• Tuberculosis and Respiratory Diseases
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• v.86 no.1
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• pp.33-46
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• 2023

Background: Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year period. Methods: This was an open-label, multicentre, observational, post-marketing surveillance study. A total of 3,375 patients were enrolled consecutively in 52 hospitals, by 53 physicians, between July 2014 and July 2020. Patients who were administered UMEC/VI (fixed-dose 62.5 ㎍/25 ㎍) at least once and were monitored for safety and effectiveness were included in the analysis. Incidence and severity of adverse events (AEs) reported after administrating at least one dose of UMEC/VI were monitored, including unexpected adverse events (UAEs) and adverse drug reactions (ADRs). Effectiveness of UMEC/VI after 24 weeks of administration was also assessed using physician's evaluation (effective, ineffective/no change, worsening, indeterminable) and lung function improvement. Results: Of 3,375 patients, 3,086 were included in the safety assessment group (mean age±standard deviation: 69.76±8.80 years; 85.9% male [n=2,652]; 73.1% aged ≥65 years [n=2,255]). The overall incidence of AEs was 28.8% (n=890), of which 2.2% (n=67) were ADRs. Serious AEs and UAEs were reported in 181 (5.9%) and 665 (21.6%) patients, respectively, and two patients (<0.1%) reported unexpected severe ADR. Of the 903/3,086 patients analysed for effectiveness, most (82.8%, n=748) showed overall disease improvement after UMEC/VI treatment. Conclusion: This study confirmed UMEC/VI administered to Korean patients according to the prescribing information was well-tolerated and can be considered an effective option for COPD treatment.

• The Korean Journal of Pain
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• v.37 no.1
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• pp.73-83
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• 2024

Background: Failed back surgery syndrome (FBSS) is a chronic condition that is characterized by persistent back pain following one or more spinal surgeries. Pharmacological interventions, such as the use of opioids and gabapentinoids, are frequently used in the treatment of FBSS. However, prolonged and excessive use of these medications can lead to dependence and adverse effects. This study investigates trends in opioid and gabapentinoid prescriptions among patients with FBSS in Korea from 2016 to 2020. Methods: Data from the Health Insurance and Review Agency were analyzed, and claims listing FBSS were selected for the study. Prescription patterns of opioids and gabapentinoids were classified based on the number of days prescribed per year. Results: Of the 390,095 patients diagnosed with FBSS, 41.6% of the patients were prescribed gabapentinoids, and 42.0% of them were prescribed opioids, while 10.6% of the patients were classified as long-term gabapentinoid users, 11.4% as long-term opioid users, and 7.4% of the patients were found to have long-term prescriptions for both drugs. The proportion of patients who received both gabapentinoid and opioid prescriptions increased annually. The doses of opioids prescribed have also increased along with the increase in the number of patients receiving opioid prescriptions. Conclusions: The prescription rates of opioids and gabapentinoids among patients with FBSS in Korea continue to increase steadily, posing potential risks of addiction and adverse effects. Further research is needed to better understand the actual status of addiction in patients with FBSS.

• Archives of Plastic Surgery
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• v.39 no.4
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• pp.317-321
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• 2012

Background Many topical hemostatics are widely applied for bleeding control. They can be classified into two categories according to their mechanism of action on the clotting cascade in a biologically active or passive manner. Passive hemostatics include cellulose and gelatin. We performed an experimental study to compare the effect of passive hemostatics in wound healing by applying them to a rectus abdominis muscle defect of white mice. Methods Surgicel is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Spongostan is an absorbable hemostatic gelatin sponge. In 30 mice, a $1{\times}1$ cm defect was created on the rectus abdominis muscle and the materials were applied in three ways: control group, cellulose (Surgicel) group, gelatin (Spongostan) group. For the histologic analysis, biopsies were performed at 3 and 28 days. Results After 3 days, the cellulose group showed limited granulation formation with acute inflammatory reactions similar to the control group. At the 28th day, moderate amounts of granulation tissue formation was observed with milder inflammatory reactions than the control group. In the gelatin group, after 3 days, gelatin remnants were observed surrounded by severe inflammatory changes. After 28 days, the same quantity of gelatin remnants could be still observed. Conclusions This study suggests that cellulose is associated with minimal morbidity in wound healing, while the use of gelatin shows severe adverse tissue reactions with delayed wound healing. Consequently, cellulose is better than gelatin when considering wound healing.

• Pediatric Infection and Vaccine
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• v.8 no.2
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• pp.150-159
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• 2001

Purpose : We need to reconsider booster vaccination schedule of Japanese encephalitis vaccination. To do that we evaluate the long-term immunogenicity and the incidence of adverse events with inactivated mouse brain derived Nakayama Japanese encephalitis vaccine. Methods : We tested neutalizing antibody for 311 elementary school students by plaque reduction neutralizing test(PRNT) at USAMC-AFRIMS(United States Armed Forces Research Institute of Medical Science/Department of Virology). We evaluated vaccine related adverse events by spontaneous reporting prospectively among 15,487 vaccinees who were vaccinated at public health center and 2,277 elementary school students who were immunized previously by a questionnaire and school health record. Results : According to the time interval from the last booster injection of 311 children, PRNT antibody titers gradually decreased as the interval increased; 239 mIU/mL, 188 mIU/mL, 134 mIU/mL, 49 mIU/mL each at 6, 18, 30, 42 months after the last booster injection. The seropositivity rates were 98%, 99%, 95.6%, 71.4% each at 6, 18, 30, 42 months after the last booster injection. There were 21(0.13%) cases with systemic reactions among 15,487 vaccinees who had visited the hospital by prospective passive reporting system at public health center. According to the questionnaires and school health records in elementary school students, local induration and pain were 17.4% and 14.8%, respectively. Systemic reactions including fever, vomiting, rash were reported in few cases. Conclusion : Biannual booster vaccination that has been recommended so far should not be necessary. Surveillance for adverse events with inactivated mouse brain derived Nakayama vaccine should be strengthened to better assess the number of cases and reactions associated with immunization.

• Korean Journal of Clinical Pharmacy
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• v.30 no.1
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• pp.19-30
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• 2020

Objective: To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. Methods: We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability. Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. Results: Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. Conclusion: BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.

• Journal of Ginseng Research
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• v.42 no.4
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• pp.571-576
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• 2018

Background: Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safety of KRG intake for 24 weeks. Methods: We randomized 1,000 participants in a 1:1 ratio into two groups, which were treated daily with 2 g of KRG or a placebo for 24 weeks. The primary endpoint was all adverse events and adverse drug reactions (ADRs) that occurred after KRG or placebo administration, which were reported at week 4, 12, and 24 after the baseline visit. Results: In total, 192 and 211 participants experienced adverse events in the KRG and placebo groups (39.2% and 42.0%, respectively; p = 0.361), and 59 and 57 KRG- and placebo-treated individuals reported ADRs (12.0% and 11.4%, respectively; p = 0.737). The frequently occurring ADRs were pruritus (2.0%), headache (1.6%), diarrhea (1.4%), and dizziness (1.2%) in the KRG group and pruritus (2.0%), headache (1.8%), dizziness (1.6%), rash (1.4%), and diarrhea (1.2%) in the placebo group. Discontinuation of drug administration due to ADRs was reported in 13 participants, six (1.2%) and seven (1.4%) in the KRG and placebo groups, respectively (p = 0.814). No significant abnormal changes were revealed by anthropometric, laboratory, and vital sign measurements in the KRG group compared with those in the placebo group. Conclusion: The present study confirms the safety and tolerability of daily intake of 2 g of KRG for 24 weeks by healthy adults.

• International Journal of Air-Conditioning and Refrigeration
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• v.16 no.3
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• pp.89-99
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• 2008

Indoor ozone has received attention because of its well-documented adverse effects on health. In addition to the inherently harmful effects of ozone, it can also initiate a series of reactions that generate potentially irritating oxidation products, including free radicals, aldehydes, organic acids and secondary organic aerosols (SOA). Especially, ozone reacts actively with terpene. The overarching goal of this work was to better understand ozone and terpene distributions within rooms. Towards this end, the paper has two parts. The first describes the development of a cylindrical test chamber that can be used to obtain the second order rate constant $(k_b)$ for the bi-molecular chemical reaction of ozone and terpene in the air phase. The second consists of model room experiments coupled with Computational Fluid Dynamics (CFD) analysis of the experimental scenarios to obtain ozone and terpene distributions in various turbulent flow fields. The results of CFD predictions were in reasonable agreement with the experimental measurements.

• Proceedings of the Korean Society of Applied Pharmacology
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• 2006.11a
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• pp.51-66
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• 2006

The field of cytochrome P450 pharmacogenomics has progressed rapidly during the past 25 years. Recently, conjugating enzymes including sulfotransferase, acetyltransferase, glucuronosyltransferase and glutathione transferase have been also extensively studied. All the major human drug-metabolizing P450 enzymes and some conjugating enzymes have been identified and cloned, and the major gene variants that cause inter-individual variability in drug response and are related to adverse drug reactions have been identified. This information now provides the basis for the use of predictive pharmacogenomics to yield drug therapies that are more efficient and safer. Today, we understand which drugs warrant dosing based on pharmacogenomics to improve drug treatment. It is anticipated that genotyping could be used to personalize drug treatment for vast numbers of subjects, decreasing the cost of drug treatment and increasing the efficacy of drugs and health in general. It is assumed that such personalized P450 gene-based treatment which is so-called tailor(order)-made drug therapy would be relevant for 10-20% of all drug therapy in the future.

• Journal of Environmental Health Sciences
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• v.36 no.2
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• pp.77-81
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• 2010

Tobacco smoking and secondhand smoke exposure are linked to a number of adverse health outcomes. There is a new concept of thirdhand smoke that is residual tobacco smoke contamination remained after the cigarette is extinguished. This paper reviews published studies examining the residual tobacco smoke. Tobacco smoke can be attached to various surfaces and reemitted to air for long period of time. The dynamic process can allow thirdhand smoke exposure to tobacco smoke without direct exposure to secondhand smoke. One critical evidence of the thirdhand smoke exposure was significantly high urinary cotinine level of infant who did not have direct secondhand smoke exposure. Potential exposure to new and more potent chemicals generated from chemical reactions between residual tobacco smoke and ambient air pollutants can get more attention. Considering toxicity and exposure route, children are uniquely susceptible to thirdhand smoke exposure. The review provides strong background information for thirdhand smoke but warrant more researches on this issue.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.22
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• pp.9875-9877
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• 2014

Objective: To access the safety of chemotherapy for elderly cancer patients complicated with hypertension. Methods: Elderly cancer patients who were complicated with hypertension and treated by chemotherapy were recruited. All patients were treated by chemotherapy after an intervention on hypertension by psychotherapy, exercise guidance, salt regulation and nutrition support, therapy on hypertension, as well as prevention on hypertension associated complications. Results: In 68 eligible patients, two suspended chemotherapy because of adverse reactions and 4 because of disease progression. The remaining 62 patients completed chemotherapy smoothly based on good hypertension control. Conclusion: With effective control of blood pressure, chemotherapy for elderly cancer patients complicated with hypertension is generally safe.