Li Yu-Jing, Yu Ze-Yu, Zhang Di, Zhang Fu-Rong, Zhang Dong-Mei, Chen Meng
School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, NO.11 North Third Ring Road East, Chaoyang District, Beijing, 100029, China.
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
Heliyon. 2024 Aug 24;10(17):e36890. doi: 10.1016/j.heliyon.2024.e36890. eCollection 2024 Sep 15.
Extracellular vesicles (EVs) are being considered as a potential therapeutic option for ulcerative colitis (UC), and numerous preclinical studies have been conducted on the use of EVs for UC.
A systematic review was conducted to compare the therapeutic effects of mammalian EVs and placebo on UC in animal models, along with a meta-analysis comparing naïve (unmodified) EVs and placebo. The search was performed in four databases (PubMed, Web of Science, Scopus, and EMBASE) up to September 13th, 2023. The primary outcomes included disease activity index (DAI), colonic mucosal damage index (CMDI), and adverse effects (PROSPERO ID: CRD42023458039).
A total of 69 studies were included based on pre-determined criteria, involving 1271 animals. Of these studies, 51 measured DAI scores, with 98 % reporting that EVs could reduce DAI scores. Additionally, 5 studies reported CMDI and all showed that EVs could significantly reduce CMDI. However, only 3 studies assessed adverse effects and none reported any significant adverse effects. The meta-analysis of these studies (40 studies involving 1065 animals) revealed that naïve EVs could significantly decrease the DAI score (SMD = -3.00; 95 % CI: -3.52 to -2.48) and CMDI (SMD = -2.10; 95 % CI: -2.85 to -1.35).
The results indicate that mammalian EVs have demonstrated therapeutic benefits in animal models of UC; however, the safety profile of EVs remains inadequate which highlights the need for further research on safety outcomes.
细胞外囊泡（EVs）被认为是溃疡性结肠炎（UC）的一种潜在治疗选择，并且已经进行了大量关于使用EVs治疗UC的临床前研究。
进行了一项系统评价，以比较哺乳动物EVs和安慰剂在动物模型中对UC的治疗效果，并进行了一项荟萃分析，比较天然（未修饰）EVs和安慰剂。检索截至2023年9月13日在四个数据库（PubMed、Web of Science、Scopus和EMBASE）中进行。主要结局包括疾病活动指数（DAI）、结肠黏膜损伤指数（CMDI）和不良反应（PROSPERO编号：CRD42023458039）。
根据预先确定的标准共纳入69项研究，涉及1271只动物。在这些研究中，51项测量了DAI评分，98%报告EVs可降低DAI评分。此外，5项研究报告了CMDI，均显示EVs可显著降低CMDI。然而，只有3项研究评估了不良反应，均未报告任何显著不良反应。这些研究的荟萃分析（40项研究涉及1065只动物）显示，天然EVs可显著降低DAI评分（标准化均数差[SMD]=-3.00；95%可信区间[CI]：-3.52至-2.48）和CMDI（SMD=-2.10；95%CI：-2.85至-1.35）。
结果表明，哺乳动物EVs在UC动物模型中已显示出治疗益处；然而，EVs的安全性仍不充分，这突出了对安全性结局进行进一步研究的必要性。
