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富血小板凝胶联合中药治疗糖尿病足的疗效:一项平行随机对照临床试验。

The Efficacy of Autologous Platelet-Rich Gel and Traditional Chinese Medicine in Diabetic Foot Treatment: A Parallel Randomized Controlled Clinical Trial.

机构信息

Department of Endocrinology, Yueyang Hospital of Traditional Chinese Medicine, Yueyang City, Hunan Province.

Department of Endocrinology, Yueyang Hospital of Traditional Chinese Medicine, Yueyang City, Hunan Province.

出版信息

Ann Vasc Surg. 2022 Nov;87:529-537. doi: 10.1016/j.avsg.2022.07.026. Epub 2022 Sep 2.

Abstract

BACKGROUND

Diabetic foot (DF) is a prevalent metabolic infection. DF wounds are the basis for all cases of nontraumatic lower limb amputations in diabetes. DF care approaches include debridement of wound, pressure relief in the wounded area, proper wound, infection, and ischemia management. However, there is a need for research to develop more effective therapeutic approaches. This study investigated the effectivity and safety of autologous platelet-rich gel combined with conventional treatment and traditional Chinese medicine (TCM) in DF ulcer therapy.

METHODS

Sixty DF ulcer patients were divided into treatment and control groups of 30 patients each. The treatment group involved a combination of autologous platelet-rich gel, conventional treatment, and TCM. The control group was only treated with a combination of conventional therapy and TCM. Laboratory variables, including platelets, hemoglobin (Hb), albumin, and HbA1c, were analyzed and compared between the treatment and the control groups at baseline and endpoint. Healing area, volume, and rates were compared in both groups.

RESULTS

Basic patients' data and the wound conditions had no significant difference between the treatment and the control group. The treatment and control groups cure rates were 93.3% vs. 50%, respectively. The healing rate per 2 weeks was significantly higher in the treatment than in the control group (0.78 ± 0.05 vs. 0.43 ± 0.04). There was no statistically significant difference in the platelets, Hb, albumin, and HbA1c levels in the treatment and control groups.

CONCLUSIONS

Autologous platelet-rich gel combined with conventional treatment and TCM is effective and safe for DF ulcer treatment.

摘要

背景

糖尿病足(DF)是一种常见的代谢性感染。DF 伤口是糖尿病患者非创伤性下肢截肢的所有病例的基础。DF 护理方法包括清创、伤口区域减压、适当处理伤口、感染和缺血管理。然而,需要研究开发更有效的治疗方法。本研究调查了自体富血小板凝胶联合常规治疗和中药(TCM)在 DF 溃疡治疗中的效果和安全性。

方法

60 例 DF 溃疡患者分为治疗组和对照组,每组 30 例。治疗组采用自体富血小板凝胶、常规治疗和 TCM 联合治疗。对照组仅采用常规治疗和 TCM 联合治疗。分析并比较两组患者在基线和终点时的实验室变量,包括血小板、血红蛋白(Hb)、白蛋白和 HbA1c。比较两组的愈合面积、体积和愈合率。

结果

治疗组和对照组的基础患者数据和伤口状况无显著差异。治疗组和对照组的治愈率分别为 93.3%和 50%。治疗组每 2 周的愈合率明显高于对照组(0.78±0.05 对 0.43±0.04)。治疗组和对照组的血小板、Hb、白蛋白和 HbA1c 水平无统计学差异。

结论

自体富血小板凝胶联合常规治疗和 TCM 对 DF 溃疡治疗有效且安全。

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