Below-knee elastic compression stockings to prevent the post-thrombotic syndrome - A randomized, controlled trial

Below-knee elastic compression stockings to prevent the post-thrombotic syndrome - A randomized, controlled trial
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DOI:
10.7326/0003-4819-141-4-200408170-00004
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发表时间:
2004-08-17
影响因子:
39.2
通讯作者:
Girolami, A
Girolami, A
中科院分区:
医学1区
文献类型:
--
作者:
Prandoni, P;Lensing, AWA;Girolami, A

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背景资料:由于只有有限的证据表明弹力袜可以预防有症状的深静脉血栓形成(DVT)患者的血栓后综合征,因此弹力袜没有被广泛使用。目的:评价弹力袜预防近端DVT患者血栓后综合征的疗效。设计:随机对照临床试验。地点:大学医院。患者:连续180例首次发作的症状性近端DVT患者接受常规抗凝治疗。干预措施:出院前,患者被随机分配到穿或不穿膝下压缩弹性袜(30至40毫米汞柱的脚踝)2年。随访进行了长达5 years.Measurements:血栓后综合征的存在和严重程度进行了评分,通过使用一个标准化scale.Results:血栓后后遗症开发44的90个对照组(严重的10)和23的90例穿着弹力袜(严重的3)。除1起事件外,所有事件均发生在前2年。对照组血栓后综合征的累积发生率为40.0%(95% CI,29.9%-50.1%)vs 21.1%(Cl,12.7%-29.5%)6个月后,46.7% 1年后为49.1%(Cl,36.4%至57.0%)与22.2%(Cl,13.8%至30.7%),2年后为49.1%(Cl,38.7%至59.4%)与24.5%(Cl,15.6%至33.4%)。调整基线特征后,血栓后综合征的风险比在弹力袜组与对照组相比为0.49(CI,0.29至0.84; P = 0.011)。局限性:这项研究缺乏一个双盲design.Conclusions:血栓后后遗症发展近端DVT的患者几乎有一半。膝盖以下的压缩弹性袜减少了约50%的这一比率。
Background: Because only limited evidence suggests that elastic stockings prevent the post-thrombotic syndrome in patients with symptomatic deep venous thrombosis (DVT), these stockings are not widely used.Objective: To evaluate the efficacy of compression elastic stockings for prevention of the post-thrombotic syndrome in patients with proximal DVT.Design: Randomized, controlled clinical trial.Setting: University hospital.Patients: 180 consecutive patients with a first episode of symptomatic proximal DVT who received conventional anticoagulant treatment.Interventions: Before discharge, patients were randomly assigned to wear or not wear below-knee compression elastic stockings (30 to 40 mm Hg at the ankle) for 2 years. Follow-up was performed for up to 5 years.Measurements: The presence and severity of the post-thrombotic syndrome were scored by using a standardized scale.Results: Post-thrombotic sequelae developed in 44 of 90 controls (severe in 10) and in 23 of 90 patients wearing elastic stockings (severe in 3). All but 1 event developed in the first 2 years. The cumulative incidence of the post-thrombotic syndrome in the control group versus the elastic stockings group was 40.0% (95% Cl, 29.9% to 50.1%) versus 21.1% (Cl, 12.7% to 29.5%) after 6 months, 46.7% (Cl, 36.4% to 57.0%) versus 22.2% (Cl, 13.8% to 30.7%) after 1 year, and 49.1% (Cl, 38.7% to 59.4%) versus 24.5% (Cl, 15.6% to 33.4%) after 2 years. After adjustment for baseline characteristics, the hazard ratio for the post-thrombotic syndrome in the elastic stockings group compared with controls was 0.49 (Cl, 0.29 to 0.84; P = 0.011).Limitations: This study lacked a double-blind design.Conclusions: Post-thrombotic sequelae develop in almost half of patients with proximal DVT. Below-knee compression elastic stockings reduce this rate by approximately 50%.