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Abstract：
Background: Optimal frequency and duration of pneumatic compression device (PCD) therapy for lymphedema is undetermined. This prospective, randomized preliminary study evaluated the impact of different PCD dosing protocols on physiological and patient-reported outcomes (PROs) to estimate treatment effects, assess the responsiveness of various measurement techniques, and identify endpoints for a definitive PCD dosing trial. Methods and Results: Twenty-one patients with lower extremity lymphedema were randomized into three groups for treatment with the Flexitouch advanced PCD: (A) once per day for 1 hour, 12 consecutive days; (B) twice per day in 1-hour treatments, 5 consecutive days; or (C) twice per day in 2-hour treatments, 5 consecutive days. Outcomes measured were changes in limb volume (LV), tissue fluid, tissue tone, and PROs. Those in group A experienced mean (standard deviation) LV reductions of 109 (58) mL (p = 0.003) on day 1 and of 97 (86) mL (p = 0.024) on day 5. Group A also showed possible single-treatment decreases in extracellular fluid volume by bioimpedance spectroscopy (BIS) on day 5. There were no consistent changes in groups B and C. Long-term assessment of LV and BIS showed no clear change. Tonometry, ultrasound, local tissue water, and PROs showed wide variation among participants. Conclusions: LV measurements showed potential benefit for 1-hour daily PCD treatment. A definitive dosing trial should include LV, BIS, and PROs in a comparison of 1- and 2-hour daily treatment protocols conducted over a study period of 4 weeks. These data may inform appropriate outcome measures for other intervention studies in lymphedema.
摘要：
背景：气动压缩装置（PCD）治疗淋巴水肿的最佳频率和持续时间尚不确定。这个未来,随机初步研究评估了不同PCD给药方案对生理和患者报告结果（PRO）的影响，以评估治疗效果，评估各种测量技术的响应性，并确定确定PCD给药试验的终点。方法和结果：21例下肢淋巴水肿患者随机分为三组，采用Flexitouch晚期PCD治疗：（A）每天一次，持续1小时，连续12天；（B）每天两次，1小时治疗，连续5天；或（C）每天2次，2小时治疗，连续5天测量的结果是肢体体积（LV）的变化，组织液,组织色调,和PROS。A组中的那些在第1天经历109(58)mL(p=0.003)和在第5天经历97(86)mL(p=0.024)的平均(标准偏差)LV减少。在第5天,通过生物阻抗谱(BIS),A组还显示了细胞外液体积的可能的单次处理减少。B组和C组无一致变化。LV和BIS的长期评估显示无明显变化。眼压测定,超声，局部组织水，和PROs在参与者之间显示出很大的差异。结论:LV测量显示每日1小时PCD治疗的潜在益处。明确的给药试验应包括LV，BIS,和PROs在4周的研究期间进行的每日1小时和2小时治疗方案的比较中。这些数据可以为淋巴水肿的其他干预研究提供适当的结果度量。
