Galimberti Fabrizio, Lubelski Daniel, Healy Andrew T, Wang Timothy, Abdullah Kalil G, Nowacki Amy S, Benzel Edward C, Mroz Thomas E
*Cleveland Clinic Lerner College of Medicine, Cleveland, OH †Cleveland Clinic Center for Spine Health, Cleveland Clinic, Cleveland, OH ‡Department of Neurological Surgery, Cleveland Clinic, Cleveland, OH §Duke University School of Medicine, Durham, NC ¶Department of Neurological Surgery, Hospital of the University of Pennsylvania, Philadelphia, PA; and ‖Department of Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH.
Spine (Phila Pa 1976). 2015 Jul 15;40(14):1132-9. doi: 10.1097/BRS.0000000000000971.
Systematic review.
To evaluate literature comparing fusion rates in anterior lumbar interbody fusion (ALIF), posterior lumbar interbody/transforaminal lumbar interbody fusion (PLIF/TLIF), and posterolateral lumbar fusion (PLF) with and without recombinant human bone morphogenetic protein-2 (rhBMP-2).
rhBMP-2 is used for the FDA-approved indication of single-level ALIF with LT-Cage and off-label for PLIF/TLIF, and PLF. Due to recent controversies, it is essential to evaluate the literature for its effects on fusion rates to evaluate whether benefits outweigh potential complications.
A Medline search was performed of clinical studies published between May 2000 and May 2012 comparing fusion rates after ALIF, PLIF/TLIF, and PLF surgery with versus without rhBMP-2. Only studies with a control arm were reviewed.
16 studies were reviewed (1794 patients, 995 treated with rhBMP-2 and 799 without). 5 of 5 studies for PLIF/TLIF (including 301 of 301 patients), 1 of 4 for ALIF (including 279 of 589 patients), and 3 of 7 for PLF (including 272 of 904 patients) reported no significant improvement in fusion rates with rhBMP-2 compared with those without rhBMP-2 at longest follow-up investigated. Average fusion rate 24 months after surgery was 97.8% for ALIF (n = 316), 95.7% for PLIF/TLIF (n = 141), and 93.6% for PLF (n = 422) with rhBMP-2 and 88.2% (n = 228), 89.5% (n = 86), and 83.1% (n = 372) without rhBMP-2, for ALIF, PLIF/TLIF, and PLF, respectively. Odds ratio of fusion were calculated as 7.08 (95% CI: 1.54-32.7) in ALIF, 1.98 (95% CI: 0.39-10.1) in PLIF/TLIF, and 3.06 (95% CI: 1.61-5.80) in PLF with rhBMP-2 as compared with without rhBMP-2.
Although numerous studies did not show statistically significant improvement in fusion rates with rhBMP-2 use, analysis of combined studies revealed significant improvement in fusion rate with rhBMP-2 in ALIF and PLF patients. Notably, even when pooling data from several studies, rhBMP-2 did not result in statistically significantly improved fusion rates in PLIF/TLIF. However, heterogeneity of rhBMP-2 dosing, surgical techniques, and quality of papers reviewed may limit the validity of conclusions drawn.
系统评价。
评估比较腰椎前路椎间融合术（ALIF）、腰椎后路椎间融合术/经椎间孔腰椎椎间融合术（PLIF/TLIF）以及腰椎后外侧融合术（PLF）在使用和不使用重组人骨形态发生蛋白-2（rhBMP-2）情况下融合率的文献。
rhBMP-2用于经美国食品药品监督管理局（FDA）批准的LT-Cage单节段ALIF适应证，以及用于PLIF/TLIF和PLF的未获批准适应证。鉴于近期的争议，有必要评估相关文献以了解其对融合率的影响，从而评估其益处是否超过潜在并发症。
对2000年5月至2012年5月发表的比较ALIF、PLIF/TLIF和PLF手术在使用与不使用rhBMP-2情况下融合率的临床研究进行了Medline检索。仅纳入有对照组的研究进行综述。
共综述了16项研究（1794例患者，995例接受rhBMP-2治疗，799例未接受）。PLIF/TLIF的5项研究中的5项（包括301例患者中的301例）、ALIF的4项研究中的1项（包括589例患者中的279例）以及PLF的7项研究中的3项（包括904例患者中的272例）报告称，在最长随访期内，与未使用rhBMP-2相比，使用rhBMP-2并未使融合率有显著提高。使用rhBMP-2时，ALIF术后24个月的平均融合率为97.8%（n = 316），PLIF/TLIF为95.7%（n = 141），PLF为93.6%（n = 422）；未使用rhBMP-2时，ALIF为88.2%（n = 228），PLIF/TLIF为89.5%（n = 86），PLF为83.1%（n = 372）。与未使用rhBMP-2相比，使用rhBMP-2时ALIF的融合优势比为7.08（95%CI：1.54 - 32.7），PLIF/TLIF为1.98（95%CI：0.39 - 10.1），PLF为3.06（95%CI：1.61 - 5.80）。
尽管众多研究未显示使用rhBMP-2能使融合率有统计学意义的显著提高，但对综合研究的分析显示，rhBMP-2可使ALIF和PLF患者的融合率有显著提高。值得注意的是，即便汇总多项研究的数据，rhBMP-2也未使PLIF/TLIF的融合率有统计学意义的显著提高。然而，rhBMP-2剂量、手术技术以及所综述论文质量的异质性可能会限制所得结论的有效性。
4级。
