摘要
目的:对重组人酸性成纤维细胞生长因子(recombinant human acidic fibroblast growth factor,rh-aFGF)对比常规疗法治疗糖尿病足溃疡(diabetic foot ulcers,DFU)进行药物经济学评价,为临床合理用药和医疗卫生决策提供循证依据。方法:通过Meta分析比较2种治疗方案的疗效和安全性,构建决策树模型,对2种方案治疗DFU进行成本-效果分析和敏感性分析。结果:共纳入11篇文献、17组随机对照临床试验,包括1118例DFU患者。Meta分析结果显示:rh-aFGF组的有效率高于生理盐水组,差异有统计学意义[RR=1.23,95%CI(1.06,1.44),P=0.008];rh-aFGF组的创口完全愈合时间短于生理盐水组,差异有统计学意义[均数差(mean difference,MD)=-9.97,95%CI(-13.87,-6.08),P<0.01],两组均具有较好的安全性。成本-效果分析显示:rh-aFGF方案的成本较生理盐水方案低,临床有效率较生理盐水方案高,rh-aFGF方案具有经济性。敏感性分析显示,基础分析结果较为稳健。结论:rh-aFGF方案在治疗DFU患者的临床疗效和经济性方面都优于常规治疗方案(生理盐水),rh-aFGF方案为优势方案。
Objective:To conduct a pharmacoeconomic evaluation on recombinant human acidic fibroblast growth factor(rh-aFGF)compared to conventional therapy in the treatment of diabetic foot ulcers(DFU),providing an evidence-based support for rational clinical medication and healthcare decision-making.Methods:A Meta-analysis was conducted to compare the efficacy and safety of the two treatment methods.A decision tree model was constructed to perform cost-effectiveness and sensitivity analyses of the two treatment approaches for DFU.Results:A total of 11 studies,involving in 17 randomized controlled trials(RCTs),were included in this analysis,covering 1118 patients with DFU.The Meta-analysis indicated that the effective rate of the rh-aFGF group was significantly higher than that of the saline group[RR=1.23,95%CI(1.06,1.44),P=0.008].The complete wound healing time was significantly shorter in the rh-aFGF group than that in the saline group,with both groups demonstrating good safety.The cost-effectiveness analysis showed that the rh-aFGF regimen was less costly and had a higher overall effectiveness rate than the saline regimen,indicating economic advantages for rh-aFGF.Sensitivity analysis revealed that the results of the base analysis were relatively robust.Conclusion:The rh-aFGF regimen is superior to the conventional treatment(saline)in terms of both clinical efficacy and cost-effectiveness for treating DFU patients,making it the preferred treatment option.
作者
黄果
隋梦芸
朱贺
韩晟
史录文
HUANG Guo;SUI Meng-yun;ZHU He;HAN Sheng;SHI Lu-wen(School of Pharmaceutical Sciences,Peking University,Beijing 100191,China;International Research Center for Medicinal Administration,Peking University,Beijing 100191,China;Shanghai Center for Disease Control and Prevention,Shanghai 200336,China)
出处
《中国新药杂志》
北大核心
2025年第12期1313-1321,共9页
Chinese Journal of New Drugs
基金
国家自然科学基金资助项目(82273899)。
