Lee Herbert S H, Kwok Hilary H C, Xiao Muriel L Q, Wai Cynthia K C
Department of Otorhinolaryngology, Head and Neck Surgery, Kowloon West Cluster, Hong Kong, China.
Clinical Research Centre, Kowloon West Cluster, Hong Kong, China.
Eur Arch Otorhinolaryngol. 2025 Jun;282(6):2971-2975. doi: 10.1007/s00405-024-09166-y. Epub 2024 Dec 19.
The aim of this study was to compare the graft success rate, hearing outcome, and operative time in patients undergoing tympanoplasty for tympanic membrane perforation with the use of either biosynthetic or autologous graft material.
This was a prospective randomized controlled trial performed at a regional hospital. 41 patients were enrolled and randomized, with 20 patients allocated to the treatment arm (biosynthetic graft) and 21 patients allocated to the control arm (autologous graft). The primary outcome was graft success rate. The secondary outcomes were operative time and hearing outcomes (assessed by pure tone audiogram hearing threshold improvement and closure of air-bone gap at 6 months postoperatively).
There was no statistically significant difference in the graft success rate between the two groups (P = 0.645). There was also no statistically significant difference in the hearing outcomes (hearing thresholds improvement P = 0.886, air-bone gap improvement P = 0.651). However operative time was significantly shorter in the biosynthetic graft group compared with the autologous graft group (45.5 min vs. 72 min respectively; P < 0.001).
This study demonstrates that tympanoplasty using a biosynthetic graft material can achieve comparable graft success rate and hearing outcomes as compared with conventional autologous graft tympanoplasty, but with the added benefits of a shortened operative time and avoiding incisions.
本研究旨在比较使用生物合成或自体移植材料进行鼓膜穿孔鼓室成形术患者的移植物成功率、听力结果和手术时间。
这是一项在地区医院进行的前瞻性随机对照试验。41例患者被纳入并随机分组，20例患者分配至治疗组（生物合成移植物），21例患者分配至对照组（自体移植物）。主要结局是移植物成功率。次要结局是手术时间和听力结果（通过纯音听力图听力阈值改善情况及术后6个月气骨导间距缩小情况评估）。
两组之间的移植物成功率无统计学显著差异（P = 0.645）。听力结果也无统计学显著差异（听力阈值改善P = 0.886，气骨导间距改善P = 0.651）。然而，与自体移植物组相比，生物合成移植物组的手术时间明显更短（分别为45.5分钟和72分钟；P < 0.001）。
本研究表明，与传统自体移植物鼓室成形术相比，使用生物合成移植物材料进行鼓室成形术可获得相当的移植物成功率和听力结果，但具有缩短手术时间和避免切口的额外益处。
