• The Journal of Korean Medicine
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• v.36 no.1
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• pp.45-60
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• 2015

Objectives: The purpose of this study was to understand the status of reporting and characteristics of adverse drug reactions (ADRs) induced by herbal drugs and to make a suggestion for the domestic pharmacovigilance system on herbal medicine. Methods: We carried out a hospital-based observational study at Dongguk University Ilsan Oriental Hospital from April 2012 to December 2014. We reviewed all the herbal-drug-associated ADRs reports registered to the spontaneous ADR reporting system in electronic medical records of the hospital in the period. Results: We found out 101 reports including 163 herbal-drug-associated ADRs from 97 patients. Females (69.3%) outnumbered males and the most frequent age group was the 50s (44, 27.0%). No serious adverse event was observed. The most commonly reported ADR was gastro-intestinal system disorders (68, 41.5%) followed by skin-related disorders (42, 25.8%). Diarrhea (29, 17.8%) was the most frequently referred clinical manifestation. Most ADRs were induced by internal medicines (160, 98.2%) including manufactured (36, 22.1%) and self-prepared decoction (160, 76.1%). The pairs of Igi-hwan-diarrhea, gamiboa-tang-vomiting, and Magnoliae Flos-gastro-intestinal-system-related ADRs were observed twice each and the others appeared only once. Conclusions: We propose Korean government to take an initiative in national pharmacovigilance system for herbal medicine. To perform the surveillance on herbal drugs, the Association of Korean Medicine (AKOM) should set up a nationwide network by designating centers connecting the Korean medical hospitals, local Korean medicine clinics, and the public health centers. The government and AKOM should also educate and encourage them to understand the pharmacovigilance system and report the ADRs actively.

• Korean Journal of Clinical Pharmacy
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• v.10 no.1
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• pp.30-37
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• 2000

Adverse drug reactions (ADR) may result in increased hospital admissions, morbidity and mortality, adding extra cost to healthcare expenditures. Thus, it is critical to activate ADR monitoring and reporting program in tertiary hospitals in developing countries such as Korea. This study was performed to identify the types of ADR being reported in a tertiary hospital, Samsung Medical Center, and to find out the ways to improve current ADR monitoring system. Of 464 ADR reports submitted to the pharmacy department during the 6-month survey period, $97.8\%$ of the reports were from out patient and $48.5\%$ were from patients aged between 50 and 60. The medical department with the highest frequency in ADR reporting was Internal Medicines $(35.6\%)$. The most common ADR manifestations were gastrointestinal complaints $(43.4\%)\;and\;75\%$ of the reported cases were mild in their severity. The most common drugs suspected of causing ADR were CNS drugs which accounted for $32.8\%$. In terms of causality assessment, $85.1\%$ of the reports were probable cases by WHO causality assessment criteria. In regards to sources of report, $75.6\%$ of ADR were reported by physicians and $24.4\%$ by nurses. There were no ADR reported by pharmacists. In conclusion, there is an urgent need to improve ADR monitoring system for inpatient and to motivate pharmacist involvement in ADR monitoring and reporting in Korea.

• Korean Journal of Clinical Pharmacy
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• v.23 no.3
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• pp.223-231
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• 2013

Objective: This study aimed to identify the status and risk factors of rituximab infusion-related adverse events (ADE) in rituximab-na$\ddot{i}$ve patients with cancer diseases. Method: A retrospective analysis using electronic medical records review was conducted. Inclusions were patients with a diagnosis of cancer disease with the initiation of rituximab-included treatment who were na$\ddot{i}$ve to rituximab during January 2011 to March 2013 at National Cancer Center (NCC) in Korea. Result: Total 110 patients, 582 cases of rituximab administrations, were reported in the study. About 57.2% of patients were 51-70 years old and evenly distributed between two genders and 72.7% were BMI less than $25kg/m^2$. All of study patients were diagnosed with non-Hodgkin lymphoma. Fifty patients (45.4%) and 54 cases (9.3%) were experienced rituximab infusion-related AEs even with conservative administration protocol at NCC. The most frequently occurring AEs were shivering followed by rash and itching. In single variant analysis, we found that the early stage of NHL, low exposure to rituximab administrations, high white blood cell counts, high lymphocyte counts, high absolute neutrophil count and low lactate dehydrogenase were associated with infusion-related AEs (p<0.05). The early stage of disease, high lymphocyte counts, low exposure to rituximab administrations were also related significantly with AEs in multiple variants analysis (p<0.05). Conclusion: Rituximab infusion-related AEs for patients who were na$\ddot{i}$ve to rituximab were still a concern with conservative administration protocol. The adverse drug reactions were significantly associated with early stage of NHL, higher lymphocyte counts and low exposure to rituximab administrations. The factors need to be considered with close monitoring to prevent rituximab infusion-related AE.

• ETRI Journal
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• v.46 no.2
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• pp.290-306
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• 2024

To treat the novel COronaVIrus Disease (COVID), comparatively fewer medicines have been approved. Due to the global pandemic status of COVID, several medicines are being developed to treat patients. The modern COVID medicines development process has various challenges, including predicting and detecting hazardous COVID medicine responses. Moreover, correctly predicting harmful COVID medicine reactions is essential for health safety. Significant developments in computational models in medicine development can make it possible to identify adverse COVID medicine reactions. Since the beginning of the COVID pandemic, there has been significant demand for developing COVID medicines. Therefore, this paper presents the transferlearning methodology and a multilabel convolutional neural network for COVID (MLCNN-COV) medicines development model to identify negative responses of COVID medicines. For analysis, a framework is proposed with five multilabel transfer-learning models, namely, MobileNetv2, ResNet50, VGG19, DenseNet201, and Inceptionv3, and an MLCNN-COV model is designed with an image augmentation (IA) technique and validated through experiments on the image of three-dimensional chemical conformer of 17 number of COVID medicines. The RGB color channel is utilized to represent the feature of the image, and image features are extracted by employing the Convolution2D and MaxPooling2D layer. The findings of the current MLCNN-COV are promising, and it can identify individual adverse reactions of medicines, with the accuracy ranging from 88.24% to 100%, which outperformed the transfer-learning model's performance. It shows that three-dimensional conformers adequately identify negative COVID medicine responses.

• The Journal of Pediatrics of Korean Medicine
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• v.28 no.3
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• pp.1-16
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• 2014

Objectives The purpose of this study is to investigate the incidence and clinical features of adverse events associated with herbal medicine, and to analyze their causality and severity. Methods This study was carried out from 159 children and adolescents who took herbal medicine in the Department of Pediatrics, ${\bigcirc}{\bigcirc}$ Korean Medical Hospital from december, 2013 to april, 2014. The data was collected by survey in person or telephone. The World Health Organization (WHO)-Uppsala Monitoring Center (UMC) criteria was used to analyze causality for each adverse events. Results 1. 207 cases were surveyed from 159 children and adolescents who took one or more kinds of herbal medicine. 2. A total of 12 general adverse events (5.8%) were reported from the study. Among these adverse events, 8 cases (3.9%) were associated with herbal medicine. 3. Gastro-intestinal system disorders were most frequently reported (70%) as adverse events, which is followed by psychiatric disorders (15%), skin and appendages disorders (10%), urinary system disorders (5%). 4. The most common clinical symptom was abdominal pain (20%), followed by diarrhea (15%), loose stools (10%), vomiting (10%) and borborygmus (10%). 5. The severity of adverse drug reactions was mostly mild (87.5%), and moderate (12.5%). There was no severe case. Conclusions The adverse events from herbal medicine on children and adolescents were mostly minor, most of them could continue herbal medicines.

• Journal of Dental Anesthesia and Pain Medicine
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• v.20 no.3
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• pp.107-118
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• 2020

Chloral hydrate is the oldest and most common sedative drug used in moderate sedation for pediatric dental patients. Hence, the purpose of this article is to review the safety and possible adverse events of this drug when used for pediatric dental treatment. A bibliographic search in PubMed, MEDLINE, Cochrane Library and KMbase, KISS, DBpia, KoreaMed, and RISS databases was performed. Using the keywords "dental sedation," "chloral hydrate," and "children or adolescent," 512 scientific articles were found. Subsequently, 183 studies were individually assessed for their suitability for inclusion in this literature review. Altogether, 24 studies were selected. They included 12 cases of death before, during, or after chloral hydrate sedation for dental treatment, majorly due to dosing error and use of multiple sedatives. Additionally, intraoperative adverse events were mostly respiratory problems such as hypoxia and apnea, but most events were temporary. After treatment, prolonged sedation, including excessive sleep and less activity were the most common postoperative adverse events, and even death cases were reported. Despite the wide acceptance of chloral hydrate as a sedative-hypnotic agent, the risk of adverse events and adequate dose should be of great concern when using it for pediatric dental sedation.

• Korean Journal of Clinical Pharmacy
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• v.31 no.3
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• pp.188-197
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• 2021

Objective: PD-1 inhibitors have demonstrated improved health outcomes in cancer patients. PD-1 inhibitors are well-tolerated and associated with immune-related adverse events. The objectives of this study are to analyze use patterns of PD-1 inhibitors in patients with cancer and to investigate the incidence of thyroid-related adverse reactions in patients treated with PD-1 inhibitors. Methods: The study included patients who had been administered PD-1 inhibitors (either nivolumab or pembrolizumab) at the Samsung Medical Center between October 1, 2016 and June 30, 2017. Data was collected from electronic medical records and tested using Mann-Whitney tests and Chi-Square tests for statistical significance. Associations between PD-1 inhibitors and incidence of adverse events were tested using Cox regression for age, gender, BMI, ECOG PS and medication. Results: Two hundred fifteen patients were identified as eligible for analyses. Thyroid-related adverse events occurred in 20% of patients (n=43). Thyroid function tests (TFTs) was performed in 109 patients (50.7%). Positive results of PD-L1 testing were found in 53.2% of the 94 patients who had the test. Approved doses of nivolumab (3 m/kg) and pembrolizumab (200 mg) were administered in 70.4% and 53% of patients, respectively. The analysis of risk factor of thyroid-related adverse reaction did not show statistically significant differences (Cox regression). Conclusion: Thyroid-related adverse events are common in patients treated with PD-1 inhibitors and hypothyroidism is the most frequent adverse reaction. Routine TFTs monitoring is strongly recommended to evaluate thyroid function in real-world clinical practice.

• The Journal of Churna Manual Medicine for Spine and Nerves
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• v.10 no.2
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• pp.51-60
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• 2015

Objectives: The purpose of this study is to investigate the safety, injury mechanism, complication and adverse reactions associated with Chuna manual theraphy(CMT), to report one case of adverse reaction with Thai Massage(TM). Methods: A 76-year-old woman presented with chest pain and dorsalgia. The patient undertook a TM. The patient's chest pain didn't improve by Korean medecine. In MRI study, sternal fracture was diagnosed. Results and Conclusions : It is supposed that this patient suffered chest pain and dorsalgia due to a TM. From this case, we can understand the etiology of sternal fracture to some extent and consider the complication of Chuna manual theraphy through TM. In addition, This study raises the awareness of the possibility of a sternal fracture caused by a low-energy CMT technique.

• The Journal of Churna Manual Medicine for Spine and Nerves
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• v.9 no.2
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• pp.115-124
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• 2014

Objectives: The purpose of this study is to investigate the safety, injury mechanism, complication and adverse reactions associated with Chuna manual theraphy(CMT), to report one case of adverse reaction with CMT. Methods: A 39-year-old woman presented with low back pain and left leg pain. The patient undertook a lumbar Chuna manual theraphy. After this maneuver, the patient complained of dorsalgia. The patient's dorsalgia didn't improve. In CT study, T5-6 hard disc bulging was diagnosed. Results and Conclusions : It is supposed that this patient suffered dorsalgia secondarily due to a lumbar Chuna manual theraphy. From this case, we can understand the etiology of dorsalgia to some extent and consider the complication of Chuna manual theraphy. In the future, more study, research and prospective trial for complications of a lumbar Chuna manual theraphy is required.

• Toxicological Research
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• v.17
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• pp.211-216
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• 2001

Drugs can have various adverse effects on the immune system including unintended immun-osuppression, induction of both drug-specific immune responses (including drug allergies) and non-specific immunostimulation (including autoimmune reactions), and direct activation of effector mechanisms (such as histamine release). As a practical matter, the Center for Drug Evaluation (CDER) relies on standard non-clinical toxicology studies to detect unintended immunosuppression. Specific assays using guinea pigs and mice are available to identify drugs that can induce immune-mediated dermal hypersensitivity reactions. Respiratory and systemic hypersensitivity and autoimmune reactions are more difficult to model in non-clinical studies. Unintended nonspecific immunstimulation can be detected in animal studies. CDER is currently developing specific guidance for evaluating potential drug immunotoxicity.