缓解巴西发型化妆品眼部不良事件的措施:一项描述性和相关性研究(2022-2024)。

IF 2.5 Q1 Multidisciplinary
Epidemiologia e Servicos de Saude Pub Date : 2025-05-02 eCollection Date: 2025-01-01 DOI:10.1590/S2237-96222024v34e20240449.en
Daniel Marques Mota, Leonardo Oliveira Leitão, Ronald Santos Silva, Cássia de Fátima Rangel Fernandes, Marcus Tolentino Silva
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引用次数: 0

摘要

目的:描述巴西卫生监管机构(ANVISA)实施的健康监测行动,以减轻巴西与美发膏相关的眼部不良事件病例,并验证报告病例与这些行动之间的相关性。方法:基于文献分析和ANVISA病例报告数据库,在2022年3月至2024年3月期间进行描述性和相关性研究。使用Spearman相关系数来检验ANVISA用药与不良事件病例之间的相关性(p值)。结果:确定了与ANVISA用药(n=172)和报告病例(n=636)相关的三个不同时期。第二阶段(2022年12月至2023年6月)的行动数量最多(n=125;72.7%),与病例报告高峰相吻合(n=550)。在此期间,发布了两次安全警报,并下令对在巴西销售的所有美发霜实施预防性禁令,禁令持续了38天。在第三个时期(2023年7月至2024年3月),奶油营销取消的数量最多(n= 3122;79.3%),毒理学分析表明6份(30.0%)样品被列为严重刺激性/腐蚀性。这些行动与报告病例之间存在较强的正相关关系,p值在0.53 ~ 0.74之间,p值为0.006 ~ 0.74。结论:较强的正相关关系表明,ANVISA的行动是对病例报告增加的反应,这表明积极监测和快速干预对控制公共卫生风险的重要性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Actions to mitigate ocular adverse events related to hair styling cosmetics in Brazil: a descriptive and correlational study (2022-2024).

Objective: To describe health surveillance actions implemented by the Brazilian Health Regulatory Agency (ANVISA) to mitigate cases of ocular adverse events related to hair styling creams in Brazil and verify correlation between reported cases and these actions.

Methods: This is a descriptive and correlational study based on analysis of documents and the ANVISA case reporting database, between March 2022 and March 2024. Spearman's correlation coefficient was used to examine correlation between ANVISA actions and cases of adverse events (p-value<0.05).

Results: Three distinct periods were identified in relation to ANVISA actions (n=172) and reported cases (n=636). The second period (December 2022 to June 2023) presented the highest number of actions (n=125; 72.7%), coinciding with the peak of case reports (n=550). During this period, two safety alerts were published and a precautionary ban was ordered on all hair styling creams sold in Brazil, which lasted 38 days. In the third period (July 2023 to March 2024), the highest number of cream marketing cancellations occurred (n=3,122; 79.3%), and toxicology analyses indicated that six (30.0%) samples were classified as severely irritant/corrosive. There was a positive and strong correlation between the actions and the reported cases, ranging from 0.53 (p-value 0.006) to 0.74 (p-value<0.001).

Conclusion: The strong positive correlation demonstrates that ANVISA's actions were reactive to the increase in case reports, reinforcing the importance of active surveillance and rapid interventions to control risks to public health.

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来源期刊
Epidemiologia e Servicos de Saude
Epidemiologia e Servicos de Saude PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-
CiteScore
4.90
自引率
0.00%
发文量
88
审稿时长
21 weeks
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