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莫比德尔加压绷带在乳腺癌相关淋巴水肿患者消肿治疗强化期的安全性和有效性:一项随机对照试验

Safety and Efficacy of a Mobiderm Compression Bandage During Intensive Phase of Decongestive Therapy in Patients with Breast Cancer-Related Lymphedema: A Randomized Controlled Trial.

作者信息

Dhar Anita, Srivastava Anurag, Pandey Ravindra M, Shrestha Prasanna, Villet Stéphanie, Gogia Arun Rekha

机构信息

Department of Surgical Disciplines and All India Institute of Medical Sciences, New Delhi, India.

Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.

出版信息

Lymphat Res Biol. 2023 Feb;21(1):52-59. doi: 10.1089/lrb.2021.0104. Epub 2022 Jun 8.

Abstract

Breast cancer-related lymphedema (BCRL) after primary therapy is a common condition, causing physical and psychological distress. Decongestive lymphedema therapy (DLT) using multi-layered compression bandages is an effective treatment. We conducted a randomized controlled trial evaluating the use of a specific mobilizing bandage (Mobiderm) on lymphedema volume reduction during the intensive phase of DLT. Fifty female BCRL patients were randomized to receive either conventional multi-layered bandages or mobilizing bandaging by using Mobiderm. Affected limb volume and excess volume were evaluated at baseline (D0) and after 15 days. The primary outcome was change in affected limb volume after adjustment for baseline. Symptom scores were evaluated by visual analogue scale (VAS); safety and tolerability were also assessed. Baseline characteristics were comparable. Affected limb volume reduction was observed in both study groups after 15 days: by 19.0% in the Mobiderm arm and 8.6% in controls (adjusted values). The between-group mean difference in adjusted volume reduction at day 15 was 256 mL (95% confidence interval [CI], 92.5 to 421.3 mL;  = 0.003) favoring Mobiderm. Reductions in excess volume of 57.3% (Mobiderm) and 25.1% (controls) were observed (adjusted values); with between-group mean difference in adjusted excess volume of 220.2 mL (95% CI, 69.3 to 371.3 mL;  = 0.006) favoring Mobiderm. Pain/heaviness VAS scores fell significantly in both groups, with mean reductions of 1.84 (Mobiderm) versus 0.83 (control;  = 0.001). Both regimens were well tolerated. The use of Mobiderm in multilayer compression bandaging shows benefit in lymphedema reduction and in alleviating functional symptoms/pain in patients with BRCL.

摘要

原发性治疗后的乳腺癌相关淋巴水肿(BCRL)是一种常见病症,会导致身体和心理上的痛苦。使用多层加压绷带的消肿淋巴水肿疗法(DLT)是一种有效的治疗方法。我们进行了一项随机对照试验,评估在DLT强化阶段使用一种特定的活动绷带(Mobiderm)对淋巴水肿体积减少的作用。50名女性BCRL患者被随机分为两组,分别接受传统多层绷带或使用Mobiderm的活动绷带治疗。在基线期(D0)和15天后评估患侧肢体体积和多余体积。主要结局是在对基线进行校正后患侧肢体体积的变化。通过视觉模拟量表(VAS)评估症状评分;同时也评估安全性和耐受性。两组的基线特征具有可比性。15天后,两个研究组的患侧肢体体积均有减少:Mobiderm组减少了19.0%,对照组减少了8.

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