• 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.29 no.1
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• pp.56-60
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• 2019

Oseltamivir is an antiviral medication prescribed to prevent and treat influenza A and B. A case from a community pharmacy in Korea was reported for an adverse event associated with oseltamivir administration. A 20-month-old boy had psychiatric symptoms after receiving 2 doses of oseltamivir. Therefore, an evaluation of whether the psychiatric symptoms were caused by oseltamivir was required. To determine whether the adverse event resulted from the administrated medication or other factors, three tools were used: the Naranjo scale, the Korean causality assessment algorithm (Ver.2), and the World Health Organization-Uppsala Monitoring Center (WHO-UMC) criteria. The psychiatric symptoms occurred after oseltamivir administration, and were attenuated after oseltamivir termination. A possible cause of the psychiatric symptoms is high fever, but information on the body temperature of the patient was not sufficient. Therefore, it was unclear whether there were other nonpharmacological causes of adverse drug reaction. For these reasons, in terms of causality, the results evaluated by the three tools represented, "possible", "probable", and "probable/likely", respectively.

• Korean Journal of Health Education and Promotion
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• v.11 no.2
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• pp.48-56
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• 1994

In order to study the factors influencing upon right medication of antibiotic for the consumers who can easily buy antibiotic from pharmacy, the study carried out questionnaires to 568 consumers who bought antibiotics from pharmacies located in Seoul And Kyung-gi do from the 1st of February, 1994 to the 28th of the same month. Materials have been analyzed with $X^-test$ of SAS, and its results are as follows. 1. Among 568 objects of this study, the group which can medicare antibiotic properly (the right use group of antibiotic) is 45.5% with 258, while the group which does not recognize correctly the use of antibiotic or does not have any information about it (the abuse group of antibiotic) is 54.6% with 310. 2. Knowledge for advantage of antibiotic the right use group has is high in comparing with that of the abuse group (p<0.001), and also in case of pregnancy, understanding for an adverse reaction of antibiotic is high (p<0.001). The right use group has had many chances to take health education (p<0.001), and the way to buy antibiotic is very safe (p<0.001). But there is no outstanding difference for recognition of an adverse reaction of antibiotic between two groups. 3. In comparing with the abuse group, the right use group keeps well taking time of antibiotics as directions (p<0.001), and keeping rate of antibiotic dosage is high (p<0.001). Also the experiences of an adverse reaction of antibiotic is low (p<0.001). 4. In comparing with the abuse group, the right use group has high educational backgrounds (p<0.001) and many experiences of the education for health promotion (p<0.001), while there is no difference in age, sex, and economic status. 5. In comparing with the abuse group, the right use group has taken antibiotic many times (p<0.001), and there are many antibiotic takers of his/her family (p<0.01). 6. In comparing with the abuse group, the right use group has made much effort not only to check blood pressure and the pulse (p<0.05) but also for food habits (p<0.05). But there is no outstanding difference in the effort to get health information and the effort for regular exercises between these two group. 7. In comparing with the abuse group, the right use group has made an exertion in buying foodstuffs (p<0.001). But there is no big difference in efforts to keep the good attitude for physical health and mental heath, and sleeping hours between these two group.

• Korean Journal of Clinical Pharmacy
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• v.22 no.3
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• pp.251-259
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• 2012

Ulcerative colitis (UC) is characterized by a life-long chronic course with remissions and exacerbations. Use of biological therapies may reduce or delay the surgical procedures in patients with UC. The aim of this study was to determine the impact of infliximab (IFX) use on the rate of remission, surgical interventions, and the effect on quality of life in patients with moderate to severe UC. Literature was searched for studies that investigated the efficacy of IFX on the rate of remission, colectomy and quality of life (QoL) between January 1990 and June 2012 at MEDLINE, January 1988 and June 2012 at EMbase and others. Eleven trials were included in the meta-analysis; divided into placebo controlled 8 trials and intravenous corticosteroid controlled group 3 trials. In comparison to placebo control groups, patients who received IFX had an odds ratio (OR) of 3.712 (95% CI: 2.714, 5.079) for the short-term clinical remission, and 3.053 (95% CI: 2.044, 4.559) for the rate of long-term remission. In colectomy rate and quality of life (QoL), odds ratio were 0.566(95% CI: 0.387, 0.827) and 0.658 (0.505, 0.811) respectively. Any adverse reactions including infections, infusion reaction, rash and arthralgia were equivalent in both groups. Compared with intravenous corticosteroid controlled group, patients who received IFX had lower remission rate with short-term odds ratio 0.227 (95% CI: 0.033, 1.556) and long-term odds ratio 1.054 (95% CI: 0.317, 3.502) respectively. However, statistical significance was not showed with both two analyses. The higher adverse drug reaction (ADR) rates were occurred in the corticosteroid controlled groups. 73.3% of patients treated corticosteroid reported Cushing-like syndrome with moon face. In conclusion, IFX does increase remission rate and decrease the rate of colectomy in patients with UC without elevating any adverse reactions significantly. IFX also improves QoL in moderate to severe UC patients. It would not exceed the efficacy of intravenous corticosteroid, whereas intravenous corticosteroid also reported high rate of adverse reactions.

• Journal of Acupuncture Research
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• v.36 no.4
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• pp.245-250
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• 2019

Background: This study was designed to evaluate the clinical safety of Bee Venom (BV) pharmacopuncture at craniofacial acupuncture points. Methods: This was a retrospective study of 108 patients diagnosed with peripheral facial paralysis, trigeminal neuralgia, or facial spasm who were admitted to Kyung Hee University Korean Medicine Hospital at Gangdong, from April 1st, 2017 to August 30th, 2017. Patients were allocated into either, Group 1 (the non-allergy group of patients who did not have an allergic reaction to BV) or Group 2, the group who had allergic reactions to BV. To evaluate the clinical safety of BV pharmacopuncture after each treatment, several criteria were used to measure any side effects: outcome, Common Terminology Criteria for Adverse Events scale, Mueller HL scale, treatment decision after adverse reaction, causality, measures performed for patients with adverse reactions, and efficacy assessment. Results: BV pharmacopuncture delivered in 0.1-0.2 mL at a concentration of 1:30,000 at the craniofacial acupuncture points, showed no statistically significant differences in baseline characteristics between non-allergy Group 1 and allergy Group 2. Amongst the 108 patients, 11 reported side effects after BV pharmacopuncture treatment. These adverse events included rash (n = 7), pruritus (n = 5), swelling (n = 1), vesicles (n = 1), erythema (n = 1), and hives (n = 1). All side effects resolved without sequelae. Conclusion: In this study, BV pharmacopuncture delivered at low doses at the craniofacial acupuncture points, resulted in 10% of patients experiencing non serious side effects suggesting that BV pharmacopuncture was clinically well tolerated.

• Korean Journal of Clinical Pharmacy
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• v.22 no.3
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• pp.268-273
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• 2012

The definition of anaphylaxis is 'a serious, life-threatening generalized or systemic hypersensitivity reaction' and is considered as the life threatening adverse drug reaction. We experienced a case of cefotetan induced anaphylaxis with negative pre-skin test, used for surgical prophylaxis. A 82-year-old female was scheduled for total knee replacement therapy. She had no previous history of allergy and her skin test results were also negative. On her right knee surgery, she underwent cefotetan therapy as a surgical prophylaxis for a week with no problems identified. Next left knee surgery, she also received the prophylaxis of intravenous cefotetan. However, a few minutes later, anaphylactic reaction developed with vomiting, severe hypotension, bronchospasm, and dyspnea. After immediate intensive care treatment, she recovered without significant complications. Though commonly used laboratory data in case reports, such as the specific IgE, tryptase, histamine, or allergic skin prick test were limited, we successfully confirmed anaphylaxis based on clinical criteria for diagnosing anaphylaxis based on WAO 2011 guideline with through concurrent patient°Øs medical history review and the process of identifying the causes.

• Proceedings of the Korean Society of Propulsion Engineers Conference
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• 2017.05a
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• pp.1036-1037
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• 2017

This study investigated the aging reactions of three kinds of igniters(BKNO3, THPP, ZPP). The life-time of igniter depends on oxygen and moisture in the air. For example, Magnesium contained in the $BKNO_3$ reacts with oxygen and water to form oxide and hydrate. This reaction has an adverse effect on ignition reaction and could be information to analyze aging. Thermodynamic calculation could interpret the aging reaction by calculating flame temperature applying several variables(initial temperature, composition, etc.). If combustion is not completed because of aging igniters, flame temperature will be formed at a low range. The result of this research is expected to support the analysis of igniters aging reactions.

• Proceedings of the Korean Society of Veterinary Clinics Conference
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• 2009.04a
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• pp.242-242
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• 2009

• Proceedings of the Korea Contents Association Conference
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• 2016.05a
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• pp.433-434
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• 2016

Cerebellar atrophy was found that a patient was taking oral phenytoin for 3 years. 53 years old female patient with General tonic clonic(GTC) type seizure was prescribed phenytoin. In the process, she developed ataxic gate, dysarthria. Brain magnetic resonance imaging(MRI) finding was revealed differential diagnosis cerebellar atrophy. She was prescribed epileptol instead of phenytoin. But leukopenia, thrombocytopenia occurred. As a result, phenytoin restarted. Development of medical state decreased abuse of anticonvulsants. Considering various convulsive disorders, we must give attention to using anticonvulsants.