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自体软骨细胞移植的成本效益分析:骨膜贴片与 I/III 型胶原膜的比较。

Cost-effectiveness analysis of autologous chondrocyte implantation: a comparison of periosteal patch versus type I/III collagen membrane.

机构信息

Department of Orthopaedic Surgery and Rehabilitation, University of Nebraska Medical Center, 981080 Nebraska Medical Center, Omaha, NE 68198-1080, USA.

出版信息

Am J Sports Med. 2012 Jun;40(6):1252-8. doi: 10.1177/0363546512441586. Epub 2012 Apr 5.

Abstract

BACKGROUND

Autologous chondrocyte implantation (ACI) involves the use of a periosteal patch (ACI-P) as a cover for transplanted chondrocytes. Theoretically, this periosteal patch provides mesenchymal stem cells and growth factors that encourage chondrocyte development/differentiation. However, there is a significant rate of graft hypertrophy with the use of periosteum compared with using a type I/III collagen patch (ACI-C). This type I/III collagen patch, although not approved by the United States Food and Drug Administration for ACI, has been used extensively in Europe and in an "off-label" nature in the United States as a cover during ACI.

PURPOSE

To examine the cost effectiveness of ACI and determine whether ACI-C is more cost effective than ACI-P.

STUDY DESIGN

Economic and decision analysis; Level of evidence, 2.

METHODS

Outcome data and complication rates from patients undergoing ACI (ACI-P and ACI-C) were derived from the best evidence in the literature. Costs were determined by examining the typical patient charges undergoing ACI at a local orthopaedic hospital. The costs, results, and complication rates were used to develop a decision analysis model comparing ACI-P to ACI-C.

RESULTS

The cost of ACI-P was $66,752 and for ACI-C was $66,939.50 ($187.50 difference). The cost per quality-adjusted life year (QALY) for ACI-P was $9466 compared with $9243 for ACI-C. Sensitivity analysis was performed regarding the additional cost of the type I/III collagen patch ($780) in ACI-C as well as the rate of graft hypertrophy after ACI-P (25%). This analysis revealed that the cost of the type I/III collagen patch would have to reach $1721, or the rate of graft hypertrophy after ACI-P reduced to almost 11%, before ACI-P became more cost effective than ACI-C.

CONCLUSION

This cost-effectiveness analysis reveals that, while both ACI-P and ACI-C are cost effective, ACI-C is slightly more cost effective than ACI-P. This is likely secondary to the significant rate of patch-related complications associated with ACI-P, which is significantly reduced with ACI-C. Although the model is very sensitive to differences in outcomes between ACI-P and ACI-C, there is no high-quality evidence to suggest that there is a significant difference between the two. Thus, ACI-P becomes more cost effective if the cost of the type I/III collagen membrane is significantly increased or if the rate of graft hypertrophy after ACI-P were to be markedly reduced.

摘要

背景

自体软骨细胞移植(ACI)涉及使用骨膜贴片(ACI-P)作为移植软骨细胞的覆盖物。理论上,这种骨膜贴片提供间充质干细胞和生长因子,可促进软骨细胞的发育/分化。然而,与使用 I/III 型胶原贴(ACI-C)相比,使用骨膜的移植物肥大率显著增高。尽管这种 I/III 型胶原贴未获得美国食品和药物管理局(FDA)批准用于 ACI,但在欧洲已广泛使用,并以“超适应证”的方式在美国作为 ACI 的覆盖物使用。

目的

探讨 ACI 的成本效益,并确定 ACI-C 是否比 ACI-P 更具成本效益。

研究设计

经济和决策分析;证据等级,2 级。

方法

从文献中最佳证据中获得接受 ACI(ACI-P 和 ACI-C)治疗的患者的结局数据和并发症发生率。通过检查当地骨科医院接受 ACI 治疗的典型患者费用来确定成本。使用成本、结果和并发症发生率来开发比较 ACI-P 与 ACI-C 的决策分析模型。

结果

ACI-P 的成本为 66752 美元,ACI-C 的成本为 66939.50 美元(相差 187.50 美元)。ACI-P 的每质量调整生命年(QALY)成本为 9466 美元,而 ACI-C 的成本为 9243 美元。针对 ACI-C 中 I/III 型胶原贴的额外成本(780 美元)以及 ACI-P 后移植物肥大率(25%)进行了敏感性分析。该分析表明,只有当 I/III 型胶原贴的成本达到 1721 美元,或者 ACI-P 后移植物肥大率降低至近 11%,ACI-P 才会比 ACI-C 更具成本效益。

结论

这项成本效益分析表明,尽管 ACI-P 和 ACI-C 均具有成本效益,但 ACI-C 略优于 ACI-P。这可能是由于 ACI-P 与移植物相关的并发症发生率较高,而 ACI-C 则显著降低了这种并发症。尽管该模型对 ACI-P 和 ACI-C 之间的结局差异非常敏感,但没有高质量的证据表明两者之间存在显著差异。因此,如果 I/III 型胶原膜的成本显著增加,或者 ACI-P 后移植物肥大率显著降低,ACI-P 会更具成本效益。

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