Multicenter phase III trial of regenerative treatment for chronic tympanic membrane perforation
Multicenter phase III trial of regenerative treatment for chronic tympanic membrane perforation
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DOI：
10.1016/j.anl.2021.02.007
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发表时间：
2021-08-16
影响因子：
1.7
通讯作者：
Fukushima, Masanori
中科院分区：
文献类型：
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作者：
Kanemaru, Shin-ichi;Kanai, Rie;Fukushima, Masanori
目的：评价再生治疗鼓膜穿孔（TMP）使用明胶海绵，碱性成纤维细胞生长因子（bFGF），和纤维蛋白glue.Methods的有效性和安全性：这是一个多中心，非随机，单臂研究进行三级转诊中心。20例慢性TMP患者（年龄23-78岁，6例男性，14例女性）来自3家机构。所有接受治疗的患者均纳入安全性分析人群。通过鼓膜切开术机械破坏TMP的边缘，放置几片浸入bFGF的明胶海绵并用纤维蛋白胶固定以覆盖穿孔。4 +/-1周后检查TMP。重复该方案最多4次，直至闭合完成。主要结果指标为最终再生手术（FRP）后16周评估的TMP闭合或尺寸减小、听力改善和气骨间隙。结果：20例患者中有15例在16周时达到TMP完全闭合（75.0%，95%可信区间[CI]：50.9%-91.3%），大小平均减小92.2%（95%CI：82.9%-100.0%）。术后16周听力改善率和气骨导差分别为100%（20/20; 95%CI：83.2%-100%）和5.3 ± 4.2 dB（p
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