摘要
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 assess systematically the safety and effects of stem cell transplantation in stroke patients. Method CENTRAL (April 2007),MEDLINE (1966 to April 2007),EMBASE (1980 to April 2007), and other databases were searched for RCT of the use of stem cell transplantation for patients with stroke. We critically appraised the quality of included studies according to luny 2001. We assessed the effects of stern cell therapy on mortality,functional outcomes,cognitive functions,image changes,quality of life,and adverse effects by doing meta-analysis with The Cochrane Collaboration's Review Manager. Dichotomous outcomes were reported as relative risk and continuous outcome measures as weighted mean differences,with 95% confidence intervals. Result Three RCTs and one historical controlled trial were included involving a total of 69 participants. Only one trial reported the effect on mortality,but because of the small number of death it was not possible to detect any significant differences between stem cell transplantation and routine treatment (RR 0.11,95%CI 0.01 to 2.31,P = 0.16). Three studies indicated a statistically significant improvement of some functional outcomes in patients treated by stem cell transplantation. Improvements of cognitive function were reported in another trial. One trial showed that the stem cell transplantation significantly improved quality of life compared with the control group. Conclusions The current evidence is insufficient to determine whether or not stem cell transplantation is a safe and effective therapy for stroke patients. High-quality,large-scale randomized trials are needed to assess the role of stem cell transplantation for stroke.
出处
《中国循证医学杂志》
CSCD
2007年第10期743-749,共7页
Chinese Journal of Evidence-based Medicine
关键词
脑卒中
干细胞移植
系统评价
Stroke Stem cell transplantation
Systematic review