Laboratory of Teaching and Research in Social Pharmacy (LEPFS-UFS), Department of Pharmacy, Federal University of Sergipe, Cidade Universitária "Prof. José Aloísio Campos", Jardim Rosa Elze, São Cristóvão, SE, 49100-000, Brazil.
Health Sciences Graduate Program, Federal University of Sergipe, São Cristóvão, Brazil.
Int J Clin Pharm. 2021 Oct;43(5):1293-1301. doi: 10.1007/s11096-021-01249-8. Epub 2021 Mar 3.
Adverse drug reactions are a problem in healthcare systems worldwide. Children are more susceptible than adults, especially when exposed to specific drug classes, such as antibiotics.
To assess the incidence, causality, severity, and avoidability of antibiotic-associated adverse drug reactions in hospitalized pediatric patients.
Pediatric ward of a high-complexity public hospital in northeast Brazil.
A prospective cohort study was conducted over six months, including children aged between 28 days and 12 years, hospitalized for more than 48 h, and receiving antibiotics. Liverpool's causality and avoidability assessment tools were used. Primary outcome measures: Incidence of adverse drug reactions, causality, severity, and avoidability, major antibiotics implicated, risk factors.
A total of 183 patients were followed, and 35 suspected adverse drug reactions were recorded overall incidence equal to 14.7%. Most adverse drug reactions were classified as moderate severity (76.7%), probable (57.1%) and defined (28.6%) causality, and unavoidable (66.7%). The affected organs were the gastrointestinal system (74.1%) and skin (25.9%). Major antibiotics implicated were ceftriaxone (40.7%), azithromycin (25.9%), and crystalline penicillin (11.1%). The number of antibiotics prescribed per patient during hospitalization and the length of stay were the risk factors identified.
Causality and severity assessment indicated that most adverse drug reactions were probable and moderate. Possibly avoidable reactions occurred due to inappropriate prescribing when preventive measures were not implemented. Monitoring the use of antibiotics in children is essential to ensure the safety of these patients.
药物不良反应是全球医疗体系中的一个问题。儿童比成年人更容易受到影响，尤其是在接触特定药物类别（如抗生素）时。
评估住院儿科患者中抗生素相关药物不良反应的发生率、因果关系、严重程度和可避免性。
巴西东北部一家高复杂度公立医院的儿科病房。
进行了为期六个月的前瞻性队列研究，纳入年龄在 28 天至 12 岁之间、住院时间超过 48 小时且接受抗生素治疗的儿童。使用了利物浦因果关系和可避免性评估工具。主要结局指标：药物不良反应的发生率、因果关系、严重程度和可避免性、主要涉及的抗生素、危险因素。
共随访了 183 名患者，共记录了 35 例疑似药物不良反应，总发生率为 14.7%。大多数药物不良反应被归类为中度严重程度（76.7%）、可能（57.1%）和确定（28.6%）因果关系，且不可避免（66.7%）。受影响的器官是胃肠道系统（74.1%）和皮肤（25.9%）。主要涉及的抗生素是头孢曲松（40.7%）、阿奇霉素（25.9%）和结晶青霉素（11.1%）。住院期间每个患者开的抗生素种类数量和住院时间是确定的危险因素。
因果关系和严重程度评估表明，大多数药物不良反应是可能的和中度严重的。由于未实施预防措施，导致可能避免的反应发生，是由于处方不当引起的。监测儿童抗生素的使用对于确保这些患者的安全至关重要。
