1.Repeated Administration of Newly Synthesized Aceclofenac Sustained Release Form Causes Agranulocytosis: Case Report of an Unforeseen Adverse Event during the Phase 1 Trial.
Hui JIN ; Renhua ZHENG ; Bohyung KIM ; Sung Vin YIM
Translational and Clinical Pharmacology 2014;22(1):11-12
Aceclofenac is a non-steroidal anti-inflammatory drug (NSAIDs) for inflammatory diseases. In this report, we report a serious adverse event (AE) occurred during the phase I clinical trial for a new sustained-release (SR) formulation of aceclofenac. There was a serious adverse event (AE), agranulocytosis, induced by aceclofenac SR form. An open-labeled, repeated-doses, randomized, crossover study was conducted at Kyung Hee University Hospital and 26 Korean healthy male volunteers were enrolled. All subjects received both aceclofenac SR 200 mg once daily and aceclofenac IR 100 mg twice daily for 4 days with 11 days washout period. After 11 days washout period, one subject showed a serious decrease in the segment neutrophil (267/mm3) on a laboratory test prior to the reference drug administration in period 2. We first report a case of agranulocytosis, during a phase I clinical trial.
Agranulocytosis*
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Cross-Over Studies
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Humans
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Male
;
Neutrophils
;
Volunteers
2.Sleep Problems in Autism Spectrum Disorder.
Young Hui YANG ; Ji Hoon KIM ; Jin Seong LEE
Sleep Medicine and Psychophysiology 2013;20(2):53-58
Autism Spectrum Disorder (ASD) is characterized by persistent deficits in social communication and restricted, repetitive patterns of behavior and interest. Sleep problems are not uncommon in children with autism spectrum disorders. Symptoms of insomnia are the most frequent sleep problems in individuals with ASD. Sleep problems can cause significant difficulties in the daily life of children with ASD and their families. Genetic factor, deregulations of melatonin synthesis, extraneous environmental stimuli and psychiatric and medical conditions may cause sleep problems. The first line treatment of sleep problems in ASD includes managements for potential contributing factors and parent education about sleep hygiene care for child and behavioral therapy. Supplementation with melatonin may be effective before considering other medications, such as risperidone, clonidine, and mirtazapine.
Autistic Disorder*
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Child
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Autism Spectrum Disorder*
;
Clonidine
;
Education
;
Genetics
;
Humans
;
Hygiene
;
Melatonin
;
Parents
;
Risperidone
;
Sleep Initiation and Maintenance Disorders
3.Treatment of Nonunion of Long Bone by the Ilizarov External Fixator.
Hui Taek KIM ; Jin Heon SONG ; Chong Il YOO
The Journal of the Korean Orthopaedic Association 1998;33(5):1407-1418
The Ilizarov technique has been used successfully in the treatment of nonunion of long bone accompanied by infection, severe bone and soft tissue defects, and deformity. We report the results of treatment of 21 cases of nonunion using the Ilizarov technique. There were 20 males and 1 female with an average age of 34.2 years (range, 8-72 years). The average follow up period was 45 months (range, 12-74months). Infected nonunion(15/21 cases) was the most common cause of nonunion. The treatment methods include simple compression method(4 cases) and internal and external bone transport method(17 cases). Bony union was achieved in 20 cases out of 21 cases. One case is still having difficulty in achieving union. The mean time to union was 7.3 months in femurs and 6.3 months in tibias. The amount of bone defect that developed after the removal of infected bone fragments and soft tissue averaged 3.8cm (range, 2.3-9cm). The healing index, in cases of bone transport, was an average of 45 days per cm (range, 30-62 days per cm). Complications developed in 17 cases out of 21 cases. Pin site infection occurred in 5 cases, premature consolidation in ~1 case, angulation deformity in 2 cases, LOM of the knee in 2 cases, equinus deformity in 2 cases, ankle stiffness in 3 cases, and nonunion in 1 case. The Ilizarov technique is thought to be effective in the treatment of complicated nonunion combined with shortening, deformity, bone defect and infection. However, in order to reduce complications caused by the Ilizarov method, accurate surgical techniques and postoperative care are necessary.
Ankle
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Congenital Abnormalities
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Equinus Deformity
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External Fixators*
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Female
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Femur
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Follow-Up Studies
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Humans
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Ilizarov Technique
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Knee
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Male
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Postoperative Care
;
Tibia
4.Developmental coax vara, Operative treatment
Sang Jin CHEON ; Hui Taek KIM ; Chong Il YOO
The Journal of the Korean Orthopaedic Association 1996;31(1):17-26
Hip arthrograghy is a valuable procedure for visualization of the intrinsic obstructive factors impeding closed reduction and for critical assessment of quality of reduction in developmental dislocation of the hip. The authors have analyzed 25 cases of developmentally dislocated hips in 24 patients who have been followed up for more than 1 year postoperatively by roentgenographies and arthrographies. Among them 16 cases in 16 patients who had been treated by closed reduction according to acceptable quality of initial reduction were studied to estimate a value of arthrography and to evaluate an outcome of closed rediction performed on the base of an arthrographic finding. The following results were obtained. 1. The frequency of the common arthrographic observations were assessed. Medial dye columns identifying the depth of reduction were observed 25 cases(100%), configuration of osteocartilaginous structures in 24 cases(96.0%), limbus in 24 cases(96.0%), and ligamentum teres in 18cases(75.0%). 2. Good closed reduction classified according to Race and Herring on initial arthrography was associated with rapid improvement of acetabular angle and the CE angle and low incidence of avascular necrosis, compared with adequate or poor reduction. 3. In cases of initial good and adequate reductions, initial AP arthrograms showed some dye filling shadows owing to folding or redundancy of lax joint capsule of the dislocated hip after reduction just lateral to the limbus, of which finding decreased markedly on the second arthrograms. 4. The widths of medial dye column decreased with time during the first postoperative 7 weeks by an average of 0.5mm in cases with initial good quality of reduction, 3.5mm in adequate reductions and 0.5mm in poor reductions. 5. In cases with adequate closed reduction on initial arthrogram, but without substantial decrease in width of medial dye column on the second arthogram the outcome was poor. In those cases with decrease in width of medial dye column on the second arthrogram compared with initial arthogram, the shorter the period of immobilization in a plaster cast was, the worse eventual result was. 6. We think that hip arthography is a helpful procedure for visualization of obstacle obstructing closed reduction and for determination of treatment modality in developmental dislocation of the hip.
Acetabulum
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Arthrography
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Casts, Surgical
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Continental Population Groups
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Dislocations
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Hip
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Humans
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Immobilization
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Incidence
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Joint Capsule
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Necrosis
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Round Ligaments
5.The Useful Clinical Indicators of Performing a Spinal Tapping During an Outbreak of Enteroviral Meningitis .
Hye Rim KIM ; Hui Kwon KIM ; Hong Jin LEE ; Won Il PARK
Journal of the Korean Child Neurology Society 2009;17(2):185-191
PURPOSE: Although spinal tapping and cerebrospinal fluid analysis is essential for diagnosis of aseptic meningitis, it is equivocal that all patients with headache and vomiting should receive spinal tapping for diagnosis of meningitis during an outbreak of enteroviral meningitis in summer seasons. The purpose of this study was to find clinical indicators that may be useful for differentiation of bacterial meningitis, and also to compare the clinical course between spinal tapping group and non-spinal tapping group confirmed enteroviral infection. METHODS: We retrospectively reviewed medical record of 65 cases of reverse transcription-polymerase chain reaction(RT-PCR) proven enteroviral meningitis, and 30 cases of culture proven bacterial meningitis admitted in Chunchon Sacred Heart Hospital. We compared the difference of clinical factors between bacterial and enteroviral meningitis groups and also clinical course between spinal tapping and non-spinal tapping groups. RESULTS: Children with bacterial meningitis had younger age onset, high incidence of seizure and altered consciousness, increased C-reactive protein(CRP) levels(P<0.05), but no difference in fever degree at admission and white blood cell and platelet count, erythrocyte sedimentation rate(P>0.05). Children with spinal tapping group with enteroviral meningitis had longer hospital stay and duration of fever as compared to children in non-spinal tapping group(P<0.05), but no difference in duration of headache in both groups. CONCLUSION: We recommend children with younger age, altered consciousness, having seizure and increased CRP levels receive spinal tapping for the differentiation of bacterial meningitis during an outbreak of enteroviral meningitis, and introduction of rapid diagnostic technique may reduce unnecessary spinal tapping, hospital stay and antibiotics therapy.
Anti-Bacterial Agents
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Blood Sedimentation
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Child
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Consciousness
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Fever
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Headache
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Heart
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Humans
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Incidence
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Length of Stay
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Leukocytes
;
Medical Records
;
Meningitis
;
Meningitis, Aseptic
;
Meningitis, Bacterial
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Platelet Count
;
Retrospective Studies
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Seasons
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Seizures
;
Spinal Puncture
;
Vomiting
7.Island Falp in the Hand
Chong Il YOO ; Yong Jin KIM ; Hui Taeg KIM ; Kuen Tak SUH ; Jeung Tak SUH
The Journal of the Korean Orthopaedic Association 1994;29(3):932-939
Soft tissue reconstruction of the hand remains a challenge for the hand surgeon, who must choose whether to use a local flap, a distant flap or a free flap. Local flaps, derived from tissue immediately adjacent to the primary defect, are the first choice. But there is a shortage of skin in the hand and there are regions of the hand that should not be used as donor sites since cover of the resultant secondary defect with a skin graft would be inappropriate. We used island flaps for the small soft tissue defects in the hand which were difficult to cover with a conventional skin graft or local flap. The results were as follows; 1. The causes of the soft tissue defects were traumatic amputation in 4 cases, camptodactyly in 4 cases, replantation in 3 cases, infection in 3 cases and tumor in 1 case. 2. The sites of the soft tissue defects were thumb tip in 6 cases, fifth finger PIP joint volar aspect in 3 cases, index tip in 2 cases, thumb volar and dorsal surface in 2 cases, third and fourth MP joint dorsal surface in 1 case, fourth finger PIP joint volar aspect in 1 case and first interdigital web space in 1 case. 3. The donor flaps were fourth finger neurovascular island flap in 8 cases, reverse dorsal matacarpal flap in 5 cases and first dorsal metacarpal artery flap in 4 cases. 4. The sizes of the flap were from 1. 0×1. 5cm to 2.0×4.0cm and and average of 1.5×2.0cm. 5. The flaps were survive completely with a touch sensat,ion except 2 cases which were covered by reverse 5th dorsal metacarpal flap.
Amputation, Traumatic
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Arteries
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Fingers
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Free Tissue Flaps
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Hand
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Humans
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Joints
;
Replantation
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Skin
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Surgical Flaps
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Thumb
;
Tissue Donors
;
Transplants
8.Pleural fluid to serum cholinesterase ratio for the differential diagnosis of transudates and exsudates.
Ho CHO ; Hyun Il KIM ; Min Sup EUM ; Han Jin KWON ; Yong Leul OH ; Kwang Suk KIM ; Hui Jung KIM
Tuberculosis and Respiratory Diseases 2000;48(5):781-787
BACKGROUND: The criteria established by Light et al in 1972 have been used widely for the differential diagnosis of the pleural effusions in transudates and exsudates. However, in recent years, several reports have agreed that these criteria misclassified an important number of effusions. For this reason, different parameters have been proposed for differentiation the transudates from exudates. Nevertheless, all these alternative parameters have not been better than the past criteria of Light et al. In response the usefulness of two parameters for differentiation pleural transudate from exudates were evaluated : pleural fluid cholinesterase level and pleural fluid to serum cholinesterase ratio. METHODS: A total of forty-three patient with know causes of the pleura effusion by diagnostic thoracentesis were studied. The following criteria for differentiating the pleural effusions in transudates and exsudates were analyzed : Light's criteria, the pleural fluid cholesterol level, the pleural fluid to serum cholesterol ratio. the pleural fluid cholinesterase level, and the pleural fluid to serum cholinesterase ratio. RESULTS: The conditions of forty-three patients were diagnosed. Ten were classified as having transudates and thirty-three as exudates. The percentage of effusions misclassified by each parameter was as follows : Light's criteria, 9.3% ; pleural fluid cholesterol, 2.3% ; pleural fluid to serum cholesterol ratio, 2.3% ; pleural fluid cholinesterase, 4.7% ; and pleural fluid to serum cholinesterase ratio, 2.3%. CONCLUSIONS: The pleural fluid to serum cholinesterase ratio is one of the accurate criteria for differentiating pleural transudates from exudates. If further studies confirm these results, the cholinesterase ratio could be used as the first step in the evaluation of pleural effusion and if evaluated together with the other criteria, the differentiation of pleural transudate from exsudates will become more accurate.
Cholesterol
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Cholinesterases*
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Diagnosis, Differential*
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Exudates and Transudates*
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Humans
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Pleura
;
Pleural Effusion
9.Sleep and Psychological Problems in Medical Students.
Dae Wook KIM ; Sung Gon KIM ; Ji Hoon KIM ; Young Hui YANG ; Woo Young JUNG ; Jin Seong LEE
Sleep Medicine and Psychophysiology 2013;20(2):69-74
INTRODUCTION: Although it is well known that medical students are not getting an adequate amount of sleep, there have been only a few studies on the sleep patterns of medical students and the related factors. Therefore, the present study aimed to investigate the medical students' sleep patterns and the related factors. METHODS: A questionnaire package was administered to the 1st to 4th year medical students at one medical school. It consisted of questions asking about their lifestyles as well as Pittsburgh sleep quality index (PSQI), Epworth sleepiness scale (ESS), global assessment of recent stress scale (GASS), the center for epidemiologic studies-depression scale (CES-D), and Moudsley obsessive-compulsive inventory (MOCI). A total of 352 students (206 males and 146 females) responded to the survey and the result was analyzed using the independent t-test, the chi-square test, the paired t-test, Pearson's correlation and ANOVA. p-values of less than 0.05 were considered statistically significant in analyses. RESULTS: The weekend bedtime was significantly delayed (0 : 49 on weekday ; 1 : 34 on weekend ; t=-5.23, p<0.001), the weekend rise time was delayed (6 : 58 on weekday ; 9 : 30 on weekend ; t=-24.48, p<0.001) and the total sleep time was increased on weekends (5 : 36 on weekday ; 7 : 39 on weekend ; t=15.94, p<0.001). The PSQI score of all subjects was 6.43+/-2.64. PSQI was positively correlated with ESS (r=0.383, p<0.001), GASS (r=0.326, p<0.001), CES-D (r=0.393, p<0.001), and MOCI (r=0.247, p<0.001), but not with GPA (r=0.072, p=0.228. The more senior students had lower PSQI, GASS, CES-D, and MOCI score (p<0.05). CONCLUSION: Medical students were experiencing a lack of sleep during weekdays as they have a later bedtime and earlier rise time, and consequently had more hours of sleep on weekends. Overall, the medical students were experiencing poor sleep quality and sleep deprivation. Poor sleep quality is associated with psychological problems (daytime sleepiness, stress, depression, and obsessive tendency).
Depression
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Humans
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Life Style
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Male
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Surveys and Questionnaires
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Schools, Medical
;
Sleep Deprivation
;
Students, Medical*
10.Sleep and Alcohol.
Jin Seong LEE ; Sung Gon KIM ; Woo Young JUNG ; Young Hui YANG
Sleep Medicine and Psychophysiology 2013;20(2):59-62
Alcohol has been used as sedatives historically. The effect of alcohol on sleep is different according to its dose, timing of ingestion, and drinking frequency. Sleep problems may play a role in the development and course of alcohol-related disorders. Insomnia in alcohol-dependent patients is common and early treatment of insomnia may reduce the rate of relapse. Sleep apnea, restless legs syndrome, periodic limbs movement disorder, and altered circadian rhythm may be more frequent in this patients. Management of sleep and alcohol problems is important in treating alcohol-related disorder and sleep disorders, respectively.
Alcohol-Related Disorders
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Circadian Rhythm
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Drinking
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Eating
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Extremities
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Humans
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Hypnotics and Sedatives
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Movement Disorders
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Recurrence
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Restless Legs Syndrome
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Sleep Apnea Syndromes
;
Sleep Wake Disorders
;
Sleep Initiation and Maintenance Disorders