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目的系统评价干细胞移植治疗脑卒中患者的有效性和安全性。方法检索CENTRAL(2007年4月)、MEDLINE(1966年至2007年4月)、EMBase(1980年至2007年4月)等资源库,纳入干细脆移植治疗脑卒中的临床研究,并按照Juni等的标准对纳入研究的质量进行评价,对干细胞治疗在病死率、功能性结局、认知功能改善、影像学改变、生命质量和副作用等方面的效果进行评估。二分类变量以相对危险度及其95%表示;连续性变量以加权均数差及其试验95%CI表示。统计分析采用RevMan软件。结果纳入3个随机对照,1个历史回顾性研究,共69例。其中1个试验报告了不同治疗对于病死率的影响,显示干细胞移植与仅使用常规疗法相比,并不能降低患者病死率[RR0.11,95%CI(0.01,2.31),P=0.16]。有3个研究的结果显示干细胞移植能改善某些功能性结局,与对照组相比结果有统计学意义。另有一篇文章报告干细胞移植可改善认知功能。一个试验显示与对照组比较,干细胞移植显著提高了患者生活质量。结论现有证据还不足以证明干细胞移植治疗脑卒中患者安全、有效。评价干细胞移植对于脑卒中的作用还有赖于更多高质量且大规模的随机对照试验。
Objective To evaluate the efficacy and safety of stem cell transplantation in the treatment of stroke patients. Methods The databases of CENTRAL (April 2007), MEDLINE (1966 to April 2007) and EMBase (1980 to April 2007) were included into the clinical study of stem-brittle implants for stroke. According to Juni , Etc. The quality of the included studies was evaluated to assess the effects of stem cell therapy on mortality, functional outcome, improvement of cognitive function, imaging changes, quality of life, and side effects. The dichotomous variables were expressed as relative risk and 95% of them; continuous variables were expressed as weighted mean difference and 95% CI of their trials. Statistical analysis using RevMan software. Results Three randomized controlled trials and one historical retrospective study were included. A total of 69 cases were included. One of these trials reported the effect of different treatments on mortality and showed that stem cell transplantation did not reduce patient mortality compared with conventional therapies alone (RR 0.11, 95% CI, 0.01, 2.31). Three studies have shown that stem cell transplantation can improve some functional outcomes, compared with the control group, the results were statistically significant. Another article reports that stem cell transplantation can improve cognitive function. One trial showed that stem cell transplantation significantly improved patient quality of life when compared to controls. Conclusion The available evidence is not enough to prove that stem cell transplantation is safe and effective for the treatment of stroke patients. Assessing the effects of stem cell transplantation on stroke also depends on more high-quality, large-scale randomized controlled trials.