Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, California, USA.
Department of Plastic Surgery, The Ohio State University Medical Center, Columbus, Ohio, USA.
Lymphat Res Biol. 2023 Dec;21(6):581-584. doi: 10.1089/lrb.2022.0085. Epub 2023 Sep 20.
A recently completed clinical trial compared a novel nonpneumatic compression device (NPCD) with a traditional advanced pneumatic compression device (APCD) for the treatment of breast cancer-related lymphedema (BCRL); the study revealed that the NPCD produced superior clinical and quality-of-life (QOL) outcomes. In this subanalysis, we sought to examine these results within the subset of trial subjects aged ≥65 years. A randomized crossover head-to-head trial was conducted to compare the NPCD with a commercially available APCD. Patients were randomly assigned to one or the other device for 28 days of use, followed by a 4-week washout period before a comparable 28-day utilization of the alternate device. Limb edema, adherence to daily device use, and QOL measures were collected at day 0 and 28 of each period. A total of 14 subjects were aged ≥65. During NPCD use, subjects experienced a mean decrease in limb edema of 100.3% ( = 0.0082) as well as improvements in mean overall and subscale scores of the Lymphedema Quality of Life Questionnaire (LYMQOL). By comparison, during APCD use limb edema decreased by a mean of 2.9% ( = 0.8899) with no significant changes in any LYMQOL scores. Mean adherence was significantly higher during NPCD use (96.6%) than during APCD use (58.3%, < 0.0001). The novel NPCD produced superior clinical and QOL outcomes in older subjects with BCRL. ClinicalTrials.gov ID: NCT04908254.
一项最近完成的临床试验比较了一种新型非气动压缩设备（NPCD）与传统的高级气动压缩设备（APCD）治疗乳腺癌相关淋巴水肿（BCRL）的效果；研究结果表明，NPCD 产生了更好的临床和生活质量（QOL）结果。在这项亚分析中，我们试图在年龄≥65 岁的试验受试者亚组中检查这些结果。 一项随机交叉头对头试验比较了 NPCD 与市售的 APCD。患者被随机分配到一种或另一种设备中使用 28 天，然后在使用替代设备的 4 周洗脱期后进行为期 28 天的可比较使用。在每个周期的第 0 天和第 28 天收集肢体水肿、日常设备使用依从性和 QOL 测量值。 共有 14 名受试者年龄≥65 岁。在 NPCD 使用期间，受试者的肢体水肿平均减少 100.3%（=0.0082），并且 Lymphedema Quality of Life Questionnaire（LYMQOL）的总评分和子量表评分均有改善。相比之下，在 APCD 使用期间，肢体水肿平均减少 2.9%（=0.8899），LYMQOL 评分无显著变化。NPCD 使用时的平均依从性明显高于 APCD 使用时（96.6%比 58.3%， < 0.0001）。 新型 NPCD 为年龄较大的 BCRL 患者带来了更好的临床和 QOL 结果。ClinicalTrials.gov ID：NCT04908254。
