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索非罗尼治疗原发性多汗症的疗效与安全性:一项系统评价

Efficacy and safety of sofpironium in treatment of primary hyperhidrosis: a systematic review.

作者信息

Odat Ramez M, Yousef Aldalati Abdullah, Hammadeh Bara M, Mohammad Hussein Ayham, Idrees Muhammad, Marzouk Hamza, Alshwayyat Sakhr, Hanifa Hamdah

机构信息

Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan.

Faculty of Medicine, Al-Balqa' Applied University, Salt, Jordan.

出版信息

J Dermatolog Treat. 2025 Dec;36(1):2441258. doi: 10.1080/09546634.2024.2441258. Epub 2024 Dec 13.

Abstract

BACKGROUND

Primary axillary hyperhidrosis has limited noninvasive and effective treatment, and we present the use of sofpironium bromide as a promising treatment option. We aimed to assess the efficacy and safety of sofpironium in patients with primary hyperhidrosis.

METHODS

We systematically searched the databases for Studies that assessed sofpironium bromide in patients with primary axillary hyperhidrosis. Methodological quality was determined using the Cochrane Risk of Bias Assessment tool and Newcastle-Ottowa scale.

RESULTS

Five studies were included (752 patients). They used 5% sofpironium, except for one study that used 5%, 10%, and 15% sofpironium. Studies have shown a significant difference in the incidence of patients with an HDSS score of 1 or 2 ranging from 53.9% to 86.7% and reported a greater reduction in the mean change in the DLQI score in the sofpironium group. They also noted a more significant reduction in the total gravimetric weight of sweat in the sofpironium group. A 1.5 point or greater improvement in HDSM-Ax score ranged from 48.2% to 69.1%. Serious adverse events were not observed in the intervention group.

CONCLUSION

Sofpironium gel provides notable improvements in symptom severity, sweat reduction, and quality of life, with mostly mild localized adverse events.Hyperhidrosis is relatively common, affecting 4.8% of the US population and negatively affects physical, social, and psychological well-being.Sofpironium bromide is recently approved by the FDA for the treatment of primary axillary hyperhidrosisSofpironium bromide showed promising results in terms of safety and efficacy for treating hyperhidrosisWe systematically assessed the use of sofpironium gel reported in five studies (752 patients)Sofpironium gel provides notable improvements in symptom severity, sweat reduction and quality of life, with mostly mild localized adverse events.

摘要

背景

原发性腋窝多汗症的非侵入性有效治疗方法有限,我们介绍了使用溴化索罗非宁作为一种有前景的治疗选择。我们旨在评估溴化索罗非宁对原发性多汗症患者的疗效和安全性。

方法

我们系统检索了评估溴化索罗非宁治疗原发性腋窝多汗症患者的研究数据库。使用Cochrane偏倚风险评估工具和纽卡斯尔-渥太华量表确定方法学质量。

结果

纳入了五项研究(752例患者)。除一项研究使用5%、10%和15%的溴化索罗非宁外,其他研究均使用5%的溴化索罗非宁。研究表明,HDSS评分为1或2的患者发生率在53.9%至86.7%之间存在显著差异,并且报告溴化索罗非宁组的DLQI评分平均变化降低幅度更大。他们还指出,溴化索罗非宁组汗液总重量的减少更为显著。HDSM-Ax评分提高1.5分或更高的比例在48.2%至69.1%之间。干预组未观察到严重不良事件。

结论

溴化索罗非宁凝胶在症状严重程度、汗液减少和生活质量方面有显著改善,主要是轻度局部不良事件。多汗症相对常见,影响4.8%的美国人口,对身体、社交和心理健康产生负面影响。溴化索罗非宁最近被美国食品药品监督管理局批准用于治疗原发性腋窝多汗症。溴化索罗非宁在治疗多汗症的安全性和有效性方面显示出有前景的结果。我们系统评估了五项研究(752例患者)中报告的溴化索罗非宁凝胶的使用情况。溴化索罗非宁凝胶在症状严重程度、汗液减少和生活质量方面有显著改善,主要是轻度局部不良事件。

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