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1.
Korean Journal of Clinical Pharmacy ; : 86-96, 2023.
Article in English | WPRIM | ID: wpr-1002112

ABSTRACT

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 alphaadrenoceptor 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.

2.
Korean Journal of Rehabilitation Nursing ; : 61-69, 2022.
Article in English | WPRIM | ID: wpr-969200

ABSTRACT

Purpose@#The purpose of this study was to evaluate health-related quality of life (HRQoL) and associated factors among Korean elderly with diabetes mellitus using nationally representative data. @*Methods@#This study was a retrospective cross-sectional study using secondary data analysis. Data for 432 elderly 65 years and older with diabetes from the Korea National Health and Nutrition Examination Survey 2019 were included. HRQoL was measured using the HINT-8 (Health-related quality of life instrument with 8 items) questionnaire for Korean.Independent variables were demographics and health-related characteristics. Factors associated with HRQoL were analyzed using hierarchical linear regression analysis. @*Results@#HRQoL was significantly different according to sex, age, educational level, living alone, house income, economic activity, stress perception, depression mode, subjective health status, activity limitation, days of walking, aerobic exercise, and drinking. Lower house income, higher stress perception, and poor subjective health status were significantly related to lower HRQoL in Korean elderly with diabetes. @*Conclusion@#House income, stress perception level, and subjective health status should be considered in older adults with diabetes to improve their HRQoL.

3.
The Korean Journal of Internal Medicine ; : 631-638, 2022.
Article in English | WPRIM | ID: wpr-927029

ABSTRACT

Background/Aims@#Hip fracture and acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) could increase mortality in patients with COPD. There are no data on the relationship between AE-COPD and hip fracture, which may significantly affect the prognosis of patients with COPD. Therefore, we conducted this study to determine the effects of AE-COPD on hip fractures in patients with COPD. @*Methods@#This retrospective, nested, case-control study included 253,471 patients with COPD (≥ 40 years of age) identified from the Korea National Health Insurance Service-National Health Screening Cohort (NHIS-HEALS) from 2002 to 2015. Among 176,598 patients with COPD, 1,415 patients with hip fractures were identified. Each case was matched to one control for age (within 10 years), sex, and year of COPD diagnosis. We estimated the adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for hip fractures associated with AE-COPD using conditional logistic regression analysis, adjusting for underlying diseases and smoking history. @*Results@#In patients with AE-COPD, the risk of hip fracture was 2.50 times higher, regardless of systemic corticosteroid use and underlying disease (aOR, 2.50; 95% CI, 1.67 to 3.75). The risk of hip fracture increased if there was one episode of AE in the year before hip fractures (aOR, 2.25; 95% CI, 1.66 to 3.05). Moreover, the risk of hip fracture also increased in patients with more than two episodes of AE the year before hip fractures (aOR, 2.57; 95% CI, 1.61 to 4.10). @*Conclusions@#AE-COPD increases the risk of hip fracture regardless of underlying diseases, including osteoporosis, and treatment with systemic corticosteroids.

4.
Journal of Korean Medical Science ; : e148-2022.
Article in English | WPRIM | ID: wpr-925963

ABSTRACT

Background@#To investigate the use of cyclooxygenase-2 (COX-2) inhibitors as an initial drug treatment for knee osteoarthritis (OA) patients. @*Methods@#From 2013 to 2015, patients with knee OA were identified from the Korean nationwide claims database. Among them, we extracted incident cases of knee OA to identify the initial drug treatment. Trends in the use of non-steroid anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors were analyzed during the first year after their diagnosis. Associated factors for COX-2 inhibitor use were examined using a multivariate logistic regression model. @*Results@#We identified 2,857,999 incident knee OA patients (955,259 in 2013, 981,314 in 2014, and 921,426 in 2015). The mean ± standard deviation age of patients was 64.2 ± 9.8 years. The frequency of COX-2 inhibitor use as initial treatment increased from 3.5% in 2013 to 7.2% in 2015 (P < 0.01). In patients taking the medication regularly for one year after diagnosis (medication possession ratio ≥ 50%), COX-2 inhibitor use also rapidly increased from 5.5% in 2013 to 11.1% in 2015 (P < 0.01). However, the frequencies of non-selective NSAID and analgesic use did not decrease remarkably. Factors associated with patients using COX-2 inhibitors on initial drug treatment were older age (odds ratio [OR], 1.08), female (OR, 1.24), and comorbidity (OR, 1.03). Type of institution, physician speciality, and insurance type of patients were also associated. @*Conclusion@#In Korea, COX-2 inhibitors have rapidly increased as an initial treatment for knee OA patients, but it has not appeared to reduce the use of non-selective NSAIDs and analgesics.

5.
Korean Journal of Clinical Pharmacy ; : 171-179, 2021.
Article in English | WPRIM | ID: wpr-894156

ABSTRACT

Background@#Need for regulatory science is emerging with the development of pharmaceutical industry. It is essential to train regulatory science experts to meet the needs of technology and regulations to evaluate advanced products. Major regulatory science countries are conducting the regulatory science activities and fostering the experts. @*Methods@#Published literature and the relevant website of European Union (EU) were reviewed and criteria were developed. In particular, we focused on in depth descriptions of the Innovative Medicines Initiative program, which was conducted twice. @*Results@#EU is striving to provide funding and training experts for the development of the regulatory science by horizon 2020 and regulatory science to 2025. Innovative medicines initiative (IMI) is a public-private partnership aimed at the development of the pharmaceutical industry, including the regulatory science. IMI education and training projects have provided various education and training course including short-term curriculum and master and doctoral course. The difference between South Korea’s regulatory science expert training project in 2021 and the EU’s IMI education and training projects is participation of pharmaceutical companies. While the pharmaceutical companies participate in the IMI project to select project topics and form a community, South Korea’s project is focused on the Ministry of Food and Drug Safety and universities. @*Conclusion@#Through successful active networks with regulatory party, pharmaceutical companies, and universities, a great innovative advance of regulatory science in South Korea is expected.

6.
Journal of Korean Medical Science ; : e143-2021.
Article in English | WPRIM | ID: wpr-892313

ABSTRACT

Background@#We aimed to examine the uptake of infliximab and etanercept biosimilars in patients with rheumatoid arthritis (RA) and its economic implication for healthcare expenditure. @*Methods@#Using Korean Health Insurance Review and Assessment Service National Patient Samples, we extracted RA patients who used biologic disease modifying anti-rheumatic drugs (bDMARDs) between 2009 and 2018. Descriptive statistics were used to explain the basic features of the data. We calculated the proportion of users of each bDMARD among total patients with bDMARDs half-yearly. We assessed changes in the utilization proportions of bDMARDs including 4 tumor necrosis factor inhibitors (TNFis) and 2 non-TNFis, which have been approved for RA in Korea: etanercept, infliximab, adalimumab, golimumab, tocilizumab, and abatacept, and analyzed the changes in market share of biosimilars among the bDMARDs after their introduction. Overall trends of medical costs for each bDMARD were presented over the 10-year period. @*Results@#Since the introduction of the biosimilar TNFis in 2012, the proportion of their use among bDMARDs steadily increased to 15.8% in 2018. While there has been a gradual increase in the use of biosimilar TNFis, the use of the corresponding originators has been decreasing. The introduction of biosimilar TNFis has resulted in a decrease in the medical costs of patients using either originator or biosimilar TNFis. @*Conclusion@#In Korea, the proportional use of biosimilar TNFis has gradually increased since their introduction. The availability of less expensive biosimilar TNFis seems to have brought about a decrease in the medical costs of users of the originators.

7.
Korean Journal of Clinical Pharmacy ; : 171-179, 2021.
Article in English | WPRIM | ID: wpr-901860

ABSTRACT

Background@#Need for regulatory science is emerging with the development of pharmaceutical industry. It is essential to train regulatory science experts to meet the needs of technology and regulations to evaluate advanced products. Major regulatory science countries are conducting the regulatory science activities and fostering the experts. @*Methods@#Published literature and the relevant website of European Union (EU) were reviewed and criteria were developed. In particular, we focused on in depth descriptions of the Innovative Medicines Initiative program, which was conducted twice. @*Results@#EU is striving to provide funding and training experts for the development of the regulatory science by horizon 2020 and regulatory science to 2025. Innovative medicines initiative (IMI) is a public-private partnership aimed at the development of the pharmaceutical industry, including the regulatory science. IMI education and training projects have provided various education and training course including short-term curriculum and master and doctoral course. The difference between South Korea’s regulatory science expert training project in 2021 and the EU’s IMI education and training projects is participation of pharmaceutical companies. While the pharmaceutical companies participate in the IMI project to select project topics and form a community, South Korea’s project is focused on the Ministry of Food and Drug Safety and universities. @*Conclusion@#Through successful active networks with regulatory party, pharmaceutical companies, and universities, a great innovative advance of regulatory science in South Korea is expected.

8.
Journal of Korean Medical Science ; : e143-2021.
Article in English | WPRIM | ID: wpr-900017

ABSTRACT

Background@#We aimed to examine the uptake of infliximab and etanercept biosimilars in patients with rheumatoid arthritis (RA) and its economic implication for healthcare expenditure. @*Methods@#Using Korean Health Insurance Review and Assessment Service National Patient Samples, we extracted RA patients who used biologic disease modifying anti-rheumatic drugs (bDMARDs) between 2009 and 2018. Descriptive statistics were used to explain the basic features of the data. We calculated the proportion of users of each bDMARD among total patients with bDMARDs half-yearly. We assessed changes in the utilization proportions of bDMARDs including 4 tumor necrosis factor inhibitors (TNFis) and 2 non-TNFis, which have been approved for RA in Korea: etanercept, infliximab, adalimumab, golimumab, tocilizumab, and abatacept, and analyzed the changes in market share of biosimilars among the bDMARDs after their introduction. Overall trends of medical costs for each bDMARD were presented over the 10-year period. @*Results@#Since the introduction of the biosimilar TNFis in 2012, the proportion of their use among bDMARDs steadily increased to 15.8% in 2018. While there has been a gradual increase in the use of biosimilar TNFis, the use of the corresponding originators has been decreasing. The introduction of biosimilar TNFis has resulted in a decrease in the medical costs of patients using either originator or biosimilar TNFis. @*Conclusion@#In Korea, the proportional use of biosimilar TNFis has gradually increased since their introduction. The availability of less expensive biosimilar TNFis seems to have brought about a decrease in the medical costs of users of the originators.

9.
Tuberculosis and Respiratory Diseases ; : 159-166, 2021.
Article in English | WPRIM | ID: wpr-875542

ABSTRACT

Background@#E-cigarettes are steadily gaining popularity in Korea. However, the characteristics of e-cigarette smokers, especially nicotine dependence and stress susceptibility, have not been evaluated in comparison to those of nonsmokers or combustible cigarette smokers in Korea. @*Methods@#In this study, 28,059 participants from the Korea National Health and Nutrition Examination Survey (2013–2017) were classified into the following three groups: non-smokers, smokers (current smokers and ex-smokers of combustible cigarettes only), and e-smokers (current smokers and ex-smokers of e-cigarettes regardless of combustible cigarette use). @*Results@#Among the participants, 16,980 (60.5%), 9,247 (33.0%), and 1,832 (6.4%) subjects were non-smokers, smokers, and e-smokers, respectively. E-smokers were younger, more educated, and had a higher household income than nonsmokers or smokers. The number of e-smokers who smoked within 5 minutes of waking up (31.5% vs. 19.8%, p<0.001) and who planned to quit smoking within 6 months (39.1% vs. 35.7%, p<0.05) was greater than that of smokers. E-smokers perceived stress as “very much” (7.0% vs. 4.4%, p<0.001) and “a lot” (29.1% vs. 20.5%, p<0.001) compared to non-smokers. Suicidal ideation (6.5% vs. 4.7%, p<0.001), plans (2.4% vs. 1.3%, p<0.001), and attempts (1.1% vs. 0.5%, p<0.001) were higher in e-smokers than in non-smokers. Depressive episodes in 1 year (14.2% vs. 11.4%, p<0.05) and suicidal plans (2.4% vs. 1.8%, p<0.05) were more frequent among e-smokers than among smokers. @*Conclusion@#E-smokers were younger, more educated, and had a higher income, but they were more dependent on nicotine and susceptible to stress than non-smokers and smokers. Smoking cessation counseling should be tailored according to the characteristics of e-smokers.

10.
Journal of Korean Academy of Fundamental Nursing ; : 311-319, 2021.
Article in Korean | WPRIM | ID: wpr-919766

ABSTRACT

Purpose@#This study was done to investigate factors related to quality of life of patients with failed back surgery syndrome. @*Methods@#One hundred and eighty four patients were recruited from a hospital pain clinic. Data were collected from March 12 to April 9, 2018 using structured questionnaires which included questions about quality of life, hope, and family support. Data analysis was done with descriptive statistics, independent t-test, one-way ANOVA, Pearson's correlation coefficient, and stepwise multiple regression analysis with SPSS version 25.0. @*Results@#The factors related to quality of life were hope, family support, and frequency of pain. These three factors accounted for 53.1% of the total variance in quality of life. @*Conclusion@#In order to increase quality of life of patients with failed back surgery syndrome, it is necessary to design intervention programs that effectively manage hope, family support, and frequency of pain.

11.
Korean Journal of Clinical Pharmacy ; : 257-267, 2021.
Article in English | WPRIM | ID: wpr-917567

ABSTRACT

Background@#The need for regulatory science development to evaluate advanced regulatory products is gradually increasing without hindering the technological development. Creating a research environment and fostering experts through the establishment of regulatory agency-led policies are essential for the development of regulatory science. Method: This is a comparative study of the United States, Japan, Singapore, and Korea. The literature and websites of each regulatory agency were reviewed, and the focus was on advantages and comparing advantages based on definition, development trends, and expert training projects. @*Results@#The United States is striving to develop regulatory science in response to changes in the new pharmaceutical industry through the regulatory science report, and to foster expert both inside and outside the Food and Drug Administration (FDA). Japan is promoting regulatory science centered on regulatory science centers, and is focusing on researching work-related regulatory science within the Pharmaceuticals and Medical Devices Agency (PMDA) and improving employees’ ability to make regulatory decisions. Singapore was aiming to improve Southeast Asia’s regulatory capabilities under the leadership of Centre of Regulatory Excellence (CoRE) within Duke-NUS University. In 2021, Korea is in its early stages, starting to run a university's degree program related to regulatory science this year. @*Conclusion@#Regulatory science should be developed with the aim of improving the regulatory ability of the Ministry of Food and Drug Safety with Korea’s independent concept of regulatory science.

12.
Health Communication ; (2): 35-45, 2021.
Article in English | WPRIM | ID: wpr-914418

ABSTRACT

Background@#: The purpose of this study was to identify the degrees of emotional labour, practice environment of nursing work and intention of retention and to investigate the mediating effect of practice environment of nursing work between emotion labour and intention of retention in nurses. @*Methods@#: A cross-sectional descriptive study design was used. A total of 156 participants was surveyed using a self-report questionnaires including general characteristics, a emotional labour, practice environment of nursing work and intention of retention scale. The descriptive statistics, independent t-test, one-way ANOVA, Pearson’s correlation, and a mediating effect analyses were used for data analysis. @*Results@#: Significant correlations among emotional labour, practice environment of nursing work and intention of retention were noted. Practice environment of nursing work showed a significant mediating effect on the relationships between emotional labour and intention of retention and the relationship between emotional labour and intention of retention. @*Conclusion@#: These results highlight the importance of intension of retention and can be used as meaningful data for intervention research to reduce the emotional labour and to improve practice environment of nursing work.

13.
Health Communication ; (2): 75-82, 2021.
Article in English | WPRIM | ID: wpr-914414

ABSTRACT

Background@#: This study was to investigate the factors associated with nurse’s character of nursing students. @*Methods@#: The subjects in this study were 211 nursing students of 3 university, in 2 regions of South Korea. Data were collected using self-reported questionnaires from March 2 to April 30, 2019, and analyzed using the IBM SPSS Win 25.0 program. @*Results@#: The significant predictors on nurse ‘s character of nursing students were nursing professionalism (β=.36), self-leadership (β=.34) and learning flow (β=.19). Theses variables explained 41.7% of the variance in nurse’s character of nursing students. @*Conclusion@#: These results highlight the importance of nurse’s character and can be used as meaningful data for intervention research to promote the self-leadership and learning flow.

14.
Health Communication ; (2): 225-234, 2021.
Article in English | WPRIM | ID: wpr-914400

ABSTRACT

Background@#The purpose of this study was to investigate the conditional effect of school support between learning agility and academic burnout in nursing students. @*Methods@#A cross-sectional descriptive study design was used. A total of 213 participants was surveyed using a self-report questionnaires including general characteristics, a learning agility, academic burnout and school support scale. The descriptive statistics, independent t-test, one-way ANOVA, Pearson’s correlation, and PROCESS Macro (Model 7) and bootstrapping method. @*Results@#Educational environment support had a significant mediating effect between the learning agility and academic burnout. Professor support had a significant moderating mediation effect in the Educational environment support between the learning agility and academic burnout. And friend and senior support had only direct effect to learning agility and academic burnout. @*Conclusion@#These results highlight the importance of school support and can be used as meaningful data for intervention research to reduce the academic burnout and to learning agility for nursing students.

15.
Korean Journal of Clinical Pharmacy ; : 19-30, 2020.
Article in English | WPRIM | ID: wpr-894124

ABSTRACT

Objective@#To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. @*Methods@#We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability.Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. @*Results@#Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. @*Conclusion@#BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.

16.
Korean Journal of Family Medicine ; : 146-152, 2020.
Article | WPRIM | ID: wpr-833931

ABSTRACT

An increasing number of studies are using healthcare claims databases to assess healthcare intervention utilization patterns or outcomes in real-world clinical settings. However, methodological issues affecting study design or data analysis can make conducting and reporting these types of studies difficult. This review presents an overview of the types of information contained in claims data, describes some advantages and limitations of using claims data for research purposes, and outlines steps for utilizing the Korea Health Insurance Review and Assessment and National Health Insurance Service databases. The study also reviews epidemiological approaches utilizing healthcare claims databases (including cross-sectional, case-control, case-crossover, and cohort designs) with respect to protocol development, analysis, and reporting of results, and introduces relevant guidelines and checklists, including the Guidelines for Good Pharmacoepidemiology Practices, the Strengthening the Reporting of Observational Studies in Epidemiology checklist, and the Risk of Bias in Nonrandomized Studies of Interventions tool.

17.
Yonsei Medical Journal ; : 741-749, 2020.
Article | WPRIM | ID: wpr-833411

ABSTRACT

Purpose@#Non-vitamin K antagonist oral anticoagulants (NOACs) are widely used in patients with atrial fibrillation (AF) because of their effectiveness in preventing stroke and their better safety, compared with warfarin. However, there are concerns for an increased risk of bleeding associated with concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) or selective serotonin reuptake inhibitors (SSRIs) with NOACs. In this study, we aimed to evaluate the risk of bleeding events in individuals taking concomitant NSAIDs or SSRIs with NOACs after being diagnosed with AF. Materials and Methods: A nested case-control analysis to assess the safety of NSAIDs and SSRIs among NOAC users with AF was performed using data from Korean National Health Insurance Service from January 2012 to December 2017.Among patients who were newly prescribed NOACs, 1233 cases hospitalized for bleeding events were selected, and 24660 controls were determined. @*Results@#The risk of bleeding events was higher in patients receiving concomitant NSAIDs [adjusted odds ratio (aOR) 1.41; 95% confidence interval (CI) 1.24–1.61] or SSRIs (aOR 1.92; 95% CI 1.52–2.42) with NOACs, compared to no use of either drug, respectively.The risk of upper gastrointestinal bleeding was higher in patients receiving concomitant NSAIDs or SSRIs without proton pump inhibitors (PPIs) (NSAIDs: aOR 2.47; 95% CI 1.26–4.83, SSRI: aOR 10.8; 95% CI 2.41–2.48) compared to no use. @*Conclusion@#When NSAIDs or SSRIs are required for NOAC users with AF, physicians need to monitor bleeding events and consider the use of PPIs, especially for combined use of both drugs or when initiating NOACs treatment.

18.
Korean Journal of Clinical Pharmacy ; : 19-30, 2020.
Article in English | WPRIM | ID: wpr-901828

ABSTRACT

Objective@#To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. @*Methods@#We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability.Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. @*Results@#Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. @*Conclusion@#BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.

19.
Journal of Rheumatic Diseases ; : 179-185, 2019.
Article in English | WPRIM | ID: wpr-766184

ABSTRACT

OBJECTIVE: To evaluate the nonsteroidal anti-inflammatory drugs (NSAID)-sparing effect of symptomatic slow-acting drugs for osteoarthritis (SYSADOA) in knee osteoarthritis (OA) patients. METHODS: A retrospective study was conducted on a cohort of knee OA patients who visited a single academic referral hospital from 2013 to 2014. Among all patients, NSAID users in their first visit were extracted and divided into SYSADOA users and SYSADOA non-users. All patients were observed from their first visit with knee OA to their last visit, NSAID discontinuation, or the date of data collection, July 2017 (mean observational periods: 369.1 days). To evaluate the NSAID-sparing effect of SYSADOA, Cox regression analysis was performed after adjusting for confounding factors. RESULTS: Patients for this study (n=212) were divided into SYSADOA users (n=57) and SYSADOA non-users (n=155). The mean age (68.8 vs. 66.6 years old, p=0.31) and the number of comorbidities (p=0.73) were comparable between the two groups. The SYSADOA users showed higher Kellgren–Lawrence (KL) grade (66.7% of patients with more than KL grade 3) than SYSADOA non-users (42.6% of patients with more than KL grade 3) (p=0.02). In treatment, the frequency of intra-articular injection was higher in the SYSADOA user group than the SYSADOA non-user group (33.3% vs. 9.0%, p<0.01). In Cox regression analysis, SYSADOA use contributed to NSAID discontinuation in knee OA patients (hazard ratio 2.97, 95% confidential interval 1.42∼6.22). CONCLUSION: This real-world analysis demonstrated that SYSADOA use combined with NSAIDs had a significant effect on NSAID discontinuation in patients with knee OA.


Subject(s)
Humans , Anti-Inflammatory Agents, Non-Steroidal , Cohort Studies , Comorbidity , Data Collection , Injections, Intra-Articular , Knee , Osteoarthritis , Osteoarthritis, Knee , Referral and Consultation , Retrospective Studies
20.
Journal of Korean Medical Science ; : e55-2019.
Article in English | WPRIM | ID: wpr-765165

ABSTRACT

BACKGROUND: This study aimed to estimate the incidence and prevalence of idiopathic inflammatory myopathies (IIM) and associated comorbidities in Korea from 2006 to 2015. METHODS: IIM between 2004 to 2015 were identified using the Korean National Health Insurance Service medical claim database. The case definition required more than one visit based on diagnostic codes including juvenile dermatomyositis (JDM), dermatomyositis (DM), or polymyositis (PM) and registration in the Individual Copayment Beneficiaries Program (ICBP) for rare and intractable diseases. IIM patients with a disease-free period of 24 months before the index date were defined as incident cases. The Elixhauser comorbidity score was calculated. RESULTS: Using the base case definition, 1,150 prevalent patients with IIM (117 JDM, 521 DM, 512 PM) were recorded in 2006 and 2,210 (130 JDM, 1,101 DM, 869 PM) in 2015. The prevalence was estimated at 2.3–4.0 (0.9–1.2 for JDM, 1.2–2.7 for DM, 1.4–2.1 for PM)/100,000 person-year (PY). We identified 218 incident cases of IIM in 2006 (18 JDM, 98 DM, 102 PM) and 191 cases (7 JDM, 83 DM, 101 PM) in 2015. The incidence was estimated at 2.9–5.2 (0.7–1.9 for JDM, 1.8–4.0 for DM, 1.6–3.0 for PM)/1,000,000 PY. The mean age (± standard deviation) of prevalent patients with IIM was 51.2 (± 16.9) years, and the percentage of women was 72.1%. More than two-thirds of patients (70.7%) had more than two comorbidities. Twenty percent of patients had interstitial lung diseases. CONCLUSION: In Korea, the incidence and prevalence of IIM were 2.9–5.2/1,000,000 PY and 2.3–4.0/100,000 PY, respectively.


Subject(s)
Female , Humans , Comorbidity , Dermatomyositis , Incidence , Korea , Lung Diseases, Interstitial , Myositis , National Health Programs , Polymyositis , Prevalence
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