Department of Otorhinolaryngology, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
Department of Otorhinolaryngology, Yonsei University Wonju College of Medicine, Wonju, Korea.
Acta Otorhinolaryngol Ital. 2018 Dec;38(6):554-562. doi: 10.14639/0392-100X-1839.
Acellular human dermal allografts have been shown to be effective for soft-tissue implantation. We compared treatment outcomes of tympanoplasty using tragal perichondrium and acellular human dermal allograft (MegaDerm). In a prospective randomised controlled study, 60 patients scheduled to undergo tympanoplasty were randomly assigned to the autologous tragal perichondrium group (n = 33) or acellular human dermal allograft group (n = 27). Postoperative hearing gain, graft success rate at 1 and 6 months and operation times were compared between groups. Graft success rate, defined as the complete closure of tympanic membrane perforation, did not show any significant intergroup difference (75.8% vs 85.2%, p = 0.519). Air conduction thresholds and air-bone gaps showed significant improvements in both groups; from 38.7 ± 15.9 dB to 30.2 ± 15.6 dB (p < 0.001) and from 17.8 ± 7.3 dB to 11.5 ± 7.0 (p = 0.001) in the autologous tragal perichondrium group, and from 30.4 ± 12.2 dB to 24.5 ± 13.0 dB (p = 0.006) and from 14.3 ± 5.1 dB to 7.6 ± 4.6 dB (p < 0.001) in the acellular human dermal allograft group. The amount of hearing gain (p = 0.31) and closure of air-bone gap (p = 0.863) were not meaningfully different between groups. The mean operation time was significantly lower in the acellular human dermal allograft group (35.2 min vs 27.4 min, p = 0.039). In this prospective randomised controlled study, acellular human dermal allograft was shown to be an effective alternative to tragal perichondrium, with similar graft success rates and postoperative hearing results, but with reduced operation times.
脱细胞异体真皮移植物已被证明在软组织植入中是有效的。我们比较了使用耳屏软骨膜和脱细胞异体真皮移植物（MegaDerm）进行鼓室成形术的治疗效果。在一项前瞻性随机对照研究中，60 名计划接受鼓室成形术的患者被随机分为自体耳屏软骨膜组（n = 33）或脱细胞异体真皮移植物组（n = 27）。比较两组患者术后听力提高、1 个月和 6 个月时移植物成活率和手术时间。移植物成活率定义为鼓膜穿孔完全闭合，两组间无显著差异（75.8%比 85.2%，p = 0.519）。两组的气导阈值和气骨间隙均有显著改善；自体耳屏软骨膜组从 38.7 ± 15.9 dB 降至 30.2 ± 15.6 dB（p < 0.001），从 17.8 ± 7.3 dB 降至 11.5 ± 7.0 dB（p = 0.001）；脱细胞异体真皮移植物组从 30.4 ± 12.2 dB 降至 24.5 ± 13.0 dB（p = 0.006），从 14.3 ± 5.1 dB 降至 7.6 ± 4.6 dB（p < 0.001）。两组间听力提高量（p = 0.31）和气骨间隙闭合量（p = 0.863）无显著差异。脱细胞异体真皮移植物组的平均手术时间明显更短（35.2 min 比 27.4 min，p = 0.039）。在这项前瞻性随机对照研究中，脱细胞异体真皮移植物是耳屏软骨膜的有效替代物，具有相似的移植物成活率和术后听力结果，但手术时间更短。
