• Archives of Craniofacial Surgery
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• v.19 no.3
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• pp.168-174
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• 2018

Background: Safety, efficacy, and time to onset of effect of botulinum toxin type A is of importance to persons who seek improvement in glabellar frown lines, but this has not been well studied. The aim of this study was to determine the safety, efficacy, and onset of action of a newly developed botulinum toxin type A (Nabota) for the treatment of glabellar frown lines. Methods: This was a single-arm, open-label, and phase 4 clinical study. Forty-two subjects with glabellar lines were treated with five times of intramuscular injection of 0.1 mL (4 U/0.1 mL) for a total of 20 U of Nabota. Efficacy and safety were assessed at 2, 3, 4, 5, and 14 days. Efficacy was assessed by the investigator and it was defined as a 1-point change on a 4-point scale. Results: Improvement in glabellar frown lines at maximum frown was observed in 85.4% of subjects 2 days after administration. Improvement in glabellar lines at rest was observed in 51.2% of subjects 2 days after administration, and the proportion of subjects showing improvement increased with time. No severe adverse events were recorded. Conclusion: Onset of action was observed in the majority of subjects by 2 days after administration of Nabota. In addition, Nabota was found to be safe and effective for the treatment of glabellar frown lines.

• The Korean journal of internal medicine
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• v.39 no.1
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• pp.123-136
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• 2024

Background/Aims: Despite short-acting β₂-agonist (SABA) overuse being associated with poor asthma outcomes, data on SABA use in South Korea is scarce. Herein, we describe prescription patterns of SABA and other asthma medications in patients from the South Korean cohort of the SABA use IN Asthma (SABINA) III study. Methods: This study included patients with asthma aged ≥ 12 years, who had ≥ 3 consultations with the same healthcare provider, and medical records containing data for ≥ 12 months prior to the study visit. Patients were classified by investigator-defined asthma severity (per 2017 Global Initiative for Asthma recommendations) and practice type (primary or specialist care). Data on disease characteristics, asthma treatments, and clinical outcomes in the 12 months before the study visit were collected using electronic case report forms. Results: Data from 476 patients (mean age, 55.4 years; female, 63.0%) were analyzed. Most patients were treated by specialists (83.7%) and had moderate-to-severe asthma (91.0%). Overall, 7.6% of patients were prescribed ≥ 3 SABA canisters (defined as over-prescription). In patients prescribed SABA in addition to maintenance therapy, 47.4% were over-prescribed SABA. Most patients (95.4%) were prescribed a fixed-dose combination of an inhaled corticosteroid and a long-acting β₂-agonist as maintenance therapy. Although asthma was well-controlled/partly-controlled in 91.6% of patients, 29.6% experienced ≥ 1 severe asthma exacerbation. Conclusions: SABA over-prescription was reported in nearly 50% of patients prescribed SABA in addition to maintenance therapy, underscoring the need to align clinical practices with the latest evidence-based recommendations and educate physicians and patients on appropriate SABA use.

• The Journal of Dong Guk Oriental Medicine
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• v.8 no.2
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• pp.25-46
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• 2000

Pain can be evaluated by experimental methods and clinical methods, but due to subjective characteristics of pain, clinical methods are generally used. The clinical pain measurement tools are divided into unidimensional and multidimensional assessment tools. The former include Visual Analogue Scale, Verbal Rating Scale, Numerical Rating Scale, Pain Faces Scale, and Poker Chip Tool and the latter include McGill Pain Questionnaire, MMPI, Pain Behavior Scale, Pain disability index, and Pain Rating Scale. Unidimensional pain scales mainly measure the intensity of pain on the basis of the patient's self report and their simple construction and ease of use enable the invesgator to assess acute pain. Multidimensional pain scales are used to evaluate subjective, psychological and behavioral aspects of pain and because of its comprehensive and confidential properties they are applied to chronic pain. Patient's linguistic and cognitive abilities are major factors to restrain accurate assessment of pain. Although behavioral patterns and vital sign are inferior to self-report in the measurement of pain, they can be useful indexes in those situations. When deciding on a pain-assessment tool, the investigator must determine which aspect of pain he or she wishes to evaluate on the characteristics of the group of patients, their backgrounds, and their communication skills. Making the proper choice will facilitate the acquisition of meaningful data and the formulation of valid conclusions.

• The Journal of KAIRB
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• v.5 no.2
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• pp.51-58
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• 2023

Purpose: To validate the effectiveness of obtaining consent education on errors in the consent process and to develop the education program for researchers. Methods: From February 2019 to February 2022, a 30-minute, 1:1 face-to-face consent education developed using the ADDIE model was conducted on 78 nurses as principal investigators. An informed consent audit tool, which includes 6 items developed by Asan Medical Center Human Research Protection Center, was used to analyze errors in obtaining informed consent process. Data analysis was performed using the SPSS ver. 25.0, and the Mann-Whitney U-test and χ²-test were utilized to verify the difference in errors between the experimental and control groups. Results: The participants consisted of 42 in the experimental group and 36 in the control group, with no statistically significant difference between the 2 groups. Both 2 groups showed the highest frequency of documentation errors, followed by format errors, errors related to a suitability of investigator, participant, or participant's legally acceptable representative, witness and confidentiality issues. After education, there was a significant decrease in both format errors (p=0.002) and documentation errors (p<0.001) in the experimental group. The proportion of participants without any errors in all items was higher in the experimental group (35.7%) compared to the control group (5.6%), and this difference was statistically significant (p=0.001). Conclusion: The obtaining consent education program was found to be effective in reducing informed consent errors. This study emphasizes the importance of education, suggesting the need for its expansion and accessibility, as well as the necessity for all researchers conducting clinical studies to receive the obtaining consent education.

• Tuberculosis and Respiratory Diseases
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• v.53 no.4
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• pp.389-400
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• 2002

Background : The rapid diagnostic tests for tuberculosis are needed to facilitate early treatment of tuberculosis and prevention of Mycobacterium tuberculosis transmission. The Xeniss Rapid TB kit is a rapid, card-based immunochromatographic test for the detection of antibodies directed against M. tuberculosis antigens including antigen 5(38-kDa antigen). The objective of this study was to evaluate the performance of the Xeniss Rapid TB kit for the diagnosis of active tuberculosis with serums from patients, asymptomatic healthy and close contact controls. Methods : 188 patients with active tuberculosis were tested; 177 with pulmonary tuberculosis(18 with combined pleurisy), and 11 with extrapulmonary tuberculosis. The control groups were composed of 82 close contacts and 57 healthy adults. Study subject were drawn from one national tuberculosis hospital for patients and close contacts, and another private hospital for healthy adults in Masan city, Korea. The Xeniss Rapid TB kit(Xeniss Life Science Co., Ltd., Seoul, Korea) was evaluated by using serum samples according to the instructions of the manufacturer by an investigator masked to the clinical and microbiological status of the study subjects. Results : The diagnostic sensitivity of the Xeniss Rapid TB kit was 73.9% in patients and specificities were 73.2% and 93.0% in close contact and healthy adults respectively. The positive predictive value in patients was 84.2% and the negative predictive value in controls was 85.8%. Conclusion : This study shows that the Xeniss Rapid TB test is a simple and fast method to diagnose active TB. The results of the sensitivity and specificites suggest that serodiagnosis using this point of care testing(POCT) device would be valuable and advantageous for screening tuberculosis in the clinical field.

• Journal of Korean Dental Science
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• v.1 no.1
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• pp.15-21
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• 2008

Purpose : This epidemiological research was conducted to investigate the relationship between the groups of TMD and the behavioral, psychological, and physical symptoms through RDC/TMD. Subjects and Methods : The subjects of this research were the 286 patients who had visited Seoul National University Bundang Hospital; their common chief complaint was temporomandibular discomfort. The mean age of the patients was 32.9 from 11 to 85, and the number of men and women was 67 and 219, respectively. The patients were examined through clinical and radiological methods and diagnosed by 1 investigator. They were divided into 3 groups: myogenous group (group 1), arthrogenous group (group 2), and combined group (group 3). The behavioral, psychological, and physical symptoms were evaluated through questionnaires on RDC/TMD. Specific items were selected to calculate the graded chronic pain (characteristic pain intensity, disability points), jaw disability, depression, and non-specific physical symptoms (pain items included/excluded) in the questionnaire. One-way ANOVA, Kruskal-Wallis test, and chi-square test were applied as statistical methods. Results : As a result of classifying temporomandibular disorder in this study, the patients were distributed as follows: 9.1% of group 1, 79.7% of group 2, and 11.2% of group 3. In the analysis of graded chronic pain (characteristic pain intensity, disability points), jaw disability, and non-specific physical symptoms (pain items included/excluded), group 3 had the highest score, and the difference was significant (p<0.001). Moreover, the depression score of group 3 was significantly higher than groups 1 and 2 (p<0.05). Note that that the second order of jaw disability score was group 2, on the other hand, those of the other groups were group 1. Conclusion : Myofascial pain could be assumed to be related closely to the behavioral, psychological, and physical symptoms except jaw disability compared to joint pain through RDC/TMD.

• Tuberculosis and Respiratory Diseases
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• v.80 no.1
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• pp.52-59
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• 2017

Background: Inhaled indacaterol (Onbrez Breezhaler), a long-acting ${\beta}_2$-agonist, is approved in over 100 countries, including South Korea, as a once-daily bronchodilator for maintenance and treatment of chronic obstructive pulmonary disease (COPD). Here, we present an interim analysis of a post-marketing surveillance study conducted to evaluate the real-world safety and effectiveness of indacaterol in the Korean population. Methods: This was an open-label, observational, prospective study in which COPD patients, who were newly prescribed with indacaterol (150 or $300{\mu}g$), were evaluated for 12 or 24 weeks. Safety was assessed based on the incidence rates of adverse events (AEs) and serious adverse events (SAEs). Effectiveness was evaluated based on physician's assessment by considering changes in symptoms and lung function, if the values of forced expiratory volume in 1 second were available. Results: Safety data were analyzed in 1,016 patients of the 1,043 enrolled COPD patients receiving indacaterol, and 784 patients were included for the effectiveness analysis. AEs were reported in 228 (22.44%) patients, while 98 (9.65%) patients reported SAEs. The COPD condition improved in 348 patients (44.4%), while the condition was maintained in 396 patients (50.5%), and only 40 patients (5.1%) exhibited worsening of ailment as compared with baseline. During the treatment period, 90 patients were hospitalized while nine patients died. All deaths were assessed to be not related to the study drug by the investigator. Conclusion: In real-life clinical practice in South Korea, indacaterol was well tolerated in COPD patients, and can be regarded as an effective option for their maintenance treatment.

• The Journal of Korean Medicine
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• v.31 no.6
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• pp.40-46
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• 2010

Objective: This study investigated the therapeutic possibility of natural therapy in atopy-camp for children with atopic dermatitis. Methods: 30 children (19 boys and 11 girls, median age 11.5 years, ranging from 9 to 15) participated in natural environment-based activities in a camp-village located in Geumsan-gun for five days. Assessment of symptom change was conducted by self-reporting numeric scale (NRS) for pruritus and sleeping difficulty, investigator global assessment (IGA), eczema area and severity index (EASI score), serum histamine and IgE concentration before and after the camp period. Statistical significance was analyzed by paired t-test. Results: NRS for pruritus ($4.7{\pm}2.0$ into $4.3{\pm}2.1$), sleeping difficulty ($3.1{\pm}2.1$ into $2.9{\pm}2.0$), and serum histamine concentration ($4.27{\pm}7.39$ mol / L into $3.21{\pm}6.08$ mol / L) showed positive changes but didn't reach statistical significance (p > 0.05). IGA ($3.8{\pm}0.9$ into $4.13{\pm}1.0$), while EASI score ($10.8{\pm}9.7$ into $9.1{\pm}9.2$) and IgE ($408{\pm}320$ IU / mL into $385{\pm}3.8$ IU / mL) were significantly improved (p < 0.01). Conclusions: In spite of the limitation of the clinical trial protocol, this study may provide the possibility of natural environment-based therapy for children with atopic dermatitis.

• Maxillofacial Plastic and Reconstructive Surgery
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• v.41
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• pp.29.1-29.10
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• 2019

Background: Reduction in postoperative complications is of vital considerations in impacted third molar teeth surgery. The aim of this study was to compare postoperative complications of impacted third molar surgeries for bone removal using laser, piezoelectric equipment, and conventional rotary instruments. Methods: To address the research purpose, the investigator designed the prospective double-blind clinical trial study. The sample size was determined 20 (40 teeth) by sampling formula in any kind of operation. The data of patients were obtained in the different periods in terms of pain, trismus, swelling, ecchymosis, and patient's satisfaction and then analyzed using SPSS 20 software via paired t test and Wilcoxon and McNemar's tests. Results: The pain immediately after surgery and 2 days and 7 days after surgery was higher in the laser group. The swelling immediately after surgery was more in the laser group but not significant. The amount of mouth opening immediately after surgery and 2 days and 7 days after surgery was significantly lower in the laser group than in the piezosurgery group. The total duration of surgery and duration of osteotomy were significantly longer in the laser group. The patient's satisfaction from surgery with piezosurgery was more than that with laser, but this difference was not significant. Conclusion: Due to the rising demand for impacted wisdom tooth surgery, the present study suggests that hard tissue laser surgery and piezosurgery can clear the future of impacted molar surgery, and these approaches are more efficient in reducing postoperative complications compared to the conventional surgeries.

• Journal of Periodontal and Implant Science
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• v.46 no.4
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• pp.266-276
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• 2016

Purpose: The aim of the present study was to retrospectively investigate the influence of potential risk indicators on the development of peri-implant disease. Methods: Overall, 103 patients referred for implant treatment from 2000 to 2012 were randomly enrolled. The study sample consisted of 421 conventional-length (>6 mm) non-turned titanium implants that were evaluated clinically and radiographically according to preestablished clinical and patient-related parameters by a single investigator. A non-parametric Mann-Whitney U test or Kruskal-Wallis rank test and a logistic regression model were used for the statistical analysis of the recorded data at the implant level. Results: The diagnosis of peri-implant mucositis and peri-implantitis was made for 173 (41.1%) and 19 (4.5%) implants, respectively. Age (${\geq}65$ years), patient adherence (professional hygiene recalls <2/year) and the presence of plaque were associated with higher peri-implant probing-depth values and bleeding-on-probing scores. The logistic regression analysis indicated that age (P=0.001), patient adherence (P=0.03), the absence of keratinized tissue (P=0.03), implants placed in pristine bone (P=0.04), and the presence of peri-implant soft-tissue recession (P=0.000) were strongly associated with the event of peri-implantitis. Conclusions: Within the limitations of this study, patients aged ${\geq}65$ years and non-adherent subjects were more prone to develop peri-implant disease. Therefore, early diagnosis and a systematic maintenance-care program are essential for maintaining peri-implant tissue health, especially in older patients.