Increased swelling complications associated with off-label usage of rhBMP-2 in the anterior cervical spine
Increased swelling complications associated with off-label usage of rhBMP-2 in the anterior cervical spine
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DOI：
10.1097/01.brs.0000245863.52371.c2
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发表时间：
2006-11-15
期刊：
影响因子：
3
通讯作者：
Heller, John G.
中科院分区：
文献类型：
--
作者：
Smucker, Joseph D.;Rhee, John M.;Heller, John G.
学习设计/设置。与同期对照的独立的，回顾性的临床记录回顾。目的：确定重组人骨形态发生蛋白-2是否与颈椎前路融合术患者术后椎前肿胀的发生率增加有关。骨形态发生蛋白-2(rhBMP-2)是FDA批准的腰椎前路融合术中的骨移植替代物。重组人骨形态发生蛋白-2也被用于颈椎前路融合术。我们怀疑rhBMP-2可能会增加不良肿胀事件的发生率。共有234名患者(年龄12-82岁)在一家机构接受了为期两年的颈椎前路融合术，其中包括接受和不接受重组人骨形态发生蛋白-2融合的患者。计算临床相关椎前肿胀的发生率。对两组人群进行比较，并确定其统计学意义。共有234名患者符合研究标准，其中69名患者接受了使用重组人骨形态发生蛋白-2的颈椎前路融合术；使用重组人骨形成蛋白-2组的患者中有27.5%的患者出现了临床上显著的肿胀事件，而在非重组骨形态发生蛋白-2组的患者中只有3.6%的患者出现了明显的肿胀事件。这一差异在统计学上是显著的(P<；0.0001)，在控制了其他显著的肿胀预测因素后仍然如此。在颈椎前路非标记性使用重组人骨形态发生蛋白-2与临床相关肿胀事件的发生率增加有关。
Study Design/Setting. Independent, retrospective clinical record review with a concurrent control.Objective. To identify whether rhBMP-2 is associated with an increased incidence of clinically relevant postoperative prevertebral swelling problems in patients undergoing anterior cervical fusions.Summary of Background Data. Bone Morphogenetic Protein-2 (rhBMP-2) is FDA approved as a bone graft substitute in anterior lumbar interbody fusions. rhBMP-2 has also been used "off-label" in anterior cervical fusions. We suspected that rhBMP-2 might increase the incidence of adverse swelling events.Methods. A total of 234 consecutive patients (ages 12-82 years) undergoing anterior cervical fusion with and without rhBMP-2 over a 2-year period at one institution comprised the study population. The incidence of clinically relevant prevertebral swelling was calculated. The populations were compared and statistical significance was determined.Results. A total of 234 patients met the study criteria, 69 of whom underwent anterior cervical spine fusions using rhBMP-2; 27.5% of those patients in the rhBMP-2 group had a clinically significant swelling event versus only 3.6% of patients in the non-rhBMP-2 group. This difference was statistically significant (P < 0.0001) and remained so after controlling for other significant predictors of swelling.Conclusions. Off-label use of rhBMP-2 in the anterior cervical spine is associated with an increased rate of clinically relevant swelling events.