Peeters Weem S M O, Teraa M, de Borst G J, Verhaar M C, Moll F L
Department of Vascular Surgery, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.
Department of Vascular Surgery, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.
Eur J Vasc Endovasc Surg. 2015 Dec;50(6):775-83. doi: 10.1016/j.ejvs.2015.08.018. Epub 2015 Oct 12.
OBJECTIVE/BACKGROUND: Critical limb ischemia (CLI) is the most advanced stage of peripheral artery disease (PAD), and many patients with CLI are not eligible for conventional revascularization. In the last decade, cell based therapies have been explored as an alternative treatment option for CLI. A meta-analysis was conducted of randomized placebo controlled trials investigating bone marrow (BM) derived cell therapy in patients with CLI.
The MEDLINE, Embase, and the Cochrane Controlled Trials Register databases were systematically searched, and all included studies were critically appraised by two independent reviewers. The meta-analysis was performed using a random effects model.
Ten studies, totaling 499 patients, were included in this meta-analysis. No significant differences were observed in major amputation rates (relative risk [RR] 0.91; 95% confidence interval [CI] 0.65-1.27), survival (RR 1.00; 95% CI 0.95-1.06), and amputation free survival (RR 1.03; 95% CI 0.86-1.23) between the cell treated and placebo treated patients. The ankle brachial index (mean difference 0.11; 95% CI 0.07-0.16), transcutaneous oxygen measurements (mean difference 11.88; 95% CI 2.73-21.02), and pain score (mean difference -0.72; 95% CI -1.37 to -0.07) were significantly better in the treatment group than in the placebo group.
This meta-analysis of placebo controlled trials showed no advantage of stem cell therapy on the primary outcome measures of amputation, survival, and amputation free survival in patients with CLI. The potential benefit of more sophisticated cell based strategies should be explored in future randomized placebo controlled trials.
目的/背景：严重肢体缺血（CLI）是外周动脉疾病（PAD）的最晚期阶段，许多CLI患者不符合传统血管重建术的条件。在过去十年中，基于细胞的疗法已被探索作为CLI的替代治疗选择。对调查CLI患者骨髓（BM）来源细胞治疗的随机安慰剂对照试验进行了荟萃分析。
系统检索MEDLINE、Embase和Cochrane对照试验注册数据库，所有纳入研究均由两名独立评审员进行严格评估。使用随机效应模型进行荟萃分析。
本荟萃分析纳入了10项研究，共499例患者。在接受细胞治疗和安慰剂治疗的患者之间，主要截肢率（相对风险[RR]0.91；95%置信区间[CI]0.65 - 1.27）、生存率（RR 1.00；95% CI 0.95 - 1.06）和无截肢生存率（RR 1.03；95% CI 0.86 - 1.23）方面未观察到显著差异。治疗组的踝臂指数（平均差异0.11；95% CI 0.07 - 0.16）、经皮氧测量值（平均差异11.88；95% CI 2.73 - 21.02）和疼痛评分（平均差异 - 0.72；95% CI - 1.37至 - 0.07）显著优于安慰剂组。
这项安慰剂对照试验的荟萃分析表明，干细胞疗法在CLI患者的截肢、生存和无截肢生存等主要结局指标上没有优势。未来应在随机安慰剂对照试验中探索更复杂的基于细胞策略的潜在益处。
