干细胞治疗缺血性卒中患者的系统评价及Meta分析

Clinical efficacy and Meta-analysis of stem cell therapies for patients with ischemic stroke

目的：系统评价及Meta分析干细胞移植治疗缺血性脑卒中的临床疗效和安全性。方法：计算机检索Cochrane Library、Pub Med、Ovid、CBM、中国知网、万方和维普数据库,检索干细胞移植治疗缺血性脑卒中的随机对照研究（RCT）,检索时限从建库至2015年12月。所有检索后的文献由2位作者按照纳入与排除标准分别独立进行文献筛选和数据资料提取及偏倚风险评价,并采用Rev Man5.3软件进行Meta分析。结果：共纳入16个研究（18个独立干预治疗）进行Meta分析,得到的结果如下（使用各结局指标的基线终值差进行合并）：神经功能缺损评分（NIHSS）（MD=1.57,95%CI 0.64～2.51,I2=57%,P=0.001）、运动功能FMA（MD=4.23,95%CI 3.08～5.38,I2=0%,P〈0.000 01）、日常生活能力Barthel（MD=8.37,95%CI 4.83～11.91,I2=63%,P〈0.000 01）和功能独立性FIM（MD=8.89,95%CI 4.70～13.08,I2=79%,P〈0.000 1）等结局指标合并后（干细胞移植组和对照组的均数差MD）的结果均是有利于干细胞移植治疗组,且各差异均有统计学意义。结论：干细胞治疗对缺血性脑卒中病人的神经功能和日常生活质量均有不同程度的改善,且不良反应少。但是还需要更多高质量的大数据随机对照研究来进一步证实干细胞移植治疗的有效性。

Objective： To achieve the systematical review and Meta-analysis of the efficacy and safety of stem cell transplantation therapies in patients with ischemic stroke. Methods： We searched Cochrane Library,Pub Med,Ovid,CBM,CNKI,Wan Fang and VIP Data from its inception to December 2015,to collect randomized controlled trials（ RCT） of stem cell transplantation therapies for ischemic stroke. Two authors independently screened literatures according to the inclusion and exclusion criteria,extracted data,and assessed the risk of bias. Then,Meta-analysis was performed by Rev Man 5. 3 software. Results： Sixteen studies and eighteen independent studies were included in the Meta-analysis. The results of pooled mean difference from baseline to follow-up points showed that the stem cell transplantation group was superior to the control group with statistical significance in the neurologic deficits score（ NIHSS,MD = 1. 57,95% CI 0. 64-2. 51,I2= 57%,P = 0. 001）,motor function（ FMA,MD = 4. 23,95% CI 3. 08-5. 38,I2= 0%,P 〈 0. 000 01）,daily life ability（ Barthel,MD = 8. 37,95% CI 4. 83-11. 91,I2= 63%,P 〈 0. 000 01）,and functional independence（ FIM,MD = 8. 89,95% CI 4. 70-13. 08,I2=79%,P 〈 0. 000 1）. Conclusion： The published literatures suggest that the stem cell transplantation therapies for patients with ischemic stroke can improve the neurological deficits and the daily life quality,with no serious adverse events. However,more studies with high-quality and larger data are needed to further investigate the clinical efficacy of the stem cell transplantation.