Local application of recombinant human fibroblast growth factor-2 on bone repair: A dose-escalation prospective trial on patients with osteotomy
Local application of recombinant human fibroblast growth factor-2 on bone repair: A dose-escalation prospective trial on patients with osteotomy
复制标题
DOI：
10.1002/jor.20315
复制
发表时间：
2007-04-01
影响因子：
2.8
通讯作者：
Nakamura, Kozo
中科院分区：
文献类型：
--
作者：
Kawaguchi, Hiroshi;Jingushi, Seiya;Nakamura, Kozo
基于动物模型的临床前证据，本研究在剂量递增的前瞻性试验中检验了重组人成纤维细胞生长因子-2促进骨修复的临床有效性和安全性。对59例膝关节骨性关节炎患者行胫骨高位截骨术，术中将200、400、800 mg3种剂量的重组人成纤维细胞生长因子-2分别注入截骨区，并对其中57例进行16周的监测。重组人成纤维细胞生长因子-2剂量依赖性地增加了放射学骨愈合患者的百分比，减少了骨愈合所需的平均时间。高剂量组中无疼痛和完全负重的患者比例也高于低剂量组，尤其是在临床危重期6、8和10周。无论是血液化学指标还是临床不良事件都与重组人成纤维细胞生长因子-2剂量无关。因此，我们得出结论，明胶水凝胶中的重组人成纤维细胞生长因子-2至少在所使用的剂量下具有促进手术截骨的放射学骨愈合的剂量依赖性，提示该制剂用于骨修复的临床疗效。(C)2007年整形外科研究会。由威利期刊出版公司出版。
Based on preclinical evidence in animal models, the present study examined the clinical efficacy and safety of recombinant human fibroblast growth factor-2 (rhFGF-2) to accelerate bone repair in a dose-escalation prospective trial. One of three dosages (200, 400 or 800 mu g) of rhFGF-2 in a biodegradable gelatin hydrogel was injected during surgery into the osteotomy site of 59 knee osteoarthritis patients undergoing high tibial osteotomy, and 57 of them were monitored for 16 weeks. The rhFGF-2 dose dependently increased the percentage of patients with radiographic bone union, and decreased the average time needed for such union. The percentages of patients with an absence of pain and full-weight bearing were also greater in the higher dosage groups than in the low dosage group, especially in the clinically critical periods 6, 8, and 10 weeks. Neither blood chemistries nor clinical adverse events were associated with the rhFGF-2 dosages. We therefore conclude that the rhFGF-2 in gelatin hydrogel dose dependently accelerated radiographic bone union of a surgical osteotomy with a safety profile at least at the dosages used, suggesting the clinical efficacy of this agent for bone repair. (c) 2007 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.