自体干细胞疗法治疗严重肢体缺血：随机对照试验的荟萃分析

Autologous Stem Cell Therapy in Critical Limb Ischemia: A Meta-Analysis of Randomized Controlled Trials.

作者信息

Xie Baocheng, Luo Houlong, Zhang Yusheng, Wang Qinghui, Zhou Chenhui, Xu Daohua

机构信息

Department of Pharmacology, Guangdong Medical University, Dongguan 523808, China.

Institute of Laboratory Medicine, Guangdong Medical University, Dongguan 523808, China.

出版信息

Stem Cells Int. 2018 May 24;2018:7528464. doi: 10.1155/2018/7528464. eCollection 2018.

OBJECTIVE

Critical limb ischemia (CLI) is the most dangerous stage of peripheral artery disease (PAD). Many basic researches and clinical treatment had been focused on stem cell transplantation for CLI. This systematic review was performed to review evidence for safety and efficacy of autologous stem cell therapy in CLI.

METHODS

A systematic literature search was performed in the SinoMed, PubMed, Embase, ClinicalTrials.gov, and Cochrane Controlled Trials Register databases from building database to January 2018.

RESULTS

Meta-analysis showed that cell therapy significantly increased the probability of ulcer healing (RR = 1.73, 95% CI = 1.45-2.06), angiogenesis (RR = 5.91, 95% CI = 2.49-14.02), and reduced the amputation rates (RR = 0.59, 95% CI = 0.46-0.76). Ankle-brachial index (ABI) (MD = 0.13, 95% CI = 0.11-0.15), TcO (MD = 12.22, 95% CI = 5.03-19.41), and pain-free walking distance (MD = 144.84, 95% CI = 53.03-236.66) were significantly better in the cell therapy group than in the control group ( < 0.01).

CONCLUSIONS

The results of this meta-analysis indicate that autologous stem cell therapy is safe and effective in CLI. However, higher quality and larger RCTs are required for further investigation to support clinical application of stem cell transplantation.

目的

严重肢体缺血（CLI）是外周动脉疾病（PAD）最危险的阶段。许多基础研究和临床治疗都集中在CLI的干细胞移植上。本系统评价旨在回顾自体干细胞治疗CLI的安全性和有效性证据。

方法

从数据库建立至2018年1月，在中华医学期刊全文数据库、PubMed、Embase、ClinicalTrials.gov和Cochrane对照试验注册数据库中进行系统文献检索。

结果

Meta分析显示，细胞治疗显著提高了溃疡愈合的概率（RR = 1.73，95%CI = 1.45 - 2.06）、血管生成（RR = 5.91，95%CI = 2.49 - 14.02），并降低了截肢率（RR = 0.59，95%CI = 0.46 - 0.76）。细胞治疗组的踝肱指数（ABI）（MD = 0.13，95%CI = 0.11 - 0.15）、经皮氧分压（TcO）（MD = 12.22，95%CI = 5.03 - 19.41）和无痛步行距离（MD = 144.84，95%CI = 53.03 - 236.66）均显著优于对照组（P < 0.01）。