Objective: This study aimed to analyze the important medical adverse events (IMEs) of cyclosporine and tacrolimus using the reports in US FDA adverse event reporting system (FAERS) and to detect related signals. Methods: The FAERS database was used to analyze the IMEs reported for cyclosporine or tacrolimus during 2017-2021. Reporting odds ratio (ROR) and information component were used to analyze signals for adverse events of both drugs. It was investigated whether the detected signals were present on drug labels in Korea and the United States. Results: Among the total 24,688 reports, the reports on tacrolimus accounted 75.8%. Mean age of the patients was 47.9 years old and median number of adverse events was 2.0 per report. The number of patients hospitalized for adverse events was 7,979 (25.3%). Among the adverse reactions reported on the cyclosporine and tacrolimus, 576 and 1,363 events were detected as signals for cyclosporine and tacrolimus, respectively, and of these, IMEs accounted for 44.8 and 59.2%, respectively. The IMEs related with infections/infestations, renal/urinary disorders, and blood and lymphatic system disorders were reported frequently for both drugs. The most frequently detected IMEs were renal impairment for cyclosporine and acute kidney injury for tacrolimus. Among the top 3 IMEs for each reported SOC for cyclosporine and tacrolimus, 9 and 2 unexpected adverse events were identified, respectively. Conclusion This study identified the IMEs and signals of cyclosporine and tacrolimus, and detected unidentified adverse events in a drug information database.

PURPOSE: This research was aimed at evaluating the differences in depression by skinfold thickness, and the relationship between two variables. METHODS: Research design was a non-experimental descriptive survey. Using a caliper, we measured skinfold thickness on the triceps, and then on the suprailiac, and the mid-thigh. Depression was evaluated using the Geriatric Depression Scale-Short Form (GDS-SF). Data were collected for one month from Sept 1st to 30th, 2011. There were 52 subjects, 25 of which were from elderly welfare centers and 27 were hospitalized. RESULTS: Subjects were an average age of 76.4+/-4.45, and the incidence rate of depression (> or =6) was 36.5% and those who had a sum of 3 skinfolds over 62 mm were 22.7%. The GDS-SF was significantly different in only the suprailiac skinfold thickness (F=7.25, p<.05). CONCLUSION: Findings indicate that depression is different based on suprailiac thickness in older adult women at elderly welfare centers and those who were hospitalized in an medical ward. It suggests that the suprailiac skinfold may be an indicator of abdominal obesity when considering depression in elderly women. Further study is needed to evaluate a cutoff score of skinfold thickness in obesity for older adult women.
Adult* ; Aged ; Depression* ; Female ; Humans ; Incidence ; Obesity ; Obesity, Abdominal ; Research Design ; Skinfold Thickness*

Background: This study aimed to investigate the effect of selecting commercially available blending teas and applying them to bovine teeth on color change over time. Methods: After selecting healthy bovine teeth, using a cutting-disc, 105 specimens with a dimension of 5×5×3 mm were prepared, and 15 specimens were distributed to each group. Black tea was used as a positive control, water was used as a negative control, and blended tea of five types was used as an experimental group. First, pH and buffering capacity were measured with a pH meter, and tooth color was determined using a spectrophotometer before immersion in the blending tea solution and 1, 5, 7, 14, and 21 days after immersion. Thereafter, the shape change of the enamel surface was observed using a scanning electron microscope, and SPSS ver.26 was used to analyze the color change. Results: The average pH of the five blending teas in the experimental group was 3.78, and the pH of group 3 (strawberry rhubarb) was the lowest at 3.22. The pH levels of black tea and water were 5.19 and 7.30, respectively. The buffering capacity was the highest in group 3 at both pH levels of 5.5 and 7.0. The L*a*b* color change according to immersion time was the largest in group 4 (rooibos yellow flower), and the amount of color change was large in black tea and group 4. As a result of observing the enamel surface of bovine teeth, changes in the surface shape were noted in all groups immersed in the experimental solution for 21 days, except for water. Conclusion There was a significant difference between the experimental groups in terms of color change according to the immersion time, and color and enamel surface changes were observed in black tea and all experimental groups, except for water.

BACKGROUND AND OBJECTIVES: In patients with fibromyalgia (FM) syndrome, stress and pain may chronically enhance sympathetic activity, altering cardiovascular responses and inducing the arterial wall-stiffening process. We investigated arterial stiffness in FM patients using pulse wave velocity (PWV) and analyzed whether arterial stiffness was affected by the clinical parameters of FM. SUBJECTS AND METHODS: This study included 108 female FM patients (51.5+/-8.9 years) without any known cardiovascular diseases and 76 healthy female controls (50.1+/-8.9 years). FM patients underwent a manual tender point survey for tender point counts, and completed the visual analogue scale (VAS) of pain and fibromyalgia impact questionnaire (FIQ), which were composed of a physical and feel score. Brachial-ankle pulse-wave velocity (baPWV) was measured with an automated device. The study participants were subdivided into 2 groups based on the sum of the FIQ score (group A: FIQ > or =50, group B: <50). RESULTS: Patients with FM had significantly higher baPWV than the controls, and significant increase were noted in baPWV values of group A compared with those of group B. BaPWV showed a significant positive correlation (correlation coefficient=6.83, p=0.022) with severity of disease assessed by FIQ. CONCLUSION: The patients with FM showed significantly increased arterial stiffness, suggesting a pathophysiologic link between FM and endothelial dysfunction. This study provides a basis for clarifying the mechanism by which chronic pain syndrome is associated with an increased risk of vascular stiffness.
Aluminum Hydroxide ; Carbonates ; Cardiovascular Diseases ; Chronic Pain ; Compliance ; Female ; Fibromyalgia ; Humans ; Pulse Wave Analysis ; Vascular Stiffness ; Surveys and Questionnaires

Orientia tsutsugamushi, a causative pathogen of Scrub typhus, is a gram-negative intracellular bacterium. Outer membrane vesicles (OMVs) are produced from the membrane of bacteria and play many roles related to the survival of the pathogen. However, there have been no reports confirming whether O. tsutsugamushi indeed produce OMVs. O. tsutsugamushi boryong was cultured in ECV-304 cells for the purification of OMVs. Western blot analysis and immunoenrichment using anti-O. tsutsugamushi monoclonal antibody and electron microscopy were employed for identification and characterization of OMVs. We confirm the presence of OMVs derived from O. tsutsugamushi, and also found that those OMVs contain a major surface antigen of 56-kDa protein and variant immunogenic antigens.
Antibodies, Monoclonal/*immunology ; Antigens, Bacterial/*immunology ; Antigens, Surface/*immunology ; Cell Line ; Cell Membrane/immunology ; Humans ; Microscopy, Electron ; Orientia tsutsugamushi/*immunology/metabolism ; Scrub Typhus/diagnosis/microbiology ; Secretory Vesicles/*immunology

BACKGROUND AND OBJECTIVES: An association between emotional or physical stressful triggers and adverse cardiovascular events, such as death and myocardial infarction, has been recognized for many years. The clinical features of transient left apical ballooning syndrome have been clearly described, but the effect of chronic stress on the myocardium is unknown. Our objective was to assess left ventricular (LV) function in patients with fibromyalgia (FM) with chronic emotional and physical stress. SUBJECTS AND METHODS: We investigated 30 consecutive postmenopausal women (mean age, 48+/-8 years) satisfying the criteria for FM with atypical chest pain and 20 age-matched healthy controls by means of standard and 2-dimensional strain (2DS) echocardiography. Patients with hypertension, coronary heart disease, or diabetes were excluded. Global and segmental longitudinal deformation parameters of LV function from 3 apical views were analyzed, and patients underwent a manual tender point survey for the number of tender points and tender point counts, and completed the Fibromyalgia Impact Questionnaire (FIQ), which was comprised of physical and feel scores, the Brief Fatigue Inventory (BFI), and the Beck Depression Inventory (BDI). RESULTS: Both global and segmental longitudinal LV strains were significantly reduced in FM patients with high FIQ scores (>50) compared to FM patients with low FIQ scores (-18.98% vs. -22.72%). Various emotional and physical stress indexes were significantly correlated with global LV strain. CONCLUSION: Global and segmental LV strains were negatively associated with fatigue, tender point count, and FIQ score. However, there was no significant association between depression and LV strain. This study demonstrated that chronic emotional or physical stress in FM patients might reduce myocardial longitudinal deformation.
Chest Pain ; Coronary Disease ; Depression ; Echocardiography ; Fatigue ; Female ; Fibromyalgia ; Humans ; Hypertension ; Myocardial Infarction ; Myocardium ; Sprains and Strains ; Stress, Psychological ; Takotsubo Cardiomyopathy ; Surveys and Questionnaires

Wet wipes are being increasingly used because of their convenience. Particularly, oral wet wipes are useful for regular cleaning of a baby's mouth after birth. Therefore, the consumption of oral wet wipes has increased over the past few years and a variety of products are commercially available. However, product information on safety is not sufficiently provided and still raises doubts regarding adverse effects. To confirm the safety of wet wipes as an oral hygiene item and provide information for their use, we investigated the cytotoxicity of oral wet wipes and verified the underlying mechanism. The anti-bacterial effect of oral wet wipes was analyzed using the disk diffusion method. The cytotoxic effects of oral wet wipes were observed based on morphological changes using microscopy and determined using a 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay in gingival epithelial cells and gingival fibroblasts. Evaluation of apoptosis by oral wet wipes was explored using propidium iodide flow cytometric analysis and a terminal deoxynucleotidyl transferase (TdT)-mediated deoxyuridine triphosphate (dUTP) nick-end labeling (TUNEL) assay. Apoptosis-related molecules were also analyzed using western blotting. Five types of oral wet wipes were tested, and two products from Fisher-Price and Dr. Kennedy revealed strong cytotoxic effects on gingiva epithelial cells and gingiva fibroblasts, although they also showed intense anti-bacterial effects on oral bacteria. Cell cycle arrest in the G2/M phase and apoptosis were observed based on treatment of extracts from Fisher-Price and Dr. KENNEDY. Relatively high TUNEL levels, reduction of proliferating cell nuclear antigen and cyclin-dependent kinase 4 expression, and fragmentation of poly (ADP-ribose) polymerase were also elucidated. These results suggest that commercial oral wet wipes could exert cytotoxic influences on oral tissue, although there are anti-bacterial effects, and careful attention is required, especially for infants and toddlers.
Apoptosis ; Bacteria ; Blotting, Western ; Cell Cycle ; Cell Cycle Checkpoints ; Cell Survival ; Cyclin-Dependent Kinase 4 ; Deoxyuridine ; Diffusion ; DNA Nucleotidylexotransferase ; Epithelial Cells ; Fibroblasts ; Gingiva ; Humans ; In Situ Nick-End Labeling ; Infant ; Methods ; Microscopy ; Mouth ; Oral Hygiene ; Parturition ; Proliferating Cell Nuclear Antigen ; Propidium

Coronavirus disease 2019 (COVID-19) is rapidly spreading around the world, causing much morbidity and mortality everywhere. However, effective treatments or vaccines are still not available. Although convalescent plasma (CP) therapy can be useful in the treatment of COVID-19, it has not been widely used in Korea because of the concerns about adverse effects and the difficulty in matching patients to donors. The use of ABO-incompatible plasma is not contraindicated in treatment, but can be hesitated due to the lack of experience of physicians. Here, we describe a 68-year old man with COVID-19 who was treated ABO-incompatible plasma therapy; additionally, we comment on the acute side effects associated with ABO mismatch transfusion. To overcome the obstacles of donor-recipient connections (schedule and distance), we propose the storage of frozen plasma, modification of the current Blood Management Law, and the establishment of a CP bank. We suggest that experience gained in CP therapy will be useful for not only the treatment of COVID-19, but also for coping with new emerging infectious diseases.

BACKGROUND/AIMS: Few studies have investigated the prognosis of non-gastric gastrointestinal stromal tumors (GISTs) under the modified National Institutes of Health (NIH) consensus criteria in Korea. This study aims to clarify the clinical usefulness of the modified NIH criteria for risk stratification. METHODS: From January 2000 through October 2012, 88 patients who underwent curative resection for primary GISTs were included in this study. The enrolled patients were stratified to predict recurrence by the original NIH criteria and modified NIH criteria. RESULTS: In all, 88 patients had non-gastric GISTs, including 82 and 6 patients with GISTs of the small intestine and colorectum, respectively. The mean age was 57.3+/-13.0 years, and the median follow-up duration was 3.40 years (range, 0.02-12.76 years). All patients who were placed in the intermediate-risk category according to the original NIH criteria were reclassified into the high-risk category according to the modified NIH criteria. Therefore, the proportion of cases in the intermediate-risk category declined to 0.0% from 25.0% (22/88), and the proportion of cases in the high-risk category increased to 43.2% (38/88) from 18.2% (16/88) under the modified NIH criteria. Among the 22 reclassified patients, 6 (27.3%) suffered a recurrence during the observational period, and the recurrence rate of high-risk category patients was 36.8% (14/38). CONCLUSIONS: Patients in the high-risk category according to the modified NIH criteria had a high GIST recurrence rate. Therefore, the modified NIH criteria are clinically useful in selecting patients who need imatinib adjuvant chemotherapy after curative surgical resection.
Chemotherapy, Adjuvant ; Consensus ; Follow-Up Studies ; Gastrointestinal Stromal Tumors* ; Humans ; Imatinib Mesylate ; Intestine, Small ; Korea ; National Institutes of Health (U.S.)* ; Prognosis ; Recurrence*

Coronary artery fistula to pulmonary artery is common. However, to the best of our knowledge, a case of coronary artery fistula to pulmonary artery associated with aortopulmonary fistula remains unreported. We herein report a 64-year-old female with a left anterior descending coronary artery and ascending aorta to pulmonary artery fistulas, and conduct a brief review of the literature.
Aorta ; Arterio-Arterial Fistula ; Coronary Vessels ; Echocardiography ; Female ; Fistula ; Humans ; Middle Aged ; Pulmonary Artery