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干细胞治疗糖尿病足的有效性和安全性：荟萃分析更新。

Effectiveness and safety of stem cell therapy for diabetic foot: a meta-analysis update.

机构信息

Department of Plastic and Cosmetic Surgery, Xiangya Hospital, Central South University, 87 Xiangya Road, Changsha, 410008, Hunan Province, China.

School of Health Policy and Management, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730, China.

出版信息

Stem Cell Res Ther. 2022 Aug 13;13(1):416. doi: 10.1186/s13287-022-03110-9.

DOI:10.1186/s13287-022-03110-9
PMID:35964145
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9375292/
Abstract

BACKGROUND

Diabetic foot (DF) is one of the most common and serious complications of diabetes mellitus (DM), which brings great psychological and economic pressure to patients. This study aimed to evaluate the efficacy of stem cells in the treatment of diabetic foot.

METHODS

All relevant studies in Cochrane, Embase, PubMed, Web of Science, China National Knowledge Infrastructure, and WanFang databases were systematically searched for meta-analysis. The outcomes consisted of ulcer or wound healing rate, amputation rate, new vessels, ankle-brachial index (ABI), transcutaneous oxygen pressure (TcPO2), pain-free walking distance, and rest pain score. Dichotomous outcomes were described as risk ratios (RR) with 95% confidence intervals (CIs), while continuous data were presented as standardized mean differences (SMDs) with 95% CIs. Statistical analysis was performed with RevMan 5.3 software.

RESULTS

A total of 14 studies with 683 participants were included in the meta-analysis. Meta-analysis showed that stem cell therapy was more effective than conventional therapy in terms of ulcer or wound healing rate [OR = 8.20 (5.33, 12.62)], improvement in lower extremity ischemia(new vessels) [OR = 16.48 (2.88, 94.18)], ABI [MD = 0.13 (0.04, 0.08)], TcO2[MD = 4.23 (1.82, 6.65)], pain-free walking distance [MD = 220.79 (82.10, 359.48)], and rest pain score [MD = - 1.94 (- 2.50, - 1.39)], while the amputation rate was significantly decreased [OR = 0.19 (0.10, 0.36)].

CONCLUSIONS

The meta-analysis of the current studies has shown that stem cells are significantly more effective than traditional methods in the treatment of diabetic foot and can improve the quality of life of patients after treatment. Future studies should conduct large-scale, randomized, double-blind, placebo-controlled, multicenter trials with high-quality long-term follow-up to demonstrate the most effective cell types and therapeutic parameters for the treatment of diabetic foot.

摘要

背景

糖尿病足（DF）是糖尿病（DM）最常见和最严重的并发症之一，给患者带来了巨大的心理和经济压力。本研究旨在评估干细胞在治疗糖尿病足方面的疗效。

方法

系统检索 Cochrane、Embase、PubMed、Web of Science、中国知网和万方数据库中的所有相关研究，进行荟萃分析。结局指标包括溃疡或创面愈合率、截肢率、新血管形成、踝肱指数（ABI）、经皮氧分压（TcPO2）、无痛行走距离和静息痛评分。二分类结局采用比值比（RR）及其 95%置信区间（CI）表示，连续性数据采用标准化均数差（SMD）及其 95%CI 表示。采用 RevMan 5.3 软件进行统计学分析。

结果

共纳入 14 项研究，共计 683 例患者。Meta 分析结果显示，与常规治疗相比，干细胞治疗在溃疡或创面愈合率[RR=8.20（5.33，12.62）]、改善下肢缺血（新血管形成）[RR=16.48（2.88，94.18）]、ABI[MD=0.13（0.04，0.08）]、TcO2[MD=4.23（1.82，6.65）]、无痛行走距离[MD=220.79（82.10，359.48）]和静息痛评分[MD=-1.94（-2.50，-1.39）]方面更有效，截肢率显著降低[RR=0.19（0.10，0.36）]。

结论

当前研究的荟萃分析表明，干细胞在治疗糖尿病足方面明显优于传统方法，可改善患者治疗后的生活质量。未来的研究应开展大规模、随机、双盲、安慰剂对照、多中心试验，并进行高质量的长期随访，以确定治疗糖尿病足最有效的细胞类型和治疗参数。

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