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芦荟/大车前草凝胶治疗糖尿病足溃疡的疗效:一项随机双盲临床试验。

Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial.

作者信息

Najafian Younes, Khorasani Zahra M, Najafi Mona N, Hamedi Shokouh S, Mahjour Marjan, Feyzabadi Zohre

机构信息

Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.

出版信息

Curr Drug Discov Technol. 2019;16(2):223-231. doi: 10.2174/1570163815666180115093007.

DOI:10.2174/1570163815666180115093007
PMID:29336265
Abstract

BACKGROUND

Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFU.

METHODS

Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.

RESULTS

At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.

CONCLUSION

Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

摘要

背景

糖尿病足溃疡(DFU)是糖尿病患者最常见的并发症之一。大多数情况下,不愈合的DFU会导致感染、坏疽、截肢甚至死亡。伤口的高成本和愈合不良需要一种新的治疗方法,如替代医学。因此,本研究的目的是评估芦荟/大车前草凝胶(Plantavera凝胶)治疗DFU的疗效。

方法

40例DFU患者参加了一项双盲随机临床试验。随机分为干预组(n = 20)的患者,除常规护理外,还接受局部Plantavera凝胶治疗;而对照组(n = 20)的患者,除常规护理外,接受局部安慰剂凝胶治疗。两组均每天进行两次干预,持续4周。通过检查表对DFU愈合情况进行拍照和评估,然后在基线和每周结束时进行评分。收集的数据用SPSS软件进行分析。

结果

研究结束时,两组在总溃疡评分方面存在显著差异(P<0.001),与对照组相比,Plantavera凝胶显著减少了溃疡面积(P = 0.039)。然而,两组在溃疡深度方面无显著差异(P = 0.263)。在本研究中,干预组未观察到Plantavera凝胶的副作用。

结论

局部应用Plantavera凝胶似乎是一种有效、廉价且安全的治疗方法。当然,还需要进一步的研究来证实这种凝胶的伤口愈合特性。

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