达比加群酯治疗脑静脉血栓形成的有效性和安全性:与华法林的比较

目的比较达比加群酯与华法林治疗脑静脉血栓形成(cerebral venous thrombosis,CVT)安全性和有效性。方法回顾性分析2017年1月至2018年12月在河南省人民医院神经内科住院治疗的CVT患者的病历资料,根据用药情况分为达比加群酯组和华法林组。主要转归指标为治疗后6个月时的功能转归良好,定义为改良Rankin量表评分0~2分。次要转归指标包括受累静脉窦再通率以及出血发生率。结果共纳入152例CVT患者,其中达比加群酯组34例,华法林组118例。两组人口统计学和基线资料比较均差异无统计学意义。治疗6个月时,达比加群酯组和华法林组功能转归良好率(94.1%对93.2%;χ^2=0.043,P=0.836)以及受累静脉窦再通率(94.1%对93.2%;χ^2=0.043,P=0.836)均差异无统计学意义。达比加群酯组出血发生率显著低于华法林组(8.8%对27.1%;χ^2=4.985,P=0.026),两组轻微出血发生率差异无统计学意义(8.8%对16.1%;χ^2=0.618,P=0.432),但达比加群酯组严重出血发生率有显著低于华法林组的趋势(0%对11.0%;Fisher精确检验P=0.074)。达比加群酯组无死亡病例,华法林组死亡2例,其中1例妊娠期女性患者在治疗4个月时死于CVT复发,1例男性患者在治疗2个月时死于急性心肌梗死。两组病死率差异无统计学意义(0%对1.7%;Fisher精确检验P=1.000)。结论达比加群酯治疗CVT的有效性不逊于华法林,且出血并发症风险更低。

Efficacy and safety of dabigatran in the treatment of cerebral venous thrombosis:a comparison with warfarin

Objective To compare the safety and efficacy of dabigatran and warfarin in the treatment of cerebral venous thrombosis(CVT).Methods The medical records of patients with CVT admitted to the Department of Neurology,Henan Provincial People's Hospital from January 2017 to December 2018 were analyzed respectively.According to the drug use,they were divided into dabigatran group and warfarin group.The main outcome measure was good functional outcome at 6 months after treatment,defined as the modified Rankin Scale score of 0-2.The secondary outcome measures included the rate of recanalization of the affected venous sinus and the incidence of bleeding.Results A total of 152 patients with CVT were included,including 34 in the dabigatran group and 118 in the warfarin group.There were no significant differences in demographic and baseline data between the two groups.At 6 months after treatment,the rate of good functional outcomes(94.1%vs.93.2%;χ^2=0.043,P=0.836)and the affected venous sinus recanalization(94.1%vs.93.2%;χ^2=0.043,P=0.836)in the dabigatran group and the warfarin group were not statistically significant.The bleeding rate of the dabigatran group was significantly lower than that of the warfarin group(8.8%vs.27.1%;χ^2=4.985,P=0.026).There was no significant difference in the incidence of minor bleeding between the two groups(8.8%vs.16.1%;χ^2=0.618,P=0.432),but the incidence of severe bleeding in the dabigatran group tended to be lower than that in the warfarin group(0%vs.11.0%;Fisher's exact test P=0.074).There were no deaths in the dabigatran group and 2 deaths in the warfarin group,of which 1 pregnant woman died of recurrence of CVT at 4 months after treatment,and 1 male patient died of acute myocardial infarction at 2 months after treatment.There was no significant difference in mortality between the two groups(0%vs.1.7%;Fisher's exact test P=1.000).Conclusions Dabigatran is as effective as warfarin in the treatment of CVT,and the risk of bleeding complications is lower.