12种干预措施治疗糖尿病足溃疡的疗效比较：一项网状Meta分析

Comparison of the efficacy of 12 interventions in the treatment of diabetic foot ulcers: a network meta-analysis.

作者信息

Hu Xuyang, Meng Huixin, Liang Jiaru, An Hang, Zhou Jiaqi, Gao Yuling, You Chong, Zhang Zhenni, Gong Xiaoyang, Liu Yong

机构信息

Department of Rehabilitation Medicine, The First Affiliated Hospital of Dalian Medical University, Dalian, China.

Institute (College) of Integrative Medicine, Dalian Medical University, Dalian, China.

出版信息

PeerJ. 2025 Aug 11;13:e19809. doi: 10.7717/peerj.19809. eCollection 2025.

DOI:10.7717/peerj.19809

PMID:40821981

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12352421/

Abstract

OBJECTIVE

This study aimed to comprehensively compare the efficacy of 12 interventions for diabetic foot ulcer (DFU) using a network meta-analysis (NMA).

METHODS

The NMA was conducted by PRISMA guidelines, and the protocol was registered in PROSPERO (CRD42023461811). PubMed, Web of Science, Cochrane Library, and Embase databases were systematically searched from inception to September 2023. Randomized controlled trials (RCTs) enrolling patients with DFU were included if they compared epidermal growth factor (EGF), platelet-derived growth factor (PDGF), platelet-rich plasma (PRP), stem cells (SC), low-frequency ultrasound (LFU), negative pressure wound therapy (NPWT), low-level laser therapy (LLLT), electric stimulation (ES), extracorporeal shockwave therapy (ESWT), amniotic membrane therapy (AMT), hyperbaric oxygen therapy (HBOT), and topical oxygen therapy (TOT) against standard of care (SOC) or placebo. The primary endpoint assessed was the wound healing rate. Secondary endpoints comprised wound healing time, percentage area reduction (PAR), and amputation rate. The surface under the cumulative ranking curve (SUCRA) was calculated to rank the efficacy of interventions.

RESULTS

A total of 99 RCTs involving 7,356 patients were included. Among the 12 interventions analyzed, only LFU (OR = 2.20; 95% CI [0.99-4.91]) and ES (OR = 1.88; 95% CI [0.87-4.05]) did not demonstrate statistically significant improvements in ulcer healing rate compared with SOC. Based on SUCRA rankings, SC (SUCRA = 89.7%; OR = 5.71; 95% CI [2.64-12.34]) and AMT (SUCRA = 89.2%; OR = 5.11; 95% CI [3.12-8.37]) ranked highest in promoting ulcer healing, while LFU (29.4%) and SOC (10.4%) ranked lowest. Regarding wound healing time, AMT (MD = -26.91 days; 95% CI [-44.27 to -9.55]), PRP (MD = -21.65 days; 95% CI [-33.61 to -9.69]), and NPWT (MD = -16.79 days; 95% CI [-31.12 to -2.26]) significantly reduced healing durations compared to SOC. SUCRA rankings indicated that AMT (84.7%) and PRP (74.6%) ranked highest, while LFU (29.4%) and SOC (10.4%) remained lowest. Concerning PAR, LLLT (MD = 34.27; 95% CI [17.35-51.20]) and ESWT (MD = 27.50; 95% CI [11.00-44.00]) showed significant improvements over SOC, with LLLT (SUCRA = 93.9%) and ESWT (SUCRA = 84.0%) ranking highest, while SOC (21.0%) and TOT (18.3%) ranked lowest. For amputation rate, SC (OR = 0.12; 95% CI [0.03-0.55]) and HBOT (OR = 0.35; 95% CI [0.16-0.78]) significantly lowered the risk compared to SOC, with SUCRA rankings placing SC (79.9%) and PRP (73.2%) as most effective, while NPWT (26.4%) and SOC (9.9%) were least effective.

CONCLUSIONS

SC and AMT emerged as highly effective, demonstrating superior efficacy in improving healing rate compared to PDGF, ES, and HBOT. AMT also showed significant effects in shortening ulcer healing time. LLLT exhibited considerable effectiveness in reducing ulcer areas, and SC therapy was associated with reduced amputation rate.

摘要

目的

本研究旨在通过网络荟萃分析（NMA）全面比较12种干预措施对糖尿病足溃疡（DFU）的疗效。

方法

按照PRISMA指南进行NMA，并将方案注册于PROSPERO（CRD42023461811）。从数据库建库至2023年9月，系统检索PubMed、Web of Science、Cochrane图书馆和Embase数据库。纳入招募DFU患者的随机对照试验（RCT），这些试验比较了表皮生长因子（EGF）、血小板衍生生长因子（PDGF）、富血小板血浆（PRP）、干细胞（SC）、低频超声（LFU）、负压伤口治疗（NPWT）、低强度激光治疗（LLLT）、电刺激（ES）、体外冲击波治疗（ESWT）、羊膜治疗（AMT）、高压氧治疗（HBOT）和局部氧疗（TOT）与标准治疗（SOC）或安慰剂的疗效。评估的主要终点为伤口愈合率。次要终点包括伤口愈合时间、面积缩小百分比（PAR）和截肢率。计算累积排序曲线下面积（SUCRA）以对干预措施的疗效进行排序。

结果

共纳入99项RCT，涉及7356例患者。在分析的12种干预措施中，与SOC相比，仅LFU（OR = 2.20；95%CI[0.99 - 4.91]）和ES（OR = 1.88；95%CI[0.87 - 4.05]）在溃疡愈合率方面未显示出统计学显著改善。基于SUCRA排序，SC（SUCRA = 89.7%；OR = 5.71；95%CI[2.64 - 12.34]）和AMT（SUCRA = 89.2%；OR = 5.11；95%CI[3.12 - 8.37]）在促进溃疡愈合方面排名最高，而LFU（29.4%）和SOC（10.4%）排名最低。关于伤口愈合时间，与SOC相比，AMT（MD = -26.91天；95%CI[-44.27至 - 9.55]）、PRP（MD = -21.65天；95%CI[-33.61至 - 9.69]）和NPWT（MD = -16.79天；95%CI[-31.12至 - 2.26]）显著缩短了愈合持续时间。SUCRA排序表明，AMT（84.7%）和PRP（74.6%）排名最高，而LFU（29.4%）和SOC（10.4%）仍然最低。关于PAR，LLLT（MD = 34.27；95%CI[17.35 - 51.20]）和ESWT（MD = 27.50；95%CI[11.00 - 44.00]）相对于SOC显示出显著改善，LLLT（SUCRA = 93.9%）和ESWT（SUCRA = 84.0%）排名最高，而SOC（21.0%）和TOT（18.3%）排名最低。对于截肢率，与SOC相比，SC（OR = 0.12；95%CI[0.03 - 0.55]）和HBOT（OR = 0.35；95%CI[0.16 - 0.78]）显著降低了风险，SUCRA排序显示SC（79.9%）和PRP（73.2%）最有效，而NPWT（26.4%）和SOC（9.9%）最无效。