Barker A T, Dixon R A, Sharrard W J, Sutcliffe M L
Lancet. 1984 May 5;1(8384):994-6. doi: 10.1016/s0140-6736(84)92329-8.
Patients with tibial fractures which had remained un-united for at least 52 weeks were randomly allocated to either active or dummy pulsed magnetic field stimulators and treated in full leg plasters for 24 weeks with a non-weightbearing conservative regimen, as is usual with such techniques. Fractures in 5 of the 9 patients with working machines united and fractures in 5 of the 7 patients with dummy machines also united. These early results of this double-blind trial are compatible with a difference in success rate at 24 weeks on active treatment of + 33% to -61% (95% confidence limits) compared with the success rate on the dummy stimulators. The high proportion of fractures uniting in the control group suggests that conservative management of non-union is effective and this may explain much of the success attributed to pulsed magnetic field therapy.
胫骨骨折至少52周未愈合的患者被随机分配到有源或模拟脉冲磁场刺激器组,并按照此类技术的常规做法,在非负重保守治疗方案下用全腿石膏固定治疗24周。使用有源刺激器的9例患者中有5例骨折愈合,使用模拟刺激器的7例患者中也有5例骨折愈合。这项双盲试验的这些早期结果表明,与模拟刺激器相比,有源治疗在24周时的成功率差异为+33%至-61%(95%置信区间)。对照组骨折愈合的比例很高,这表明对骨不连的保守治疗是有效的,这可能解释了许多归因于脉冲磁场疗法的成功案例。