Department of Otolaryngology and HNS, Hearing Disturbance and Eardrum Regeneration Center, Medical Research Institute, Kitano Hospital, Public Interest Incorporated Foundation, Tazuke Kofukai, Osaka, Japan.
Department of Otolaryngology-Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Otol Neurotol. 2024 Oct 1;45(9):1030-1036. doi: 10.1097/MAO.0000000000004285. Epub 2024 Aug 19.
To evaluate tympanic membrane regeneration therapy (TMRT) for pediatric tympanic membrane perforations (TMPs).
Intervention study.
Research institute hospital.
In this study, 20 patients with chronic TMP (M/F: 13/7, 13/8 ears, age 0-15 years) treated with TMRT were evaluated. As comparison, 20 pediatric patients with chronic TMP who underwent myringoplasty/tympanoplasty were included.
For the TM repair procedure, the edge of the TMP was disrupted mechanically, and gelatin sponge immersed in basic fibroblast growth factor was placed inside and outside the tympanic cavity and covered with fibrin glue. The TMP was examined 4 ± 1 weeks later. The protocol was repeated up to four times until closure was complete.
Closure of the TMP and hearing improvement were evaluated at 16 weeks after the final regenerative procedure. Adverse events were monitored.
The mean follow-up period was 427.1 days. The TM regenerated in all cases, but pinhole reperforation occurred in two cases, and the final closure rate was 90.5% (19 of 21). Hearing improved to 24.9 ± 7.6 dB on average before surgery and to 13.8 ± 5.4 dB after surgery. The AB gap improved from 12.9 ± 8.0 to 5.2 ± 3.5 dB.The myringoplasty/tympanoplasty group had significantly lower AB gap improvement compared with the TMRT group. There were no adverse events.
TMRT can be expected to regenerate near-normal TMs with a high closure ratio, resulting in better-hearing improvement compared with the myringoplasty/tympanoplasty group, and is an effective treatment for children with long life expectancy.
评估鼓膜再生治疗（TMRT）治疗小儿鼓膜穿孔（TMP）的效果。
干预性研究。
研究所医院。
本研究纳入 20 例接受 TMRT 治疗的慢性 TMP 患者（M/F：13/7，13/8 耳，年龄 0-15 岁），并将其作为研究对象。同时纳入 20 例接受鼓膜成形术/鼓室成形术的慢性 TMP 患儿作为对照。
对于 TM 修复程序，TMP 的边缘通过机械方式破裂，将浸有碱性成纤维细胞生长因子的明胶海绵置于鼓室内外，并覆盖纤维蛋白胶。4±1 周后检查 TMP。该方案最多重复四次，直到完全闭合。
最后一次再生手术后 16 周评估 TMP 闭合和听力改善情况。监测不良事件。
平均随访期为 427.1 天。所有病例的鼓膜均再生，但有两例出现针孔再穿孔，最终闭合率为 90.5%（21 例中的 19 例）。术前平均听力提高至 24.9±7.6dB，术后提高至 13.8±5.4dB。AB 差从 12.9±8.0dB 改善至 5.2±3.5dB。与 TMRT 组相比，鼓膜成形术/鼓室成形术组的 AB 差改善程度显著较低。无不良事件发生。
TMRT 有望再生接近正常的鼓膜，具有较高的闭合率，与鼓膜成形术/鼓室成形术组相比，听力改善效果更好，是一种对预期寿命长的儿童有效的治疗方法。
