人羊膜（HAM）在鼓室成形术中的应用：系统评价与荟萃分析。

文献信息

中文摘要

鼓膜穿孔是一种常见的耳科疾病。在未发生自发性闭合，或穿孔伴有对生活质量产生不利影响的临床显著症状时，通常需要手术修复。本综述与荟萃分析旨在综合并严格评价当前关于使用人羊膜（HAM）作为鼓室成形术移植材料的证据。我们在多个数据库中对截至2025年11月发表的研究进行了系统性文献检索。在标题和摘要中使用了以下检索词（并在PubMed中应用了相应的MeSH词）：“Amnion” OR “Placenta” AND “Tympanoplasty”。采用随机效应模型进行单臂荟萃分析，以评估气骨导差（ABG）的改善和解剖闭合率。应用标准化方法学标准评估研究质量和偏倚风险。在630条已识别记录中，纳入了8项研究，评估了265例使用羊膜移植（AMG）的鼓室成形术（264例患者）。大多数非随机研究存在严重偏倚风险。对4项研究进行的单臂荟萃分析显示，汇总完全解剖闭合率为92%（95% CI 0.79-0.98；I2 = 44.1%）。通过4项研究的单臂荟萃分析进行的功能评估显示，气骨导差（ABG）改善的汇总平均差为12.66 dB（95% CI -0.22至25.54），但在统计学上不显著，尽管研究间异质性较高（I2 = 99.4%）。2项报告研究中的AMG手术时间范围差异很大，但一项比较研究指出，与颞肌筋膜移植相比，AMG手术时间显著更短（54.3 vs. 75.3分钟）。术后移植失败率较低，主要由少数感染或移植片外侧化病例所致。由于纳入研究数量较少，无法正式评估发表偏倚。HAM是一种有前景的传统移植材料替代品，具有优异的解剖闭合率、改善但不显著的ABG以及更短的手术时间。尽管当前研究结果支持HAM作为鼓室成形术中传统移植物的可行替代方案，但非随机研究占主导、样本量小以及方法学异质性限制了结论的强度。需要高质量、具有足够把握度的随机对照试验，以更好地确定HAM在中耳手术中应用的最佳适应证、技术和长期结局。

英文摘要

Tympanic membrane perforation is a common otologic disorder. In cases where spontaneous closure does not occur, or when the perforation is associated with clinically significant symptoms that adversely affect quality of life, surgical repair is often indicated. This review and meta-analysis aimed to synthesize and critically appraise the current evidence on the use of human amniotic membrane (HAM) as a graft material in tympanoplasty. A systematic literature search was conducted in multiple databases for studies published up to November 2025. The following search terms were used in titles and abstracts (with corresponding MeSH terms applied in PubMed): "Amnion" OR "Placenta" AND "Tympanoplasty." Single-arm meta-analysis using a random effects model was performed to assess improvement in the air-bone gap (ABG) and anatomical closure rates. Standardized methodological criteria were applied to assess study quality and risk of bias. Out of 630 identified records, eight studies evaluating 265 tympanoplasties (264 patients) using amniotic membrane grafting (AMG) were included. The majority of non-randomized studies carried a serious risk of bias. A single-arm meta-analysis of 4 studies demonstrated a pooled complete anatomical closure rate of 92% (95% CI 0.79-0.98; I2 = 44.1%). Functional assessment via single-arm meta-analysis of 4 studies showed a statistically non-significant pooled mean difference in air-bone gap (ABG) improvement of 12.66 dB (95% CI-0.22 to 25.54), though between-study heterogeneity was high (I2 = 99.4%). Operative times for AMG ranged widely across 2 reporting studies, but one comparative study noted significantly shorter times for AMG compared to temporalis fascia grafting (54.3 vs. 75.3 min). Postoperative graft failure rates were low, primarily driven by sparse instances of infection or graft lateralization. Publication bias could not be formally assessed due to the small number of included studies. HAM is a promising alternative to conventional graft material with excellent anatomical closure, improved but non-significant ABG, and lower operative times. Although current findings support HAM as a viable alternative to conventional grafts in tympanoplasty, the predominance of non-randomized studies, small sample sizes, and methodological heterogeneity constrain the strength of the conclusions. High-quality, adequately powered RCTs are required to better define the optimal indications, techniques, and long-term outcomes associated with HAM use in middle ear surgery.