干细胞疗法在急性心肌梗死中的安全性和有效性：一项关于通过心脏磁共振成像评估不良事件、梗死面积和左心室射血分数的系统评价和荟萃分析。

Safety and efficacy of stem cell therapy in acute myocardial infarction: a systematic review and meta-analysis of adverse events, infarct size and LV ejection fraction assessed by CMRI.

作者信息

Moeswir Dede, Nurbaeti Putri, Hendarto Hari, Abdul Rahman Muhammad Farhan

机构信息

Division of Cardiology, Department of Internal Medicine, UIN Syarif Hidayatullah, Jakarta, Indonesia.

Division of Endocrine-Metabolic-Disease, Department of Internal Medicine, UIN Syarif Hidayatullah, Jakarta, Indonesia.

出版信息

Open Heart. 2025 Jun 27;12(1):e003301. doi: 10.1136/openhrt-2025-003301.

DOI:10.1136/openhrt-2025-003301

PMID:40579230

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12207128/

Abstract

INTRODUCTION

The current standard treatment for ST-segment elevation myocardial infarction is prompt reperfusion through primary percutaneous coronary intervention. However, myocardial infarction remains the leading cause of heart failure, contributing to prolonged hospital stay and a 30% rehospitalisation rate within 6 months. Stem cell therapy has emerged as a potential approach to repair myocardial damage.

METHODS

This study is a meta-analysis of randomised clinical trials available online. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed, and the study was conducted according to the Cochrane Handbook for Systematic Reviews of Interventions.

RESULTS

21 articles from 15 trials (21 clinical trial interventions) with a total of 1218 participants were included. Stem cell therapy was associated with fewer adverse events than controls (OR 0.66, 95% CI 0.44 to 0.99, p=0.05), supporting its short-term to mid-term safety. No cardiac-related cancer cases were reported in any group, but longer follow-up is needed to assess potential oncogenic risks. Efficacy analyses showed no significant effect on infarct size (absolute or relative) or left ventricular ejection fraction (LVEF) in short-term follow-up. In long-term follow-up, relative infarct size became statistically significant in favour of stem cell therapy only after exclusion of an outlier study (standardised mean difference -0.63, 95% CI -0.94 to -0.32, p<0.0001). Long-term LVEF improvement was also significant (mean difference 2.63%, 95% CI 0.50% to 4.76%, p=0.02), although substantial heterogeneity remained unexplained despite sensitivity analyses, including the removal of low-correlation studies.

CONCLUSION

Stem cell therapy for acute myocardial infarction demonstrates a favourable safety profile. While overall efficacy remains uncertain, long-term benefits may exist, particularly for relative infarct size and LVEF. However, interpretation is limited by study heterogeneity. Future trials with standardised protocols and longer follow-up are warranted.

摘要

引言

ST段抬高型心肌梗死的当前标准治疗方法是通过直接经皮冠状动脉介入治疗迅速实现再灌注。然而，心肌梗死仍然是心力衰竭的主要原因，导致住院时间延长以及6个月内30%的再住院率。干细胞疗法已成为修复心肌损伤的一种潜在方法。

方法

本研究是对在线随机临床试验的荟萃分析。遵循系统评价和荟萃分析的首选报告项目指南，并根据Cochrane干预措施系统评价手册进行研究。

结果

纳入了来自15项试验（21项临床试验干预措施）的21篇文章，共有1218名参与者。干细胞疗法与对照组相比不良事件更少（比值比0.66，95%置信区间0.44至0.99，p = 0.05），支持其短期至中期安全性。任何组均未报告与心脏相关的癌症病例，但需要更长时间的随访来评估潜在的致癌风险。疗效分析显示，短期随访中对梗死面积（绝对或相对）或左心室射血分数（LVEF）无显著影响。在长期随访中，仅在排除一项异常值研究后，相对梗死面积在统计学上才显著有利于干细胞疗法（标准化均数差-0.63，95%置信区间-0.94至-0.32，p < 0.0001）。长期LVEF改善也很显著（均数差2.63%，95%置信区间0.50%至4.76%，p = 0.02），尽管进行了敏感性分析，包括去除低相关性研究后，仍有大量异质性无法解释。