Gothard Lone, Stanton Anthony, MacLaren Julie, Lawrence David, Hall Emma, Mortimer Peter, Parkin Eileen, Pritchard Joyce, Risdall Jane, Sawyer Robert, Woods Mary, Yarnold John
Department of Radiotherapy, Royal Marsden NHS Trust, Sutton, Surrey SM2 5PT, UK.
Radiother Oncol. 2004 Mar;70(3):217-24. doi: 10.1016/S0167-8140(03)00235-4.
Radiation-induced arm lymphoedema is a common and distressing complication of curative treatment for early breast cancer. Hyperbaric oxygen (HBO(2)) therapy promotes healing in bone rendered ischaemic by radiotherapy, and may help some soft-tissue injuries too, but is untested in arm lymphoedema.
Twenty-one eligible research volunteers with a minimum 30% increase in arm volume in the years after axillary/supraclavicular radiotherapy (axillary surgery in 18/21 cases) were treated with HBO(2). The volunteers breathed 100% oxygen at 2.4 ATA for 100 min in a multiplace hyperbaric chamber on 30 occasions over a period of 6 weeks. The volume of the ipsilateral limb, measured opto-electronically by a perometer and expressed as a percentage of contralateral limb volume, was selected as the primary endpoint. A secondary endpoint was local lymph drainage expressed as fractional removal rate of radioisotopic tracer, measured using lymphoscintigraphy.
Three out of 19 evaluable patients experienced >20% reduction in arm volume at 12 months. Six out of 13 evaluable patients experienced a >25% improvement in (99)Tc-nanocolloid clearance rate from the ipsilateral forearm measured by quantitative lymphoscintigraphy at 12 months. Overall, there was a statistically significant, but clinically modest, reduction in ipsilateral arm volume at 12 months follow-up compared with baseline (P = 0.005). The mean percentage reduction in arm volume from baseline at 12 months was 7.51. Moderate or marked lessening of induration in the irradiated breast, pectoral fold and/or supraclavicular fossa was recorded clinically in 8/15 evaluable patients. Twelve out of 19 evaluable patients volunteered that their arms felt softer, and six reported improvements in shoulder mobility at 12 months. No significant improvements were noted in patient self-assessments of quality of life.
Interpretation is limited by the absence of a control group. However, measurement of limb volume by perometry is reportedly reliable, and lymphoscintigraphy is assumed to be operator-independent. Taking all data into account, there is sufficient evidence to justify a double-blind randomised controlled trial of hyperbaric oxygen in this group of patients.
放射性手臂淋巴水肿是早期乳腺癌根治性治疗常见且令人痛苦的并发症。高压氧（HBO₂）疗法可促进因放疗导致缺血的骨骼愈合，对一些软组织损伤可能也有帮助，但在手臂淋巴水肿方面未经测试。
21名符合条件的研究志愿者，在腋窝/锁骨上放疗（21例中有18例进行了腋窝手术）后的几年中，手臂体积至少增加了30%，接受了HBO₂治疗。志愿者在多人高压舱中，于6周内的30个疗程中，以2.4ATA吸入100%氧气100分钟。通过周径仪以光电方式测量同侧肢体体积，并表示为对侧肢体体积的百分比，以此作为主要终点。次要终点是局部淋巴引流，用放射性核素示踪剂的分数清除率表示，通过淋巴闪烁显像测量。
19例可评估患者中有3例在12个月时手臂体积减少超过20%。13例可评估患者中有6例在12个月时通过定量淋巴闪烁显像测量，同侧前臂的（99）Tc-纳米胶体清除率提高超过25%。总体而言，在12个月随访时，与基线相比，同侧手臂体积有统计学上显著但临床上适度的减少（P = 0.005）。12个月时手臂体积较基线的平均减少百分比为7.51。15例可评估患者中有8例临床记录显示照射乳房、胸皱襞和/或锁骨上窝的硬结有中度或明显减轻。19例可评估患者中有12例表示他们的手臂感觉更柔软，6例报告在12个月时肩部活动度有所改善。患者对生活质量的自我评估未发现显著改善。
由于缺乏对照组，解释受到限制。然而，据报道通过周径仪测量肢体体积是可靠的，并且假定淋巴闪烁显像与操作人员无关。综合所有数据，有足够证据证明对该组患者进行高压氧双盲随机对照试验是合理的。
