局部应用负载苯妥英的纳米结构脂质载体对糖尿病足溃疡的影响。
The impact of topical phenytoin loaded nanostructured lipid carriers in diabetic foot ulceration.
作者信息
Motawea Amira, Abd El-Gawad Abd El-Gawad H, Borg Thanaa, Motawea Mohamad, Tarshoby Manal
机构信息
Department of Pharmaceutics, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt.
Department of Diabetes and Endocrinology, Faculty of Medicine, Mansoura University, Mansoura 35516, Egypt.
出版信息
Foot (Edinb). 2019 Sep;40:14-21. doi: 10.1016/j.foot.2019.03.007. Epub 2019 Mar 14.
OBJECTIVE
The aim of this study is to develop, and characterize nanostructured lipid carriers (NLCs) of phenytoin (PHT) in order to improve its entrapment efficiency and sustained release to improve the healing process.
METHODS
Twenty-seven patients with neuropathic diabetic foot ulceration (DFU) were enrolled in this study. Patients were comparable regarding size, grading of ulcer and control of diabetes with no major deformity. All patients were managed by weekly sharp debridement if indicated and offloaded with cast shoes. They were equally divided into three groups: PHT-NLC-hydrogel (0.5%w/v), phenytoin hydrogel (0.5%w/v) and blank hydrogel groups. Changes in wound area were monitored over 2 months.
RESULTS
Baseline wound area of PHT-NLC, PHT and blank hydrogels were 5.50 ± 3.66, 3.94 ± 1.86 and 5.36 ± 2.14 cm, respectively. Ulcers treated with PHT-NLC hydrogel showed smaller wound area compared to control groups (ρ < 0.05). The overall reduction in ulcer size were 95.82 ± 2.22% for PHT-NLC-hydrogel in comparison to 47.10 ± 4.23% and -34.91 ± 28.33% for PHT and blank-hydrogel (ρ < 0.001), respectively.
CONCLUSION
PHT-NLC hydrogel speeds up the healing process of the DFU without adverse effects when compared to the positive and negative control hydrogels. Moreover, the study can open a window for topical application of NLCs loaded with PHT in the treatment of numerous dermatological disorders that resist conventional treatment.
KEY MESSAGE
The delivery of drug molecules and their localization into the skin is the main purpose of the topical dosage forms. In this manuscript, the impact of topical phenytoin loaded nanostructured lipid carrier in improving wound healing in patients with neuropathic diabetic foot ulceration was investigated. Phenytoin loaded nanostructured lipid carrier dressing was found to be more effective than phenytoin hydrogel at the same concentration in healing of neuropathic diabetic foot ulcer.
目的
本研究旨在开发并表征苯妥英（PHT）的纳米结构脂质载体（NLCs），以提高其包封率和缓释性能，从而促进愈合过程。
方法
本研究纳入了27例神经性糖尿病足溃疡（DFU）患者。患者在溃疡大小、分级及糖尿病控制情况方面具有可比性，且无严重畸形。所有患者如有指征则每周进行一次锐性清创，并使用支具鞋减负。他们被平均分为三组：PHT-NLC水凝胶组（0.5%w/v）、苯妥英水凝胶组（0.5%w/v）和空白水凝胶组。在2个月内监测伤口面积的变化。
结果
PHT-NLC、PHT和空白水凝胶的基线伤口面积分别为5.50±3.66、3.94±1.86和5.36±2.14平方厘米。与对照组相比，PHT-NLC水凝胶治疗的溃疡伤口面积更小（ρ<0.05）。PHT-NLC水凝胶组溃疡大小的总体减少率为95.82±2.22%，而PHT组和空白水凝胶组分别为47.10±4.23%和-34.91±28.33%（ρ<0.001）。
结论
与阳性和阴性对照水凝胶相比，PHT-NLC水凝胶可加速DFU的愈合过程且无不良反应。此外，该研究可为负载PHT的NLCs在治疗多种难治性皮肤病中的局部应用打开一扇窗。
关键信息
药物分子的递送及其在皮肤中的定位是局部剂型的主要目的。在本手稿中，研究了局部负载苯妥英的纳米结构脂质载体对改善神经性糖尿病足溃疡患者伤口愈合的影响。发现在治疗神经性糖尿病足溃疡时，相同浓度下负载苯妥英的纳米结构脂质载体敷料比苯妥英水凝胶更有效。
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