0.05%纳米封装咪喹莫特水凝胶治疗光化性唇炎的功效和安全性：药物释放分析和临床研究。
Efficacy and safety of a 0.05 % nanoencapsulated imiquimod hydrogel for the treatment of actinic cheilitis: Drug release analysis and clinical study.
发表日期：2024 Aug 13
作者：
Eduardo Liberato da Silva, Erick Souza Pedraça, Arthur Pias Salgueiro, Rafaela Pletsch Gazzi, Júlia Silveira Nunes, Juliano Cavagni, Marco Antônio Trevizani Martins, Pantelis Varvaki Rados, Adriana Raffin Pohlmann, Silvia Stanisçuaski Guterres, Luiza Abrahão Frank, Fernanda Visioli
来源：
Nanomedicine
摘要：
光化性唇炎（AC）是一种唇部疾病，没有标准治疗方法。咪喹莫特（IMIQ）是一种治疗癌前病变的免疫调节剂；然而，其商业形式会造成严重的不利影响。本研究旨在评估含有 0.05% 纳米封装 (NANO) 咪喹莫特 (IMIQ-0.05%-NANO) 的壳聚糖水凝胶中 IMQ 的释放及其在 AC 治疗中的功效。该水凝胶是通过将壳聚糖掺入装有 IMQ 的聚合物纳米胶囊 (NCimiq) 中来制备的，该纳米胶囊是使用预成型聚合物的界面沉积方法生产的。使用自动化 Franz Cells 评估 IMQ 释放。一项三盲随机对照试验（49 名受试者）比较了以下药物的功效：IMIQ-0.05%-NANO、5% 游离咪喹莫特 (IMIQ-5%)、0.05% 游离咪喹莫特 (IMIQ-0.05%) 和安慰剂水凝胶。 IMIQ-NANO-0.05% 和 IMIQ-5% 组的临床改善率显着更高 (p<0.05)；然而，与其他组相比，IMIQ-5% 组（92.3% 的受试者）经历了更多的不良反应 (p<0.05)。总之，在研究样本中，IMIQ-NANO-0.05% 是治疗 AC 的安全有效的选择。版权所有 © 2024。由 Elsevier Inc. 出版。
Actinic cheilitis (AC) is a lip disorder, with no standard treatment. Imiquimod (IMIQ) is an immunomodulator that treat precancerous lesions; however, its commercial form causes severe adverse effects. This study aimed to assess IMQ release from a chitosan hydrogel containing 0.05 % nanoencapsulated (NANO) imiquimod (IMIQ-0.05 %-NANO) and its efficacy in AC treatment. The hydrogels were prepared by incorporating chitosan into polymeric nanocapsules (NCimiq) loaded with IMQ, produced using the interfacial deposition of preformed polymer method. IMQ release was evaluated using automated Franz Cells. A triple-blind randomized controlled trial (49 subjects) compared the efficacy of: IMIQ-0.05 %-NANO, 5 % free imiquimod (IMIQ-5 %), 0.05 % free imiquimod (IMIQ-0.05 %), and placebo hydrogel. The IMIQ-NANO-0.05 % and IMIQ-5 % groups exhibited significantly higher rates of clinical improvement (p < 0.05); however, the IMIQ-5 % group experienced more adverse effects (92.3 % of subjects) compared to other groups (p < 0.05). In conclusion, in the studied sample, IMIQ-NANO-0.05 % was a safe and effective option to treat AC.Copyright © 2024. Published by Elsevier Inc.