A Local Application of Recombinant Human Fibroblast Growth Factor 2 for Tibial Shaft Fractures: A Randomized, Placebo-Controlled Trial
A Local Application of Recombinant Human Fibroblast Growth Factor 2 for Tibial Shaft Fractures: A Randomized, Placebo-Controlled Trial
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DOI：
10.1002/jbmr.146
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发表时间：
2010-12-01
影响因子：
6.2
通讯作者：
Nakamura, Kozo
中科院分区：
文献类型：
--
作者：
Kawaguchi, Hiroshi;Oka, Hiroyuki;Nakamura, Kozo
成纤维细胞生长因子-2(成纤维细胞生长因子-2)是一种有效的间充质细胞有丝分裂原，在我们的动物实验和外科截骨术患者的预备剂量递增试验中，已有报道将重组人成纤维细胞生长因子-2(rh-fg-2)局部应用于明胶水凝胶中以促进骨愈合。安慰剂对照试验中，新鲜横形或短斜型胫骨骨折患者被随机分为三组，在连续两年的髓内钉手术结束时，向骨折间隙注射含有安慰剂或0.8 mg(低剂量组)或24 mg(高剂量组)的明胶水凝胶，其中85例符合资格标准。和70名患者(安慰剂组24人，低剂量组和高剂量组各23人)完成了为期24周的研究。与安慰剂组相比，重组人成纤维细胞生长因子-2治疗组(低剂量组和高剂量组分别为031和009)的放射学骨愈合患者的累积百分比更高，尽管在24周时，安慰剂组、低剂量组和高剂量组的患者之间没有显著差异(p=776)，但安慰剂组、低剂量组和高剂量组的患者继续显示延迟愈合，没有患者接受二次干预，三组无痛负重时间差异无统计学意义(p=567)。三组不良事件发生率也无显著差异。结论：局部应用重组人成纤维细胞生长因子-2水凝胶加速胫骨骨折愈合具有安全性(C)2010年美国骨与矿物研究学会
Fibroblast growth factor 2 (FGF-2) is a potent mitogen for mesenchymal cells, and a local application of recombinant human FGF-2 (rhFGF-2) in a gelatin hydrogel has been reported to accelerate bone union in our animal studies and preparatory dose-escalation trial on patients with surgical osteotomy We have performed a randomized, double-blind, placebo-controlled trial in which patients with fresh tibial shaft fractures of transverse or short oblique type were randomly assigned to three groups receiving a single injection of the gelatin hydrogel containing either placebo or 0 8 mg (low-dosage group) or 24 mg (high-dosage group) of rhFGF-2 into the fracture gap at the end of an intramedullary nailing surgery Of 194 consecutive patients over 2 years, 85 met the eligibility criteria, and 70 (24 in the placebo group and 23 each in low- and high-dosage groups) completed the 24-week study The cumulative percentages of patients with radiographic bone union were higher in the rhFGF-2-treated groups (p = 031 and 009 in low- and high-dosage group, respectively) compared with the placebo group, although there was no significant difference between low- and high-dosage groups (p = 776) At 24 weeks, 4, 1, and 0 patients in the placebo, low-dosage, and high-dosage groups, respectively, continued to show delayed union No patient underwent a secondary intervention, and the time to full weight bearing without pain was not significantly different among the three groups (p = 567) There also was no significant difference in the profiles of adverse events among the groups In conclusion, a local application of the rhFGF-2 hydrogel accelerated healing of tibial shaft fractures with a safety profile (C) 2010 American Society for Bone and Mineral Research