• 대한한방소아과학회지
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• 제28권1호
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• pp.52-60
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• 2014

Objectives The purpose of this study is to report the clinical effects of oriental medical treatment on Extensive limb swelling which is rare adverse reaction of vaccination. Methods A 11 months old infant who appealed unilateral thigh swelling after immunization and signs of local inflammation was administered a complex herbal medicine consisting of five decoctions; Gwakhyangjunggisan, Binsosan, Danggwisusan, Samchulgunbitang and Gwibitang. The length of the constant regions of the thigh circumference was measured every visit. Each process was recorded by photograph. After one year from the first visit, phone call was conducted to follow-up. Results The length of the thigh after administration of herbal medicine did not change much, but the part where swelled hard became little bit softer. A year later, patient's growth and walking was normal but the swollen part not changed. Since then the similar adverse effects did not recur on booster doses vaccines. Conclusions The adverse reactions of vaccination are rarely reported and there is no specific treatment for swelling from Hepatitis B vaccine. It will be more helpful to study if more cases reported about any adverse drug reactions or any side effects from the immunization.

• 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.

• 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.

• The Korean Journal of Pain
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• 제32권2호
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• pp.97-104
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• 2019

Background: This study was conducted to compare the effectiveness of low-dose ketamine versus ketorolac in pain control in patients with acute renal colic presenting to the emergency department (ED). Methods: This is a double-blind randomized clinical trial. The initial pain severity was assessed using the numerical rating scale (NRS). Then, ketamine or ketorolac was administered intravenously at a dose of 0.6 mg/kg and 30 mg respectively. The pain severity and adverse drug reactions were recorded 5, 15, 30, 60, and 120 min thereafter. Results: The data of 62 subjects in the ketamine group and 64 patients in the ketorolac group were analyzed. The mean age of the patients was $34.2{\pm}9.9$ and $37.9{\pm}10.6\;years$ in the ketamine and ketorolac group, respectively. There was no significant difference in the mean NRS scores at each time point, except for the 5 min, between the two groups. Despite a marked decrease in pain severity in the ketamine group from drug administration at the 5 min, a slight increase in pain was observed from the 5 min to the 15 min. The rate of adverse drug reactions, including dizziness (P = 0.001), agitation (P = 0.002), increased systolic blood pressure (> 140 mmHg), and diastolic blood pressure (> 90 mmHg) was higher in the ketamine group. Conclusions: Low dose ketamine is as effective as ketorolac in pain management in patients with renal colic presenting to the ED. However, it is associated with a higher rate of adverse drug reactions.

• 한국임상약학회지
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• 제33권2호
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• pp.86-96
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• 2023

Background: Using KIDS-KAERS database (KIDS-KD) from 2016 to 2020, the aim is to investigate signals of adverse events of alpha-adrenoceptor antagonists and to present adverse events that are not included in the precautions for use when marketing approval. Methods: This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of alpha-adrenoceptor antagonists, such as terazosin, doxazosin, alfuzosin, silodosin, and tamsulosin. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). Detected signals were compared with product labeling and the European Medicines Agency-Important Medical Events list. Results: Out of the total number of 408,077 reports for adverse events, 6,750 cases were reported as adverse events of alpha-adrenoceptor antagonists. Dizziness, mouth dryness, hypotension postural, and oedema peripheral are identified as common adverse events of five alpha-adrenoceptor antagonists and are typically listed on drug labels. However, new signals were detected for pneumonia, chronic obstructive airway disease, eye diseases such as glaucoma and cataracts, fracture, and ileus of tamsulosin that were not previously listed on the drug labels in Korea. Conclusions: This study identified signals related to adverse drug reactions of alpha-adrenoceptor antagonists and presented serious adverse events, suggesting new adverse reactions to be aware of when using alpha-adrenoceptor antagonists.

• 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.

• 대한의생명과학회지
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• 제23권2호
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• pp.111-117
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• 2017

Leukocytes in blood components are involved in diverse adverse transfusion reactions such as febrile non-hemolytic transfusion reactions. Therefore, leukocyte reduction is required to reduce these adverse reactions. The objective of this study was to compare the efficiency of pre-storage filtration and post-storage filtration. Filtration time, residual leukocyte count, RBC recovery, and hemolysis were assessed after pre-storage or post-storage filtration. Compared to pre-storage filtration, filtration time was prolonged and hemolysis was dramatically increased when post-storage filtration was performed. Residual leukocytes count and RBC recovery after post-storage filtration were similar with those obtained after pre-storage filtration. These results suggest that pre-storage filtration has better efficiency than post-storage filtration. These are thought to contribute to the production of better quality of leukoreduction blood components.

• 사상체질의학회지
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• 제20권3호
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• pp.107-117
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• 2008

1. Objective The aim of this study was to survey the adverse reactions by the prescriptions of Soeumin.Soyangin and to compare the tendency of their symptoms according to Sasang constitutional type. 2. Methods The clinical data for this study were based on the medical records of total 91 cases collected from an oriental clinic during 1996-2004. Their constitutional types were diagnosed by a specialist and then confirmed by drug reactions. To evaluate reliability of the analysis, we only analysed the cases above grade C. The target prescriptions were Palmulgunja-tang, Bojungikgi-tang, Hyangsayangwi-tang, Ijung-tang, Hyeongbangsabaek-san, Jeoryeongchajeonja-tang, Yanggyeoksanhwa-tang, Yangdokbaekho-tang and the sorts of Jihwang-tang. 3. Results and Conclusion The prescriptions which were not suitable for their Sasang constitutional type induced indigestion, stomachache and evacuation troubles basically. Besides, the prescriptions of Soeumin caused some fever of the upper body and skin on Taeeumin and Soyangin. And the prescriptions of Soyangin lead to more severe digestive and evacuation troubles on Taeeumin and Soeumin. 4. Conclusion: This study need to be compensated by additional clinical studies which are more systematic and continuous. This way we can make the firm evidence for approving the difference of drug susceptibility according to the Sasang constitutional type.

• Toxicological Research
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• 제35권4호
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• pp.319-330
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• 2019

Adverse drug reactions (ADRs) constitute key factors in determining successful medication therapy in clinical situations. Integrative analysis of electronic medical record (EMR) data and use of proper analytical tools are requisite to conduct retrospective surveillance of clinical decisions on medications. Thus, we suggest that electronic medical recording and human genetic databases are considered together in future directions of pharmacovigilance. We analyzed EMR-based ADR studies indexed on PubMed during the period from 2005 to 2017 and retrospectively acquired 1161 (29.6%) articles describing drug-induced adverse reactions (e.g., liver, kidney, nervous system, immune system, and inflammatory responses). Of them, only 102 (8.79%) articles contained useful information to detect or predict ADRs in the context of clinical medication alerts. Since insufficiency of EMR datasets and their improper analyses may provide false warnings on clinical decision, efforts should be made to overcome possible problems on data-mining, analysis, statistics, and standardization. Thus, we address the characteristics and limitations on retrospective EMR database studies in hospital settings. Since gene expression and genetic variations among individuals impact ADRs, pharmacokinetics, and pharmacodynamics, appropriate paths for pharmacovigilance may be optimized using suitable databases available in public domain (e.g., genome-wide association studies (GWAS), non-coding RNAs, microRNAs, proteomics, and genetic variations), novel targets, and biomarkers. These efforts with new validated biomarker analyses would be of help to repurpose clinical and translational research infrastructure and ultimately future personalized therapy considering ADRs.

• 대한상한금궤의학회지
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• 제9권1호
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• pp.47-58
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• 2017

Objective : The purpose of this paper is to report the adverse drug reactions of patient with cervical spondylotic myelopathy(CSM) treated by herb medicine, Soshiho-tang. Methods : The patient was prescribed Soshiho-tang herbal medicine for 9days. The patient complained of dizziness, difficulty of concentration and elevation of blood pressure on the 6th day. The doctor made the patient stop to take the herbal medicine and every symptoms and abnormal blood pressure are normalized after 6 days. The abnormal responses were assessed by WHO-UMC Causality Categories and LDS scale. Results : The WHO-UMC Causality is 'probable/likely' and LDS scale is 5, it means 'moderate' severity. Conclusions : The herbal medicine, Soshiho-tang is relevant to abnormal responses of the patient with CSM. This is a first case report of hypertension induced by herbal medicine, Soshiho-tang in Korea.