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原发性多汗症治疗方法的系统循证综述。

A systematic evidence-based review of treatments for primary hyperhidrosis.

作者信息

Stuart Michael E, Strite Sheri A, Gillard Kristin Khalaf

机构信息

Delfini Group, LLC, Bellingham, WA, USA.

Dermira, Inc., a wholly-owned subsidiary of Eli Lilly and Company, Menlo Park, CA, USA.

出版信息

J Drug Assess. 2020 Dec 24;10(1):35-50. doi: 10.1080/21556660.2020.1857149.

Abstract

OBJECTIVE

Hyperhidrosis (excessive sweating) is associated with significant quality-of-life burden yet is often undertreated. With limited FDA-approved treatments, health care providers must determine optimal treatment among approved and off-label options. Key objectives of this review were to reassess, update, and expand a previous systematic review of commonly used treatment options for primary hyperhidrosis, including consideration of aluminum and zirconium compounds.

METHODS

We performed a qualitative systematic review of efficacy, health-related quality of life, satisfaction, and safety of interventions, replicating and expanding the strategy outlined in a previous systematic review, with the addition of studies utilizing a within-patient design. We performed a critical appraisal of identified studies to determine risk of bias (RoB) and strength of evidence (SOE).

RESULTS

A total of 32 studies were eligible for critical appraisal. Only three studies - two clinical trials of glycopyrronium cloth (2.4%) and one trial of botulinum toxin A injections in axillary hyperhidrosis were rated as "low" RoB; both had SOE ratings of "moderate" for use in axillary hyperhidrosis - the highest rating included in this review.

CONCLUSIONS

Optimal treatment choice depends on several factors, including understanding the quality of evidence regarding each treatment's efficacy and safety (considerations of convenience and cost are beyond the scope of this review). In hyperhidrosis, as in other clinical conditions, treatment decisions should be patient centered. At this time, because of the quality of evidence, only imprecise estimates of effect are possible for hyperhidrosis treatments included in this review, and statements about comparative effectiveness are not possible.

摘要

目的

多汗症(出汗过多)会给生活质量带来严重负担,但往往治疗不足。由于美国食品药品监督管理局(FDA)批准的治疗方法有限,医疗保健提供者必须在批准的和未标明适应证的治疗方案中确定最佳治疗方法。本综述的主要目的是重新评估、更新并扩展先前关于原发性多汗症常用治疗方案的系统综述,包括对铝和锆化合物的考量。

方法

我们对干预措施的疗效、健康相关生活质量、满意度和安全性进行了定性系统综述,重复并扩展了先前系统综述中概述的策略,增加了采用患者自身对照设计的研究。我们对纳入的研究进行了严格评价,以确定偏倚风险(RoB)和证据强度(SOE)。

结果

共有32项研究符合严格评价标准。只有三项研究——两项格隆溴铵布的临床试验(2.4%)和一项肉毒杆菌毒素A注射治疗腋窝多汗症的试验被评为“低”RoB;两者在腋窝多汗症中的应用SOE评级均为“中等”——这是本综述中的最高评级。

结论

最佳治疗选择取决于多个因素,包括了解每种治疗方法的疗效和安全性证据的质量(便利性和成本的考量超出了本综述的范围)。与其他临床情况一样,多汗症的治疗决策应以患者为中心。目前,由于证据质量的原因,本综述中纳入的多汗症治疗方法只能得到不精确的疗效估计,无法进行比较疗效的陈述。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ff8/7781989/e434426f1574/IJDA_A_1857149_F0001_C.jpg

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