乳突填塞的生物材料与组织工程策略：临床与临床前证据的系统综述。

文献信息

中文摘要

背景/目的： 乳突填塞正越来越多地用于减少乳突切除术后与术腔相关的并发症。除自体移植物外，合成生物材料和组织工程方法已成为潜在的替代方案。本系统综述综合了关于乳突填塞生物材料的临床与临床前证据，重点关注有效性、安全性、生物整合及转化潜力。方法：按照系统综述和荟萃分析首选报告条目（PRISMA）规范，检索了PubMed、Scopus和Web of Science，纳入2010年1月至2026年5月间发表的研究。符合条件的研究评估了临床环境或实验模型中用于乳突填塞的生物材料。提取了研究设计、生物材料类型、干预措施、结局、并发症及生物学终点等数据。采用非随机干预研究偏倚风险工具（ROBINS-I）、修订版Cochrane随机试验偏倚风险工具（RoB 2）以及系统综述中心实验动物实验偏倚风险工具（SYRCLE）评估偏倚风险。结果：共纳入28项研究（19项临床研究，9项临床前研究）。临床证据支持乳突填塞是改善术腔稳定性、减少慢性耳漏、促进上皮化及辅助胆脂瘤控制的有效策略。结局似乎更多取决于术腔是否成功消除，而非某一特定生物材料的优越性。自体材料显示出可靠且可重复的结果，而S53P4生物活性玻璃表现出相当的有效性并具有额外的抗菌特性。羟基磷灰石基材料及同种异体移植物显示出更多变的结果。生物学增强方法，包括浓缩生长因子和复合构建体，产生了有前景但有限的临床证据。临床前研究表明，传统生物材料主要具有骨传导性，而复合支架、骨形态发生蛋白-2（BMP-2）递送系统及基于干细胞的策略可能增强成骨和组织整合。然而，临床转化仍然有限。结论：乳突填塞是一种有效的重建策略，其成功主要取决于稳定的术腔缩小和充分的上皮覆盖。自体材料和S53P4生物活性玻璃目前具有最强的临床支持，而先进的组织工程方法尚需通过前瞻性比较研究、标准化结局、长期随访及转化研究进一步验证。

英文摘要

Background/Objectives: Mastoid obliteration is being increasingly used to reduce cavity-related morbidity after mastoidectomy. Alongside autologous grafts, synthetic biomaterials and tissue-engineering approaches have emerged as potential alternatives. This systematic review synthesized the clinical and preclinical evidence on biomaterials for mastoid obliteration, focusing on efficacy, safety, biological integration, and translational potential. Methods: A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-compliant search of PubMed, Scopus, and Web of Science identified studies published between January 2010 and May 2026. Eligible studies evaluated biomaterials for mastoid obliteration in clinical settings or experimental models. Data on study design, biomaterial type, intervention, outcomes, complications, and biological endpoints were extracted. Risk of bias was assessed using the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I), Revised Cochrane Risk of Bias Tool for Randomized Trials (RoB 2), and the Systematic Review Centre for Laboratory Animal Experimentation (SYRCLE) risk-of-bias tool. Results: Twenty-eight studies were included (19 clinical, 9 preclinical). Clinical evidence supported mastoid obliteration as an effective strategy for improving cavity stability, reducing chronic otorrhea, promoting epithelialization, and aiding cholesteatoma control. Outcomes appeared to depend more on successful cavity elimination than on the superiority of a specific biomaterial. Autologous materials showed reliable and reproducible results, while S53P4 bioactive glass demonstrated comparable effectiveness with additional antibacterial properties. Hydroxyapatite-based materials and allografts showed more variable outcomes. Biologically enhanced approaches, including concentrated growth factors and composite constructs, yielded promising but limited clinical evidence. Preclinical studies indicated that conventional biomaterials are primarily osteoconductive, whereas composite scaffolds, bone morphogenetic protein-2 (BMP-2) delivery systems, and stem cell-based strategies may enhance osteogenesis and tissue integration. However, clinical translation remains limited. Conclusions: Mastoid obliteration is an effective reconstructive strategy whose success depends mainly on stable cavity reduction and adequate epithelial coverage. Autologous materials and S53P4 bioactive glass currently have the strongest clinical support, whereas advanced tissue-engineering approaches require further validation through prospective comparative studies, standardized outcomes, long-term follow-up, and translational research.