;Department of Neurology,Tianjin First Central Hospital,Tianjin 300192,China;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,科教处,天津300192 [3]天津市第一中心医院,神经内科,天津300192 [4]天津医科大学药学院,天津300070

出　　处：《中国医院药学杂志》2022年第19期2051-2056,共6页Chinese Journal of Hospital Pharmacy

基　　金：天津市卫生健康科技项目(编号:KJ20143)。

摘　　要：目的:探讨利伐沙班在缺血性脑卒中(IS)合并小腿肌间静脉血栓(CMVT)患者中疗效与安全性的影响因素。方法:将134例IS合并CMVT患者根据利伐沙班剂量分为低剂量(10 mg·d^(-1)和15 mg·d^(-1))组(n=80)和标准剂量(20 mg·d^(-1))组(n=54),收集并比较2组患者临床基线资料。随访记录治疗后的无效事件和出血事件,采用单因素和多因素Logistic回归分析危险因素,并建立风险预测模型。结果:低剂量组患者肌酐清除率(CrCl)<50 mL·min^(-1)、合用阿司匹林比例显著高于标准剂量组(P<0.05),低密度脂蛋白胆固醇(LDL-C)>2.6 mmol·L^(-1)比例显著低于标准剂量组(P<0.05)。低剂量组患者治疗无效事件发生率明显高于标准剂量组、出血事件发生率明显低于标准剂量组(P<0.05)。多因素分析显示,标准剂量(20 mg·d^(-1))是影响无效事件和出血事件的独立危险因素(P<0.05),美国国立卫生研究院卒中量表(NIHSS)评分、合并冠心病是影响出血事件的独立危险因素(P<0.05)。出血事件联合预测因子Z=-3.642+1.341X_(剂量)+0.153X_(NIHSS)+1.334X_(合并冠心病),ROC曲线的AUC值为0.833,表明有良好的预测性能。结论:低剂量利伐沙班(10 mg·d^(-1)和15 mg·d^(-1))可能更适合IS合并CMVT患者,临床应结合剂量、NIHSS评分、合并冠心病3种危险因素综合评估出血风险。OBJECTIVE To explore the influencing factors in the efficacy and safety of rivaroxaban in the treatment of ischemic stroke(IS)patients with calf muscular vein thrombosis(CMVT).METHODS Totally 134 IS patients with CMVT were divided into low-dose(10 mg·d^(-1)and 15 mg·d^(-1))group(n=80)and standard dose(20 mg·d^(-1))group(n=54).The clinical baseline data of two groups were collected and compared.After treatment,ineffective events and bleeding events were recorded.Risk factors were analyzed by univariate and multivariate Logistic regression analysis,and the risk prediction models was established.RESULTS Compared with those in the standard dose group,the proportion of creatinine clearance rate(CrCl)<50 mL·min^(-1)and combined aspirin were significantly higher(P<0.05),the proportion of low density lipoprotein(LDL-C)>2.6 mmol·L^(-1) was significantly lower(P<0.05),the incidence of ineffective events was significantly higher(P<0.05),and the incidence of bleeding events was significantly lower(P<0.05)in low-dose group.Multivariate analysis showed that standard dose(20 mg·d^(-1))was independent risk factors for ineffective events and bleeding events(P<0.05).National institute of health stroke scale(NIHSS)score and combined coronary heart disease were independent risk factors for bleeding events(P<0.05).The combined predictor of bleeding events was Z=-3.642+1.341X_(dose)+0.153X_(NIHSS)+1.334X_(combined with coronary heart disease).ROC curve indicated that combined predictor Z(AUC=0.833)had a better predictive capability.CONCLUSION Low-dose rivaroxaban(10 mg·d^(-1)and 15 mg·d^(-1))may be more appropriate for IS patients with CMVT.Clinical evaluation of bleeding risk should be comprehensively combined with such risk factors as dose,NIHSS score and coronary heart disease.

关 键 词：卒中 小腿肌间静脉血栓 利伐沙班 安全 

分 类 号：R969[医药卫生—药理学]