A型肉毒毒素联合口服低剂量抗胆碱能药物治疗原发性腋窝多汗症的研究
Study on combined treatment of primary axillary hyperhidrosis with botulinum toxin A and lower dosage of oxybutynin
李静妮 1梁振 1杨敏利 1苏敏 1王娟1
作者信息
- 1. 空军军医大学西京医院整形外科,陕西 西安 710032
- 折叠
摘要
目的 评估A型肉毒毒素联合口服低剂量抗胆碱能药物治疗原发性腋窝多汗症(primary axillary hyperhidrosis,PAH)的有效性和安全性.方法 自2022年5月至2023年5月,空军军医大学西京医院整形外科纳入84例PAH患者,随机分为3组,28例/组,其中A组患者接受单次A型肉毒毒素治疗,B组接受奥昔布宁口服治疗,C组接受A型肉毒毒素与奥昔布宁联合治疗.通过汗液称重、多汗症严重程度量表、皮肤病生活质量指数对治疗前及及治疗后4、12、36周患者的出汗情况、治疗效果及生活质量进行评价.并记录3组患者报告的不良事件.结果 3组患者的一般资料[年龄、性别、BMI、病程、排汗量、多汗症严重程度量表(hyperhidrosis disease severity scale,HDSS)评分、皮肤病生活质量指数(dermatology life quality index,DLQI)评分]比较,差异无统计学意义(P＞0.05).3组患者治疗后4、12、36周,排汗量、HDSS评分、DLQI评分均较治疗前明显降低.组间比较,C组患者治疗后12、36周,HDSS评分、DLQI评分低于A、B组,差异有统计学意义(P＜0.05).此外,C组中有更多患者达到了最佳治疗效果(HDSS达到1～2分且排汗量较治疗前减少≥50％).A组未报告任何不良事件.B、C组报告的不良事件严重程度为"轻微"和"中等",无严重不良事件、因不良事件退出研究或死亡的报告.相较于C组,B组患者出现不良事件及抗胆碱能不良事件的频率更高(P＜0.05),口干是最常见的不良事件.结论 A型肉毒毒素联合口服低剂量抗胆碱能药物是药物治疗PAH的一种有效方法,可以显著提高治疗效果并减少奥昔布宁单药治疗时的不良反应.
Abstract
Objective To assess the efficacy and safety of combined treatment with botulinum toxin A and a lower dosage of oxy-butynin in patients with primary axillary hyperhidrosis.Methods From May 2022 to May 2023,84 patients with primary axillary hyper-hidrosis were enrolled and randomly divided into three groups,with 28 patients in each group.Group A received botulinum toxin A,Group B received oxybutynin and Group C received combined treatment with botulinum toxin A and oxybutynin.Sweat production,treatment effi-cacy,and quality of life were evaluated at baseline and 4,12,and 36 weeks post-treatment using gravimetric sweat measurement,the hy-perhidrosis disease severity scale(HDSS),and the dermatology life quality index(DLQD.Adverse events were also documented.Results The general data(age,gender,BMI,course of disease,gravimetric weight of sweat,HDSS and DLQI scores)of the three groups showed no statis-tically significant differences(P＞0.05).Total gravimetric weight of sweat,HDSS and DLQI scores of the 3 groups were significantly lower at 4,12,and 36 weeks post-treatment than before treatment.Comparatively,at 12 and 36 weeks post-treatment,the HDSS and DLQI scores in Group C were significantly lower than those in Groups A and B(P＜0.05).In addition,more patients in the Group C achieved the optimal treatment outcomes(patients satisfied both criteria with an HDSS of 1 to 2 and a 50％or more reduction in total gravimetric sweat weight from baseline).No adverse events were reported in Group A.In Groups B and C,adverse events were mild to moderate in severity,with no reports of severe adverse events,discontinuations due to adverse events(AEs),or deaths.Compared with Group C,more AEs and anti-cholinergic AEs were reported in Group B(P＜0.05),and xerostomia was the most common AEs.Conclusion Combined treatment of pri-mary axillary hyperhidrosis with BTX-A and lower dosage of oxybutynin is effective which can improve the clinical conditions of patients and reduce the side effects of oxybutynin administered alone.
关键词
原发性多汗症/原发性腋窝多汗症/A型肉毒毒素/奥昔布宁Key words
Primary hyperhidrosis/Primary axillary hyperhidrosis/Botulinum toxin A/Oxybutynin引用本文复制引用
出版年
2024
NETL
NSTL
万方数据