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粒细胞集落刺激因子(G-CSF)对急性脊髓损伤患者功能预后的影响:一项单盲随机对照试验。

Effect of granulocyte colony-stimulating factor (G-CSF) in functional outcome of acute spinal cord injury patients: A single-blinded randomized controlled trial.

作者信息

Mounissamy Prabu, Premraj A C, Chanadrashekar Sushma, Jeyaraman Naveen, Ramasubramanian Swaminathan, Jeyaraman Madhan

机构信息

Department of Orthopaedics, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, 605006, India.

Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, 600077, Chennai, Tamil Nadu, India.

出版信息

J Orthop. 2024 Nov 26;64:97-101. doi: 10.1016/j.jor.2024.11.025. eCollection 2025 Jun.

Abstract

BACKGROUND

Spinal Cord Injury (SCI) is a major public health issue causing significant disability and economic burden. Current treatments primarily focus on mitigating secondary injury, with limited effective therapies available. This study explores the efficacy of the Granulocyte Colony-Stimulating Factor (G-CSF) in improving functional outcomes in acute SCI patients.

MATERIALS AND METHODS

This single-blinded randomized control trial was conducted at JIPMER's orthopedic department. Patients with acute spinal cord injury (SCI) were enrolled based on specific inclusion and exclusion criteria. Participants were divided into two groups: Group A (n = 16) received a G-CSF injection whereas Group B (n = 18) received a placebo (normal saline) injection. The primary evaluation was based on the changes in the ASIA impairment scale at 1-, 3-, and 6-months post-injury.

RESULTS

The study involved 34 participants, predominantly male. Initial assessments showed significant differences in ASIA scores between the groups. Group A demonstrated marked improvement in neurological status at 1, 3, and 6 months post-treatment compared to Group B. The frequency of adverse events was comparable between the two groups.

CONCLUSION

G-CSF showed significant improvement in ASIA scores at various time points post-administration compared to placebo. These findings suggest G-CSF as a potential therapeutic agent in acute SCI treatment. However, due to the small sample size, further research is necessary to confirm these results.

摘要

背景

脊髓损伤(SCI)是一个重大的公共卫生问题,会导致严重的残疾和经济负担。目前的治疗主要集中在减轻继发性损伤,有效的治疗方法有限。本研究探讨粒细胞集落刺激因子(G-CSF)对改善急性脊髓损伤患者功能结局的疗效。

材料与方法

本单盲随机对照试验在JIPMER骨科进行。根据特定的纳入和排除标准招募急性脊髓损伤(SCI)患者。参与者分为两组:A组(n = 16)接受G-CSF注射,而B组(n = 18)接受安慰剂(生理盐水)注射。主要评估基于伤后1个月、3个月和6个月时ASIA损伤量表的变化。

结果

该研究纳入了34名参与者,以男性为主。初始评估显示两组之间ASIA评分存在显著差异。与B组相比,A组在治疗后1个月、3个月和6个月时神经功能状态有明显改善。两组不良事件的发生率相当。

结论

与安慰剂相比,G-CSF在给药后的不同时间点ASIA评分有显著改善。这些发现表明G-CSF可能是急性脊髓损伤治疗的一种潜在治疗药物。然而,由于样本量较小,需要进一步研究来证实这些结果。

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