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与肉毒毒素注射相关的不良事件:对 1819 名患者的 5310 次治疗进行的多部门回顾性研究。

Adverse events associated with botulinum toxin injection: a multidepartment, retrospective study of 5310 treatments administered to 1819 patients.

机构信息

Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine , Seoul , Korea.

出版信息

J Dermatolog Treat. 2014 Aug;25(4):331-6. doi: 10.3109/09546634.2013.789473. Epub 2013 Apr 24.

DOI:10.3109/09546634.2013.789473
PMID:23537074
Abstract

BACKGROUND

The injection of botulinum toxin is now commonly used for many therapeutic and cosmetic purposes but because of its increased use more adverse events are being reported.

OBJECTIVE

To retrospectively evaluate and analyze the safety of botulinum toxin injections in terms of purpose and the type of toxin administered.

MATERIALS AND METHODS

Data were collected on 1819 patients who underwent a total of 5310 treatments between 2005 and 2011 at a single tertiary medical center. Information on the dosage, treatment purpose, type of botulinum toxin, and any adverse events associated with these treatments were collected and analyzed. The generalized estimating equation (GEE) with the logistic link function was used to estimate the overall frequencies of adverse events. A multivariable GEE with the logistic link function was used to identify the factors associated with adverse events.

RESULTS

Among the 5310 botulinum toxin treatments in our study cohort, 2258 of which (42.5%) were used to treat hemifacial spasm, 184 adverse events (3.73%) were recorded, 114 (2.26%) muscle-related, and 71 (1.47%) muscle-unrelated. The highest number of adverse events (8.29%) was associated with the treatment of blepharospasm and the lowest (1.07%) with masseter hyperplasia. By multivariate analysis, the odds ratio for females was 1.577 (95% confidence interval [CI] = 1.052-2.364; p = 0.027) and for the dose was 1.006 (95% CI = 1.002-1.010; p = 0.005). When compared with upper face wrinkles, the odds ratio was 2.510 (95% CI = 1.400-4.499; p = 0.002) for blepharospasm, 0.375 (95% CI = 0.202-0.695; p = 0.002) for cervical dystonia, and 0.114 (95% CI: 0.015-0.862; p = 0.035) for masseter hyperplasia.

CONCLUSION

When injecting botulinum toxin for cosmetic purposes, practitioners should be cautious, especially when targeting the areas around the eyes, as these treatments are prone to cause adverse events.

摘要

背景

肉毒毒素注射目前广泛应用于多种治疗和美容目的,但由于其使用增加,更多的不良反应报告。

目的

回顾性评估和分析肉毒毒素注射的安全性,从治疗目的和所使用的毒素类型方面进行评估。

材料和方法

在一家三级医学中心,2005 年至 2011 年间共对 1819 名患者进行了 5310 次治疗,收集了这些患者的数据。收集了剂量、治疗目的、肉毒毒素类型以及与这些治疗相关的任何不良反应的信息,并进行了分析。采用广义估计方程(GEE)和逻辑链接函数来估计不良反应的总体频率。采用多变量 GEE 和逻辑链接函数来识别与不良反应相关的因素。

结果

在我们的研究队列中,5310 次肉毒毒素治疗中有 2258 次(42.5%)用于治疗半面痉挛,记录了 184 次不良反应(3.73%),114 次(2.26%)与肌肉相关,71 次(1.47%)与肌肉无关。不良反应发生率最高的是治疗眼睑痉挛(8.29%),最低的是治疗咬肌肥大(1.07%)。通过多变量分析,女性的比值比为 1.577(95%置信区间[CI]为 1.052-2.364;p = 0.027),剂量的比值比为 1.006(95%CI = 1.002-1.010;p = 0.005)。与上脸皱纹相比,眼睑痉挛的比值比为 2.510(95%CI = 1.400-4.499;p = 0.002),颈肌张力障碍为 0.375(95%CI = 0.202-0.695;p = 0.002),咬肌肥大为 0.114(95%CI:0.015-0.862;p = 0.035)。

结论

当出于美容目的注射肉毒毒素时,医生应谨慎,尤其是在眼部周围进行治疗时,因为这些治疗容易引起不良反应。

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