Jiamsathit Warisara, Bunarong Kansuda, Papenkort Sonthiya, Cox Anthony R, Jarernsiripornkul Narumol
Sirindhorn College of Public Health Khon Kaen, Faculty of Public Health and Allied Health Sciences, Praboromarajchanok Institute, Khon Kaen 40000, Thailand.
Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand.
J Clin Med. 2025 Jan 28;14(3):857. doi: 10.3390/jcm14030857.
Serious adverse drug reactions (ADRs) can lead to hospital admission and can be fatal, but some of them are preventable. This study aimed to determine the types and frequencies of serious cutaneous ADRs and the methods employed to manage and prevent them, as well as to assess the factors related to their seriousness. A cross-sectional study was conducted retrospectively on inpatients and outpatients at a tertiary care hospital. All data were collected from the medical records database over a period of 3 years. Serious cutaneous ADRs were identified in the hospital database using the International Classification of Disease and Related Health Problems, 10th Revision (ICD-10). A total of 2151 cases were retrieved using the ICD-10, and 436 patients were randomly selected for this study. Of these, 218 patients experienced ADRs (50.0%). The major clinical symptoms of the eight serious ADRs included anaphylaxis (38.5%) and urticaria (30.2%). The most commonly suspected drug group was antibiotics (45.0%). The main methods of ADR management were drug treatment (84.4%) and drug withdrawal (81.2%). The primary method of ADR prevention was patient drug allergy cards (52.3%). Factors affecting the severity of ADRs were having an underlying condition ( = 0.031) and the concomitant use of drugs ( = 0.044). Anaphylaxis was the most common serious ADR. Patients with underlying diseases and those taking concomitant drugs are more likely to present with serious ADRs. The prevention of serious ADRs should be promoted at all levels in hospitals to reduce harm and prevent their reoccurrence.
严重药物不良反应（ADR）可导致住院，甚至可能致命，但其中一些是可预防的。本研究旨在确定严重皮肤ADR的类型和频率、管理和预防方法，以及评估与严重程度相关的因素。对一家三级医院的住院患者和门诊患者进行了回顾性横断面研究。所有数据均从3年期间的病历数据库中收集。在医院数据库中使用国际疾病分类及相关健康问题第十版（ICD-10）识别严重皮肤ADR。使用ICD-10检索到2151例病例，随机选择436例患者进行本研究。其中，218例患者发生了ADR（50.0%）。八种严重ADR的主要临床症状包括过敏反应（38.5%）和荨麻疹（30.2%）。最常怀疑的药物类别是抗生素（45.0%）。ADR管理的主要方法是药物治疗（84.4%）和停药（81.2%）。ADR预防的主要方法是患者药物过敏卡（52.3%）。影响ADR严重程度的因素是患有基础疾病（P = 0.031）和联合用药（P = 0.044）。过敏反应是最常见的严重ADR。患有基础疾病的患者和联合用药的患者更有可能出现严重ADR。应在医院各级推广严重ADR的预防，以减少伤害并防止其再次发生。
