Dimitriou R, Dahabreh Z, Katsoulis E, Matthews S J, Branfoot T, Giannoudis P V
St. James's University Hospital, Beckett Street, Leeds LS9 7TF, UK.
Injury. 2005 Nov;36 Suppl 4:S51-9. doi: 10.1016/j.injury.2005.10.010.
The purpose of this study was to evaluate the efficacy and safety of recombinant bone morphogenetic protein 7 (rhBMP-7 or OP-1) as a bone-stimulating agent in the treatment of persistent fracture non-unions. Twenty-five consecutive patients [19 males, mean age 39.4 years (range: 18-79)] with 26 fracture non-unions were treated with rhBMP-7. There were 10 tibial non-unions, eight femoral, three humeral, three ulnar, one patellar, and one clavicular non-union. The mean follow-up was 15.3 months. The mean number of operations performed prior to rhBMP-7 application was 3.2, with autologous bone graft and bone marrow injection being used in 10 cases (38.5%). Both clinical and radiological union occurred in 24 (92.3%) cases, within a mean time of 4.2 months and 5.6 months, respectively. Of the remaining two cases, one patient ultimately underwent a below knee amputation, secondary to recurrence of deep sepsis. The other patient with recalcitrant ulnar non-union although the radiological union was incomplete, declined further intervention, as he was asymptomatic. No complications or adverse effects from the use of rhBMP-7 were encountered. This study supports the view that the application of rhBMP-7 as a bone-stimulating agent is safe and a power adjunct to be considered in the surgeon's armamentarium for the treatment of these challenging clinical conditions.
本研究的目的是评估重组骨形态发生蛋白7（rhBMP-7或OP-1）作为一种骨刺激剂在治疗持续性骨折不愈合中的疗效和安全性。连续25例患者[19例男性，平均年龄39.4岁（范围：18 - 79岁）]共26处骨折不愈合接受了rhBMP-7治疗。其中有10例胫骨不愈合、8例股骨不愈合、3例肱骨不愈合、3例尺骨不愈合、1例髌骨不愈合和1例锁骨不愈合。平均随访时间为15.3个月。在应用rhBMP-7之前平均进行的手术次数为3.2次，10例（38.5%）使用了自体骨移植和骨髓注射。24例（92.3%）患者实现了临床和影像学愈合，平均时间分别为4.2个月和5.6个月。其余2例中，1例患者因深部脓毒症复发最终接受了膝下截肢。另1例尺骨顽固性不愈合患者，尽管影像学愈合不完全，但由于无症状而拒绝进一步干预。未发现使用rhBMP-7的并发症或不良反应。本研究支持以下观点，即应用rhBMP-7作为骨刺激剂是安全的，并且是外科医生在治疗这些具有挑战性的临床病症时可考虑的有力辅助手段。
