• Biomolecules & Therapeutics
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• 제32권1호
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• pp.1-12
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• 2024

Adverse drug reactions (ADRs) are an inherent aspect of drug use. While approximately 80% of ADRs are predictable, immune system-mediated ADRs, often unpredictable, are a noteworthy subset. Skin-related ADRs, in particular, are frequently unpredictable. However, the wide spectrum of skin manifestations poses a formidable diagnostic challenge. Comprehending the pathomechanisms underlying ADRs is essential for accurate diagnosis and effective management. The skin, being an active immune organ, plays a pivotal role in ADRs, although the precise cutaneous immunological mechanisms remain elusive. Fortunately, clinical manifestations of skin-related ADRs, irrespective of their severity, are frequently rooted in immunological processes. A comprehensive grasp of ADR morphology can aid in diagnosis. With the continuous development of new pharmaceuticals, it is noteworthy that certain drugs including immune checkpoint inhibitors have gained notoriety for their association with ADRs. This paper offers an overview of immunological mechanisms involved in cutaneous ADRs with a focus on clinical features and frequently implicated drugs.

• Genomics & Informatics
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• 제11권4호
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• pp.254-262
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• 2013

The multidrug resistance protein 2 (MRP2, ABCC2) gene may determine individual susceptibility to adverse drug reactions (ADRs) in the central nervous system (CNS) by limiting brain access of antiepileptic drugs, especially valproic acid (VPA). Our objective was to investigate the effect of ABCC2 polymorphisms on ADRs caused by VPA in Korean epileptic patients. We examined the association of ABCC2 single-nucleotide polymorphisms and haplotype frequencies with VPA related to adverse reactions. In addition, the association of the polymorphisms with the risk of VPA related to adverse reactions was estimated by logistic regression analysis. A total of 41 (24.4%) patients had shown VPA-related adverse reactions in CNS, and the most frequent symptom was tremor (78.0%). The patients with CNS ADRs were more likely to have the G allele (79.3% vs. 62.7%, p=0.0057) and the GG genotype (61.0% vs. 39.7%, p=0.019) at the g.-1774delG locus. The frequency of the haplotype containing g.-1774Gdel was significantly lower in the patients with CNS ADRs than without CNS ADRs (15.8% vs. 32.3%, p=0.0039). Lastly, in the multivariate logistic regression analysis, the presence of the GG genotype at the g.-1774delG locus was identified as a stronger risk factor for VPA related to ADRs (odds ratio, 8.53; 95% confidence interval, 1.04 to 70.17). We demonstrated that ABCC2 polymorphisms may influence VPA-related ADRs. The results above suggest the possible usefulness of ABCC2 gene polymorphisms as a marker for predicting response to VPA-related ADRs.

• Allergy, Asthma & Respiratory Disease
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• 제6권6호
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• pp.315-321
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• 2018

Purpose: Radiocontrast media are widely used in medical imaging to improve diagnostic accuracy. However, studies on the adverse reactions of radiocontrast media in children are limited. We aimed to describe the characteristics of adverse reactions to radiocontrast media among children who had a computed tomography scan or magnetic resonance imaging in a tertiary university hospital. Methods: We retrospectively collected data on adverse reactions to radiocontrast media by the reporting system of a tertiary university hospital. We selected data from children under the age of 19 from July 2011 to December 2017 and analyzed their characteristics. We focused mainly on the characteristics of the index case which is defined by the first adverse event of each subject. Results: During the period, a total of 88,050 radiocontrast media-enhanced imaging studies were performed and 184 cases of adverse reactions were reported. A total of 71 were identified as index cases. Forty-nine (69.0%) were male and the mean age was $12.7{\pm}3.2$ years. The incidence of radiocontrast media-related adverse reactions was 0.09% and severe reactions were 0.002%. The most common clinical feature was skin manifestations (54.9%), followed by gastrointestinal symptoms (40.8%) and neuropsychiatric symptoms (7.4%). Conclusion: Adverse reactions to radiocontrast media rarely occur in children and the incidence of severe reactions is low. Most reactions are mild and are related to the skin and gastrointestinal system. This report would provide good evidence for establishing a management strategy in children scheduled for imaging studies using radiocontrast media.

• 한국임상약학회지
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• 제27권4호
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• pp.221-227
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• 2017

Background: As personalized healthcare industry has attracted much attention, big data analysis of healthcare data is essential. Lots of healthcare data such as product labeling, biomedical literature and social media data are unstructured, extracting meaningful information from the unstructured text data are becoming important. In particular, text mining for adverse drug reactions (ADRs) reports is able to provide signal information to predict and detect adverse drug reactions. There has been no study on text analysis of expert opinion on Korea Adverse Event Reporting System (KAERS) databases in Korea. Methods: Expert opinion text of KAERS database provided by Korea Institute of Drug Safety & Risk Management (KIDS-KD) are analyzed. To understand the whole text, word frequency analysis are performed, and to look for important keywords from the text TF-IDF weight analysis are performed. Also, related keywords with the important keywords are presented by calculating correlation coefficient. Results: Among total 90,522 reports, 120 insulin ADR report and 858 tramadol ADR report were analyzed. The ADRs such as dizziness, headache, vomiting, dyspepsia, and shock were ranked in order in the insulin data, while the ADR symptoms such as vomiting, 어지러움, dizziness, dyspepsia and constipation were ranked in order in the tramadol data as the most frequently used keywords. Conclusion: Using text mining of the expert opinion in KIDS-KD, frequently mentioned ADRs and medications are easily recovered. Text mining in ADRs research is able to play an important role in detecting signal information and prediction of ADRs.

• 한국임상약학회지
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• 제16권2호
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• pp.155-164
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• 2006

Great inter-variability in drug response and adverse drug reactions is related to inter-variability of drug bioavailability, drug interaction and patient's disease and physyological state that cause change in absorption, distribution, metabolism and excretion of drugs. However, these alone do not sufficiently predict and explain inter-variability in drug response. In recent studies, it is reported that inter-variability in drug response and adverse drug reactions may largely resulted from genetically determined differences in drug absoption, distribution, metabolism and drug target proteins. Especially, the major human drug-metabolizing enzymes such as CYP450, N-acetyl tranferase, thiopurine S-methyl transferase, glutathione S-transferase are identified as the major gene variants that cause inter-individual variability in drug's response and adverse drug reactions. These variations may have most significant implications for those drugs that have narrow therapeutic index and serious adverse drug reactions. Therefore, the genetic variation such as polymorphisms in drug metabolizing enzymes can affect the response of individuals to drugs that are used in the treatment of depression, psychosis, cancer, cardiovascular disorders, ulcer and gastrointestinal disorders, pain and epilepsy, among others. This review describes the pharmacogenomics of the drug metabolizing enzymes associated with the drug response and its clinical applications.

• Tuberculosis and Respiratory Diseases
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• 제78권3호
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• pp.161-167
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• 2015

Tuberculosis (TB) remains a major global health problem, and the incidence of TB cases has not significantly decreased over the past decade in Korea. The standard short course regimen is highly effective against TB, but requires multiple TB-specific drugs and a long treatment duration. Recent studies using late-generation fluoroquinolones and/or high-dose rifapentine-containing regimens to shorten the duration of TB treatment showed negative results. Extending the treatment duration may be considered in patients with cavitation on the initial chest radiograph and positivity in sputum culture at 2 months of treatment for preventing TB relapse. Current evidence does not support the use of fixed-dose combinations compared to separate drugs for the purpose of improving treatment outcomes. All patients receiving TB treatment should be monitored regularly for response to therapy, facilitation of treatment completion, and management of adverse drug reactions. Mild adverse effects can be managed with symptomatic therapy and changing the timing of the drug administration, but severe adverse effects require a discontinuation of the offending drugs.

• 간호행정학회지
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• 제22권1호
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• pp.91-98
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• 2016

Purpose: The aim of this study was to identify the relationship between nurses' knowledge of adverse drug reactions (ADR), attitudes, and monitoring practices and to establish an effective ADR reporting system and provide baseline data for its activation. Methods: The participants in this study were chosen by convenience sampling and included 182 nurses working at major general hospitals that operate a Regional Drug Safety Center. Data were collected from June 1 to 12, 2015 and analyzed using Cronbach's ${\alpha}$, descriptive statistics, independent t-test, one way ANOVA, Pearson correlation coefficient and stepwise regression with the SPSS program. Results: The nurses' average score for knowledge was 7.62 points, for attitude, 41.04 points and for monitoring practices, 34.22 points. ADR monitoring practices positively correlated with knowledge (r=.19, p=.011), attitude (r=.41, p<.001), drug performance competency (r=.54, p<.001), and drug education satisfaction (r=.54, p<.001). Drug performance competency, drug education satisfaction, and attitudes explained 42.0% of the ADR monitoring practices (Adj $R^2=.42$, F=43.95, p<.001). Conclusion: In order to facilitate and encourage nurses' voluntary monitoring practice of ADR, efforts must be made to create positive attitudes toward ADR, and to increase drug performance competency and drug education satisfaction.

• 대한한방내과학회지
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• 제35권2호
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• pp.111-118
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• 2014

Drugs may cause adverse effects, and spontaneous adverse drug reaction (ADR) reports have been used as the main method of drug safety evaluation after drugs have been released. The World Health Organization (WHO) collects ADR data reported from pharmacovigilance organizations in each nations. In China, pharmacovigilance centers operate with hierarchical structure at local, provincial and national levels. Also, Japan and Korea each operate their own respective independent pharmacovigilance organizations. WHO is collecting ADR reports for herbal medicine and 15~20% of all ADRs was related to herbal medicine in China. There are status reports of ADRs for herbal medicine in Japan as well. However, in Korea, there is no ADR reporting system regarding herbal medicine. In light of these overseas cases, a spontaneous ADR reporting system for herbal medicine in Korea should be necessary as well.

• 한국콘텐츠학회논문지
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• 제16권9호
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• pp.473-481
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• 2016

뇌경색으로 입원하여 덱스트란 40을 투여받고 약물유해반응이 발생하여 의약품 부작용 보고서에 의해 보고된 전주예수병원 환자 22명을 대상으로 하였다. 이 연구의 목적은 뇌경색으로 덱스트란 40을 투여받은 환자를 대상으로 덱스트란 40의 약물유해반응과 부작용을 조사 및 보고함으로써 약물유해반응을 줄이기 위한 방안을 제시하고자 한다. 덱스트란의 부작용은 저혈압, 오심, 호흡곤란, 전신적인 두드러기, 열이고 과량 투여 시 폐부종을 유발한다. 평균 입원 기간은 20일로 입원환자의 26.8%가 입원기간의 연장을 경험하였고 덱스트란 40의 약물유해반응 발생률은 12.4%였고, 9명(28.1%)이 itching, rash는 7명(21.9%)이었다. 주입초기에, 초회 주사에서 덱스트란 아나필락틱 반응이 나타날 수 있다고 보고되고 있으나 투여 후 4일째에 부작용이 발생한 환자가 4명으로 18.2%에 이른다. 우리나라에는 덱스트란 1이 아직 널리 알려져 있지 않지만 미국 FAD에서는 사용을 권장하고 있으며, 덱스트란 40의 약물유해반응을 줄이기 위해서는 덱스트란 1의 사용을 고려해 볼 필요가 있다.

• Journal of Oral Medicine and Pain
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• 제44권4호
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• pp.183-188
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• 2019

Erythema multiforme (EM) is an inflammatory immune-mediated mucosal disease. EM is classified as EM minor or EM major, depending on the severity of symptoms. Most patients with minor or major forms of EM have oral lesions. EM can occur as a result of adverse drug reactions but this is difficult to establish. Several indicators have been developed that can be used as a criterion of evaluation to ensure objectivity in identifying the causality of adverse drug reactions. The Naranjo algorithm was used in the evaluation to ensure objectivity in identifying the causality of adverse drug reactions. There were two cases of patients suspected of having EM induced by drugs. They were both assessed using the Naranjo algorithm to confirm the causality of the disease.