利伐沙班治疗孤立远端深静脉血栓的回顾性研究

Efficacy and safety of rivaroxaban in different doses for the treatment of isolated distal deep vein thrombosis

目的评估不同剂量利伐沙班治疗孤立远端深静脉血栓形成的有效性和安全性。方法回顾性分析2018年1月至2020年12月在南京鼓楼医院就诊的853例孤立远端深静脉血栓形成患者的临床资料。结果标准剂量组和低剂量组的血栓复发率随着随访时间的延长而增高,标准剂量组的血栓复发率低于低剂量组(HR=0.44,95%CI:0.25~0.78,P=0.005),差异有统计学意义,血栓复发主要发生在随访的第1年内。在大出血事件方面两组差异没有统计学意义(HR=1.70,95%CI:0.56~5.14,P=0.530),在临床相关非大出血事件方面标准剂量组的发生率高于低剂量组(HR=2.36,95%CI:1.26~4.44,P=0.020)。对抗凝时长进行亚组分析时发现,抗凝时长>1.5个月时,与低剂量组相比,标准剂量组血栓复发风险降低(1.5~3个月:HR=0.11,95%CI:0.01~0.87;>3个月:HR=0.19,95%CI:0.04~0.95),且抗凝时长和剂量存在交互作用(P=0.007)。结论根据血栓复发和出血事件的风险,针对孤立远端深静脉血栓形成患者,推荐使用利伐沙班标准剂量(20 mg qd),同时抗凝时长应当保持在1.5个月以上。

Objective To evaluate the efficacy and safety of of rivaroxaban for different doses in the treatment of isolated distal deep vein thrombosis.Methods The clinical data of 853 patients of isolated distal deep vein thrombosis attending Nanjing Drum Tower Hospital from Jan 2018 to Dec 2020 was retrospectively analyzed.Results Thrombotic recurrence rate increased with increasing follow-up in the standard and low dose groups,and it was significantly lower in the standard dose group than in the low dose group(HR=0.44,95%CI:0.25-0.78,P=0.005)with most thrombosis occurring within the first year of follow-up.There was no statistical difference between the two groups in terms of major bleeding events(HR=1.70,95%CI 0.56-5.14,P=0.530)and the incidence of clinically relevant non-major bleeding events was significantly higher in the standard dose group than in the low dose group(HR=2.36,95%CI 1.26-4.44,P=0.020).Subgroup analysis on anticoagulation duration found when anticoagulation duration was longer than 1.5 months,the risk of thrombosis was lower in the standard dose group than the low dose group(1.5-3 months:HR=0.11,95%CI 0.01-0.87,>3 months:HR=0.19,95%CI 0.04-0.95),there was an interaction between anticoagulation duration and dose(P=0.007).Conclusions Based on the risk of thrombosis recurrence and bleeding events,the standard dose of rivaroxaban(20 mg qd)is recommended for patients with isolated distal deep vein thrombosis,and the anticoagulant duration should be maintained for 1.5 months or more.