重组人血小板源生长因子辅助治疗糖尿病足溃疡疗效的Meta分析  

Effects of recombinant human platelet-derived growth factor as adjuvant treatment for diabetes-related foot ulcer:a Meta-analysis

作　　者：王君 田建洲 何仁姣 黄国鑫 裴斌 闫柳[4] 艾金伟 李德胜 WANG Jun;TIAN Jianzhou;HE Renjiao;HUANG Guoxin;PEI Bin;YAN Liu;AI Jinwei;LI Desheng(Evidence-Based Medicine Center,Xiangyang No.1 People’s Hospital Affiliated to Hubei University of Medicine,Xiangyang 441000,Hubei Province,China;Department of Cardiovascular Medicine,Xiangyang No.1 People’s Hospital Affiliated to Hubei University of Medicine,Xiangyang 441000,Hubei Province,China;The Third Department of Orthopedics/Department of Plastic Surgery,Xiangyang No.1 People’s Hospital Affiliated to Hubei University of Medicine,Xiangyang 441000,Hubei Province,China;Department of Plastic Surgery and Regenerative Medicine,Fujian Medical University Union Hospital,Fuzhou 350001,China)

机构地区：[1]湖北医药学院附属襄阳市第一人民医院循证医学中心,湖北襄阳441000 [2]湖北医药学院附属襄阳市第一人民医院心血管内科,湖北襄阳441000 [3]湖北医药学院附属襄阳市第一人民医院骨科三病区/整形外科,湖北襄阳441000 [4]福建医科大学附属协和医院整形外科与再生医学科,福州350001

出　　处：《数理医药学杂志》2025年第4期276-286,共11页Journal of Mathematical Medicine

基　　金：湖北省“323”攻坚行动襄阳市第一人民医院重点专项科研基金项目(XYY2022-323)。

摘　　要：目的评价重组人血小板源生长因子(recombinant human platelet-derived growth factor,rhPDGF)辅助治疗糖尿病足溃疡(diabetes-related foot ulcer,DFU)的安全性和有效性。方法系统检索PubMed、Embase、the Cochrane Library、中国知网、中国生物医学文献服务系统(SinoMed)、维普、万方数据库中rhPDGF辅助治疗DFU的随机对照试验(randomized controlled trials,RCTs),检索时间为建库至2024年6月28日。对纳入的研究进行资料提取、方法学质量评价,运用RevMan 5.3和R 4.3.1软件进行Meta分析,通过排除中-低质量研究及逐一排除法进行敏感性分析,绘制漏斗图检测发表偏倚。结果最终纳入14项RCTs,合计1388例DFU患者。Meta分析结果显示,与标准治疗相比,rhPDGF辅助治疗可增加DFU创面愈合率[总体:OR=1.70,95%CI(1.33~2.18),P<0.001;5~12周:OR=2.32,95%CI(1.36~3.93),P=0.002;13~24周:OR=1.57,95%CI(1.20~2.06),P=0.001;神经性:OR=1.81,95%CI(1.36~2.41),P<0.001;非感染性:OR=1.70,95%CI(1.30~2.22),P<0.001],然而在创面愈合时间、创面减少面积及并发症发生率方面差异无统计学意义(P>0.05)。排除中-低质量研究后,合并结果仍显示rhPDGF辅助治疗能增加DFU创面愈合率[OR=1.68,95%CI(1.27~2.23),P<0.001],采用逐一排除法行敏感性分析结果未发生显著改变,漏斗图显示本研究存在发表偏倚的可能性小。结论rhPDGF辅助治疗DFU可增加创面愈合率,且未增加并发症发生率。受限于纳入研究质量等,上述研究结论仍需更多高质量RCTs予以证实。Objective To assess the safety and efficacy of recombinant human platelet-derived growth factor(rhPDGF)in adjuvant treatment of diabetes-related foot ulcer(DFU).Methods Randomized controlled trials(RCTs)on rhPDGF as an adjuvant treatment for DFU were systematically searched in PubMed,Embase,the Cochrane Library,CNKI,SinoMed,VIP,and WanFang Data from the establishment of databases to June 28,2024.Data extraction and methodological quality evaluation were conducted on the included studies.RevMan 5.3 and R 4.3.1 softwares were used for Meta-analysis.Sensitivity analysis was performed by excluding moderate-low quality studies and leave-one-out method,and a funnel plot was constructed to detect the risk of publication bias.Results 14 RCTs were included,involving a total of 1388 DFU patients.The results indicated that compared with the standard of care,the rhPDGF adjuvant treatment could increase the wound healing rate of DFU[overall:OR=1.70,95%CI(1.33-2.18),P<0.001;5-12 weeks:OR=2.32,95%CI(1.36-3.93),P=0.002;13-24 weeks:OR=1.57,95%CI(1.20-2.06),P=0.001;neuropathic:OR=1.81,95%CI(1.36-2.41),P<0.001;noninfectious:OR=1.70,95%CI(1.30-2.22),P<0.001].However,there were no significant statistical differences in wound healing time,wound area reduction,and complication rate(P>0.05).The combined results after excluding low-quality studies also showed that rhPDGF adjuvant treatment could increase the wound healing rate of DFU[OR=1.68,95%CI(1.27-2.23),P<0.001],and the results of sensitivity analysis by leave-outone method were not significantly changed.The funnel plot demonstrated that there was a low probability of publication bias in this study.Conclusion rhPDGF adjuvant treatment of DFU can increase the wound healing rate without increasing the complication rate.Limited by research quality and other factors,the above conclusions still need to be confirmed by more high-quality RCTs.

关 键 词：糖尿病足溃疡 重组人血小板源生长因子 标准疗法 创面愈合 META分析 

分 类 号：R587.2[医药卫生—内分泌]