分离利多卡因稀释肉毒杆菌毒素（不含肾上腺素）对注射疼痛和术后并发症的影响：试点随机临床试验

Q1 Medicine

Journal of oral biology and craniofacial research Pub Date : 2025-09-06 DOI:10.1016/j.jobcr.2025.09.001

Farzin Sarkarat , Marzie Naeini , Roozbeh Kahali , Mehdi Sezavar , Vahid Rakhshan

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引用次数: 0

摘要

肉毒毒素注射的疼痛和并发症是降低患者满意度的重要因素。利多卡因（含或不含肾上腺素）毒素衰减可能减轻疼痛。除了最近的一项研究外，没有研究评估单独使用利多卡因（不含肾上腺素/添加剂）对肉毒杆菌毒素的影响。方法采用多中心双盲随机安慰剂对照临床试验，将102例患者随机分为实验组（利多卡因不加肾上腺素组）和对照组（生理盐水组）。患者接受了100单位肉毒杆菌毒素。实验组用不含肾上腺素的2%利多卡因1 ml稀释肉毒杆菌毒素；在安慰剂组，肉毒杆菌毒素用1毫升生理盐水稀释。注射后使用11分的数值评定量表“0-10”评估疼痛。24 h后根据患者报告和外科医生观察评估注射后并发症。数据分析采用Student t检验和Fisher精确检验（α = 0.05）。结果两组患者年龄、性别比较平衡（P > 0.05）。安慰剂组和利多卡因组的平均（SD）疼痛水平分别为3.70±2.05和3.39±1.78 （P = 0.310， t检验）。各组均未见上睑下垂、复视。对照组4例（8.7%），实验组5例（8.9%）存在不对称性（P = 1.0, Fisher）。对照组补片治疗12例（26.1%）；利多卡因组有11例（19.6%）患者需要补片治疗（Fisher, P = 0.482）。结论用利多卡因稀释肉毒杆菌毒素不能减轻注射疼痛，也不能改变24 h后并发症的发生率。

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Effects of botulinum toxin dilution with isolated lidocaine (without epinephrine) on injection pain and post-operative complications: pilot randomized clinical trial

Introduction

Pain and complications of botulinum toxin injection are important deterrents that may reduce patient satisfaction. Toxin attenuation via lidocaine (with or without epinephrine) might alleviate pain. Except a recent study, no study has assessed the effects of the incorporation of lidocaine alone (without epinephrine/additives) to botulinum toxin.

Methods

This pilot multicenter double-blind randomized placebo-controlled clinical trial was performed on 102 patients randomly divided into two groups of experimental (lidocaine without epinephrine) or control (normal saline). Patients received 100 units of botulinum toxin. In the experimental group, botulinum toxin was diluted with 1 ml of 2 % lidocaine without adrenalin; in the placebo group, botulinum toxin was diluted with 1 ml of normal saline. Pain was assessed after injection using a 11-point numerical rating scale ‘0–10’. Post-injection complications were assessed 24 h later based on patients' reports and surgeons' observations. Data were analyzed using Student t-test and Fisher exact test (α = 0.05).

Results

The groups were balanced in terms of age and gender (P > 0.05). The mean (SD) pain levels in the placebo and lidocaine groups were 3.70 ± 2.05 and 3.39 ± 1.78, respectively (P = 0.310, t-test). Ptosis and diplopia were not observed in any groups. Asymmetry existed in 4 control subjects (8.7 %) and 5 experimental subjects (8.9 %) (P = 1.0, Fisher). In the control group, 12 patients needed retouch treatment (26.1 %); in the lidocaine group, 11 patients needed retouch therapy (19.6 %) (Fisher, P = 0.482).

Conclusions

Dilution of botulinum toxin with lidocaine might not reduce injection pain or alter the incidence of the assessed complications after 24 h.

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来源期刊

Journal of oral biology and craniofacial research Medicine-Otorhinolaryngology

CiteScore

4.90

自引率

0.00%

发文量

133

审稿时长

167 days

期刊介绍： Journal of Oral Biology and Craniofacial Research (JOBCR)is the official journal of the Craniofacial Research Foundation (CRF). The journal aims to provide a common platform for both clinical and translational research and to promote interdisciplinary sciences in craniofacial region. JOBCR publishes content that includes diseases, injuries and defects in the head, neck, face, jaws and the hard and soft tissues of the mouth and jaws and face region; diagnosis and medical management of diseases specific to the orofacial tissues and of oral manifestations of systemic diseases; studies on identifying populations at risk of oral disease or in need of specific care, and comparing regional, environmental, social, and access similarities and differences in dental care between populations; diseases of the mouth and related structures like salivary glands, temporomandibular joints, facial muscles and perioral skin; biomedical engineering, tissue engineering and stem cells. The journal publishes reviews, commentaries, peer-reviewed original research articles, short communication, and case reports.