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.Validation of the Korean version of the European Community Respiratory Health Survey screening questionnaire for use in epidemiologic studies for adult asthma
Woo Jung SONG ; So Hee LEE ; Min Gyu KANG ; Ju Young KIM ; Mi Young KIM ; Eun Jung JO ; Suh Young LEE ; Seung Eun LEE ; Min Hye KIM ; Min Suk YANG ; Sae Hoon KIM ; Hye Ryun KANG ; Hye Kyung PARK ; Heung Woo PARK ; Yoon Seok CHANG ; Sun Sin KIM ; Jong Myung LEE ; Kyung Up MIN ; Sang Heon CHO
Asia Pacific Allergy 2015;5(1):25-31
BACKGROUND: Standardized questionnaire is one of key instruments for general population surveys. OBJECTIVE: The present study aimed to develop and validate the Korean version of the European Community Respiratory Health Survey (ECRHS) screening questionnaire for adult asthma surveys. METHODS: The ECRHS screening questionnaire was translated into Korean language according to the international criteria. Study participants were prospectively recruited from six referral hospitals and one health check-up center. Comprehensibility of the translation was tested in a pilot study of 10 patients. The reliability was evaluated by internal consistency and test-retest repeatability. Validity was assess with regard to physician-diagnosed asthma. RESULTS: A total of 100 adult asthma patients and 134 volunteers were recruited. Reliability was examined for 10 items in 100 asthmatics; Cronbach α coefficients were 0.84, and test-retest repeatability was good (Cohen κ coefficient, 0.71-1.00). Validity was assessed for 8 items in 234 participants; in particular, 'recent wheeze' showed a high sensitivity (0.89) for physician-diagnosed asthma. 'Recent asthma attack' and 'current asthma medication' showed high specificity (0.96-0.98). CONCLUSION: The present study demonstrated that the Korean version of the ECRHS screening questionnaire was comprehensible, reliable and valid. We suggest the questionnaire to be utilized in further epidemiological studies for asthma in Korean adult populations.
Adult
;
Asthma
;
Epidemiologic Studies
;
Epidemiology
;
European Union
;
Health Surveys
;
Humans
;
Mass Screening
;
Pilot Projects
;
Prospective Studies
;
Referral and Consultation
;
Sensitivity and Specificity
;
Volunteers
3.The Factors that Predict Using Mechanical Ventilation for Patients with Organophosphate Intoxication.
Dong Chan PARK ; Jung Bae PARK ; Yun Jeong KIM ; Soo Jeong SHIN ; You Ho MUN ; Sin Ryul PARK ; Hyun Wook RYOO ; Kang Suk SEO ; Jae Myung CHUNG
Journal of The Korean Society of Clinical Toxicology 2010;8(2):106-112
PURPOSE: The purpose of this study is to investigate the factors that predict using mechanical ventilation for patients with organophosphate intoxication. METHODS: We retrospectively reviewed the medical records of 111 patients with acute organophosphate intoxication and who were treated in our emergency center from January 2000 to December 2008. We compared the toxicologic characteristics, the laboratory findings and the APACHE II scores between the Mechanical Ventilation group (MV group) and the non-Mechanical Ventilation group (the non MV group). RESULTS: Sixty three patients were in the MV group and 48 patients were in the non MV group. In the MV group, the patients had an older age (p<0.001), a larger amount of ingestion (p<0.001), a lower initial serum cholinesterase level (p=0.003), a higher APACHE II score (p<0.001) and they ingested a more toxic agent (p=0.001). There were no significant differences in gender, the type of visit and the arrival time between the MV group and the non MV group. CONCLUSION: We suggest that the patient's age, the amount of organophosphate ingestion, the toxicity of the agent, the initial serum cholinesterase level and the APACHE II score are important factors to determine if mechanical ventilation will be applied for patients with organophosphate intoxication.
APACHE
;
Cholinesterases
;
Eating
;
Emergencies
;
Humans
;
Medical Records
;
Respiration, Artificial
;
Retrospective Studies
;
Ventilation
4.Necessity for a Whole-body CT Scan in Alert Blunt Multiple Trauma Patients.
You Ho MUN ; Yun Jeong KIM ; Soo Jeong SHIN ; Dong Chan PARK ; Sin Ryul PARK ; Hyun Wook RYU ; Kang Suk SEO ; Jung Bae PARK ; Jae Myung CHUNG ; Ji Hye BAE
Journal of the Korean Society of Traumatology 2010;23(2):89-95
PURPOSE: Whole-body CT is a very attractive diagnostic tool to clinicians, especially, in trauma. It is generally accepted that trauma patients who are not alert require whole-body CT. However, in alert trauma patients, the usefulness is questionable. METHODS: This study was a retrospective review of the medical records of 146 patients with blunt multiple trauma who underwent whole body CT scanning for a trauma workup from March 1, 2008 to February 28, 2009. We classified the patients into two groups by patients' mental status (alert group: 110 patients, not-alert group: 36 patients). In the alert group, we compared the patients' evidence of injury (present illness, physical examination, neurological examination) with the CT findings. RESULTS: One hundred forty six(146) patients underwent whole-body CT. The mean age was 44.6+/-18.9 years. One hundred four (104, 71.2%) were men, and the injury severity score was 14.0+/-10.38. In the not-alert group, the ratios of abnormal CT findings were relatively high: head 23/36(63.9%), neck 3/6(50.0%), chest 16/36(44.4%) and abdomen 9/36(25%). In the alert group, patients with no evidence of injury were rare (head 1, chest 6 and abdomen 2). Nine(9) patients did not need any intervention or surgery. CONCLUSION: Whole-body CT has various disadvantages, such as radiation, contrast induced nephropathy and high medical costs. In multiple trauma patients, if they are alert and have no evidence of injury, they rarely have abnormal CT findings, and mostly do not need invasive treatment. Therefore, we should be cautious in performing whole-body CT in alert multiple trauma patients.
Abdomen
;
Head
;
Humans
;
Injury Severity Score
;
Male
;
Medical Records
;
Multiple Trauma
;
Neck
;
Physical Examination
;
Radiation Injuries
;
Retrospective Studies
;
Thorax
5.Colon Obstruction due to Colonic Metastasis of a Breast Carcinoma.
Do Hyoung KIM ; In Kyu LEE ; Chang Hyun OH ; Yoon Suk LEE ; Jong Kyung PARK ; Woo Chan PARK ; Hae Myung JEON ; Jae Ho BYUN ; Gyeoung Sin PARK ; Suk Kyun CHANG
Journal of the Korean Society of Coloproctology 2008;24(2):144-147
Breast cancer is a common malignancy in women and metastasizes to the liver, the lung, the brain, and the bone, but metastasis to the colon is rare. We describe a 58-year-old woman with colon metastasis of breast cancer. She was diagnosed with right colon cancer, and during investigation for colon cancer, we found a breast cancer. She received a palliative right hemicolectomy due to obstruction before chemotherapy. The histology of the tissue taken from the right colon was shown to be the same as that of the left breast mass. This is a case of colonic metastasis from breast cancer and we report this case with a review of literature.
Brain
;
Breast
;
Breast Neoplasms
;
Colon
;
Colonic Neoplasms
;
Female
;
Humans
;
Liver
;
Lung
;
Middle Aged
;
Neoplasm Metastasis
6.Comparison of Secondary Procedures for Recurrent Stress Urinary Incontinence after a Transobturator Tape Procedure: Shortening of the Tape versus Tension-free Vaginal Tape Redo.
Jun Sung KOH ; Hyo Sin KIM ; Hyun Woo KIM ; Yong Seok LEE ; Suk Il KIM ; Kyu Sung LEE ; Myung Soo CHOO ; Ji Youl LEE
Korean Journal of Urology 2007;48(11):1149-1154
PURPOSE: Although the reported failure rate of the transobturator tape procedure(TOT) is low, recurrence after this procedure have been reported, and no standard treatment has yet been established for the recurrence. We compared a shortening of the previously implanted tape with a repeat tension-free vaginal tape(TVT) procedure after a failed TOT procedure. MATERIALS AND METHODS: We enrolled eighteen women(mean age: 54.38+/-9.15 years, range: 38-72) who underwent shortening of the previously implanted tape or they underwent a repeated TVT procedure due to persistent or recurrent SUI. Of the 18 women, 10 patients underwent shortening of implanted tape and the others underwent repeat TVT. All the patients were evaluated preoperatively with a detailed history, pelvic examination, urinalysis, voiding diary and urodynamic study that included the Valsalva leak point pressure(VLPP). The postoperative outcomes were assessed by a review of admissions and the medical charts. RESULTS: The mean interval from first surgery to recurrence was 6.88+/-2.61 months for Monarc, 12 months for TVT-O and 4.71+/-2.42 months for T-sling. Of the 10 patients who underwent shortening of the implanted tape, 7(70%) patients were cured and the others failed. Of the 8 patients who underwent repeat TVT, 7(87.5%) patients were cured and one was significantly improved. The success rate is significantly higher in the repeated TVT group(p<0.05). CONCLUSIONS: Both a shortening of the previously implanted tape and a repeated TVT procedure are safe, effective, viable options in the event of initial TOT sling failure. However, the success rate of the repeated TVT group is higher than that of the shortening of implanted tape group, especially for patients with an internal sphincteric deficiency. Therefore, a repeated TVT procedure is a first option in the event of initial TOT sling failure.
Female
;
Gynecological Examination
;
Humans
;
Recurrence
;
Suburethral Slings*
;
Urethra
;
Urinalysis
;
Urinary Incontinence*
;
Urodynamics
7.Critical Pathway for Colorectal and Gastric Cancer.
In Kyu LEE ; Sang Myong LEE ; Sin Sun KIM ; Yoon Suk LEE ; Woo Lee KOH ; Hyun Kyung KIM ; Seong Taek OH ; Hae Myung JEON ; Suck Kyun CHANG
Journal of the Korean Society of Coloproctology 2007;23(2):80-86
PURPOSE: The critical pathway (CP) is to standardize the clinical practice of specialists working to optimize care. The objective of this study was to develop a critical pathway for the surgical treatment of patients with colorectal or gastric cancer and to evaluate the results of the CP. METHODS: Twenty-one patients with colorectal cancer, who were managed according to the CP between August 2005 and November 2005, were compared with 18 patients for whom this pathway had not been used between June 2004 and September 2004. Forty-eight patients with gastic cancer, who were managed according to the CP between June 2005 and September 2005, were compared with 49 patients for whom this pathway had not been used daring the same period in 2004. The length of stay and the cost per patients were compared between the CP group and the non-CP group. RESULTS: For patients with colorectal cancer, the postoperative hospital length of stay in the CP group was significantly shorter (9.0 vs. 12.3 days, P<0.001), but for patients with gastric caner, there was no difference (10.6 vs. 11.4, P=0.134). The mean hospital charges were won5,037,816 and won5,263,508 for colorectal cancer and for gastric cancer, respectively, and won4,808,602 and won4,674,329, for the CP and the non-CP groups, respectively, but these differences were not significant. CONSLUSIONS: The critical pathway in colorectal and stomach surgery decreased the length of stay and might regulate hospital charges. Such a pathway could be easily designed and implemented at hospitals and could standardize clinical practice.
Colorectal Neoplasms
;
Critical Pathways*
;
Hospital Charges
;
Humans
;
Length of Stay
;
Specialization
;
Stomach
;
Stomach Neoplasms*
8.Anal Diseases among Patients with Leukemia.
Won Kyung KANG ; Hyo Sin JEON ; Hyung Jin KIM ; In Kyu LEE ; Hae Myung JEON ; Myung Ah LEE ; Suk Kyun CHANG ; Seong Taek OH
Journal of the Korean Society of Coloproctology 2006;22(2):86-90
PURPOSE: Anal diseases are a common complication among patients with leukemia, and the perianal abscess may prove to be the most fatal among anal diseases. We report here the prevalence, the treatment methods, and the prognosis for anal diseases among patients with leukemia. METHODS: Among the 310 patients who were diagnosed with and treated for leukemia between October 1999 and September 2000, we investigated the medical records of 53 patients with complications due to anal diseases. RESULTS: Among the 310 patients with leukemia, 53 (17.1%) reported anal diseases. There were 30 patients with hemorrhoids, 15 patients with a perianal abscess, 3 patients with an anal fistula, 3 patients with a fissure and 2 patients with hemorrhoids and fistulas. Anal pain was the most common complaint. Conservative treatment improved the symptoms in 42 patients (79.2%) while surgery was necessary in the remaining 11 patients (20.8%). A hemorrhoidectomy was undertaken in 4 patients, a drainage procedure in 4 paients, and a fistulotomy in 3 patients. Throughout the study period, 6 patients died (11.3%), 3 of them with perianal abscesses. Among the 15 patients with a perianal abscess, 13 showed fever (87%), and 9 patients underwent drainage (4 surgical drainages and 5 natural drainages). E. coli was the most commonly cultured organism. CONCLUSIONS: The incidence of anal diseases in patients with leukemia was high. Nonsurgical methods were sufficient for hemorrhoids and fistulas. For a perianal abscess, drainage should be undertaken when abscess formation is evident. When abscess formation is not evident, medical treatment is the primary modality, and surgery should be considered only when medical treatment fails to improve or worsens the patient's condition, but the prognosis is poor.
Abscess
;
Drainage
;
Fever
;
Fistula
;
Hemorrhoidectomy
;
Hemorrhoids
;
Humans
;
Incidence
;
Leukemia*
;
Medical Records
;
Prevalence
;
Prognosis
;
Rectal Fistula
9.A case of capsule endoscopic finding on Churg-Strauss syndrome with gastrointestinal involvement.
Jae Ha MAENG ; Hae Won HAN ; Seung Kyun SONG ; Jin Ho JEON ; Woo Sin KIM ; Suk Joon PARK ; Myung Kyu CHOI
Korean Journal of Medicine 2006;70(6):719-724
Churg-Strauss syndrome is a disorder of hypereosinophilia and systemic vasculitis in subjects with asthma and allergic rhinitis. Clinically, this syndrome can be involved with various manifestations of disease of lung, heart, skin, musculoskeletal system, nerve system, gastrointestinal and hepatobiliary tract. Gastrointestinal manifestations often occur in patients. However, endoscopic finding is rare because of risk on intestinal perforation and hemorrhage in vasculitis-phase. We experienced a case of Churg-Strauss syndrome in a 27-year-old male patient with severe abdominal pain and diarrhea. He also showed leukocytosis with peripheral eosinophilia, bronchial asthma, and chronic paranasal sinusitis. Based on findings, we suggested Churg-Strauss syndrome with gastrointestinal involvement and he received a capsules endoscopy and gastroduodenal endoscopy. Capsules endoscopy showed diffuse erythema and mucosal edema on proximal jejunum to ileum, which meant the Churg-Strauss syndrome with gastrointestinal involvement. We report this case with a review of the relevant literatures.
Abdominal Pain
;
Adult
;
Asthma
;
Capsules
;
Churg-Strauss Syndrome*
;
Diarrhea
;
Edema
;
Endoscopy
;
Eosinophilia
;
Erythema
;
Heart
;
Hemorrhage
;
Humans
;
Ileum
;
Intestinal Perforation
;
Jejunum
;
Leukocytosis
;
Lung
;
Male
;
Musculoskeletal System
;
Rhinitis
;
Sinusitis
;
Skin
;
Systemic Vasculitis
10.The Validation of the Admission Systemic Inflammatory Response Syndrome Score as the Trauma Score.
Sin Youl PARK ; Kang Suk SEO ; Hyun Wook RYOO ; Kyung Woo LEE ; Jeong Ho LEE ; Jun Seok SEO ; Hui Jung LEE ; Jeong Bae PARK ; Jae Myung CHUNG
Journal of the Korean Society of Emergency Medicine 2005;16(1):104-113
PURPOSE: Multiple trauma is one of the major causes of deaths and physical disabilities of the young. Thus, a trauma scoring system which is easy, fast, and accurate is the most important factor for reducing the mortality due to multiple trauma. As studies have shows the systemic inflammatory response syndrome (SIRS) score is useful in estimating the severity of and determining the prognosis of the disease, so we investigated the usefulness of the SIRS score as a trauma score. METHODS: This study was a retrospective analysis of data collected from January 2002 to December 2002. Three hundred sixity nine trauma patients who were admitted to the emergency department were included. Patients who were transferred from other hospitals, children under the age of 15 years and patients transferred to other hospitals for ICU care and emergency operations were excluded. The SIRS score was defined according to the criteria of the American College of Chest Physicians and the Society of Critical Care Medicine (ACCP/SCCM). Patients were grouped by using the SIRS score(0 to 4) calculated at admission. RESULTS: Among the 369 trauma patients, 174 patients (47.2%) had a SIRS score > or =2 at admission, and 30 of the 369 patients expired. The admission SIRS score was significantly correlated with the injury severity score (ISS). The mortality rate and the length of stay (LOS) significantly increased as the admission SIRS score increased. Analysis of the variance, adjusting for age and ISS, should that are SIRS score> or =2 was a significant predictor of mortality and LOS. CONCLUSION: The admission SIRS score has been shown to be useful in estimating the severity of and the prognosis for a trauma. If we apply it to the trauma patients who visit ED, it should provide a more useful means for determining the severity of the trauma and the prognosis for the patient.
Cause of Death
;
Child
;
Critical Care
;
Emergencies
;
Emergency Service, Hospital
;
Humans
;
Injury Severity Score
;
Length of Stay
;
Mortality
;
Multiple Trauma
;
Prognosis
;
Retrospective Studies
;
Systemic Inflammatory Response Syndrome*
;
Thorax

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