Mestre S, Calais C, Gaillard G, Nou M, Pasqualini M, Ben Amor C, Quere I
Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.
Female specificity of the dysfunctions of Vascular Interfaces Laboratory EA2992, Montpellier 1, University, Montpellier and Nimes, France.
Support Care Cancer. 2017 Aug;25(8):2455-2462. doi: 10.1007/s00520-017-3652-5. Epub 2017 Mar 9.
Breast cancer-related lymphedema (BCRL) is a debilitating condition. The recommended treatment is based on decongestive lymphedema therapy (DLT) with two separate phases: a short-term intensive phase to reduce lymphedema volume and a long-term maintenance phase to stabilize it. Optimizing compression therapy and compliance during maintenance phase are key factors for long-term control of lymphedema. The primary objective of this pilot prospective open-label randomized study was to assess the benefit of a new auto-adjustable nighttime arm sleeve (MOBIDERM® Autofit) on lymphedema volume during the maintenance phase after the intensive phase.
Forty women with BRCL were consecutively enrolled and randomized (D0) for 1 month in 1:1 ratio either in night-use group: with MOBIDERM® Autofit (on top of a daytime compression hosiery), or in no night-use group: without MOBIDERM® Autofit (daytime hosiery alone). From Day 31 to Day 90, all patients were fitted with MOBIDERM® Autofit. Primary endpoint was lymphedema volume variation between Day 0 and Day 30. Secondary endpoints were compliance, quality of life (LYMQOL arm questionnaire), functional symptoms (heaviness, limb use limitation, pain), sleep quality, and safety.
In ITT population, between Day 0 and Day 30, mean lymphedema volume increase was higher in no night-use group with 92.9 mL (i.e., 3.2%) than in night-use group with 46.7 mL (i.e., 1.80%), p = 0.757. Between Day 30 and Day 90, all patients fitted with MOBIDERM® Autofit, lymphedema volume remained stable in both groups. The device improved functional symptoms and function domain of the LYMQOL arm questionnaire. MOBIDERM® Autofit was worn overnight almost 85% of the nights. It was well accepted by the patients and no adverse reaction leading to permanent device discontinuation occurred.
Our results suggest that MOBIDERM® Autofit offers clinical benefits during maintenance phase of lymphedema treatment and enhances patient's self-management.
乳腺癌相关淋巴水肿（BCRL）是一种使人衰弱的病症。推荐的治疗方法基于消肿淋巴水肿疗法（DLT），分为两个不同阶段：短期强化阶段以减少淋巴水肿体积，长期维持阶段以使其稳定。在维持阶段优化压力治疗和依从性是淋巴水肿长期控制的关键因素。这项前瞻性开放标签随机试验的主要目的是评估一种新型自动调节夜间手臂袖套（MOBIDERM® Autofit）在强化阶段后的维持阶段对淋巴水肿体积的益处。
40名患有BRCL的女性连续入组并随机分组（D0），按1:1的比例分为夜间使用组：使用MOBIDERM® Autofit（在日间压力袜之上），或非夜间使用组：不使用MOBIDERM® Autofit（仅使用日间袜子），为期1个月。从第31天到第90天，所有患者均佩戴MOBIDERM® Autofit。主要终点是第0天和第30天之间淋巴水肿体积的变化。次要终点包括依从性、生活质量（LYMQOL手臂问卷）、功能症状（沉重感、肢体使用受限、疼痛）、睡眠质量和安全性。
在意向性分析人群中，在第0天和第30天之间，非夜间使用组的平均淋巴水肿体积增加量为92.9毫升（即3.2%），高于夜间使用组的46.7毫升（即1.80%），p = 0.757。在第30天到第90天之间，所有患者均佩戴MOBIDERM® Autofit，两组的淋巴水肿体积均保持稳定。该装置改善了LYMQOL手臂问卷的功能症状和功能领域。MOBIDERM® Autofit在近85%的夜晚整夜佩戴。患者对其接受度良好，未发生导致永久停用该装置的不良反应。
我们的结果表明，MOBIDERM® Autofit在淋巴水肿治疗的维持阶段具有临床益处，并增强了患者的自我管理能力。
