Mudgal Shiv Kumar, Kumar Subodh, Gaur Rakhi, Singh Harminder, Saikia Dibyajyoti, Varshney Saurabh, Gupta Pratima, Grover Ashoo, Varikasuvu Seshadri Reddy
All India Institute of Medical Sciences (AIIMS), Deoghar, Jharkhand, India.
All India Institute of Medical Sciences (AIIMS), Guwahati, Assam, India.
Int J Low Extrem Wounds. 2024 Jan 31:15347346241227530. doi: 10.1177/15347346241227530.
Diabetic foot (DF) represents a severe complication of diabetes mellitus, imposing substantial psychological and economic burdens on affected individuals. This investigation sought to assess the therapeutic efficacy of stem cell interventions in the management of DF complications. A comprehensive systematic search across PubMed, Embase, CINAHL, Scopus, and the Cochrane library databases was conducted to identify pertinent studies for meta-analysis. Outcome measures encompassed ulcer or wound healing rates, amputation rates, angiogenesis, ankle-brachial index (ABI), and pain-free walking distance. Dichotomous outcomes were expressed as risk differences (RDs) with 95% confidence intervals (CIs), while continuous data were articulated as standardized mean differences (SMDs) with corresponding 95% CIs. Statistical analyses were executed using RevMan 5.3 and Open Meta, with bootstrapped meta-analysis conducted through OpenMEE software. A total of 20 studies, comprising 24 arms and involving 1304 participants, were incorporated into the meta-analysis. The findings revealed that stem cell therapy exhibited superior efficacy compared to conventional interventions in terms of ulcer or wound healing rate [RD = 0.36 (0.28, 0.43)], pain-free walking distance [SMD = 1.27 (0.89, 1.65)], ABI [SMD = 0.61 (0.33, 0.88)], and new vessel development [RD = 0.48 (0.23, 0.78)], while concurrently reducing the amputation rate significantly [RD = -0.19 (-0.25, -0.12)]. Furthermore, no statistically significant difference in adverse events was observed [RD -0.07 (-0.16, 0.02)]. The Grading of Recommendations, Assessment, Development, and Evaluation assessment indicated varying levels of evidence certainty, ranging from very low to moderate, for different outcomes. Bootstrapping analysis substantiated the precision of the results. The meta-analysis underscores the significant superiority of stem cell therapy over conventional approaches in treating DF complications. Future investigations should prioritize large-scale, randomized, double-blind, placebo-controlled, multicenter trials, incorporating rigorous long-term follow-up protocols. These studies are essential for elucidating the optimal cell types and therapeutic parameters that contribute to the most effective treatment strategies for DF management.
糖尿病足（DF）是糖尿病的一种严重并发症，给患者带来了巨大的心理和经济负担。本研究旨在评估干细胞干预措施在治疗DF并发症方面的疗效。我们对PubMed、Embase、CINAHL、Scopus和Cochrane图书馆数据库进行了全面系统的检索，以确定适合进行荟萃分析的相关研究。结局指标包括溃疡或伤口愈合率、截肢率、血管生成、踝臂指数（ABI）和无痛步行距离。二分结局以风险差异（RD）及95%置信区间（CI）表示，连续性数据则以标准化均数差（SMD）及相应的95%CI表示。使用RevMan 5.3和Open Meta进行统计分析，并通过OpenMEE软件进行自抽样荟萃分析。共有20项研究（包括24个研究组）纳入了荟萃分析，涉及1304名参与者。研究结果显示，在溃疡或伤口愈合率[RD = 0.36（0.28，0.43）]、无痛步行距离[SMD = 1.27（0.89，1.65）]、ABI[SMD = 0.61（0.33，0.88）]和新血管生成[RD = 0.48（0.23，0.78）]方面，干细胞疗法比传统干预措施疗效更佳，同时显著降低了截肢率[RD = -0.19（-0.25，-0.12）]。此外，未观察到不良事件有统计学显著差异[RD -0.07（-0.16，0.02）]。推荐分级、评估、制定和评价评估表明，不同结局的证据确定性水平各不相同，从极低到中等不等。自抽样分析证实了结果的准确性。荟萃分析强调了干细胞疗法在治疗DF并发症方面相对于传统方法具有显著优势。未来的研究应优先开展大规模、随机、双盲、安慰剂对照、多中心试验，并纳入严格的长期随访方案。这些研究对于阐明有助于DF管理最有效治疗策略的最佳细胞类型和治疗参数至关重要。
