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수면 장애가 있는 환자에게 적용한 디지털 치료기기의 임상적 유효성에 대한 체계적 문헌고찰: 대조군분류에 따른 하위 분석
한국임상약학회 한국임상약학회지 제33권 제4호 2023.12 pp.221-241
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5,700원
Background: The purpose of this systematic review was to investigate the effects of digital therapeutics for insomnia on sleep disorders and mental health improvement compared to the control group. Methods: Following the guidelines on systematic review(PRISMA, NECA), a literature search was conducted through PubMed, Cochrane Library, EMBASE, RISS, KISS, and KoreaMed using keywords. The Cochrane Risk of Bias Tool and Review Manager version 5.3 were used for risk of bias and effect size assessment. Results: Thirty eight RCT met criteria for inclusion. When compared against three control conditions, the digital therapeutics for insomnia was an effective intervention for improvement sleep disorders and mental health in comparison to waiting list and Patient-directed care with some intervention by medical staff. However, digital therapeutics for insomnia were no more effective than face-to-face CBT-I control group. Conclusion: The efficacy of digital therapeutics for insomnia was evaluated differently depending on the control group. Therefore, in phase 3 clinical trials for efficacy evaluation, it is necessary to review whether the control group has been properly established.
CYP3A4 기질과 억제제 약물의 병용 고령환자에서 부정맥 부작용 연관성
한국임상약학회 한국임상약학회지 제33권 제4호 2023.12 pp.242-253
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4,300원
Background: Arrhythmia due to QT prolongation is one of the most serious adverse events with drug interactions in the elderly. This study aimed to examine the incidence of arrhythmia in Korean elderly patients who administered both cytochrome P450 3A4 (CYP3A4) substrates and inhibitors. Methods: Patients using CYP3A4 substrate and inhibitor were selected from the 2017 elderly patient dataset (the Korean Health Insurance Review and Assessment Service - Aged Population Sample). Selection criteria were patients with a medication possession ratio over 80%, medication duration of at least 7 days, and a follow-up period of 3 months or more. The patient’s basic information is age, gender, health insurance type, and comorbidities. The top 50 drug pairs and comorbidity with high-incidence arrhythmia were presented. Results: In patien ts with drug combinations for over 7 days, there were 981 incidences of arrhythmia, and 351 incidences in those with combinations for over 30 days. The comorbidities of congestive heart failure and myocardial infarction had a significant association with incidence of arrhythmia. Among patients with 7 days or longer, the drug pairs [substrates-inhibitors] with significant adjusted odds ratio (aOR) were [propranolol-cimetidine] (aOR, 2.25; 95% confidence interval [CI], 1.66-3.04). Among patients with 30 days or longer, the drug pairs with significant aOR were [tramadolamiodarone] (aOR, 2.87; 95% CI, 1.97-4.19). Conclusions: In elderly patients, the incidence of arrhythmia was high with drug interactions of CYP3A4 substrates and inhibitors. The comorbidity of congestive heart failure was the risk factor.
한국인 HIV/AIDS 환자의 복약순응도에 미치는 위험 인자 연구
한국임상약학회 한국임상약학회지 제33권 제4호 2023.12 pp.254-260
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4,000원
Background: Adherence to antiretroviral treatment (ART) is crucial for maintaining the HIV-RNA suppression in patients living with HIV/AIDS. This study aims to analyze the risk factors contributing to low medication adherence among individuals with HIV/ AIDS by analyzing data from the Korean HIV/AIDS cohort study. Methods: The dependent variable is ART medication adherence. The depressive symptom and anxiety scores were collected as main independence variables. Covariates included gender, age, transmission route, alcohol and smoking information, and antiviral treatment regimen details. To predict the relationship between ordinal dependent variables and independent variables, an ordered logistic regression analysis was conducted, and odds ratios (OR) were calculated. Results: The results of the ordered logistic regression analysis showed that female was associated with a higher risk of low medication adherence (OR=2.91, 95% CI=1.08, 7.83). Among the subjects who were non-smokers and non-drinkers, the risk of low medication adherence was lower (OR=0.36, 95% CI=0.18, 0.70). Depending on the ART treatment group, individuals taking integrase inhibitor had a lower risk of medication adherence (OR=0.31, 95% CI=0.13, 0.76), and those experiencing depressive symptoms were related with a higher risk of low medication adherence (OR=1.97, 95% CI=1.12, 3.46). Conclusions: The encouragement and emotional support of healthcare professionals are essential for patients living with HIV/AIDS who experience depressive symptoms to maintain ART adherence. Additionally, further research is needed to ensure that HIV/AIDS infected female with concurrent depressive symptoms can achieve appropriate ART therapeutic effect.
외래 급성 비부비동염 환자의 잠재적으로 부적절한 항생제 사용
한국임상약학회 한국임상약학회지 제33권 제4호 2023.12 pp.261-269
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4,000원
Background: Acute rhinosinusitis (ARS) is a common condition encountered in ambulatory practice and is one of the most common reasons for antibiotic prescriptions. This study aimed to evaluate the potentially inappropriate antibiotic prescribing for ARS in South Korea and identify influencing factors. Methods: We analyzed Health Insurance Review and Assessment Service-National Patient Samples data. We selected outpatients aged 20 to 64 with ARS, prescribed antibiotics between February and November 2020. Potentially inappropriate antibiotic prescribing was categorized as: 1) inappropriate antibiotic selection and 2) inappropriate antibiotic dosage or duration. Multiple logistic regression was conducted to estimate the impact of various factors on inappropriate antibiotic prescribing. Results: Of 1,210 patients, 80.83% received potentially inappropriate ARS antibiotic prescriptions. Inappropriate antibiotic selection accounted for 43.55%, and inappropriate antibiotic dosage and duration contributed to 37.28%. Otolaryngologists had higher odds ratio (OR) of potentially inappropriate antibiotic prescribing compared to internal medicine practitioners, while dentists had lower OR. Patients aged 20 to 29 years had a higher OR than other age groups, and those who visited primary care clinics had a higher OR than those who visited hospitals. Conclusion: Potentially inappropriate antibiotic prescribing for ARS is prevalent in South Korea. This study identified physician specialty, patient age group, and the level of healthcare facility as factors influencing potentially inappropriate antibiotic prescriptions. Addressing this issue through targeted interventions, such as improved guidelines adherence and patient education, is imperative to mitigate the risks associated with antibiotic misuse and antibiotic resistance.
4,000원
Background: As per guidelines for treating dyslipidemia, the recommended low-density lipoprotein cholesterol (LDL-C) level in extremely high-risk patients, including those with coronary artery diseases is <55 mg/dL. Although this recommendation has been adopted in the guidelines for dyslipidemia in various countries, there is limited evidence of its efficacy in reducing cardiovascular diseases (CVDs), especially among East Asian patients. This study aimed to investigate whether an LDL-C value below 55 mg/dL is associated with decreased risk of CVDs. Methods: Seven clinical trials including 50,970 patients that compared intensive lipidlowering therapy with less therapy or placebo in patients who had >6 months of follow-up, those with a sample size of ≥150 were selected as the final literature for analysis. Risk ratios (RR) using random effects were represented with 95% confidence intervals (CI) for the reliability of the results. Results: An LDL-C level of <55 mg/dL was related to significantly reduced events of major CVDs (RR: 0.88; 95% CI: 0.80-0.98) and myocardial infarction (RR: 0.81; 95% CI: 0.73-0.90) and a reduced risk of ischemic stroke (RR 0.79; 95% CI 0.69-0.89, mean follow-up=2 years). However, an LDL-C level below 55 mg/dL did not reduce the incidence of CVD in intensive therapy in East Asian patients. Conclusions: A goal LDL-C value below 55 mg/dL was identified to be related to a decreased risk of developing CVD. However, the relation to LDL-C below 55 mg/dL with a decreased risk of CVD was not observed in East Asian patients.
다제내성결핵 환자에서 메타분석을 통한 Linezolid의 효능 및 안전성 평가
한국임상약학회 한국임상약학회지 제33권 제4호 2023.12 pp.278-289
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4,300원
Background: Linezolid has been widely used in the treatment for multidrug-resistant tuberculosis. However, there are limitations to use it such as long treatment, because of related side effects, even adequate treatment period has been needed for remission of multidrug-resistant tuberculosis (MDR-TB). Method: The meta-analysis was performed based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria. To choose literatures, systematic literature reviews were conducted with databases of PubMed, Web of Science, and EMBASE. Results: Efficacy and safety of Linezolid were determined by 85% (95% CI=79~89%, p<0.05) in the sputum culture conversion and 55% (95% CI=45~64%, p<0.01) in side effects related to linezolid, respectively. In addition, I2 was estimated by 72%. In the subgroup analysis, efficacy and safety by dose and region were analyzed. In the subgroup analysis, compared with the linezolid dose in groups greater than 600 mg/day and less than 600 mg/day, this study showed 85% (95% CI 79~90%, p>0.05) in 206 patients and 82% (95% CI 73~89%, p<0.05) in 297 patients, respectively. Also, in the subgroup analysis, adverse effects caused by linezolid occurred more than 50% of treated patients. Conclusion: Therapeutic efficacy of linezolid for MDR-TB patients was confirmed regardless of the initial dose of linezolid, especially for sputum culture conversion and it was recommended that the dose of linezolid has been more effective below 600 mg/day. However, it should be necessary to closely monitored for safety issues since serious side effects possibly occurred by administration of long period treatment.
새로운 알츠하이머 치료제의 안전성 유효성에 관한 체계적 문헌고찰
한국임상약학회 한국임상약학회지 제33권 제4호 2023.12 pp.290-304
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4,800원
Background: Innovative Alzheimer’s disease drugs received approval in the United States in 2021 and 2023. This study aims to assess the safety and efficacy of these novel treatments, elucidate their mechanisms of action, and compare their impact on cognitive function improvement with approved drugs. Methods: We conducted a comprehensive search of pivotal clinical studies related to Alzheimer’s disease treatments in PubMed/Medline, Embase, and the Cochrane Library databases from January 1st, 2020 to December 31st, 2022. Meta-analysis was performed using RevMan 5.4 software. Results: A total of 14 studies were included in this systematic review. When compared to the placebo, the new drugs did not exhibit a statistically significant effect on MMSE (Mini- Mental State Examination) (mean difference= −0.04, 95% confidence intervals [CIs]: −0.31, 0.23, N=3662, I2=0%). However, they demonstrated a significant impact on ADAS-cog (Alzheimer’s Disease Assessment Scale-Cognitive Subscale) (standardized mean difference= −0.15, 95% CIs: −0.2, −0.1, N=6710, I2=17%). When compared to the approved drugs, the new drugs showed a statistically significantly lower effect on MMSE (test for subgroup difference Chi2=23.13, N = 5870, p<0.00001) but showed only a trend of decreased efficacy on ADAS-cog (Chi2=1.16, N = 8670, p=0.28). Conclusion: New drugs yielded diverse clinical endpoint results compared to the placebo, and in comparison to existing approved drugs, they exhibited lower efficacy in improving cognitive function. The safety profile of these new drugs, as reported in clinical trials, was generally well-tolerated.
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