Department of Pharmacology, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Polytechnic Institute of Coimbra, Coimbra Health School, Coimbra, Portugal.
Drug Saf. 2023 Nov;46(11):1133-1148. doi: 10.1007/s40264-023-01351-y. Epub 2023 Oct 12.
Opioids are commonly used as analgesics; however, like any medicine, they can produce adverse drug reactions (ADRs), including nausea, constipation, dependence, and respiratory depression, that result in harmful and fatal events. Therefore, it is essential to monitor the safety of these drugs in clinical practice.
This study aimed to characterize the safety profile of opioids by conducting a descriptive study based on a spontaneous reporting system (SRS) for ADRs in The Netherlands, focusing on abuse, misuse, medication errors, and differences between sexes.
Reports submitted to the Netherlands Pharmacovigilance Centre Lareb from January 2003 to December 2021 with an opioid drug as the suspected/interacting medicine were analyzed. Reporting odds ratios (RORs) for drug-ADR combinations were calculated, analyzed, and corrected for sex and drug utilization (expenditure) for the Dutch population.
A total of 8769 reports were analyzed. Tramadol was the opioid with the most reports during the period (n = 2746), while oxycodone or tramadol had the highest number of reports per year in the study period. The most reported ADRs from opioid use were nausea, followed by dizziness and vomiting, independent of sex, and all of them were more often reported in women. Vomiting associated with tramadol (ROR females/males = 2.17) was significantly higher in women. Buprenorphine was responsible for most ADRs when corrected for expenditure, with high RORs observed with application site hypersensitivity, application site reaction, and application site rash. Fentanyl gave rise to most of the reports of ADRs concerning abuse, misuse, and medication errors.
Patients treated with opioids experienced ADRs, primarily nausea, dizziness, and vomiting. For those groups of drugs, no significant differences were found between the sexes, except for the vomiting associated with tramadol. In general, ADRs related to opioids presented higher RORs when uncorrected and corrected for sexes and expenditure than other drugs. There was more disproportionate reporting for ADRs concerning abuse, misuse, and medication errors for opioids than other drugs in the Dutch SRS.
阿片类药物通常被用作镇痛药；然而，像任何药物一样，它们会产生不良反应（ADR），包括恶心、便秘、依赖和呼吸抑制，这些不良反应会导致有害和致命的事件。因此，在临床实践中监测这些药物的安全性至关重要。
本研究旨在通过对荷兰自发报告系统（SRS）中阿片类药物不良反应的描述性研究，描述阿片类药物的安全性概况，重点关注滥用、误用、用药错误以及性别差异。
分析了 2003 年 1 月至 2021 年 12 月期间向荷兰药物警戒中心 Lareb 报告的与阿片类药物相关的可疑/相互作用药物的报告。计算并分析了药物-ADR 组合的报告比值比（ROR），并针对性别和荷兰人口的药物利用（支出）进行了校正。
共分析了 8769 份报告。曲马多是该时期报告数量最多的阿片类药物（n=2746），而在研究期间，羟考酮或曲马多的报告数量最高。阿片类药物使用最常见的不良反应是恶心，其次是头晕和呕吐，与性别无关，所有这些不良反应在女性中更为常见。与曲马多相关的呕吐（女性/男性 ROR=2.17）在女性中显著更高。布比卡因在支出校正后引起的不良反应报告最多，观察到应用部位过敏反应、应用部位反应和应用部位皮疹的高 ROR。芬太尼引起了大多数关于滥用、误用和用药错误的 ADR 报告。
接受阿片类药物治疗的患者经历了不良反应，主要是恶心、头晕和呕吐。对于这些药物组，除了与曲马多相关的呕吐外，男女之间没有发现显著差异。一般来说，未校正和校正性别和支出后的阿片类药物不良反应的 ROR 高于其他药物。与其他药物相比，荷兰 SRS 中报告的阿片类药物与滥用、误用和用药错误相关的不良反应报告比例更高。
