以黄芪为基础的中药治疗糖尿病足溃疡的有效性和安全性：随机对照试验的系统评价和荟萃分析

IF 1.7 4区医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE

European Journal of Integrative Medicine Pub Date : 2025-09-24 DOI:10.1016/j.eujim.2025.102561

Bingrui Zhang , Kebin Wang , Yuxiao Li , Qinhua Fan , Qingxiao Li , Yingqiu Sun , Yawei Du , Wenquan Su , Shengxian Wu

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引用次数: 0

摘要

黄芪（astragalus aceus， AM）是一种传统的补气中药，特别用于治疗溃疡。本系统综述旨在研究AMPs治疗糖尿病足溃疡（DFU）的有效性和安全性。方法我们检索了8个数据库，以AMPs治疗DFU为重点的随机对照试验（rct）。计算具有95%置信区间（CI）的平均差值（MD）和相对危险度（RR）并用于meta分析。结果纳入44项随机对照试验，涉及3238名受试者。amp包括24个口服AM制剂、14个外用AM制剂、4个单独外用AM制剂和2个注射剂。总体而言，研究质量较低。与西药（WM）相比，AMPs具有更高的治愈率（RR 1.64, 95% CI 1.4 ~ 1.9, 8个rct， n = 747）、更小的溃疡面积（MD -12.11 cm2, 95% CI -19.23 ~ -4.99, 4个rct， n = 304）和更短的愈合时间（MD -7.82天，95% CI -10.59 ~ -5.05, 4个rct， n = 353）。AMPs加WM在治愈率（RR 1.22, 95% CI 1.07 ~ 1.4, 20个rct， n = 1497）、截肢率（RR 0.42, 95% CI 0.27 ~ 0.66, 3个rct， n = 265）、死亡率（RR 0.29, 95% CI 0.12 ~ 0.71, 3个rct， n = 265）、溃疡大小（MD -1.78 cm2, 95% CI -2.55 ~ -1.01, 10个rct， n = 761）、愈合时间、踝臂指数（ABI）、疼痛评分、临床有效率和一般症状等方面均优于WM。amp组无严重不良事件报告。结论抗菌肽对溃疡愈合、增加ABI、减轻疼痛具有潜在的作用。AMPs治疗DFU的确切疗效需要通过高质量的双盲随机对照试验来证实。本综述的注册方案通过PROSPERO注册（CRD42024613403）。国家科技重大专项[批准号：2017ZX09304019]。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Effectiveness and safety of Astragalus membranaceus-based traditional Chinese medicine in treating diabetic foot ulcers: A systematic review and meta-analysis of randomized controlled trials

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Effectiveness and safety of Astragalus membranaceus-based traditional Chinese medicine in treating diabetic foot ulcers: A systematic review and meta-analysis of randomized controlled trials

Introduction

Astragalus membranaceus (AM) is a traditional Chinese medicine employed for supplementing qi and particularly used for ulcer treatment. This systematic review aimed to examine the effectiveness and safety of AM-based prescriptions (AMPs) for diabetic foot ulcer (DFU).

Methods

We searched eight databases to identify randomized controlled trials (RCTs) focusing on AMPs for DFU. The mean difference (MD) and relative risk (RR) with 95% confidence interval (CI) were calculated and used in the meta-analysis.

Results

We included 44 RCTs involving 3,238 participants. The AMPs included 24 oral AM formulas, 14 topical AM formulas, 4 topical AM alone, and 2 injections. Overall, study quality was low. Compared with Western medicine (WM), AMPs were associated with a higher healing rate (RR 1.64, 95% CI 1.4 to 1.9, 8 RCTs, n = 747), smaller ulcer size (MD –12.11 cm², 95% CI –19.23 to –4.99, 4 RCTs, n = 304) and shorter healing time (MD –7.82 days, 95% CI –10.59 to –5.05, 4 RCTs, n = 353). AMPs plus WM were more efficacious than WM in healing rate (RR 1.22, 95% CI 1.07 to 1.4, 20 RCTs, n = 1497), amputation rate (RR 0.42, 95% CI 0.27 to 0.66, 3 RCTs, n = 265), mortality (RR 0.29, 95% CI 0.12 to 0.71, 3 RCTs, n = 265), ulcer size (MD –1.78 cm², 95% CI –2.55 to –1.01, 10 RCTs, n = 761), healing time, ankle-brachial index (ABI), pain scores, clinical effective rate, and general symptoms. No severe adverse events were reported in the AMPs group.

Conclusion

AMPs may have potential effectiveness in ulcer healing, ABI increase, and pain alleviation. The exact efficacy of AMPs for DFU needs to be confirmed using high-quality double-blind RCTs.

Registration

Protocol of this review was registered via PROSPERO (CRD42024613403).

Funding

National Science and Technology Major Project of China [grant number 2017ZX09304019].

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来源期刊

European Journal of Integrative Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-

CiteScore

4.70

自引率

4.00%

发文量

102

审稿时长

33 days

期刊介绍： The European Journal of Integrative Medicine (EuJIM) considers manuscripts from a wide range of complementary and integrative health care disciplines, with a particular focus on whole systems approaches, public health, self management and traditional medical systems. The journal strives to connect conventional medicine and evidence based complementary medicine. We encourage submissions reporting research with relevance for integrative clinical practice and interprofessional education. EuJIM aims to be of interest to both conventional and integrative audiences, including healthcare practitioners, researchers, health care organisations, educationalists, and all those who seek objective and critical information on integrative medicine. To achieve this aim EuJIM provides an innovative international and interdisciplinary platform linking researchers and clinicians. The journal focuses primarily on original research articles including systematic reviews, randomized controlled trials, other clinical studies, qualitative, observational and epidemiological studies. In addition we welcome short reviews, opinion articles and contributions relating to health services and policy, health economics and psychology.