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A型肉毒毒素治疗系统性硬化症雷诺现象的疗效:一项随机自身对照试验。

The efficacy of botulinum toxin A in the treatment of Raynaud's phenomenon in systemic sclerosis: A randomized self-controlled trial.

作者信息

Du Wei, Zhou Mo, Zhang Chunying, Sun Qiuning

机构信息

Department of Dermatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Department of Internal Medicine, China-Japan Friendship Hospital, Beijing, China.

出版信息

Dermatol Ther. 2022 Jul;35(7):e15529. doi: 10.1111/dth.15529. Epub 2022 Apr 27.

DOI:10.1111/dth.15529
PMID:35441772
Abstract

The current conservative and surgical treatments are not fully effective and have complications for Raynaud's phenomenon (RP) secondary to systemic sclerosis (SSc). Botulinum toxin A (BTX-A) can be used to manage RP, but the literature mostly includes case reports and case series. Thus, we performed a randomized controlled trial to explore the efficacy of BTX-A in the treatment of RP secondary to SSc. Sixteen patients with RP secondary to SSc were recruited. One hand was randomly included in the BTX-A group and the other as control. Both hands were tested before treatment and 4 weeks later using qualitative and quantitative dermatoscopic assessments and the cold water test. Reynolds score (from 6.7 ± 4.0 to 2.9 ± 3.7, p < 0.001), T (from 25.8 ± 3.0°C to 27.9 ± 2.1°C, p = 0.031) and T (from 2.1 ± 1.2°C to 4.5 ± 2.1°C, p < 0.001) in the experimental group were improved, while there were no improvements in T and T in the control group. In the experimental group, the sum of the six dermoscopic parameters was improved after treatment (from 4.00 (3.00, 5.75) to 3.00 (2.00, 5.00), p = 0.002); the nailfold capillary pattern staging was also improved (from 2.00 (2.00, 3.00) to 2.00 (1.00, 3.00), p = 0.004). There were no improvements in the dermoscopic assessment in the control group. None of the patients reported adverse reactions such as infection, hematoma, hand muscle weakness, allergic reaction and nerve injury. In conclusion, local injection BTX-A to treat RP secondary to SSc might be safe and effective.

摘要

目前针对系统性硬化症(SSc)继发雷诺现象(RP)的保守治疗和手术治疗并不完全有效,且存在并发症。肉毒杆菌毒素A(BTX-A)可用于治疗RP,但文献大多为病例报告和病例系列。因此,我们进行了一项随机对照试验,以探讨BTX-A治疗SSc继发RP的疗效。招募了16例SSc继发RP的患者。一只手随机纳入BTX-A组,另一只手作为对照组。在治疗前和4周后,使用定性和定量皮肤镜评估及冷水试验对双手进行检测。实验组的雷诺评分(从6.7±4.0降至2.9±3.7,p<0.001)、T(从25.8±3.0°C升至27.9±2.1°C,p=0.031)和T(从2.1±1.2°C升至4.5±2.1°C,p<0.001)有所改善,而对照组的T和T没有改善。实验组治疗后六项皮肤镜参数总和有所改善(从4.00(3.00,5.75)降至3.00(2.00,5.00),p=0.002);甲襞毛细血管形态分期也有所改善(从2.00(2.00,3.00)降至2.00(1.00,3.00),p=0.004)。对照组的皮肤镜评估没有改善。没有患者报告感染、血肿、手部肌肉无力、过敏反应和神经损伤等不良反应。总之,局部注射BTX-A治疗SSc继发RP可能是安全有效的。

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