Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium.
BMJ. 2011 Sep 1;343:d5326. doi: 10.1136/bmj.d5326.
To determine the preventive effect of manual lymph drainage on the development of lymphoedema related to breast cancer.
Randomised single blinded controlled trial.
University Hospitals Leuven, Leuven, Belgium.
160 consecutive patients with breast cancer and unilateral axillary lymph node dissection. The randomisation was stratified for body mass index (BMI) and axillary irradiation and treatment allocation was concealed. Randomisation was done independently from recruitment and treatment. Baseline characteristics were comparable between the groups.
For six months the intervention group (n = 79) performed a treatment programme consisting of guidelines about the prevention of lymphoedema, exercise therapy, and manual lymph drainage. The control group (n = 81) performed the same programme without manual lymph drainage.
Cumulative incidence of arm lymphoedema and time to develop arm lymphoedema, defined as an increase in arm volume of 200 mL or more in the value before surgery.
Four patients in the intervention group and two in the control group were lost to follow-up. At 12 months after surgery, the cumulative incidence rate for arm lymphoedema was comparable between the intervention group (24%) and control group (19%) (odds ratio 1.3, 95% confidence interval 0.6 to 2.9; P = 0.45). The time to develop arm lymphoedema was comparable between the two group during the first year after surgery (hazard ratio 1.3, 0.6 to 2.5; P = 0.49). The sample size calculation was based on a presumed odds ratio of 0.3, which is not included in the 95% confidence interval. This odds ratio was calculated as (presumed cumulative incidence of lymphoedema in intervention group/presumed cumulative incidence of no lymphoedema in intervention group)×(presumed cumulative incidence of no lymphoedema in control group/presumed cumulative incidence of lymphoedema in control group) or (10/90)×(70/30).
Manual lymph drainage in addition to guidelines and exercise therapy after axillary lymph node dissection for breast cancer is unlikely to have a medium to large effect in reducing the incidence of arm lymphoedema in the short term. Trial registration Netherlands Trial Register No NTR 1055.
确定手动淋巴引流对乳腺癌相关淋巴水肿发展的预防效果。
随机单盲对照试验。
比利时鲁汶大学医院。
160 例连续的乳腺癌和单侧腋窝淋巴结清扫术患者。随机分组按体重指数（BMI）和腋窝照射分层，治疗分配被隐藏。随机分组与招募和治疗分开进行。两组基线特征无差异。
干预组（n=79）在 6 个月内接受治疗方案，包括预防淋巴水肿、运动治疗和手动淋巴引流的指导方针。对照组（n=81）接受相同的方案，但不进行手动淋巴引流。
手臂淋巴水肿的累积发生率和发生手臂淋巴水肿的时间，定义为手术前手臂体积增加 200ml 或更多。
干预组有 4 例患者和对照组有 2 例患者失访。术后 12 个月，干预组（24%）和对照组（19%）的手臂淋巴水肿累积发生率无差异（比值比 1.3，95%置信区间 0.6 至 2.9；P=0.45）。术后第一年，两组手臂淋巴水肿的发生时间无差异（风险比 1.3，0.6 至 2.5；P=0.49）。样本量计算基于假定的比值比为 0.3，该比值不在 95%置信区间内。该比值比计算为（干预组假定的淋巴水肿累积发生率/干预组假定的无淋巴水肿累积发生率）×（对照组假定的无淋巴水肿累积发生率/对照组假定的淋巴水肿累积发生率）或（10/90）×（70/30）。
乳腺癌腋窝淋巴结清扫术后，除了指南和运动治疗外，手动淋巴引流不太可能在短期内对降低手臂淋巴水肿的发生率产生中等至较大的影响。试验注册荷兰临床试验注册中心 NTR 1055。
