BACKGROUND: Aprotinin, a serine protease inhibitor, has an anti-inflammatory and hemostatic effect and has been used to reduce perioperative blood loss and lung injury after cardiopulmonary bypass in cardiac surgery. Acute respiratory distress syndrome (ARDS), which results in clinical manifestations due to non-cardiogenic permeability edema is a fatal condition associated with a mortality rate of 50 to 80%. The purpose of this study was to evaluate the effects of aprotinin on acute lung injury induced by bacterial endotoxin in rabbits. METHODS: Nineteen rabbits were anesthetized with intravenous xylazine, Ketamine and vecuronium and ventilated with a Harvard apparatus maintaining normocapnea. In 7 rabbits, 2 mg/Kg of lipopolysaccharide from E. coli was infused intravenously for 30 min (Toxin group) and in another 7 rabbits aprotonin loading with 200,000 KIU/Kg followed by a continuous infusion of 50,000 KIU/Kg/hr was performed 30 min before the endotoxin infusion throughout the experiment (Aprotinin group). At 1, 2, 3, and 4 hours after endotoxin infusion, arterial blood gas, blood cell count, prothrombin time, activated partial thromboplastin time, fibrinogen, and hemodynamic profiles were checKed. At four hours, the animals were dissected at which time the lungs were divided into three regions for wet/dry weight ratio (WW/DW), myeloperoxidase activity and microscopic examination. RESULTS: In the Aprotinin group, pulmonary vascular resistance, arterial oxygen partial pressure and coagulation function were well preserved compared with the Toxin group. Furthermore, lung WW/DW, myeloperoxidase activity, and inflammatory responses also increased less in the Aprotinin group. CONCLUSIONS: The results of the current data showed that aprotinin has prophylactic effects against acute lung injury and coagulation impairment induced by bacterial endotoxin in rabbits.
Acute Lung Injury* ; Animals ; Aprotinin* ; Blood Cell Count ; Cardiopulmonary Bypass ; Edema ; Fibrinogen ; Hemodynamics ; Ketamine ; Lung ; Lung Injury ; Mortality ; Oxygen ; Partial Pressure ; Partial Thromboplastin Time ; Permeability ; Peroxidase ; Prothrombin Time ; Rabbits* ; Respiratory Distress Syndrome, Adult ; Serine Proteases ; Thoracic Surgery ; Vascular Resistance ; Vecuronium Bromide ; Xylazine

The purpose of this study was to develop and test the validity of standardized Korean nomenclature of the International Classification for Nursing Practice (ICNP), developed by the International Council of Nursing (ICN). The four phases of the study were: (1) Two professors and 15 graduate students translated who were taking a nursing intervention course, translated nursing phenomena and nursing action of the ICNP into Korean; (2) 12 nurses with various clinical backgrounds reviewed the nomenclature taking into consideration of the definition, and contents for each Korean nursing terminology, and the Delphi method was used to determine the best appropriate nomenclature for each terminology; (3) 20 academic and clinical experts in nursing were given a questionnaire to rate the validity of each Korean nomenclature using a 5 point Likert scale ranging from very inappropriate to very appropriate; (4) five members of the Korean Nurses Association Research Committee reviewed the survey results and determined the most appropriate Korean nomenclature for each nursing phenomena and activity of the ICNP. Most nomenclature of the ICNP had a score of more than 4.0, but four nursing phenomena had a score between 3.5 and 4.0: Unilateral neglect(3.86), Care Giver strain (3.86), Health denial(3.86), Health Adjustment (3.86) and draining(2.63) . In nursing activity 726 items, except for twelve items, had a score of over 4.0: Drainage(2.63) Weaning(3.13), Caring(3.75), Cold Wrapping(3.63), distraction Technique(3.57), drawing(3.88), Establishing Report with(3.5), Heating Wrapping(3.5), Manipulating(3.75), Performing(3.88), Reading material(3.75) and Restricting(3.75).
Caregivers ; Classification ; Heating ; Hot Temperature ; Humans ; Nursing

This study was carried out to reduce children's sugar, natrium and fat intakes and establish their healthy lifestyle. To achieve these goals, we developed an educational web site and an e-learning system. The targets of this web site are children, parents and educators. This site has various information about sugar, natrium and fat, and has special menus for each target: such as the 'Let's study' for children, 'Guides for child's eating' for parents, and 'Educational softwares, Lesson plans/materials, and Textbooks/Teaching guides' for educators. We developed three nutrient characters and applied them to the web site. We provided information in the form of texts, images, flash and sounds. This site has special boards in 'Nutrition cafe' menu to interchange information or their successful stories between the connecters. We developed an e-learning system with two courses. One is for junior elementary students and the other is for senior students. Children can study each nutrient step by step in a course according to their academic ability and concern. Also, they can evaluate their academic achievement in this system, which was uploaded into 'Let's study' in children menu in the web site. Conclusively this web site and e-learning system could contribute to reducing children's sugar, natrium and fat intakes by helping children study them systematically and effectively by on-line system. We expect this e-learning system would be a new nutrition education system to make nutrition education more active.
Achievement ; Child ; Humans ; Life Style ; Online Systems ; Parents

Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.
Equipment and Supplies ; Equipment Safety ; In Vitro Techniques ; Indicators and Reagents ; Korea* ; Licensure ; Magnets ; Needles

PURPOSE: Tegafur, an oral prodrug of 5-fluorouracil (5-FU), has been used in the treatment of gastric cancers. UFT (tegafur + uracil) has been developed to enhance the efficacy of tegafur. This study was conducted to assess the pharmacokinetics (PK) of tegafur in gastric cancer patients given the ECU-E regimen (epirubicin, cisplatin, UFT-E, an enteric-coated formula of UFT). A preliminary evaluation of antitumor efficacy and toxicity of ECU-E regimen was also performed. MATERIALS AND METHODS: Of the 32 gastric cancer patients registered for the ECU-E regimen, 8 participated in the PK study. The plasma concentration of tegafur was determined using HPLC. RESULTS: Seven out of the 8 patients were evaluable for response after 2 cycles, and showed 3 partial responses, 1 stable disease and 3 progressive diseases. No major toxicities were observed. Plasma profiles of the tegafur after the first dose showed significant differences in the amount and rate of absorption, i.e., rapid absorption group vs. slow absorption group. The level of C(max) in the rapid absorption group was 1.8 fold higher, and the AUC(0-5h) 4 fold greater, than those in the slow absorption group, nonetheless, the steady state concentrations showed no significant difference. These data indicate that the different absorption rates may not affect the overall exposure to tegafur. The patients with low Cp(ss, peak) showed poor efficacy compared to those with high Cp(ss, peak), suggesting that the concentration of tegafur may be one of the pharmacodynamic determinants in patients administered with ECU-E. CONCLUSION: This study evaluated the pharmacokinetics of tegafur in gastric patients given the ECU-E regimen, and provides preliminary data on the relationship between the plasma tegafur level and the efficacy, which warrants further evaluation.
Absorption ; Chromatography, High Pressure Liquid ; Cisplatin* ; Epirubicin* ; Fluorouracil ; Humans ; Pharmacokinetics* ; Plasma ; Stomach Neoplasms* ; Tegafur* ; Uracil

BACKGROUND: Because doxylamine succinate (DS) is an over-the-counter medicine, it can be obtained easily and is frequently used in suicidal attempts. Patients usually recover without serious complications, but occasionally rhabdomyolysis and even death can occur in DS intoxication. In this study, the authors tried to find out the independent predictors of high peak serum CK levels, i.e. probable rhabdomyolysis in DS intoxication. METHODS: The medical records of 41 patients who visited a hospital for DS intoxication from January 1, 2002 to April 30, 2003, were reviewed retrospectively. RESULTS: In the group of DS only, initial occult blood of urine (P=0.003), initial WBC count (P=0.003) and confusion (P=0.007) were the best predictors of the peak serum CK level (2=0.724). In the group of DS with other drugs intoxication, initial creatinine level (P=0.003) and initial occult blood of urine (P=0.007) were the best predictors of the peak serum CK level (r2=0.784). In the cases of rhabdomyolysis patients, the time taken for the CK level to be increased over 1,000 IU/L was 1.9level to be increased over 1,000 IU/L was 1.9+/-0.6 days. CONCLUSION: In DS only intoxication, occult blood in initial urine analysis, initial high WBC count and confusion can be thought of as useful clinical predictors for high peak serum CK level case. In DS with other drugs intoxication, initial creatinine level and initial occult blood of urine can be considered as the best predictors. More than 2 days will be needed for the observation of serious complications in DS intoxication.
Creatinine ; Doxylamine* ; Humans ; Medical Records ; Occult Blood ; Retrospective Studies ; Rhabdomyolysis ; Succinic Acid

BACKGROUND: Metastatic breast cancer is a systemic disease, and its treatment aims at the palliation or cure of the disease. In recent years, good results have been reported in the treatment of metastatic breast cancer by using single-agent paclitaxel chemotherapy. METHODS: We performed a retrospective study by analyzing the medical records of patients treated at Kangnam St. Mary's Hospital between May 1995 and May 1997. A total of 29 patients with metastatic breast cancer were treated by a 135-mg/m2, 3-hour infusion of paclitaxel. The results were reviewed with respect to the response rates and the toxicities of paclitaxel. RESULTS: The overall response rate was 13.8%: CR (complete response rate) 3.4% (1 out of 29) and PR (partial response rate) 10.3%(3 out of 29). The most common and severe toxicity was leukopenia. However, there was no mortality, and the patients were tolerated this therapy. CONCLUSIONS: Paclitaxel as a single-agent therapy for metastatic breast cancer is tolerable, but less effective, than reported.
Breast Neoplasms* ; Breast* ; Drug Therapy ; Humans ; Leukopenia ; Medical Records ; Mortality ; Paclitaxel* ; Retrospective Studies

This study was conducted to reduce sodium (Na) intake and to establish healthy dietary lifestyles of children. To achieve these goals, we searched, collected, and analyzed the materials related to the Na education, based on which the research personnel-professors and graduate students in nutrition and child education and elementary school teachers discussed to figure out major topics, objectives, and detailed contents and activities appropriate for Na intake reduction. Also a survey was done on the sodium intake and nutrition knowledge of the elementary students. We also organized an advisory committee composed of 15 professionals in related fields to discuss the adequacy and validity of the specific contents. Finally, we systematically organized the contents and developed children's textbooks and teacher's guidebooks. Considering the different cognitive development stages of junior and senior elementary students, we developed two different textbooks for each of them which are easy to read and understand, fun to play with lots of activities, and designed to practice into daily life. The contents cover three major topics-the concept of Na, Na in food, Na in life and are composed of 6 units in total. To help teachers understand and instruct, teacher's guidebook contains an overview of the education, specific information and practical guidelines for each class. We developed these education materials with the aim of lowering children's Na consumption and eventually promoting their health welfare; hopefully we expect these materials would be useful for children's nutritional education in the field.
Advisory Committees ; Child ; Humans ; Life Style ; Sodium

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission.Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission.Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.