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重组人骨形态发生蛋白-2作为枕颈部后路器械融合术辅助剂的应用:安全性、有效性及剂量分析

Use of recombinant human bone morphogenetic protein-2 as an adjunct for instrumented posterior arthrodesis in the occipital cervical region: An analysis of safety, efficacy, and dosing.

作者信息

Hamilton D Kojo, Smith Justin S, Reames Davis L, Williams Brian J, Shaffrey Christopher I

机构信息

Department of Neurosurgery, University of Maryland School of Medicine, Baltimore, Maryland.

出版信息

J Craniovertebr Junction Spine. 2010 Jul;1(2):107-12. doi: 10.4103/0974-8237.77674.

DOI:10.4103/0974-8237.77674
PMID:21572631
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3075826/
Abstract

BACKGROUND

There have been few reports on the use of recombinant human bone morphogenetic protein (rhBMP)-2 in posterior spine. However, no study has investigated the dosing, safety, and efficacy of its use in the posterior atlantoaxial, and/or craniovertebral junction. Recent case report of the cytokine-mediated inflammatory reaction, following off label use of rhBMP-2 as an adjunct for cervical fusion, particularly in complex cases, has increased concern about complications associated with the product.

OBJECTIVE

To assess the safety, efficacy, and dosing of rhBMP-2 as an adjunct for instrumented posterior atlantoaxial and/or craniovertebral junction arthrodesis.

MATERIALS AND METHODS

We included all patients treated by the senior author that included posterior atlantoaxial and/or craniovertebral junction instrumented fusion using rhBMP-2 from 2003 to 2008 with a minimum two year follow-up. Diagnosis, levels fused, rhBMP-2 dose, complications, and fusion were assessed.

RESULTS

Twenty three patients with a mean age of 60.9 years (range 4 - 89 years) and an average follow-up of 45 months (range 27 to 84 months) met inclusion criteria. The indications for surgery included, atlantoaxial instability (n = 16), basilar invagination (n = 6), and kyphoscoliosis (n = 1). The specific pathologic diagnosis included type 2 dens fracture (n = 7), complex C1 and C2 ring fracture (n = 2), chordoma (n = 2), degenerative/osteoporosis (n = 3), rheumatoid disease (n = 8), and pseudogout (n = 1). The average rhBMP-2 dose was 2.38 mg/level, with a total of 76 levels treated (average 3.3 levels, SD= 1.4 levels). There were no complications. During the most recent follow-up, all patients had achieved fusion.

CONCLUSIONS

In a series of patients with complex pathology and/or rheumatoid arthritis, 100% fusion rate was achieved with adjunct use of rhBMP-2, with a safe and effective average rhBMP-2 dose of 2.38 mg per level.

摘要

背景

关于重组人骨形态发生蛋白(rhBMP)-2在后路脊柱手术中的应用报道较少。然而,尚无研究探讨其在寰枢椎后路和/或颅颈交界区使用的剂量、安全性及有效性。近期有病例报告称,rhBMP-2在颈椎融合术中超适应证使用(尤其是在复杂病例中)后出现细胞因子介导的炎症反应,这增加了人们对该产品相关并发症的担忧。

目的

评估rhBMP-2作为后路寰枢椎和/或颅颈交界区器械辅助融合术辅助用药的安全性、有效性及剂量。

材料与方法

纳入2003年至2008年间由资深作者治疗的所有患者,这些患者接受了使用rhBMP-2的后路寰枢椎和/或颅颈交界区器械辅助融合术,且随访时间至少为两年。评估诊断情况、融合节段、rhBMP-2剂量、并发症及融合情况。

结果

23例患者符合纳入标准,平均年龄60.9岁(范围4 - 89岁),平均随访45个月(范围27至84个月)。手术适应证包括寰枢椎不稳(n = 16)、基底凹陷(n = 6)和脊柱侧凸(n = 1)。具体病理诊断包括Ⅱ型齿状突骨折(n = 7)、C1和C2复杂环形骨折(n = 2)、脊索瘤(n = 2)、退行性变/骨质疏松(n = 3)、类风湿病(n = 8)和假性痛风(n = 1)。rhBMP-2平均剂量为2.38 mg/节段,共治疗76个节段(平均3.3个节段,标准差= 1.4个节段)。未出现并发症。在最近一次随访时,所有患者均实现融合。

结论

在一系列患有复杂病理情况和/或类风湿关节炎的患者中,联合使用rhBMP-2实现了100%的融合率,rhBMP-2平均剂量为2.38 mg/节段,安全有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f05/3075826/58e68537ef83/JCVJS-1-107-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f05/3075826/ab0a8ff33bd6/JCVJS-1-107-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f05/3075826/d3709f204b40/JCVJS-1-107-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f05/3075826/b894bc165624/JCVJS-1-107-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f05/3075826/58e68537ef83/JCVJS-1-107-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f05/3075826/ab0a8ff33bd6/JCVJS-1-107-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f05/3075826/d3709f204b40/JCVJS-1-107-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f05/3075826/b894bc165624/JCVJS-1-107-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f05/3075826/58e68537ef83/JCVJS-1-107-g007.jpg

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