间充质基质/干细胞治疗急性呼吸窘迫综合征的有效性和安全性：一项伞状综述。
完整摘要 · 中文译文
背景：急性呼吸窘迫综合征（ARDS）因其死亡率和发病率持续居高不下而与公共卫生密切相关。间充质干细胞/基质细胞（MSCs）治疗凭借其再生和免疫调节特性，已成为一种有前景的治疗方法。基于伞状综述方法学，我们旨在从多个角度全面整合关于MSCs治疗ARDS有效性和安全性的现有数据。 方法：本研究遵循PRISMA 2020标准开展。全面检索了PubMed、Embase、Web of Science和Cochrane Library数据库1995年至2025年10月间的文献，以查找涉及MSCs治疗ARDS的伞状综述。使用Review Manager和Stata MP软件对结局指标进行meta分析。纳入研究的方法学质量采用AMSTAR-2量表评估，系统评价的偏倚风险采用ROBIS工具评估。证据确定性采用GRADE流程评估。 结果：共纳入15篇系统评价，其中10篇与随机临床试验（RCTs）相关，5篇与对照临床前研究相关。根据临床研究系统评价的发现，MSCs治疗可能降低ARDS患者的死亡率（风险比[RR] = 0.79，95%置信区间[CI] 0.66-0.96），证据确定性为中等。在低证据确定性下，接受MSC治疗的组间不良事件无显著差异 接受该治疗的患者与接受传统治疗的患者相比（RR = 0.98，95% CI 0.85-1.12）。在对照的临床前研究中，接受间充质干细胞（MSCs）治疗的ARDS动物模型死亡率更低、肺损伤评分更低（RR = 0.50，95% CI 0.40-0.62；标准化均数差[SMD] = - 3.19，95% CI - 4.33至- 2.05），但伴随证据可信度低和显著异质性。 结论：我们的伞状综述显示，MSCS治疗在降低ARDS患者死亡率方面具有潜在获益，尤其是在UC-MSCs研究中，并且可能降低ARDS动物模型的肺损伤程度。MSCs的安全性已在临床试验中得到验证，尽管证据确定性较低。我们的伞状综述明确了标准化治疗方案和临床试验对于确认MSCs治疗疗效并促进其临床转化的重要性。然而，当前证据受到显著异质性的限制，确定性极低，需要在足够把握度、标准化、多中心的随机对照试验（RCTs）中加以确认，以促进其向人类患者的转化应用。试验注册 系统综述注册：PROSPERO注册号CRD420251267987和CRD420251268056。
完整摘要 · 英文原文
BACKGROUND: Acute respiratory distress syndrome (ARDS) is closely related to public health because of its consistently high rates of mortality and morbidity. Mesenchymal stem/stromal cells (MSCs) treatment has become a promising therapeutic approach due to the regenerative and immunomodulatory qualities of it. Based on an umbrella review methodology, we seek to thoroughly integrate the available data on the effectiveness and safety of MSCs treatment for ARDS from various angles. METHODS: This study was conducted following PRISMA 2020 standards. PubMed, Embase, Web of Science, and Cochrane Library databases were searched thoroughly between 1995 and October 2025 in order to find umbrella reviews that addressed the use of MSC treatment for ARDS. Review Manager and Stata MP software were used to carry out a meta-analysis of outcome measures. The methodological quality of the included research was assessed using the AMSTAR-2 scale, while the risk of bias in systematic reviews was assessed using the ROBIS tool. The certainty of the evidence was assessed using the GRADE procedure. RESULTS: A total of 15 systematic reviews were included, of which 10 were related to randomized clinical trials (RCTs) and 5 were related to controlled preclinical studies. MSCs therapy may lower the death rate of ARDS patients (risk ratio [RR] = 0.79, 95% confidence interval [CI] 0.66-0.96) with moderate certainty of evidence, according to findings from systematic evaluations of clinical studies. With low certainty of evidence, adverse events did not significantly differ between the groups receiving MSCs therapy and those receiving conventional treatment (RR = 0.98, 95% CI 0.85-1.12). In controlled preclinical studies, ARDS animal models treated with MSCs had lower mortality rates and lower lung injury score (RR = 0.50, 95% CI 0.40-0.62; standardized mean difference [SMD] = - 3.19, 95% CI - 4.33 to - 2.05), which was accompanied by low credibility and significant heterogeneity. CONCLUSIONS: Our umbrella review shows the potential benefit of MSCS treatment in reducing mortality among ARDS patients, particularly in studies of UC-MSCs, and the possibility of reducing the degree of lung injury in ARDS animal models. The safety of MSCs has been validated in clinical trials, although the certainty of evidence is low. Our umbrella review clarifies the importance of standardized treatment protocols and clinical trials for confirming the efficacy of MSCs treatment and facilitating its clinical translation. However, the current evidence was limited by the substantial heterogeneity with very low certainty and requires confirmation in adequately powered, standardized, multicenter RCTs to promote translational application to human patients. Trial registration Systematic Review Registration: PROSPERO registration CRD420251267987 and CRD420251268056.