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Adverse drug reactions associated with the use of biological agents
bioRxiv - Pharmacology and Toxicology Pub Date : 2020-09-24 , DOI: 10.1101/2020.09.24.311241
Jorge Enrique Machado-Alba , Anyi Liliana Jiménez-Morales , Yulieth Carolina Moran-Yela , Ilsa Yadira Parrado-Fajardo , Luis Fernando Valladales-Restrepo

Introduction . Biotech drugs open new possibilities to treat diseases for which drug therapy is limited, but they may be associated with serious adverse drug reactions (ADRs). Objective : To identify the ADRs associated with the use of biotech drugs in Colombia. Methods : This was a retrospective study of ADR reports from 2014 to 2019, contained in the database of the pharmacovigilance program of Audifarma SA. The ADRs, groups of associated drugs, and affected organs were classified. Results : A total of 5,415 reports of ADRs associated with biotech 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 commonly affected organ system (16.8%), followed by the skin and adnexa (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%). Conclusions : There has been an incremental increase in the reporting of ADRs associated with the use of biotech drugs in the pharmacovigilance program, related to the strengthening and appropriation of the patient safety culture and improvement in the quality of the generated information. It is important to empower physicians and entire health teams to ensure the traceability of ADRs and to perform interdisciplinary interventions derived from pharmacovigilance at the individual and population levels.

中文翻译:

与使用生物制剂有关的药物不良反应

介绍 。生物技术药物为治疗药物治疗受限的疾病提供了新的可能性,但它们可能与严重的药物不良反应(ADR)相关。目的:确定哥伦比亚与使用生物技术药物相关的ADR。方法:这是Audafarma SA药物警戒计划数据库中2014年至2019年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。结果:在哥伦比亚的78个城市中,共鉴定了5,415份与生物技术药物相关的ADR报告。共有76.1%的案件与女性有关。多数被分类为A型(55.0%)和B型(28.9%),严重病例为16.7%。呼吸道是最常见的器官系统(16.8%),其次是皮肤和附件(15。6%)。抗肿瘤和免疫调节药物占报告的70.6%,与ADR最多的药物为阿达木单抗(12.2%)和依那西普(11.6%)。结论:在药物警戒计划中与使用生物技术药物有关的ADR报告越来越多,这与加强和分配患者安全文化以及改善所生成信息的质量有关。重要的是要授权医师和整个医疗团队确保ADR的可追溯性,并在个人和人群水平上执行源自药物警戒的跨学科干预措施。2%)和依那西普(11.6%)。结论:在药物警戒计划中与使用生物技术药物有关的ADR报告越来越多,这与加强和分配患者安全文化以及改善所生成信息的质量有关。重要的是要授权医师和整个医疗团队确保ADR的可追溯性,并在个人和人群水平上执行源自药物警戒的跨学科干预措施。2%)和依那西普(11.6%)。结论:在药物警戒计划中与使用生物技术药物有关的ADR报告越来越多,这与加强和分配患者安全文化以及改善所生成信息的质量有关。重要的是要授权医师和整个医疗团队确保ADR的可追溯性,并在个人和人群水平上执行源自药物警戒的跨学科干预措施。
更新日期:2020-09-25
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