干细胞治疗糖尿病足溃疡的临床结果和安全性:重叠荟萃分析的横断面分析

Clinical Outcomes and Safety of Stem Cell Therapy for Diabetic Foot Ulcers: A Cross-Sectional Analysis of Overlapping Meta-Analyses.

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摘要(中文译文)

糖尿病足溃疡(DFU)的诊疗仍然是临床上的一个显著挑战。干细胞疗法与传统治疗对DFU的疗效和安全性尚存争议。对荟萃分析进行横断面分析能够对相互重叠的综述进行结构化比较,有助于识别不一致之处,并在结论存在差异时支持循证决策。本研究旨在对现有比较干细胞治疗与传统治疗对DFU结局影响的荟萃分析进行横断面分析,以识别质量最高的现有证据,并阐明一致性与差异所在。我们系统检索了研究干细胞疗法与传统治疗对DFU疗效比较的荟萃分析。所有数据库的完整电子检索策略均按照PRISMA 2020建议提供。方法学质量采用牛津证据等级(Oxford Levels of Evidence)和原始AMSTAR工具进行评估。数据提取和质量评价均独立进行,并应用Jadad决策算法确定提供方法学上最稳健证据的荟萃分析。本研究共纳入9项荟萃分析。其中5项被归类为II级证据,其余4项被归类为III级证据。AMSTAR评分为7至10分(中位数9分)。Jadad算法识别出的最稳健荟萃分析一致显示,与传统治疗相比,干细胞治疗可提高溃疡愈合率(< 0.0001)、增加无痛行走距离(< 0.00001)、降低截肢率(< 0.0001)。此外,干细胞组的不良事件发生率低于传统治疗组(< 0.001)。该研究表明,干细胞疗法似乎是改善临床结局的一种有前景的治疗选择。然而,由于原始研究存在重叠、异质性以及本横断面评价的二次研究性质,结论应谨慎解读。此外,在质量最高的荟萃分析中未发现严重不良事件增加的明确证据。

Abstract

The care of diabetic foot ulcers (DFU) continues to be a notable clinical challenge. The efficacy and safety of stem cell therapies versus conventional treatments for DFU are debated. Cross-sectional analyses of meta-analyses enable structured comparisons of overlapping reviews, facilitate the identification of inconsistencies, and support evidence-based decision-making when conclusions differ. This study aimed to conduct a cross-sectional analysis of existing meta-analyses comparing stem cell and conventional treatments for DFU outcomes to identify the highest-quality available evidence and clarify areas of consistency and discrepancy. We systematically searched for meta-analyses that investigated stem cell therapies versus conventional treatments for DFU. The complete electronic search strategies for all databases are provided in accordance with PRISMA 2020 recommendations. Methodological quality was assessed using the Oxford Levels of Evidence and original AMSTAR instrument. Data abstraction and quality evaluation were performed independently, and the Jadad decision algorithm was applied to determine the meta-analysis providing the most methodologically robust evidence. Nine meta-analyses were included in this study. Five were categorized as Level II evidence, while the remaining four were classified as Level III evidence. The AMSTAR scores ranged from 7 to 10 (median 9). The Jadad algorithm identified the most robust meta-analysis consistently showing improved ulcer healing rates ( < 0.0001), greater pain-free walking distance ( < 0.00001), lower amputation rates ( < 0.0001) compared with conventional treatments. Furthermore, the incidence of adverse events in the stem cell groups was lower compared to conventional treatments ( < 0.001). The study indicated that stem cell therapy appeared to be a promising therapeutic option for improving clinical outcomes. However, conclusions should be interpreted with caution due to overlapping primary studies, heterogeneity, and the secondary nature of this cross-sectional evaluation. Moreover, no clear evidence of increased serious adverse events was identified in the highest-quality meta-analysis.

如何引用

AMA

Ying Du, Zhendong Xu, Tianlin Wen, Xinxin Meng, Bolun Zhang, Qiantai Gao, et al. Clinical Outcomes and Safety of Stem Cell Therapy for Diabetic Foot Ulcers: A Cross-Sectional Analysis of Overlapping Meta-Analyses.. Diabetes, metabolic syndrome and obesity : targets and therapy. 2026; doi:10.2147/DMSO.S593437.

APA

Ying Du, Zhendong Xu, Tianlin Wen, Xinxin Meng, Bolun Zhang, Qiantai Gao, et al (2026). Clinical Outcomes and Safety of Stem Cell Therapy for Diabetic Foot Ulcers: A Cross-Sectional Analysis of Overlapping Meta-Analyses.. Diabetes, metabolic syndrome and obesity : targets and therapy. https://doi.org/10.2147/DMSO.S593437

GB/T 7714

Ying Du, Zhendong Xu, Tianlin Wen, Xinxin Meng, Bolun Zhang, Qiantai Gao, et al. Clinical Outcomes and Safety of Stem Cell Therapy for Diabetic Foot Ulcers: A Cross-Sectional Analysis of Overlapping Meta-Analyses.[J]. Diabetes, metabolic syndrome and obesity : targets and therapy, 2026 doi:10.2147/DMSO.S593437.

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