脱细胞真皮基质在脊柱手术中的应用：一项系统综述

文献信息

中文摘要

背景： 脱细胞真皮基质（ADM）是一种组织工程生物支架，已广泛应用于整形重建外科，但其在脊柱手术中的应用在很大程度上仍未得到充分探索。此前尚无系统综述对现有证据进行综合。方法：按照PRISMA 2020指南（PROSPERO：CRD420261326660），对PubMed、Embase、Cochrane CENTRAL、Web of Science和Scopus进行了从建库至2026年7月31日的系统检索。研究预先分为三个证据层级：直接脊柱手术证据、颅椎/神经轴证据和间接颅脑证据。采用ROBINS-I和JBI清单评估偏倚风险；使用GRADE评定确定性。结果：十项研究共纳入385例患者符合纳入标准：七项研究提供直接脊柱手术证据，共172例患者；两项颅椎/神经轴研究共13例患者；一项以颅脑硬脑膜成形术为主的系列研究共200例患者。共识别出五个应用类别。唯一一项比较性研究——一项纳入108例接受ACDF患者的倾向评分匹配队列——报告在预先设定的三个月终点时吞咽障碍评分较低（0.26±0.16 vs. 0.68±0.27，p=0.01，经Bonferroni校正后显著），尽管观察到的差异（Δ=0.42）低于建议的最小临床重要差异，且两组间粘连评分无差异。其余所有研究均为非对照研究。所有结局的GRADE确定性均极低。结论：根据当前证据基础，无法确定ADM在脊柱手术中的疗效。报告的不良事件不常见，但确定方式既非标准化也非前瞻性，这些数据不足以确立安全性。研究结果具有产品和适应证特异性，不应推广至不同ADM制剂或临床应用。

英文摘要

Acellular dermal matrix (ADM) is a tissue-engineered biological scaffold widely adopted in plastic reconstructive surgery, yet its application in spine surgery remains largely underexplored. No prior systematic review has synthesized the available evidence. A systematic search of PubMed, Embase, Cochrane CENTRAL, Web of Science, and Scopus was performed from inception through 31 July 2026, following PRISMA 2020 guidelines (PROSPERO: CRD420261326660). Studies were stratified a priori into three evidence tiers: direct spine surgery evidence, craniovertebral/neuraxis evidence, and indirect cranial evidence. Risk of bias was assessed with ROBINS-I and JBI checklists; certainty was rated using GRADE. Ten studies comprising 385 enrolled patients met inclusion criteria: 172 patients in seven studies providing direct spine surgery evidence, 13 patients in two craniovertebral/neuraxis studies, and 200 patients in one predominantly cranial duraplasty series. Five application categories were identified. The single comparative study-a propensity score-matched cohort of 108 patients undergoing ACDF-reported lower Swallowing Impairment Scores at the pre-specified three-month endpoint (0.26 ± 0.16 vs. 0.68 ± 0.27, p = 0.01, significant after Bonferroni correction), although the observed difference (Δ = 0.42) fell below the suggested minimal clinically important difference, and adhesion scores did not differ between groups. All remaining studies were uncontrolled. GRADE certainty was very low across all outcomes. Efficacy of ADM in spine surgery cannot be determined from the current evidence base. Reported adverse events were infrequent, but ascertainment was neither standardized nor prospective, and these data are insufficient to establish safety. Findings are product- and indication-specific and should not be generalized across ADM formulations or clinical applications.