1.Greenness and kidney? A review of epidemiological studies on the association between green space and kidney disease
Jiwoo PARK ; Hyewon YUN ; Whanhee LEE
Kidney Research and Clinical Practice 2024;43(1):63-70
Recent accumulating epidemiological evidence underlines the important role of environmental exposures on kidney diseases. Among environmental exposures, this study addresses “Green space,” which has been recognized as one of the major environmental exposures at the population level. We review a total of seven epidemiological studies currently published on greenness and kidney disease. We also discuss knowledge gaps in the epidemiological evidence in relation to study design, greenness exposure index, emerging kidney outcomes, and inequalities. With an increase in public attention regarding environmental risks and climate change, an improved understanding of the beneficial effects of green space can play an important role in promoting kidney health.
2.Cardiomyopathy in Patients with Myasthenia Gravis Crisis
Hyewon LEE ; Sihyun KIM ; Kwando PARK ; Min Su PARK
Journal of the Korean Neurological Association 2019;37(4):400-402
Myasthenia gravis (MG) crisis is a life-threatening condition characterized by respiratory failure requiring intubation and mechanical ventilation. Cardiac problem in patients with MG crisis is a rare condition, presenting as cardiomyopathy, arrhythmia, heart failure and sudden death. We report two cases that developed arrhythmia and stress-induced cardiomyopathy during MG crisis episodes.
Arrhythmias, Cardiac
;
Cardiomyopathies
;
Death, Sudden
;
Heart Failure
;
Humans
;
Intubation
;
Myasthenia Gravis
;
Respiration, Artificial
;
Respiratory Insufficiency
3.Regional Citrate Anticoagulation for Continuous Renal Replacement Therapy in Children.
Journal of the Korean Society of Pediatric Nephrology 2005;9(1):76-82
PURPOSE: Regional anticoagulation with trisodium citrate for continuous renal replacement therapy(CRRT) is an effective and safe method, with lower bleeding risk. However it is not widely used because of complex current protocols used to prevent anticipated metabolic derangements. We evaluated simplified regional anticoagulation protocols with ACD-A(R) solution and commercially available calcium-containing dialysis solution. METHODS: The medical records of twenty-eight patients who underwent CRRT were reviewed. Hemofilter life span according to the anticoagulation method used was compared, and laboratory findings at pre- and 48 hours post-CRRT initiation were compared in the citrate-based CRRT group. RESULTS: Of the twenty-eight patients, five patients underwent citrate-based CRRT. Hemofilter life span was 1.60+/-0.72 days, showing no significant differences with the hemofilter life span in the heparin based and LMWH based CRRT group. No patients experienced hemorrhagic complications. PT, aPTT, sodium, tCO2, iCa levels showed no difference in pre- and post-CRRT. Total calcium levels were increased. At the recommended postfilter iCa level, i.e., 0.25-0.39 mmol/L, all five patients needed increased amount of citrate infusion, and Ca infusion requirement was decreased. CONCLUSION: Simplified regional citrate anticoagulation with calcium-containing dialysate is an effective and safe method, and is not associated with increased hemofilter clotting. However, increased postfilter iCa level is recommended.
Calcium
;
Child*
;
Citric Acid*
;
Dialysis
;
Hemorrhage
;
Heparin
;
Heparin, Low-Molecular-Weight
;
Humans
;
Medical Records
;
Renal Replacement Therapy*
;
Sodium
4.Continuous Renal Replacement Therapy in Pediatrics.
Korean Journal of Pediatrics 2004;47(1):1-5
Continous renal replacement therapy(CRRT) is becoming increasingly popular for the support of critically ill patients with acute renal failure, and the development of pump-driven volumetric-control CRRT machines with small extracorporeal volumes has lead to the widespread use of venovenous form of CRRT in pediatric field. Basic principles are diffusion and convection. CRRT is indicated in the hemodynamically unstable pediatric patients for hypervolemic anuric acute renal failure, electrolyte abnormalities, multiorgan failure, catabolic patients with increased nutritional needs and hyperammonemia, etc. To date, experiences are limited for pediatric CRRT, but current reports support that CRRT is feasible and useful in children and even infants, and the survival rate of the patients on CRRT is as same as adults. We describe the basic principles, equipments, methods and complications of CRRT, with special considerations on small children to meet the current need for CRRT.
Acute Kidney Injury
;
Adult
;
Child
;
Convection
;
Critical Illness
;
Diffusion
;
Humans
;
Hyperammonemia
;
Infant
;
Pediatrics*
;
Renal Replacement Therapy*
;
Survival Rate
5.Late Cytomegalovirus Disease Causes Ileal Perforation after Kidney trasplantation.
Hee Woo LEE ; Hyewon HAHN ; Young Seo PARK
Journal of the Korean Society of Pediatric Nephrology 2011;15(1):76-80
Cytomegalovirus (CMV) is the single most common infection following kidney transplantation and despite prophylactic strategies and the development of new antiviral agents, it still remains a cause of considerable morbidity and mortality. Current literature suggests that CMV infection may trigger rejection. We report a case of late CMV disease in a preemptive seropositive recipient who did not receive CMV prophylaxis. Diarrhea and abdominal cramping persisted after the administration of mycophenolate mofetil (MMF) six months after transplantation and resulted in ileal perforation at eight months after transplantation. The boy recovered after six weeks of treatment with ganciclovir. MMF has been mooted as a risk factor for CMV infection since its introduction, and further investigations are required to confirm its role. More attention to infectious complications is necessary and serial monitoring of viral load is recommended when MMF is administered.
Antiviral Agents
;
Colic
;
Cytomegalovirus
;
Diarrhea
;
Ganciclovir
;
Kidney
;
Kidney Transplantation
;
Mycophenolic Acid
;
Risk Factors
;
Transplants
;
Viral Load
8.Comparison of the Expedited Programs for Innovative Drug Development and Approval among United States, European Union, and Republic of Korea
Jiyeon PARK ; Hyewon SHIN ; Jangik. I. LEE
Korean Journal of Clinical Pharmacy 2024;34(1):39-61
Background:
The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs.
Methods:
The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The informa-tion on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale,application procedure, and maintenance.
Results:
FDA’s programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA’s regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions.
Conclusion
Each expedited program requiresa different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innova-tive medication development.
9.Comparison of the Expedited Programs for Innovative Drug Development and Approval among United States, European Union, and Republic of Korea
Jiyeon PARK ; Hyewon SHIN ; Jangik. I. LEE
Korean Journal of Clinical Pharmacy 2024;34(1):39-61
Background:
The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs.
Methods:
The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The informa-tion on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale,application procedure, and maintenance.
Results:
FDA’s programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA’s regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions.
Conclusion
Each expedited program requiresa different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innova-tive medication development.
10.Comparison of the Expedited Programs for Innovative Drug Development and Approval among United States, European Union, and Republic of Korea
Jiyeon PARK ; Hyewon SHIN ; Jangik. I. LEE
Korean Journal of Clinical Pharmacy 2024;34(1):39-61
Background:
The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs.
Methods:
The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The informa-tion on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale,application procedure, and maintenance.
Results:
FDA’s programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA’s regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions.
Conclusion
Each expedited program requiresa different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innova-tive medication development.