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24小时复溶肉毒杆菌毒素中pH改变可减轻注射部位疼痛:一项关于美容应用的随机对照研究结果

Reduced Injection Site Pain with Altered pH in 24-h Reconstituted Botulinum Toxin: Findings from a Randomized Controlled Study on Cosmetic Applications.

作者信息

Kherallah Kenan, Turkmani Mohammed G, Fakih-Gomez Nabil, Muñoz-González Cristina

机构信息

Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.

Department of Dermatology, Derma Clinic, Riyadh, Saudi Arabia.

出版信息

Aesthetic Plast Surg. 2025 Mar;49(6):1750-1754. doi: 10.1007/s00266-024-04436-w. Epub 2024 Oct 11.

DOI:10.1007/s00266-024-04436-w
PMID:39394540
Abstract

BACKGROUND

Botulinum toxin (BTX) injections are widely recognized for many cosmetic applications, but still commonly encounter a challenge: injection site pain (ISP). This discomfort can impact the overall patient experience and satisfaction, highlighting a need for innovative solutions to this problem.

OBJECTIVE

This randomized controlled study aimed to determine whether adjusting the pH levels in a 24-h reconstituted botulinum toxin can serve as a strategy to mitigate ISP.

METHODS

A controlled trial involving 24 volunteers was executed. Participants received incobotulinum toxin A. One side of each participant's face was treated with fresh toxin, while the other received a 24-h reconstituted version. Pain perceptions post-injection were assessed using the visual analogue scale (VAS).

RESULTS

pH values of the fresh toxin were more acidic (6.17) than the 24-h reconstituted toxin (7.17). Out of 24 patients, 13 reported reduced ISP with the 24-h reconstituted toxin. The mean VAS score for the fresh toxin was 5.92, in contrast to 4.17 for the reconstituted toxin, indicating a significant difference (p<0.01).

CONCLUSION

Limitations include the use of a VAS and a relatively small sample size. Altering the pH of BTX demonstrates potential in ISP reduction. However, broader, large-scale investigations are important for comprehensive validation.

LEVEL OF EVIDENCE III

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

摘要

背景

肉毒杆菌毒素(BTX)注射在许多美容应用中已得到广泛认可,但仍普遍面临一个挑战:注射部位疼痛(ISP)。这种不适会影响患者的整体体验和满意度,凸显了针对这一问题寻求创新解决方案的必要性。

目的

这项随机对照研究旨在确定调整24小时复溶肉毒杆菌毒素的pH值是否可作为减轻注射部位疼痛的一种策略。

方法

进行了一项涉及24名志愿者的对照试验。参与者接受了incobotulinum毒素A。每位参与者脸部的一侧用新鲜毒素治疗,另一侧接受24小时复溶后的毒素治疗。注射后使用视觉模拟量表(VAS)评估疼痛感受。

结果

新鲜毒素的pH值(6.17)比24小时复溶后的毒素(7.17)更偏酸性。在24名患者中,13名报告使用24小时复溶后的毒素时注射部位疼痛减轻。新鲜毒素的平均VAS评分为5.92,而复溶后毒素的平均VAS评分为4.17,表明存在显著差异(p<0.01)。

结论

局限性包括使用视觉模拟量表以及样本量相对较小。改变肉毒杆菌毒素的pH值在减轻注射部位疼痛方面显示出潜力。然而,更广泛、大规模的研究对于全面验证很重要。

证据水平III:本刊要求作者为每篇文章指定证据水平。有关这些循证医学评级的完整描述,请参阅目录或在线作者须知www.springer.com/00266。

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本文引用的文献

1
Botulinum Neurotoxins: Biology, Pharmacology, and Toxicology.肉毒杆菌神经毒素:生物学、药理学与毒理学
Pharmacol Rev. 2017 Apr;69(2):200-235. doi: 10.1124/pr.116.012658.
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Botulinum toxin therapy: reduction of injection site pain by pH normalisation.肉毒杆菌毒素疗法:通过调节pH值减轻注射部位疼痛
J Neural Transm (Vienna). 2016 May;123(5):527-31. doi: 10.1007/s00702-016-1522-9. Epub 2016 Mar 22.
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Acid-Sensing Ion Channels and nociception in the peripheral and central nervous systems.酸敏感离子通道与外周和中枢神经系统中的伤害感受
Neuropharmacology. 2015 Jul;94:49-57. doi: 10.1016/j.neuropharm.2015.02.009. Epub 2015 Feb 24.
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Easing Botox administration with EMLA cream.使用复方利多卡因乳膏减轻肉毒杆菌毒素注射的不适感。
Aesthet Surg J. 2004 Jan-Feb;24(1):79-81. doi: 10.1016/j.asj.2003.10.002.
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Pain sensation during intradermal injections of three different botulinum toxin preparations in different doses and dilutions.不同剂量和稀释度的三种不同肉毒杆菌毒素制剂皮内注射时的疼痛感觉。
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