• Korean Journal of Clinical Pharmacy
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• v.32 no.1
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• pp.1-7
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• 2022

Objective: The purpose of this study was to detect signals of Adverse Events (AEs) after varenicline treatment using spontaneous AEs reporting system in Korea. Methods: This study was conducted by Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through Korea Adverse Event Reporting System. Signals of varenicline that satisfied the data-mining indices, proportional reporting ratio, reporting odds ratio and information component were defined. The detected signals were checked whether they included in drug labels in South Korea and United States of America (USA). Results: A total number of drug AE reports associated with all drugs in the KIDS-KD reported between January 2013 and December 2017 was 2,665,429. Among them, the number of AE reports associated with varenicline was 1,398. Eighteen meaningful signals of varenicline were detected that satisfied with the criteria of data-mining indices. Finally, two signals such as hypotonia, incorrected dose administered were not included in the drug labels. Conclusion: New AE signals of varenicline that were not listed on the drug labels in South Korea and USA were detected. However, further pharmacoepidemiological studies such as randomized controlled trial are needed to evaluate the causality of the signals of varenicline.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.27 no.5
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• pp.298-312
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• 2024

Purpose: Cytomegalovirus (CMV) infection affects the hepatic, neurologic, hematopoietic, respiratory, gastrointestinal, and other organs, resulting in a high mortality rate and longterm sequelae. It may cause acute or chronic hepatitis, or even lead to hepatic cirrhosis. Valganciclovir (VGCV) is an effective, safe, and well-tolerated treatment for congenital CMV infection, without any serious adverse effects. This study was conducted to evaluate the clinical, biochemical, and virological profiles of infants with CMV with intrahepatic cholestasis and to determine the outcomes with or without treatment with VGCV. Methods: Twenty infants aged <6 months diagnosed with congenital CMV infection with evidence of intrahepatic cholestasis were included in this study. Randomization was used to divide the study participants into 2 groups. The control group (n=10) was treated with only supportive management, and the intervention group (n=10) was treated with oral VGCV at 16 mg/kg/dose 12 hours a day for 6 weeks plus supportive treatments. Physical examinations and biochemical, serological, and virological tests were performed at the time of diagnosis and at the end of 6 weeks and 6 months. Results: The control and intervention groups were compared in terms of clinical and laboratory parameters such as jaundice, dark urine, pale stool, hepatomegaly, total bilirubin, aminotransferases, gamma-glutamyl transferase, alkaline phosphatase, and CMV polymerase chain reaction load, which showed a significant reduction after treatment in the intervention group (p<0.05) with oral VGCV, with very few side effects, whereas the control group showed no significant changes. Conclusion: Oral VGCV can be used to effectively treat CMV infection with intrahepatic cholestasis without notable side effects.

• Journal of Korean Academy of Nursing
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• v.54 no.3
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• pp.386-402
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• 2024

Purpose: The purpose of this study was to conduct a pre-conception care program for women of childbearing age with inflammatory bowel disease (IBD) in Korea and verify its effects on self-efficacy for IBD management, IBD-related pregnancy knowledge, and IBD-related pregnancy anxiety. It also aimed to explore the changes in participants through the program. Methods: A convergent mixed-methods study design was adopted. In the quantitative phase, 35 women (17 and 18 in the intervention and control group, respectively) participated. The intervention group attended a program that included small-group sessions and individual tele-coaching. To confirm the effects, data were collected before and one and four weeks after the intervention. In the qualitative stage, focus group interviews and tele-coaching were conducted with the intervention group. Results: After the program ended, significant differences were observed over time between the intervention and control groups for self-efficacy for IBD management (Wald χ² = 4.41, p = .036), IBD-related pregnancy knowledge (Wald χ² = 13.80, p < .001) and IBD-related pregnancy anxiety (Wald χ² = 8.61, p = .003). Qualitative data analysis revealed the following themes: (1) improving confidence in IBD management and awareness for planned pregnancy; (2) improving IBD awareness related to pregnancy and childbirth; and (3) relieving anxiety about and actively facing pregnancy. Conclusion: This study is meaningful in that, to the best of our knowledge, it is the first to develop a pre-conception care program for women diagnosed with IBD and confirm its effectiveness. Furthermore, this program is expected to be suitable for patient counseling and education in clinical practice.

• The Journal of the Society of Stroke on Korean Medicine
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• v.23 no.1
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• pp.25-40
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• 2022

■Objectives This study aimed to collect and analyze clinical studies on the significance of acupuncture in the treatment of hypertension among Korean patients. ■Methods Among Korean patients with a blood pressure (BP) of 120 mmHg or higher and a diastolic BP of 80 mmHg or higher, those, treated with acupuncture only, were included. A literature search was conducted through 'Embase', 'Medline', 'Science and Technology Information Integration Service (NDSL)', 'Traditional Korean Knowledge Portal (OASIS)', 'PubMed', and 'Scopus'. The search keywords were (hypertension OR 'blood pressure') AND acupuncture. The papers, published before the day of the search (02. January 2022), were included in this study. ■Results Among the 12 selected papers, seven involved randomized controlled trial (RCT), four before-and-after studies, and one case series. The number of RCTs has increased yearly. The treatment methods used in the studies included needle acupuncture in eight studies, auricular acupuncture in two, pharmacopuncture in one, and si-acupuncture in one. The average numbers of patients enrolled in RCTs, before-and-after studies, and case series were 21.1, 30, and 23 respectively. Six studies were conducted on prehypertensive patients, two on stage 1 hypertension patients, and four on stage 2 hypertension patients. The involved acupoints have been reported to be ST36 in eight papers, LI11 in four papers, and PC6 in three papers. The treatment period lasted for < 1 week in eight studies and 8 weeks in four studies. Acupuncture successfully lowered blood pressure in nine out of 12 studies ■Conclusions Acupuncture is a viable alternative treatment option for prehypertensive patients, who are not taking medications. Additionally, it is also useful in further lowering the BP of patients with stage 1 and stage 2 hypertension in the short term. Large-scale and long-term studies on acupuncture for hypertension should be conducted.

• The Journal of Korean Medicine
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• v.43 no.2
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• pp.61-74
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• 2022

Objectives: This study aimed to explore the short-term effects of bilateral masticatory training using an intraoral device on memory and concentration, which is an advanced form of Gochi, compared to the unilateral form with gum. Methods: Thirty young healthy participants (age, 16-30 years) were screened and randomly assigned to one of two sequences in a crossover design. The participants assigned to sequence A (n=15) performed bilateral mastication using an intraoral device with a total of 300 taps, followed by unilateral mastication using gum with the same number of repetitions and frequency, separated by a 7-day washout period. A reverse order was used for sequence B. The primary and secondary outcomes were the digit span test result and the symbol digit modality test and the word list recall results, respectively, which were conducted before and after each intervention. Results: Symbol digit modality test scores increased by 12.03±8.33 with bilateral mastication, which was significantly higher than that obtained with chewing gum (5.17 points;95% confidence interval: 0.99, 9.34; p<0.05). Changes in the digit span test and word list recall scores were not significantly different between the two groups. In the digit span test forward, symbol digit modality test, and word list recall test, bilateral mastication was not inferior to unilateral mastication in improving memory and concentration. Conclusions: Bilateral masticatory exercises using an intraoral device are not inferior to unilateral mastication with gum for improving memory in healthy young individuals. Further research is needed to determine the efficacy of bilateral masticatory training on cognitive function.

• The Korea Journal of Herbology
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• v.24 no.4
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• pp.205-213
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• 2009

Objectives : Cancer incidence is increasing in all countries and chemotherapy-induced peripheral neuropathy (CIPN) in patients undergoing chemotherapeutic agents have been a clinically serious problems. So far therapeutic options for CIPN patients are limited and no confirmed methods have yet been established for dealing with peripheral neuropathy. Therefore this review is to provide an evidence-based summary of oriental medicine and CAM (complementary and alternative medicine) neuroprotective and treatment therapies which have gone through clinical trials. Methods : An overview of the domestic and international papers of adult clinical trials relating management of only CIPN symptoms through 1990 to present were searched by electronic databases. Search key words were chemotherapy-induced neurotoxicity, chemotherapy-induced peripheral neuropathy, chemotherapy toxicity & herb, chemotherapy toxicity & acupuncture, chemotherapy toxicity & CAM. Only English and Korean written papers were reviewed. Total 25 papers were reviewed in this study, 18 papers were retrieved by electronic search. Results : Clinical studies of managing CIPN were rare, two acupuncture clinical studies and four herb medicinal studies were found. Rest of 19 papers were about other CAM clinical studies. Total 25 papers were analyzed, and all interventions were focused on their pain control efficacy. Other 24 trials of potential therapies except one proved to be effective for CIPN, however some described to be inadequate positive or sufficient negative. Conclusions : As most of the studies were pilot studies, interventions for the prevention and treatment of CIPN have to go through prospective confirmatory studies, such as larger scale randomized, double-blinded, placebo controlled clinical trials must be done for the safe and effective use of proposed therapies. Also standard measurement scales have to be developed for the better clinical study of CIPN.

• Korean Journal of Acupuncture
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• v.33 no.2
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• pp.67-74
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• 2016

Objectives : The Knee degenerative osteoarthritis patients are not satisfied with the conventional therapies of KDOA, which results in the use of alternative therapies. The miniscalpel acupuncture is effective in treating chronic soft tissue, releasing contractures. However, there is little scientific evidence supporting the use of miniscalpel acupuncture in knee degenerative osteoarthritis. This study was designed to obtain basic data for a further large-scale trial as well as provide information about the feasibility of miniscalpel acupuncture in knee degenerative osteoarthritis patients. Methods : We describe the protocol for a randomized controlled pilot clinical trial of 5 weeks duration. Twenty patients will be recruited and randomly allocated to two treatment groups: miniscalpel acupuncture treatment(experimental group); and acupuncture and electro-acupuncture treatment(control group). Miniscalpel acupuncture will be performed once with a 1-week interval for 3 weeks. Electro-acupuncture will be administered twice per week for a period of 3 weeks. The primary outcomes will be measured by visual analogue scale and range of motion. The secondary outcomes will be short-form McGill Pain Questionnaire and Western Ontario and McMaster Universities Osteoarthritis Index. Both primary and secondary outcomes will be measured at baseline and at 1, 2, 3 and 5 weeks(i.e. 2 weeks after treatment completion). Conclusions : This pilot study will provide a basic foundation for a future large-scale trial as well as information about the feasibility of miniscalpel acupuncture in knee degenerative osteoarthritis.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.21 no.7
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• pp.54-65
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• 2020

This randomized pre-post-controlled experimental study determined the effect on patients' anxiety, stress, systolic blood pressure, heart rate and Bis index when the Healing Beats program is applied after epidural blockage. The subjects were selected from the patients who visited the Department of Anesthesiology and Pain for the treatment of epidural blockage and volunteered through the recruitment announcement. A total of 74 sets of data were collected and analyzed with 25 subjects in the experimental group, 24 in the placebo group, and 25 in the control group. The data was analyzed using descriptive statistics, x2-tests, F-tests and repeated measures of ANOVA. As a result of the study, the general characteristics and variables of the experimental group, placebo group, and control group were all the same, and anxiety was measured twice before and after the study. There were significant differences between groups (F=27.175, p<.001), and stress (F=4.78, p<.001), heart rate (F=4.22, p<.001) and the Bis index (F=7.96, p<.001) were analyzed by variance according to population and time. There was a significant difference. However, there was no significant difference in systolic blood pressure (F=1.23, p=.298). In conclusion, the Healing Beats program can be used as an effective and effective intervention for sedation in clinical situations or stressful situations.

• Nutrition Research and Practice
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• v.14 no.4
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• pp.322-333
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• 2020

BACKGROUND/OBJECTIVES: Arterial stiffness and endothelial dysfunction are 2 of the independent predictors for cardiovascular disease, while Acanthopanax senticosus Harms (ASH) is a traditional medicinal plant that can improve cardiovascular health. This study aimed to investigate the efficacy of the fruit of ASH on vascular function in apparently healthy subjects. SUBJECTS/METHODS: A 12-week, randomized, double-blind, placebo-controlled design, consisting of healthy adults with at least 2 of the following 3 conditions: borderline high blood pressure (BP; 120 mmHg ≤ systolic BP ≤ 160 mmHg or 80 mmHg ≤ diastolic BP ≤ 100 mmHg), smoking (≥10 cigarettes/day), and borderline blood lipid levels (220 ≤ total cholesterol ≤ 240, 130 ≤ low density lipoprotein cholesterol ≤ 165, or 150 ≤ triglyceride ≤ 220 mg/dL). Randomly assigned 76 subjects who received a placebo or 2 doses of ASH fruit (low, 500 mg/day; high, 1,000 mg/day) completed the intervention. Brachial-ankle pulse wave velocity (baPWV), flow-mediated dilation, carotid intima-media thickness, and BP were measured both at baseline and following the 12-week intervention. Endothelial nitric oxide synthase (eNOS) phosphorylation was assessed by western blotting. RESULTS: Compared with the placebo group, the low-dose group showed more significant changes after the 12-week intervention period in terms of systolic BP (0.1 vs. -7.7 mmHg; P = 0.044), baPWV (31.3 vs. -98.7 cm/s; P = 0.007), and the ratio of phospho-eNOS/eNOS (0.8 vs. 1.22; P = 0.037). CONCLUSIONS: These results suggest that ASH fruit extract at 500 mg/day has the potential to improve BP and arterial stiffness via endothelial eNOS activation in healthy adults with smoking and the tendency of having elevated BP or blood lipid parameters.

• The Korean Journal of Pain
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• v.27 no.3
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• pp.278-284
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• 2014

Background: Establishment of laparoscopic cholecystectomy as an outpatient procedure has accentuated the clinical importance of reducing early postoperative pain, as well as postoperative nausea and vomiting (PONV). We therefore planned to evaluate the role of a multimodal approach in attenuating these problems. Methods: One hundred and twenty adult patients of ASA physical status I and II and undergoing elective laparoscopic cholecystectomy were included in this prospective, randomized, placebo-controlled study. Patients were divided into four groups of 30 each to receive methylprednisolone 125 mg intravenously or etoricoxib 120 mg orally or a combination of methylprednisolone 125 mg intravenously and etoricoxib 120 mg orally or a placebo 1 hr prior to surgery. Patients were observed for postoperative pain, fentanyl consumption, PONV, fatigue and sedation, and respiratory depression. Results were analyzed by the ANOVA, a Chi square test, the Mann Whitney U test and by Fisher's exact test. P values of less than 0.05 were considered to be significant. Results: Postoperative pain and fentanyl consumption were significantly reduced by methylprednisolone, etoricoxib and their combination when compared with placebo (P<0.05). The methylprednisolone + etoricoxib combination caused a significant reduction in postoperative pain and fentanyl consumption as compared to methylprednisolone or etoricoxib alone (P<0.05); however, there was no significant difference between the methylprednisolone and etoricoxib groups (P>0.05). The methylprednisolone and methylprednisolone + etoricoxib combination significantly reduced the incidence and severity of PONV and fatigue as well as the total number of patients requiring an antiemetic treatment compared to the placebo and etoricoxib (P<0.05). Conclusions: A preoperative single-dose administration of a combination of methylprednisolone and etoricoxib reduces postoperative pain along with fentanyl consumption, PONV, antiemetic requirements and fatigue more effectively than methylprednisolone or etoricoxib alone or a placebo.