小剂量肉毒杆菌毒素A治疗腋部多汗症的随机并列开放标记研究

作     者：Heckmann M Plewig G 李晓莉 

作者机构：Skin Care Centre and Clinic Kreuzstrasse 26 82319 Starnberg GermanyDr 

出 版 物：《世界核心医学期刊文摘（皮肤病学分册）》 (Digest of the World Core Medical JOurnals:Dermatology)

年 卷 期：2006年第2卷第1期

页      面：30-31页

学科分类：1002[医学-临床医学] 100206[医学-皮肤病与性病学] 10[医学] 

主　　题：肉毒杆菌毒素 多汗症 腋部 随机临床试验 基线水平 大学医院 England 

摘      要：Objective: To compare 2 doses of botulinum toxin A in view of dose-dependent efficacy, longevity, and safety. Design: Sideby-side, controlled, randomized clinical trial with extended follow-up over 2 treatment cycles. Patients were injected with 200 U of botulinum toxin A (Dysport; Ipsen Ltd, Wrexham, England) into one axilla and 100 U into the other axilla in a randomized fashion. After 48 weeks of follow-up, the patients were given a second treatment with identical doses to the respective axillae and were again followed up for 48 weeks. Gravimetr ic measurements of sweat production and the patients’own rating of sweating wer e monitored. Setting: University-based outpatient clinic. Patients: Forty-thre e subjects with primary axillary hyperhidrosis that was unresponsive to topical therapy. Main Outcome Measure: Absolute values of sweat production. Results: Two weeks after treatment, the sweat production was significantly reduced compared with baseline levels. Both doses were equally effective. At week 48, the sweat p roduction had returned to baseline levels irrespective of the dose. After the se cond treatment, both doses were again equally effective at any follow-up point. At the end of the follow-up period (96 weeks) for the second treatment, the sw eat production was significantly lower than at the end of the first follow-up p eriod (48 weeks). The treatment was well tolerated, and there were no lasting or severe adverse effects. Conclusions: Short-and long-term results show that do ses of 100 and 200 U of botulinum toxin A are equally safe and effective. Howeve r, because of cost considerations and possible adverse effects, the lower dose i s preferable for treating axillary hyperhidrosis.