Moura Mirian Conceicao, Novaes Maria Rita Carvalho Garbi, Zago Yuri S S P, Eduardo Emanoel Junio, Casulari Luiz Augusto
Hospital Regional da Asa Norte, State Secretariat of Health of the Federal District, DF, Brazil.
School of Health Sciences, DF, and University of Brasilia, Brazil.
J Clin Med Res. 2016 Apr;8(4):317-24. doi: 10.14740/jocmr2495w. Epub 2016 Feb 27.
Published studies seeking to improve survival in amyotrophic lateral sclerosis (ALS) have poor results in humans, although there are several studies in animal models with positive results.
We conducted a systematic review and meta-analysis of studies that were published between March 2009 and March 2015 on stem cell therapy and survival in animal models and patients with ALS. A total of 714 articles were identified, and from these, we selected preclinical in vivo studies and retrospective clinical studies.
A meta-analysis confirmed the efficacy of stem cell therapy in improving survival in preclinical trials, where a mean difference of 9.79 days (95% confidence interval: 4.45 - 15.14) in lifespan favored stem cell therapy. In contrast, the number of clinical studies is still insufficient to assess their effectiveness, and these studies only demonstrate the absence of serious adverse events. However, even this conclusion should be interpreted with caution because clinical studies are retrospective and heterogeneous and have an unsatisfactory quality.
尽管在动物模型中有多项研究取得了阳性结果，但旨在提高肌萎缩侧索硬化症（ALS）患者生存率的已发表研究在人体中的效果不佳。
我们对2009年3月至2015年3月期间发表的关于干细胞治疗以及动物模型和ALS患者生存率的研究进行了系统评价和荟萃分析。共识别出714篇文章，从中我们选择了临床前体内研究和回顾性临床研究。
荟萃分析证实了干细胞治疗在改善临床前试验生存率方面的有效性，在寿命方面，干细胞治疗的平均差异为9.79天（95%置信区间：4.45 - 15.14）。相比之下，临床研究的数量仍不足以评估其有效性，这些研究仅表明未出现严重不良事件。然而，即使是这一结论也应谨慎解读，因为临床研究是回顾性的且具有异质性，质量不尽人意。
