Department of Preventive Medicine, College of Medicine, The Catholic University of Korea, Seoul.
Department of Preventive Medicine, College of Medicine, The Catholic University of Korea, Seoul ; Clinical Research Coordinating Center, Catholic Medical Center, Seoul.
Int J Stem Cells. 2014 Nov;7(2):63-9. doi: 10.15283/ijsc.2014.7.2.63.
Stem cell-based therapy is a potential new approach in the treatment of stroke. However, the efficacy and safety of these treatments are not yet fully understood. Therefore, we performed a meta-analysis of available single-arm studies using stem cell-based therapy in patients with stroke.
We searched MEDLINE, EMBASE, and the Cochrane database for studies of stem cell therapy in patients with stroke from its inception through July 2014. The articles included in the search were restricted to the English language, studies with at least 5 patients, and those using cell-based therapies for treating stroke.
Fourteen studies included in the meta-analysis. The pooled mean difference in National Institutes of Health Stroke Scale (NIHSS) scores from baseline to follow-up points was 5.7 points (95%CI: -8.2 to -3.2, I(2) =91.5%) decreased. Also the pooled mean difference in modified Bathel index (BI) score was increased by 31.5 points (95%CI: 35.6∼14.9, I(2) =52.7%) and the pooled incidence rate to achieve on modified Rankin score (mRS)≤2 was 40% (95% CI: 30%∼51%, I(2) =35.4%) at follow-up points. The pooled incidence rates of death, seizure, and infection were 13% (95%CI, 8∼23%), 15% (95%CI, 8∼25%), and 15% (95%CI, 8∼23%), respectively.
The published data suggest that stem cell-based therapy for patients with stroke can be judged as effective based on single arm clinical studies. However, clinical benefits of stem cell therapy for patients with stroke need further investigation and reevaluation to test the clinical efficacy.
基于干细胞的治疗是中风治疗的一种新的潜在方法。然而，这些治疗的疗效和安全性尚未完全了解。因此，我们对使用基于干细胞的治疗中风患者的现有单臂研究进行了荟萃分析。
我们检索了 MEDLINE、EMBASE 和 Cochrane 数据库，从其建立到 2014 年 7 月，检索了干细胞治疗中风患者的研究。搜索到的文章仅限于英文，至少有 5 名患者的研究，以及使用细胞治疗治疗中风的研究。
共有 14 项研究纳入荟萃分析。从基线到随访点，国立卫生研究院中风量表（NIHSS）评分的平均差值为 5.7 分（95%CI：-8.2 至-3.2，I(2) =91.5%）降低。改良巴氏量表（BI）评分的平均差值也增加了 31.5 分（95%CI：35.6∼14.9，I(2) =52.7%），在随访点，达到改良 Rankin 量表（mRS）≤2 的累积发生率为 40%（95%CI：30%∼51%，I(2) =35.4%）。死亡、癫痫发作和感染的累积发生率分别为 13%（95%CI，8∼23%）、15%（95%CI，8∼25%）和 15%（95%CI，8∼23%）。
已发表的数据表明，基于单臂临床研究，中风患者的基于干细胞的治疗可被判断为有效。然而，中风患者的干细胞治疗的临床获益需要进一步的研究和重新评估，以测试其临床疗效。
