Department of Pharmacology, Key Laboratory of Drug Targeting and Drug Delivery System of the Education Ministry, Sichuan Engineering Laboratory for Plant-Sourced Drug and Sichuan Research Center for Drug Precision Industrial Technology, West China School of Pharmacy, Sichuan University, Chengdu, China.
Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, China.
Front Endocrinol (Lausanne). 2022 Feb 24;13:749368. doi: 10.3389/fendo.2022.749368. eCollection 2022.
Diabetic foot ulcers are a major complication of diabetes mellitus (DM), when heparin and heparin related substances may be potentially used as an adjuvant treatment. We aimed to evaluate the efficacy and safety of heparin and heparin related substances for the treatment of diabetic foot ulcers.
We searched up to March 2021 in the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; EBSCO CINAHL; VIP Chinese Science and Technique Journals Database; China National Knowledge Infrastructure (CNKI) Database and Wan Fang Database investigating heparin or heparin-related substances in patients with diabetic foot ulcers. The primary outcomes included proportion of ulcers completely healed and time to complete ulcer healing. We assessed each included study with the Cochrane 'Risk of bias' tool and used the GRADE approach to assess the overall quality of the evidence.
We included nine randomized studies involving 620 participants in the meta-analysis, involving two different heparin and heparin-related substances, low molecular weight heparin (LMWH) and hyaluronic acid. Our study did not show the benefits from LMWH on increasing chance of the ulcer healing (RR: 1.26; 95% CI: 0.78 to 2.04; P=0.35; very low) or shortening the time to complete ulcer healing (SMD: 0.13 d; 95% CI: -0.29 to 0.56; P=0.54; very low). Hyaluronic acid may improve the complete ulcer healing (RR: 1.57; 95% CI: 1.29 to 1.91; P˂0.00001; very low) and shorten the time to complete ulcer healing (SMD -0.84, 95% CI -1.15 to -0.53; P<0.00001; low). Hyaluronic acid and LMWH were generally well tolerated for treating diabetic foot ulcers in this review.
Hyaluronic acid may improve diabetic foot ulcer with very low quality evidence but not LMWH. However, the benefits and harms need further validation in larger trials with different population.
[https://www.crd.york.ac.uk/prospero/], identifier [PROSPERO, CRD42021269212].
糖尿病足溃疡是糖尿病（DM）的一种主要并发症，肝素和肝素类物质可能被用作辅助治疗。我们旨在评估肝素和肝素类物质治疗糖尿病足溃疡的疗效和安全性。
我们检索了截至 2021 年 3 月的 Cochrane 对照试验中央注册库（CENTRAL）；Ovid MEDLINE；Ovid Embase；EBSCO CINAHL；维普中文科技期刊数据库；中国知网（CNKI）数据库和万方数据库，以调查肝素或肝素类物质在糖尿病足溃疡患者中的应用。主要结局包括溃疡完全愈合的比例和溃疡完全愈合的时间。我们使用 Cochrane“风险偏倚”工具评估了每一项纳入的研究，并使用 GRADE 方法评估了证据的总体质量。
我们纳入了 9 项随机研究，涉及 620 名参与者的荟萃分析，包括两种不同的肝素和肝素类物质，即低分子量肝素（LMWH）和透明质酸。我们的研究并未显示 LMWH 增加溃疡愈合的几率（RR：1.26；95%CI：0.78 至 2.04；P=0.35；极低）或缩短溃疡完全愈合的时间（SMD：0.13d；95%CI：-0.29 至 0.56；P=0.54；极低）。透明质酸可能改善完全溃疡愈合（RR：1.57；95%CI：1.29 至 1.91；P˂0.00001；极低）并缩短溃疡完全愈合的时间（SMD -0.84，95%CI -1.15 至 -0.53；P<0.00001；低）。在本综述中，透明质酸和 LMWH 通常可耐受用于治疗糖尿病足溃疡。
透明质酸可能改善糖尿病足溃疡，但其疗效证据质量极低，而 LMWH 则不然。然而，其益处和危害需要在更大规模、不同人群的试验中进一步验证。
[https://www.crd.york.ac.uk/prospero/]，标识符[PROSPERO，CRD42021269212]。
