Sayama Christina, Willsey Matthew, Chintagumpala Murali, Brayton Alison, Briceño Valentina, Ryan Sheila L, Luerssen Thomas G, Hwang Steven W, Jea Andrew
Neuro-Spine Program, Division of Pediatric Neurosurgery, and.
Department of Neurosurgery, Baylor College of Medicine, Houston, Texas;
J Neurosurg Pediatr. 2015 Jul;16(1):4-13. doi: 10.3171/2014.10.PEDS14199. Epub 2015 Apr 10.
OBJECT The aim of this study was to determine the safety of recombinant human bone morphogenetic protein-2 (rhBMP-2) use in posterior instrumented fusions in the pediatric population, focusing on cancer risk. In a previous study, the authors reported the short-term (mean follow-up of 11 months) safety and efficacy of rhBMP-2 in the pediatric age group. The present study reports their results with a minimum of 24 months' follow-up. METHODS The authors retrospectively reviewed 57 consecutive cases involving pediatric patients who underwent posterior occiptocervical, cervical, thoracic, lumbar, or lumbosacral spine fusion from October 1, 2007, to June 30, 2011, at Texas Children's Hospital. Seven cases were excluded from further analysis because of loss to follow-up. Three patients died during the follow-up period and were placed in a separate cohort. RESULTS The patients' average age at the time of surgery was 11 years, 4 months (range 9 months to 20 years). The mean duration of follow-up was 48.4 months (range 24-70 months). Cancer status was determined at the most recent encounter with the patient and/or caretaker(s) in person, or in telephone follow-up. Twenty-four or more months after administration of rhBMP-2, there were no cases of new malignancy, degeneration, or metastasis of existing tumors. The cause of death of the patients who died during the study period was not related to BMP or to the development, degeneration, or metastasis of cancer. CONCLUSIONS Despite the large number of adult studies reporting increased cancer risk associated with BMP use, the authors' outcomes with rhBMP-2 in the pediatric population suggest that it is a safe adjunct to posterior spine fusions of the occipitocervical, cervical, thoracic, lumbar, and lumbosacral spine. There were no new cases of cancer, or degeneration or metastasis of existing malignancies in this series.
目的 本研究的目的是确定重组人骨形态发生蛋白-2（rhBMP-2）在儿科患者后路器械融合术中使用的安全性，重点关注癌症风险。在先前的一项研究中，作者报告了rhBMP-2在儿科年龄组中的短期（平均随访11个月）安全性和有效性。本研究报告了他们至少随访24个月的结果。方法 作者回顾性分析了2007年10月1日至2011年6月30日在德克萨斯儿童医院接受后路枕颈、颈椎、胸椎、腰椎或腰骶椎融合术的57例儿科患者的连续病例。7例因失访而被排除在进一步分析之外。3例患者在随访期间死亡，并被纳入一个单独的队列。结果 患者手术时的平均年龄为11岁4个月（范围9个月至20岁）。平均随访时间为48.4个月（范围24 - 70个月）。通过亲自与患者和/或看护人最近一次接触或电话随访来确定癌症状态。给予rhBMP-2 24个月或更长时间后，没有新的恶性肿瘤、现有肿瘤退变或转移的病例。研究期间死亡的患者的死亡原因与BMP或癌症的发生、退变或转移无关。结论 尽管大量成人研究报告称使用BMP会增加癌症风险，但作者在儿科人群中使用rhBMP-2的结果表明，它是枕颈、颈椎、胸椎、腰椎和腰骶椎后路脊柱融合术的一种安全辅助手段。本系列中没有新的癌症病例，也没有现有恶性肿瘤的退变或转移。
