Medication Utilization Analysis of Basiliximab as a Maintenance Immunosuppressant in Renal Failure Patients Undergoing Lung Transplantation

Background@#Basiliximab is used as an alternative to tacrolimus in patients with decreased renal function. However, studies on basiliximab as a maintenance immunosuppressant, particularly in patients with lung transplantation, are limited. Therefore, here, we investigated the efficacy and safety of basiliximab in patients with lung transplantation. @*Methods@#Adult patients with acute kidney injury (AKI) who received lung transplantation at a single general hospital between July 1, 2014 and June 30, 2018, were selected and classified in tacrolimus and basiliximab groups. Both groups received a triple-drug regimen (tacrolimus, mycophenolate mofetil, and steroids). However, tacrolimus was discontinued in the basiliximab group when AKI occurred, and two or more repeat basiliximab doses were administered within 3 months after transplantation. The electronic medical records were analyzed retrospectively. @*Results@#Of the 85 patients who met the selection criteria, 61 and 24 were assigned to the tacrolimus and basiliximab groups, respectively. Significant improvement in renal function was observed in the basiliximab group (p <0.001).However, there were no differences in acute and chronic rejection rates in both the groups. No difference was observed in the incidence rate of complications between the groups, except for chronic kidney disease, which showed higher incidence in the basiliximab group (25.0% vs. 4.9%; p =0.013). @*Conclusions@#We suggest the use of basiliximab as an immunosuppressant alternative to tacrolimus in patients with acute renal failure after lung transplantation. Basiliximab demonstrated effectiveness as an immunosuppressant and improved renal function. Therefore, basiliximab can be used in patients with decreased renal function.

The Effect of the Vitamin Protocol for Treating Sepsis or Septic Shock in Pediatric Intensive Care Unit

Background@#Recently, a study comprising adult patients with sepsis admitted in the intensive care unit (ICU) was conducted. The patients were treated with high doses of intravenous ascorbic acid, thiamine, and hydrocortisone; the clinical outcomes demonstrated significant therapeutic benefits. The mortality rate in children with sepsis is approximately 25%. However, the effects of additional treatment with ascorbic acid and thiamine (“vitamin protocol”) in children are rarely investigated. @*Methods@#A retrospective analysis was performed using medical records of patients diagnosed with sepsis and admitted to the pediatric ICU (PICU) between September 2016 and June 2019. The control group received treatment only as per sepsis protocol, whereas the treated group received both sepsis protocol and the vitamin protocol. The primary endpoint was change in Vasoactive-Inotropic Score (VIS) for 5 days. The secondary endpoints included the length of stay in the PICU, duration of using mechanical ventilators and vasopressors, and mortality rate. @*Results@#The number of patients in the treated and control groups was 33 and 24, respectively. The treated group showed greater decrease in their VIS for 5 days than the control group (44.4 vs 18.6); however, the difference was not statistically significant. The length of stay in the PICU was significantly longer for the treated group than for the control group [10.0 days (Interquartile range (IQR), 6-18) vs 4.5 days (IQR, 4-10.3); p=0.004]. @*Conclusions@#No significant treatment benefits were observed following vitamin protocol administration to the pediatric patients with sepsis. Further studies are necessary for improving the efficacy and safety of the vitamin protocol.

Efficacy and Safety of Antipsychotics for Delirium Treatment in Cancer Patients Receiving Palliative Care

Background@#Delirium is a neuropsychiatric disorder characterized by sudden impairments in consciousness, attention, and perception. The evidence of successful pharmacological interventions for delirium is limited, and medication recommendations for managing delirium are not standardized. This study aimed to provide evidence of antipsychotics for symptomatic treatment of delirium in cancer patients receiving palliative care. @*Methods@#We retrospectively reviewed adult cancer patients in palliative care who received antipsychotic delirium treatment at Severance Hospital between January 2016 and June 2019. The efficacy was evaluated primarily by resolution rates. The resolution of delirium was defined as neurological changes from drowsiness, confusion, stupor, sedation, or agitation to alertness or significant symptomatic improvements described in the medical records. The safety was studied primarily by adverse drug reaction incidence ratios. @*Results@#Of the 63 enrolled patients, 60 patients were included in the statistical analysis and were divided into three groups based on which antipsychotic medication they were prescribed [quetiapine (n=27), haloperidol (n=25) and co-administration of quetiapine and haloperidol (n=8)]. The resolution ratio showed quetiapine to be more effective than haloperidol (p=0.001). No significant differences were seen in adverse drug reaction rates among the three groups (p=0.332). @*Conclusions@#Quetiapine was considered the most effective medication for delirium, with no significant differences in adverse drug reaction rates. Therefore, quetiapine may be considered a first-line medication for treating delirium in cancer patients receiving palliative care. However, further studies comparing more diverse antipsychotics among larger populations are still needed.

Medication Utilization Analysis of Basiliximab as a Maintenance Immunosuppressant in Renal Failure Patients Undergoing Lung Transplantation

Background@#Basiliximab is used as an alternative to tacrolimus in patients with decreased renal function. However, studies on basiliximab as a maintenance immunosuppressant, particularly in patients with lung transplantation, are limited. Therefore, here, we investigated the efficacy and safety of basiliximab in patients with lung transplantation. @*Methods@#Adult patients with acute kidney injury (AKI) who received lung transplantation at a single general hospital between July 1, 2014 and June 30, 2018, were selected and classified in tacrolimus and basiliximab groups. Both groups received a triple-drug regimen (tacrolimus, mycophenolate mofetil, and steroids). However, tacrolimus was discontinued in the basiliximab group when AKI occurred, and two or more repeat basiliximab doses were administered within 3 months after transplantation. The electronic medical records were analyzed retrospectively. @*Results@#Of the 85 patients who met the selection criteria, 61 and 24 were assigned to the tacrolimus and basiliximab groups, respectively. Significant improvement in renal function was observed in the basiliximab group (p <0.001).However, there were no differences in acute and chronic rejection rates in both the groups. No difference was observed in the incidence rate of complications between the groups, except for chronic kidney disease, which showed higher incidence in the basiliximab group (25.0% vs. 4.9%; p =0.013). @*Conclusions@#We suggest the use of basiliximab as an immunosuppressant alternative to tacrolimus in patients with acute renal failure after lung transplantation. Basiliximab demonstrated effectiveness as an immunosuppressant and improved renal function. Therefore, basiliximab can be used in patients with decreased renal function.

The Effect of the Vitamin Protocol for Treating Sepsis or Septic Shock in Pediatric Intensive Care Unit

Background@#Recently, a study comprising adult patients with sepsis admitted in the intensive care unit (ICU) was conducted. The patients were treated with high doses of intravenous ascorbic acid, thiamine, and hydrocortisone; the clinical outcomes demonstrated significant therapeutic benefits. The mortality rate in children with sepsis is approximately 25%. However, the effects of additional treatment with ascorbic acid and thiamine (“vitamin protocol”) in children are rarely investigated. @*Methods@#A retrospective analysis was performed using medical records of patients diagnosed with sepsis and admitted to the pediatric ICU (PICU) between September 2016 and June 2019. The control group received treatment only as per sepsis protocol, whereas the treated group received both sepsis protocol and the vitamin protocol. The primary endpoint was change in Vasoactive-Inotropic Score (VIS) for 5 days. The secondary endpoints included the length of stay in the PICU, duration of using mechanical ventilators and vasopressors, and mortality rate. @*Results@#The number of patients in the treated and control groups was 33 and 24, respectively. The treated group showed greater decrease in their VIS for 5 days than the control group (44.4 vs 18.6); however, the difference was not statistically significant. The length of stay in the PICU was significantly longer for the treated group than for the control group [10.0 days (Interquartile range (IQR), 6-18) vs 4.5 days (IQR, 4-10.3); p=0.004]. @*Conclusions@#No significant treatment benefits were observed following vitamin protocol administration to the pediatric patients with sepsis. Further studies are necessary for improving the efficacy and safety of the vitamin protocol.

Analysis of Compliance and Clinical Outcomes by Expanding Physician's Departments in Pediatric Nutrition Support Team

PURPOSE@#Malnutrition in hospitalized children has an impact on growth, morbidity, and mortality. For this reason, the implementation of pediatric nutrition support team (PNST) has been suggested. On April 2017, in Severance Hospital, more PNST physician's departments participated in PNST, and a PNST physician assigning system was changed to be the same departments with the attending physician and PNST physician. This study performed a comparative analysis of the compliance and clinical outcomes after expanding the participation of the PNST physician's department.@*METHODS@#Pediatric patients, who were referred to a PNST consultant, were divided into two groups: an unmatched group (different departments with the attending physician and PNST physician [154 patients, 233 consultations from May 2016 to October 2016]), and a matched group (same departments with the attending physician and PNST physician [169 patients, 302 consultations from May 2017 to October 2017]). The PNST compliance and clinical outcomes, such as the total delivered/required caloric and protein ratio, % ideal body weight (%IBW), serum total protein, and serum albumin, in the two groups were compared.@*RESULTS@#The compliance was significantly higher in the matched group than the unmatched group (63.4% vs. 47.3%, P=0.005). Although there was no significant difference, the total delivered/required caloric and protein ratio, and %IBW in the matched group tended to increase. The serum total protein (0.7±0.7 g/dL vs. −0.4±1.3 g/dL, P=0.004) and serum albumin (0.5±0.5 g/dL vs. −0.1±0.6 g/dL, P=0.003) were significantly higher in the matched group.@*CONCLUSION@#After expanding the physician's departments in PNST, the compliance was significantly higher in the matched group and the clinical outcomes tended to better. The physician assigning system to be matched with the departments between the attending physician and the PNST physician may help increase the compliance of NST consultations, resulting in an improvement of the patient's clinical outcomes.

Validation of Voriconazole Therapeutic Drug Monitoring in Lung Transplant Recipients Receiving Voriconazole alone for Treatment of Invasive Aspergillosis

BACKGROUND: Invasive aspergillosis (IA) is associated with high morbidity and mortality, particularly among immunocompromised patients, such as lung transplant recipients. Voriconazole, the first-line therapy for IA, shows a non-linear pharmacokinetic profile and has a narrow therapeutic range. Careful and appropriate administration is necessary, primarily because it is used for critically ill patients; however, the clinical usefulness of therapeutic drug monitoring (TDM) has not been sufficiently verified. Therefore, in this study, we validated the safety and efficacy of voriconazole TDM in lung transplant recipients receiving only voriconazole for IA treatment. METHODS: The electronic medical records of lung transplant recipients (≥19 years of age) administered only voriconazole for > 7 days for treatment of IA from June 1, 2013 to May 31, 2018 were analyzed retrospectively. RESULTS: Among the 54 patients, 27 each were allocated to TDM and non-TDM groups, respectively. There were no significant differences in patient characteristics between the two groups except for ICU-hospitalization status. Of the TDM group patients, 81.5% needed adjustment of voriconazole dosage because the levels were out of target range. Comparison of two groups showed that treatment response was higher throughout treatment and switching rates of second-line agents were significantly lower in the TDM group, but it was insufficient to confirm safety improvements through voriconazole TDM. CONCLUSION: Considering that the treatment response tended to be higher and the rates of switching to second-line antifungal agents were lower in the TDM group, voriconazole TDM may increase the therapeutic effect on IA in lung transplant patients.

Delayed Elimination After High-dose Methotrexate in Pediatric Patients with Acute Lymphoblastic Leukemia and Non-Hodgkin Lymphoma

BACKGROUND: High doses of methotrexate (MTX) are often used in various chemotherapy protocols to treat acute lymphoblastic leukemia (ALL) and non-Hodgkin's lymphoma (NHL) in children, but its delayed elimination increases the occurrence of adverse events, such as bone marrow suppression. The aim of this study was to investigate the elimination of MTX at 24 and 48 hours. METHODS: We retrospectively analyzed electronic medical records of ALL or NHL pediatric patients who received 5 g/m² MTX infusion over 24 hours (between June, 2012 and July, 2018) at the Yonsei University Health System, Korea. The delayed elimination of MTX concentrations was assessed with 100 or 150 µM MTX at 24 hours, and 2 or 5 µM at 48 hours. RESULTS: Among the 85 MTX cycles administered, 23 cycles were classified in delayed elimination group, and 62 cycles showed normal elimination. At 24 hours, the delayed elimination group with MTX concentration > 100 µM showed higher percentage than group with MTX concentration < 100 µM (45.8% vs. 19.7%, p = 0.015). However, no differences were observed at 150 µM MTX (p = 0.66). At 48 hours, the delayed elimination was higher than the normal elimination at both concentration baselines (p < 0.001 at 2 µM, p = 0.024 at 5 µM). CONCLUSIONS: MTX concentrations greater than 100 µM show high probability of delayed elimination at 24 hours. When MTX levels are above normal, leucovorin and hydration regimens should be continued to prevent delayed elimination.

Comparison of Piperacillin/Tazobactam Dosing (13.5 g/day vs. 18 g/day) for the Treatment of Hospital-Acquired Pneumonia and Ventilator-associated Pneumonia in Intensive Care Unit

BACKGROUND: In July 2016, the Infectious diseases society of america and the american thoracic society (IDSA & ATS) published a guideline recommending piperacillin/tazobactam (Pip/Tazo) 18 g/day as the anti-pseudomonal dose for the treatment of pathogenic pneumonia. After the guideline was published, the Pip/Tazo dose used for the treatment of pathogenic pneumonia was changed from 13.5 g/day to 18 g/day in a superior general hospital intensive care unit (ICU). In this study, we analyzed the effectiveness and safety of the new dose. METHODS: Adult patients aged ≥19 years who were diagnosed with pneumonia in ICU and who received Pip/Tazo for 7 days or more from September 1, 2015 to May 31, 2017 were included in the study. The electronic medical record (EMR) was retrospectively analyzed. RESULTS: At baseline, there was a significant difference between 44 patients treated with 13.5 g/day and 31 patients treated with 18 g/day of Pip/Tazo. The 18 g/day-treatment group comprised more elderly patients than the 13.5 g/day-treatment group (p=0.028). The results of the treatment-effects analysis showed no significant difference between the two groups. In case of safety data, there were significant differences in two parameters related to blood count, namely hemoglobin (p=0.016) and platelet count (p=0.011). CONCLUSION: Based on the significant difference in baseline age, there is a possibility that high-dose Pip/Tazo showed improved therapeutic effect. However, when high-dose Pip/Tazo was used, the blood cell count was found to drop from the reference value more frequently. Therefore, blood cell count should be monitored carefully when high-dose Pip/Tazo is administered.

Posaconazole for Prophylaxis of Fungal Infection in Pediatric Patients with Acute Myeloid Leukemia undergoing Induction Chemotherapy

BACKGROUND: Posaconazole is a broad-spectrum triazole antifungal agent and the most recommended prophylactic antifungal agent for patients with acute myeloid leukemia (AML) undergoing induction chemotherapy. In this study, we evaluated the status and effectiveness of posaconazole as a prophylactic antifungal agent in pediatric patients receiving induction chemotherapy for AML. METHODS: We retrospectively reviewed the electronic medical records of 36 pediatric patients with AML (between January 2013 and September 2017) at the Yonsei University Health System. Invasive fungal disease (IFD) was assessed as the primary endpoint of prophylactic antifungal effect. The secondary endpoints were incidence of fever, persistent fever despite the use of broad-spectrum antibiotics for 72 h, alteration of antifungal agent, intensive care unit admission, and death within 100 days. RESULTS: Among the 36 patients, 18 patients used posaconazole, 12 were treated with suspension formula, and 6 of them were treated with tablets. Eighteen patients did not use antifungal agents prophylactically. The mean number of days of posaconazole administration was 26.8±16 days. IFD occurred in 2/18 (11.1%) patients in the no prophylaxis group and in 1/18 (5.6%) patients in the posaconazole group (p=0.49). CONCLUSION: Posaconazole is expected to be useful for the prevention of IFD in pediatric patients with AML undergoing induction chemotherapy. Prospective studies of the effectiveness of posaconazole prophylaxis should be conducted in more pediatric patients in the future.

Effects of Parenteral Nutrition in Pediatric Patients with Hematopoietic Stem Cell Transplantation

PURPOSE: This study examined the effects of parenteral nutrition (PN) on the nutritional status, clinical improvement, and PN-related complications in pediatric patients who had undergone hematopoietic stem cell transplantation (HSCT). METHODS: A retrospective audit of 110 pediatric patients (age≤18), who underwent HSCT from March 2015 to February 2017 was undertaken. The patients were divided into 3 groups based on the ratio of daily calorie supplementation to the daily calorie requirement (ROCS). The clinical factors related to the nutritional status, such as difference in body weight (BW), body mass index (BMI), percent ideal body weight (PIBW), total protein (T.protein), and albumin; the early clinical outcome, such as PN-duration, length of hospitaliaztion (LOH), engraftment day (ED), graft-versus-host disease, sepsis, pneumonia and mucositis; and PN-related complications, including elevation of total bilirubin (T.bil), direct bilirubin (D.bil), aspartate aminotransferase, alanine aminotransferase, glucose and cholesterol levels, and hepatic veno-occlusive disease were analyzed using the electronic medical records. Additional analysis subject to auto-HSCT and allo-HSCT patients was also performed. RESULTS: The very-low-ROCS, low-ROCS, and satisfied-ROCS group were 30 (27.3%), 47 (42.7%), and 33 (30.0%) patients, respectively. The PN-duration (P=0.005, z=−2.271), LOH (P=0.023, z=−2.840), ED (P < 0.001, z=−3.695), T.bil elevation (P < 0.001, z=−3.660), and D.bil elevation (P=0.002, z=−3.064) tended to decrease with increasing ROCS. The difference in the PN-duration (P=0.017), ED (P=0.001), T.bil elevation (P=0.001), and D.bil elevation (P=0.011) in the 3 groups was statistically significant. In the auto-HSCT patients, the change in BW (P=0.031, z=+2.154), PIBW (P=0.029, z=+2.187), and BMI (P=0.021, z=+2.306) tended to increase. In the allo-HSCT patients, the change in T.protein (P=0.022, z=+2.286) increased but the ED (P=0.021, z=−2.304) decreased. CONCLUSION: Aggressive PN supplementation has an effect on maintaining the nutritional status and achieving better early outcomes in pediatric HSCT patients, whereas it has no effect on increasing the PN-related complications.

The Development of Multidisciplinary Cancer Patient Education·Counseling Questionnaire and Satisfaction Survey

BACKGROUND: Presently, a multidisciplinary team of doctors, pharmacists, nurses, and dietitians provides patient education to impart information on chemotherapy. However, studies on multidisciplinary education satisfaction are inadequate. In this study, we aimed to contribute to the improvement of quality of multidisciplinary education counseling for patients with cancer by developing a satisfaction questionnaire and analyzing the satisfaction survey. METHODS: A questionnaire was developed by an expert group, and the responses were recorded using the 5-point Likert scale. After conducting a pre-test, factor analysis was performed to evaluate validity. The reliability of the questionnaire was measured by Cronbach's alpha coefficient. A satisfaction survey was conducted by self-administration method. RESULTS: Based on the results of factor analysis, factors can be divided into two parts: “overall education” and “each team member's education” (total 14 questions). The construct validity and reliability of the questionnaire are sufficiently high. Fifty-one patients took the survey between January 2, 2018 and January 20, 2018. Twenty-six (51%) patients responded that they were “very satisfied” and 22 (43.1%) patients responded that they were “satisfied”. CONCLUSION: By developing a questionnaire on multidisciplinary education counseling for patients with cancer, it is possible to perform evaluation and research of cancer patient education. This study will contribute to the management and improvement of quality of multidisciplinary education.

Dapagliflozin's Effects on Glycemia and Cardiovascular Risk Factors and Incidence of Adverse Events in Patients with Type 2 Diabetes

BACKGROUND: Dapagliflozin is an oral selective inhibitor of sodium-glucose cotransporter 2(SGLT2), the kidney transporter chiefly responsible for glucose reabsorption from the glomerular filtrate. Because this mechanism does not require the action of insulin, dapagliflozin rarely causes hypoglycemia. Dapagliflozin may affect blood glucose control as well as blood pressure and the body weight which are one of the cardiovascular disease risk factors. However, dehydration and ketoacidosis are reported as the side effects of the dapagliflozin treatment and the safety issues have been occurred. The aim of this study is to analyze the effectiveness and adverse events of dapagliflozin in Korean patients. METHODS: From December 2014 to August 2015, we retrospectively reviewed the electronic medical records of type 2 diabetes patients who were prescribed dapagliflozin at Severance Hospital. RESULTS: A total of 202 Korean patients were enrolled in this study. The effectiveness in the reduction of blood glucose was statistically significant(p < 0.001). Dapagliflozin decreased 0.74% of HbA1c after 24 weeks. Significantly more participants achieved the target HbA1c level(HbA1c < 7%) after 24 weeks(n=42, 35.3%) than before taking dapagliflozin(n=21, 17.6%). Blood pressure decreased 5.7 mmHg s ystolic b lood p ressure(SBP), 1.9 mmHg d iastolic b lood p ressure(DBP) a fter 24 weeks. M ore than o ne q uarter of participants(n=35, 29.4%) experienced weight loss. Most common adverse event was genitourinary symptoms. CONCLUSION: In this study, the effectiveness of dapagliflozin in improving glycemic control, blood pressure control, and weight loss was statistically significant. However, elderly and female patients, who have higher incidence of adverse events, should use dapagliflozin cautiously.

Influence of Fish Oil-Containing Lipid Emulsions on Parenteral Nutrition-Associated Liver Disease in Neonates

PURPOSE: This study is a comparative evaluation of the incidence of parenteral nutrition-associated liver disease (PNALD) when administering intravenous fat emulsions containing fish oil. METHODS: The medical records of patients who were in the neonatal intensive care unit at Severance Hospital from January, 2012 to December 2015, were reviewed retrospectively. Patients who were administered either soybean oil (SO) or SMOF (containing soybean oil, medium chain triglycerides, olive oil, and fish oil) more than 14 days were included. The patients were excluded if they were administered both agents or had underlying hepatic disease. An increase in bilirubin to 2 mg/dL was defined as PNALD. RESULTS: PNALD occurred in only 8 out of a total of 77 patients: 6 out of 31 (19.4%) in the SO group and 2 out of 46 (4.3%) in the SMOF group (P=0.055). The number of patients, whose lab values, such as direct bilirubin, total bilirubin, asparate aminotransferase (AST), alanine amino-transferase, gamma-glutamyl transpeptidase, C-reactive protein, serum triglyceride, and alkaline phosphate, exceeded the normal range, were similar in both groups. The gestational age, birth body weight, and APGAR score at 1 min and 5 min were significantly higher in the SO group and the PN duration was significantly long in the SMOF group. Considering only term infants, there were no significant differences in baseline characteristics and incidence of PNALD. The number of patients whose AST exceeded the normal range was significantly higher in the SO group (P=0.034). CONCLUSION: The incidence of PNALD was similar in both groups. On the other hand, considering the tendency, there was a high correlation between the type of lipid emulsion and an increased direct bilirubin level in the SO group.

A Comparison of Vancomycin and Metronidazole for the Treatment of Clostridium difficile-associated Diarrhea (CDAD) in Medical Intensive Care Unit (MICU)

BACKGROUND: Clostridium difficile associated diarrhea (CDAD) is a leading cause of hospital-associated gastrointestinal illness. Risk factors for CDAD include advanced age, long-term admission, antibiotics, proton-pump inhibitor or H₂ blocker use and immunosuppression. The practice guideline of American Journal of Gastroenterology (2013) suggests metronidazole for the first-line therapy of mild-moderate CDAD as well as vancomycin for severe CDAD. MICU inpatients receiving stress ulcer prophylaxis and antibiotics are susceptible to nosocomial CDAD. Therefore, this study aimed to evaluate occurrence and treatment of CDAD in MICU. METHODS: Patients who were admitted to the MICU and had CDAD from August 2012 to August 2015 were analyzed retrospectively. RESULTS: Of the 90 patients with CDAD, 20 patients (2.22%) had mild-moderate CDAD (16 received metronidazole and 4 received vancomycin therapy) and 70 patients (77.8%) had severe CDAD(54 received metronidazole and 16 received vancomycin therapy). Among the patients with mild-moderate CDAD, treatment with metronidazole or vancomycin resulted in same clinical cure in 50% of the patients (p=1.00). Among the patients with severe CDAD, treatment with metronidazole or vancomycin resulted in clinical cure in 40.7% and 50.0% of the patients, respectively (p=0.511). Clinical symptoms recurred in 7.4% of the severe CDAD patients treated with metronidazole and 6.3% of those treated with vancomycin (p=0.875). CONCLUSION: Our findings suggest that metronidazole and vancomycin are equally effective for the treatment of mild-moderate CDAD; however, vancomycin demonstrated higher clinical cure rate and lower recurrence rate for severe CDAD, although the difference was not statistically significant. For better clinical outcomes, appropriate medication use by disease severity is needed.

Changes in Renal Function by Nebulized Colistimethate Treatment

BACKGROUND: Nebulized colistimethate is increasingly used, because there are problems such as renal dysfunction and low distribution within the lungs when colistimethate is administered intravenously. This study was designed to compare and analyze the changes in renal function by of nebulized colistimethate treatment for its safe administration. METHODS: This study retrospectively reviewed the electronic medical records of adult patients above 19 years old, receiving only the nebulized colistimethate at least 4 days in Yonsei university health system from Nov 2014 to Aug 2015. Acute kidney injury (AKI) was determined by using the RIFLE criteria (Risk, Injury, Failure, Loss and End-stage renal disease) according to serum creatinine (SCr) levels before and after use of nebulized colistimethate. RESULTS: 48 patients were included our study and their SCr increased significantly after nebulized colistimethate treatment (SCr₀ vs. SCr₁; 0.85±0.80 vs. 1.00±0.82 mg/dL, n=48, p0.05). The study has a significance in that it reviewed the safety of nebulized colistimethate only treatment to national patients, analyzing its nephrotoxicity. It has confirmed that nebulized colistimethate is a safer method than intravenous injection, and requires to establish a guideline for the use of nebulized colistimethate in further studies with broader patient groups. (a): SCr Male 0.68-1.19 mg/dL, Female 0.49-0.91 mg/dL

Clinical Features of Serious Adverse Drug Reactions in a Tertiary Care Hospital in Korea / 대한내과학회지

BACKGROUND/AIMS: Several studies have reported on the clinical aspects of adverse drug reactions (ADRs). To date, no study has evaluated serious adverse drug reactions (SADRs) in Korea. The current study evaluates the clinical expression of SADRs in a Korean hospital. METHODS: We reviewed a total of 3,386 cases of SADR occurring between March 2012 and November 2015 in a single tertiary care institution (Regional Pharmacovigilance Center). RESULTS: When classified by organ system, the most common SADRs were white cell and reticuloendothelial system disorders (n = 511). Skin/appendage (n = 296) and gastrointestinal (n = 216) disorders were the fourth- and eighth-most common SADRs, respectively. The three most common single symptoms were leukopenia (n = 499 events), hypotension (n = 444) and anaphylaxis (n = 215). Leukopenia was mainly caused by anti-tumor drugs, followed by piperacilin/tazobactam (n = 28), vancomycin (n = 10) and methimazole (n = 6). Hypotension was most often caused by propacetamol injection (n = 145), while anaphylaxis was mainly caused by cefaclor (n = 19), ranitidine (n = 12), iopamidol (n = 10) and multi-vitamin infusion (n = 9). CONCLUSIONS: Significant differences were noted in the clinical aspects of ADRs and SADRs. Additional studies are warranted to further assess SADRs in response to frequently used causative drugs.

Effects of Compliance with the Nutrition Support Team in Critically Ill Pediatric Patients

PURPOSE: This study performed a comparative evaluation of nutritional condition's improvement and clinical effects in accordance with the Nutrition Support Team (NST) consultation compliance of critically ill pediatric patients. METHODS: The medical records of 64 critically ill pediatric patients (2 to 18 years old), who were officially referred to a NST consultant in pediatric intensive care unit from January to August 2015, were reviewed. The patients were divided into 2 groups according to the compliance of NST consultation answers. The total delivered/required caloric and protein ratio, weight, serum total protein, serum albumin, hemoglobin, and hematocrit were compared. RESULTS: According to the NST consultation answer, 'nutrition support increase' occupied the largest proportion at 38.5%; 'maintenance' and 'decrease' accounted for 35.7% and 18.2% respectively. The NST compliance group and non-compliance group were 20 and 14 patients, respectively. Although total delivered/required caloric ratio was significantly increased in the NST compliance group (19.7%, P=0.036), there was no significant difference in the NST non-compliance group (5.1%, P=0.692). The total delivered/required protein ratio was increased (15.1%, P=0.163) in the NST compliance group and decreased (-4.7%, P=0.774) in the NST non-compliance group. The NST non-compliance group (-8.6%, P=0.219) was further reduced weight than the NST compliance group (-1.0%, P=0.820). The serum albumin was significantly increased in the NST compliance group (13.1%, P=0.003), but there was no difference in the NST non-compliance group (7.1%, P=0.433). CONCLUSION: Although 56.7% of NST consultations were needed for nutritional interventions, a lower NST compliance (53.8%) is the limit of nutritional support. The NST compliance group was supplied adequately with more calories and protein than before consultation and a more improved nutritional status. Therefore, aggressive NST consultation can help increase the therapeutic effect by improving the nutritional status. This study will form the basis to seek ways to further enhance NST compliance.

Effect of Voriconazole or Itraconazole on the Plasma Concentrations of Tacrolimus in Lung Transplant Recipients

OBJECTIVE: This study was performed to compare the changes in the blood concentrations of tacrolimus when either itraconazole or voriconazole is together with tacrolimus to prevent or treat invasive aspergillus pneumonia (IAP) in patients with lung transplants. Therefore we can compare the degree of drug-drug interactions between tacrolimus and itraconazole against tacrolimus and voriconazole. METHODS: Patients who were admitted and had lung transplants in a territory referral hospital from September 2012 to May 2015 were analyzed retrospectively. The effects of itraconazole and voriconazole on the plasma concentrations of tacrolimus were analyzed. RESULTS: Mean tacrolimus concentrations was 10.49±2.35 ng/mL vs. 10.95±2.98 ng/mL (p=0.722), and mean concentration of tacrolimus over the dose of tacrolimus per day was 8.510±5.890 (ng/mL)/(mg/d) vs. 15.45±28.47 (ng/mL)/(mg/d) (p=0.947) in itraconazole vs. voriconazole group each. The ratio of the number of the results out of target tacrolimus concentrations to the total number of tacrolimus concentration results was 18.0±13.3% vs. 24.4±18.5% (p=0.185). CONCLUSION: There were no significant differences between itraconzaole and voriconazole to have influences on mean concentrations of tacrolimus over tacrolimus dose per weight per day. However voriconazole tended to raise tacrolimus plasma concentrations more than itraconazole. Safer and more effective drug management to prevent and treat fungal infections should be done by therapeutic drug monitoring not only of tacrolimus but of itraconazole and voriconazole in lung transplant patients.