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膝关节骨髓浓缩术(bone marrow concentrate procedures)后静脉血栓栓塞症的发生率:我们是否应该抗凝?

The rate of venous thromboembolism after knee bone marrow concentrate procedures: should we anticoagulate?

机构信息

Centeno-Schultz Clinic, Broomfield, CO, USA.

Regenexx, LLC, Research and Development, Broomfield, CO, USA.

出版信息

Int Orthop. 2022 Oct;46(10):2213-2218. doi: 10.1007/s00264-022-05500-3. Epub 2022 Jul 18.

Abstract

PURPOSE

Intra-articular injections of autologous, minimally manipulated, cell therapies such as bone marrow concentrate (BMC) to treat knee osteoarthritis (OA) may delay or prevent future total knee arthroplasty (TKA). Arthroplasty has the known and substantial risk of venous thromboembolism (VTE) and requires routine prophylaxis, whereas the VTE risk associated with knee BMC injections is unknown. We report on the rate of VTE from a large orthobiologics patient registry and assess whether knee BMC procedures require routine prophylaxis.

METHODS

A retrospective analysis of knee osteoarthritis cases tracked in a treatment registry and treated at 72 clinical sites with BMC from 2007 to 2020 who were not prophylactically anticoagulated was performed to identify adverse events (AEs) associated with VTE. Treating physicians were contacted to improve discovery of possible occurrences of VTE.

RESULTS

Twenty cases (0.16%) of VTE were identified from the registry of 12,780 knee BMC treatments. These events were less frequent than the published data demonstrate for anticoagulated TKA patients.

CONCLUSION

Based on the rates of VTE from our retrospective treatment registry analysis compared to the risk of medication-induced haemorrhage, routine prophylactic anticoagulation is not recommended for intra-articular knee BMC procedures. Further research into safety and efficacy of BMC treatment for knee OA is warranted.

CLINICAL TRIAL IDENTIFIER

NCT03011398, retrospectively registered.

摘要

目的

关节内注射自体、微创处理的细胞疗法,如骨髓浓缩物 (BMC),可治疗膝关节骨关节炎 (OA),并可能延迟或预防未来的全膝关节置换术 (TKA)。关节置换术具有已知的、巨大的静脉血栓栓塞 (VTE) 风险,需要常规预防,而膝关节 BMC 注射相关的 VTE 风险尚不清楚。我们报告了来自大型骨科生物制品患者登记处的 VTE 发生率,并评估了膝关节 BMC 手术是否需要常规预防。

方法

对 2007 年至 2020 年间在 72 个临床中心接受 BMC 治疗的膝关节 OA 病例进行了回顾性分析,这些病例未预防性抗凝,以确定与 VTE 相关的不良事件 (AE)。联系治疗医生以更好地发现可能发生的 VTE。

结果

从 12780 例膝关节 BMC 治疗的登记处中发现了 20 例 (0.16%) VTE 病例。这些事件的发生率低于发表的抗凝 TKA 患者数据。

结论

基于我们回顾性治疗登记处分析的 VTE 发生率与药物诱导出血风险的比较,不建议对膝关节 BMC 关节内注射进行常规预防性抗凝。需要进一步研究 BMC 治疗膝关节 OA 的安全性和疗效。

临床试验标识符

NCT03011398,回顾性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/adde/9492566/9466305c4c97/264_2022_5500_Fig1_HTML.jpg

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