【 文献重点摘要 】
 

Background: Botulinum toxin A (BTX-A) is a medical product that is used widely in cosmetics, and concern over the safety profile has increased among injectors and patients.

Objective: The purpose was to enhance the statistical effect size using a meta-analysis to detect the incidence rate of adverse events (AEs) in the treatment of facial wrinkles.

Methods: A systematic search was performed for randomized, double-blind, placebo-controlled trials published through July 2015.

Results: We searched 16 trials, including 42,405 individual participants, and found that in all enrolled facial rejuvenation studies, patients in the BTX-A group had significantly more AEs than those patients in the placebo group (RR = 1.24; 95 % CI 1.07–1.43; p = 0.003). For crow’s feet lines injection analysis, the BTX-A group did not exhibit any significant increase in AEs compared with the control group (RR = 1.19; 95 % CI 0.96–1.48; p = 0.12), except in injection site hematoma (RR = 2.14; 95 % CI 1.13–4.07; p = 0.02) in the treatment group. For frown wrinkle injection analysis, AEs were significantly observed in the BTX-A group (RR = 1.47; 95 % CI 1.23–1.77; p<0.0001), particularly headaches (RR = 1.53; 95 % CI 1.15–2.03; p = 0.003), eyelid ptosis (RR = 5.56; 95 % CI 1.68–18.38; p = 0.005), and heavy eyelids (RR = 6.94; 95 % CI 1.27–37.93; p = 0.03).

Conclusion: This meta-analysis confirmed the safety profile of BTX-A for glabellar and crow’s feet lines, and BTX-A usage for the removal of upper facial wrinkles, which have some significant mild-to-moderate adverse profiles, including headache, eye disorder, eyelid ptosis, and heavy eyelids. Facial injectors should abide by the technical standards of neurotoxic drugs and be familiar with the local pharmacological effects to lessen the severe side effects.

Keywords: Adverse events, Botulinum toxin type A, Glabellar lines, Crow’s feet, Meta-analysis

背景：A型肉毒毒素(BTX-A)是一种广泛应用于化妆品的医用产品，注射者和患者对其安全性的关注日益增加。

目的：通过荟萃分析来检测面部皱纹治疗中不良事件(AEs)的发生率，以提高统计效应大小。

方法：对截至2015年7月发表的随机、双盲、安慰剂对照试验进行系统搜索。

结果：我们检索了16项试验，包括42,405名个体参与者，发现在所有登记的面部年轻化研究中，BTX-A组患者的不良反应明显多于安慰剂组患者(RR=1.24；95%CI1.07-1.43；p=0.003)。在鱼尾纹注射分析中，除治疗组注射部位血肿(RR=2.14；95%CI为1.13~4.07；P=0.02)外，BTX-A组的AEs与对照组相比无显著性差异(RR=1.19；95%CI为0.96~1.48；p=0.12)。在皱眉注射分析中，BTX-A组有明显的不良反应(RR=1.4795%CI1.23~1.77p<0.0001)，尤其是头痛(RR=1.5395%CI1.15~2.03p=0.003)、眼睑下垂(RR=5.5695%CI1.68~18.38p=0.005)、重眼皮(RR=6.9495%CI1.27~37.93；p=0.03)。

结论：这项荟萃分析证实了BTX-A用于治疗眉间纹和鱼尾纹的安全性，以及BTX-A用于去除面部上部皱纹的安全性，这些皱纹具有明显的轻到中度不良反应，包括头痛、眼疾、眼睑下垂和重眼皮。面部注射器应遵守神经毒性药物的技术标准，熟悉局部药理作用，减少严重副作用。

关键词：不良事件，A型肉毒毒素，眉间纹，鱼尾纹，荟萃分析