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重组酸性成纤维细胞生长因子促进创伤性美国脊髓损伤协会损伤量表A级脊髓损伤患者的运动恢复并减轻脊髓软化。

Recombinant Acidic Fibroblast Growth Factor Facilitates Motor Recovery and Reduces Myelomalacia in Traumatic American Spinal Injury Association Impairment Scale A Spinal Cord Injured Patients.

作者信息

Chang Wan-Ya, Huang Wen-Cheng, Tsai Yun-An, Yang Lin-Hsue, Su Yi-Tien, Huang Shih-Fong, Huang Chiau-Li, Lee Ya-Hui, Hsu Shu-Shong, Fay Li-Yu

机构信息

Eusol Biotech Co., Ltd., Taipei, Taiwan.

Institute of Pharmacology, National Yang Ming Chiao Tung University, Taipei, Taiwan.

出版信息

Neurotrauma Rep. 2024 Oct 2;5(1):910-915. doi: 10.1089/neur.2024.0063. eCollection 2024.

Abstract

This study aims to evaluate the potential benefits of treating spinal cord injury (SCI) patients with acidic fibroblast growth factor (aFGF), a potent neurotrophic factor that preserves neuronal survival. The study involved 12 tetraplegic patients with American Spinal Injury Association Impairment Scale (AIS) Grade A SCI who were randomly assigned to receive either a recombinant human aFGF or a placebo every 4 weeks for three doses. Participants underwent comprehensive evaluations of medical, neurological, and functional parameters at baseline and every 4 weeks after the first dose until the 48th week. The first dose was administered directly to the injury site during surgery within 6 weeks of the SCI, while the subsequent two doses were administered via lumbar puncture with a 4-week interval. The results revealed promising beneficial effects of aFGF on AIS Grade A SCI patients. The study report highlights aFGF's potential to expedite motor recovery in complete SCI patients and significantly increase the probability of a 10-point improvement when compared to the placebo group (odds ratio = 6.06, = 0.0004). Furthermore, aFGF treatment exhibited a significant reduction ( < 0.01) in the incidence or exacerbation rate of myelomalacia, a known secondary complication following SCIs.

摘要

本研究旨在评估用酸性成纤维细胞生长因子(aFGF)治疗脊髓损伤(SCI)患者的潜在益处,aFGF是一种能维持神经元存活的强效神经营养因子。该研究纳入了12例美国脊髓损伤协会损伤分级(AIS)为A级的四肢瘫痪SCI患者,他们被随机分配,每4周接受一次重组人aFGF或安慰剂注射,共注射三剂。参与者在基线时以及首次给药后的每4周直至第48周,接受了医学、神经学和功能参数的全面评估。首剂在SCI后6周内手术期间直接注射到损伤部位,随后两剂通过腰椎穿刺给药,间隔4周。结果显示aFGF对AIS A级SCI患者有显著的有益效果。该研究报告强调了aFGF在完全性SCI患者中加快运动恢复的潜力,与安慰剂组相比,显著提高了改善10分的概率(优势比=6.06,P=0.0004)。此外,aFGF治疗使脊髓软化(一种已知的SCI继发性并发症)的发生率或加重率显著降低(P<0.01)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dcab/11491575/29c4c8e624af/neur.2024.0063_figure1.jpg

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