骨髓来源干细胞移植治疗急性心肌梗死患者的临床疗效和安全性的Meta分析

目的 对骨髓来源干细胞移植治疗急性心肌梗死患者的临床疗效和安全性进行系统评价。方法 计算机检索Pubmed、EMbase、Cochrane Library、维普数据库、万方数据库及CNKI数据库有关骨髓来源干细胞移植治疗急性心肌梗死患者的随机对照试验，检索时间为建库至2018年5月。经过两名系统评价员根据文献纳入与排除标准筛选文献，并提取资料中的相关重要信息，采用RevMan 5.2软件评价纳入文献的偏倚风险，采用Stata 14.0软件进行Meta 分析。结果 通过系统筛选共纳入 39 篇临床随机对照研究，总计 3 314 例急性心肌梗死患者（接受移植治 疗 1 879例，对照1 435例）。异质性检验结果显示纳入的研究之间无明显异质性，Begg和Egger定量检验结果显示各研究间也不存在发表偏倚（P＞0.1）。与对照组相比，输注骨髓来源干细胞能有效改善左心室舒张末期容积（LVEDV）和左心室收缩末期容积（LVESV），而左心室射血分数（LVEF）和心肌梗死面积（MIS）在输注骨髓来源干细胞之后与对照组之间差异无统计学意义。敏感性分析结果显示所纳入的39项研究对于各结局指标合并效应量的影响程度较小，稳定性好，结果较为可信。7项研究报道了后期随访期间出现了不同程度的不良反应，包括死亡、支架 内再狭窄、冠状动脉闭塞，这些不良反应是否与细胞输注相关尚待进一步研究。结论 骨髓来源干细胞移植治疗急性心肌梗死有助于抑制患者左心室重构，临床应用的安全性需要进一步多中心临床试验及长期随访加以评估。

Meta-analysis of clinical efficacy and safety of bone marrow-derived stem cells in the treatment for patients with acute myocardial infarction

Objective To evaluate systematically the clinical efficacy and safety of bone marrow-derived stem cell therapies for patients with acute myocardial infarction. Methods Pubmed, EMbase, the Cochrane Library, VIP database,Wan fang database and CNKI database were searched by computer for randomized controlled trials of bone marrow-derived stem cell therapies in patients with acute myocardial infarction. The retrieval time was from the setup of the database to May 2018. Two systematic evaluators screened the literatures according to the inclusion and exclusion standard, and extracted the important information of literature. After assessing the quality of included studies, the risk of bias was analyzed by RevMan 5.2 software, and Meta-analysis was evaluated by Stata 14.0 software. Results There were 39 case-control studies included in systematic screening including total of 3 314 patients of acute myocardial infarction (1 879 cases received transplantation and 1 435 cases were control). Heterogeneity test showed that there was no significant heterogeneity in the included studies, and Begg’s and Egger’s quantitative tests showed that there was no publication bias among the included studies (P＞0.1). Compared with the control group, bone marrow-derived stem cells could improve effectively left ventricular end diastolic volume (LVEDV) and left ventricular end systolic volume (LVESV), but there were no significant differences in left ventricular ejection fraction (LEVF) and myocardial infarction area (MIS) after infusion of bone marrow-derived stem cells between the two groups. The sensitivity analysis showed that the 39 included studies had less influence on the combination effect of the outcome indicators, and the stability was good, and the results were more credible. Seven studies reported different degrees of adverse reactions after stem cell transplantation, including death, in-stent restenosis and coronary occlusion. Whether these adverse effects are related to cell infusion remains to be further studied. Conclusion The results from systematic evaluation and Meta-analysis suggest that bone marrow-derived stem cell transplantation can improve left ventricular remodeling of patients with acute myocardial infarction, and its clinical safety requires further evaluation of multicenter clinical trials and long-term follow-up.