Zhou Siyuan, Yan Su, Ming Shaopeng
The Second Affiliated Hospital of Guangxi Medical University, Nanning, China.
J Cosmet Dermatol. 2025 Jan;24(1):e16787. doi: 10.1111/jocd.16787.
Benzoyl peroxide (BPO) is widely used in dermatological aesthetics for treating acne and other skin conditions. However, its potential adverse reactions remain a concern.
This study aimed to investigate the application of BPO in dermatological aesthetics, analyze its associated adverse reactions, and provide insights into patient safety.
The study analyzed adverse reaction reports related to BPO in the Food and Drug Administration's Adverse Event Reporting System database from 2004 to 2024. Demographic characteristics, types of adverse reactions, and specific issues related to the novel drug EPSOLAY (5% microencapsulated BPO) were examined.
The findings reveal that BPO users are predominantly female (74.18%), with a significant proportion falling within the 18-44 age group (37.45%). The most common adverse reactions involve skin and subcutaneous tissue disorders (36.34%), including skin swelling, pain, and burning sensations. Reports on EPSOLAY indicate adverse reactions such as erythema, pruritus, and skin exfoliation, but no tumor-related reports have been recorded.
BPO usage in dermatological aesthetics is associated with various adverse reactions, primarily affecting the skin. The introduction of EPSOLAY has not altered the adverse reaction profile significantly. However, the risk of BPO decomposing into the carcinogen benzene under certain conditions necessitates enhanced patient education, improved production processes, and continuous post-marketing surveillance to ensure drug safety.
过氧化苯甲酰（BPO）在皮肤美容领域被广泛用于治疗痤疮和其他皮肤疾病。然而，其潜在的不良反应仍然令人担忧。
本研究旨在调查BPO在皮肤美容中的应用，分析其相关的不良反应，并为患者安全提供见解。
该研究分析了2004年至2024年美国食品药品监督管理局不良事件报告系统数据库中与BPO相关的不良反应报告。研究了人口统计学特征、不良反应类型以及与新型药物EPSOLAY（5%微囊化BPO）相关的具体问题。
研究结果显示，使用BPO的患者以女性为主（74.18%），其中很大一部分年龄在18 - 44岁之间（37.45%）。最常见的不良反应涉及皮肤和皮下组织疾病（36.34%），包括皮肤肿胀、疼痛和烧灼感。关于EPSOLAY的报告显示有红斑、瘙痒和皮肤脱屑等不良反应，但未记录到与肿瘤相关的报告。
BPO在皮肤美容中的使用与多种不良反应相关，主要影响皮肤。EPSOLAY的引入并未显著改变不良反应情况。然而，BPO在某些条件下分解为致癌物苯的风险，需要加强患者教育、改进生产工艺并持续进行上市后监测以确保用药安全。
