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一项针对乳腺癌女性淋巴水肿治疗的充血性淋巴治疗的随机试验。

Randomized trial of decongestive lymphatic therapy for the treatment of lymphedema in women with breast cancer.

机构信息

Ian S. Dayes, Tim J. Whelan, Jim A. Julian, Sameer Parpia, and Mark N. Levine, McMaster University; Tim J. Whelan, Jim A. Julian, Sameer Parpia, Kathleen I. Pritchard, and Mark N. Levine, Ontario Clinical Oncology Group; Ian S. Dayes, Tim J. Whelan, and Mark N. Levine, Juravinski Cancer Centre; Donna Reise, Talspar Nursing Services; Jennifer Wiernikowski, Hamilton Health Sciences, Hamilton; Kathleen I. Pritchard and Lee Manchul, University of Toronto; Kathleen I. Pritchard, Odette Sunnybrook Cancer Centre; Lee Manchul, University Health Network, Toronto; David Paul D'Souza and Lyn Kligman, London Regional Cancer Program, London; David Paul D'Souza, University of Western Ontario, London, Ontario; Linda LeBlanc, Dr Leon Richard Oncology Centre, Moncton, New Brunswick; Margaret L. McNeely, University of Alberta; and Margaret L. McNeely, Cross Cancer Institute, Edmonton, Alberta, Canada.

出版信息

J Clin Oncol. 2013 Oct 20;31(30):3758-63. doi: 10.1200/JCO.2012.45.7192. Epub 2013 Sep 16.

Abstract

PURPOSE

Because of its morbidity and chronicity, arm lymphedema remains a concerning complication of breast cancer treatment. Although massage-based decongestive therapy is often recommended, randomized trials have not consistently demonstrated benefit over more conservative measures.

PATIENTS AND METHODS

Women previously treated for breast cancer with lymphedema were enrolled from six institutions. Volumes were calculated from circumference measurements. Patients with a minimum of 10% volume difference between their arms were randomly assigned to either compression garments (control) or daily manual lymphatic drainage and bandaging followed by compression garments (experimental). The primary outcome was percent reduction in excess arm volume from baseline to 6 weeks.

RESULTS

A total of 103 women were randomly assigned, and 95 were evaluable. Mean reduction of excess arm volume was 29.0% in the experimental group and 22.6% in the control group (difference, 6.4%; 95% CI, -6.8% to 20.5%; P = .34). Absolute volume loss was 250 mL and 143 mL in the experimental and control groups, respectively (difference, 107 mL; 95% CI, 13 to 203 mL; P = .03). There was no difference between groups in the proportion of patients losing 50% or greater excess arm volume. Quality of life (Short Form-36 Health Survey) and arm function were not different between groups.

CONCLUSION

This trial was unable to demonstrate a significant improvement in lymphedema with decongestive therapy compared with a more conservative approach. The failure to detect a difference may have been a result of the relatively small size of our trial.

摘要

目的

由于手臂淋巴水肿的发病率和慢性,它仍然是乳腺癌治疗的一个令人担忧的并发症。尽管按摩为主的消肿治疗经常被推荐,但随机试验并没有一致证明其优于更保守的措施。

患者和方法

从六个机构招募了先前因乳腺癌而患有淋巴水肿的女性。体积是通过周长测量计算的。手臂之间体积差异最小为 10%的患者被随机分配到压缩服装(对照组)或每日手动淋巴引流和包扎后再穿压缩服装(实验组)。主要结果是从基线到 6 周时过度手臂体积的减少百分比。

结果

共有 103 名女性被随机分配,95 名可评估。实验组过度手臂体积的平均减少率为 29.0%,对照组为 22.6%(差异为 6.4%;95%置信区间为-6.8%至 20.5%;P =.34)。实验组和对照组的绝对体积损失分别为 250 毫升和 143 毫升(差异为 107 毫升;95%置信区间为 13 至 203 毫升;P =.03)。两组中失去 50%或更多过度手臂体积的患者比例没有差异。两组之间的生活质量(SF-36 健康调查)和手臂功能没有差异。

结论

与更保守的方法相比,本试验未能证明消肿治疗在淋巴水肿方面有显著改善。未能检测到差异可能是由于我们的试验规模相对较小。

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