A randomized controlled study on the treatment of erythematous telangiectatic rosacea with different concentrations of botulinum toxin type a microdroplet injections
不同浓度A型肉毒毒素微滴注射治疗红斑毛细血管扩张型玫瑰痤疮的随机对照研究

摘要

目的 比较不同浓度A型肉毒毒素治疗红斑毛细血管扩张型玫瑰痤疮的临床效果。方法 纳入65例红斑毛细血管扩张型玫瑰痤疮患者，随机分为高浓度组（25 U/mL）和低浓度组（12.5 U/mL），均行面部A型肉毒毒素微滴注射，58例完成研究。分别于治疗前、治疗后4周及6个月采用玫瑰痤疮标准评分系统（SGS）和视觉模拟疼痛评分（VAS）评估疗效及疼痛程度。结果 治疗后4周，两组SGS评分均较治疗前显著降低（P<0.05），且高浓度组改善更明显（P<0.05）；6个月时两组SGS评分与治疗前无显著差异（P>0.05）。低浓度组VAS评分高于高浓度组（P<0.05）；两组均无严重不良反应。结论 总剂量相同时，不同浓度A型肉毒毒素治疗玫瑰痤疮均安全有效，高浓度方案起效更快、疼痛更轻，远期疗效相近。

Abstract

Objective To compare the clinical effects of different concentrations of botulinum toxin type A in the treatment of erythematous telangiectatic rosacea.
Methods A total of 65 patients with erythematous telangiectatic rosacea were included and randomly divided into a high-concentration group (25 U/mL) and a low-concentration group (12.5 U/mL). All patients underwent facial botulinum toxin type A microdroplet injections. 58 patients completed the study. The standard scale for rosacea (SGS) and visual analogue scale for pain (VAS) were used to evaluate the efficacy and pain level before treatment, 4 weeks after treatment, and 6 months after treatment.
Results At 4 weeks after treatment, the SGS scores of both groups were significantly lower than those before treatment (P<0.05), and the improvement in the high-concentration group was more significant (P<0.05); at 6 months, there was no significant difference in the SGS scores between the two groups compared with those before treatment (P>0.05). The VAS score of the low-concentration group was higher than that of the high-concentration group (P<0.05); there were no serious adverse reactions in both groups.
Conclusion   At the same total dose, different concentrations of botulinum toxin type A are safe and effective in the treatment of rosacea. The high-concentration regimen takes effect faster and causes less pain, and the long-term efficacy is similar.