Machado-Alba Jorge Enrique, Ruiz Andrés Felipe, Machado-Duque Manuel Enrique
Grupo de Investigación en Farmacoepidemiología y Farmacovigilancia, Universidad Tecnológica de Pereira-Audifarma S.A., Pereira, Colombia,
Audifarma S.A., Bogotá, Colombia.
Rev Panam Salud Publica. 2014 Dec;36(6):396-401.
This study describes the adverse drug reactions (ADRs) and their incidence in patients with rheumatoid arthritis who were treated in the Colombian health system. A retrospective cohort study was conducted using information from all patients who were diagnosed with rheumatoid arthritis and attended specialized health care centers in the cities of Bogotá, Cali, Manizales, Medellin, and Pereira between 1 December 2009 and 30 August 2013. The ADRs were obtained from medical records and the pharmacovigilance system registry and sorted by frequency and affected tissue according to World Health Organization Adverse Reaction Terminology (WHO-ART). A total of 949 reports of ADRs were obtained from 419 patients (32.8 ADRs per 100 patient-years); these patients were from a cohort of 1,364 patients being treated for rheumatoid arthritis and followed up for an average of 23.8 months (± 12.9). The cohort was mostly female (366, 87.4%) and had a mean age of 52.7 years (± 13.1). The highest numbers of ADRs were reported following the use of tocilizumab, rituximab, and infliximab (28.8, 23.1, and 13.3 reports per 100 patient-years respectively). The most frequently reported ADRs were elevated transaminase levels and dyspepsia. Overall, 87.7% of ADRs were classified as type A, 36.6% as mild, 40.7% as moderate, and 22.7% as severe. As a result, 73.2% of patients who experienced an ADR stopped taking their drugs. The occurrence of ADRs in patients treated for rheumatoid arthritis is common, especially in those associated with the use of biotechnologically produced anti-rheumatic drugs. This outcome should be studied in future research and monitoring is needed to reduce the risks in these patients.
本研究描述了在哥伦比亚医疗系统接受治疗的类风湿性关节炎患者的药物不良反应（ADR）及其发生率。采用2009年12月1日至2013年8月30日期间所有被诊断为类风湿性关节炎并在波哥大、卡利、马尼萨莱斯、麦德林和佩雷拉等城市的专科医疗中心就诊的患者信息进行了一项回顾性队列研究。药物不良反应从医疗记录和药物警戒系统登记处获取，并根据世界卫生组织不良反应术语（WHO-ART）按频率和受影响组织进行分类。共从419名患者中获得了949份药物不良反应报告（每100患者年32.8次ADR）；这些患者来自1364名接受类风湿性关节炎治疗的患者队列，平均随访23.8个月（±12.9）。该队列大多为女性（366名，87.4%），平均年龄为52.7岁（±13.1）。使用托珠单抗、利妥昔单抗和英夫利昔单抗后报告的ADR数量最多（分别为每100患者年28.8、23.1和13.3份报告）。最常报告的ADR是转氨酶水平升高和消化不良。总体而言，87.7%的ADR被分类为A型，36.6%为轻度，40.7%为中度，22.7%为重度。因此，73.2%经历ADR的患者停止了用药。类风湿性关节炎治疗患者中ADR的发生很常见，尤其是与使用生物技术生产的抗风湿药物相关的患者。这一结果应在未来研究中进行探讨，并且需要进行监测以降低这些患者的风险。
