A pilot study of regenerative therapy using controlled release of recombinant human fibroblast growth factor for patients with pre-collapse osteonecrosis of the femoral head
A pilot study of regenerative therapy using controlled release of recombinant human fibroblast growth factor for patients with pre-collapse osteonecrosis of the femoral head
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DOI：
10.1007/s00264-015-3083-1
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发表时间：
2016-08-01
影响因子：
2.7
通讯作者：
Akiyama, Haruhiko
中科院分区：
文献类型：
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作者：
Kuroda, Yutaka;Asada, Ryuta;Akiyama, Haruhiko
目的评价重组人成纤维细胞生长因子（rhFGF）-2明胶水凝胶局部注射治疗股骨头坏死（ONFH）的安全性和临床疗效。（崩溃前阶段a千分之一货币符号2）接受800 μ g rhFGF-2的单次局部给药，植入明胶水凝胶并随访1年。手术采用微创技术进行，包括1 cm皮肤切口，术后第1天允许行走。主要结局包括不良事件和并发症的发生率。次要结局包括Harris髋关节评分、疼痛评分视觉模拟量表、加州大学洛杉矶分校（UCLA）活动评分和放射学images.Results的变化，我们纳入了10例患者，其中5例发生了14起不良事件，包括1例脊髓麻醉并发症。然而，患者从所有不良事件中完全恢复。与术前评分相比，术后1年的平均临床评分显著改善（术前与术后：疼痛视觉模拟评分，21.2与5.3 mm; UCLA活动评分，5.5与6.6; Harris髋关节评分，81.0与96.9分）。只有1例股骨头塌陷;然而，这发生在髋关节广泛坏死。其他9例病例未发生分期进展和虚脱。结论rhFGF-2明胶水凝胶治疗股骨头坏死是安全可行的。
Purpose We evaluated the safety and clinical outcomes of a single local administration of gelatin hydrogel impregnated with recombinant human fibroblast growth factor (rhFGF)-2 for the treatment of the precollapse stage of osteonecrosis of the femoral head (ONFH).Methods Patients with ONFH (precollapse stage a parts per thousand currency sign2) received a single local administration of 800 mu g of rhFGF-2-impregnated gelatin hydrogel and were followed up for one year. The surgery was performed using a minimally invasive technique involving a 1-cm skin incision, and walking was allowed from day one postoperatively. The primary outcomes included occurrence of adverse events and complications. The secondary outcomes included changes in the Harris hip scores, visual analog scale for pain scores, University of California, Los Angeles (UCLA) activity scores, and radiological images.Results We included ten patients, of which five experienced 14 adverse events, including one complication from spinal anesthesia. However, patients completely recovered from all adverse events. The mean clinical scores significantly improved by one year postoperatively compared with the pre-operative scores (before vs. after: visual analog score for pain, 21.2 vs. 5.3 mm; UCLA activity score, 5.5 vs. 6.6; Harris hip score, 81.0 vs. 96.9 points). There was only one case of femoral head collapse; however, this occurred in a hip with extensive necrosis. Stage progression and collapse did not occur in the other nine cases. Computed tomography confirmed bone regeneration in the femoral heads.Conclusions Clinical application of rhFGF-2-impregnated gelatin hydrogel for patients with precollapse ONFH was feasible and safe.