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奥替尼啶与分散酶凝胶用于基底细胞癌患者冷冻治疗后伤口愈合的比较

Octenidine Versus Dispase Gels for Wound Healing After Cryosurgery Treatment in Patients with Basal Cell Carcinoma.

作者信息

Stratidakis Nektarios, Tagka Anna, Geronikolou Styliani A, Giannakopoulos Efstathios, Panagiotopoulos Antonios, Malachia Evdokia, Vitsos Andreas, Karalis Evangelos, Dallas Paraskevas, Stratigos Alexandros, Rallis Michail

机构信息

Division of Pharmaceutical Technology, School of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.

First Department of Dermatology and Venereology, "Andreas Syggros" Hospital, National and Kapodistrian University of Athens, Medical School, Athens, Greece.

出版信息

Adv Exp Med Biol. 2023;1425:591-601. doi: 10.1007/978-3-031-31986-0_57.

Abstract

For a specific group of patients with basal cell carcinoma (small, low risk), cryosurgery could be the suggested treatment, which results in the formation of an ulcer in the lesion area. The proteolytic enzymes' contribution to the wound healing is an ongoing research goal. Preclinical animal experiments in the Laboratory of the Pharmaceutical Technology Department of the National and Kapodistrian University of Athens have showed that a dose of 5 U/mL of dispase gel after the formation of tissue rashes, significantly promoted wound healing. Herein, a feasibility study in 16 patients enrolled by the First Department of Dermatology of Andreas Syggros Hospital was designed: 5 U/mL of dispase gel (once every 3 days) versus a drug reference containing octenidine (daily administration). The evaluation of the healing effect, safety, and tolerance was done on days 1 (cryosurgery), 2, 7, 21, and 60. The study end point was considered either the ulcer complete healing or the eighth week since treatment initiation. Wound healing was faster with dispase gel and hemoglobin reduced rapidly after the seventh day. Yet, hydration was higher in the control group. Our non-parametric analysis provides evidence that the dispase gel shows faster healing compared to the reference drug, in humans, meriting further investigation in larger human sample sizes before massive production of the product.

摘要

对于特定组的基底细胞癌患者(小面积、低风险),冷冻手术可能是建议的治疗方法,这会导致病变区域形成溃疡。蛋白水解酶对伤口愈合的作用是一个正在进行研究的目标。雅典国立与卡波迪斯特里亚大学药学技术系实验室的临床前动物实验表明,在出现皮疹后使用5 U/mL的分散酶凝胶,可显著促进伤口愈合。在此,设计了一项由安德烈亚斯·西格罗斯医院皮肤科一部招募16名患者参与的可行性研究:5 U/mL的分散酶凝胶(每3天一次)与含奥替尼啶的药物对照(每日给药)。在第1天(冷冻手术后)、第2天、第7天、第21天和第60天对愈合效果、安全性和耐受性进行评估。研究终点被认为是溃疡完全愈合或治疗开始后的第八周。使用分散酶凝胶时伤口愈合更快,且在第7天后血红蛋白迅速降低。然而,对照组的水合作用更高。我们的非参数分析提供了证据,表明在人类中,与对照药物相比,分散酶凝胶显示出更快的愈合速度,在该产品大规模生产之前,值得在更大的人类样本量中进行进一步研究。

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