小剂量华法林预防老年住院患者静脉血栓的效果评价

Efficacy and safety of low dose warfarin in prevention of venous thromboembolism in high risk elderly inpatients

关键词:  华法林  老年  住院患者  静脉血栓栓塞症  预防

Key words:  warfarin  elderly  inpatient  venous thromboembolism  prevention

摘要:

目的 评估小剂量华法林钠在老年住院静脉血栓栓塞症（venous thromboembolism, VTE）高危患者中预防性应用的疗效及安全性。方法 采用前瞻性随机对照临床研究，纳入符合标准的220例老年住院VTE高危患者，随机分为试验组和对照组，试验组给予华法林钠1~3mg/d口服，维持国际标准化比值(international normalized ratio, INR)1.5~2.0，疗程28d，对照组未予抗凝治疗。所有患者均在入组及随访结束时检测整合素β1、β2、β3亚单位表达情况，入组1、14、28d常规行下肢静脉加压超声检查。随访28d，以VTE发生或死亡为终点事件。记录用药期间的出血等不良事件的发生情况。结果 最终入组分析206例，包括试验组（101例）和对照组（105例）。入组时两组间年龄、性别、高危因素及合并症均未见明显差异（P>0.05），组间D-Dimer，高敏C反应蛋白(high sensitivity C reactive protein, hsCRP)及整合素β1、β2、β3分布等亦未见明显差异（P>0.05）。28d随访结束时两组间整合素β1、β2比较未见明显差异（P1=0.725，P2=0.075），但整合素β3在试验组明显低于对照组（P=0.001）。101例试验组在观察终点发生1例（0.99%）深静脉血栓（deep vein thrombosis, DVT），105例对照组在观察终点发生8例（7.62%）DVT，其中3例合并PTE（2.86%），两组间DVT的发生率差异有统计学意义（P=0.035）。试验组与对照组间出血发生率未见显著性差异（P=0.164）。结论 小剂量华法林钠用于老年VTE高危人群预防有效且相对安全。

Abstract:

Objective To assess the efficacy and safety of low dose warfarin in prevention of venous thromboembolism (VTE) in high risk elderly inpatients. Methods Two hundred and twenty patients ≥65 year admitted in hospital were randomly assigned into two groups. Patients in study group were given warfarin 1-3mg/d (INR 1.5-2.0) for 28d, and patients in control group were not given anticoagulant therapy. The expression of integrin β1, β2 and β3 subunits was detected at enrollment and the end of follow-up. The ultrasonic examination of venous comprression of lower limbs was performed at d1, d14 and d28 after enrollment. During 28d follow-up, the occurrence of VTE, the adverse events and all causes of death were documented. Results Two hundred and six inpatients entered the analysis, including 101 cases in the study group and 105 cases in the control group. At the enrollment, there were no significant differences in age, gender, risk factors and complications between the two groups (P>0.05); and no significant differences in D-Dimer, hsCRP and integrin β1, β2 and β3 levels between the two groups (P>0.05). At the end of 28d follow-up, there were no significant differences in integrin β1 and β2 between the two groups (P=0.725, 0.075), but integrin β3 was significantly lower in the study group than that in the control group (P=0.001). At the end of observation, there were 1 case of deep venous thrombosis (DVT) (0.99%) occurred in the study group, and 8 cases of DVT (7.62%) occurred in the control group with 3 cases in combination with pulmonary thromboembolism (PTE) (2.86%) (P=0.035). There was no significant difference in the incidence of bleeding between the two groups (P=0.164). Conclusion A low dose of warfarin for VTE prevention in high risk elderly inpatients effective and relatively safe.