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自体骨髓细胞疗法治疗外周动脉疾病患者:一项随机对照试验的荟萃分析。

Autologous bone marrow cell therapy for patients with peripheral arterial disease: a meta-analysis of randomized controlled trials.

机构信息

Nanjing University Medical School, Center of Translational Medicine, Nanjing 210093, China.

出版信息

Expert Opin Biol Ther. 2011 Dec;11(12):1581-9. doi: 10.1517/14712598.2011.626401. Epub 2011 Oct 6.

DOI:10.1517/14712598.2011.626401
PMID:21973046
Abstract

OBJECTIVE

Early-phase clinical trials suggest that autologous bone-marrow-derived cells (BMCs) may have a positive effect on patients with severe peripheral arterial disease (PAD). However, the therapeutic effects of BMCs treatment in various aspects remain controversial.

RESEARCH DESIGN AND METHODS

We conducted a meta-analysis using data from randomized controlled trials (RCTs) by comparing autologous BMCs therapy with controls in patients with severe PAD. Pubmed, EMBASE, EBSCO and the Cochrane Central Register of Controlled Trials ( to approximately April 2011) were searched.

RESULTS

Seven RCTs with 276 patients were included. Pooled comparisons of studies found that BMCs therapy significantly improved ankle-brachial index (ABI) by 0.10 (95% CI, 0.07 to 0.14; p < 0.00001), transcutaneous oxygen tension (TcO(2)) by 13.39 mmHg (95% CI, 6.69 to 20.1 mmHg; p < 0.0001) and pain-free walking distance by 119.91 m (95% CI, 90.71 to 149.11 m; p < 0.00001). BMCs therapy significantly decreased scale of rest pain by 1.13 (95% CI, -1.71 to -0.54, p = 0.0002) and helped heal ulcers (OR, 7.17; 95% CI, 2.66 to 19.32; p < 0.0001).

CONCLUSIONS

Our analysis based on seven RCTs suggests that autologous BMCs therapy, has a beneficial effect on physiologic and anatomic parameters in patients with severe PAD.

摘要

目的

早期临床试验表明,自体骨髓源性细胞(BMCs)可能对严重外周动脉疾病(PAD)患者有积极影响。然而,BMCs 治疗在各个方面的治疗效果仍存在争议。

研究设计和方法

我们通过比较严重 PAD 患者自体 BMCs 治疗与对照组,使用来自随机对照试验(RCT)的数据进行了荟萃分析。检索了 PubMed、EMBASE、EBSCO 和 Cochrane 对照试验中心注册库(至 2011 年 4 月左右)。

结果

纳入了 7 项包含 276 名患者的 RCT。研究的汇总比较发现,BMCs 治疗可显著提高踝肱指数(ABI)0.10(95%CI,0.07 至 0.14;p < 0.00001)、经皮氧分压(TcO(2))13.39mmHg(95%CI,6.69 至 20.1mmHg;p < 0.0001)和无痛行走距离 119.91m(95%CI,90.71 至 149.11m;p < 0.00001)。BMCs 治疗可显著降低静息疼痛评分 1.13(95%CI,-1.71 至 -0.54,p = 0.0002)和有助于溃疡愈合(OR,7.17;95%CI,2.66 至 19.32;p < 0.0001)。

结论

我们基于 7 项 RCT 的分析表明,自体 BMCs 治疗对严重 PAD 患者的生理和解剖参数具有有益影响。

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