骨形态发生蛋白在腰椎融合中作用的临床证据_《中国循证医学杂志》

作者：

刘熹 ¹ , 舒德芬 ² , 李涛 ¹ ,  刘浩 ¹

1. 四川大学华西医院骨科（成都 610041）；2. 四川大学华西医院老年科（成都 610041）;

关键词：

骨形态发生蛋白脊柱融合腰椎成本- 效果分析

DOI：

10.7507/1672-2531.20080176

视频：

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摘要 全文 图表 视频 参考文献 施引文献 补充材料

目的　探讨骨形态发生蛋白应用于腰椎融合术的效果、成本及最佳应用方案。
方法　按照PICO 原则，针对患者的临床问题，计算机检索ACP Journal Club（1991 ～ 2008.2）、Cochrane 图书馆（2007 年第4 期）、PubMed（1990 ～ 2008.2）及其他相关数据库，收集关于骨形态发生蛋白临床应用的系统评价、临床随机对照试验及卫生经济学评价等，并对所获证据质量进行评价。
结果　现有证据显示骨形态发生蛋白用于腰椎前路椎体间融合和后外侧融合具有良好的诱导融合效果，其安全性等于或高于自体髂骨，产生的直接成本与自体髂骨相当。目前用于临床的骨形态发生蛋白种类为BMP-2 和BMP-7，推荐用法为前路椎体间融合使用固定搭配的成品，后外侧融合BMP-2 每侧20 mg，BMP-7 每侧3.5 mg，载体类型根据融合方式有所不同。
结论　国内可尝试引进骨形态发生蛋白用于腰椎融合手术。但要广泛应用于临床还需要专门针对国人的大规模高质量临床随机对照研究作为依据，同时也需要进一步的研究来确定用于国人的最佳剂量和剂型。

引用本文： 刘熹,舒德芬,李涛,刘浩. 骨形态发生蛋白在腰椎融合中作用的临床证据. 中国循证医学杂志, 2008, 08(9): 786-790. doi: 10.7507/1672-2531.20080176 复制

1.	Boden SD. Overview of biology of lumbar spine fusion and principles for selecting a bone graft substitute. Spine, 2002, 27(16 Suppl 1): 26-31.
2.	Helm GA, Dayoub H, Jane JA Jr. Bone graft substitutes for the promotion of spinal arthrodesis. Neurosurg Focus, 2001, 10(4): E4.
3.	Vaccaro AR, Chiba K, Heller JG, et al. Bone grafting alternatives in spinal surgery. Spine J, 2002, 2(3): 206-215.
4.	Guyatt GH, Rennie D. The evidence-based medicine working group. Users’ guides to the medical literature: A manual for evidence-based clinical practice. Chicago: AMA Press, 2002.
5.	Burkus JK, Heim SE, Gornet MF, et al. Is INFUSE bone graft superior to autograft bone? An integrated analysis of clinical trials using the LT-CAGE lumbar tapered fusion device. J Spinal Disord Tech, 2003, 16(2): 113-122.
6.	Garrison KR, Donell S, Ryder J, et al. Clinical effectiveness and cost effectiveness of bone morphogenetic proteins in the non-heal ing of fractures and spinal fusion: a systematic review. Health Technol Assess, 2007, 11(30): 1-150, iii-iv.
7.	Boden SD, Zdebl ick TA, Sandhu HS, et al. The use of rhBMP-2 in interbody fusion cages. Definitive evidence of osteoinduction in humans: a preliminary report. Spine, 2000, 25(3): 376-381.
8.	Dimar JR, Glassman SD, Burkus KJ, et al. Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/ compression resistant matrix versus iliac crest bone graft. Spine, 2006, 31(22): 2534-2539; discussion 2540.
9.	Glassman SD, Dimar JR, Carreon LY, et al. Initial fusion rates with recombinant human bone morphogenetic protein-2/compression resistant matrix and a hydroxyapatite and tricalcium phosphate/ collagen carrier in posterolateral spinal fusion. Spine, 2005, 30(15): 1694-1698.
10.	Vaccaro AR, Patel T, Fischgrund J, et al. A pilot study evaluating the safety and efficacy of OP-1 Putty (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis for degenerative spondylolisthesis. Spine, 2004, 29(17): 1885-1892.
11.	Kanayama M, Hashimoto T, Shigenobu K, et al. A prospective randomized study of posterolateral lumbar fusion using osteogenic protein-1 (OP-1) versus local autograft with ceramic bone substitute: emphasis of surgical exploration and histologic assessment. Spine, 2006, 31(10): 1067-1074.
12.	Johnsson R, Stromqvist B, Aspenberg P. Randomized radiostereometric study comparing osteogenic protein-1 (BMP-7) and autograft bone in human noninstrumented posterolateral lumbar fusion: 2002 Volvo Award in clinical studies. Spine, 2002, 27(23): 2654-2661.
13.	Vaccaro AR, Anderson DG, Patel T, et al. Comparison of OP-1 Putty (rhBMP-7) to iliac crest autograft for posterolateral lumbar arthrodesis: a minimum 2-year follow-up pilot study. Spine, 2005, 30(24): 2709-2716.
14.	Haid RW Jr, Branch CL Jr, Alexander JT, et al. Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages. Spine J, 2004, 4(5): 527-38; discussion 538-539.
15.	Burkus JK, Gornet MF, Dickman CA, et al. Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages. J Spinal Disord Tech, 2002, 15(5): 337-349.
16.	Burkus JK, Sandhu HS, Gornet MF. Influence of rhBMP-2 on the heal ing patterns associated with allograft interbody constructs in comparison with autograft. Spine, 2006, 31(7): 775-781.
17.	Burkus JK, Transfeldt EE, Kitchel SH, et al. Clinical and radiographic outcomes of anterior lumbar interbody fusion using recombinant human bone morphogenetic protein-2. Spine, 2002, 27(21): 2396-2408.
18.	Burkus JK, Dorchak JD, Sanders DL. Radiographic assessment of interbody fusion using recombinant human bone morphogenetic protein type 2. Spine, 2003, 28(4): 372-377.
19.	Coric D, Fischgrund JS, Patel T, et al. 772 Two-year follow-up on patients in a pilot safety and efficacy study of OP-1 (rhBMP-7) in posterolateral lumbar fusion as a replacement for iliac crest autograft neurological surgeons. Neurosurg, 2004, 55(2): 477.
20.	Ackerman SJ, Mafilios MS, Polly DW. Economic evaluation of bone morphogenetic protein versus autogenous iliac crest bone graft in single-level anterior lumbar fusion: an evidence-based model ing approach. Spine, 2002, 27(16 Suppl 1): S94-99.
21.	Anand N, Hamilton JF, Perri B, et al. Cantilever TLIF with structural allograft and RhBMP2 for correction and maintenance of segmental sagittal lordosis: long-term clinical, radiographic, and functional outcome. Spine, 2006, 31(20): E748-753.
22.	Mummaneni PV, Pan J, Haid RW, et al. Contribution of recombinant human bone morphogenetic protein-2 to the rapid creation of interbody fusion when used in transforaminal lumbar interbody fusion: a preliminary report. J Neurosurg Spine, 2004, 1(1): 19-23.
23.	Joseph V, Rampersaud YR. Heterotopic bone formation with the use of rhBMP2 in posterior minimal access interbody fusion: a CT analysis. Spine, 2007, 32(25): 2885-2890.
24.	Boden SD, Kang J, Sandhu H, et al. Use of recombinant human bone morphogenetic protein-2 to achieve posterolateral lumbar spine fusion in humans: a prospective, randomized clinical pilot trial: 2002 Volvo Award in clinical studies. Spine, 2002, 27(23): 2662-2673.
25.	Sasso RC, LeHuec JC, Shaffrey C. Iliac crest bone graft donor site pain after anterior lumbar interbody fusion: a prospective patient satisfaction outcome assessment. J Spinal Disord Tech, 2005, 18(Suppl): S77-81.

1. Boden SD. Overview of biology of lumbar spine fusion and principles for selecting a bone graft substitute. Spine, 2002, 27(16 Suppl 1): 26-31.
2. Helm GA, Dayoub H, Jane JA Jr. Bone graft substitutes for the promotion of spinal arthrodesis. Neurosurg Focus, 2001, 10(4): E4.
3. Vaccaro AR, Chiba K, Heller JG, et al. Bone grafting alternatives in spinal surgery. Spine J, 2002, 2(3): 206-215.
4. Guyatt GH, Rennie D. The evidence-based medicine working group. Users’ guides to the medical literature: A manual for evidence-based clinical practice. Chicago: AMA Press, 2002.
5. Burkus JK, Heim SE, Gornet MF, et al. Is INFUSE bone graft superior to autograft bone? An integrated analysis of clinical trials using the LT-CAGE lumbar tapered fusion device. J Spinal Disord Tech, 2003, 16(2): 113-122.
6. Garrison KR, Donell S, Ryder J, et al. Clinical effectiveness and cost effectiveness of bone morphogenetic proteins in the non-heal ing of fractures and spinal fusion: a systematic review. Health Technol Assess, 2007, 11(30): 1-150, iii-iv.
7. Boden SD, Zdebl ick TA, Sandhu HS, et al. The use of rhBMP-2 in interbody fusion cages. Definitive evidence of osteoinduction in humans: a preliminary report. Spine, 2000, 25(3): 376-381.
8. Dimar JR, Glassman SD, Burkus KJ, et al. Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/ compression resistant matrix versus iliac crest bone graft. Spine, 2006, 31(22): 2534-2539; discussion 2540.
9. Glassman SD, Dimar JR, Carreon LY, et al. Initial fusion rates with recombinant human bone morphogenetic protein-2/compression resistant matrix and a hydroxyapatite and tricalcium phosphate/ collagen carrier in posterolateral spinal fusion. Spine, 2005, 30(15): 1694-1698.
10. Vaccaro AR, Patel T, Fischgrund J, et al. A pilot study evaluating the safety and efficacy of OP-1 Putty (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis for degenerative spondylolisthesis. Spine, 2004, 29(17): 1885-1892.
11. Kanayama M, Hashimoto T, Shigenobu K, et al. A prospective randomized study of posterolateral lumbar fusion using osteogenic protein-1 (OP-1) versus local autograft with ceramic bone substitute: emphasis of surgical exploration and histologic assessment. Spine, 2006, 31(10): 1067-1074.
12. Johnsson R, Stromqvist B, Aspenberg P. Randomized radiostereometric study comparing osteogenic protein-1 (BMP-7) and autograft bone in human noninstrumented posterolateral lumbar fusion: 2002 Volvo Award in clinical studies. Spine, 2002, 27(23): 2654-2661.
13. Vaccaro AR, Anderson DG, Patel T, et al. Comparison of OP-1 Putty (rhBMP-7) to iliac crest autograft for posterolateral lumbar arthrodesis: a minimum 2-year follow-up pilot study. Spine, 2005, 30(24): 2709-2716.
14. Haid RW Jr, Branch CL Jr, Alexander JT, et al. Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages. Spine J, 2004, 4(5): 527-38; discussion 538-539.
15. Burkus JK, Gornet MF, Dickman CA, et al. Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages. J Spinal Disord Tech, 2002, 15(5): 337-349.
16. Burkus JK, Sandhu HS, Gornet MF. Influence of rhBMP-2 on the heal ing patterns associated with allograft interbody constructs in comparison with autograft. Spine, 2006, 31(7): 775-781.
17. Burkus JK, Transfeldt EE, Kitchel SH, et al. Clinical and radiographic outcomes of anterior lumbar interbody fusion using recombinant human bone morphogenetic protein-2. Spine, 2002, 27(21): 2396-2408.
18. Burkus JK, Dorchak JD, Sanders DL. Radiographic assessment of interbody fusion using recombinant human bone morphogenetic protein type 2. Spine, 2003, 28(4): 372-377.
19. Coric D, Fischgrund JS, Patel T, et al. 772 Two-year follow-up on patients in a pilot safety and efficacy study of OP-1 (rhBMP-7) in posterolateral lumbar fusion as a replacement for iliac crest autograft neurological surgeons. Neurosurg, 2004, 55(2): 477.
20. Ackerman SJ, Mafilios MS, Polly DW. Economic evaluation of bone morphogenetic protein versus autogenous iliac crest bone graft in single-level anterior lumbar fusion: an evidence-based model ing approach. Spine, 2002, 27(16 Suppl 1): S94-99.
21. Anand N, Hamilton JF, Perri B, et al. Cantilever TLIF with structural allograft and RhBMP2 for correction and maintenance of segmental sagittal lordosis: long-term clinical, radiographic, and functional outcome. Spine, 2006, 31(20): E748-753.
22. Mummaneni PV, Pan J, Haid RW, et al. Contribution of recombinant human bone morphogenetic protein-2 to the rapid creation of interbody fusion when used in transforaminal lumbar interbody fusion: a preliminary report. J Neurosurg Spine, 2004, 1(1): 19-23.
23. Joseph V, Rampersaud YR. Heterotopic bone formation with the use of rhBMP2 in posterior minimal access interbody fusion: a CT analysis. Spine, 2007, 32(25): 2885-2890.
24. Boden SD, Kang J, Sandhu H, et al. Use of recombinant human bone morphogenetic protein-2 to achieve posterolateral lumbar spine fusion in humans: a prospective, randomized clinical pilot trial: 2002 Volvo Award in clinical studies. Spine, 2002, 27(23): 2662-2673.
25. Sasso RC, LeHuec JC, Shaffrey C. Iliac crest bone graft donor site pain after anterior lumbar interbody fusion: a prospective patient satisfaction outcome assessment. J Spinal Disord Tech, 2005, 18(Suppl): S77-81.

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骨形态发生蛋白在腰椎融合中作用的临床证据

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《中国循证医学杂志》

骨形态发生蛋白在腰椎融合中作用的临床证据

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