Stem Cell Research Laboratory, NHS-Blood and Transplant, John Radcliffe Hospital, Oxford, United Kingdom.
PLoS One. 2012;7(5):e37373. doi: 10.1371/journal.pone.0037373. Epub 2012 May 24.
To investigate whether there are important sources of heterogeneity between the findings of different clinical trials which administer autologous stem cell treatment for acute myocardial infarction (AMI) and to evaluate what factors may influence the long-term effects of this treatment.
MEDLINE (1950-January 2011), EMBASE (1974-January 2011), CENTRAL (The Cochrane Library 2011, Issue 1), CINAHL (1982-January 2011), and ongoing trials registers were searched for randomised trials of bone marrow stem cells as treatment for AMI. Hand-searching was used to screen recent, relevant conference proceedings (2005-2010/11). Meta-analyses were conducted using random-effects models and heterogeneity between subgroups was assessed using chi-squared tests. Planned analyses included length of follow-up, timing of cell infusion and dose, patient selection, small trial size effect, methodological quality, loss of follow-up and date of publication. Thirty-three trials with a total of 1,765 participants were included. There was no evidence of bias due to publication or time-lag, methodological quality of included studies, participant drop-out, duration of follow-up or date of the first disclosure of results. However, in long-term follow-ups the treatment seemed more effective when administered at doses greater than 10(8) cells and to patients with more severe heart dysfunction.
Evaluation of heterogeneity between trials has not identified significant sources of bias in this study. However, clinical differences between trials are likely to exist which should be considered when undertaking future trials.
探讨不同临床试验中自体干细胞治疗急性心肌梗死(AMI)的结果是否存在重要的异质性来源,并评估哪些因素可能影响这种治疗的长期效果。
检索了 MEDLINE(1950 年 1 月至 2011 年 1 月)、EMBASE(1974 年 1 月至 2011 年 1 月)、CENTRAL(the Cochrane Library 2011 年第 1 期)、CINAHL(1982 年 1 月至 2011 年 1 月)和正在进行的试验登记处,以寻找骨髓干细胞作为 AMI 治疗的随机试验。使用手工检索筛选了最近的相关会议记录(2005-2010/11 年)。使用随机效应模型进行荟萃分析,并使用卡方检验评估亚组间的异质性。计划分析包括随访时间、细胞输注和剂量的时间、患者选择、小试验规模效应、方法学质量、失访和发表日期。共纳入 33 项试验,共 1765 名参与者。由于出版或时间滞后、纳入研究的方法学质量、参与者脱落、随访时间或结果首次披露的日期,不存在偏倚的证据。然而,在长期随访中,当给予大于 10(8)个细胞的剂量和更严重心功能障碍的患者时,治疗似乎更有效。
对试验间异质性的评估未发现本研究中有显著的偏倚来源。然而,试验之间可能存在临床差异,在进行未来的试验时应予以考虑。