• Journal of rehabilitation welfare engineering & assistive technology
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• v.11 no.2
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• pp.125-132
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• 2017

Intermittent pneumatic compression is frequently used for prophylaxis of deep vein thrombosis, however there is a lot of complains by frequent adverse event. In this paper, we analyzed the cause of adverse event and we tried to improve for the cause of machine, nurses, patients, system by diverse strategy. And we could improve the index of each cause, the rate of error was decreased finally. The proactive activity of quality improvement for medical device can contribute to decrease the error, that will improve the quality of medical service and achieve the safe medial culture.

• Journal of Korean Academy of Nursing
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• v.52 no.4
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• pp.378-390
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• 2022

Purpose: This study developed an in-service training program for patient safety and aimed to evaluate the impact of the program on nurses in the operating room (OR). Methods: A pretest-posttest self-controlled survey was conducted on OR nurses from May 6 to June 14, 2020. An in-service training program for patient safety was developed on the basis of the knowledge-attitude-practice (KAP) theory through various teaching methods. The levels of safety attitude, cognition, and attitudes toward the adverse event reporting of nurses were compared to evaluate the effect of the program. Nurses who attended the training were surveyed one week before the training (pretest) and two weeks after the training (posttest). Results: A total of 84 nurses participated in the study. After the training, the scores of safety attitude, cognition, and attitudes toward adverse event reporting of nurses showed a significant increase relative to the scores before the training (p < .001). The effects of safety training on the total score and the dimensions of safety attitude, cognition, and attitudes toward nurses' adverse event reporting were above the moderate level. Conclusion: The proposed patient safety training program based on KAP theory improves the safety attitude of OR nurses. Further studies are required to develop an interprofessional patient safety training program. In addition to strength training, hospital managers need to focus on the aspects of workflow, management system, department culture, and other means to promote safety culture.

• The Journal of Internal Korean Medicine
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• v.45 no.1
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• pp.55-74
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• 2024

Objectives: This study reviewed the status of adverse event (AE) reporting in VigiAccess using anti-obesity agents as examples and explored the possibility of its use and future challenges. Methods: AE reports related to some representative drugs among herbal medicines (HMs), complex HM prescriptions, ingredients of supplements, and over-the-counter and prescription medicines were investigated using VigiAccess on February 1, 2024. Results: AE reports on prescription drugs were overwhelmingly higher than those on HMs or supplements. Although most reports were submitted from North America, reports on Ephedra sinica and green tea extract (GTE) were more from Asia and Europe, respectively. The female population reported more, and the difference in the sex ratio was the smallest for Ephedra spp. The age group was concentrated on young adults, but many older patients reported GLP-1 receptor agonist-related AEs. Symptoms related to the gastrointestinal and nervous systems were most commonly reported, but mental and cardiac disorders were common in Ephedra-type HMs. Hepatobiliary disorders are also commonly found in GTE-related reports. Conclusions: VigiAccess was useful for easily checking the global status of AE reporting for prescription drugs. However, several limitations were observed in using VigiAccess for HMs because of the few reports. Thus, it is necessary to increase the number of reports by education and to promote AE reporting among HM prescribers and users. The full range of HMs should be included in the pharmacovigilance system, and the coding and classification of HMs should be revised.

• Journal of Convergence Korean Medicine
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• v.6 no.1
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• pp.5-20
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• 2024

Objectives: This study was aimed to evaluate the hemodynamic feasibility using pulse parameters as a way to establish safe dose guidelines for Chunwangbosim-dan, and to provide a foundation for developing evidence-based guidelines for clinical use. Methods: Forty-one volunteers were recruited to participate in a study examining the changes in pulse wave characteristics following the ingestion of Chunwangbosim-dan, over a period of 2 weeks, and pulse wave measurements were taken before and after the administration. Pulse wave parameters were measured in this study using a 3-dimensional radial pulse tonometry device(DMP-Lifeplus). In addition, questionnaire, blood pressure, temperature, and body composition were also measured as secondary measures. Results: Fifteen minutes after administration of Chunwangbosim-dan, the non-adverse event group(non-AE) exhibited a statistically significant increase in several power and pressure-related parameters, including h1, h3, h4, h5, SA, PA and PW, while the adverse event group(AE) showed a trend of decreasing stroke volume and increasing Systemic Vascular Resistance Index(SVRI) and applied pressure. After 2 weeks of administration, non-adverse event group(non-AE) exhibited significant changes in standard deviation of pulse rate and HRV_LH ratio. Notably, there are significant differences between AE group and non-AE group in h4/h1, w/t, applied pressure, SV and pulse rate. Conclusion: These findings suggest that pulse parameters may be a useful way to establish safe dosing guidelines for Chunwangbosim-dan. Further research is needed to confirm these results and to develop evidence-based guidelines for clinical use.

• Journal of Physiology & Pathology in Korean Medicine
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• v.34 no.5
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• pp.215-221
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• 2020

Adulterated herbal medicine is intentionally added with undeclared improper or inferior ingredients which should not be in herbal medicine. The contamination with potentially hazardous substances such as heavy metal, pesticides, fungus, and microorganism sometimes can be regarded as one of adulteration in a broad sense. The problem of adulteration is that adulterated herbal medicine shows poor quality and/or can cause adverse events. Therefore, it is important to control adulteration issues for quality assurance and qualitative improvement of herbal medicines. This study aims to summarize and make a reference how to control adulterated herbal medicine. In this process, this study is to investigate studies about adulterated herbal medicine via searching Korean and foreign electronic databases such as PubMed, NDSL and OASIS. Finally eighteen papers were included to this study and analyzed according to the type of study, the category and efficacy of adulterants, the type of analysis methodologies and possible adverse events of adulterants. Phosphodiesterase type 5 (PDE-5) inhibitors for male sexual enhancement and anorexic, laxative, diuretic agents for weight loss and treating obesity has been used frequently as adulterants. The range of adverse event caused by adulterated herbal medicine were very wide from mild symptoms such as diarrhea, constipation, dizziness and blurred vision to very severe symptoms such as heart failure, hypoglycemia and renal impairment. This study showed the recent trend on the research of adulterated herbal medicine and this will be the ground to develop more detailed systems to control adulterated herbal medicine.

• 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 The Korean Dental Society of Anesthesiology
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• v.11 no.1
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• pp.22-26
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• 2011

Background: There is controversy regarding the relative perioperative benefits of desflurane when used for induction of anesthesia. Inhalation induction with desflurane alone causes adverse airway events, such as coughing, bronchospasm, laryngospasm, and copious secretion of varying severity. The aim of this study was to determine whether desflurane minimize cardiovascular activation during induction. Methods: Sixty ASA I and II patients were randomized to receive 1 MAC or 1.5 MAC of desflurane during manual vernilation or not. Patients received propofol (2 mg/kg) to induce loss of consciousness (LOC). Rocuronium (0.8 mg/kg) was given at LOC and the trachea was intubated after 90 seconds of manual breathing support with or without inhaled anesthetics. Vital signs and adverse airway events were recorded until 10 minutes post-intubation. Results: A significant increase in blood pressure and heart rate were seen in no desflurane group. The stable vital signs were seen in desflurane groups. The adverse airway events were increased in 1.5 MAC group but 1 MAC group. Conclusions: Desflurane was able to be stable blood pressure and heart rate at 1 MAC but adverse airway events were increased at 1.5 MAC of desflurane.

• Allergy, Asthma & Respiratory Disease
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• v.6 no.6
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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.

• Journal of Physiology & Pathology in Korean Medicine
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• v.24 no.5
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• pp.753-757
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• 2010

The objectives of this paper is to propose the pharmacoepidemiologic methodology to Research for Sasang Constitutional Pharmacology. We mainly searched "Journal of Pharmacoepidemiology and Risk Management". And we also searched "J Korean Oriental Med.", "J of Sasang Constitutional Med.", "J. Oriental Physiology & Pathology", "Korean J Orient Int Med." using these kew words - "adverse event" or "side effect" and "Sasang Contitution" or "Constitution" or "Constitutional medicine". Through the examination of the Pharmacoepidemiologic methodology and current research for sasang constitiutional pharmacology, we could establish the proposal to collect objective constitutional medical reaction. For the actualization of this proposal, the more advanced studies will have to be carried out continuously.

• Nuclear Engineering and Technology
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• v.29 no.3
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• pp.211-217
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• 1997

Adverse effects caused by the surveillance test for the components of nuclear power plant involve plant transients, unnecessary wear, burden on licensee's time, and the radiation exposure to personnel along with the characteristics of each component. The optimization methodology of STI and AOT has been developed and applied to AFWPs of a reference plant. The approach proposed in this paper consist of the resole in minimal mean unavailability of the two-out-of-four system with adverse effects are analytically calculated for the example system. The surveillance testing strategy are given by the sequential test, the staggered test and the train staggered test which is a mined test scheme. In the system level, the sensitivity analyses for the STI and AOT, are performed for the measure of the system unavailability of the top event in the fault tree developed for the example system. This methodology may contribute to establishing the basis for the risk-based regulations.