骨形態發生蛋白在腰椎融合中作用的臨床證據_《中國循證醫學雜志》

作者：

劉熹 ¹ , 舒德芬 ² , 李濤 ¹ ,  劉浩 ¹

1. 四川大學華西醫院骨科（成都 610041）；2. 四川大學華西醫院老年科（成都 610041）;

關鍵詞：

骨形態發生蛋白脊柱融合腰椎成本- 效果分析

DOI：

10.7507/1672-2531.20080176

視頻：

導出 下載 收藏 掃碼 引用

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目的　探討骨形態發生蛋白應用于腰椎融合術的效果、成本及最佳應用方案。
方法　按照PICO 原則，針對患者的臨床問題，計算機檢索ACP Journal Club（1991 ～ 2008.2）、Cochrane 圖書館（2007 年第4 期）、PubMed（1990 ～ 2008.2）及其他相關數據庫，收集關于骨形態發生蛋白臨床應用的系統評價、臨床隨機對照試驗及衛生經濟學評價等，并對所獲證據質量進行評價。
結果　現有證據顯示骨形態發生蛋白用于腰椎前路椎體間融合和后外側融合具有良好的誘導融合效果，其安全性等于或高于自體髂骨，產生的直接成本與自體髂骨相當。目前用于臨床的骨形態發生蛋白種類為BMP-2 和BMP-7，推薦用法為前路椎體間融合使用固定搭配的成品，后外側融合BMP-2 每側20 mg，BMP-7 每側3.5 mg，載體類型根據融合方式有所不同。
結論　國內可嘗試引進骨形態發生蛋白用于腰椎融合手術。但要廣泛應用于臨床還需要專門針對國人的大規模高質量臨床隨機對照研究作為依據，同時也需要進一步的研究來確定用于國人的最佳劑量和劑型。

引用本文： 劉熹,舒德芬,李濤,劉浩. 骨形態發生蛋白在腰椎融合中作用的臨床證據. 中國循證醫學雜志, 2008, 08(9): 786-790. doi: 10.7507/1672-2531.20080176 復制

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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《中國循證醫學雜志》

骨形態發生蛋白在腰椎融合中作用的臨床證據

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