Grupo de Investigación en Farmacoepidemiología y Farmacovigilancia, Universidad Tecnológica de Pereira-Audifarma S.A, Pereira, Risaralda, Colombia.
Universidad Tecnológica de Pereira-Audifarma S.A, Pereira, Risaralda, Colombia.
PLoS One. 2020 Dec 18;15(12):e0240276. doi: 10.1371/journal.pone.0240276. eCollection 2020.
Biological drugs open new possibilities to treat diseases for which drug therapy is limited, but they may be associated with adverse drug reactions (ADRs).
To identify the ADRs associated with the use of biological drugs in Colombia.
This was a retrospective study of ADR reports from 2014 to 2019, contained in the database of Audifarma SA pharmacovigilance program. The ADRs, groups of associated drugs, and affected organs were classified.
In total, 5,415 reports of ADRs associated with biological drugs were identified in 78 Colombian cities. A total of 76.1% of the cases corresponded to women. The majority were classified as type A (55.0%) and B (28.9%), and 16.7% were serious cases. The respiratory tract was the most affected organ system (16.8%), followed by the skin and appendages (15.6%). Antineoplastic and immunomodulatory drugs accounted for 70.6% of the reports, and the drugs related to the greatest number of ADRs were adalimumab (12.2%) and etanercept (11.6%).
The reporting of ADRs has increased in recent years and these reactions are mostly classified as tyoe A or B, categorized as serious in almost one-fifth of the reported cases and associated mainly with immunomodulators and antineoplastic agents. This type of study can support decision makers in ways that benefit patient safety and interaction with health systems.
生物药物为治疗药物治疗有限的疾病开辟了新的可能性，但它们可能与药物不良反应（ADR）有关。
确定与哥伦比亚使用生物药物相关的 ADR。
这是一项对 2014 年至 2019 年 Audifarma SA 药物警戒计划数据库中包含的 ADR 报告的回顾性研究。对 ADR、相关药物组和受影响的器官进行了分类。
在 78 个哥伦比亚城市中，共发现与生物药物相关的 5415 份 ADR 报告。病例中 76.1%为女性。大多数被归类为 A 型（55.0%）和 B 型（28.9%），16.7%为严重病例。呼吸道是受影响最严重的器官系统（16.8%），其次是皮肤和附属物（15.6%）。抗肿瘤和免疫调节剂药物占报告的 70.6%，与最多 ADR 相关的药物是阿达木单抗（12.2%）和依那西普（11.6%）。
近年来，ADR 的报告有所增加，这些反应主要分类为 A 型或 B 型，近五分之一的报告病例被归类为严重，主要与免疫调节剂和抗肿瘤药物相关。这种类型的研究可以支持决策者以有利于患者安全和与卫生系统互动的方式做出决策。
