乳腺癌相关淋巴水肿 (BCRL) 是一种令人衰弱的后遗症，影响多达三分之一的乳腺癌幸存者。目前的治疗是姑息性的，不能解决潜在的淋巴损伤。最近，临床前和非随机研究显示，使用脂肪源性再生细胞 (ADRC) 和脂肪移植通过淋巴组织再生减轻 BCRL 具有良好的效果。然而，尚未进行随机对照试验来试图消除安慰剂效应。这项随机、双盲、安慰剂对照试验纳入了无选择、持续致残的单侧 BCRL 患者。患者以 1:1 的比例随机分配，接受自体 ADRC（4.20x10 7±1.75x10 7 细胞）和 30cc 脂肪移植或安慰剂（盐水）至腋窝。主要结果是治疗一年后 BCRL 体积的变化。次要结局包括生活质量、吲哚菁绿淋巴管造影分期、生物阻抗和安全性的变化。共纳入 80 名患者，其中 39 名接受 ADRC 和脂肪移植治疗，41 名接受安慰剂治疗。两组的基线特征相似。治疗一年后，治疗组或安慰剂组没有观察到客观改善。相比之下，治疗组和安慰剂组均出现显着的主观改善。该试验未能证实 ADRC 和脂肪移植在 BCRL 治疗中的益处。这些非证实性结果表明，目前不应推荐使用 ADRC 和脂肪移植来缓解 BCRL。然而，我们不能排除重复治疗或更高剂量的 ADRC 或脂肪移植可能产生临床效果。版权所有 © 2024 美国整形外科医生协会。

Breast cancer-related lymphedema (BCRL) is a debilitating sequela affecting up to one in three breast cancer survivors. Current treatments are palliative and does not address the underlying lymphatic injury. Recently, preclinical and non-randomized studies have shown promising results using Adipose-Derived Regenerative Cells (ADRCs) and lipotransfer in alleviating BCRL through regeneration of lymphatic tissue. However no randomized controlled trial has been performed in an attempt to eliminate a placebo effect.This randomized, double-blinded, placebo-controlled trial included patients with no-option, persistent disabling unilateral BCRL. Patients were randomly assigned in a 1:1 ratio to receive either autologous ADRCs (4.20x10 7±1.75x10 7 cells) and 30cc lipotransfer or placebo (saline) to the axilla. The primary outcome was a change in BCRL volume one year after treatment. Secondary outcomes included changes in the quality of life, indocyanine green lymphangiography stage, bioimpedance, and safety.Eighty patients were included, of which 39 were allocated to ADRCs and lipotransfer treatment and 41 to placebo treatment. Baseline characteristics were similar in both groups. One year after treatment, no objective improvements were observed in the treatment or placebo groups. In contrast, significant subjective improvements were noted for both the treatment and placebo groups.This trial failed to confirm a benefit of ADRCs and lipotransfer in the treatment of BCRL. These non-confirmatory results suggest that ADRC and lipotransfer should not be recommended for alleviating BCRL at this time. However, we cannot exclude that repeated treatments or higher doses of ADRCs or lipotransfer could yield a clinical effect.Copyright © 2024 by the American Society of Plastic Surgeons.