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rhBMP-2 在成人脊柱畸形手术中应用的成本-效用分析。

Cost-Utility Analysis of rhBMP-2 Use in Adult Spinal Deformity Surgery.

机构信息

Department of Orthopaedic Surgery, The Johns Hopkins University, Baltimore, MD.

Department of Orthopaedic Surgery, Baylor Scoliosis Center, Plano, TX.

出版信息

Spine (Phila Pa 1976). 2020 Jul 15;45(14):1009-1015. doi: 10.1097/BRS.0000000000003442.

Abstract

STUDY DESIGN

Economic modeling of data from a multicenter, prospective registry.

OBJECTIVE

The aim of this study was to analyze the cost utility of recombinant human bone morphogenetic protein-2 (BMP) in adult spinal deformity (ASD) surgery.

SUMMARY OF BACKGROUND DATA

ASD surgery is expensive and presents risk of major complications. BMP is frequently used off-label to reduce the risk of pseudarthrosis.

METHODS

Of 522 ASD patients with fusion of five or more spinal levels, 367 (70%) had at least 2-year follow-up. Total direct cost was calculated by adding direct costs of the index surgery and any subsequent reoperations or readmissions. Cumulative quality-adjusted life years (QALYs) gained were calculated from the change in preoperative to final follow-up SF-6D health utility score. A decision-analysis model comparing BMP versus no-BMP was developed with pseudarthrosis as the primary outcome. Costs and benefits were discounted at 3%. Probabilistic sensitivity analysis was performed using mixed first-order and second-order Monte Carlo simulations. One-way sensitivity analyses were performed by varying cost, probability, and QALY estimates (Alpha = 0.05).

RESULTS

BMP was used in the index surgery for 267 patients (73%). The mean (±standard deviation) direct cost of BMP for the index surgery was $14,000 ± $6400. Forty patients (11%) underwent revision surgery for symptomatic pseudarthrosis (BMP group, 8.6%; no-BMP group, 17%; P = 0.022). The mean 2-year direct cost was significantly higher for patients with pseudarthrosis ($138,000 ± $17,000) than for patients without pseudarthrosis ($61,000 ± $25,000) (P < 0.001). Simulation analysis revealed that BMP was associated with positive incremental utility in 67% of patients and considered favorable at a willingness-to-pay threshold of $150,000/QALY in >52% of patients.

CONCLUSION

BMP use was associated with reduction in revisions for symptomatic pseudarthrosis in ASD surgery. Cost-utility analysis suggests that BMP use may be favored in ASD surgery; however, this determination requires further research.

LEVEL OF EVIDENCE

摘要

研究设计

来自多中心前瞻性注册研究的数据经济建模。

目的

本研究旨在分析重组人骨形态发生蛋白-2(BMP)在成人脊柱畸形(ASD)手术中的成本效用。

背景数据概要

ASD 手术费用昂贵,并存在发生重大并发症的风险。BMP 常被超适应证使用以降低假关节形成的风险。

方法

在 522 例接受 5 个或更多脊柱节段融合的 ASD 患者中,367 例(70%)具有至少 2 年的随访。总直接成本通过将索引手术的直接成本与任何后续的再次手术或再次入院的成本相加来计算。通过术前到最终随访的 SF-6D 健康效用评分的变化来计算累计质量调整生命年(QALY)。建立了一个比较 BMP 与无 BMP 的决策分析模型,以假关节形成为主要结局。成本和效益按 3%贴现。使用混合一阶和二阶蒙特卡罗模拟进行概率敏感性分析。通过改变成本、概率和 QALY 估计值(Alpha=0.05)进行单向敏感性分析。

结果

在索引手术中,267 例患者(73%)使用了 BMP。BMP 索引手术的平均(±标准差)直接成本为 14000 美元±6400 美元。40 例患者(11%)因症状性假关节形成而行翻修手术(BMP 组 8.6%;无 BMP 组 17%;P=0.022)。假关节形成患者的 2 年直接成本明显高于无假关节形成患者(138000 美元±17000 美元比 61000 美元±25000 美元)(P<0.001)。模拟分析显示,BMP 与 67%患者的增量效用相关,在 52%以上的患者中,BMP 被认为在 150000 美元/QALY 的支付意愿阈值下是有利的。

结论

BMP 的使用与 ASD 手术中因症状性假关节形成而行翻修手术的减少有关。成本效用分析表明,BMP 的使用可能在 ASD 手术中受到青睐;然而,这一结论需要进一步研究。

证据水平

2 级。

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