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A型肉毒杆菌毒素治疗眉间纹的疗效与安全性:随机对照试验的网状Meta分析

Efficacy and Safety of Botulinum Toxin Type A for Treatment of Glabellar Lines: A Network Meta-Analysis of Randomized Controlled Trials.

作者信息

Li Xue, Sui Changlin, Xia Xiujuan, Chen Xianjin

机构信息

Department of Dermatology, Qingdao University Medical College Affiliated Yantai Yuhuangding Hospital, No 20, Yuhuangding East Road, Zhifu district, Yantai, Shandong province, China.

出版信息

Aesthetic Plast Surg. 2023 Feb;47(1):365-377. doi: 10.1007/s00266-022-03018-y. Epub 2022 Sep 12.

DOI:10.1007/s00266-022-03018-y
PMID:36097079
Abstract

BACKGROUND

Botulinum toxin type A (BoNT/A) has been used in aesthetic applications worldwide, including glabellar lines. Currently, four BoNT/A preparations were approved for the improvement of moderate-to-severe glabellar lines: onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, and prabotulinumtoxinA. DaxibotulinumtoxinA is a new form of BoNT/A drug that is developed in clinical application. We performed this network meta-analysis (NMA) to assess the efficacy and safety of all these different BoNT/A formulations for treating glabellar lines.

METHODS

The investigators searched randomized controlled trials (RCTs) using the Medical Subject Headings (MeSH) terms "botulinum toxin" and "glabellar lines." We searched the relevant studies in electronic databases as following: PubMed, Elsevier, EMBASE and the Cochrane Library. The end points included the percentage of subjects with a glabellar line severity (GLS) score of none (0) or mild (1), and the percentage of subjects achieving ≥ 1-point and 2-point improvement in glabellar line severity at maximum frown at approximately month 1 by the investigators' assessment.

RESULTS

All formulations of BoNT/A were far superior to placebo in efficacy. DaxibotulinumtoxinA was the only treatment that significantly increased the proportion of subjects achieving ≥ 1 point improvement in GLS score compared with other BoNT/A formulations. Moreover, daxibotulinumtoxinA was ranked the highest for the proportion of subjects achieving ≥ 2-point improvement in GLS score. No significant differences were revealed for the incidence of any adverse events (AEs) that related to treatment or drug among all BoNT/A preparations.

CONCLUSION

The overall results of this NMA suggested that daxibotulinumtoxinA is a new BoNT/A preparation that may be not only more effective but also well-tolerated for the treatment of glabellar lines.

LEVEL OF EVIDENCE I

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

A型肉毒毒素(BoNT/A)已在全球范围内用于美容领域,包括眉间纹。目前,有四种BoNT/A制剂被批准用于改善中度至重度眉间纹:肉毒杆菌毒素A、阿柏西普肉毒杆菌毒素A、因卡肉毒杆菌毒素A和普拉博肉毒杆菌毒素A。达昔肉毒杆菌毒素A是一种正在临床应用中开发的新型BoNT/A药物。我们进行了这项网络荟萃分析(NMA),以评估所有这些不同的BoNT/A制剂治疗眉间纹的疗效和安全性。

方法

研究人员使用医学主题词(MeSH)“肉毒毒素”和“眉间纹”检索随机对照试验(RCT)。我们在以下电子数据库中检索相关研究:PubMed、爱思唯尔、EMBASE和考克兰图书馆。终点包括眉间纹严重程度(GLS)评分为无(0)或轻度(1)的受试者百分比,以及研究人员评估在大约第1个月最大皱眉时眉间纹严重程度改善≥1分和2分的受试者百分比。

结果

所有BoNT/A制剂在疗效上均远优于安慰剂。与其他BoNT/A制剂相比,达昔肉毒杆菌毒素A是唯一能显著提高GLS评分改善≥1分的受试者比例的治疗方法。此外,达昔肉毒杆菌毒素A在GLS评分改善≥2分的受试者比例方面排名最高。在所有BoNT/A制剂中,与治疗或药物相关的任何不良事件(AE)发生率均未显示出显著差异。

结论

这项NMA的总体结果表明,达昔肉毒杆菌毒素A是一种新型BoNT/A制剂,治疗眉间纹可能不仅更有效,而且耐受性良好。

证据水平I:本杂志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,请参阅目录或作者在线指南www.springer.com/00266 。

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