Almeida Szczesny Lariana, Nunes Dos Santos Raíssa, de Oliveira Silveira Juliano, de Almeida Silvana, Pasqualini Genro Júlia, Fiegenbaum Marilu
Programa de Pós-graduação em Biociências, Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA, Rio Grande do Sul, Porto Alegre 90050-170, Brazil.
Departamento de Ciências Básicas da Saúde, Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA, Rio Grande do Sul, Porto Alegre 90050-170, Brazil.
ACS Omega. 2025 May 21;10(21):22158-22164. doi: 10.1021/acsomega.5c01527. eCollection 2025 Jun 3.
Adverse Drug Reactions (ADRs) present a significant challenge to healthcare systems, contributing substantially to hospital admissions. Opioid analgesics are widely used in the pharmacological treatment of various types of pain; however, ADRs represent a major limitation to their use. This study aims to investigate the profile of ADRs reported in Vigimed (the official Brazilian ADR reporting system) following the implementation of active surveillance through pharmacovigilance trackers. Additionally, it evaluates pharmacogenetic evidence to identify genes potentially involved in opioid-related ADRs. This retrospective cross-sectional study analyzed ADR cases reported to Vigimed from January 2018 to April 2023. Data were extracted from Vigimed, tabulated, and subjected to statistical analysis, using the reporting odds ratio (ROR) to assess the strength of associations between opioids and ADRs. During the study period, there were 238,363 ADR reports, of which 6,001 were related to opioid treatment. The distribution among opioids was as follows: 36.7% morphine, 32.4% tramadol, 21.6% fentanyl, 5.4% methadone, 3.7% codeine, and 0.2% oxycodone. The most frequent adverse events associated with opioids were cardiac disorders (ROR 1.70), skin and subcutaneous tissue disorders (ROR 2.18), gastrointestinal disorders (ROR 2.88), and nervous system disorders (ROR 1.19). Furthermore, pharmacogenetic evidence indicates that the gene has a Level 1 association for codeine and tramadol and a Level 2 association for oxycodone. These findings highlight significant associations between specific opioids and ADRs, emphasizing the influence of genetic variations on adverse reactions and the need for personalized medicine in pain management.
药物不良反应（ADR）给医疗系统带来了重大挑战，在很大程度上导致了住院情况。阿片类镇痛药广泛用于各类疼痛的药物治疗；然而，ADR是其使用的主要限制因素。本研究旨在调查通过药物警戒追踪器实施主动监测后，巴西官方ADR报告系统Vigimed中报告的ADR概况。此外，本研究评估药物遗传学证据，以确定可能与阿片类药物相关ADR有关的基因。这项回顾性横断面研究分析了2018年1月至2023年4月向Vigimed报告的ADR病例。数据从Vigimed中提取、制表并进行统计分析，使用报告比值比（ROR）评估阿片类药物与ADR之间关联的强度。在研究期间，共有238,363份ADR报告，其中6,001份与阿片类药物治疗有关。阿片类药物的分布如下：吗啡占36.7%，曲马多占32.4%，芬太尼占21.6%，美沙酮占5.4%，可待因占3.7%，羟考酮占0.2%。与阿片类药物相关的最常见不良事件是心脏疾病（ROR 1.70）、皮肤和皮下组织疾病（ROR 2.18）、胃肠道疾病（ROR 2.88）和神经系统疾病（ROR 1.19）。此外，药物遗传学证据表明，该基因与可待因和曲马多有1级关联，与羟考酮有2级关联。这些发现突出了特定阿片类药物与ADR之间的显著关联，强调了基因变异对不良反应的影响以及疼痛管理中个性化医疗的必要性。
