Primary Care Department, USL Toscana Sud Est-Grosseto, Grosseto, Italy; Clinical and Experimental Medicine PhD Program, University of Modena and Reggio Emilia, Modena, Italy.
Division of Pathology, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Italy.
Ageing Res Rev. 2021 May;67:101257. doi: 10.1016/j.arr.2021.101257. Epub 2021 Jan 9.
Stem cells are a promising therapy for various medical conditions. The literature regarding their adoption for the clinical care of cardiovascular diseases (CVD) is still conflicting. Therefore, our aim is to assess the strength and credibility of the evidence on clinical outcomes and application of stem cells derived from systematic reviews and meta-analyses of intervention studies in CVD.
Umbrella review of systematic reviews with meta-analyses of randomized controlled trials (RCTs) using placebo/no intervention as control group. For meta-analyses of RCTs, outcomes with a random-effect p-value <0.05, the GRADE (Grading of Recommendations Assessment, Development and Evaluation) assessment was used, classifying the evidence from very low to high. From 184 abstracts initially identified, 11 meta-analyses (for a total of 34 outcomes) were included. Half of the outcomes were statistically significant (p < 0.05), indicating that stem cells are more useful than placebo. High certainty of evidence supports the associations of the use of stem cells with a better left ventricular end systolic volume and left ventricular ejection fraction (LVEF) in acute myocardial infarction; improved exercise time in refractory angina; a significant lower risk of amputation rate in critical limb ischemia; a higher successful rate in complete healing in case of lower extremities ulcer; and better values of LVEF in systolic heart failure, as compared to placebo.
The adoption of stem cells in clinical practice is supported by a high certainty of strength in different CVD, with the highest strength in acute myocardial infarction and refractory angina.
干细胞是治疗各种医学病症的一种有前景的疗法。关于将其应用于心血管疾病(CVD)临床治疗的文献仍然存在争议。因此,我们的目的是评估系统评价和荟萃分析中干预研究的临床结果和干细胞应用的证据强度和可信度,这些研究涉及来自系统评价和荟萃分析的随机对照试验(RCT)。
采用安慰剂/无干预作为对照的 RCT 系统评价和荟萃分析的伞式综述。对于 RCT 的荟萃分析,采用随机效应 p 值 <0.05 的结果,使用 GRADE(推荐评估、制定与评价)评估,将证据从极低到高进行分类。从最初确定的 184 个摘要中,纳入了 11 项荟萃分析(共 34 项结果)。一半的结果具有统计学意义(p < 0.05),表明干细胞比安慰剂更有效。高确定性证据支持使用干细胞与急性心肌梗死后左心室收缩末期容积和左心室射血分数(LVEF)改善、难治性心绞痛运动时间延长、临界肢体缺血截肢率降低、下肢溃疡完全愈合成功率提高以及收缩性心力衰竭时 LVEF 值改善相关。
在不同的 CVD 中,干细胞的临床应用得到了高强度的有力支持,在急性心肌梗死和难治性心绞痛中强度最高。