• Korean Journal of Clinical Pharmacy
• /
• v.31 no.4
• /
• pp.324-331
• /
• 2021

To investigate signals of adverse drug reactions of finasteride by using the Korea Adverse Events Reporting System (KAERS) database. This pharmacovigilance was based on the database of the drug-related adverse reactions reported spontaneously to the KAERS from 2013 to 2017. This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of finasteride. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The signals of finasteride were compared with those of the other drugs; dutasteride (similar mechanism of action), minoxidil (different mechanism but similar indications for alopecia), silodosin (different mechanism but similar indications for BPH). It was examined whether the detected signals exist in drug labels in Korea. The total number of adverse event-drug pairs was reported 2,665,429 from 2013 to 2017, of which 1,426 were associated with finasteride. The number of investigated signals of finasteride was 42. The signals that did not include in the drug label were 29 signals, including mouth dry, hypotension, dysuria etc. The signal of finasteride was similar to that of dutasteride and silodosin but was different to that of minoxidil. Early detection of signals through pharmacovigilance is important to patient safety. We investigated 29 signals of finasteride that do not exist in drug labels in Korea. Further pharmacoepidemiological studies should be needed to evaluate the signal causality with finasteride.

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

• Korean Journal of Clinical Pharmacy
• /
• v.33 no.2
• /
• pp.122-127
• /
• 2023

Background: This study was aimed to identify the safety signals of metoclopramide in Korea Adverse Event Reporting System (KAERS) database by proportionality analysis methods. Methods: The study was conducted using Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through KAERS. Signals of metoclopramide that satisfied the data-mining indices of proportional reporting ratio (PRR), reporting odds ratio (ROR) and information component (IC) were defined. The detected signals were checked whether they included in drug labels in the Ministry of Food and Drug Safety (MFDS), U.S. Food and Drug Administration (FDA) and Micromedex^®. Results: A total number of drug AE reports associated with all drugs of data in this study was 2,665,429. Among them, the number of AE reports associated with metoclopramide was 22,583. Forty-two meaningful signals of metoclopramide were detected that satisfied with the criteria of data-mining indicies. Especially neurological signals including extrapyramidal reactions, represented in the safety letter of regulatory agencies were identified in this study. Conclusion: Neurological signals of metoclopramide including extrapyramidal reactions were detected. It is believed that this search for signals can contribute to ensuring safety in the use of metoclopramide.

• Korean Journal of Clinical Pharmacy
• /
• v.33 no.2
• /
• pp.86-96
• /
• 2023

Background: Using KIDS-KAERS database (KIDS-KD) from 2016 to 2020, the aim is to investigate signals of adverse events of alpha-adrenoceptor antagonists and to present adverse events that are not included in the precautions for use when marketing approval. Methods: This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of alpha-adrenoceptor antagonists, such as terazosin, doxazosin, alfuzosin, silodosin, and tamsulosin. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). Detected signals were compared with product labeling and the European Medicines Agency-Important Medical Events list. Results: Out of the total number of 408,077 reports for adverse events, 6,750 cases were reported as adverse events of alpha-adrenoceptor antagonists. Dizziness, mouth dryness, hypotension postural, and oedema peripheral are identified as common adverse events of five alpha-adrenoceptor antagonists and are typically listed on drug labels. However, new signals were detected for pneumonia, chronic obstructive airway disease, eye diseases such as glaucoma and cataracts, fracture, and ileus of tamsulosin that were not previously listed on the drug labels in Korea. Conclusions: This study identified signals related to adverse drug reactions of alpha-adrenoceptor antagonists and presented serious adverse events, suggesting new adverse reactions to be aware of when using alpha-adrenoceptor antagonists.

• Korean Journal of Radiology
• /
• v.24 no.7
• /
• pp.626-639
• /
• 2023

Objective: To investigate the association of clinical, pathologic, and magnetic resonance imaging (MRI) variables with progressive disease (PD) during neoadjuvant chemotherapy (NAC) and distant metastasis-free survival (DMFS) in patients with triple-negative breast cancer (TNBC). Materials and Methods: This single-center retrospective study included 252 women with TNBC who underwent NAC between 2010 and 2019. Clinical, pathologic, and treatment data were collected. Two radiologists analyzed the pre-NAC MRI. After random allocation to the development and validation sets in a 2:1 ratio, we developed models to predict PD and DMFS using logistic regression and Cox proportional hazard regression, respectively, and validated them. Results: Among the 252 patients (age, 48.3 ± 10.7 years; 168 in the development set; 84 in the validation set), PD was occurred in 17 patients and 9 patients in the development and validation sets, respectively. In the clinical-pathologic-MRI model, the metaplastic histology (odds ratio [OR], 8.0; P = 0.032), Ki-67 index (OR, 1.02; P = 0.044), and subcutaneous edema (OR, 30.6; P = 0.004) were independently associated with PD in the development set. The clinical-pathologic-MRI model showed a higher area under the receiver-operating characteristic curve (AUC) than the clinical-pathologic model (AUC: 0.69 vs. 0.54; P = 0.017) for predicting PD in the validation set. Distant metastases occurred in 49 patients and 18 patients in the development and validation sets, respectively. Residual disease in both the breast and lymph nodes (hazard ratio [HR], 6.0; P = 0.005) and the presence of lymphovascular invasion (HR, 3.3; P < 0.001) were independently associated with DMFS. The model consisting of these pathologic variables showed a Harrell's C-index of 0.86 in the validation set. Conclusion: The clinical-pathologic-MRI model, which considered subcutaneous edema observed using MRI, performed better than the clinical-pathologic model for predicting PD. However, MRI did not independently contribute to the prediction of DMFS.

• Clinical Endoscopy
• /
• v.56 no.3
• /
• pp.298-307
• /
• 2023

Background/Aims: We compared outcomes between use of 15 vs. 20 mm lumen-apposing metal stents (LAMSs) in endoscopic ultrasound-guided gastroenterostomy (EUS-GE) for gastric outlet obstruction. Methods: Databases were queried for studies that used LAMS for EUS-GE to relieve gastric outlet obstruction, and a proportional meta-analysis was performed. Results: Thirteen studies were included. The 15 mm and 20 mm LAMS had pooled technical success rates of 93.2% (95% confidence interval [CI], 90.5%-95.2%) and 92.1% (95% CI, 68.4%-98.4%), clinical success rates of 88.6% (95% CI, 85.4%-91.1%) and 89.6% (95% CI, 79.0%-95.1%), adverse event rates of 11.4% (95% CI, 8.1%-15.9%) and 14.7% (95% CI, 4.4%-39.1%), and reintervention rates of 10.3% (95% CI, 6.7%-15.4%) and 3.5% (95% CI, 1.6%-7.6%), respectively. Subgroup analysis revealed no significant differences in technical success, clinical success, or adverse event rates. An increased need for reintervention was noted in the 15 mm stent group (pooled odds ratio, 3.59; 95% CI, 1.40-9.18; p=0.008). Conclusions: No differences were observed in the technical, clinical, or adverse event rates between 15 and 20 mm LAMS use in EUS-GE. An increased need for reintervention is possible when using a 15 mm stent compared to when using a 20 mm stent.

• Journal of Hospice and Palliative Care
• /
• v.18 no.2
• /
• pp.120-127
• /
• 2015

Purpose: We aimed to investigate how serum vitamin D levels are related to survival of terminally ill cancer patients. Methods: From May 2012 through June 2013, a retrospective chart review was performed on 96 hospice patients. Univariate and multivariate logistic regression analyses were conducted to identify factors associated with severe vitamin D deficiency and Coxcy and Coxional hazard analyses were used to evaluate effects on survival. Results: The mean vitamin D level in patients was $8.60{\pm}7.16ng/ml$. Vitamin D was severely deficient (<10 ng/ml) in 75 patients (78.2%), deficient (10~20 ng/ml) in 13 patients (13.5%), relatively insufficient (21~29 ng/ml) in five patients (8.3%) and sufficient ((t ng/ml) in three patients (3.1%). Hyperbilirubinemia (${\geq}1.2g/dl$) was the only factor associated with severe vitamin D deficiency according to the multiple logistic regression analysis (Odds ratio, OR=18.48, P<0.05). Although hyperbilirubinemia showed a strong association with survival (Hazard ratio, HR=2.25, P<0.01), no association was found between severe vitamin D deficiency and survival (HR=1.15, P>0.05) in Cox's proportional hazard analysis. Conclusion: Although serum vitamin D levels were severely low in terminally ill cancer patients, we found no association between severe vitamin D deficiency and patient survival.

• Journal of Veterinary Clinics
• /
• v.28 no.4
• /
• pp.339-343
• /
• 2011

This study determined the effects of twin birth on subsequent postpartum disorders, culling and reproductive performance, and its risk factors in dairy cows. Detailed data related to reproduction, health, and calving events, including dates of artificial insemination (AI) and calving, hormonal treatment prior to conception, cow parity, twin birth, retained placenta, metabolic disorders, and endometritis were collected from 1,717 individual calvings on 9 dairy farms. The incidence rate of twin birth was 3.4%. Gestation length was shorter in cows with twin birth ($270.6{\pm}2.0$ days) than cows giving birth to singletons ($279.5{\pm}0.2$ days, P < 0.01). The incidence of retained placenta (47.5 vs. 16.0%), metabolic disorders (18.6 vs. 3.8%) endometritis (62.7 vs. 28.2%), and culling rate (32.2 vs. 16.5%) was greater in cows with twin birth than in cows giving birth to singletons, respectively (P < 0.01). The hazard of pregnancy (adjusted hazard ratio, AHR) by 210 days in milk analyzed using Cox proportional hazards model was affected by calving season, in that the rate of pregnancy for cows calved during spring was less than for cows calved during winter (AHR = 0.80; P = 0.01); this was also true for endometritis (AHR = 0.46, P < 0.01). AHR was not affected by twin birth. Logistic analysis demonstrated that increasing the cow parity (P < 0.01) and hormonal treatment prior to conception (adjusted odds ratio, AOR = 1.84, P < 0.05) increased the risk of twin birth. These results demonstrate that twin births are responsible for severe economic losses through the increased occurrence of postpartum disorders and culling; thus, appropriate management for the deleterious impact of twin birth, and/or reducing the risk factors by herd control regarding cow parity and the use of reproductive hormones prior to conception might be necessary.

• Asian Pacific Journal of Cancer Prevention
• /
• v.15 no.23
• /
• pp.10209-10215
• /
• 2015

To assess the contribution of tumor necrosis factor $(TNF){\beta}$ +252 polymorphisms to risk and prognosis of hepatocellular carcinoma (HCC), we enrolled 150 pairs of sex- and age-matched patients with HCC, patients with cirrhosis alone, and unrelated healthy controls. $TNF{\beta}$ +252 genotypes were determined by polymerase chain reaction with restriction fragment length polymorphism. Multivariate analysis indicated that $TNF{\beta}$ G/G genotype [odds ratio (OR), 3.64; 95%CI, 1.49-8.91], hepatitis B surface antigen (OR, 16.38; 95%CI, 8.30-32.33), and antibodies to hepatitis C virus (HCV) (OR, 39.11; 95%CI, 14.83-103.14) were independent risk factors for HCC. There was an additive interaction between $TNF{\beta}$ G/G genotype and chronic hepatitis B virus (HBV)/HCV infection (synergy index=1.15). Multivariate analysis indicated that factors associated with $TNF{\beta}$ G/G genotype included cirrhosis with Child-Pugh C (OR, 4.06; 95%CI, 1.34-12.29), thrombocytopenia (OR, 6.55; 95%CI, 1.46-29.43), and higher serum ${\alpha}$-fetoprotein concentration (OR, 2.53; 95%CI, 1.14-5.62). Patients with $TNF{\beta}$ G/G genotype had poor cumulative survival (p=0.005). Cox proportional hazard model indicated that $TNF{\beta}$ G/G genotype was a biomarker for poor HCC survival (hazard ratio, 1.70; 95%CI, 1.07-2.69). In conclusion, there are independent and additive effects between $TNF{\beta}$ G/G genotype and chronic HBV/HCV infection on risk for HCC. It is a biomarker for poor HCC survival. Carriage of this genotype correlates with disease severity and advanced hepatic fibrosis, which may contribute to a higher risk and poor survival of HCC. Chronic HBV/HCV infected subjects with this genotype should receive more intensive surveillance for early detection of HCC.

• Tuberculosis and Respiratory Diseases
• /
• v.75 no.1
• /
• pp.18-24
• /
• 2013

Background: We investigated the prevalence of latent tuberculosis infection (LTBI) among the health care workers (HCWs) and analyzed its risk factors in South Korea. Methods: A standard questionnaire regarding the baseline demographics and risk factors for LTBI was given to each participant and tuberculin skin test (TST), QuantiFERON-TB GOLD In-Tube (QFT-GIT) assay, and chest radiography were performed. Results: A total of 493 participants, 152 (30.8%) doctors and 341 (69.2%) nurses were enrolled in eight tertiary referral hospitals. The mean age of the subjects was 30.6 years old, and 383 (77.7%) were female. Of the 152 doctors, 63 (41.4%) and 36 (23.7%) were positive by TST and by QTF-GIT, respectively, and among the 341 nurses, 119 (34.9%) and 49 (14.4%) had positive TST and QFT-GIT results, respectively. Overall, the agreement between the two tests was 0.22 by the chance corrected proportional agreement rate (kappa coefficient) in 493 subjects. Experience of working in tuberculosis (TB)-related departments was significantly associated with positive LTBI test results by QFT-GIT assay, not by TST. In multivariate analysis, only age was independently associated with increased risk of a positive TST result, while age and experience of working in TB-related departments (odds ratio, 2.29; 95% confidence interval, 1.01-5.12) were independently associated with increased risk of a positive QFT-GIT result. Conclusion: A high prevalence of LTBI was found among South Korean HCWs. Considering the association between the experience of working in TB-related departments and high risk of LTBI, QFT-GIT may be a better diagnostic test for LTBI than TST in HCWs.