重组牛碱性成纤维细胞生长因子治疗糖尿病足溃疡的随机对照试验的系统评价和Meta分析  

Systematic review and meta-analysis of randomized controlled trials of recombinant bovine basic fibroblast growth factor in thetreatment diabetic foot ulcers

作　　者：刘晓波 杨国勋 武智强 朱彩 阙渟 Liu Xiaobo;Yang Guoxun;Wu Zhiqiang;Zhu Cai;Que Ting(Department of Burns,Plastics and Wound Repair Surgery,The First Affiliated Hospital of Dali University,Dali,Yunnan 671000,China)

机构地区：[1]大理大学第一附属医院烧伤整形创面修复科,云南大理671000

出　　处：《感染、炎症、修复》2025年第1期8-15,共8页Infection Inflammation Repair

基　　金：云南省昆虫生物医药研发重点实验室2024年度开放课题(AG2024006)。

摘　　要：目的:通过对已发表的采用随机对照试验方法研究重组牛碱性成纤维细胞生长因子(rb-bFGF)治疗糖尿病足溃疡的文献进行系统评价,明确其治疗糖尿病足溃疡的疗效和安全性。方法:对以下中英文数据库进行全面检索:Medline、EMBASE、Cochrane临床试验登记数据库(CENTRAL)、中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、中国科技期刊全文数据库(VIP)、万方数据库,检索范围为1995年1月至2024年7月发表的rb-bFGF治疗糖尿病足溃疡、自述为随机对照试验的报告,提取基线资料,采用Cochrane协作网偏倚风险评价标准评价文献质量。连续性变量的合并以加权均数差(WMD)或标准均数差(SMD)表示,二分类变量的合并以相对危险度(RR)表示,并计算95%置信区间(CI)。采用GRADE指南推荐的方法对结果进行证据等级评价。结果:最终纳入16篇文献,共1111例患者。rb-bFGF较对照组能提高糖尿病足溃疡的治愈率(RR=1.41;95%CI:1.31-1.52),缩短溃疡愈合时间(WMD=-10.74 d;95%CI:-13.43--8.05)。GRADE评级均为中等级别证据。结论:中等强度级别的证据支持rb-bFGF单用或联用均能提高糖尿病足溃疡的治愈率,并缩短溃疡愈合时间。Objective:To systematically review the published randomized controlled trials of recombinant bovine basic fibroblast growth factor(rb-bFGF)in the treatment of diabetic foot ulcers to clarify its efficacy and safety in the treatment of diabetic foot ulcers.Methods:A comprehensive search of the following Chinese and English databases:Medline,EMBASE,Cochrane Clinical Trial Registry(CENTRAL),China Biomedical Literature Database(CBM),China Journal Full-Text Database(CNKI),China Science and Technology Journal Full-Text Database(VIP),Wanfang Database.Self-reported randomized controlled trials of rb-bFGF in the treatment of diabetic foot ulcers published between January 1995 and July 2024 were searched.Baseline data were extracted and the literature quality was assessed using the Cochrane Collaborative Network bias risk assessment criteria.The combination of continuity variables is expressed as weighted mean difference(WMD)or standard mean difference(SMD),and the combination of bitaxonomic variables is expressed as relative risk(RR),and 95%confidence intervals(CI)are calculated.The results were graded with evidence using the methods recommended by the Grading of Recommendations Assessment,Development and Evaluation(GRADE)guidelines.Results:Finally,16 articles were included,with a total of 1111 patients.rb-bFGF could increase the cure rate of diabetic foot ulcer compared with the control group(RR=1.41;95CI:1.31 to 1.52)and shorten the ulcer healing time(WMD=-10.74;95%CI:-13.43 to-8.05).The GRADE ratings were medium grade evidence.Conclusions:Moderate-level evidence supports that rb-bFGF alone or in combination can improve the cure rate and shorten the healing time of diabetic foot ulcers.

关 键 词：重组牛碱性成纤维细胞生长因子 糖尿病足溃疡 随机对照试验 系统评价 META分析 

分 类 号：R587.2[医药卫生—内分泌]