间充质干细胞治疗肝硬化的疗效和安全性：系统评价和荟萃分析。

AIM: Although the efficacy and safety of mesenchymal stem cell therapy for liver cirrhosis have been demonstrated in several studies. Clinical cases of mesenchymal stem cell therapy for patients with liver cirrhosis are limited and these studies lack the consistency of treatment effects. This article aimed to systematically investigate the efficacy and safety of mesenchymal stem cells in the treatment of liver cirrhosis. METHOD: The data source included PubMed/Medline, Web of Science, EMBASE, and Cochrane Library, from inception to May 2023. Literature was screened by the PICOS principle, followed by literature quality evaluation to assess the risk of bias. Finally, the data from each study's outcome indicators were extracted for a combined analysis. Outcome indicators of the assessment included liver functions and adverse events. Statistical analysis was performed using Review Manager 5.4. RESULTS: A total of 11 clinical trials met the selection criteria. The pooled analysis' findings demonstrated that both primary and secondary indicators had improved. Compared to the control group, infusion of mesenchymal stem cells significantly increased ALB levels in 2 weeks, 1 month, 3 months, and 6 months, and significantly decreased MELD score in 1 month, 2 months, and 6 months, according to a subgroup analysis using a random-effects model. Additionally, the hepatic arterial injection favored improvements in MELD score and ALB levels. Importantly, none of the included studies indicated any severe adverse effects. CONCLUSION: The results showed that mesenchymal stem cell was effective and safe in the treatment of liver cirrhosis, improving liver function (such as a decrease in MELD score and an increase in ALB levels) in patients with liver cirrhosis and exerting protective effects on complications of liver cirrhosis and the incidence of hepatocellular carcinoma. Although the results of the subgroup analysis were informative for the selection of mesenchymal stem cells for clinical treatment, a large number of high-quality randomized controlled trials validations are still needed.

目的：虽然已有多项研究证实间充质干细胞治疗肝硬化的疗效和安全性，但间充质干细胞治疗肝硬化患者的临床病例有限，且这些研究缺乏治疗效果的一致性。本文旨在系统评价间充质干细胞治疗肝硬化的疗效和安全性。

方法：资料来源包括 PubMed/Medline、Web of Science、EMBASE 和 Cochrane Library，检索时间从建库至 2023 年 5 月。采用 PICOS 原则筛选文献，然后进行文献质量评估以评价偏倚风险，最后提取每个研究结局指标的数据进行合并分析。评估的结局指标包括肝功能和不良事件。采用 Review Manager 5.4 进行统计学分析。

结果：共纳入 11 项临床试验。汇总分析结果表明，主要和次要结局指标均有改善。与对照组相比，间充质干细胞输注后，白蛋白（ALB）水平在 2 周、1 个月、3 个月和 6 个月时显著升高，MELD 评分在 1 个月、2 个月和 6 个月时显著降低，亚组分析采用随机效应模型。此外，肝动脉注射有利于改善 MELD 评分和 ALB 水平。重要的是，纳入的研究均未报告任何严重不良事件。

结论：结果表明，间充质干细胞治疗肝硬化有效且安全，可改善肝硬化患者的肝功能（如 MELD 评分降低和 ALB 水平升高），对肝硬化并发症和肝细胞癌的发生具有保护作用。虽然亚组分析的结果为间充质干细胞的临床治疗选择提供了信息，但仍需要更多高质量的随机对照试验验证。