Anand S S
Hamilton General Hospital, Ontario, Canada.
Vasc Med. 2001 Nov;6(4):269-70. doi: 10.1177/1358836x0100600413.
Is anticoagulant treatment for calf vein thrombosis for 6 weeks duration associated with acceptable recurrence and safety outcomes? Is anticoagulant therapy for 3 months duration for proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) associated with acceptable recurrence and safety outcomes?
Men and women with a first episode of symptomatic calf vein thrombosis or proximal DVT confirmed by ultrasound or venography, or PE confirmed by lung scan or angiography. Patients with pregnancy, thrombophilia, severe PE, and cancer were excluded.
After treatment with heparin and oral anticoagulants targeting an INR of 2-3, patients with calf DVT were randomized to 6 weeks (n = 105) versus 3 months (n = 92) of treatment, and patients with proximal DVT and/or PE were randomized to 3 months (n = 270) versus 6 months (n = 269) of treatment. The outcome events were recurrences and major, minor, or fatal bleeding complications. The mean follow-up time was 12 months.
A total of 736 patients were enrolled. For calf vein thrombosis the recurrence of DVT or PE after 6 weeks of therapy was 2/105 (2.0%) versus 3/92 (3.4%) with 3 months of therapy, relative risk of 0.58 (95% CI: 0.10-3.36). The rates of major bleeding were 1/105 (1.0%) and 3/92 (3.4%) respectively, relative risk of 0.29 (95% CI: 0.03-2.72). For proximal DVT or PE, the recurrence rate after 3 months of therapy was 21/270 (8.1%) versus 23/269 (8.7%) after 6 months of treatment, relative risk of 0.93 (95% CI: 0.53-1.65). The rates of major bleeding were 5/270 (1.9%) versus 7/269 (2.6%) respectively, relative risk of 0.73 (95% CI: 0.24-2.27).
After isolated calf vein DVT, 6 weeks of oral anticoagulation is sufficient. For proximal DVT or PE, 3 and 6 months of anticoagulant therapy is equivalent. For patients with temporary risk factors who have a low risk of recurrence, 3 months of treatment seems to be sufficient.
为期6周的小腿静脉血栓抗凝治疗是否具有可接受的复发率和安全性结果？为期3个月的近端深静脉血栓形成（DVT）或肺栓塞（PE）抗凝治疗是否具有可接受的复发率和安全性结果？
经超声或静脉造影确诊为首次发作的有症状小腿静脉血栓或近端DVT，或经肺部扫描或血管造影确诊为PE的男性和女性。排除妊娠、血栓形成倾向、严重PE和癌症患者。
在使用肝素和口服抗凝剂治疗使国际标准化比值（INR）达到2 - 3后，小腿DVT患者被随机分为接受6周治疗组（n = 105）和3个月治疗组（n = 92），近端DVT和/或PE患者被随机分为接受3个月治疗组（n = 270）和6个月治疗组（n = 269）。观察指标为复发情况以及严重、轻微或致命性出血并发症。平均随访时间为12个月。
共纳入736例患者。对于小腿静脉血栓，6周治疗后DVT或PE的复发率为2/105（2.0%），3个月治疗后为3/92（3.4%），相对风险为0.58（95%可信区间：0.10 - 3.36）。严重出血率分别为1/105（1.0%）和3/92（3.4%），相对风险为0.29（95%可信区间：0.03 - 2.72）。对于近端DVT或PE，3个月治疗后的复发率为21/270（8.1%），6个月治疗后为23/269（8.7%），相对风险为0.93（95%可信区间：0.53 - 1.65）。严重出血率分别为5/270（1.9%）和7/269（2.6%），相对风险为0.73（95%可信区间：0.24 - 2.27）。
孤立性小腿静脉DVT后，6周口服抗凝治疗足够。对于近端DVT或PE，3个月和6个月的抗凝治疗效果相当。对于复发风险低的有临时危险因素的患者，3个月治疗似乎足够。
