缺血性中风患者静脉注射间充质干细胞的疗效和安全性,系统回顾和荟萃分析

Maged Elsayed Hassanein, Jaber Fayad, Jilan Ali Shabana, Esraa M. AlEdani, M. Hefnawy, Hazem. S Ghaith, A. Negida
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摘要

临床试验评估了静脉间充质干细胞(MSCs)治疗急性和亚急性缺血性中风的疗效。因此,我们进行了这项荟萃分析,研究急性和亚急性缺血性中风患者静脉注射间充质干细胞治疗与安慰剂相比的疗效和安全性。我们检索了PubMed、SCOPUS、Web of Science和Cochrane CENTRAL的随机对照试验,以评估急性和亚急性缺血性中风患者静脉注射间充质干细胞的任何临床试验。本研究的疗效指标是美国国立卫生研究院卒中量表(NIHSS)评分、改良Rankin量表(mRS)良好评分和Barthel指数(BI)评分的改善率,而安全性指标是死亡率和卒中复发率。我们利用 R 软件中的固定效应荟萃分析模型对静脉间充质干细胞和安慰剂治疗进行了比较。在荟萃分析中,间充质干细胞治疗在改善 mRS(MD -0.95,95% CI [-1.39,-0.52])或 BI(MD 21.36,95% CI [9.96,32.75])评分方面优于安慰剂治疗,而在改善 NIHSS 评分方面,间充质干细胞治疗不优于安慰剂治疗(MD -1.81,95% CI [-4.123,0.494])。间充质干细胞既不会降低死亡率,也不会降低中风复发率(风险比分别为 0.58 和 0.59;P 值分别为 0.51 和 0.533)。对于符合神经组织进一步损伤条件的急性和亚急性缺血性中风患者,间充质干细胞具有很高的疗效和可接受的安全性。Prospero,唯一 ID:CRD42023457655。
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Efficacy and safety of intravenous mesenchymal stem cells for ischemic stroke patients, a systematic review and meta-analysis
Clinical trials have evaluated the efficacy of intravenous mesenchymal stem cells (MSCs) for acute and subacute ischemic stroke. Therefore, we conducted this meta-analysis to investigate the efficacy and safety of intravenous MSC treatments compared to placebo for acute and subacute ischemic stroke patients.We searched PubMed, SCOPUS, Web of Science, and Cochrane CENTRAL for randomized controlled trials evaluating any clinical trials of intravenous MSCs for acute and subacute ischemic stroke patients. The efficacy outcomes of this study were the rates of improvement in National Institutes of Health Stroke Scale (NIHSS) scores, good scores on the modified Rankin Scale (mRS), and Barthel Index (BI) scores, while the safety outcomes were the rates of mortality and stroke recurrence. We compared intravenous MSC and placebo treatments on a fixed-effect meta-analysis model in R software.Four randomized controlled studies involving 97 patients were included in the analysis. In the meta-analysis, MSC treatments were superior to placebo treatments in good mRS (MD −0.95, 95% CI [−1.39, −0.52]) or BI (MD 21.36, 95% CI [9.96, 32.75]) scores, and MSC treatments were not superior to placebo treatments in the rate of improvement of the NIHSS scores (MD −1.81, 95% CI [−4.123, 0.494]). MSCs were associated with neither decreased mortality nor stroke recurrence (risk ratio 0.58 and 0.59, respectively; p-value = 0.51 and p-value = 0.533, respectively).For patients with acute and subacute ischemic stroke who are eligible for further damage to neural tissue, MSCs achieve high efficacy and acceptable safety.Prospero, unique ID: CRD42023457655.
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