Epidemiology and evaluation of adverse drug reactions in a Korean hospital database for spontaneous reports in the period 2009 to 2018.

IF 0.9 4区医学 Q4 PHARMACOLOGY & PHARMACY

International journal of clinical pharmacology and therapeutics Pub Date : 2022-04-29 DOI:10.5414/CP204060

H. Jeong, B. Chun, D. Kang, H. Kang

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引用次数: 1

Abstract

OBJECTIVE To evaluate the epidemiology of adverse drug reactions (ADRs) in the Korean population and to identify their characteristics and factors affecting their severity. MATERIALS AND METHODS The analysis was based on the ADRs reported to the Seoul National University Hospital between 2009 and 2018. Statistical assessment (SPSS Statistics 25) included frequency analysis and the χ2-test. Risk factors were assessed using logistic regression analysis. Results were considered significant at p < 0.05. RESULTS A total of 44,122 cases were analyzed of which 24,801 (56.2%) cases concerned females and 19,321 (43.8%) males. A total of 47% of cases involved persons aged between 50 and 79 years. Antineoplastic agents, immunomodulating agents, and systemically administered anti-infective agents accounted for 57.6% of all drugs reported. Gastro-intestinal system disorders accounted for the largest proportion (25.8%) of adverse drug reactions reported. A total of 3,429 (7.8%) ADRs were reported as being in the category severe. Multivariate analysis showed that the risk of an ADR being reported as severe is higher in males than in females (OR = 1.25, 95% CI: 1.16 - 1.35), and higher in those aged 0 - 4 years (OR = 1.74, 95% CI: 1.46 - 2.08), in those aged 5 - 19 years (OR = 1.19, 95% CI: 1.07 - 1.31), and in those aged 65 years and over (OR = 1.26, 95% CI: 1.16 - 1.37), compared to those aged 20 - 64 years. DISCUSSION AND CONCLUSION From a public health perspective, ADRs are important because they are preventable. Important determinants, such as differences in specific age groups and drug classes, for the occurrence of ADRs and the occurrence of severe ADRs in particular, were identified. These determinants need to be carefully monitored in both private medical practices, clinics and hospitals. This monitoring of specific groups will involve close attention factors associated with gender, age group, and drug classes.

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2009年至2018年韩国医院自发报告数据库中药物不良反应的流行病学和评价

目的了解韩国人群药物不良反应(adr)的流行病学特点及影响其严重程度的因素。材料与方法本分析基于2009年至2018年向首尔国立大学医院报告的adr。统计学分析(SPSS Statistics 25)采用频率分析和χ2检验。采用logistic回归分析评估危险因素。p < 0.05认为结果显著。结果共分析44,122例，其中女性24,801例(56.2%)，男性19,321例(43.8%)。47%的病例涉及年龄在50至79岁之间的人。抗肿瘤药物、免疫调节剂和全身给药的抗感染药物占所有报告药物的57.6%。报告的药物不良反应以胃肠道系统紊乱为主，占25.8%。共有3429例(7.8%)adr报告为严重adr。多变量分析表明,ADR报告严重的风险在男性比女性更高(或= 1.25,95%置信区间CI: 1.16 - 1.35),和更高的0 - 4岁(或= 1.74,95%置信区间CI: 1.46 - 2.08),在5 - 19岁(或= 1.19,95%置信区间CI: 1.07 - 1.31),在那些65岁及以上(或= 1.26,95%置信区间CI: 1.16 - 1.37),相比20 - 64岁。讨论与结论从公共卫生的角度来看，不良反应是重要的，因为它们是可以预防的。确定了不良反应发生的重要决定因素，如特定年龄组和药物类别的差异，特别是严重不良反应的发生。私人诊所、诊所和医院都需要仔细监测这些决定因素。这种对特定群体的监测将涉及与性别、年龄组和药物类别相关的密切关注因素。

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来源期刊

International journal of clinical pharmacology and therapeutics 医学-药学

CiteScore

1.70

自引率

12.50%

发文量

116

审稿时长

4-8 weeks

期刊介绍： The International Journal of Clinical Pharmacology and Therapeutics appears monthly and publishes manuscripts containing original material with emphasis on the following topics: Clinical trials, Pharmacoepidemiology - Pharmacovigilance, Pharmacodynamics, Drug disposition and Pharmacokinetics, Quality assurance, Pharmacogenetics, Biotechnological drugs such as cytokines and recombinant antibiotics. Case reports on adverse reactions are also of interest.