BACKGROUND: Ischemic heart disease is the most common type of heart disease and an important cause of death in Korea. Among marketed anti-anginal medications, molsidomine, nicorandil, and trimetazidine are approved in Korea with unique mechanism of actions. As these drugs are not approved by the US Food and Drug Administration, the access to the up-to-dated and comprehensive safety-related information has been less than optimal from drug information resources used by Korean pharmacists. METHODS: A systematic review was conducted using Embase and Korean manuscripts to compile safety updates for these medications. Out of 418 articles from keyword searches, 52 studies were reviewed in full to compare adverse effects (AEs) with the approved package inserts (PI). RESULTS: Molsidomine related adverse effects were mostly mild or moderate, but anxiety, palpitation, epigastric pain, and sexual potency reduction were additional AEs found from the review not listed in PI. Although PI has included ulceration in oral cavity and gastrointestinal tracts including anus by nicorandil, the Korea FDA recently recommended adding corneal, genital, and skin ulcers to the approved PI. Trimetazidine induced Parkinsonism, worsening of the symptoms for patients diagnosed with Parkinson's disease, gastrointestinal burning, and muscle cramps were additionally identified AEs not listed in PI for trimetazidine. CONCLUSION: Continuous evaluations of the safety profile of these agents are needed to balance the risks and benefits to provide evidence-based safety counseling to the patients. In addition, more focused efforts on spontaneous reporting are warranted by healthcare professionals to safeguard patients against AEs.
Anal Canal ; Anxiety ; Burns ; Cause of Death ; Counseling ; Delivery of Health Care ; Gastrointestinal Tract ; Heart Diseases ; Humans ; Korea ; Molsidomine* ; Mouth ; Muscle Cramp ; Myocardial Ischemia ; Nicorandil* ; Parkinson Disease ; Parkinsonian Disorders ; Pharmacists ; Product Labeling ; Risk Assessment ; Skin Ulcer ; Trimetazidine* ; Ulcer ; United States Food and Drug Administration

BACKGROUND: Green tea extracts are approved as nonprescription drug and available as health functional foods, health foods, and beverages. Clinical information on the products is lacking. METHODS: Information about the products on green tea nonprescription drugs was obtained from the website of the Korea Pharmaceutical Information Center. The Naver, i.e., a top ranking online search portal, was used for compiling the list of the health functional food products using key words of ‘green tea catechin’ on August 23, 2018. The recommended daily dosages of catechins were calculated as 30% of the total dried mass of green tea and about 50% of the catechins were considered as epigallocatechin gallate (EGCG). RESULTS: A total of two types of nonprescription drugs containing green tea powder or extracts, nine health functional food products, and three types of health foods were found. The regulatory requirements of the EGCG exceeding 800 mg were reported to be associated with adverse effects of elevated liver enzyme. If consumers take several green tea products concurrently, such as nonprescription drugs with health functional foods or health foods, it could exceed the recommended amount of EGCG. CONCLUSION: The concurrent use of green tea products as nonprescription drugs, health functional foods, and healthy foods may lead to an increased exposure to EGCG. Pharmacists should be aware the availability of various types of green tea products and the potential risk of liver toxicity due to excessive consumption of EGCG.
Beverages ; Catechin ; Functional Food ; Humans ; Information Centers ; Korea ; Liver ; Nonprescription Drugs ; Pharmacists ; Tea* ; Weight Loss*

PURPOSE: Enteral nutrition is recommended in critically ill patients. On the other hand, the recommendation of nutritional support is limited and often controversial in critically ill patients in the prone position. Therefore, this study evaluated the clinical outcomes of nutritional support in critically ill patients in the prone position. METHODS: A retrospective evaluation of the electronic medical records was conducted, including adult patients who were in the medical intensive care unit (ICU) in the prone position in Seoul National University Bundang Hospital from May 1, 2015 to June 30, 2017. The patients' characteristics, nutritional support status while they were in the prone position, mortality in ICU and during hospitalization, ICU length of stay, mechanical ventilation days, and complications, such as ventilator associated pneumonia (VAP) and vomiting were collected. RESULTS: In total, 100 patients were included. Of these, 12 received enteral nutrition and parenteral nutrition and 88 received only parenteral nutrition. The groups were similar in terms of age, sex, number of comorbidity, weight, PaO₂/FiO₂, hours of prone position, Simplified Acute Physiology Score II (SAPS II), Acute Physiologic and Chronic Health Evaluation II (APACHE II) score, and Sequential Organ Failure Assessment (SOFA) score. No differences were observed in ICU mortality (75.0% vs. 46.6%; P=0.065), hospital mortality (83.3% vs. 58.0%; P=0.081), ICU length of stay (22.2±14.6 vs. 18.2±21.2; P=0.128) and mechanical ventilation days (19.3±14.8 vs. 14.5±19.1; P=0.098). In addition, there were no differences in the possible complications of the prone position, such as VAP (8.3% vs. 4.5%; P=0.480) and vomiting (8.3% vs. 1.1%; P=0.227). CONCLUSION: No significant differences in the clinical outcomes were observed. Further studies will be needed to confirm the way of nutrition support while in the prone position.
Adult ; Comorbidity ; Critical Illness* ; Electronic Health Records ; Enteral Nutrition ; Hand ; Hospital Mortality ; Hospitalization ; Humans ; Intensive Care Units ; Length of Stay ; Mortality ; Nutritional Support ; Parenteral Nutrition ; Physiology ; Pneumonia, Ventilator-Associated ; Prone Position* ; Respiration, Artificial ; Retrospective Studies ; Seoul ; Vomiting

Background: Denosumab (Prolia®) is administered every 6 months for osteoporosis treatment. Co-administration of calcium and vitamin D is required to minimize hypocalcemia risk. We evaluated clinical outcomes based on the administration interval of denosumab and co-prescription with calcium-vitamin D combination products. Methods: A retrospective study was conducted using electronic medical records from 668 patients who started denosumab therapy between January 1 and December 31, 2018, at Seoul National University Bundang Hospital. Clinical outcomes, as measured by changes in T-score, were evaluated by the intervals and concurrent prescriptions with calcium–vitamin D combination products. Results: Of the 668 patients, 333 patients met the eligibility criteria. These patients were divided into two groups based on appropriateness of the administration interval: “Appropriate” (304 patients, 91.3%) and “Inappropriate” (29 patients, 8.3%). T-score changes were significantly higher in the “Appropriate” than in the “Inappropriate” group (0.30±0.44 vs. 0.13±0.37, p=0.048). At the beginning of the treatment, 221 patients (66.4%) were prescribed calcium-vitamin D combination products, but the changes in T-scores were not significantly different by the prescription status of the product (0.29±0.46 vs. 0.28±0.38, p=0.919). Conclusion T-scores were significantly improved in patients with appropriate administration intervals. No significant changes in T-scores were observed by the prescription status with calcium-vitamin D combination products. For optimal treatment outcomes, prescribers should encourage adherence to the approved prescription information on dosage and administration, and pharmacists should provide medication counseling for patients.

Objectives: Hyponatremia is prevalent electrolyte disorder and can be fatal in older adults. Evaluative studies on hyponatremia among older adults are scarce, especially targeting for those who visited emergency department (ED). We aimed to estimate the prevalence and to identify risk factors of hyponatremia among elderly patients visiting the ED. Methods: A retrospective chart review was completed including 65 or older patients who visited ED at Seoul National University Bundang Hospital from September to December 2019. Patients with the serum sodium concentration of less than 130mEq/L was defined as a hyponatremia group. Logistic regression analysis was conducted to assess predictive factors for hyponatremia. Results: Of the total 2,445 patients, 155 (6.3%) were confirmed to have hyponatremia at the time of ED visits. Risk factors for hyponatremia identified in logistic regression analysis were thiazides (aOR=2.64, 95% CI 1.66-4.21), opioids (exclude tramadol) (aOR=3.45, 95% CI 1.72-6.94), and desmopressin (aOR=6.98, 95% CI 2.45-19.84). Compared to the use of thiazides alone, it was confirmed that the possibility of hyponatremia was more than quadrupled when proton pump inhibitor (PPI) was used together (aOR=4.08, 95% CI 1.74-9.55). Conclusions About 6.3% of older adults visiting the ED had hyponatremia. Age, number of medications taken, previous history of hyponatremia, heart failure, cirrhosis, pneumonia, sepsis, prescribed drugs including thiazides, opioids (exclude tramadol), or desmopressin or taking PPI together with thiazides was confirmed to correlate with the risk of hyponatremia.

BACKGROUND: The role of clinical pharmacists in medication therapy to improve clinical and economic outcomes has been reported in the literature. This study was conducted to analyze the changes in details of medication interventions before and after the introduction of clinical pharmacists into the care of neurocritical care unit (NCU) patients, and to evaluate the economic effects of clinical pharmacists by calculating the avoidance cost. METHODS: A retrospective study was conducted reviewing the electronic medical records from June 2013 to May 2014 (before), and from June 2016 to May 2017 (after). We calculated the number and rates of intervention, the acceptance rates of it, and also reviewed the list of interventions. We calculated avoidance cost if there was no intervention. RESULTS: The monthly mean number of interventions increased from 8.0 (±5.7) to 31.7 (±12.8) (P < 0.001) and the frequency of intervention also increased from 0.8% to 1.6% (P=0.003). The most frequently provided pharmacist intervention was nutritional support before introduction of clinical pharmacists and discussions on the medication plan after. The number of classified interventions was 14 before introduction of clinical pharmacist services and 33 after. The calculated cost avoidance associated with a clinical pharmacists' integration was 77,990,615 won per year. CONCLUSION: Introduction of clinicals pharmacist into the NCU was associated with increased intervention rates and expanded types of clinical interventions. The cost avoidance achieved by the pharmacists' interventions can be further explored to evaluate if similar expansions of pharmacists' services achieve similar results in other settings.
Costs and Cost Analysis ; Electronic Health Records ; Humans ; Intensive Care Units ; Medication Reconciliation ; Nutritional Support ; Pharmacists ; Retrospective Studies

Purpose: Malnutrition is a common problem in hospitalized patients that can increase the risk of complications, including infections and length of hospitalization. Appropriate nutritional support is important, particularly in pediatric patients, because growth and development are closely related to the nutritional supply. This study examined the status of nutritional support for pediatric patients in general wards to determine if interventions of the pediatric nutrition support team (pNST) contribute to appropriate nutritional support and help improve their nutritional status. Methods: Between July 2016 and June 2017, all pediatric inpatients who received parenteral nutrition support at the Seoul National University Bundang Hospital were recruited and divided into the NST group and non-NST group according to the activities of pNST. The nutritional status was assessed in all subjects, and the calories and proteins delivered through nutritional support in each group were calculated and then compared with the recommended requirements in pediatric patients. Results: The number of patients recruited was 174: 100 (57.5%) in the NST group and 74 (42.5%) in the non-NST group. Significantly more calories and protein were supplied in the NST group than the non-NST group in hospitalized children aged between four and 17 years (P＜0.05). In the non-NST group, the amounts of calories supplied were insufficient compared to the recommended requirements. The proportion of patients supplied with the appropriate number of calories was 60.0% in the NST group and 20.0% in the non-NST group (P＜0.001), and the proportion of cases supplied with the appropriate amount of protein was 87.0% in the NST group and 62.2% in the non-NST group (P＜0.001). Conclusion Interventions of the pediatric nutrition support team contributed to the sufficient supply of calories and protein and the improvement of clinical outcomes in hospitalized children on parenteral nutrition therapy.

BACKGROUND: Hematopoietic stem cell transplantation (HSCT) patients need parenteral nutrition because of nausea, vomiting, and mucositis caused by conditioning regimens. The demand for glutamine increases during the HSCT period. We evaluated the effects of glutamine-containing parenteral nutrition on the clinical outcomes of HSCT patients. METHODS: In this retrospective analysis, we reviewed HSCT patients from Seoul National University from August 2013 to July 2017. Depending on their glutamine supplementation status, 91 patients were divided into 2 groups: glutamine group (N=44) and non-glutamine group (N=47). We analyzed the rate of weight change, infection (clinically/microbiologically documented), complications (duration of mucositis and neutropenia, acute graft versus host disease), and 100-days mortality in each group. RESULTS: Regarding the clinical characteristics of the patients, there were no significant differences between the 2 groups except that there was a larger proportion of myeloablative conditioning regimen in the glutamine group (P=0.005). In the glutamine group, the average number of days of glutamine use, parenteral nutrition, and mucositis was 7.6±1.4, 14.6±9.9, and 13.3±9.5, respectively. Furthermore, multivariate analysis revealed odds ratios of 0.37 (95% CI, 0.14–0.96; P=0.042) and 0.08 (95% CI, 0.01–0.98; P=0.048) for clinically documented infection and 100-days mortality, respectively, in the glutamine group. CONCLUSION: Results showed that the glutamine group had less clinically documented infection and 100-days mortality than the non-glutamine group, but the other outcomes did not show significant differences. The extended duration of glutamine supplementation according to the period of total parenteral nutrition and mucositis should be considered.
Adult ; Glutamine ; Hematopoietic Stem Cell Transplantation ; Hematopoietic Stem Cells ; Humans ; Mortality ; Mucositis ; Multivariate Analysis ; Nausea ; Neutropenia ; Odds Ratio ; Parenteral Nutrition ; Parenteral Nutrition, Total ; Retrospective Studies ; Seoul ; Transplants ; Vomiting

BACKGROUND: Health-related quality of life (HRQoL) is considered an important outcome measure in chronic diseases, in particular cardiovascular disease (CVD), which is known to be associated with impaired HRQoL. However, few studies have examined HRQoL in individuals at high risk of CVD. METHODS: Using the Fifth Korea National Health and Nutrition Examination Survey 2010-2012, we analyzed data from 10,307 adults aged > or =30 years. The study subjects were stratified into 3 groups on the basis of their Framingham risk score-a 10-year estimate of CVD risk: <10.0% (low risk), 10.0%-19.9% (moderate risk), and > or =20.0% (high risk). The EuroQol-5D (EQ-5D) was used to evaluate HRQoL. RESULTS: A significantly higher proportion of high-risk subjects than low-risk participants had impaired HRQoL (defined as the lowest quartile of the EQ-5D index); this held true even after adjustment for confounding factors in multivariable logistic regression analysis (men: odds ratio [OR], 1.62; 95% confidence interval [CI], 1.24-2.11; women: OR, 1.46; 95% CI, 1.02-2.08). In terms of the 5 EQ-5D dimensions, a 10-year CVD risk > or =20.0% was significantly associated with self-reported problems of mobility in men (OR, 3.15; 95% CI, 2.02-4.90), and of mobility (OR, 1.56; 95% CI, 1.09-2.24), self-care (OR, 2.14; 95% CI, 1.09-4.22), and usual activity problems (OR, 1.80; 95% CI, 1.17-2.78) in women. CONCLUSION: A high CVD risk is associated with impaired HRQoL. After adjustment for demographic and clinical factors, a 10-year CVD risk > or =20.0% is an independent predictor of impaired HRQoL in the general population; in particular, of mobility problems in men, and of mobility, self-care, and usual activity problems in women.
Adult* ; Cardiovascular Diseases* ; Chronic Disease ; Female ; Humans ; Korea ; Logistic Models ; Male ; Nutrition Surveys ; Odds Ratio ; Outcome Assessment (Health Care) ; Quality of Life* ; Risk Assessment ; Self Care

Objective: : While balanced crystalloid (BC) could be a relevant fluid regimen with buffer system compared with normal saline (NS), there have been no studies on the optimal fluid for surgery of an unruptured intracranial aneurysm (UIA). This study aimed to compare the effects of fluid regimens between NS and BC on the metabolic and clinical outcomes of patients who underwent surgery for UIA. Methods: : This study was designed as a propensity score matched retrospective comparative study and included adult patients who underwent UIA clipping. Patient groups were categorized as NS and BC groups based on the types of pre-operative fluid and the amount of fluid administered during surgery. The primary outcomes were defined as electrolyte imbalance and acidosis immediately after surgery. The secondary outcomes were the length of stay in the intensive care unit (ICU) and duration from the end of the operation to extubation. Results: : A total of 586 patients were enrolled in this study, with each of 293 patients assigned to the NS and BC groups, respectively. Immediately after surgery, serum chloride levels were significantly higher in the NS group. Compared to the NS group, the BC group had lower incidence rates of acidemia (6.5% vs. 11.6%, p=0.043) and metabolic acidosis (0.7% vs. 4.4%, p=0.007). As compared to NS group, BC group had significantly shorter duration from the end of the operation to extubation (250±824 vs. 122±372 minutes, p=0.016) and length of stay in ICU (1.37±1.11 vs. 1.12±0.61 days, p=0.001). Throughout multivariable analysis, use of BC was found to be significant factor for favorable post-operative results. Conclusion : This study showed that the patients who received BC during UIA clipping had lower incidence of metabolic acidosis, earlier extubation and shorter ICU stay compared to those who received NS. Therefore, using BC as a peri-operative fluid can be recommended for patients who undergo surgery for UIA.