The safety and efficacy of mesenchymal stromal cells in ARDS: a meta-analysis of randomized controlled trials.
The safety and efficacy of mesenchymal stromal cells in ARDS: a meta-analysis of randomized controlled trials.
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DOI：
10.1186/s13054-022-04287-4
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发表时间：
2023-01-20
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间充质基质细胞（MSC）在急性呼吸窘迫综合征（ARDS）的动物和人体试验中显示出潜在功效。特别是在 COVID-19 大流行期间，人们对 MSC 进行了深入研究，以治疗 COVID-19 引起的 ARDS。本研究的目的是通过随机对照试验 (RCT) 的荟萃分析来评估 MSC 在 ARDS 中的安全性和有效性。因此，对 MSC 作为 ARDS 治疗的 RCT 进行了荟萃分析。本次审查的方案已在开放科学框架上注册。不受语言限制，按照“PICOs”原则，在Pubmed和Embase上检索MSC治疗ARDS的临床文献。任何将 MSC 与对照治疗 ARDS 进行比较（其中 MSC 和对照静脉注射任何剂量）的随机对照试验都有资格纳入。总共 13 项 RCT 评估了 MSC 与对照治疗 ARDS 的疗效，共纳入 655 例病例，符合纳入标准并出现在本次荟萃分析中。使用χ2检验进行异质性评估，其中P值小于0.05被认为是显着的。固定效应或随机效应模型的选择由每次分析中的 I2 值决定。这项荟萃分析表明，MSC 与 ARDS 对照之间的不良事件没有显着差异（OR = 0.64，95% CI [0.34，1.20]，P = 0.17，I2 = 0%）。与对照组相比，MSC可降低ARDS的死亡率（OR = 0.66，95% CI [0.46，0.96]，P = 0.03，I2 = 10%）。根据我们的荟萃分析结果，MSC的安全性被证明不劣于标准治疗，并且MSC可以降低ARDS的死亡率。尽管主要结果的异质性较低（I2< 25%），但仍需要更多高质量和大规模的临床试验来进一步证实我们的发现。在线版本包含可在 10.1186/s13054-022-04287-4 获取的补充材料。
Mesenchymal stromal cells (MSC) have shown potential efficacy in both animal and human trials of acute respiratory distress syndrome (ARDS). Especially during the COVID-19 pandemic, MSC was intensely studied for treating COVID-19-induced ARDS. The purpose of this study is to evaluate the safety and efficacy of MSC in ARDS via a meta-analysis of randomized controlled trials (RCTs). Therefore, a meta-analysis of RCTs of MSC as a therapy for ARDS was conducted. The protocol of this review was registered on Open Science Framework. With no language restriction and according to the “PICOs” principle, searches were conducted on Pubmed and Embase to retrieve any clinical literature on MSC for ARDS. Any RCT, which compared MSC to controls for ARDS, where MSC and controls were intravenously infused, of any dosage, was eligible for inclusion. A total of 13 RCTs, which evaluated MSC versus control for treating ARDS, enrolling a total of 655 cases, met the inclusion criteria and appeared in this meta-analysis. A heterogeneity assessment was carried out using the χ2 test, where a P value less than 0.05 was considered significant. The choice of a fixed-effect or a random-effect model was decided by the I2 value in each of the analyses. This meta-analysis indicated that there was no significant difference in terms of adverse events between MSC and control for ARDS (OR = 0.64, 95% CI [0.34, 1.20], P = 0.17, and I2 = 0%). In comparison with control, MSC could reduce the mortality of ARDS (OR = 0.66, 95% CI [0.46, 0.96], P = 0.03, and I2 = 10%). Based on the results of our meta-analysis, the safety of MSC was demonstrated to be non-inferior to that of standard treatment, and MSC may reduce the mortality rate of ARDS. Though the heterogeneity in the main results was low (I2 < 25%), more high-quality and large-scale clinical trials are needed to further confirm our findings. The online version contains supplementary material available at 10.1186/s13054-022-04287-4.
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