• 한국임상약학회지
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• 제30권2호
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• pp.102-112
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• 2020

Objective: To analyze the prescription patterns for the treatment of ulcerative colitis (UC) and to investigate factors co-occurring with systemic corticosteroid use. Methods: We used patient-level data from Korean National Health Insurance claims database to identify patients diagnosed with UC (ICD-10 code : K51) and their medications prescribed for UC between January 1 and Decemeber 31, 2017. We found that medications for UC treatment were 5-aminosalicylic acid (5-ASA), immunomodulators, biologics, and corticosteroids. We presented the prescription pattern according to the sex, age group, type of health insurance, site of UC, type of medical institution, and concomitant medication. To evaluate factors associated with prescription of systemic corticosteroids for UC, we used a multivariate logistic regression model to estimate adjusted odds ratios (aORs) and their 95% confidence intervals (CIs). Results: Of 1,469 UC patients, 74.5% used 5-ASA and 15.2% used systemic corticosteroids. 5-ASA constituted 77.5% of all prescriptions and systemic corticosteroids accounted for 13.1%. The most widely used therapy was 5-ASA monotherapy (54.8%), followed by a double therapy with 5-ASA and immunomodulators (8.2%) or 5-ASA and systemic corticosteroids (7.2%). Systemic corticosteroids were more likely to be prescribed with immunomodulators (aOR=1.88, 95% CI=1.54-2.28) and biologics (aOR=2.82, 95% CI=2.28-3.50) than without them. Conclusions: We found that 15.2% of UC patients were prescribed with a systemic corticosteroid, which is less than reported previously. Systemic corticosteroids were more likely to be prescribed with immunomodulators and biologics.

• 한국임상약학회지
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• 제29권3호
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• pp.147-155
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• 2019

Objectives: The purpose of this study was to investigate the association between fracture risk and proton pump inhibitor (PPI) use to establish evidence for defining high-risk groups of fracture among PPI users. Methods: A case-control study was performed using the National Health Insurance Sample Cohort Database from January 2002 to December 2013. The cases included all incidences of major fractures identified from January 2011 to December 2013, and up to four controls were matched to each case by age, gender, osteoporosis, and Charlson comorbidity index. Conditional logistic regression was used to calculate the adjusted odds ratio (aOR) and associated 95% confidence interval (CI). Results: Overall, 14,295 cases were identified, and 63,435 controls were matched to the cases. The aOR of fractures related to the use of PPIs was 1.06 (95% CI: 1.01-1.11). There was a statistically significant association between fracture and PPI use within 3 months of the last dose, and a trend of increasing fracture risk with increasing cumulative PPI dose. The risk of fracture was significantly higher in patients who took PPIs for more than 1 year during the 2-year observation period. Conclusion: Patients who have been using PPIs for more than 1 year should be warned about the risk of fracture during or at least 3 months after discontinuing the PPI.

• 한국임상약학회지
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• 제31권4호
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• pp.324-331
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• 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.

• 한국임상약학회지
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• 제32권4호
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• pp.352-361
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• 2022

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.

• 한국임상약학회지
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• 제33권2호
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• pp.86-96
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• 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.

• International Journal of Heart Failure
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• 제6권2호
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• pp.76-81
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• 2024

Background and Objectives: Real-world clinical data, outside of clinical trials and expert centers, on adverse events related to the use of SyncCardia total artificial heart (TAH) remain limited. We aim to analyze adverse events related to the use of SynCardia TAH reported to the Food and Drug Administration (FDA)'s Manufacturers and User Defined Experience (MAUDE) database. Methods: We reviewed the FDA's MAUDE database for any adverse events involving the use of SynCardia TAH from 1/01/2012 to 9/30/2020. All the events were independently reviewed by three physicians. Results: A total of 1,512 adverse events were identified in 453 "injury and death" reports in the MAUDE database. The most common adverse events reported were infection (20.2%) and device malfunction (20.1%). These were followed by bleeding events (16.5%), respiratory failure (10.1%), cerebrovascular accident (CVA)/other neurological dysfunction (8.7%), renal dysfunction (7.5%), hepatic dysfunction (2.2%), thromboembolic events (1.8%), pericardial effusion (1.8%), and hemolysis (1%). Death was reported in 49.4% of all the reported cases (n=224/453). The most common cause of death was multiorgan failure (n=73, 32.6%), followed by CVA/other non-specific neurological dysfunction (n=44, 19.7%), sepsis (n=24, 10.7%), withdrawal of support (n=20, 8.9%), device malfunction (n=11, 4.9%), bleeding (n=7, 3.1%), respiratory failure (n=7, 3.1%), gastrointestinal disorder (n=6, 2.7%), and cardiomyopathy (n=3, 1.3%). Conclusions: Infection was the most common adverse event following the implantation of TAH. Most of the deaths reported were due to multiorgan failure. Early recognition and management of any possible adverse events after the TAH implantation are essential to improve the procedural outcome and patient survival.

• 대한한방내과학회지
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• 제43권6호
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• pp.1045-1062
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• 2022

Objectives: The aim of this study was to analyze the latest clinical studies on Korean medicine treatment of idiopathic thrombocytopenic purpura (ITP) in the Chinese National Knowledge Infrastructure (CNKI) database. Methods: We searched the last 6 years of clinical studies discussing Oriental medicine-based treatments for ITP in the CNKI database. A meta-analysis of 13 RCTs was performed by synthesizing the outcomes, including the measured platelet count and total effective rate. The quality of the studies was assessed using Cochrane's risk of bias (RoB) tool. RevMan 5.4.1 software was used for data analysis. Results: Of the 15 selected studies, 1 was a non-randomized controlled trial (nRCT), 2 were case series, and 12 were randomized controlled trials (RCTs). Treatments in all studies included oral herbal medicine. The most frequently used herbal decoction was the Liangxue Jiedu prescription (凉血解毒方), and the most commonly used herb was Agrimonia pilosa (仙鶴草), Astragali Radix (黃芪), Fossilia Glycyrrhizae Radix et Rhizoma (甘草), and Rehmannia glutinosa Liboschitz ex Steudel (地黃). The meta-analysis showed significantly better improvement in platelet counts and total effective rate for ITP in the treatment group than in the control group. Conclusion: Treatment with herbal medicine was effective in treating ITP. However, the significance of this conclusion is somewhat limited due to the low quality of the available studies. Multifaceted and scientifically designed clinical studies are required to develop treatments for ITP based on Korean medicine. The results of this study could be used as basic data for further ITP studies.

• 전기학회논문지P
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• 제61권1호
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• pp.9-12
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• 2012

This paper analyzes a web-based clinical management system and conducts research on the pulse. Pulse analysis and the clinical study management system proposed by the web-based research holds significance in that it improves the objectivity and accuracy of pulse diagnosis. In particular, exact data must be analyzed through the clinical interpretation of these studies. Eventually oriental pulse standardization work will be continuously sustained. The findings of this study will help achieve remote diagnosis and consultation and updating of database. Research must be expanded to the development of telemedicine technology to create u-Health that will lead this present era.

• 대한임상검사과학회지
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• 제38권3호
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• pp.203-207
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• 2006

The purpose of this study was to develop discriminant analysis models for predicting cervical normal/dysplasia case diagnoses using cytometric features derived from the digital image analysis of cell monolayers. The database consisted of 19 cases diagnosed either as normal (n=5), moderate dysplasia (n=7), severe dysplasia (n=7) on monolayer preparations. We studied the nuclear and cytoplasmic characteristics of cells in the normal, moderate dysplasia and severe dysplasia on cervical samples. The morphometric parameters selected for the analysis were nuclear/cytoplasmic ratio and the nuclear variations measured by image analysis on normal and precancerous lesions of cervical smears; several shape factors; area; perimeter; maximal, minimal and equivalent circle diameters. The results showed that the dysplasia samples exhibited changes in both cellular and nuclear form and size but lacked substantial differences in the tumor grades. The coefficient of nuclear variation is as follows to normal cell $21.8{\pm}3.2%$, moderate dysplasia $33.5{\pm}6.1%$, severe dysplasia $27.7{\pm}5.8$ of cervical smears.

• 한방비만학회지
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• 제6권2호
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• pp.51-58
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• 2006

Objectives : Obesity causes serious medical complications and impairs quality of life in older persons. We review the literature on the clinical issues related to obesity in elderly and suggest appropriate weight-management guidelines for obese older patients. Methods : PubMed Database and RISS were searched for articles relating to obesity in the elderly. We classified articles according to clinical characteristics, assessments, medical complications, and therapy. Results and Conclusions : The current data show that obesity in elderly is associated with increased mortality, metabolic abnormalities, arthritis, pulmonary abnormalities, urinary incontinence, cancer, and impaired quality of life. Therefore, clinical studies are needed to demonstrate the effectiveness andsafety of weight-loss treatments in obese elderly.