前路颈椎融合术中骨形态发生蛋白（BMP）使用的二十年回顾性分析：单外科医生研究中严重吞咽困难和气道并发症的发生率。

文献信息

中文摘要

研究设计： 回顾性、非随机。
目的： 本研究旨在评估由单一外科医生使用低剂量骨形态发生蛋白（BMP）进行前路颈椎间盘切除融合术（ACDF）的患者中严重吞咽和气道并发症的发生率。
背景资料摘要： FDA于2008年发布了对ACDF手术中使用BMP的黑框警告，但很少有研究报告警告中引用的并发症发生率。此外，很少有研究纵向追踪低剂量BMP在颈椎中的使用并报告并发症率。本研究旨在通过提供单一外科医生使用低剂量BMP的20年纵向回顾来填补文献空白。
方法： 该回顾性分析评估了2003年至2023年间由单一外科医生进行ACDF手术的患者。确定了患者人口统计学和手术特征。根据FDA黑框警告定义的并发症被前瞻性记录。统计分析包括二元逻辑回归以预测并发症。
结果： 本研究共纳入1010名患者。2.2%的患者出现了黑框并发症。针对这些并发症，1.5%的患者接受了静脉注射类固醇，0.2%的患者被重新插管，0.2%的患者接受了第二次手术以引流手术部位，2.1%的患者因吞咽或气道并发症再次入院。没有患者需要气管切开术。
结论： 本研究的并发症发生率与已发表的未使用BMP的ACDF手术发生率相当。鉴于本研究以及越来越多支持低剂量BMP安全性和有效性的证据，应重新考虑对颈椎中使用BMP的绝对警告。
证据等级： III级。

英文摘要

STUDY DESIGN: Retrospective, nonrandomized.
OBJECTIVE: The objective of this study is to assess the incidence of severe swallowing and airway complications in patients who underwent anterior cervical discectomy and fusion (ACDF) with low-dose bone morphogenetic protein (BMP) by a single surgeon.
SUMMARY OF BACKGROUND DATA: The FDA released a black box warning against the use of BMP in ACDF surgeries in 2008, but few studies have reported the incidence of complications cited in the warning. Further, few studies have longitudinally tracked the use of low-dose BMP in the cervical spine and reported complication rates. This study aims to fill a gap in the literature by providing a 20-year longitudinal review of the use of low-dose BMP by a single surgeon.
METHODS: The retrospective analysis assessed patients who underwent ACDF surgeries from 2003 to 2023 by a single surgeon. Patient demographics and surgical characteristics were identified. Complications, as defined by the FDA Black Box Warning, were prospectively recorded. Statistical analysis included binary logistic regressions to predict complications.
RESULTS: One thousand ten patients were included in this study. 2.2% of the patients developed a Black Box Complication. In response to these complications, 1.5% of patients received intravenous steroids, 0.2% of patients were reintubated, 0.2% of patients underwent second surgeries to drain the surgical site, and 2.1% of patients were readmitted for swallowing or airway complications. No patients required a tracheostomy.
CONCLUSIONS: The complication rates of the current study are comparable to the published rates of ACDF procedures without BMP. Given the current study and the growing body of evidence supporting the safety and efficacy of low-dose BMP, categorical cautions against the use of BMP in the cervical spine should be reconsidered.
LEVEL OF EVIDENCE: Level III.