*Spine Section, Department of Orthopaedic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan; †Spinal Cord Injury Center, Hokkaido Chuo Rosai Hospital, Hokkaido, Japan; ‡Department of Orthopaedic Surgery, Kobe Red Cross Hospital, Kobe, Japan; §Department of Orthopaedic Surgery, Japan LHWO Spinal Injuries Center, Iizuka, Japan; and ¶Department of Clinical Research, Chiba University Hospital, Chiba, Japan.
Spine (Phila Pa 1976). 2014 Feb 1;39(3):213-9. doi: 10.1097/BRS.0000000000000121.
An open-labeled multicenter prospective nonrandomized controlled clinical trial.
To confirm the feasibility of using granulocyte colony-stimulating factor (G-CSF) for treatment of acute spinal cord injury (SCI).
We previously reported that G-CSF promotes functional recovery after compression-induced SCI in mice. On the basis of these findings, we conducted a multicenter prospective controlled clinical trial to assess the feasibility of G-CSF therapy for patients with acute SCI.
The trial ran from August 2009 to March 2011, and included 41 patients with SCI treated within 48 hours of onset. Informed consent was obtained from all patients. After providing consent, patients were divided into 2 groups. In the G-CSF group (17 patients), G-CSF (10 μg/kg/d) was intravenously administered for 5 consecutive days, and in the control group (24 patients), patients were similarly treated except for the G-CSF administration. We evaluated motor and sensory functions using the American Spinal Cord Injury Association score and American Spinal Cord Injury Association impairment scale at 1 week, 3 months, 6 months, and 1 year after onset.
Only 2 patients did not experience American Spinal Cord Injury Association impairment scale improvement in the G-CSF group. In contrast, 15 patients in the control group did not experience American Spinal Cord Injury Association impairment scale improvement. In the analysis of increased American Spinal Cord Injury Association motor score, a significant increase in G-CSF group was detected from 1 week after the administration compared with the control group. After that, some spontaneous increase of motor score was detected in control group, but the significant increase in G-CSF group was maintained until 1 year of follow-up.
Despite the limitation that patient selection was not randomized, the present results suggest the possibility that G-CSF administration has beneficial effects on neurological recovery in patients with acute SCI.
一项开放性、多中心、前瞻性、非随机对照临床试验。
确认粒细胞集落刺激因子（G-CSF）治疗急性脊髓损伤（SCI）的可行性。
我们先前的研究报告表明，G-CSF 可促进小鼠压迫性 SCI 后的功能恢复。基于这些发现，我们开展了一项多中心前瞻性对照临床试验，以评估 G-CSF 治疗急性 SCI 患者的可行性。
试验于 2009 年 8 月至 2011 年 3 月进行，纳入了 41 例发病后 48 小时内的 SCI 患者。所有患者均获得知情同意。同意后，患者分为 2 组。G-CSF 组（17 例）给予 G-CSF（10 μg/kg/d）连续静脉输注 5 天，对照组（24 例）给予相同的治疗，除外 G-CSF 给药。发病后 1 周、3 个月、6 个月和 1 年，我们采用美国脊髓损伤协会评分和美国脊髓损伤协会损伤量表评估运动和感觉功能。
G-CSF 组仅 2 例患者的美国脊髓损伤协会损伤量表评分无改善，而对照组有 15 例患者无改善。在分析美国脊髓损伤协会运动评分增加方面，与对照组相比，G-CSF 组在给药后 1 周即有显著增加。此后，对照组的运动评分出现了一些自发性增加，但 G-CSF 组的显著增加一直持续到 1 年随访。
尽管患者选择未随机，但本研究结果提示，G-CSF 给药可能对急性 SCI 患者的神经恢复有有益作用。
3 级。
