PURPOSE: This post-marketing surveillance study (NCT00750360) assessed the safety and reactogenicity of an inactivated, trivalent split-virion influenza vaccine licensed for use in the Korea since 2002. METHODS: Eight hundred and eighty three subjects aged > or =6 months received a single dose of the vaccine; an additional dose was administered to those aged <9 years and unprimed with an influenza vaccine. Four hundred and eleven subjects used diary cards to record safety information; this report presents data from these subjects. Incidence of solicited local, general and unsolicited adverse events (4-days and 21-days post-vaccination follow-up periods, respectively) were recorded. Serious adverse events (SAEs) were recorded throughout the study period. RESULTS: Injection site pain (subjects aged <6 years: 12.6% of subjects, > or =6 years: 34.7%), fever (<6 years: 1.3%) and myalgia (> or =6 years: 13.9%) were the most frequently recorded solicited local and general adverse events. Grade 3 solicited adverse events were reported by < or =4.0% subjects. No vaccine-related SAEs were recorded (KFDA criteria). CONCLUSION: Considering the vaccine's well-established immunogenicity and its favourable safety and reactogenicity profile across all age groups and its high coverage rate in Korea, it may be recommended as a candidate to facilitate annual seasonal influenza vaccination for all ages as part of the Korean National Immunization Program.
Aged ; Fever ; Follow-Up Studies ; Humans ; Immunization Programs ; Incidence ; Influenza Vaccines ; Influenza, Human ; Korea ; Seasons ; Vaccination

BACKGROUND: The recent studies shows that LV relaxation abnormalities are the important factors of heart failure in elders. To determine the association between LV diastolic functions and heart failure, we assessed LV diastolic functions in elderly patients with pulmonary congestion and in asymptomatic elders by using pulsed doppler echocardiography. METHODS: In order to assess LV diastolic function, we performed pulsed doppler echocardiography to elderly patients with pulmonary congestion and asymptomatic elders from Mar.2001 to Sep.2001. The following parameters were used as indices of LV diastolic function; Mitral E wave(E), Mitral A wave(A), Deceleration time(DT), Isovolumic relaxation time(IVRT), Systolic pulmonary venous flow(PVs), Diastolic pulmonary venous flow(PVd). RESULTS: In elderly patients groups, there was significant increase in deceleration time compared with asymptomatic elders(255.83+/-54.41 vs 210.80+/-48.53, p<0.05). There was significant increase in isovolumic relaxation time in elderly patient group compared with asymptomatic elders(123.06+/-25.07 vs 98.78+/-15.12, p<0.01). Although there was no significant difference, decreased E/A ratio and increased PVs/PVd were noted in both groups. CONCLUSIONS: The results shows that the impairments of LV diastolic function were noted in both groups. Especially DT and JVRT were significant increase in elderly patient group with pulmonary congestion. Therefore these parameters, such as DT, IVRT, can be helpful as predictive indices of diastolic heart failure in elders.
Aged* ; Deceleration ; Echocardiography, Doppler, Pulsed ; Estrogens, Conjugated (USP)* ; Heart Failure ; Heart Failure, Diastolic ; Humans ; Relaxation

PURPOSE: Cow's milk protein-induced enterocolitis (CMPIE) is a symptom complex of vomiting and/ or diarrhea caused by delayed hypersensitivity and may result in serious complications. This study was undertaken to identify high risk factors to facilitate the early recognition of CMPIE. METHODS: We reviewed the data of 101 patients, aged 15 to 45 days, admitted due to vomiting and/ or diarrhea between 2003 and 2004. After excluding 13 patients absolutely breast-fed and 2 patients transferred from other hospitals with the impression of CMPIE, the 86 study subjects were divided into three groups based on the underlying etiologies; CMPIE, infectious and non-infectious group. RESULTS: CMPIE was diagnosed in 11 patients (12.8%). On admission, failure to gain weight (P= 0.003), hypoalbuminemia (P=0.003), peripheral leukocytosis (P=0.015), and metabolic acidosis (P=0.014) were more significant in the CMPIE group than in the others. Multiple logistic regression analysis showed that the independent predictors of high risks for CMPIE were failure to gain weight < 10 g/day (OR, 10.25[95% CI, 1.62-65.06]) and serum hypoalbuminemia < 3.5 g/dL (OR, 9.18[95% CI, 1.69- 49.74]). Cow's milk challenges were performed in the 11 CMPIE patients; vomiting (81.8%), abnormal stool test (80.0%), peripheral leukocyte count and absolute neutrophil count (ANC) increase (100.0%) (P< 0.05), and enteropathy (100.0%). CONCLUSION: CMPIE is not a rare clinical disease in early infancy. The high risk factors of CMPIE were identified as follow: failure to gain weight below 10 g/day, hypoalbuminemia on admission and a rapid decrease during admission. Cow's milk challenge test with endoscopic duodenal biopsy was helpful to confirm CMPIE.
Acidosis ; Biopsy ; Diarrhea ; Enterocolitis* ; Humans ; Hypersensitivity, Delayed ; Hypoalbuminemia ; Leukocyte Count ; Leukocytosis ; Logistic Models ; Milk* ; Neutrophils ; Risk Factors* ; Vomiting

BACKGROUND: Lipoprotein (a) concentration is mainly determined by apo (a) genotype, but elevated in the atherosclerotic vascular disease more than in normal group with the same apo (a) phenotype. It has been known that Lp (a) has independent metabolism in contrast with other lipoproteins and that the use of cholesterol lowering agent such as HMG-CoA reductase inhibitor for 6 months does not change the level of Lp (a). The results of several studies suggests that Lp (a) may be related to inflammation of atherosclerotic plaque and therefore, long term use of cholesterol lowering agents make plaque stable by reduction of inflammation at plaque. We hypothesized that there is a relationship between long term use of HMG-CoA reductase inhibitor and change of Lp (a) level. We prospectively measured Lp (a), lipids and inflammatory markers before and after long term use of HMG-CoA reductase inhibitor to examine our hypothesis. METHODS: Forty-nine subjects (M:F=28:21, age=59.1+/-12.0) with hyperlipidemia were administered HMG-CoA reductase inhibitor for 15 months (minimum 6 months, maximun 44 months), and Lp (a), lipids and inflammatory markers were measured before and after use of the HMG-CoA reductase inhibitor. In control group (ninty-nine subjects, M:F=60:39, age=61.2+/-9.2), these parameters were measured more than 6 months. RESULTS: In the hyperlipidemia group who were given HMG-CoA reductase inhibitor, baseline levels of total cholesterol, TG, LDL were significantly elevated more than those of the control group, but Lp (a) and inflammatory markers were not significantly different. After use of HMG-CoA reductase inhibitor, the level of Lp (a) was reduced significantly (before 28.9+/-29.3 mg/dl, after 20.0+/-19.0 mg/dl, p=0.009), but not significantly in the control group. There was a minimal relation between baseline Lp (a) levels and percent changes of Lp (a) levels. Total cholesterol and LDL levels reduced significantly after use of the drug, but inflammatory markers did not. CONCLUSION: These data showed that Lp (a) level in the hyperlipidemia group after the long term use of HMG-CoA reductase inhibitor decreased significantly. We suggest that these changes of Lp (a) level may be one of reliable markers for plaque stability in atherosclerotic vascular disease.
Atherosclerosis ; Cholesterol ; Genotype ; Hyperlipidemias ; Inflammation ; Lipoprotein(a) ; Lipoproteins ; Metabolism ; Oxidoreductases* ; Phenotype ; Plaque, Atherosclerotic ; Prospective Studies ; Vascular Diseases

OBJECTIVE: As per the requirement of Korean Food and Drug Administration, this post-marketing surveillance was conducted in Korea to evaluate the safety and reactogenicity of Poliorix(TM) following its introduction in 2006. METHODS: In this open, multicenter study, the vaccine was administered as per the current practice of Korean doctors and in reference to the guidebook by the Korean Pediatric Society and as indicated in the Korean label which was as follows - for primary vaccination three doses were given to infants at ages 2, 4 and 6 months whereas, for the booster dose a single dose was given to children aged 4-6 years. Safety data during this six year surveillance was collected using diary cards which were distributed to the parents to record adverse events. RESULTS: A total of 639 subjects were enrolled into the study. Of these, 617 subjects and 22 subjects received the vaccine as a primary and booster dose, respectively. At least one unsolicited symptom was reported in 11.4% (73/639) of the subjects during the 7-day follow-up period; upper respiratory tract infection (2.5%;16/639) was the most frequently reported unsolicited symptom. One subject reported at least one unsolicited symptom (gastroenteritis) of grade 3 intensity within the 31-day post-vaccination period. Approximately 1.7% (11/639) of subjects reported 13 serious adverse events (SAEs). All SAEs were resolved by the end of the study. CONCLUSION: In Korea, primary and booster vaccination with Poliorix(TM) was well-tolerated in healthy subjects when administered according to the prescribing information as part of routine clinical practice.
Child ; Follow-Up Studies ; Humans ; Infant ; Korea* ; Parents ; Poliomyelitis* ; Respiratory Tract Infections ; United States Food and Drug Administration ; Vaccination

BACKGROUND AND OBJECTIVES: Despite the trend in the medical field to understand the effect of diseases on the quality of life, such a study regarding sleep apnea has not been prevailing in Korea. This study analyzed the result of a Medical Outcome Study Short Form-36 (SF-36), which is widely used to evaluate the effect of sleep apnea on patient's medical condition. SUBJECTS AND METHOD: This study included 131 patients of over 18 years of age and who participated in the SF-36 survey and finished the polysomnography study. The relationship between parameters was conducted with Spearman, and the comparison with the independent variables was done by running a paired t-test. RESULTS: AHI was on average 30.9+/-23.5 and BMI was on average 26+/-3.9 kg/m. Except body pain, all values which derived from the statistics of eight categories of SF-36 from the patients was significantly lower than those of the healthy control. In the comparable analysis of polysomnography and SF-36, AHI, the total sleep time, and the sleep efficacy (%) had significant correlation, but correlation coefficient was low (r<3.0). CONCLUSION: It is recommended that the quality of life of OSAS patients should be evaluated beside PSG in order to find out the degree of seriousness of OSAS and result of treatment.
Humans ; Korea ; Outcome Assessment (Health Care) ; Polysomnography ; Quality of Life ; Running ; Sleep Apnea Syndromes ; Sleep Apnea, Obstructive

OBJECTIVE: To investigate the kinematic and kinetic characteristics of stair ascent in patients with knee osteoarthritis. METHOD: Twenty patients with knee osteoarthritis and twenty healthy controls were recruited. The kinematic and kinetic data were obtained through a three dimensional motion analyzer. The kinematic and kinetic data during stair ascent were compared between two groups. RESULTS: The total required time of stair ascent was significantly longer in the osteoarthritis group than that of the control group (p<0.05). In comparison with the control group, the angle of maximal pelvis anterior tilting, minimal and maximal hip flexion and minimal knee flexion were significantly increased (p<0.05). However, the angle of knee flexion and ankle dorsiflexion at initial contact were significantly decreased in the osteoarthritis group (p<0.05). The maximal moment and power of knee extension and ankle plantarflexion were significantly decreased in the osteoarthritis group (p<0.05). Sixteen patients (80.0%) in the osteoarthritis group showed flexion arc after initial contact. "W" sign was shown in 16 patients (80.0%). CONCLUSION: We found the unique kinematic and kinetic patterns during stair ascent in patients with knee osteoarthritis, and that knee osteoarthritis influence not only kinematic and kinetic patterns of knee but also those of hip and ankle.
Ankle ; Hip ; Humans ; Knee* ; Osteoarthritis ; Osteoarthritis, Knee* ; Pelvis

Burkitt's lymphoma is a distinct clinical entity classified as an undifferentiated lymphoma of B-lymphocytic origin. Burkitt's lymphoma cell leukemia occurs when Burkitt's lymphoma cells represent more than 20% of marrow cells and exceed about 5000/ul in blood. We report a case of Burkitt's lymphoma cell leukemia in primary gastric lymphoma in 55-year-old man with 5kg of weight loss for 2 months and epigastric pain for 3 days. Primary gastric lymphoma was diagnosed by biopsies with gastrofiberoscopy and upper abdominal CT scan in this patient. During admission, peripheral blood smear revealed sudden increase in abnormal blasts with multiple vacuoles. Burkitt's lymphoma cell leukemia was diagnosed by peripheral blood smear, bone marrow aspiration and biopsy, immunophenotyping and cytogenetic analysis in this patient. For its great rarity, we report this case with review of literature.
Biopsy ; Bone Marrow ; Burkitt Lymphoma* ; Cytogenetic Analysis ; Humans ; Immunophenotyping ; Leukemia* ; Lymphoma* ; Lymphoma, Non-Hodgkin ; Middle Aged ; Tomography, X-Ray Computed ; Vacuoles ; Weight Loss

Cases with extranodal Hodgkin's disease located in sites outside those defined as lymphatic structure are quite rare. The exact incidence of this localized form of Hodgkin's disease is unknown, but it is estimated to be only 0.25% for overall incidence of Hodgkin's disease. Localized primary extranodal Hodgkin's disease seems to have an excellent prognosis in some cases including skin, tongue, lung, stomach, small bowel, and thyroid. We report a case of primary gastrointestinal Hodgkin's disease involved in the stomach and terminal ileum in 48-year-old man with 7 kg of weight loss for 3 months, fever with chills for 1 week, and intermittent epigastric pain for 1 year. The histologic type of this case was lymphocyte predominance, which was diagnosed by biopsy of the stomach and terminal ileum with immnophenotyping study. And the stage of this case was IIE. We tried combination chemotherapy with adriamycin, bleomycin, vinblastin, and dacabazine with excellent response. For its rarity, we report this case with review of literatures.
Biopsy ; Bleomycin ; Chills ; Doxorubicin ; Drug Therapy, Combination ; Fever ; Hodgkin Disease* ; Humans ; Ileum* ; Incidence ; Lung ; Lymphocytes ; Lymphoma ; Middle Aged ; Prognosis ; Skin ; Stomach* ; Thyroid Gland ; Tongue ; Weight Loss

BACKGROUND: The incidence pattern of malignancy after kidney transplantation is different from that of the general population. Because increased exposure to immunosuppressants results in an increased incidence of malignancy, institutional reports that do not consider duration of immunosuppression have limited value for providing future kidney recipients with the actual risk for malignancy or for developing a kidney allograft recipient surveillance program. Thus, we retrospectively analyzed our institutional data with regard to the duration of exposure to immunosuppressants. METHODS: A total of 757 patients who had kidney transplantation and were followed-up for at least 6 months at our hospital were reviewed retrospectively. The crude incidence rate (CI) was calculated by counting the days of exposure to immunosuppressants. RESULTS: Most malignancies after kidney transplantation were solid tumors (85.3%). The CI of malignancies was 641.1 in allograft recipients and 329.6 in the general population per 100,000 persons per year. Solid tumor cancers of the stomach, liver, lung, breast, cervix, and pancreas showed an increased CI in the allograft recipient group than the general population but cancers of the thyroid and colon did not. Based on the type of immunosuppressive agent, the CI was highest in the cyclosporine group (866/12 months/100,000 persons) than the other groups. CONCLUSIONS: We have provided the CIs of cancers after kidney transplantation at our institute. The pattern of post-transplant malignancy is different from that of western countries. Nationwide registration is needed to provide a more rational approach to post-transplant cancer surveillance in Korea.
Breast ; Cervix Uteri ; Colon ; Cyclosporine ; Female ; Humans ; Immunosuppression ; Immunosuppressive Agents ; Incidence ; Kidney ; Kidney Transplantation ; Korea ; Liver ; Lung ; Pancreas ; Postoperative Complications ; Retrospective Studies ; Stomach ; Thyroid Gland ; Transplantation, Homologous