Calori G M, Tagliabue L, Gala L, d'Imporzano M, Peretti G, Albisetti W
Orthopaedic Institute, G. Pini University of Milan, Milan, Italy.
Injury. 2008 Dec;39(12):1391-402. doi: 10.1016/j.injury.2008.08.011. Epub 2008 Nov 22.
The purpose of this prospective randomised clinical study was to compare the efficacy of recombinant bone morphogenetic protein 7 (rhBMP-7) and platelet-rich plasma (PRP) as bone-stimulating agents in the treatment of persistent fracture non-unions. One hundred and twenty patients were randomised into two treatment groups (group rhBMP-7 vs. group PRP). Sixty patients with sixty fracture non-unions were assigned to each group (median age: 44 years, range 19-65, for the rhBMP-7 group and 41 years, range 21-62, for the PRP group, respectively). In the rhBMP-7 group, there were 15 tibial non-unions, 10 femoral, 15 humeral, 12 ulnar, and 8 radial non-unions. In the PRP group, there were 19 tibial non-unions, 8 femoral, 16 humeral, 8 ulnar, and 9 radial non-unions. The median number of operations performed prior to our intervention was 2 (range 1-5) and 2 (range 1-5) with autologous bone graft being used in 23 and 21 cases for the rhBMP-7 and PRP groups, respectively. Both clinical and radiological union occurred in 52 (86.7%) cases of the rhBMP-7 group compared to 41 (68.3%) cases of the PRP group, with a lower median clinical and radiographic healing time observed in the rhBMP-7 group (3.5 months vs. 4 months and 8 months vs. 9 months, respectively). This study supports the view that in the treatment of persistent long bone non-unions, the application of rhBMP-7 as a bone-stimulating agent is superior compared to that of PRP with regard to their clinical and radiological efficacy.
这项前瞻性随机临床研究的目的是比较重组骨形态发生蛋白7(rhBMP - 7)和富血小板血浆(PRP)作为骨刺激剂在治疗持续性骨折不愈合中的疗效。120例患者被随机分为两个治疗组(rhBMP - 7组与PRP组)。每组分配60例骨折不愈合患者(rhBMP - 7组中位年龄44岁,范围19 - 65岁;PRP组中位年龄41岁,范围21 - 62岁)。rhBMP - 7组有15例胫骨不愈合、10例股骨不愈合、15例肱骨不愈合、12例尺骨不愈合和8例桡骨不愈合。PRP组有19例胫骨不愈合、8例股骨不愈合、16例肱骨不愈合、8例尺骨不愈合和9例桡骨不愈合。在我们干预之前,rhBMP - 7组和PRP组进行手术的中位次数均为2次(范围1 - 5次),rhBMP - 7组和PRP组分别有23例和21例使用了自体骨移植。rhBMP - 7组52例(86.7%)患者实现了临床和影像学愈合,而PRP组为41例(68.3%),rhBMP - 7组的临床和影像学愈合时间中位数更低(分别为3.5个月对4个月和8个月对9个月)。这项研究支持以下观点:在治疗持续性长骨不愈合时,就临床和影像学疗效而言,应用rhBMP - 7作为骨刺激剂优于PRP。
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