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人类研究干细胞治疗糖尿病周围神经病变的疗效和安全性:系统评价和荟萃分析。

Human studies of the efficacy and safety of stem cells in the treatment of diabetic peripheral neuropathy: a systematic review and meta-analysis.

机构信息

Sina Trauma and Surgery Research Center, Tehran University of Medical Sciences, Tehran, Iran.

Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Stem Cell Res Ther. 2024 Nov 19;15(1):442. doi: 10.1186/s13287-024-04033-3.

DOI:10.1186/s13287-024-04033-3
PMID:39563393
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11577959/
Abstract

OBJECTIVE

To assess the efficacy and safety of stem cell therapy in human studies for diabetic peripheral neuropathy (DPN).

METHODS

A comprehensive literature review was performed across multiple databases, including Ovid MEDLINE ALL, Embase via Ovid SP, Scopus, Web of Science Core Collection, and Cochrane CENTRAL, up to January 31, 2024. Keywords and controlled vocabularies related to diabetic neuropathy and stem cell therapy were used. Inclusion criteria encompassed all controlled trials examining stem cell therapy for DPN, excluding animal or in vitro studies, review papers, conference abstracts, and editor letters. Data extraction and risk of bias assessment were independently performed by multiple reviewers using standardized tools.

RESULTS

Out of 5431 initial entries, seven were included. Stem cell therapies included bone marrow-derived mononuclear cells and umbilical cord-derived mesenchymal stem cells, administered mainly via intramuscular transplantation. Meta-analysis indicated significant improvements in motor nerve conduction velocity (weighted mean differences (WMD): 2.2, 95% CI 1.6-2.8) and sensory nerve conduction velocity (WMD: 1.9, 95% CI 1.1-2.6). Vibration perception threshold and Toronto Clinical Scoring System scores decreased significantly (WMD: - 2.9, 95% CI - 4.0, - 1.8, and WMD: - 3.6, 95% CI - 5.0, - 2.2, respectively). Sensitivity analysis and subgroup analysis confirmed the robustness and specificity of these findings. The complications were pain and swelling at the injection sites, which disappeared in a few days.

CONCLUSION

Stem cell therapy shows significant promise in improving clinical outcomes for DPN, with evident benefits in nerve conduction and sensory parameters. Further research is needed to consolidate these findings and optimize therapeutic protocols.

摘要

目的

评估干细胞疗法在人类糖尿病周围神经病变(DPN)研究中的疗效和安全性。

方法

我们在多个数据库中进行了全面的文献回顾,包括 Ovid MEDLINE ALL、Embase 通过 Ovid SP、Scopus、Web of Science Core Collection 和 Cochrane CENTRAL,检索时间截至 2024 年 1 月 31 日。使用与糖尿病神经病变和干细胞治疗相关的关键词和受控词汇。纳入标准包括所有检查干细胞治疗 DPN 的对照试验,不包括动物或体外研究、综述文章、会议摘要和编辑信函。数据提取和偏倚风险评估由多名审查员使用标准化工具独立进行。

结果

在 5431 篇初始文章中,有 7 篇被纳入。干细胞疗法包括骨髓源性单核细胞和脐带源性间充质干细胞,主要通过肌肉内移植进行给药。Meta 分析表明,运动神经传导速度(加权均数差(WMD):2.2,95%CI 1.6-2.8)和感觉神经传导速度(WMD:1.9,95%CI 1.1-2.6)显著改善。振动感觉阈值和多伦多临床评分系统评分显著降低(WMD:-2.9,95%CI-4.0,-1.8,和 WMD:-3.6,95%CI-5.0,-2.2)。敏感性分析和亚组分析证实了这些发现的稳健性和特异性。并发症为注射部位疼痛和肿胀,数天后消失。

结论

干细胞疗法在改善 DPN 的临床结局方面显示出显著的前景,在神经传导和感觉参数方面具有明显的益处。需要进一步的研究来巩固这些发现并优化治疗方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ac/11577959/67c4e67ca9d2/13287_2024_4033_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ac/11577959/243f23dc9dd7/13287_2024_4033_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ac/11577959/4ae44654669a/13287_2024_4033_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ac/11577959/8dc2df89a177/13287_2024_4033_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ac/11577959/e41437caea94/13287_2024_4033_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ac/11577959/67c4e67ca9d2/13287_2024_4033_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ac/11577959/243f23dc9dd7/13287_2024_4033_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ac/11577959/4ae44654669a/13287_2024_4033_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ac/11577959/8dc2df89a177/13287_2024_4033_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ac/11577959/e41437caea94/13287_2024_4033_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ac/11577959/67c4e67ca9d2/13287_2024_4033_Fig5_HTML.jpg

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