Stiel Norbert, Hissnauer Tim N, Rupprecht Martin, Babin Kornelia, Schlickewei Carsten W, Rueger Johannes M, Stuecker Ralf, Spiro Alexander S
Department of Trauma-, Hand-, and Reconstructive Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Department of Pediatric Orthopaedic Surgery, Children's Hospital, Hamburg-Altona, Germany.
J Mater Sci Mater Med. 2016 Dec;27(12):184. doi: 10.1007/s10856-016-5800-8. Epub 2016 Oct 27.
The off-label use of recombinant human bone morphogenetic protein-2 to promote bone healing in adults has significantly increased in recent years, while reports of recombinant human bone morphogenetic protein-2 application in children and adolescents are very rare. The aim of this study was to evaluate the safety of single and repetitive recombinant human bone morphogenetic protein-2 use in pediatric orthoapedics. Therefore we reviewed the medical records of 39 patients who had been treated with recombinant human bone morphogenetic protein-2 at our institution. Their mean age was 10.9 years. Recombinant human bone morphogenetic protein-2 was used in 17 patients for spine fusion, in 11 patients for the treatment of congenital pseudarthrosis of the tibia or tibial nonunion, in 5 patients for the management of femoral nonunion, in 5 patients for nonunions at other locations, and in 1 case for tibial shortening. Special attention was paid to identify all adverse events that may be attributed to recombinant human bone morphogenetic protein-2 use, including local inflammatory reactions, allergic reactions, systemic toxicity, excessive wound swelling, hematoma, compartment syndrome, infection, heterotopic ossification, excessive bone growth, carcinogenicity, and the consequences of repeated applications of recombinant human bone morphogenetic protein-2. Follow-up was a mean of 39 months. Forty-six operations with application of rhBMP-2 were performed. Complications that may be due to application of recombinant human bone morphogenetic protein-2 were seen after 18 operations including swelling, increase in temperature, wound secretion, redness and hyperthermia. We consider the three cases of necessary revisions, one due to hematoma, one due to development of a compartment syndrome, and one due to deep infection, to be the only complications related to the use of recombinant human bone morphogenetic protein-2. In conclusion, we found few complications attributable to application of recombinant human bone morphogenetic protein-2 in pediatric patients.
近年来，重组人骨形态发生蛋白-2在成人中用于促进骨愈合的非标签使用显著增加，而关于重组人骨形态发生蛋白-2在儿童和青少年中应用的报道却非常罕见。本研究的目的是评估在小儿骨科单次和重复使用重组人骨形态发生蛋白-2的安全性。因此，我们回顾了在我们机构接受重组人骨形态发生蛋白-2治疗的39例患者的病历。他们的平均年龄为10.9岁。17例患者使用重组人骨形态发生蛋白-2进行脊柱融合，11例患者用于治疗先天性胫骨假关节或胫骨骨不连，5例患者用于治疗股骨骨不连，5例患者用于治疗其他部位的骨不连，1例患者用于治疗胫骨缩短。我们特别关注识别所有可能归因于重组人骨形态发生蛋白-2使用的不良事件，包括局部炎症反应、过敏反应、全身毒性、伤口过度肿胀、血肿、骨筋膜室综合征、感染、异位骨化、过度骨生长、致癌性以及重组人骨形态发生蛋白-2重复应用的后果。平均随访39个月。共进行了46次应用rhBMP-2的手术。18次手术后出现了可能归因于重组人骨形态发生蛋白-2应用的并发症，包括肿胀、体温升高、伤口分泌物、发红和发热。我们认为3例必要的翻修手术，1例因血肿，1例因骨筋膜室综合征的发生，1例因深部感染，是与重组人骨形态发生蛋白-2使用相关的唯一并发症。总之，我们发现在儿科患者中，重组人骨形态发生蛋白-2应用引起的并发症很少。
