Gostimir Mišo, Liou Victor, Yoon Michael K
Ivey Eye Institute, Department of Ophthalmology, Western University, London, Ontario, Canada.
Department of Ophthalmology, Harvard Medical School.
Ophthalmic Plast Reconstr Surg. 2023;39(1):13-25. doi: 10.1097/IOP.0000000000002169. Epub 2022 Mar 30.
To quantitatively evaluate safety profile for botulinum toxin A (BTX-A) injections among patients undergoing treatment for cosmetic indications is produced, with special attention to clinically relevant covariates and their relative impact on safety.
A systematic literature search was performed using PubMed (1996-January 2020) and Embase (1947-January 2020) to identify all randomized controlled trials (RCTs) that reported safety data for patients receiving BTX-A for cosmetic indications compared to placebo. A meta-analysis was performed to determine pooled risk ratios (RR) for treatment-related adverse events (TRAEs) and for specific adverse events. Meta-regression and additional analyses were performed for significant and/or clinically relevant covariates.
Following the review of 8,690 studies, 32 RCTs involving 9,669 patients were included. The pooled RR of any TRAE occurring after BTX-A injection compared to placebo injection was 1.53 (95% CI, 1.33-1.77; p < 0.001). Statistically significant covariates included individual injection volume and total injection volume. The type of BTX-A formulation, treatment site, total BTX-A units, and BTX-A units per injection were not significant. Specific adverse events more likely to occur following BTX-A injection rather than placebo injection included eyelid/eyebrow malposition (RR 3.55; p < 0.001), facial paresis (RR 2.42; p = 0.316), and headache (RR 1.45; p = 0.003). Injection site reactions and injection site bruising occurred at similar rates in both groups.
The overall safety profile of BTX-A is acceptable and consistent with previous publications. The authors' additional analyses provide a relative comparison of the impact of various treatment parameters on safety.
对接受肉毒杆菌毒素A（BTX-A）美容治疗的患者的安全性进行定量评估，特别关注临床相关协变量及其对安全性的相对影响。
利用PubMed（1996年-2020年1月）和Embase（1947年-2020年1月）进行系统文献检索，以确定所有报告接受BTX-A美容治疗的患者与安慰剂相比安全性数据的随机对照试验（RCT）。进行荟萃分析以确定治疗相关不良事件（TRAEs）和特定不良事件的合并风险比（RR）。对显著和/或临床相关协变量进行荟萃回归和其他分析。
在对8690项研究进行审查后，纳入了32项涉及9669名患者的RCT。与安慰剂注射相比，BTX-A注射后发生任何TRAEs的合并RR为1.53（95%CI，1.33-1.77；p<0.001）。具有统计学意义的协变量包括个体注射量和总注射量。BTX-A制剂类型、治疗部位、BTX-A总单位数和每次注射的BTX-A单位数均无统计学意义。BTX-A注射后比安慰剂注射更可能发生的特定不良事件包括眼睑/眉毛位置异常（RR 3.55；p<0.001）、面部轻瘫（RR 2.42；p=0.316）和头痛（RR 1.45；p=0.003）。两组注射部位反应和注射部位瘀伤的发生率相似。
BTX-A的总体安全性是可接受的，与先前的出版物一致。作者的额外分析提供了各种治疗参数对安全性影响的相对比较。
