A型肉毒杆菌毒素对腋下多汗症患者生活质量指标的影响：一项随机对照试验。

Effect of botulinum toxin type A on quality of life measures in patients with excessive axillary sweating: a randomized controlled trial.

作者信息

Naumann M K, Hamm H, Lowe N J

机构信息

Department of Neurology, University of Würzburg, Josef-Schneider-Str. 11, D-97080 Würzburg, Germany.

出版信息

Br J Dermatol. 2002 Dec;147(6):1218-26. doi: 10.1046/j.1365-2133.2002.05059.x.

DOI:10.1046/j.1365-2133.2002.05059.x

PMID:12452874

Abstract

BACKGROUND

Botulinum toxin type A (BTX-A) has been shown to be a safe and effective treatment for primary focal hyperhidrosis. However, the effect of BTX-A therapy on quality of life (QOL) in patients with this condition has only recently begun to be studied in controlled clinical trials.

OBJECTIVES

To assess the impact on QOL of BTX-A treatment in patients with bilateral primary axillary hyperhidrosis.

METHODS

A multicentre, randomized, double-blind, placebo-controlled trial enrolled 320 patients who exhibited persistent, bilateral, primary axillary hyperhidrosis sufficient to interfere with daily activities. These patients were treated with either 50 U BTX-A (Botox, Allergan, Inc., Irvine, CA, U.S.A.) or placebo in each axilla. QOL was assessed using the Hyperhidrosis Impact Questionnaire (HHIQ) at baseline and 1, 4, 8, 12 and 16 weeks post-treatment, as well as the Medical Outcomes Trust Short Form-12 Health Survey(SF-12) at baseline and 16 weeks post-treatment.

RESULTS

At baseline, participants reported a marked negative impact of hyperhidrosis on various measures, including emotional status, ability to participate in daily and social activities, productivity at work and number of clothing changes per day. During the post-treatment period, statistically and clinically significantly greater improvements in all of these parameters were observed for the BTX-A group compared with the placebo group (P < 0.01). The BTX-A group improvements were observed within 1 week of treatment, and were sustained with little or no decline throughout the 16-week follow-up period. Compared with the baseline HHIQ responses regarding treatment history, BTX-A treatment resulted in a greater level of overall treatment satisfaction than did many other hyperhidrosis treatments. In addition, patients treated with BTX-A exhibited statistically significantly greater improvement in the physical component summary score of the SF-12 at 16 weeks than did placebo-treated patients (P < or = 0.019).

CONCLUSIONS

Hyperhidrosis is associated with a substantial QOL burden; however, QOL is markedly improved with BTX-A treatment.

摘要

背景

A型肉毒毒素（BTX-A）已被证明是治疗原发性局限性多汗症的一种安全有效的方法。然而，BTX-A治疗对该病患者生活质量（QOL）的影响直到最近才开始在对照临床试验中进行研究。

目的

评估BTX-A治疗对双侧原发性腋窝多汗症患者生活质量的影响。

方法

一项多中心、随机、双盲、安慰剂对照试验纳入了320例表现为持续性双侧原发性腋窝多汗症且足以干扰日常活动的患者。这些患者每侧腋窝分别接受50 U BTX-A（保妥适，美国加利福尼亚州欧文市艾尔建公司）或安慰剂治疗。在基线以及治疗后1、4、8、12和16周使用多汗症影响问卷（HHIQ）评估生活质量，在基线和治疗后16周使用医学结局信托简明健康调查（SF-12）评估生活质量。

结果

在基线时，参与者报告多汗症对各种指标有明显负面影响，包括情绪状态、参与日常和社交活动的能力、工作效率以及每天更换衣物的次数。在治疗后的时间段内，与安慰剂组相比，BTX-A组在所有这些参数上均观察到统计学上和临床上显著更大的改善（P < 0.01）。BTX-A组在治疗1周内即观察到改善，并且在整个16周的随访期内持续改善，几乎没有下降。与基线时HHIQ关于治疗史的回答相比, BTX-A治疗比许多其他多汗症治疗产生了更高水平的总体治疗满意度。此外，与接受安慰剂治疗的患者相比，接受BTX-A治疗的患者在16周时SF-12的身体成分汇总得分有统计学上显著更大的改善（P≤0.019）。