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开发一种风险评分系统,以指导重组人骨形态发生蛋白-2(rhBMP-2)在成人脊柱畸形手术中的应用。

Developing a risk score to inform the use of rhBMP-2 in adult spinal deformity surgery.

作者信息

Williamson Tyler K, Onafowokan Oluwatobi O, Schoenfeld Andrew J, Robertson Djani, Owusu-Sarpong Stephane, Lebovic Jordan, Yung Anthony, Fisher Max R, Cottrill Ethan J, Diebo Bassel G, Lafage Renaud, Lafage Virginie, Crutcher Clifford L, Daniels Alan H, Passias Peter G

机构信息

Department of Orthopaedic Surgery, Duke University Medical Center, 2301 Erwin Road, Durham, NC, 27710, USA.

Department of Orthopaedic Surgery, University of Texas Health San Antonio, San Antonio, TX, USA.

出版信息

Spine Deform. 2025 Jan;13(1):231-239. doi: 10.1007/s43390-024-00946-4. Epub 2024 Aug 11.

DOI:10.1007/s43390-024-00946-4
PMID:39127991
Abstract

BACKGROUND

Recombinant human bone morphogenetic protein-2 (rhBMP-2) has not shown superior benefit overall in cost-effectiveness during adult spinal deformity (ASD) surgery.

STUDY DESIGN/SETTING: Retrospective PURPOSE: Generate a risk score for pseudarthrosis to inform the utilization of rhBMP-2, balancing costs against quality of life and complications.

METHODS

ASD patients with 3-year data were included. Quality of life gained was calculated from ODI to SF-6D and translated to quality-adjusted life years (QALYs). Cost was calculated using the PearlDiver database and CMS definitions for complications and comorbidities. Established weights were generated for predictive variables via logistic regression to yield a predictive risk score for pseudarthrosis that accounted for frailty, diabetes, depression, ASA grade, thoracolumbar kyphosis and three-column osteotomy use. Risk score categories, established via conditional inference tree (CIT)-derived thresholds were tested for cost-utility of rhBMP-2 usage, controlling for age, prior fusion, and baseline deformity and disability.

RESULTS

64% of ASD patients received rhBMP-2 (308/481). There were 17 (3.5%) patients that developed pseudarthrosis. rhBMP-2 use overall did not lower pseudarthrosis rates (OR: 0.5, [0.2-1.3]). Pseudarthrosis rates for each risk category were: No Risk (NoR) 0%; Low-Risk (LowR) 1.6%; Moderate Risk (ModR) 9.3%; High-Risk (HighR) 24.3%. Patients receiving rhBMP-2 had similar QALYs overall to those that did not (0.163 vs. 0.171, p = .65). rhBMP-2 usage had worse cost-utility in the LowR cohort (p < .001). In ModR patients, rhBMP-2 usage had equivocal cost-utility ($53,398 vs. $61,581, p = .232). In the HighR cohort, the cost-utility was reduced via rhBMP-2 usage ($98,328 vs. $211,091, p < .001).

CONCLUSION

Our study shows rhBMP-2 demonstrates effective cost-utility for individuals at high risk for developing pseudarthrosis. The generated score can aid spine surgeons in the assessment of risk and enhance justification for the strategic use of rhBMP-2 in the appropriate clinical contexts.

LEVEL OF EVIDENCE

III.

摘要

背景

重组人骨形态发生蛋白-2(rhBMP-2)在成人脊柱畸形(ASD)手术的成本效益方面总体未显示出更大优势。

研究设计/设置:回顾性研究

目的

生成假关节形成的风险评分,以指导rhBMP-2的使用,平衡成本与生活质量及并发症。

方法

纳入有3年数据的ASD患者。从脊柱功能障碍指数(ODI)到SF-6D计算获得的生活质量,并转化为质量调整生命年(QALY)。使用PearlDiver数据库和医疗保险与医疗补助服务中心(CMS)对并发症和合并症的定义计算成本。通过逻辑回归为预测变量生成既定权重,以得出假关节形成的预测风险评分,该评分考虑了身体虚弱、糖尿病、抑郁症、美国麻醉医师协会(ASA)分级、胸腰椎后凸以及三柱截骨术的使用情况。通过条件推断树(CIT)得出的阈值确定风险评分类别,测试rhBMP-2使用的成本效益,同时控制年龄、既往融合情况以及基线畸形和残疾情况。

结果

64%的ASD患者接受了rhBMP-2(308/481)。有17例(3.5%)患者发生了假关节形成。总体而言,使用rhBMP-2并未降低假关节形成率(比值比:0.5,[0.2 - 1.3])。各风险类别的假关节形成率分别为:无风险(NoR)0%;低风险(LowR)1.6%;中度风险(ModR)9.3%;高风险(HighR)24.3%。接受rhBMP-2的患者总体QALY与未接受者相似(0.163对0.171,p = 0.65)。在低风险队列中,rhBMP-2的使用具有更差的成本效益(p < 0.001)。在中度风险患者中,rhBMP-2的使用成本效益不明确(53,398美元对61,581美元,p = 0.232)。在高风险队列中,rhBMP-2的使用降低了成本效益(98,328美元对211,091美元,p < 0.001)。

结论

我们的研究表明,rhBMP-2对有假关节形成高风险的个体显示出有效的成本效益。生成的评分可帮助脊柱外科医生评估风险,并加强在适当临床背景下战略性使用rhBMP-2的合理性。

证据级别

III级

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