辅助间歇性气动压迫预防静脉血栓栓塞症。

Adjunctive Intermittent Pneumatic Compression for Venous Thromboprophylaxis.

机构信息

From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.

出版信息

N Engl J Med. 2019 Apr 4;380(14):1305-1315. doi: 10.1056/NEJMoa1816150. Epub 2019 Feb 18.

DOI:10.1056/NEJMoa1816150

PMID:30779530

Abstract

BACKGROUND

Whether adjunctive intermittent pneumatic compression in critically ill patients receiving pharmacologic thromboprophylaxis would result in a lower incidence of deep-vein thrombosis than pharmacologic thromboprophylaxis alone is uncertain.

METHODS

We randomly assigned patients who were considered adults according to the local standards at the participating sites (≥14, ≥16, or ≥18 years of age) within 48 hours after admission to an intensive care unit (ICU) to receive either intermittent pneumatic compression for at least 18 hours each day in addition to pharmacologic thromboprophylaxis with unfractionated or low-molecular-weight heparin (pneumatic compression group) or pharmacologic thromboprophylaxis alone (control group). The primary outcome was incident (i.e., new) proximal lower-limb deep-vein thrombosis, as detected on twice-weekly lower-limb ultrasonography after the third calendar day since randomization until ICU discharge, death, attainment of full mobility, or trial day 28, whichever occurred first.

RESULTS

A total of 2003 patients underwent randomization - 991 were assigned to the pneumatic compression group and 1012 to the control group. Intermittent pneumatic compression was applied for a median of 22 hours (interquartile range, 21 to 23) daily for a median of 7 days (interquartile range, 4 to 13). The primary outcome occurred in 37 of 957 patients (3.9%) in the pneumatic compression group and in 41 of 985 patients (4.2%) in the control group (relative risk, 0.93; 95% confidence interval [CI], 0.60 to 1.44; P = 0.74). Venous thromboembolism (pulmonary embolism or any lower-limb deep-vein thrombosis) occurred in 103 of 991 patients (10.4%) in the pneumatic compression group and in 95 of 1012 patients (9.4%) in the control group (relative risk, 1.11; 95% CI, 0.85 to 1.44), and death from any cause at 90 days occurred in 258 of 990 patients (26.1%) and 270 of 1011 patients (26.7%), respectively (relative risk, 0.98; 95% CI, 0.84 to 1.13).

CONCLUSIONS

Among critically ill patients who were receiving pharmacologic thromboprophylaxis, adjunctive intermittent pneumatic compression did not result in a significantly lower incidence of proximal lower-limb deep-vein thrombosis than pharmacologic thromboprophylaxis alone. (Funded by King Abdulaziz City for Science and Technology and King Abdullah International Medical Research Center; PREVENT ClinicalTrials.gov number, NCT02040103; Current Controlled Trials number, ISRCTN44653506.).

摘要

背景

在接受药物血栓预防的危重病患者中，辅助间歇性气动压迫是否会导致深静脉血栓形成的发生率低于单独药物血栓预防尚不确定。

方法

我们将被认为是成年人的患者（根据当地标准，在参与地点为≥14、≥16 或≥18 岁）随机分配，在入住重症监护病房（ICU）后 48 小时内接受每天至少 18 小时的间歇性气动压迫，以预防血栓形成，此外还接受非分级或低分子量肝素（气动压缩组）或单独药物血栓预防（对照组）。主要结局是新发生的（即新出现的）近端下肢深静脉血栓形成，通过在随机分组后的第三个日历日后每周两次进行下肢超声检查来检测，直到 ICU 出院、死亡、完全活动或试验第 28 天，以先发生者为准。

结果

共有 2003 名患者接受了随机分组，其中 991 名被分配到气动压缩组，1012 名被分配到对照组。间歇性气动压迫的中位数为每天 22 小时（四分位距为 21 至 23），中位数为 7 天（四分位距为 4 至 13）。气动压缩组 957 例患者中有 37 例（3.9%）发生主要结局，对照组 985 例患者中有 41 例（4.2%）（相对风险，0.93；95%置信区间[CI]，0.60 至 1.44；P=0.74）。气动压缩组 991 例患者中有 103 例（10.4%）发生静脉血栓栓塞症（肺栓塞或任何下肢深静脉血栓形成），对照组 1012 例患者中有 95 例（9.4%）（相对风险，1.11；95%CI，0.85 至 1.44），990 例患者中有 258 例（26.1%）和 1011 例患者中有 270 例（26.7%）在 90 天内死亡（相对风险，0.98；95%CI，0.84 至 1.13）。

结论

在接受药物血栓预防的危重病患者中，辅助间歇性气动压迫并没有显著降低近端下肢深静脉血栓形成的发生率，低于单独药物血栓预防。（由阿卜杜勒阿齐兹国王城市科学技术基金会和阿卜杜拉国王国际医学研究中心资助；PREVENT 临床试验.gov 编号，NCT02040103；当前对照试验编号，ISRCTN44653506。）