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分级加压袜无益于择期手术患者药物血栓预防
作者:小柯机器人 发布时间:2020/5/15 9:36:59

英国伦敦帝国理工学院Alun H Davies团队探讨了分级加压袜辅助择期手术患者药物血栓预防的效果。2020年5月13日出版的《英国医学杂志》发表了这项成果。

为了探讨药物-血栓预防措施用于择期手术患者静脉血栓栓塞预防时,使用分级加压袜(GCS)是否有辅助作用,研究组在英国7家国家卫生服务三级医院中进行了一项开放、多中心、随机、对照、非劣效性试验。

2016年5月至2019年1月,研究组招募了1858名静脉血栓栓塞风险中高度的择期手术住院成年患者,按1:1随机分组,其中937名接受低分子量肝素(LMWH)药物血栓预防,921名接受LMWH药物血栓预防和GCS治疗。主要结局是影像学证实的伴或不伴症状的下肢深静脉血栓形成,或术后90天内有症状的肺栓塞。

术后90天,仅LMWH组中有16名(1.7%)发生了主要结局,而LMWH+GCS组中有13名(1.4%)。两组之间的风险差异为0.30%,符合非劣效性。

总之,对于行择期手术且静脉血栓栓塞风险为中高度的患者,单独进行药物血栓预防的效果并不逊于药物血栓预防联合GCS。

附:英文原文

Title: Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial

Author: Joseph Shalhoub, Rebecca Lawton, Jemma Hudson, Christopher Baker, Andrew Bradbury, Karen Dhillon, Tamara Everington, Manjit S Gohel, Zaed Hamady, Beverley J Hunt, Gerrard Stansby, David Warwick, John Norrie, Alun H Davies

Issue&Volume: 2020/05/13

Abstract: Objectives To investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery.

Design Open, multicentre, randomised, controlled, non-inferiority trial.

Setting Seven National Health Service tertiary hospitals in the United Kingdom.

Participants 1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate.

Intervention Participants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS.

Outcome measures The primary outcome was imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality.

Results Between May 2016 and January 2019, 1905 participants were randomised. 1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery). A primary outcome event occurred in 16 of 937 (1.7%) patients in the LMWH alone group compared with 13 of 921 (1.4%) in the LMWH and GCS group. The risk difference between the two groups was 0.30% (95% confidence interval 0.65% to 1.26%). Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be non-inferior.

Conclusions For patients who have elective surgery and are at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and GCS. These findings indicate that GCS might be unnecessary in most patients undergoing elective surgery.

DOI: 10.1136/bmj.m1309

Source: https://www.bmj.com/content/369/bmj.m1309

期刊信息

BMJ-British Medical Journal:《英国医学杂志》,创刊于1840年。隶属于BMJ出版集团,最新IF:27.604
官方网址:http://www.bmj.com/
投稿链接:https://mc.manuscriptcentral.com/bmj