PURPOSE: To evaluate the efficacy and safety of BOTULAX® in subjects with essential blepharospasm.METHODS: In this study, a total of 250 subjects with essential blepharospasm were enrolled at 15 investigational sites and a total of 220 subjects completed the study. The efficacy and safety were evaluated at weeks 4 and 16 after treatment compared with baseline. In total, 240 subjects were enrolled, treated with the investigational product, and evaluable for the primary efficacy assessment at week 4 after treatment; these subjects were included in the intention-to-treat (ITT) population. With the ITT set as the main efficacy set, efficacy assessment included Jankovic rating scale (JRS), functional disability score, investigator evaluation of global response and quality of life. Safety assessment including the incidence of adverse events was also performed.RESULTS: In terms of the primary efficacy endpoint (i.e., change in JRS total score at week 4 after treatment from baseline [ITT set]), mean change indicated a statistically significant reduction (p < 0.0001) and demonstrated the non-inferiority of the test drug to similar drugs. In terms of the secondary efficacy endpoints, mean change in JRS total score at week 16 after treatment and mean change in functional disability score at weeks 4 and 16 after treatment both exhibited a statistically significant reduction compared with baseline (p < 0.0001 for all). Among the 249 subjects treated with the investigational product in this study, 44 (17.67%) experienced 76 treatment emergent adverse events but no serious adverse events were observed.CONCLUSIONS: Based on the study results, BOTULAX® is considered to be an effective and safe treatment for essential blepharospasm.

Hereditary spherocytosis is a disease caused by deficiency of erythrocyte lipid membrane protein. Hereditary spherocytosis shows hemolysis of erythrocyte, and it leads to anemia, jaundice by elevation of indirect bilirubin. Almost of patients are diagnosed in their infancy, and can be cured by splenectomy about their age 6–7. Herein, we report a rare case of 33-year-old male was suffered from gallbladder stone and cholangitis those are thought to be the late complications of hereditary spherocytosis. We performed endoscopic retrograde cholangiopancreaticography to remove common bile duct stones. After he got cholecystectomy and splenectomy, there was no recurrence of choledocholithiasis. This is the first case in Korea who didn’t undergo splenectomy until grown up, shows cholangitis as a late disease manifestation of hereditary spherocytosis.

Korean Society of Thyroid-Head and Neck Surgery appointed a Task Force to provide guidance on the implementation of a surgical treatment of oral cancer. MEDLINE databases were searched for articles on subjects related to “surgical management of oral cancer” published in English. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. The quality of evidence was rated with use RoBANS (Risk of Bias Assessment Tool for Nonrandomized Studies) and AMSTAR (A Measurement Tool to Assess the Methodological Quality of Systematic Reviews). Evidence-based recommendations for practice were ranked according to the American College of Physicians grading system. Additional directives are provided as expert opinions and Delphi questionnaire when insufficient evidence existed. The Committee developed 68 evidence-based recommendations in 34 categories intended to assist clinicians and patients and counselors, and health policy-makers. Proper surgical treatment selection for oral cancer, which is directed by patient- and subsite-specific factors, remains the greatest predictor of successful treatment outcomes. These guidelines are intended for use in conjunction with the individual patient's treatment goals.
Advisory Committees ; Bias (Epidemiology) ; Carcinoma, Squamous Cell ; Counseling ; Expert Testimony ; Humans ; Mouth Neoplasms ; Neck ; Republic of Korea

OBJECTIVE: Posttraumatic cerebral infarction (CI) is a well-known complication of traumatic brain injury (TBI). However, the causation and apportionment of trauma in patients with CI after TBI is not easy. There is a scoring method, so-called trauma apportionment score (TAS) for CI, consisted with the age, the interval, and the severity of the TBI. We evaluated the reliability of this score. METHODS: We selected two typical cases of traumatic CI. We also selected consecutive 50 patients due to spontaneous CI. We calculated TAS in both patients with traumatic and spontaneous CI. To enhance the reliability, we revised TAS (rTAS) adding three more items, such as systemic illness, bad health habits, and doctor's opinion. We also calculated rTAS in the same patients. RESULTS: Even in 50 patients with spontaneous CI, the TAS was 4 in 44 patients, and 5 in 6 patients. TAS could not assess the apportionment of trauma efficiently. We recalculated the rTAS in the same patients. The rTAS was not more than 11 in more than 70% of the spontaneous CI. Compared to TAS, rTAS definitely enhanced the discriminating ability. However, there were still significant overlapping areas. CONCLUSION: TAS alone is insufficient to differentiate the cause or apportionment of trauma in some obscure cases of CI. Although the rTAS may enhance the reliability, it also should be used with cautions.
Brain Injuries ; Cerebral Infarction* ; Compensation and Redress ; Craniocerebral Trauma ; Humans ; Research Design

PURPOSE: We undertook an observational study to investigate the effects of immunosuppressive treatment on proteinuria and renal function in 179 Korean idiopathic membranous nephropathy patients with nephrotic syndrome. MATERIALS AND METHODS: The primary outcome was regarded as the first appearance of remission and the secondary outcomes as a decline in estimated glomerular filtration rate (eGFR) >50% or initiation of dialysis, and all-cause mortality. Seventy-two (40.2%) and 50 (27.9%) patients were treated with corticosteroids alone (C) and corticosteroids plus cyclosporine (C+C), respectively, whereas 57 (31.8%) did not receive immunosuppressants (NTx). Cyclosporine was added if there was no reduction in proteinuria of >50% from baseline by corticosteroids alone within 3 months. RESULTS: There were no differences in baseline renal function and the amount of proteinuria among the three groups. Overall, complete remission (CR) was achieved in 88 (72.1%) patients by immunosuppressants. In a multivariate analysis adjusted for covariates associated with adverse renal outcome, the probability of reaching CR was significantly higher in the C [hazard ratio (HR), 4.09; p<0.001] and C+C groups (HR, 2.57; p=0.003) than in the NTx group. Kaplan-Meier analysis revealed that 5-year CR rates of C, C+C, and NTx groups were 88.5%, 86.2%, and 56.7% (p<0.001). Ten-year event-free rates for the secondary endpoints in these three groups were 91.7%, 79.9%, and 57.2% (p=0.01). CONCLUSION: Immunosuppressive treatment was effective in inducing remission and preserving renal function in these patients. Therefore, stepwise treatment using corticosteroids alone and in combination with cyclosporine is warranted in these patients.
Adrenal Cortex Hormones/adverse effects/*therapeutic use ; Adult ; Aged ; Cyclosporine/adverse effects/*therapeutic use ; Drug Administration Schedule ; Female ; Glomerular Filtration Rate/drug effects ; Glomerulonephritis, Membranous/*drug therapy/mortality ; Humans ; Immunosuppressive Agents/adverse effects/*therapeutic use ; Kaplan-Meier Estimate ; Kidney/drug effects/physiology ; Male ; Middle Aged ; Proteinuria/chemically induced ; Treatment Outcome

PURPOSE: The purpose of this study was to examine the effects of chromium chloride addition on coloration, mechanical property and microstructure of 3Y-TZP. MATERIALS AND METHODS: Chromium chloride was weighed as 0.06, 0.12, and 0.25 wt% and each measured amount was dissolved in alcohol. ZrO2 powder was mixed with each of the individual slurry to prepare chromium doped zirconia specimen. The color, physical properties and microstructure were observed after the zirconia specimen were sintered at 1450degrees C. In order to evaluate the color, spectrophotometer was used to analyze the value of L*, C*, a* and b*, after placing the specimen on a white plate, and measured according to the International Commission on Illumination (CIE) standard, Illuminant D65 and SCE system. The density was measured in the Archimedes method, while microstructures were evaluated by using the scanning electron microscopy (SEM) and XRD. Fracture toughness was calculated Vickers indentation method and indentation size was measured by using the optical microscope. The data were analyzed with 1-way ANOVA test (alpha= 0.05). The Tukey multiple comparison test was used for post hoc analysis. RESULTS: 1. Chromium chloride rendered zirconia a brownish color. While chromium chloride content was increased, the color of zirconia was changed from brownish to brownish-red. 2. Chromium chloride content was increased; density of the specimen was decreased. 3. More chromium chloride in the ratio showed increase size of grains. 4. But the addition of chromium chloride did not affect the crystal phase of zirconia, and all specimens showed tetragonal phase. 5. The chromium chloride in zirconia did not showed statistically significant difference in fracture toughness, but addition of 0.25 wt% showed a statistically significant difference (P<.05). CONCLUSION: Based on the above results, this study suggests that chromium chlorides can make colored zirconia while adding in a liquid form. The new colored zirconia showed a slight difference in color to that of the natural tooth, nevertheless this material can be used as an all ceramic core material.
Ceramics ; Edible Grain ; Chlorides ; Chromium ; Chromium Compounds ; Humans ; Lighting ; Microscopy, Electron, Scanning ; Tooth ; Zirconium

OBJECTIVES: The purpose of this study was to compare the efficacy between switching patients with Alzheimer's disease (AD) from galantamine or rivastigmine to donepezil because they were not responding adequately, and naive patients with AD who initiated therapy with donepezil. METHODS: A total of 108 patients were recruited for this 52-week study. The effect of donepezil on cognitive function was measured using Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K). Patients' activities of daily living using Seoul-Activities of Daily Living (S-ADL) and the Seoul-Instrumental Activities of Daily Living (S-IADL);behavioral symptoms using the Korean version Neuropsychiatric Inventory (K-NPI) were measured at baseline, 13-weeks, 26-weeks, 39-weeks and 52-weeks. We defined the responsive patients to donepezil at those who showed a cognitive improvement or no change during the first six-month clinical trial. RESULTS: 86 naive patients and 22 switching patients were enrolled in the study. 74 patients completed the study and 34 discontinued their treatment before week 52. There was no significant difference between two patient groups in demographic data, baseline characteristics and dementia severity except duration of illness. The total ADAS-cog-K scores were not significantly different from baseline after 52 weeks of treatment in both groups. Both groups demonstrated deterioration of S-ADL and S-IADL at 52 weeks. The NPI scores did not significantly change in both groups. Based on the operational criteria, 61.6% of the naive group and 54.5% of the switching group were responders to donepezil. CONCLUSION: The switching group had similar levels of efficacy with the naive group who initiated therapy with donepezil. These results suggest that patients not responding adequately to rivastigmine or galantamine may improve or stabilize after switching to donepezil and prior medication does not effect donepezil's efficacy.

OBJECTIVES: The purpose of this study was to compare the efficacy of donepezil treatment between patients with pure Alzheimer's disease (AD) and Mixed dementia (MD) during a 12-month trial. METHODS: A total of 139 patients were recruited for this 52-week study. The effect of donepezil on cognitive function was measured using Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K). Patients' activities of daily living using the Seoul-Instrumental Activities of Daily Living (S-IADL) and Seoul-Activities of Daily Living (S-ADL);behavioral symptoms using the Korean version Neuropsychiatric Inventory (K-NPI) were measured at baseline, 13-weeks, 26-weeks, 39-weeks and 52-weeks. We defined the responsive patients to donepezil at those who showed a cognitive improvement or no change during the first six-month clinical trial. RESULTS: 84 pure AD patients and 34 MD patients were available for intent-to-treat (ITT) last observation carried forward (LOCF) analysis. There was no significant difference between two groups in mean change from baseline in the total ADAS-cog-k, S-ADL, S-IADL and K-NPI scores at 52-week. Based on the operational criteria, 60.7% of pure AD patients and 58.8% of MD patients were responders to donepezil. CONCLUSION: MD patients had similar levels of efficacy with pure AD patients and donepezil was well tolerated in both groups. These results suggest that donepezil is an effective and well-tolerated treatment for MD patients as well as for pure AD patients.
Activities of Daily Living ; Alzheimer Disease ; Dementia ; Humans ; Indans ; Piperidines

OBJECTIVES: The purpose of this study was to compare the efficacy of donepezil treatment between patients with pure Alzheimer's disease (AD) and Mixed dementia (MD) during a 12-month trial. METHODS: A total of 139 patients were recruited for this 52-week study. The effect of donepezil on cognitive function was measured using Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K). Patients' activities of daily living using the Seoul-Instrumental Activities of Daily Living (S-IADL) and Seoul-Activities of Daily Living (S-ADL);behavioral symptoms using the Korean version Neuropsychiatric Inventory (K-NPI) were measured at baseline, 13-weeks, 26-weeks, 39-weeks and 52-weeks. We defined the responsive patients to donepezil at those who showed a cognitive improvement or no change during the first six-month clinical trial. RESULTS: 84 pure AD patients and 34 MD patients were available for intent-to-treat (ITT) last observation carried forward (LOCF) analysis. There was no significant difference between two groups in mean change from baseline in the total ADAS-cog-k, S-ADL, S-IADL and K-NPI scores at 52-week. Based on the operational criteria, 60.7% of pure AD patients and 58.8% of MD patients were responders to donepezil. CONCLUSION: MD patients had similar levels of efficacy with pure AD patients and donepezil was well tolerated in both groups. These results suggest that donepezil is an effective and well-tolerated treatment for MD patients as well as for pure AD patients.
Activities of Daily Living ; Alzheimer Disease ; Dementia ; Humans ; Indans ; Piperidines

OBJECTIVE: The distribution of disorders changes according to the change of environment or customs with time. Geriatric disorders are increasing along with the increase of the life span. A new therapeutic method may change the management of a certain disease. As a Korean neurosurgeon, they should have sufficient knowledge on certain disorders that are common or practically significant in Korea. There are few reports to evaluate the distribution or trends of neurosurgical disorders in Korea. We evaluated the distribution and trends of neurosurgical disorders of the patients who admitted to a neurosurgical department of a university hospital in Korea during a 5-year-period. METHODS: From January 1997 to December 2001, the total number of admission was 4, 772. The total number of operation was 2, 603. We used a standardized database model for collection of the patient data, which was developed by one of us. Disorders are classified into 13 categories, such as head injury, spine injury, vascular disorders, degenerative spinal disorders, cranial tumors, spinal tumors, infection, peripheral nerve disorders, functional disorders, pain, congenital disorders, and others. RESULTS: Head injury(32.5%), vascular disorders(27.7%), spine injury(15.5%), and degenerative spinal disorders(11.5%) occupied 87.2% of total disorders of the inpatient. The age distribution was peak at 61-75 year old group, about 60% of the total inpatients was 45 year old or more. During this 5-year-period, patients more than 60 year old were increasing, while patients of 16-30-year-old group were decreasing. The proportions of the head injury and vascular disorders were decreasing, while those of the degenerative spinal disorders, spine injury and cranial tumors were increasing. CONCLUSION: We should pay attention to the common or increasing disorders. It seems to be of value to collect and analyze the neurosurgical epidemiological data for education and planning of the neurosurgical manpower.
Age Distribution ; Congenital, Hereditary, and Neonatal Diseases and Abnormalities ; Craniocerebral Trauma ; Data Collection ; Education ; Epidemiology ; Head ; Humans ; Incidence ; Inpatients ; Korea ; Middle Aged ; Neurosurgery ; Peripheral Nerves ; Spine ; Vascular System Injuries