使用含碱性成纤维细胞生长因子的明胶海绵对鼓膜穿孔进行再生治疗。
Regenerative treatment for tympanic membrane perforation using gelatin sponge with basic fibroblast growth factor.
作者信息
Omae Kaoru, Kanemaru Shin-Ichi, Nakatani Eiji, Kaneda Hideaki, Nishimura Tsutomu, Tona Risa, Naito Yasushi, Kawamoto Atsuhiko, Fukushima Masanori
机构信息
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, 1-5-4 Minatojima-minamimachi, Chuo-ku, Kobe 650-0047, Japan.
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, 1-5-4 Minatojima-minamimachi, Chuo-ku, Kobe 650-0047, Japan; Department of Otolaryngology, Head and Neck Surgery, Institute of Biomedical Research and Innovation, Foundation for Biomedical Research and Innovation, 2-2 Minatojima-minamimachi, Chuo-ku, Kobe 650-0047, Japan; Department of Otolaryngology, Head and Neck Surgery, Kitano Hospital, Tazuke Kofukai Medical Research Institute, 2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan.
出版信息
Auris Nasus Larynx. 2017 Dec;44(6):664-671. doi: 10.1016/j.anl.2016.12.005. Epub 2017 Jan 22.
OBJECTIVE
The objective of this study was to evaluate safety and efficacy of regenerative treatment using gelatin sponge with basic fibroblast growth factor (bFGF) in patients with tympanic membrane perforation (TMP).
METHODS
The current study was a prospective, multicenter, open-label, single-arm, and exploratory clinical trial to evaluate the safety and efficacy of the TM regeneration procedure (TMRP). Myringotomy was used to mechanically disrupt the edge of the TMP, and a gelatin sponge immersed in bFGF was then placed over the perforation. Fibrin glue was dripped over the sponge as a sealant. TMP closure was examined 4 weeks later and, if insufficient, TMRP was repeated a maximum of three more times. TMP closure and hearing improvement 12 weeks after the final TMRP as well as safety were evaluated.
RESULTS
Of the 11 patients with TMP who participated in this study, one who fulfilled the exclusion criteria and did not undergo TMRP and one with cholesteatoma were excluded from the efficacy analysis. TMP closure and hearing improvement 12 weeks after the final TMRP were achieved in eight out of nine patients (88.9%). Mean bone conduction threshold significantly improved 12 weeks after the TMRP compared with baseline (35.7±20.3 vs 29.4±21.0dB, P=0.015). Six out of ten patients receiving TMRP experienced temporary adverse events: appendicitis (serious, severe), otorrhea (mild), otitis media (mild), and sudden hearing loss (mild). However, none were related to the protocol treatment.
CONCLUSION
TMP closure and hearing improvement were frequently confirmed following the TMRPs which were safely performed. These favorable outcomes were accompanied with significant improvement of the bone conduction threshold. These promising outcomes would encourage a large-scaled, randomized and pivotal clinical trial in the future. This trial is registered at http://www.umin.ac.jp/ctr/index.htm (identifier: UMIN000006585).
目的
本研究旨在评估使用含碱性成纤维细胞生长因子（bFGF）的明胶海绵对鼓膜穿孔（TMP）患者进行再生治疗的安全性和有效性。
方法
本研究为一项前瞻性、多中心、开放标签、单臂探索性临床试验，旨在评估鼓膜再生程序（TMRP）的安全性和有效性。采用鼓膜切开术机械破坏TMP边缘，然后将浸有bFGF的明胶海绵置于穿孔处。在海绵上滴加纤维蛋白胶作为密封剂。4周后检查TMP闭合情况，若闭合不充分，TMRP最多可再重复三次。评估最后一次TMRP后12周的TMP闭合情况、听力改善情况以及安全性。
结果
参与本研究的11例TMP患者中，1例符合排除标准未接受TMRP，1例患有胆脂瘤，二者均被排除在疗效分析之外。9例患者中有8例（88.9%）在最后一次TMRP后12周实现了TMP闭合和听力改善。与基线相比，TMRP后12周平均骨传导阈值显著改善（35.7±20.3 vs 29.4±21.0dB，P = 0.015）。接受TMRP的10例患者中有6例经历了临时不良事件：阑尾炎（严重）、耳漏（轻度）、中耳炎（轻度）和突发性听力损失（轻度）。然而，均与方案治疗无关。
结论
TMRP安全实施后，TMP闭合和听力改善情况经常得到证实。这些良好结果伴随着骨传导阈值的显著改善。这些有前景的结果将鼓励未来开展大规模、随机、关键的临床试验。本试验已在http://www.umin.ac.jp/ctr/index.htm注册（标识符：UMIN000006585）。
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