Multicenter phase III trial of regenerative treatment for chronic tympanic membrane perforation

被引：11

作者：

Kanemaru, Shin-ichi ^{[1
,2
]}

Kanai, Rie ^{[1
]}

Omori, Koichi ^{[3
]}

Yamamoto, Norio ^{[3
]}

Okano, Takayuki ^{[3
]}

Kishimoto, Ippei ^{[3
,9
]}

Ogawa, Kaoru ^{[4
]}

Kanzaki, Sho ^{[4
]}

Fujioka, Masato ^{[4
]}

Oishi, Naoki ^{[4
]}

Naito, Yasushi ^{[5
]}

Kakehata, Seiji ^{[6
]}

Nakamura, Hajime ^{[7
]}

Yamada, Shinobu ^{[8
,10
]}

Omae, Kaoru ^{[2
]}

Kawamoto, Atsuhiko ^{[2
]}

Fukushima, Masanori ^{[2
,11
]}

机构：

[1] Kitano Hosp, Med Res Inst, Dept Otolaryngol Head & Neck Surg, Kita Ku, 2-4-20 Ohgimachi, Osaka 5308480, Japan

[2] Fdn Biomed Res & Innovat Kobe, Translat Res Ctr Med Innovat, Chuo Ku, 1-5-4 Minatojima Minamimachi, Kobe, Hyogo 6500047, Japan

[3] Kyoto Univ, Grad Sch Med, Dept Otolaryngol Head & Neck Surg, Sakyo Ku, 54 Shogoin Kawaharacho, Kyoto 6068507, Japan

[4] Keio Univ, Sch Med, Dept Otorhinolaryngol Head & Neck Surg, Shinjuku Ku, 35 Shinanomachi, Tokyo 1608582, Japan

[5] Kobe City Med Ctr Gen Hosp, Dept Otolaryngol, Chuo Ku, 2-1-1 Minatojima Minamimachi, Kobe, Hyogo 6500047, Japan

[6] Yamagata Univ, Sch Med, Dept Otolaryngol Head & Neck Surg, 2-2-2 Iida Nishi, Yamagata 9909585, Japan

[7] Otsu Red Cross Hosp, Dept Otolaryngol Head & Neck Surg, 1-1-35 Nagara, Otsu, Shiga 5208511, Japan

[8] Nobelpharma Co Ltd, Chuo Ku, 1-17-24 Shinkawa, Tokyo 1040033, Japan

[9] Stanford Univ, Sch Med, Dept Otolaryngol Head & Neck Surg, 801 Welch Rd, Stanford, CA 94305 USA

[10] Japanese Fdn Canc Res, Canc Inst Hosp, Ctr Adv Med Dev, Koto Ku, 3-8-31 Ariake, Tokyo, Japan

[11] Fukushima & Partners, Med R&D, Midori Ku, 3-70 Shikayama, Nagoya, Aichi 4580045, Japan

来源：

AURIS NASUS LARYNX | 2021年 / 48卷 / 06期

关键词：

Basic fibroblast growth factor; Fibrin glue; Gelatin sponge; Multicenter investigator-initiated trial; Regenerative treatment; Tympanic membrane; FIBROBLAST-GROWTH-FACTOR;

D O I：

10.1016/j.anl.2021.02.007

中图分类号：

R76 [耳鼻咽喉科学];

学科分类号：

100213 ;

摘要：

Objective: To evaluate the efficacy and safety of regenerative treatment for tympanic membrane perforation (TMP) using gelatin sponge, basic fibroblast growth factor (bFGF), and fibrin glue. Methods: This was a multicenter, non-randomized, single-arm study conducted at tertiary referral centers. Twenty patients with chronic TMP (age 23-78 years, 6 males, 14 females) were registered from three institutions. All treated patients were included in the safety analysis population. The edges of the TMP were disrupted mechanically by myringotomy and several pieces of gelatin sponge immersed in bFGF were placed and fixed with fibrin glue to cover the perforation. The TMP was examined 4 +/- 1 weeks later. The protocol was repeated up to four times until closure was complete. The main outcome measures were closure or a decrease in size of the TMP, hearing improvement, and air-bone gap evaluated 16 weeks after the final regenerative procedure (FRP). Adverse events (AEs) were monitored throughout the study. Results: Total closure of the TMP at 16 weeks was achieved in 15 out of 20 patients (75.0%, 95% confidence interval [CI]: 50.9%-91.3%) and the mean decrease in size was 92.2% (95%CI: 82.9%-100.0%). The ratio of hearing improvement and the air-bone gap at 16 weeks after FRP were 100% (20/20; 95%CI: 83.2%-100%) and 5.3 +/- 4.2 dB (p <0.0001), respectively. Thirteen out of 20 patients (65.0%) experienced at least one AE, but no serious AEs occurred. Conclusion: The results indicate that the current regenerative treatment for TMP using gelatin sponge, bFGF, and fibrin glue is safe and effective. (C) 2021 The Authors. Published by Elsevier B.V. on behalf of Oto-Rhino-Laryngological Society of Japan Inc.

引用

页码：1054 / 1060

页数：7

共 14 条

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