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使用弹力袜预防血管迷走性晕厥复发:一项随机假对照试验。

Using Compression Stockings to Prevent Recurrence of Vasovagal Syncope: A Randomized Sham-Controlled Trial.

作者信息

Tavolinejad Hamed, Bozorgi Ali, Emkanjoo Zahra, Oraii Alireza, Shahabi Javad, Mollazadeh Reza, Kiarsi Mohamadreza, Yadangi Somayeh, Babaei Mohammadreza, Oraii Saeed, Hosseini Kaveh, Sadeghian Saeed, Zadkamali Mostafa, Mohsenzadeh Amin, Alaeddini Farshid, Raj Satish R, Fedorowski Artur, Tajdini Masih

机构信息

Tehran Heart Center, Cardiovascular Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.

Cardiac Electrophysiology Research Center, Rajaie Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, Iran.

出版信息

J Am Coll Cardiol. 2025 Aug 12;86(6):412-422. doi: 10.1016/j.jacc.2025.05.049.

Abstract

BACKGROUND

Vasovagal syncope (VVS) is a common yet challenging condition with limited effective treatments. Elastic compression stockings (ECS) have been proposed as a potential therapy, but their real-world effectiveness remains unclear.

OBJECTIVES

This study sought to compare the effectiveness of lower extremity compression with thigh-high ECS vs sham stockings for the prevention of VVS recurrence.

METHODS

This multicenter, parallel, blinded, randomized sham-controlled trial enrolled adults 18 to 65 years of age with ≥2 VVS episodes in the past year. Participants were randomized 1:1 to receive either thigh-length, open-toe active ECS (25-30 mm Hg pressure to the leg), or identical-looking sham ECS (≤10 mm Hg pressure). All participants received standard care (education and lifestyle modifications) but no medications for preventing VVS recurrence. ECS adherence was tracked using diary booklets. The coprimary outcomes were: 1) the proportion of participants with ≥1 VVS recurrence; and 2) the time to first VVS recurrence (ie, VVS-free survival).

RESULTS

Among 266 participants (mean age 39 years, 58% female), during 12 months of follow-up, VVS recurred in 29.1% (n = 39 of 134) of participants in the treatment group and 34.8% (n = 46 of 132) in the control group (absolute risk reduction: 5.7%; P = 0.315). VVS-free survival was not significantly different (HR: 0.81; 95% CI: 0.53-1.24; P = 0.333). ECS adherence was suboptimal, with discontinuation rates of 37.3% in the treatment arm vs 34.8% in the sham arm. Discontinuation rates, duration of using ECS, and adherence rates were similar between treatment groups. The median number of recurrent episodes was similar (treatment: 2.5 vs sham: 2; P = 0.839). However, significantly fewer VVS episodes occurred while actively wearing ECS (32.7% vs 45.1%; P = 0.024).

CONCLUSIONS

Treating syncope with thigh-high lower limb compression using ECS did not reduce the cumulative incidence of VVS recurrence, and did not change VVS-free survival. Additionally, ECS did not reduce the frequency of multiple VVS episodes. The results do not support routine use of thigh-length ECS, although it may be helpful for selected patients when added to standard care. Because our study specifically tested thigh-high ECS, future studies should aim to assess the effectiveness of more extensive compression targeting pelvic and abdominal venous pooling.

摘要

背景

血管迷走性晕厥(VVS)是一种常见但具有挑战性的病症,有效治疗方法有限。弹力加压袜(ECS)已被提议作为一种潜在疗法,但其在现实世界中的有效性仍不明确。

目的

本研究旨在比较大腿长度的ECS进行下肢加压与假袜预防VVS复发的有效性。

方法

这项多中心、平行、双盲、随机假对照试验纳入了18至65岁、过去一年有≥2次VVS发作的成年人。参与者按1:1随机分组,分别接受大腿长度的露趾活性ECS(腿部压力为25 - 30 mmHg)或外观相同的假ECS(压力≤10 mmHg)。所有参与者均接受标准护理(教育和生活方式调整),但不使用预防VVS复发的药物。使用日记手册追踪ECS的依从性。共同主要结局为:1)有≥1次VVS复发的参与者比例;2)首次VVS复发的时间(即无VVS生存时间)。

结果

在266名参与者(平均年龄39岁,58%为女性)中,随访12个月期间,治疗组29.1%(134名中的39名)的参与者VVS复发,对照组为34.8%(132名中的46名)(绝对风险降低:5.7%;P = 0.315)。无VVS生存时间无显著差异(HR:0.81;95% CI:0.53 - 1.24;P = 0.333)。ECS依从性欠佳,治疗组停药率为37.3%,假组为34.8%。治疗组之间的停药率、使用ECS的持续时间和依从率相似。复发发作的中位数相似(治疗组:2.5次 vs 假组:2次;P = 0.839)。然而,在积极穿着ECS时发生的VVS发作明显较少(32.7% vs 45.1%;P = 0.024)。

结论

使用ECS对大腿进行下肢加压治疗晕厥并未降低VVS复发的累积发生率,也未改变无VVS生存时间。此外,ECS并未降低多次VVS发作的频率。这些结果不支持常规使用大腿长度的ECS,尽管在标准护理基础上添加ECS可能对特定患者有帮助。由于我们的研究专门测试了大腿长度的ECS,未来研究应旨在评估针对盆腔和腹部静脉淤血进行更广泛加压的有效性。

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