采用 64 单位剂量优化的肉毒毒素 A 改善上面部表情线的疗效和持续时间：随机对照试验的系统评价和荟萃分析，并用试验序贯分析进行评估。

The Efficacy and Duration of Onabotulinum Toxin A in Improving Upper Facial Expression Lines With 64-Unit Dose Optimization: A Systematic Review and Meta-Analysis With Trial Sequential Analysis of the Randomized Controlled Trials.

机构信息

Department of Plastic and Reconstructive Surgery, Royal Free Hospital, London, UK and an evidence-based medicine editor of Aesthetic Surgery Journal.

Department of Plastic and Reconstructive Surgery, Royal Free Hospital, London, UK and a research section editor of Aesthetic Surgery Journal.

出版信息

Aesthet Surg J. 2023 Feb 3;43(2):215-229. doi: 10.1093/asj/sjac253.

DOI:10.1093/asj/sjac253

PMID:36099476

Abstract

BACKGROUND

Onabotulinumtoxin A (Onabot A) was the first treatment to be approved for aesthetic indications, namely glabellar lines (GLs), crow's feet lines (CFLs), and forehead lines (FHLs), with a cumulative dose of 64 U.

OBJECTIVES

The aim of this study was to conduct a meta-analysis to combine the available data for approved doses for GLs, CFLs, and FHLs to explore the effect and duration of simultaneous treatment with Onabot A.

METHODS

PubMed/MEDLINE, Embase, and other national clinical trial registries were searched for randomized controlled trials from January 2010 to July 2022. The meta-analysis, trial sequential analysis, and investigator-assessed time to return to nonresponder status in GLs, CFLs, and FHLs following Onabot A were plotted to elicit a cumulative dose-adjusted response curve based on Kaplan-Meier analysis with a log-rank test.

RESULTS

Fourteen randomized controlled trials were eligible for quantitative analysis. A total of 8369 subjects were recruited across the trials. The meta-analysis results show that Onabot A is very effective in reducing moderate to severe GLs, CFLs, and FHLs. The cumulative Z-curve for GLs, CFLs, and FHLs also exceeds the required information size (RIS). Kaplan-Meier analysis with a log-rank test demonstrated that simultaneous treatment of GLs, CFLs, and FHLs requires 182 days (95% CI = 179, 215 days) (P < 0.00002) to return to nonresponder status.

CONCLUSIONS

Treatment of the upper facial expression lines with Onabot A is effective, and the approved cumulative dose of 64 U gives longer-lasting effects.

摘要

背景

肉毒毒素 A（Onabot A）是第一种被批准用于美容适应症的治疗药物，即眉间纹（GL）、鱼尾纹（CFL）和额纹（FHL），累积剂量为 64U。

目的

本研究旨在进行荟萃分析，将可用数据合并用于 GL、CFL 和 FHL 的批准剂量，以探讨同时使用 Onabot A 的效果和持续时间。

方法

检索 PubMed/MEDLINE、Embase 和其他国家临床试验注册中心 2010 年 1 月至 2022 年 7 月的随机对照试验。对 GL、CFL 和 FHL 中 Onabot A 后恢复至非应答状态的时间进行荟萃分析、试验序贯分析和研究者评估，并根据 Kaplan-Meier 分析和对数秩检验绘制累积剂量调整反应曲线。

结果

有 14 项随机对照试验符合定量分析的条件。共有 8369 名受试者参加了这些试验。荟萃分析结果表明，Onabot A 对减少中度至重度 GL、CFL 和 FHL 非常有效。GL、CFL 和 FHL 的累积 Z 曲线也超过了所需的信息量（RIS）。对数秩检验的 Kaplan-Meier 分析表明，同时治疗 GL、CFL 和 FHL 需要 182 天（95%CI=179,215 天）（P<0.00002）才能恢复至非应答状态。