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イハラ トシコ
Toshiko Ito-Ihara
猪原 登志子 所属 川崎医科大学 医学部 応用医学 先端医療開発学 職種 教授 |
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| 論文種別 | 原著 |
| 言語種別 | 英語 |
| 査読の有無 | 査読あり |
| 表題 | Recombinant human FGF-2 for the treatment of early-stage osteonecrosis of the femoral head: TRION, a single-arm, multicenter, Phase II trial. |
| 掲載誌名 | 正式名：Regenerative medicine 略 称：Regen Med ISSNコード：1746076X/17460751 |
| 掲載区分 | 国外 |
| 巻・号・頁 | 16(6),pp.535-548 |
| 著者・共著者 | Yutaka Kuroda, Takeyuki Tanaka, Takaki Miyagawa, Hidetoshi Hamada, Hiroyasu Abe, Toshiko Ito-Ihara, Ryuta Asada, Yusuke Fujimoto, Daisuke Takahashi, Tomonori Tetsunaga, Ayumi Kaneuji, Michiaki Takagi, Yutaka Inaba, Satoshi Morita, Nobuhiko Sugano, Sakae Tanaka, Shuichi Matsuda, Haruhiko Akiyama, |
| 発行年月 | 2021/06 |
| 概要 | Aim: This study aimed to evaluate the 2-year outcomes from a clinical trial of recombinant human FGF-2 (rhFGF-2) for osteonecrosis of the femoral head (ONFH). Patients & methods: Sixty-four patients with nontraumatic, precollapse and large ONFHs were percutaneously administered with 800 μg rhFGF-2 contained in gelatin hydrogel. Setting the end point of radiological collapse, we analyzed the joint preservation period of the historical control. Changes in two validated clinical scores, bone regeneration and safety were evaluated. Results: Radiological joint preservation time was significantly higher in the rhFGF-2 group than in the control group. The ONFHs tended to improve to smaller ONFHs. The postoperative clinical scores significantly improved. Thirteen serious adverse events showed recovery. Conclusion: rhFGF-2 treatment increases joint preservation time with clinical efficacy, radiological bone regeneration and safety. |
| DOI | 10.2217/rme-2021-0049 |
| PMID | 34075804 |