Spadaro Joseph A, Short Walter H, Sheehe Paul R, Hickman Rebecca M, Feiglin David H
Musculoskeletal Research Laboratory, Department of Orthopedic Surgery, SUNY Upstate Medical University, Syracuse, New York 13210, USA.
Bioelectromagnetics. 2011 May;32(4):273-82. doi: 10.1002/bem.20632. Epub 2010 Dec 22.
A randomized, double-blind, sham-controlled, feasibility and dosing study was undertaken to determine if a common pulsing electromagnetic field (PEMF) treatment could moderate the substantial osteopenia that occurs after forearm disuse. Ninety-nine subjects were randomized into four groups after a distal radius fracture, or carpal surgery requiring immobilization in a cast. Active or identical sham PEMF transducers were worn on the distal forearm for 1, 2, or 4 h/day for 8 weeks starting after cast removal ("baseline") when bone density continues to decline. Bone mineral density (BMD) and bone geometry were measured in the distal forearm by dual energy X-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) at entry ("baseline") and 8, 16, and 24 weeks later. Significant average BMD losses after baseline were observed in the affected forearm at all time points (5-7% distally and 3-4% for the radius/ulna shaft). However, after adjusting for age, gender, and baseline BMD there was no evidence of a positive effect of active versus sham PEMF treatment on bone loss by DXA or pQCT for subjects completing all visits (n = 82, ∼20 per group) and for an intent-to-treat analysis (n = 99). Regardless of PEMF exposure, serum bone-specific alkaline phosphatase (BSAP) was normal at baseline and 8 weeks, while serum c-terminal collagen teleopeptide (CTX-1) was markedly elevated at baseline and less so at 8 weeks. Although there was substantial variability in disuse osteopenia, these results suggested that the particular PEMF waveform and durations applied did not affect the continuing substantial disuse bone loss in these subjects.
开展了一项随机、双盲、假对照、可行性和剂量研究，以确定一种常见的脉冲电磁场（PEMF）治疗是否可以缓解前臂废用后出现的严重骨质减少。99名受试者在桡骨远端骨折或需要用石膏固定的腕部手术后被随机分为四组。从石膏拆除后（“基线”）开始，当骨密度持续下降时，在远端前臂佩戴有源或相同的假PEMF换能器，每天佩戴1、2或4小时，持续8周。在入组时（“基线”）以及8、16和24周后，通过双能X线吸收法（DXA）和外周定量计算机断层扫描（pQCT）测量远端前臂的骨矿物质密度（BMD）和骨几何形态。在所有时间点，受影响的前臂在基线后均观察到显著的平均BMD损失（远端为5-7%，桡骨/尺骨干为3-4%）。然而，在对年龄、性别和基线BMD进行调整后，对于完成所有访视的受试者（n = 82，每组约20人）以及意向性分析（n = 99），没有证据表明有源与假PEMF治疗在DXA或pQCT测量的骨丢失方面有积极作用。无论PEMF暴露情况如何，血清骨特异性碱性磷酸酶（BSAP）在基线和8周时均正常，而血清C端胶原末端肽（CTX-1）在基线时显著升高，在8周时升高程度较小。尽管废用性骨质减少存在很大差异，但这些结果表明，所应用的特定PEMF波形和持续时间并未影响这些受试者持续的严重废用性骨质丢失。
