目的: 探究A型肉毒毒素（botulinum neurotoxin type A,BTX-A）局部注射治疗结缔组织病相关雷诺现象（Raynaud's phenomenon,RP）的临床疗效。方法: 纳入双手基线数据无差异的受试者,随机选择受试者的一只手为注射侧,于手指周围神经血管束分叉区域注射BTX-A,另一只手为对照侧,随访记录0、2、8、12周时视觉模拟疼痛量表（visual analogue pain scale,VAS）评分、雷诺评分（Raynaud's score,RS）、溃疡评分（ulcer score,US）、平均指端皮肤温度、平均毛细血管充盈时间和不良反应发生情况,应用SPSS 25.0软件进行统计分析。结果: 27例患者完成治疗和随访,治疗2、8、12周后,注射侧与对照侧对比VAS评分总体均数有统计学差异。治疗8、12周后,注射侧与对照侧对比雷诺评分总体均数有统计学差异。2周时两侧雷诺评分及2、8、12周时两侧溃疡评分,平均指端皮肤温度、平均经皮氧饱和等相比总体均属无统计学差异。治疗2、8、12周与治疗前的VAS评分对比差异均有统计学意义,治疗8、12周雷诺评分治疗前对比差异均有统计学意义,治疗8、12周溃疡评分治疗前对比差异均有统计学意义,余观察指标治疗前后对比差异均无统计学意义。结论: 局部注射A型肉毒毒素能改善雷诺患者的疼痛,减少雷诺现象发生的频率、促进溃疡愈合且不良反应少,是一种安全有效且简便易行的方法。
Abstract
Objective To investigate the clinical efficacy and safety of botulinum neurotoxin type A (BTX-A) local injection in the treatment of Raynaud's phenomenon (RP) associated with connective tissue disease. Methods Subjects with no difference in baseline data of both hands were included. Subjects were randomly selected to inject BTX-A in the area of bifurcation of neurovascular bundle around fingers with one hand as the injection side and the other hand as the control side. Visual analogue pain scale (VAS) scores, Raynaud's score (RS) and ulcer score (RS) were recorded at 0, 2, 8 and 12 weeks score, US), average fingertip skin temperature, average capillary filling time and occurrence of adverse reactions were statistically analyzed by SPSS 25.0 software. Results 27 patients completed treatment and follow-up. After 2, 8, and 12 weeks of treatment, there was a statistical difference in the overall mean VAS score between the injection side and the control side. After 8, 12 weeks of treatment, there was a statistically significant difference in the mean Reynolds score between the injection side and the control side. There were no significant differences in Reynolds score at 2 weeks, ulcer score at 2, 8 and 12 weeks, average fingerend skin temperature and average percutaneous oxygen saturation. VAS scores at 2, 8 and 12 weeks of treatment were statistically significant compared with those before treatment, Raynaud scores at 8 and 12 weeks of treatment were statistically significant compared with those before treatment, ulcer scores at 8 and 12 weeks of treatment were statistically significant compared with those before treatment, there was no significant difference in the remaining observation indicators before and after treatment. Conclusion Local injection of botulinum toxin type A can improve the pain of patients with Raynaud, reduce the frequency of Raynaud phenomenon, promote ulcer healing with less adverse reactions, and is a safe, effective, simple and feasible method.
关键词
A型肉毒毒素 /
结缔组织病 /
雷诺现象 /
手指缺血 /
手指缺血性溃疡
Key words
botulinum toxin A /
connective tissue disease /
Reynaud's phenomenon /
finger ischemia /
finger ischemic ulcer
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基金
山东省中医药科技发展计划项目“玉屏风颗粒对系统性红斑狼疮发生反复感冒影响评价的临床研究”（2019-0712）
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