Forty two high risk low birth weight infants who had been admitted in neonatal intensive care unit at Yongdong Severance Hospital from August 1987 to July 1990 and followed up in the high risk infants follow-up clinic were studied for evaluation of their development using the Bayley develop-mental test at the age of 9 month(corrected age). The results obtaincd were as follows: 1) Their Mental Developmental Index(MDI)and Psychomotor Developmental Index(PDD)were 99.4+/-12.8 and 101.8+/-16.6 MDI and PDI in birth weight 1000~1500 gm group were 95.3+/-9.8 and 99.3+/-14.3 and the indexes in birth weight 1500~2500gm group were 102.2+/-14.3 and 103.5+/-17.9. 2) There is no statistical significant relationship between the results of Bayley scales and birth weight, cranial ultrasonographic finding, APGAR score, ventilator care and neonatal seizure. However, the MDI was significantly lower in small for gestational age group than appropriate gestational age group. 3) The body weight, height and head circumference measured at the age of 9 month, at the same time when Baylcy developmcntal test was performed, were 45.0+/-29.6, 40.2+/-25.7 and 46.2+/-26.8percentile of Korean Pediatric Growth Standard(1985).
Apgar Score ; Birth Weight ; Body Weight ; Follow-Up Studies ; Gestational Age ; Head ; Humans ; Infant* ; Infant, Low Birth Weight* ; Infant, Newborn ; Intensive Care, Neonatal ; Seizures ; Ventilators, Mechanical ; Weights and Measures

BACKGROUND: To evaluate the safety and effectiveness of rosiglitazone/metformin in patients with type 2 (non-insulin-dependent) diabetes. METHODS: A total of 982 patients were enrolled by 19 physicians from November 2003 to November 2010. Patients treated with rosiglitazone/metformin at least once, were included in safety assessment. The incidences of adverse events (AEs) and serious adverse events (SAEs) were estimated. The effectiveness of rosiglitazone/metformin was evaluated through change in fasting blood glucose (FBG), 2-hour postprandial glucose (2hr PPG), Hemoglobin A1c (HbA1c). RESULTS: Of the 982 patients, 713 patients with the mean age of 56.4 +/- 11.5 years were included in the safety assessment. A total of 130 AEs were reported from 110 patients (15.4 %). The most frequent AEs were upper respiratory infection (2.4 %), oedema (2.2 %), gastritis (1.3 %), and weight increase (1.1 %). The incidence of unexpected AEs was 5.9 % (42/713, 47 AEs). Three SAEs such as bacterial pneumonia, hyperglycaemia, chest pain were reported in 2 patients. As it is about effectiveness, patients showed statistically significant reductions after treatment of rosiglitazone/metformin in FBG, 2hr PPG, and HbA1c (P<0.001 by paired t-test, for all). CONCLUSION: Our data suggest that rosiglitazone/metformin is well tolerated and effective in Korean patients with type 2 (non-insulin-dependent) diabetes.
Blood Glucose ; Chest Pain ; Fasting ; Gastritis ; Glucose ; Hemoglobins ; Humans ; Incidence ; Metformin ; Pneumonia, Bacterial ; Thiazolidinediones

BACKGROUND: To evaluate the safety and effectiveness of rosiglitazone/metformin in patients with type 2 (non-insulin-dependent) diabetes. METHODS: A total of 982 patients were enrolled by 19 physicians from November 2003 to November 2010. Patients treated with rosiglitazone/metformin at least once, were included in safety assessment. The incidences of adverse events (AEs) and serious adverse events (SAEs) were estimated. The effectiveness of rosiglitazone/metformin was evaluated through change in fasting blood glucose (FBG), 2-hour postprandial glucose (2hr PPG), Hemoglobin A1c (HbA1c). RESULTS: Of the 982 patients, 713 patients with the mean age of 56.4 +/- 11.5 years were included in the safety assessment. A total of 130 AEs were reported from 110 patients (15.4 %). The most frequent AEs were upper respiratory infection (2.4 %), oedema (2.2 %), gastritis (1.3 %), and weight increase (1.1 %). The incidence of unexpected AEs was 5.9 % (42/713, 47 AEs). Three SAEs such as bacterial pneumonia, hyperglycaemia, chest pain were reported in 2 patients. As it is about effectiveness, patients showed statistically significant reductions after treatment of rosiglitazone/metformin in FBG, 2hr PPG, and HbA1c (P<0.001 by paired t-test, for all). CONCLUSION: Our data suggest that rosiglitazone/metformin is well tolerated and effective in Korean patients with type 2 (non-insulin-dependent) diabetes.
Blood Glucose ; Chest Pain ; Fasting ; Gastritis ; Glucose ; Hemoglobins ; Humans ; Incidence ; Metformin ; Pneumonia, Bacterial ; Thiazolidinediones

BACKGROUND: Dutasteride is an inhibitor of both types I and II 5 alpha-reductase and was approved in Korea in April 2004. This post-marketing surveillance was to assess the safety of dutasteride in Korean patients with benign prostate hyperplasia in real life and to elucidate the risk factors related adverse events. METHODS: From December 2004 to January 2010, 3,977 patients were enrolled by 184 urologists. According to post-marketing surveillance regulation, patients were enrolled consecutively. Patients administered dutasteride at least once were included in safety assessment. The incidences of any adverse events and serious adverse events were evaluated. Multiple logistic regression method was used to identify risk factors related to adverse events. RESULTS: The safety assessment included 3,870 patients with the mean age of 67.3 years. The incidence of adverse events was 3.8 %. The most frequent adverse event was impotence (75 cases, 1.9 %), libido decrease (49 cases, 1.3 %), ejaculation disorder (30 cases, 0.8 %), and gynecomastia (5 cases, 0.1 %). The incidence of unexpected adverse events was 0.5 % and cerebral infarction, lung cancer, pulmonary embolism, and diarrhea were reported as serious adverse events. CONCLUSION: In this survey, impotence was the most frequently reported adverse events. Dutasteride was well tolerated in Korean patients with benign prostate hyperplasia. These results updated the safety information and would provide important additional information for prescribers.
Azasteroids ; Cerebral Infarction ; Cholestenone 5 alpha-Reductase ; Diarrhea ; Drug Toxicity ; Dutasteride ; Ejaculation ; Erectile Dysfunction ; Gynecomastia ; Humans ; Hyperplasia ; Incidence ; Korea ; Libido ; Logistic Models ; Lung Neoplasms ; Male ; Prostate ; Pulmonary Embolism ; Risk Factors

BACKGROUND: With the approval of topical retapamulin ointment in 2011, it was officially required to conduct a post-marketing surveillance (PMS) study to obtain further data of its safety profile and effectiveness, in accordance with the requirement of the Korean Ministry of Food and Drug Safety (MFDS). OBJECTIVE: This study had prospectively designed to monitor safety and tolerability with the effectiveness of topical retapamulin in clinical practices. METHODS: Open label, multi-center, non-interventional observational study was done from May 2011 to October 2015. All subjects had bacterial skin infections of locally approved prescribing information accordingly. The study mainly focused on safety issues in the local target population (3,612 eligible subjects). And, drug effectiveness was also evaluated by physicians. RESULTS: The incidence of adverse events (AEs) and adverse drug reactions (ADRs) were 2.53% and 0.97%, respectively. In terms of the incidence of unexpected AEs and ADRs, 1.45% and 0.33%, and for the incidence of serious AEs, 0.28%, whereas no serious ADRs reported. And, the effectiveness of topical retapamulin rate was 96.1% (1,697 of total 1,765 subjects). CONCLUSION: Topical retapamulin is to be well-tolerated and effective in patients with bacterial skin infections of locally approved prescribing information.
Anti-Bacterial Agents ; Drug-Related Side Effects and Adverse Reactions ; Health Services Needs and Demand ; Humans ; Incidence ; Observational Study ; Prospective Studies ; Skin ; Skin Diseases

BACKGROUND: Preventive measures need to be implemented to lower the incidence of osteoporotic fractures. Osteoporotic fractures increase morbidity and mortality as well as impose a socioeconomic burden; however, current research is limited to the administration rates of osteoporosis drugs for Korean postmenopausal females. METHODS: This study represents a nationwide, observational, and cross-sectional survey that investigates the administration rates of osteoporosis drugs based upon a bone mineral density (BMD) test performed on Korean postmenopausal patients who visited outpatient orthopedic clinics. BMD test results were examined in postmenopausal female patients (50 to 80 years of age); subsequently, the patients were classified into an osteoporosis group, osteopenia group, and normal group. The administration rates of osteoporosis drugs and bisphosphonates were then analyzed. The osteoporosis group was subdivided into a T-score less than -3.0 group and a T-score between -3.0 and -2.5 group that were separately analyzed. RESULTS: Based on the lumbar spine BMD, the rate of administration of osteoporosis drugs in the osteoporosis group was 42.1%, which was significantly higher compared to the osteopenia group or normal group. A significantly low bone mineral density was observed in patients who were administered bisphosphonates. Based on the lumbar spine BMD, the administration rate of osteoporosis drugs in the group with a T-score between -3.0 and -2.5 (34.2%) was significantly lower than the group with a T-score less that -3.0 (46.2%). The bisphosphonate administration rate was also significantly low; however, the administration rate for osteoporosis drugs was significantly lower than that of the osteopenia group. CONCLUSIONS: Only about 40% of Korean postmenopausal female patients with osteoporosis were administered osteoporosis drugs. The administration rate in patients with a T-score between -3.0 and -2.5 was particularly low and active treatment to prevent osteoporotic fractures is required in this group.
Aged ; Aged, 80 and over ; Bone Density Conservation Agents/*therapeutic use ; Cross-Sectional Studies ; Drug Prescriptions/*statistics & numerical data ; Female ; Humans ; Insurance Benefits/*methods ; Middle Aged ; Osteoporosis/*drug therapy/epidemiology ; Republic of Korea

BACKGROUND: Gatifloxacin, a new 8-methoxyquinolone, has a broad-spectrum activity with expanded potency against respiratory pathogens. In this study, we examined the in vitro activity of gatifloxacin and comparators against recently isolated bacteria from respiratory specimens of patients in Korean hospitals. METHODS: Forty-nine isolates were from respiratory specimens of patients with acute exacerbations of chronic lower respiratory infections in eight university hospitals and 108 isolates were from respiratory specimens from patients of Yonsei University Hospital. Minimum inhibitory concentrations (MICs) were determined by NCCLS agar dilution method. RESULTS: MIC90 of gatifloxacin for Streptococcus pneumoniae was 1 g/mL, which was 8-fold and 2-fold lower than those of ciprofloxacin and levofloxacin, respectively. All strains of Haemophilus in fluenzae and Moraxella (Branhamella) catarrhalis were inhibited by < or =0.06 g/mL and < or =0.25 g/mL of gatifloxacin, respectively, and were susceptible to all fluoroquinolones tested. MIC90 of gatifloxacin for Klebsiella pneumoniae was 0.06 g/mL, which was 2-fold lower than those of levofloxacin and moxifloxacin. CONCLUSION: Gatifloxacin is highly active against S. pneumoniae, H. influenzae and M. (B.) catarrhalis isolated from respiratory specimens of patients of university hospitals in Korea.
Agar ; Bacteria* ; Ciprofloxacin ; Fluoroquinolones ; Haemophilus ; Hospitals, University* ; Humans ; Influenza, Human ; Klebsiella pneumoniae ; Korea* ; Levofloxacin ; Microbial Sensitivity Tests ; Moraxella (Branhamella) catarrhalis ; Pneumonia ; Respiratory Tract Infections ; Streptococcus pneumoniae

BACKGROUND: Gatifloxacin, a new 8-methoxyquinolone, has a broad-spectrum activity with expanded potency against respiratory pathogens. In this study, we examined the in vitro activity of gatifloxacin and comparators against recently isolated bacteria from respiratory specimens of patients in Korean hospitals. METHODS: Forty-nine isolates were from respiratory specimens of patients with acute exacerbations of chronic lower respiratory infections in eight university hospitals and 108 isolates were from respiratory specimens from patients of Yonsei University Hospital. Minimum inhibitory concentrations (MICs) were determined by NCCLS agar dilution method. RESULTS: MIC90 of gatifloxacin for Streptococcus pneumoniae was 1 g/mL, which was 8-fold and 2-fold lower than those of ciprofloxacin and levofloxacin, respectively. All strains of Haemophilus in fluenzae and Moraxella (Branhamella) catarrhalis were inhibited by < or =0.06 g/mL and < or =0.25 g/mL of gatifloxacin, respectively, and were susceptible to all fluoroquinolones tested. MIC90 of gatifloxacin for Klebsiella pneumoniae was 0.06 g/mL, which was 2-fold lower than those of levofloxacin and moxifloxacin. CONCLUSION: Gatifloxacin is highly active against S. pneumoniae, H. influenzae and M. (B.) catarrhalis isolated from respiratory specimens of patients of university hospitals in Korea.
Agar ; Bacteria* ; Ciprofloxacin ; Fluoroquinolones ; Haemophilus ; Hospitals, University* ; Humans ; Influenza, Human ; Klebsiella pneumoniae ; Korea* ; Levofloxacin ; Microbial Sensitivity Tests ; Moraxella (Branhamella) catarrhalis ; Pneumonia ; Respiratory Tract Infections ; Streptococcus pneumoniae

PURPOSE: Post-authorization survey(PAS) is a useful tool for obtainting wider range of data on the safety and efficacy of new drugs following their approval, as they can detect uncommon, unreported adverse events(AEs), which enables more attention to be directed to the practioners. Especially, the limited number of patients in oncology trial cannot usually give the actual incidence of AEs. METHODS: Since Nov. 1998, when docetaxel gained Korean approval in the treatment of breast cancer, a PAS to investigate its safety profiles has been conducted targeting more than 600 patients over 4 calendar years. RESULTS: Case report forms from 626 out of 646 patients were assessable for safety and 444 for efficacy. The patient characteristics are: mean age, 48.1 years; male/female 4/622; Wt/Ht/BSA 57.9 kg/156.1 cm/1.56 m2 ; stage I-II/III/IV 109 (18.2%)/125 (20.8%)/366(61.0%). In 344 patients, 960 AEs were reported in severity of mild/moderate/severe in 6.7, 40.9 and 51.1 % of cases. From AE results, 36.0% needed dose reduction; 34.3% transient interruption of the cycle; and 1.3% permanent discontinuation of docetaxel. Thirty five serious AEs such as febrile neutropenia, alopecia, diarrhea, abdominal pain and headache were reported in 21 patients. Unexpected AEs such as skin ulcer, discoloration of skin, H. Zoster infection, ulticaria, facial flush, chest pain, hemoptysis, pneumonia, stridor, nasal bleeding, photophobia, haematuria, Cushing's syndrome, hyperglycemia and insomnia were reported regardless of any causal relationship. Factors affecting the development of AEs were age, stage, concomitant medication other than chemotherapeutic agents and the number of cycles treated. The efficacy was evaluable in 444 patients with overall response rate of 36.5% (CR/PR 6.3/30.2%). Factors affecting the efficacy were stage, concommitant medication other than chemotherapeutic agents and the number of treatment cycles. CONCLUSION: This post-authorization survey on the safety and efficacy of docetaxel in breast cancer offers oncology practice in the real world without subject selection as is the case in clinical trials, although it was performed to fulfill the registrative requirement of the Korean health authority with limited data. The efficacy and safety profile of docetaxel in breast cancer was no much different from those reported in clinical trials.
Abdominal Pain ; Alopecia ; Breast Neoplasms* ; Breast* ; Chest Pain ; Cushing Syndrome ; Diarrhea ; Epistaxis ; Febrile Neutropenia ; Headache ; Hemoptysis ; Herpes Zoster ; Humans ; Hyperglycemia ; Incidence ; Photophobia ; Pneumonia ; Respiratory Sounds ; Skin ; Skin Ulcer ; Sleep Initiation and Maintenance Disorders

PURPOSE: There are still debates on the benefit of mass screening for prostate cancer (PCA) by prostate specific antigen (PSA) testing, and on systemized surveillance protocols according to PSA level. Furthermore, there is a paucity of literature on current practice patterns according to PSA level in the Korean urologic field. Here, we report the results of a nationwide, multicenter, retrospective chart-review study. MATERIALS AND METHODS: Overall 2122 Korean men (>40 years old, PSA >2.5 ng/mL) were included in our study (from 122 centers, in 2008). The primary endpoint was to analyze the rate of prostate biopsy according to PSA level. Secondary aims were to analyze the detection rate of PCA, the clinical features of patients, and the status of surveillance for PCA according to PSA level. RESULTS: The rate of prostate biopsy was 7.1%, 26.3%, 54.2%, and 64.3% according to PSA levels of 2.5-3.0, 3.0-4.0, 4.0-10.0, and >10.0 ng/mL, respectively, and the PCA detection rate was 16.0%, 22.2%, 20.2%, and 59.6%, respectively. At a PSA level >4.0 ng/mL, we found a lower incidence of prostate biopsy in local clinics than in general hospitals (21.6% vs. 66.2%, respectively). A significant proportion (16.6%) of patients exhibited high Gleason scores (> or =8) even in the group with low PSA values (2.5-4.0 ng/mL). CONCLUSION: We believe that the results from this nationwide study might provide an important database for the establishment of practical guidelines for the screening and management of PCA in Korean populations.
Aged ; Asian Continental Ancestry Group ; Biopsy ; Humans ; Male ; Middle Aged ; Physicians ; Prostate-Specific Antigen/*blood ; Prostatic Neoplasms/*blood/*diagnosis ; Retrospective Studies ; Urology