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重组人骨形态发生蛋白-2负载可吸收胶原海绵与髂嵴植骨用于颈椎后路融合术的围手术期并发症

Perioperative complications of recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge versus iliac crest bone graft for posterior cervical arthrodesis.

作者信息

Crawford Charles H, Carreon Leah Y, McGinnis Mark D, Campbell Mitchell J, Glassman Steven D

机构信息

Department of Orthopaedic Surgery, University of Louisville School of Medicine, Louisville, KY, USA.

出版信息

Spine (Phila Pa 1976). 2009 Jun 1;34(13):1390-4. doi: 10.1097/BRS.0b013e3181a2da08.

Abstract

STUDY DESIGN

Retrospective evaluation of perioperative complications with recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge (rhBMP-2/ACS) versus iliac crest bone graft (ICBG) for instrumented posterior cervical fusion.

OBJECTIVE

To determine the risk of perioperative complications using rhBMP-2/ACS for posterior cervical fusion compared with ICBG.

SUMMARY OF BACKGROUND DATA

There is substantial use of rhBMP-2/ACS as a bone graft substitute for spine fusions outside the Food and Drug Administration-approved indication of anterior lumbar interbody fusion. Efficacy for inducing fusion and avoidance of iliac crest donor-site complications are frequent reasons cited for its use. Previous studies have reported use in the anterior lumbar spine, the posterior lumbar spine, and in the anterior cervical spine. Site-specific perioperative complications that have been reported, especially with use in the anterior cervical spine, confirm that safety and efficacy should be established for specific anatomic sites and clinical indications.

METHODS

From July 2002 to February 2005, a consecutive series of patients who underwent instrumented posterior cervical fusion were identified. Patients received either rhBMP-2/ACS or ICBG based on the discretion of the surgeon. Patients were excluded if they had a preoperative diagnosis of trauma, tumor, or infection, or if they underwent a concomitant anterior procedure. Seventy-seven patients met the inclusion criteria. Forty-one of these patients received rhBMP-2/ACS and 36 received ICBG. Standard demographic, surgical, and perioperative complication data were collected from the medical records.

RESULTS

There were no significant differences in age, gender distribution, smoking status, number of surgical levels, blood loss, operative time, or length of stay between the 2 groups. There were more posterior cervical wound complications requiring treatment in the rhBMP- 2/ACS group (6, 14.6%) versus the ICBG group (1, 2.8%), although this was not statistically significant (P = 0.113). One patient (2.8%) in the ICBG group had a wound complication at the iliac crest donor site. Additional perioperative complications were noted in 3 patients (7.3%) in the ICBG group and none in the rhBMP-2/ACS group.

CONCLUSION

The higher incidence of posterior cervical wound complications in the rhBMP-2/ACS group, although not statistically significant, may be related to an inflammatory response to rhBMP-2. This potential risk must be weighed against the elimination of donor-site complications associated with ICBG harvesting, and considered in light of ultimate clinical outcome. Additional studies are needed to clarify this issue, as well as to determine optimal dosing and carrier for usage in the posterior cervical spine.

摘要

研究设计

对使用重组人骨形态发生蛋白-2(rhBMP-2)与可吸收胶原海绵(rhBMP-2/ACS)进行颈椎后路融合术和使用髂嵴骨移植(ICBG)的围手术期并发症进行回顾性评估。

目的

确定与ICBG相比,使用rhBMP-2/ACS进行颈椎后路融合术的围手术期并发症风险。

背景数据总结

rhBMP-2/ACS作为骨移植替代物用于脊柱融合术,已超出美国食品药品监督管理局批准的前路腰椎椎间融合术适应证范围。诱导融合的有效性以及避免髂嵴供区并发症是其常用的理由。既往研究报道了其在前路腰椎、后路腰椎及前路颈椎手术中的应用。已报道的特定部位围手术期并发症,尤其是在前路颈椎手术中的应用,证实应针对特定解剖部位和临床适应证确定其安全性和有效性。

方法

2002年7月至2005年2月,连续纳入接受颈椎后路融合术的患者。根据外科医生的判断,患者接受rhBMP-2/ACS或ICBG治疗。若患者术前诊断为创伤、肿瘤或感染,或同时接受前路手术,则排除在外。77例患者符合纳入标准。其中41例患者接受rhBMP-2/ACS治疗,36例接受ICBG治疗。从病历中收集标准的人口统计学、手术及围手术期并发症数据。

结果

两组患者在年龄、性别分布、吸烟状况、手术节段数、失血量、手术时间或住院时间方面无显著差异。rhBMP-2/ACS组需要治疗的颈椎后路伤口并发症(6例,14.6%)多于ICBG组(1例,2.8%),尽管差异无统计学意义(P = 0.113)。ICBG组有1例患者(2.8%)在髂嵴供区出现伤口并发症。ICBG组有3例患者(7.3%)出现其他围手术期并发症,rhBMP-2/ACS组无并发症发生。

结论

rhBMP-2/ACS组颈椎后路伤口并发症发生率较高,虽无统计学意义,但可能与对rhBMP-2的炎症反应有关。必须权衡这种潜在风险与消除ICBG取骨相关的供区并发症,并结合最终临床结果进行考虑。需要进一步研究以阐明该问题,以及确定颈椎后路手术中rhBMP-2的最佳剂量和载体。

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