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

OBJECTIVE: This study aimed to compare the effects of conventional and orthodontic mini-implant (OMI) anchorage on tooth movement and arch-dimension changes in the maxillary dentition in Class II division 1 (CII div.1) patients. METHODS: CII div.1 patients treated with extraction of the maxillary first and mandibular second premolars and sliding mechanics were allotted to conventional anchorage group (CA, n = 12) or OMI anchorage group (OA, n = 12). Pre- and post-treatment three-dimensional virtual maxillary models were superimposed using the best-fit method. Linear, angular, and arch-dimension variables were measured with software program. Mann-Whitney U-test and Wilcoxon signed-rank test were performed for statistical analysis. RESULTS: Compared to the CA group, the OMI group showed more backward movement of the maxillary central and lateral incisors and canine (MXCI, MXLI, MXC, respectively; 1.6 mm, p < 0.001; 0.9 mm, p < 0.05; 1.2 mm, p < 0.001); more intrusion of the MXCI and MXC (1.3 mm, 0.5 mm, all p < 0.01); less forward movement of the maxillary second premolar, first, and second molars (MXP2, MXM1, MXM2, respectively; all 1.0 mm, all p < 0.05); less contraction of the MXP2 and MXM1 (0.7 mm, p < 0.05; 0.9 mm, p < 0.001); less mesial-in rotation of the MXM1 and MXM2 (2.6degrees, 2.5degrees, all p < 0.05); and less decrease of the inter-MXP2, MXM1, and MXM2 widths (1.8 mm, 1.5 mm, 2.0 mm, all p < 0.05). CONCLUSIONS: In treatment of CII div.1 malocclusion, OA provided better anchorage and less arch-dimension change in the maxillary posterior teeth than CA during en-masse retraction of the maxillary anterior teeth.
Bicuspid ; Contracts ; Dentition ; Humans ; Incisor ; Malocclusion ; Mechanics ; Molar ; Tooth ; Tooth Movement

No abstract available.
Caves ; Esophageal and Gastric Varices ; Portal Vein

A number of case reports on occupational asthma caused by herbal medicines have been issued, for example, on Sanyak, Chunkung, Banha, and Brazilian ginseng. Recently, cases of occupational asthma induced by Sanyak and Korean ginseng have been reported, but the pathogenic mechanisms involved are unknown. This study was carried out to evaluate the immunologic mechanism underlying Korean ginseng-induced occupational asthma. A patient engaged in Korean ginseng wholesale was referred for recurrent dyspnea, wheezing, and nasal symptoms, which were aggravated at work. Allergen bronchial provocation testing to Korean ginseng extract showed a typical immediate response, and skin prick testing to Korean ginseng extract also showed a strong positive response. Moreover, serum-specific IgE levels to Korean ginseng extract were significantly higher than in controls. Enzymelinked immunosorbent assay (ELISA) inhibition tests showed a dose-dependent inhibition by Korean ginseng, but not by Dermatophagoides farinae, wheat flour, or Chinese balloon flower. Sodium dodecylsulfate-poly-acrylamide gel electrophoresis (SDS-PAGE) and immunoblotting revealed four specific Immunoglobulin E (IgE) binding components at 26, 30, 47, and 60 kDa, which were not bound by control sera. These results strongly suggest that occupation asthma induced by Korean ginseng is induced via an IgE-mediated mechanism.
Animals ; Asthma/diagnosis/*etiology/*immunology ; Bronchi/metabolism ; Electrophoresis, Polyacrylamide Gel ; Enzyme-Linked Immunosorbent Assay/methods ; Flour ; Flowers ; Humans ; Hypersensitivity/*diagnosis ; Immunoglobulin E/analysis/*chemistry ; Korea ; Occupational Diseases/diagnosis/*etiology/*immunology ; Panax/*adverse effects ; Pyroglyphidae/metabolism ; *Skin Tests

We report here a case with hypereosinophilia and peripheral artery occlusion. A 32-yr-old Korean woman presented to us with lower extremity swelling and pain. Angiography revealed that multiple lower extremity arteries were occlusive. The biopsy specimen showed perivascular and periadnexal dense eosinophilic infiltration in dermis and subcutaneous adipose tissue. Laboratory investigations revealed a persistent hypereosinophilia. She was prescribed prednisolone 60 mg daily. Her skin lesion and pain were improved and the eosinophil count was dramatically decreased. After discharge, eosinophil count gradually increased again. Cyanosis and pain of her fingers recurred. She had been treated with cyclophosphamide pulse therapy. Her eosinophilia was decreased, but the cyanosis and tingling sense were progressive. The extremity arterial stenoses were slightly progressed. Skin biopsy showed perivascular eosinophilic infiltration in the dermis and CD40 ligand (CD40L) positive eosinophilic infiltration. The serum TNF-alpha was markedly increased. These results suggest that CD40L (a member of TNF-alpha superfamily) could play a role in the inflammatory processes when eosinophil infiltration and activation are observed. We prescribed prednisolone, cyclophosphamide, clopidogrel, cilostazol, beraprost and nifedipine, and she was discharged.
Adult ; Arterial Occlusive Diseases/*diagnosis/etiology ; CD40 Ligand/analysis ; Cyanosis/etiology ; Diagnosis, Differential ; Eosinophilia/*diagnosis/etiology ; Female ; Gangrene/etiology ; Humans ; Hypereosinophilic Syndrome/blood/complications/*diagnosis ; Immunohistochemistry ; Peripheral Vascular Diseases/*diagnosis/etiology ; Skin/chemistry/pathology ; Tumor Necrosis Factor-alpha/metabolism ; Vasculitis/*diagnosis/etiology

Congenital adrenal hyperplasia refers to a group of autosomal recessive disorders that is defective in the synthesis of cortisol. The enzymes most often affected are 21-hydroxylase and 11beta hydroxylase. The low levels of cortisol stimulate the pituitary gland to release ACTH. Chronic elevation of the ACTH level causes bilateral adrenal hyperplasia and a secondary increase in androgen formation. We examined a 19 year-old woman presented with clitoral hypertrophy and vaginal spotting. The subjects basal level of serum cortisol was low, but the serum levels of ACTH, 17a-hydroxyprogesterone, deoxy-corticosterone were elevated. The urinary excretions of 17-ketosteroids and 17-hydroxycorticosteroids were also increased. The karyotyping study and transrectal ultrasonography showed normal findings. The patient underwent clitoris reduction surgery and received hydrocortisone. To the best of our knowledge, this is the first case of 11beta-Hydroxylase deficiency in Korea.
17-Hydroxycorticosteroids ; 17-Ketosteroids ; Adrenal Hyperplasia, Congenital* ; Adrenocorticotropic Hormone ; Clitoris ; Female ; Humans ; Hydrocortisone ; Hyperplasia ; Hypertrophy ; Karyotyping ; Korea ; Metrorrhagia ; Pituitary Gland ; Steroid 21-Hydroxylase ; Ultrasonography ; Young Adult

BACKGROUND: As elderly people increasing, prevalence of diabetes will increase but there was paucity of data on the epidemiology of diabetes in Korean elderly population. In this study (Southwest Seoul, SWS study) we investigated the change of prevalence of diabetes mellitus for two points in time (the years 1999 and 2002) and 3-year incidence of diabetes in elderly Korean population of southwest area of Seoul. METHODS: A sampling of 1,652 subjects in 1999 and 1,214 subjects in 2002 who are over 60 years old in southwest area of Seoul were investigated. All subjects underwent a 75 g oral glucose tolerance test (OGTT), biochemical study and anthropometric measurements. Among the 1,652 subjects in 1999, 350 subjects were followed up for 3 years and 294 subjects without diabetes at baseline examination participated in retrospective cohort study. RESULTS: Prevalence of diabetes in 1999 was 20.5% [previous diagnosed people (11.9%), newly diagnosed people (8.6%)] and in 2002 was 22.1% [previous diagnosed people (15.2%), newly diagnosed people (6.9%)]. Prevalence of impaired fasting glucose (IFG) or impaired glucose intolerance (IGT) was 22.8% in 1999 and 27.8% in 2002. In 350 subjects were followed up for 3 years, prevalence of diabetes was 16.0% in 1999 and increased to 23.4% in 2002 (p=0.014). In retrospective cohort study, the annual incidence rate of diabetes was 2.9% (age and sex adjusted rate 2.5%). CONCLUSION: Prevalence of diabetes in elderly Korean population of southwest area of Seoul was 20.5% in 1999 and increased to 22.1% in 2002. Prevalence of IFG or IGT was 22.8% in 1999 and increased to 27.8% in 2002. This report supports that impaired glucose regulations and diabetes mellitus of elderly Korean population will increase in the future as aged Korean population increases.
Aged ; Asian Continental Ancestry Group ; Cohort Studies ; Diabetes Mellitus* ; Epidemiology ; Fasting ; Glucose ; Glucose Intolerance ; Glucose Tolerance Test ; Humans ; Incidence* ; Middle Aged* ; Prevalence* ; Retrospective Studies ; Seoul ; Social Control, Formal

BACKGROUND: Sensitization to food allergens is associated with development of food allergy. Although rates of sensitization to food allergens are different according to countries, there has not been surveyed on the sensitization rate to each food allergen in Korean population. The aim of this study was to evaluate the food allergen sensitization rate among patients who visited allergy clinics at several university hospitals in Korea. METHODS: This study was carried out on 1,425 patients who visited allergy clinics with various allergic symptoms. They had skin prick test for 62 items to evaluate sensitization to food allergens. RESULT: The food allergens of which sensitization rate was above 1% were pupa of a silkworm, shrimp, chestnut, curry, potato, soybean, rice flour, buckwheat, cabbage, mackerel, abalone, lobster, turban shell, arrowroot in decreasing order. The sensitization rate of pupa was highest among them by 9.4% and that of shrimp followed by 5.8%. The sensitization rates of food allergens were generally higher in males and young adults than in those of females and old people. Atopic patients for inhalant allergens showed higher sensitization rates of food allergens than non-atopic patients for inhalant allergens. CONCLUSION: Common food allergens sensitized in a Korean population were different from those in other countries. Pupa of a silkworm, shrimp, chestnut, curry, potato, soybean, rice flourbuckwheat, cabbage, mackerel were the 10 most common food allergens sensitized in Korean population above 10 years old.
Allergens* ; Bombyx ; Brassica ; Child ; Fagopyrum ; Female ; Flour ; Food Hypersensitivity ; Hospitals, University ; Humans ; Hypersensitivity ; Korea ; Male ; Marantaceae ; Perciformes ; Pupa ; Skin ; Solanum tuberosum ; Soybeans ; Young Adult

BACKGROUND AND OBJECTIVE: There are many differences in common inhalant allergens between countries and regions. We need to determine the major inhalant allergens in this country with geographical characteristics. To observe the major inhalant allergens and establish essential ones for the skin prick test in Korea, a nation-wide multicenter study was performed. METHOD: The skin prick tests were performed with the same kits of 43 allergens on 2,554 allergy patients who visited their regional hospitals for one year. RESULT: There are significant differences in the sensitization rate to common inhalant allergens among the centers. Twenty three allergens showed > or=5% sensitization rate: D. pteronyssinus, D. farinae, Tyrophagus putrescentiae, Tetranychus urticae, Panonychus citri, Alternaria alternata, Cladosporium tenuis, cat fur, dog hair, American and German cockroach, tree pollen mixture I, alder, hazel, tree pollen mixture II, birch, beech, oak, plane tree, ragweed, mugwort, hop Japanese and chrysanthemum. CONCLUSION: We suggest the major allergens such as D. pteronyssinus, D. farinae, T. putrescentiae, T. urticae, P. citri, outdoor molds, indoor molds, cat fur, dog hair, German and American cockroaches, tree pollens, mugwort, and hop Japanese pollen should be included in skin test battery in Korea.
Allergens* ; Alnus ; Alternaria ; Ambrosia ; Animals ; Artemisia ; Asian Continental Ancestry Group ; Betula ; Blattellidae ; Cats ; Chrysanthemum ; Cladosporium ; Dogs ; Fagus ; Fungi ; Hair ; Humans ; Humulus ; Hypersensitivity ; Korea* ; Periplaneta ; Pollen ; Skin ; Skin Tests

BACKGROUND: In order to evaluate the effects of the duration of hemodialysis on cell mediated immunity, we studied cellular immune responses in vitro in 12 patients on chronic hemodialysis and in 6 healthy volunteers with normal kidney function. METHODS: The patients on maintenance hemodialysis were divided into two subgroups according to the duration of the hemodialysis: Group 1 (within 5 years, n=6) and Group 2 (>5 yr and < or =10 yr, n=6). Group 3 include the normal control (n=6). The peripheral blood lymphocytes of each group were cultured in RPMI medium 1640 without/or with 3 microgram of phytohemagglutinin (=PHA) for 7 days. RESULTS: CD4 /CD8 ratio at 48hours was totally comparable between the uremic patients (Group 1 and Group 2) and the controls (Group 3). The proportions of CD25 T lymphocytes after 48 hours culture were abnormally high: 7.1+/-0.5% and 7.0+/-1.3% in the uremic patients as compared to 2.5+/-0.6 in the normal controls at the basal state and 66.7+/-2.6% and 68.8+/-1.9% in the uremic patients as compared to 78.3+/-4.6% in the normal controls at the PHA-stimulated condition. The spontaneous production of IL-2 (mean pg SEM) was significantly lower in hemodialized patients (Group 1: 34.5+/-6.0 pg/ml, Group 2: 33.8+/-6.2 pg/ml) as compared to the normal patients (Group 3: 58.8+/-10.4 pg/ml). The PHA stimulated IL-2 production was also significantly reduced in the hemodialized patients (Group 1: 53.2+/- 13.3 pg/ml, Group: 53.0+/-10.3 pg/ml) as compared to the normal patients (Group 3: 150.0+/-24.5 pg/ml). The mean proliferative response to PHA at each point in the hemodialized patients were significantly lower than those of the controls. CONCLUSIONS: These data show that there is no significant correlation between the level of the cell mediated immune response and the duration of hemodialysis. Several defects in the cell mediated immune response associated with uremia might start at an early phase of the hemodialysis.
Healthy Volunteers ; Humans ; Immunity, Cellular* ; Interleukin-2 ; Kidney ; Kidney Failure, Chronic* ; Lymphocytes ; Renal Dialysis* ; T-Lymphocytes ; Uremia