较 披露人的基底细胞癌患者离子束治疗后创面愈合,辛烷啶凝胶与溶融剂凝胶的比较。
Octenidine Versus Dispase Gels for Wound Healing After Cryosurgery Treatment in Patients with Basal Cell Carcinoma.
发表日期:2023
作者:
Nektarios Stratidakis, Anna Tagka, Styliani A Geronikolou, Efstathios Giannakopoulos, Antonios Panagiotopoulos, Evdokia Malachia, Andreas Vitsos, Evangelos Karalis, Paraskevas Dallas, Alexandros Stratigos, Michail Rallis
来源:
CLINICAL PHARMACOLOGY & THERAPEUTICS
摘要:
针对一组具有基细胞癌(小、低风险)的特定患者,冷冻手术可能是推荐的治疗方法,其导致病变区出现溃疡。蛋白酶的贡献对于创伤愈合是一个持续进行的研究目标。雅典国家与卡波迪斯特里亚大学制药技术系的实验室进行的预临床动物实验表明,在组织疹形成后使用5 U/mL的凝胶酶明显促进创面愈合。在此,由安德烈亚斯·锡格罗斯医院皮肤科一科招募的16例患者进行可行性研究:5 U/mL的凝胶酶(每3天一次)与含辛胺啉的参比药物(每日一次)进行比较。愈合效果、安全性和耐受性在第1天(冷冻手术)、第2天、第7天、第21天和第60天进行评估。研究终点被定义为溃疡完全愈合或自治疗开始后的第八周。使用凝胶酶的创面明显愈合更快,血红蛋白在第七天后迅速降低。然而,控制组的保湿度更高。我们的非参数分析提供了证据,表明凝胶酶相比参比药物在人体中显示出更快的愈合速度,在大规模生产该产品之前还需要在更大的人体样本大小上进行进一步调查。© 2023. 作者(自)独家许可给施普林格自然瑞士有限公司。
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.© 2023. The Author(s), under exclusive license to Springer Nature Switzerland AG.