Shi Hongshuo, Yuan Xin, Fan Weijing, Yang Xiao, Liu Guobin
Department of Peripheral Vascular Surgery, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Adv Wound Care (New Rochelle). 2024 May;13(5):201-216. doi: 10.1089/wound.2023.0136. Epub 2024 Jan 29.
This umbrella review aims to summarize and evaluate the evidence from current systematic reviews/meta-analyses (SRs/MAs) on the effectiveness of stem cell therapy for diabetic foot (DF). We conducted a comprehensive search in four databases for SRs/MAs that included randomized controlled trials (RCTs) on stem cell therapy for DF. Two separate researchers independently evaluated the methodological quality and evidence quality of the SRs/MAs that were included in the study. We conducted a quantitative synthesis of all RCTs included in the SRs/MAs to obtain objective and updated conclusions. Egger's test and sensitivity analysis are used to examine the reliability of the results. This umbrella review includes eight SRs/MAs, and their methodological quality and evidence quality were all deemed unsatisfactory. Out of the 8 SRs/MAs, 26 RCTs were included, with a total corrected covered area of 21.4%, indicating a high degree of overlap. The test of super-significance did not yield any significant results. Our updated meta-analysis suggests that DF patients can benefit from stem cell therapy, as indicated by effectiveness in measures, including healing rate, amputation rate, ankle-brachial index, transcutaneous oxygen pressure, ulcer size reduction, complete healing time, pain-free walking distance, rest pain score, and new angiogenesis rate. This study conducted a comprehensive evaluation and reanalysis of the current evidence regarding the effectiveness and safety of stem cell therapy for DF, which is the first of its kind. Based on the existing evidence, stem cell therapy is effective and safe for patients with DF.
本伞状综述旨在总结和评估当前系统评价/荟萃分析(SRs/MAs)中关于干细胞治疗糖尿病足(DF)有效性的证据。我们在四个数据库中全面检索了包含DF干细胞治疗随机对照试验(RCTs)的SRs/MAs。两名独立的研究人员分别评估了纳入研究的SRs/MAs的方法学质量和证据质量。我们对SRs/MAs中纳入的所有RCTs进行了定量综合分析,以得出客观且最新的结论。采用Egger检验和敏感性分析来检验结果的可靠性。本伞状综述纳入了8项SRs/MAs,其方法学质量和证据质量均被认为不令人满意。在这8项SRs/MAs中,纳入了26项RCTs,总校正覆盖面积为21.4%,表明重叠程度较高。超显著性检验未得出任何显著结果。我们更新的荟萃分析表明,DF患者可从干细胞治疗中获益,这体现在愈合率、截肢率、踝肱指数、经皮氧分压、溃疡面积缩小、完全愈合时间、无痛行走距离、静息痛评分和新生血管生成率等指标的有效性上。本研究对当前关于DF干细胞治疗有效性和安全性的证据进行了全面评估和重新分析,这尚属首次。基于现有证据,干细胞治疗对DF患者有效且安全。
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