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用于腋窝多汗症的外用奥昔布宁除臭剂:是局部作用还是全身作用?“今日试验”II期的原理与设计

Topical oxybutynin deodorant for axillary hyperhidrosis: a topic or a systemic effect? Rationale and design of the phase II today trial.

作者信息

Neves Samantha, Volpiani Giuliano Giova, Paganotti Alexia, Menegueti Felipe, Boix Ricardo Sanchez, Caffaro Roberto Augusto, Dos Santos Vanessa Prado, Ramacciotti Eduardo

机构信息

Irmandade Santa Casa de Misericórdia de São Paulo, São Paulo, SP, Brasil.

Universidade Federal da Bahia, Faculdade de Medicina da Bahia, Salvador, BA, Brasil.

出版信息

J Vasc Bras. 2025 Feb 21;24:e20240098. doi: 10.1590/1677-5449.202400982. eCollection 2025.

DOI:10.1590/1677-5449.202400982
PMID:40012967
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11864779/
Abstract

Anticholinergics have been shown to enhance quality of life and reduce sweat in patients with hyperhidrosis. However, it remains unclear whether topical application specifically exerts local or systemic effects. This study's primary aim is to assess topical oxybutynin's impact on axillary hyperhidrosis. Twenty patients will be randomized into three groups. Group A will receive 2.5 mg of oral oxybutynin from day 1 to day 35 (on a variable frequency regimen). Group B will be administered a topical placebo for 35 days and Group C will receive a 10% oxybutynin topical spray, to be used twice daily for 35 days. The primary efficacy outcome will be the evaluation of the effectiveness of topical oxybutynin spray in treating hyperhidrosis. The TODAY trial will generate high-quality evidence on the effects of topical oxybutynin, assessing whether its impact is local or systemic in patients with axillary hyperhidrosis.

摘要

抗胆碱能药物已被证明可提高多汗症患者的生活质量并减少出汗。然而,局部应用抗胆碱能药物究竟是产生局部作用还是全身作用仍不清楚。本研究的主要目的是评估局部应用奥昔布宁对腋窝多汗症的影响。20名患者将被随机分为三组。A组将从第1天至第35天接受2.5毫克口服奥昔布宁(采用可变频率给药方案)。B组将接受35天的局部安慰剂治疗,C组将接受10%奥昔布宁局部喷雾剂,每天使用两次,共35天。主要疗效指标将是评估局部奥昔布宁喷雾剂治疗多汗症的有效性。“今日”试验将产生关于局部应用奥昔布宁效果的高质量证据,评估其对腋窝多汗症患者的影响是局部性的还是全身性的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a7a/11864779/a1d00f158088/jvb-24-e20240098-g03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a7a/11864779/97b160c79345/jvb-24-e20240098-g01-en.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a7a/11864779/81d1d99e681d/jvb-24-e20240098-g02-en.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a7a/11864779/0141d1a5e768/jvb-24-e20240098-g03-en.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a7a/11864779/1677d52ac1a5/jvb-24-e20240098-g01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a7a/11864779/544bdcc23348/jvb-24-e20240098-g02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a7a/11864779/a1d00f158088/jvb-24-e20240098-g03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a7a/11864779/97b160c79345/jvb-24-e20240098-g01-en.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a7a/11864779/81d1d99e681d/jvb-24-e20240098-g02-en.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a7a/11864779/0141d1a5e768/jvb-24-e20240098-g03-en.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a7a/11864779/1677d52ac1a5/jvb-24-e20240098-g01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a7a/11864779/544bdcc23348/jvb-24-e20240098-g02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a7a/11864779/a1d00f158088/jvb-24-e20240098-g03.jpg

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A glycopyrronium bromide 1% cream for topical treatment of primary axillary hyperhidrosis: efficacy and safety results from a phase IIIa randomized controlled trial.溴化吡丙托品 1%乳膏治疗原发性腋窝多汗症的疗效和安全性:来自 IIIa 期随机对照试验的结果。
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