Department of Orthopedic Surgery, Graduate School of Medicine, Kyoto University, Shogoin, Kawahara-cho 54, Sakyo-ku, Kyoto, 606-8507, Japan.
Department of Orthopedic Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, 113-8655, Japan.
Regen Med. 2021 Jun;16(6):535-548. doi: 10.2217/rme-2021-0049. Epub 2021 Jun 2.
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). 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. 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. rhFGF-2 treatment increases joint preservation time with clinical efficacy, radiological bone regeneration and safety.
本研究旨在评估重组人成纤维细胞生长因子-2（rhFGF-2）治疗股骨头坏死（ONFH）的 2 年临床研究结果。64 例非创伤性、塌陷前期和大的 ONFH 患者经皮给予 800 μg 含有人 rhFGF-2 的明胶水凝胶。以影像学塌陷为终点，分析历史对照的关节保存期。评估了两种经过验证的临床评分的变化，即骨再生和安全性。rhFGF-2 组的影像学关节保存时间明显长于对照组。ONFH 倾向于向更小的 ONFH 发展。术后临床评分显著改善。13 例严重不良事件显示恢复。rhFGF-2 治疗可增加关节保存时间，具有临床疗效、影像学骨再生和安全性。
