1.Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE)
Nam Hoon KIM ; Juneyoung LEE ; Suk CHON ; Jae Myung YU ; In-Kyung JEONG ; Soo LIM ; Won Jun KIM ; Keeho SONG ; Ho Chan CHO ; Hea Min YU ; Kyoung-Ah KIM ; Sang Soo KIM ; Soon Hee LEE ; Chong Hwa KIM ; Soo Heon KWAK ; Yong‐ho LEE ; Choon Hee CHUNG ; Sihoon LEE ; Heung Yong JIN ; Jae Hyuk LEE ; Gwanpyo KOH ; Sang-Yong KIM ; Jaetaek KIM ; Ju Hee LEE ; Tae Nyun KIM ; Hyun Jeong JEON ; Ji Hyun LEE ; Jae-Han JEON ; Hye Jin YOO ; Hee Kyung KIM ; Hyeong-Kyu PARK ; Il Seong NAM-GOONG ; Seongbin HONG ; Chul Woo AHN ; Ji Hee YU ; Jong Heon PARK ; Keun-Gyu PARK ; Chan Ho PARK ; Kyong Hye JOUNG ; Ohk-Hyun RYU ; Keun Yong PARK ; Eun-Gyoung HONG ; Bong-Soo CHA ; Kyu Chang WON ; Yoon-Sok CHUNG ; Sin Gon KIM
Endocrinology and Metabolism 2024;39(5):722-731
Background:
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
Methods:
This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
Conclusion
This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.
2.An Automated Draft Report Generator for Peripheral Blood Smear Examinations Based on Complete Blood Count Parameters.
Young gon KIM ; Jung Ah KWON ; Yeonsook MOON ; Seong Jun PARK ; Sangwook KIM ; Hyun A LEE ; Sun Young KO ; Eun Ah CHANG ; Myung Hyun NAM ; Chae Seung LIM ; Soo Young YOON
Annals of Laboratory Medicine 2018;38(6):512-517
BACKGROUND: Complete blood count (CBC) results play an important role in peripheral blood smear (PBS) examinations. Many descriptions in PBS reports may simply be translated from CBC parameters. We developed a computer program that automatically generates a PBS draft report based on CBC parameters and age- and sex-matched reference ranges. METHODS: The Java programming language was used to develop a computer program that supports a graphical user interface. Four hematology analyzers from three different laboratories were tested: Sysmex XE-5000 (Sysmex, Kobe, Japan), Sysmex XN-9000 (Sysmex), DxH800 (Beckman Coulter, Brea, CA, USA), and ADVIA 2120i (Siemens Healthcare Diagnostics, Eschborn, Germany). Input data files containing 862 CBC results were generated from hematology analyzers, middlewares, or laboratory information systems. The draft reports were compared with the content of input data files. RESULTS: We developed a computer program that reads CBC results from a data file and automatically writes a draft PBS report. Age- and sex-matched reference ranges can be automatically applied. After examining PBS, users can modify the draft report based on microscopic findings. Recommendations such as suggestions for further evaluations are also provided based on morphological findings, and they can be modified by users. The program was compatible with all four hematology analyzers tested. CONCLUSIONS: Our program is expected to reduce the time required to manually incorporate CBC results into PBS reports. Systematic inclusion of CBC results could help improve the reliability and sensitivity of PBS examinations.
Blood Cell Count*
;
Clinical Laboratory Information Systems
;
Delivery of Health Care
;
Hematology
;
Indonesia
;
Information Storage and Retrieval
;
Programming Languages
;
Reference Values
3.Initial Experience with Concomitant Prolift(TM) System and Tension-Free Vaginal Tape Procedures in Patients with Stress Urinary Incontinence and Cystocele.
Hyoung Keun PARK ; Sung Hyun PAICK ; Byung Ki LEE ; Myung Beom KANG ; Kyung Kyu JUN ; Hyeong Gon KIM
International Neurourology Journal 2010;14(1):43-47
PURPOSE: The objective of this study is to report our initial experience about the feasibility, effectiveness, and safety of transobturator tension-free vaginal mesh (Prolift(TM)) and concomitant tension-free vaginal tape (TVT) as a treatment of female anterior vaginal wall prolapse associated with stress urinary incontinence (SUI). MATERIALS AND METHODS: We reviewed the charts of patients who underwent Prolift(TM) and TVT between April 2009 and March 2010. All patients had a physical examination and staging of cystocele. According to the International Continence Society system 2, 5 and 3 women had stage grade II, III and IV respectively. All the patients underwent pelvic examination 1, 3, 6 month and 1 year after operation and anatomical and functional outcomes were recorded. An anatomic cure after intervention was defined as stage 0 and an improvement was defined as stage I. Anatomic failures were defined as stage II or higher on the last physical examination. RESULTS: The mean follow-up was 7.1 (1-11) months. Overall success rate of cystocele repair was 90%. The anatomical cure rate of cystocele was 50%. The cystocele repair improved 4 patients, but failed in 1. SUI was cured in all patients. No significant complications including bladder or vessel injury and mesh related erosion occurred. The postoperative complication was transient voiding difficulty (2 cases). CONCLUSIONS: These preliminary results suggest that Prolift(TM) and TVT offer a safe and effective treatment for female anterior vaginal wall prolapse and SUI. However, a long-term follow up is necessary in order to support the good result maintenance.
Cystocele
;
Female
;
Follow-Up Studies
;
Glycosaminoglycans
;
Gynecological Examination
;
Humans
;
Physical Examination
;
Postoperative Complications
;
Prolapse
;
Suburethral Slings
;
Urinary Bladder
;
Urinary Incontinence
4.Treatment of Posttraumatic Facial Deformity Patient with Brown's Syndrome: Case Report.
Byung Chan PARK ; Yong Ha KIM ; Tae Gon KIM ; Jun Ho LEE ; Myung Mi KIM
Journal of the Korean Cleft Palate-Craniofacial Association 2010;11(1):33-36
PURPOSE: Brown's syndrome is characterized by the limited elevation in adduction from mechanical causes around the superior oblique tendon trochlea complex. In this particular case, post-traumatic facial deformity accompanied by Brown's syndrome was observed. We would like to report the satisfying cosmetic results obtained by reconstructing orbital roof and superior orbital rim and repositioning of zygoma. METHODS: A 12-year-old patient was observed with facial deformity with strabismus in her right eye and orbital dystopia after the car accident and was eventually diagnosed with traumatic Brown's syndrome. Reconstructive surgeries could not be performed at the time of trauma due to the cerebral hemorrhage. At the second year after the trauma, a depressed fracture of the right orbital roof and superior orbital rim were reconstructed via the intracranial approach, and orbital dystopia was corrected via the zygoma triple ostectomy. In addition, a strabismus surgery was performed one year after her plastic surgery. RESULTS: Facial deformity with orbital dystopia and strabismus was confirmed to be fully reconstructed after the surgery. Moreover, when the patient came in for a follow-up thirteen years after the operation, a developmental imbalance of the facial bones, diplopia, or any other surgical complications were not to be found. CONCLUSION: After the trauma, the patient with Brown's Syndrome accompanied by post-traumatic facial deformity, who went under the corrective surgeries after the meticulous examination and assessment pre-surgically, was able to acquire cosmetic satisfaction via those operations.
Cerebral Hemorrhage
;
Child
;
Congenital Abnormalities
;
Cosmetics
;
Diplopia
;
Eye
;
Facial Bones
;
Follow-Up Studies
;
Humans
;
Orbit
;
Porphyrins
;
Strabismus
;
Surgery, Plastic
;
Tendons
;
Zygoma
5.Effect of Traumatic Brain Injury on Healing of Femur shaft Fracture.
Myung Ho KIM ; Moon Jip YOO ; Hee Gon PARK ; Yeon Jun KIM
Journal of Korean Orthopaedic Research Society 2010;13(2):88-94
PURPOSE: Among the fracture patients, there is a tendency to form more callus and get fracture united earlier in groups with traumatic brain injury. This retrospective study is to evaluate the factors that might accelerate the bone formation by comparing two groups in serologic tests, clinical and radiologic results. MATERIALS AND METHODS: From March 2001 to July 2009, femur shaft fracture patients were divided in two groups 1) without traumatic brain injury (32cases), 2) fracture with traumatic brain injury combined (30cases). We evaluated the routine serologic exams, amount of callus formations during the follow up period. RESULTS: There was no statistical difference in WBC, CRP, total calcium, LDH level between two groups, except Alkaline phosphatase level. Amount of callus formation on AP radiograph at the last follow up period was 74.9% in study, 42.6% in control group. Lateral radiograph showed 73.2% of callus formation rate in study group and 32.0% in control group. CONCLUSION: Two groups had no significant difference with the routine serologic exam except Alkaline phosphatase. Group with traumatic brain injury had much more amount of callus formation but there was no evidence of traumatic brain injury accelerate the fracture healing.
Alkaline Phosphatase
;
Bony Callus
;
Brain
;
Brain Injuries
;
Calcium
;
Femur
;
Follow-Up Studies
;
Fracture Healing
;
Humans
;
Osteogenesis
;
Retrospective Studies
;
Serologic Tests
6.The Experience of Cystocele Repair with Monofilament polypropylene Mesh.
Byung Ki LEE ; Myung Beom KANG ; Kyung Kyu JUN ; Sung Hyun PAICK ; Yong Soo LHO ; Hyeong Gon KIM
Journal of the Korean Continence Society 2009;13(2):116-120
PURPOSE: The use of synthetic mesh to reinforce the anterior vaginal wall support for cystocele repair has been proposed to prevent recurrence. We evaluated the efficacy and safety of cystocele repair using monofilament polypropylene mesh (Gynemesh PS(TM)). MATERIALS AND METHODS: This study was performed in 53 patents who underwent cystocele repair using monofilament polypropylene mesh between January 2006 and January 2009. According to the ICS (International Continence Society) stage classification, 33, 17 and 3 women had stage II, III and IV cystocele. The operation were performed through the vaginal approach. Patients were followed up for 9 to 36 months. We defined the cure of cystocele as stage 0, improvement as stage I, and failed as stage II or greater RESULTS: The mean follow-up was 23.8 months. At follow-up, 41 women were anatomically cured (77.4%), 12 women were improved as stage I (22.6%) and no one was failed. Six cases were previously ICS stage II, 5 cases were stage III and 1 case was stage IV in improved group. No significant intraoperative complications occurred. The postoperative complications were de novo urgency (4 cases, 7.6%), erosion of mesh (2 cases, 3.8%) and anterior vaginal wall hematoma (1 case, 1.9%). CONCLUSION: The use of polypropylene mesh for correction of cystocele by transvaginal route with tension free technique seems to be a safe and effective procedure.
Classification
;
Cystocele*
;
Female
;
Follow-Up Studies
;
Hematoma
;
Humans
;
Intraoperative Complications
;
Polypropylenes*
;
Postoperative Complications
;
Recurrence
8.Gender Differences in Alcohol Metabolizing Hepatic Enzyme Genotypes in Korean Patients with Alcohol Dependence.
Sung Gon KIM ; Cheol Min KIM ; Duk Ki LEE ; In Bok HWANG ; Hyun Sook LEE ; Seong Yeon KIM ; Eun Sook JUN ; Young Sang SONG ; Je Min PARK ; Byeong Moo CHOE ; Myung Jung KIM
Journal of Korean Neuropsychiatric Association 2005;44(2):221-231
OBJECTIVES: There are a number of preceding epidemiological studies reporting gender differences in the genetic etiology of alcohol dependence. The author investigated gender difference in the frequencies of ADH2 and ALDH2 genoypes between the patients with alcohol dependence and normal control. METHODS: The subjects were 141 alcohol dependent patients (104 males, 37 females) and 138 normal control (79 males, 59 females). The frequencies of 1/1 and 1/2+2/2 (2+ afterward) genotypes for ADH2 and ALDH2 were investigated in male and female between alcohol dependence and normal control group. DNA was extracted from WBC in peripheral venous blood and PCR-RFLP method was used out for genotyping. RESULTS: First, the frequency of ADH2 1/1 genotype was significantly higher in alcohol dependent patients than normal control in both genders. Second, while there was no gender difference in the frequency of ADH2 1/1 genotype in normal controls, in the patient group however, the frequency was significantly higher in females than males. Third, in male subjects with alcohol dependence, the frequency of ALDH2 1/1 genotype was significantly higher than in male normal control subjects. On the other hand, in female subjects with alcohol dependence, the frequency of ALDH2 2+ genotype was significantly higher than in female normal control subjects. CONCLUSION: These results suggest that while the risk of alcohol dependence is predominantly affected by ALDH2 1/1 genotype in male, the female ADH2 1/1 genotype is mainly associated with the risk of alcohol dependence. This means that there are gender differences in the genetic etiology of alcohol dependence.
Alcoholism*
;
DNA
;
Epidemiologic Studies
;
Female
;
Genotype*
;
Hand
;
Humans
;
Male
9.Clinical Analysis of Blow-In Orbit Fracture and Its Treatment.
Kun Yong SUNG ; Myung Gon JUN ; Hee Chang AHN
Journal of the Korean Society of Plastic and Reconstructive Surgeons 2004;31(5):627-631
Blow-in orbit fracture is relatively rare fracture which is an inward displacement of the orbital rim or wall fragment, resulting in decreased orbital volume. The objective of this article is to analyze blow-in fracture status of orbit and to suggest appropriate management in this unusual fracture. The study included 23 cases who had treatment of blow-in fractures of orbit from July, 1995 to June, 2001. Their ages ranged from 4 years to 63 years. There were 17 males and 6 females. The diagnosis of blow-in fracture was accomplished with physical examination, ophthalmologic examination, plain X-ray, and facial CT scan. According to Antonyshyn's classification, we classified them into 2 large groups which were pure type and impure type. Pure type blow-in fractures are relatively uncommon and 5 cases were documented in a series of 23 patients. Impure type fractures included the orbital rim and 18 cases were documented. Clinical symptoms of blow-in fractures were proptosis, limitation of eyeball movement, diplopia, blepharoptosis, subconjunctival hemorrage and blindness. 2 patients with globe rupture and blindness underwent enucleation due to direct injury by bony segment. We conclude that early and appropriate surgical treatment with complete examination is very important to prevent blepharoptosis, proptosis, limitation of eyeball movement and optic nerve compression. However, when globe rupture and blindness by direct injury of bony segment happened, the operation of enucleation was needed in this particular case.
Blepharoptosis
;
Blindness
;
Classification
;
Diagnosis
;
Diplopia
;
Exophthalmos
;
Female
;
Humans
;
Male
;
Optic Nerve
;
Orbit*
;
Physical Examination
;
Rupture
;
Tomography, X-Ray Computed
10.Correlation of srum collagen type IV levels with histo-pathological findings assessed by liver biopsy in hepatitis B carrier with normal liver function test.
Myung Jun SONG ; Kyoung Gon KIM ; Yo Sig SHIN ; Nam Cheol HWANG ; Sang Joon PARK ; Yun Kwon KIM ; So Yon KIM ; Young Jung KIM ; Min Koo CHO ; Gwon Jun LEE
Korean Journal of Medicine 2002;63(1):29-35
BACKGROUND: We compared the results of liver biopsy and the levels of serum type IV collagen of the hepatitis B carriers with normal liver function test (LFT) to evaluate the clinical usefulness of serum type IV collagen in predicting the progression of histopathological findings. METHODS : Thirty one chronic hepatitis B carriers with normal LFT and no significant clinical symptoms, who were Korean combat police, were classified into three groups according to their histologic results of the liver biopsies. The classification followed the standard proposed by Korean Society of Pathology. Blood samplings for serum type IVcollagen (reference : less than 5 ng/mL) were done in the morning of the same day of the liver biopsy. RESULTS: Of thirty one patients, thirteen patients showed normal histologic findings (41.9%, Group A), eleven patients revealed histologic abnormalities without fibrosis (35.5%, Group B) and seven patients were with fibrosis on liver biopsy (22.6%, Group C). Serum type IV collagen levels of Group A, B and C were 3.53 +/- .57 ng/mL, 3.56 +/- .17 ng/mL and 3.97 +/- .88 ng/mL, respectively. The average of serum type IV collagen levels of Group C was higher than of Group B and the average of Group B higher than that of Group A without any statistical significance (p > 0.05). The averages of serum type IV collagen of eighteen patients with histologic abnormalities (Group B and C) and twenty four patients without fibrosis (Group A and B) were 3.73 +/- 1.06 ng/mL and 3.55 +/- .88 ng/mL respectively. Upon comparison of these averages with the those of Group A and C, no statistical significance was established (p > 0.05). CONCLUSION : In chronic hepatitis B carriers with normal LFT findings, levels of serum type IV collagen were elevated along with histologic severities without statistical significance, therefore can not represent the changing degree of the histologic findings. Liver biopsy is considered to be one of the most accurate tool to assess the histologic status of the liver.
Biopsy*
;
Classification
;
Collagen Type IV*
;
Collagen*
;
Fibrosis
;
Hepatitis B Surface Antigens
;
Hepatitis B*
;
Hepatitis B, Chronic
;
Hepatitis*
;
Humans
;
Liver Function Tests*
;
Liver*
;
Needles
;
Pathology
;
Police

Result Analysis
Print
Save
E-mail