Huang Hongyun, Chen Lin, Xi Haitao, Wang Hongmei, Zhang Jian, Zhang Feng, Liu Yancheng
Beijing Hongtianji Neuroscience Academy, and Department of Neurosurgery, Beijing Xishan Hospital, Beijing, China.
Clin Transplant. 2008 Nov-Dec;22(6):710-8. doi: 10.1111/j.1399-0012.2008.00865.x. Epub 2008 Jul 31.
This study was designed to clarify whether transplantation of fetal olfactory ensheathing cells (OECs) would affect the clinical course of patients with amyotrophic lateral sclerosis (ALS). Thirty-five patients with probable or definite ALS were enrolled from December 2004 to September 2006; 15 patients received OECs transplantation and 20 patients did not receive OECs transplantation. OECs were cultured and injected into the bilateral corona radiata involving the pyramidal tracts of the frontal lobes. The primary end point used to indicate effectiveness was the rate of change according to the ALS Functional Rating Scale (ALS-FRS) total score. All patients were tested five times at baseline and monthly intervals during a four-month follow-up period using assessment of ALS-FRS. Thirty-one patients (14 in the OECs treated group and 17 in the controls) completed the four-month study; the remaining four patients were lost to follow-up. Patients' data were analyzed four months after OECs transplantation and at the end of the controlled period. There was no significant difference in the rate of progression as measured by the ALS-FRS total score during the first two months (p > 0.05). The functional deterioration, however, was significantly slower in the treated group than in the control group during the last two months (p < 0.05). The mean (+/-SD) change for the ALS-FRS total score was 0.07 +/- 4.18 for the treated group and 6.12 +/- 5.49 for the control group (p = 0.002) during the four months. Of the 14 patients in the treatment group, seven experienced neurological functional improvements, two were stable compared with their clinical status at entry, and the ALS-FRS scores in the other five decreased by a mean of 4.4. Of the 17 patients in the control group, only one patient's condition remained stable while the ALS-FRS scores in the other 16 decreased by a mean of 6.5. The result indicates OECs transplantation appears to be able to slow the rate of clinical progression of ALS in the first four months posttransplantation.
本研究旨在阐明胎儿嗅鞘细胞（OECs）移植是否会影响肌萎缩侧索硬化症（ALS）患者的临床病程。2004年12月至2006年9月，招募了35例可能或确诊为ALS的患者；15例患者接受了OECs移植，20例患者未接受OECs移植。OECs经培养后注入双侧辐射冠，累及额叶的锥体束。用于表明疗效的主要终点是根据ALS功能评定量表（ALS-FRS）总分的变化率。在基线时以及在四个月的随访期内每月对所有患者进行一次测试，采用ALS-FRS评估。31例患者（OECs治疗组14例，对照组17例）完成了四个月的研究；其余4例患者失访。在OECs移植后四个月以及对照期结束时对患者数据进行分析。在前两个月，通过ALS-FRS总分测量的疾病进展率没有显著差异（p>0.05）。然而，在最后两个月，治疗组的功能恶化明显慢于对照组（p<0.05）。在四个月期间，治疗组ALS-FRS总分的平均（±标准差）变化为0.07±4.18，对照组为6.12±5.49（p=0.002）。治疗组的14例患者中，7例神经功能有改善，2例与入院时的临床状态相比保持稳定，另外5例患者的ALS-FRS评分平均下降了4.4。对照组的17例患者中，只有1例患者病情保持稳定，而其他16例患者的ALS-FRS评分平均下降了6.5。结果表明，OECs移植似乎能够在移植后的前四个月减缓ALS的临床进展速度。
