Department of Otolaryngology - Head and Neck Surgery, Rutgers New Jersey Medical School, Newark, NJ, USA.
Department of Facial Plastics and Reconstructive Surgery, Rutgers New Jersey Medical School, Newark, NJ, USA.
Aesthetic Plast Surg. 2021 Jun;45(3):1201-1209. doi: 10.1007/s00266-020-02027-z. Epub 2020 Oct 30.
Botulinum toxin treatment is the most frequently performed noninvasive cosmetic procedure performed in the USA. Because of its widespread use, an analysis of the adverse event (AE) profile of Botox injections is needed.
The FDA Adverse Event Report System was queried using an online web-based tool to determine the top 15 adverse events reported for four Botox brand names: Botox/Botox Cosmetic, Dysport, and Xeomin. The proportional reporting ratios (PRR) and relative odds ratios (ROR) were determined. A literature review was performed for eight AEs of clinical significance: eyelid/eyebrow ptosis, asthenia, muscular weakness, facial paresis, dysphagia, botulism, and death.
Botox/Botox Cosmetic had 38367 AEs. Dysport had 3582 AEs. Xeomin had 1405 AEs. All drugs with reported cases of eyelid and eyebrow ptosis had significant PRR and ROR values. The PRR and ROR values for asthenia were not significant in any of the drugs and only reached significance for Dysport for muscular weakness and dysphagia. Both Botox/Botox Cosmetic and Dysport had elevated PRRs and RORs for facial paresis and botulism. While all drugs had at least one reported case of death related to Botox injection use, none of the PRR or ROR values were significant.
Known AEs for Botox injection use include eyelid/brow ptosis and muscular weakness. Feared but rare complications of Botox injection use include dysphagia, botulism, and possibly death, owing to systemic spread of the toxin. This is the first study to analyze the AE data reported to the FDA on Botox injection use.
III.
肉毒毒素治疗是美国最常进行的非侵入性美容程序。由于其广泛应用，需要对肉毒杆菌素注射的不良事件（AE）概况进行分析。
使用在线网络工具查询 FDA 不良事件报告系统，以确定四种肉毒杆菌素品牌（Botox/Botox 美容、Dysport 和 Xeomin）报告的前 15 种不良事件。确定比例报告比（PRR）和相对优势比（ROR）。对 8 种具有临床意义的 AE 进行文献综述：眼睑/眉毛下垂、虚弱、肌肉无力、面部瘫痪、吞咽困难、肉毒中毒和死亡。
Botox/Botox 美容有 38367 例 AE。Dysport 有 3582 例 AE。Xeomin 有 1405 例 AE。所有报告眼睑和眉毛下垂病例的药物均具有显著的 PRR 和 ROR 值。在任何药物中，虚弱的 PRR 和 ROR 值均不显著，仅在 Dysport 中肌肉无力和吞咽困难达到显著水平。Botox/Botox 美容和 Dysport 均对面瘫和肉毒中毒的发生率具有较高的 PRR 和 ROR 值。虽然所有药物都至少有一例与肉毒杆菌素注射使用相关的死亡报告，但没有一个 PRR 或 ROR 值是显著的。
肉毒杆菌素注射使用的已知 AE 包括眼睑/眉毛下垂和肌肉无力。由于毒素的全身扩散，肉毒杆菌素注射使用的 feared 但罕见的并发症包括吞咽困难、肉毒中毒，可能还有死亡。这是第一项分析向 FDA 报告的肉毒杆菌素注射使用不良事件数据的研究。
EBM 级别：III。
