Goode Adam P, Richardson William J, Schectman Robin M, Carey Timothy S
Department of Community and Family Medicine, Duke University School of Medicine, 2200 West Main Street, Durham, NC 27705, USA.
Department of Orthopedics, Duke University School of Medicine, 3077 Durham, NC 27710, USA.
Spine J. 2014 Sep 1;14(9):2051-9. doi: 10.1016/j.spinee.2013.11.042. Epub 2013 Dec 7.
Nationwide estimates examining bone morphogenetic protein (BMP) use with cervical spine fusions have been limited to perioperative outcomes.
To determine the 1-year risk of complications, cervical revision fusions, hospital readmissions, and health care services utilization.
A retrospective cohort study from 2002 to 2009 using a nationwide claims database.
There were 61,937 primary cervical spine fusions of which 1,677 received BMP.
Complications, revision fusions, 30-day hospital readmission, and health care utilization.
Data for these analyses come from the Thomson Reuters MarketScan Commercial Claims and Encounters Database 2010. Patients were aged 18 to 64 years, receiving and not receiving BMP with a primary (C2-C7) cervical spine fusion. All outcomes were defined by International Classification of Diseases, 9th edition Clinical Modification and Current Procedural and Terminology, 4th edition codes. Complications were analyzed as any complication and stratified by nervous system, wound, and dysphagia or hoarseness. Cervical revision fusions were determined in the 1-year follow-up. Hospital readmission discharge records defined 30-day hospital readmission and reason for the readmission. The utilization of at least one health care service of cervical spine imaging, epidural usage or rehabilitation service was examined. Poisson regression models were used to estimate the relative risk and 95% confidence interval (CI). Linear regression was used to determine the time to hospital readmission. Results were stratified by anterior or posterior and circumferential approaches.
Patients receiving BMP were 29% more likely to have a complication (adjusted relative risk [aRR]=1.29 [95% CI, 1.14-1.46]) and a nervous system complication (aRR=1.42 [95% CI, 1.10-1.83]). Cervical revision fusions were more likely among patients receiving BMP (aRR=1.69 [95% CI, 1.35-2.13]). The risk of 30-day readmission was greater with BMP use (aRR=1.37 [95% CI, 1.07-1.73]) and readmission occurred 27.4% sooner on an average. Patients receiving BMP were more likely to receive computed tomography scans (aRR=1.34 [95% CI, 1.06-1.70]) and epidurals with anterior surgical approaches (aRR=1.29 [95% CI, 1.00-1.65]).
These findings question both the safety and effectiveness of off-label BMP use in primary cervical spine fusions.
全国范围内关于在颈椎融合手术中使用骨形态发生蛋白（BMP）的评估仅限于围手术期结果。
确定并发症、颈椎翻修融合术、再次入院以及医疗服务利用的1年风险。
一项2002年至2009年的回顾性队列研究，使用全国索赔数据库。
共有61937例初次颈椎融合手术，其中1677例使用了BMP。
并发症、翻修融合术、30天再次入院以及医疗服务利用情况。
这些分析的数据来自汤森路透市场扫描商业索赔和会诊数据库2010。患者年龄在18至64岁之间，接受或未接受BMP进行初次（C2 - C7）颈椎融合手术。所有结果均根据国际疾病分类第9版临床修订版和当前程序与术语第4版代码进行定义。并发症按任何并发症进行分析，并按神经系统、伤口以及吞咽困难或声音嘶哑进行分层。在1年随访中确定颈椎翻修融合术。医院再次入院出院记录定义了30天再次入院情况及再次入院原因。检查了至少使用一种颈椎成像、硬膜外用药或康复服务的医疗服务利用情况。使用泊松回归模型估计相对风险和95%置信区间（CI）。使用线性回归确定再次入院时间。结果按前路或后路及环形手术入路进行分层。
接受BMP的患者发生并发症的可能性高29%（调整后相对风险[aRR]=1.29 [95% CI，1.14 - 1.46]）以及发生神经系统并发症的可能性高（aRR=1.42 [95% CI，1.10 - 1.83]）。接受BMP的患者更有可能进行颈椎翻修融合术（aRR=1.69 [95% CI，1.35 - 2.13]）。使用BMP时30天再次入院风险更大（aRR=1.37 [95% CI，1.07 - 1.73]），且再次入院平均提前27.4%发生。接受BMP的患者更有可能接受计算机断层扫描（aRR=1.34 [95% CI，1.06 - 1.70]）以及在前路手术入路时接受硬膜外用药（aRR=1.29 [95% CI，1.00 - 1.65]）。
这些发现对在初次颈椎融合手术中使用BMP的安全性和有效性提出了质疑。
