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一种新型非气动压迫装置(NPCD)治疗下肢淋巴水肿的安全性和有效性的非随机、开放性研究。

A non-randomized, open-label study of the safety and effectiveness of a novel non-pneumatic compression device (NPCD) for lower limb lymphedema.

机构信息

Cardiovascular Medicine, Falk Cardiovascular Research Center, Stanford University, Stanford, CA, 94305, USA.

Carlson School of Management, University of Minnesota, Minneapolis, MN, USA.

出版信息

Sci Rep. 2022 Aug 17;12(1):14005. doi: 10.1038/s41598-022-17225-9.

DOI:10.1038/s41598-022-17225-9
PMID:35977981
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9385615/
Abstract

Lower extremity lymphedema (LEL) can result in detriments to quality of life (QOL) and impose a significant economic burden on patients and payers. A common component of treatment is pneumatic compression, which requires patients to remain immobile. We investigated a novel non-pneumatic compression device (NPCD) that allows patients to remain active during compression treatment, to see if it reduces swelling and improves QOL. We conducted a non-randomized, open-label, 12-week pilot study of adult patients with primary or secondary unilateral LEL, and measured changes in limb edema and QOL using the Lymphedema Quality of Life Questionnaire (LYMQOL). Twenty-four subjects were enrolled; the majority were female (17) with secondary lymphedema (21). Eighteen completed the study. Statistically significant improvements were observed in overall QOL, aggregated LYMQOL total score, and three of four LYMQOL subscales (Function, Appearance, Mood). The fourth (Symptoms) trended toward significant improvement (p = 0.06). The average reduction in affected limb edema was 39.4%. The novel NPCD produced statistically significant improvements in QOL, functioning, and edema volume of patients with LEL. Innovations in devices to manage LEL can be effective while allowing patients to maintain mobility and physical activity during treatment.

摘要

下肢淋巴水肿 (LEL) 可导致生活质量 (QOL) 受损,并给患者和支付方带来重大经济负担。治疗的常见方法是气动压缩,这要求患者保持不动。我们研究了一种新型的非气动压缩设备 (NPCD),它可以让患者在压缩治疗期间保持活动,以观察它是否能减轻肿胀和改善 QOL。我们进行了一项非随机、开放标签、为期 12 周的成人原发性或继发性单侧 LEL 患者的试点研究,使用淋巴水肿生活质量问卷 (LYMQOL) 测量肢体肿胀和 QOL 的变化。共纳入 24 名受试者;大多数是女性(17 名),患有继发性淋巴水肿(21 名)。18 名患者完成了研究。总体 QOL、综合 LYMQOL 总分以及四个 LYMQOL 子量表中的三个(功能、外观、情绪)均观察到统计学显著改善。第四个(症状)也呈现出显著改善的趋势(p=0.06)。受影响肢体肿胀的平均减少量为 39.4%。新型 NPCD 可显著改善 LEL 患者的 QOL、功能和肢体肿胀。管理 LEL 的设备创新在允许患者在治疗期间保持移动性和体力活动的同时,可以有效发挥作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/79aa/9385615/75b9333d4b1b/41598_2022_17225_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/79aa/9385615/81163aeb076d/41598_2022_17225_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/79aa/9385615/75b9333d4b1b/41598_2022_17225_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/79aa/9385615/81163aeb076d/41598_2022_17225_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/79aa/9385615/75b9333d4b1b/41598_2022_17225_Fig2_HTML.jpg

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