Fisher S A, Doree C, Taggart D P, Mathur A, Martin-Rendon E
Nuffield Division of Clinical Laboratory Sciences, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
Systematic Review Initiative, NHS Blood and Transplant, Oxford, UK.
Clin Pharmacol Ther. 2016 Jul;100(1):88-101. doi: 10.1002/cpt.344. Epub 2016 May 9.
Meta-analyses of cell therapy trials for heart disease have yielded discrepant results. To resolve limitations associated with meta-analyses, such as imprecision and accumulation of random errors, we conducted trial sequential analysis (TSA). Randomized controlled trials that administered autologous bone marrow-derived cells to patients who suffered acute myocardial infarction (AMI) or heart failure (HF) were included. TSA has been applied to two clinical outcomes, all-cause mortality and hospitalization for HF, and to left ventricular ejection fraction (LVEF), as a surrogate of heart function. The results suggest that there is evidence of reduction of the risk of mortality and hospitalization in HF, but insufficient evidence to determine treatment effect in AMI. Moreover, the treatment does not improve LVEF by more than a mean difference of 4% when administered to either AMI or HF patients. The required number of participants to include in a meta-analysis to detect treatment effect was also estimated.
针对心脏病的细胞治疗试验的荟萃分析得出了不一致的结果。为解决与荟萃分析相关的局限性,如不精确性和随机误差的累积,我们进行了试验序贯分析(TSA)。纳入了将自体骨髓来源细胞给予急性心肌梗死(AMI)或心力衰竭(HF)患者的随机对照试验。TSA已应用于两个临床结局,即全因死亡率和HF住院率,以及作为心脏功能替代指标的左心室射血分数(LVEF)。结果表明,有证据显示HF患者的死亡率和住院风险降低,但确定AMI治疗效果的证据不足。此外,当给予AMI或HF患者治疗时,治疗对LVEF的改善未超过平均差值4%。还估计了荟萃分析中为检测治疗效果所需纳入的参与者数量。