Rev Esc Enferm USP. 2023 Jul 28;57:e20220338. doi: 10.1590/1980-220X-REEUSP-2022-0338en. eCollection 2023.
To assess the feasibility of incorporating technology as a new alternative for treating topics on cervical lesions.
This is a randomized, double-blind, controlled clinical trial with a prospective design. During the realization of this study, 43 women were included and divided between groups A (ointment without silver nanoparticles n = 23) and B (ointment with silver nanoparticles n = 20) clinically healthy and who used the unified health system.
There were no significant differences when comparing before and after the use of ointment for IVA test (p = 0.15), Schiller test (p = 0.15), cellular changes (p = 0.47) and microbiological analysis (p = 0.89) through cytology. After use, no adverse reaction was observed in the sample studied.
Based on the results identified in this study, identified that the product is safe and does not promote adverse events. Regarding the effectiveness of the product in uterine cervical lesions, it is necessary to continue the study in phase II. Registro de Ensaios Clínicos Brasileiros: UTN: U1111-1218-2820.
评估将技术纳入治疗宫颈病变相关主题的新替代方案的可行性。
这是一项随机、双盲、对照的临床试验,采用前瞻性设计。在本研究的实施过程中,纳入了 43 名临床健康且使用统一医疗系统的女性,并将其分为 A 组(不含银纳米粒子的软膏,n=23)和 B 组(含银纳米粒子的软膏,n=20)。
IVA 试验(p=0.15)、Schiller 试验(p=0.15)、细胞学中细胞变化(p=0.47)和微生物分析(p=0.89)的软膏使用前后比较均无统计学差异。在研究样本中,使用后未观察到不良反应。
根据本研究中确定的结果,确定该产品是安全的,不会引起不良事件。关于该产品治疗宫颈病变的有效性,有必要在第二阶段继续研究。
注册号:UTN:U1111-1218-2820。