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.Contemporary Statistics of Acute Ischemic Stroke and Transient Ischemic Attack in 2021: Insights From the CRCS-K-NIH Registry
Do Yeon KIM ; Tai Hwan PARK ; Yong-Jin CHO ; Jong-Moo PARK ; Kyungbok LEE ; Minwoo LEE ; Juneyoung LEE ; Sang Yoon BAE ; Da Young HONG ; Hannah JUNG ; Eunvin KO ; Hyung Seok GUK ; Beom Joon KIM ; Jun Yup KIM ; Jihoon KANG ; Moon-Ku HAN ; Sang-Soon PARK ; Keun-Sik HONG ; Hong-Kyun PARK ; Jeong-Yoon LEE ; Byung-Chul LEE ; Kyung-Ho YU ; Mi Sun OH ; Dong-Eog KIM ; Dong-Seok GWAK ; Soo Joo LEE ; Jae Guk KIM ; Jun LEE ; Doo Hyuk KWON ; Jae-Kwan CHA ; Dae-Hyun KIM ; Joon-Tae KIM ; Kang-Ho CHOI ; Hyunsoo KIM ; Jay Chol CHOI ; Joong-Goo KIM ; Chul-Hoo KANG ; Sung-il SOHN ; Jeong-Ho HONG ; Hyungjong PARK ; Sang-Hwa LEE ; Chulho KIM ; Dong-Ick SHIN ; Kyu Sun YUM ; Kyusik KANG ; Kwang-Yeol PARK ; Hae-Bong JEONG ; Chan-Young PARK ; Keon-Joo LEE ; Jee Hyun KWON ; Wook-Joo KIM ; Ji Sung LEE ; Hee-Joon BAE ;
Journal of Korean Medical Science 2024;39(34):e278-
This report presents the latest statistics on the stroke population in South Korea, sourced from the Clinical Research Collaborations for Stroke in Korea-National Institute for Health (CRCS-K-NIH), a comprehensive, nationwide, multicenter stroke registry. The Korean cohort, unlike western populations, shows a male-to-female ratio of 1.5, attributed to lower risk factors in Korean women. The average ages for men and women are 67 and 73 years, respectively.Hypertension is the most common risk factor (67%), consistent with global trends, but there is a higher prevalence of diabetes (35%) and smoking (21%). The prevalence of atrial fibrillation (19%) is lower than in western populations, suggesting effective prevention strategies in the general population. A high incidence of large artery atherosclerosis (38%) is observed, likely due to prevalent intracranial arterial disease in East Asians and advanced imaging techniques.There has been a decrease in intravenous thrombolysis rates, from 12% in 2017–2019 to 10% in 2021, with no improvements in door-to-needle and door-to-puncture times, worsened by the coronavirus disease 2019 pandemic. While the use of aspirin plus clopidogrel for noncardioembolic stroke and direct oral anticoagulants for atrial fibrillation is well-established, the application of direct oral anticoagulants for non-atrial fibrillation cardioembolic strokes in the acute phase requires further research. The incidence of early neurological deterioration (13%) and the cumulative incidence of recurrent stroke at 3 months (3%) align with global figures. Favorable outcomes at 3 months (63%) are comparable internationally, yet the lack of improvement in dependency at 3 months highlights the need for advancements in acute stroke care.
3.Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes Mellitus: A Position Statement of the Fatty Liver Research Group of the Korean Diabetes Association
Byung-Wan LEE ; Yong-ho LEE ; Cheol-Young PARK ; Eun-Jung RHEE ; Won-Young LEE ; Nan-Hee KIM ; Kyung Mook CHOI ; Keun-Gyu PARK ; Yeon-Kyung CHOI ; Bong-Soo CHA ; Dae Ho LEE ;
Diabetes & Metabolism Journal 2020;44(3):382-401
This clinical practice position statement, a product of the Fatty Liver Research Group of the Korean Diabetes Association, proposes recommendations for the diagnosis, progression and/or severity assessment, management, and follow-up of non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM). Patients with both T2DM and NAFLD have an increased risk of non-alcoholic steatohepatitis (NASH) and fibrosis and a higher risk of cardiovascular diseases and diabetic complications compared to those without NAFLD. With regards to the evaluation of patients with T2DM and NAFLD, ultrasonography-based stepwise approaches using noninvasive biomarker models such as fibrosis-4 or the NAFLD fibrosis score as well as imaging studies such as vibration-controlled transient elastography with controlled attenuation parameter or magnetic resonance imaging-proton density fat fraction are recommended. After the diagnosis of NAFLD, the stage of fibrosis needs to be assessed appropriately. For management, weight reduction achieved by lifestyle modification has proven beneficial and is recommended in combination with antidiabetic agent(s). Evidence that some antidiabetic agents improve NAFLD/NASH with fibrosis in patients with T2DM is emerging. However, there are currently no definite pharmacologic treatments for NAFLD in patients with T2DM. For specific cases, bariatric surgery may be an option if indicated.
4.Effectiveness and Safety of Zotarolimus-Eluting Stent (Resolute™ Integrity) in Patients with Diffuse Long Coronary Artery Disease
Keun Ho PARK ; Youngkeun AHN ; Young Youp KOH ; Young Jae KI ; Sung Soo KIM ; Hyun Kuk KIM ; Dong Hyun CHOI ; Young Joon HONG ; Jin Yong HWANG ; Do Hoi KIM ; Jay Young RHEW ; Jae Kean RYU ; Jong Seon PARK ; Tae Ho PARK ; Tae Hyun YANG ; Seok Kyu OH ; Bong Ryeol LEE ; Seung Uk LEE ; Sang Gon LEE ; Kook Jin CHUN ; Jang Hyun CHO ; Kwang Soo CHA ; Jei Keon CHAE ; Seung Ho HUR ; Sun Ho HWANG ; Hun Sik PARK ; Doo Il KIM
Korean Circulation Journal 2019;49(8):709-720
BACKGROUND AND OBJECTIVES: Diffuse long coronary artery disease (DLCAD) still has unfavorable clinical outcomes after successful percutaneous coronary intervention (PCI). Therefore, we aimed to evaluate the effectiveness and safety of Resolute™ zotarolimus-eluting stent (R-ZES; Resolute™ Integrity) for patients with DLCAD. METHODS: From December 2011 to December 2014, 1,011 patients who underwent PCI using R-ZES for CAD with longer than 25 mm lesion were prospectively enrolled from 21 hospitals in Korea. We assessed the clinical outcome of major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically-driven target vessel revascularization at 12 months. RESULTS: Mean age was 63.8±10.8 years, 701 (69.3%) patients were male, 572 (87.0%) patients had hypertension, 339 (33.8%) patients had diabetes, 549 (54.3%) patients diagnosed with acute MI and 545 (53.9%) patients had multi-vessel disease (MVD). A total of 1,697 stents were implanted into a total of 1,472 lesions. The mean diameter was 3.07±0.38 mm and the length was 28.27±6.97 mm. Multiple overlapping stents were performed in 205 (13.8%) lesions. A 12-month clinical follow-up was available in 1,004 patients (99.3%). The incidences of MACE and definite stent thrombosis at 12-month were 3.0% and 0.3% respectively. On multivariate Cox-regression analysis, multiple overlapping stents implantation, previous congestive heart failure, MVD, and age ≥75 years were independent predictors of one-year MACE. CONCLUSIONS: Our study shows that R-ZES has an excellent 1-year clinical outcome in Korean patients with DLCAD.
Coronary Artery Disease
;
Coronary Vessels
;
Death
;
Drug-Eluting Stents
;
Follow-Up Studies
;
Heart Failure
;
Humans
;
Hypertension
;
Incidence
;
Korea
;
Male
;
Myocardial Infarction
;
Percutaneous Coronary Intervention
;
Prospective Studies
;
Stents
;
Thrombosis
;
Treatment Outcome
5.Effectiveness and Safety of Zotarolimus-Eluting Stent (Resoluteâ„¢ Integrity) in Patients with Diffuse Long Coronary Artery Disease
Keun Ho PARK ; Youngkeun AHN ; Young Youp KOH ; Young Jae KI ; Sung Soo KIM ; Hyun Kuk KIM ; Dong Hyun CHOI ; Young Joon HONG ; Jin Yong HWANG ; Do Hoi KIM ; Jay Young RHEW ; Jae Kean RYU ; Jong Seon PARK ; Tae Ho PARK ; Tae Hyun YANG ; Seok Kyu OH ; Bong Ryeol LEE ; Seung Uk LEE ; Sang Gon LEE ; Kook Jin CHUN ; Jang Hyun CHO ; Kwang Soo CHA ; Jei Keon CHAE ; Seung Ho HUR ; Sun Ho HWANG ; Hun Sik PARK ; Doo Il KIM
Korean Circulation Journal 2019;49(8):709-720
BACKGROUND AND OBJECTIVES:
Diffuse long coronary artery disease (DLCAD) still has unfavorable clinical outcomes after successful percutaneous coronary intervention (PCI). Therefore, we aimed to evaluate the effectiveness and safety of Resoluteâ„¢ zotarolimus-eluting stent (R-ZES; Resoluteâ„¢ Integrity) for patients with DLCAD.
METHODS:
From December 2011 to December 2014, 1,011 patients who underwent PCI using R-ZES for CAD with longer than 25 mm lesion were prospectively enrolled from 21 hospitals in Korea. We assessed the clinical outcome of major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically-driven target vessel revascularization at 12 months.
RESULTS:
Mean age was 63.8±10.8 years, 701 (69.3%) patients were male, 572 (87.0%) patients had hypertension, 339 (33.8%) patients had diabetes, 549 (54.3%) patients diagnosed with acute MI and 545 (53.9%) patients had multi-vessel disease (MVD). A total of 1,697 stents were implanted into a total of 1,472 lesions. The mean diameter was 3.07±0.38 mm and the length was 28.27±6.97 mm. Multiple overlapping stents were performed in 205 (13.8%) lesions. A 12-month clinical follow-up was available in 1,004 patients (99.3%). The incidences of MACE and definite stent thrombosis at 12-month were 3.0% and 0.3% respectively. On multivariate Cox-regression analysis, multiple overlapping stents implantation, previous congestive heart failure, MVD, and age ≥75 years were independent predictors of one-year MACE.
CONCLUSIONS
Our study shows that R-ZES has an excellent 1-year clinical outcome in Korean patients with DLCAD.
6.Aberrant growth of the anterior cranial base relevant to severe midface hypoplasia of Apert syndrome
Bong Kuen CHA ; Dong Soon CHOI ; In San JANG ; Hyun Tae YOOK ; Seung Youp LEE ; Sang Shin LEE ; Suk Keun LEE
Maxillofacial Plastic and Reconstructive Surgery 2018;40(1):40-
BACKGROUND: A 9-year-old male showed severe defects in midface structures, which resulted in maxillary hypoplasia, ocular hypertelorism, relative mandibular prognathism, and syndactyly. He had been diagnosed as having Apert syndrome and received a surgery of frontal calvaria distraction osteotomy to treat the steep forehead at 6 months old, and a surgery of digital separation to treat severe syndactyly of both hands at 6 years old. Nevertheless, he still showed a turribrachycephalic cranial profile with proptosis, a horizontal groove above supraorbital ridge, and a short nose with bulbous tip. METHODS: Fundamental aberrant growth may be associated with the cranial base structure in radiological observation. RESULTS: The Apert syndrome patient had a shorter and thinner nasal septum in panthomogram, PA view, and Waters’ view; shorter zygomatico-maxillary width (83.5 mm) in Waters’ view; shorter length between the sella and nasion (63.7 mm) on cephalogram; and bigger zygomatic axis angle of the cranial base (118.2°) in basal cranial view than a normal 9-year-old male (94.8 mm, 72.5 mm, 98.1°, respectively). On the other hand, the Apert syndrome patient showed interdigitating calcification of coronal suture similar to that of a normal 30-year-old male in a skull PA view. CONCLUSION: Taken together, the Apert syndrome patient, 9 years old, showed retarded growth of the anterior cranial base affecting severe midface hypoplasia, which resulted in a hypoplastic nasal septum axis, retruded zygomatic axes, and retarded growth of the maxilla and palate even after frontal calvaria distraction osteotomy 8 years ago. Therefore, it was suggested that the severe midface hypoplasia and dysostotic facial profile of the present Apert syndrome case are closely relevant to the aberrant growth of the anterior cranial base supporting the whole oro-facial and forebrain development.
Acrocephalosyndactylia
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Adult
;
Child
;
Exophthalmos
;
Forehead
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Hand
;
Humans
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Hypertelorism
;
Male
;
Maxilla
;
Nasal Septum
;
Nose
;
Osteotomy
;
Palate
;
Prognathism
;
Prosencephalon
;
Skull
;
Skull Base
;
Sutures
;
Syndactyly
7.Tongue Growth during Prenatal Development in Korean Fetuses and Embryos.
Soo Jeong HONG ; Bong Geun CHA ; Yeon Sook KIM ; Suk Keun LEE ; Je Geun CHI
Journal of Pathology and Translational Medicine 2015;49(6):497-510
BACKGROUND: Prenatal tongue development may affect oral-craniofacial structures, but this muscular organ has rarely been investigated. METHODS: In order to document the physiology of prenatal tongue growth, we histologically examined the facial and cranial base structures of 56 embryos and 106 fetuses. RESULTS: In Streeter's stages 13-14 (fertilization age [FA], 28 to 32 days), the tongue protruded into the stomodeal cavity from the retrohyoid space to the cartilaginous mesenchyme of the primitive cranial base, and in Streeter's stage 15 (FA, 33 to 36 days), the tongue rapidly swelled and compressed the cranial base to initiate spheno-occipital synchondrosis and continued to swell laterally to occupy most of the stomodeal cavity in Streeter's stage 16-17 (FA, 37 to 43 days). In Streeter's stage 18-20 (FA, 44 to 51 days), the tongue was vertically positioned and filled the posterior nasopharyngeal space. As the growth of the mandible and maxilla advanced, the tongue was pulled down and protruded anteriorly to form the linguomandibular complex. Angulation between the anterior cranial base (ACB) and the posterior cranial base (PCB) was formed by the emerging tongue at FA 4 weeks and became constant at approximately 124degrees-126degrees from FA 6 weeks until birth, which was consistent with angulations measured on adult cephalograms. CONCLUSIONS: The early clockwise growth of the ACB to the maxillary plane became harmonious with the counter-clockwise growth of the PCB to the tongue axis during the early prenatal period. These observations suggest that human embryonic tongue growth affects ACB and PCB angulation, stimulates maxillary growth, and induces mandibular movement to achieve the essential functions of oral and maxillofacial structures.
Adult
;
Axis, Cervical Vertebra
;
Embryonic Structures*
;
Fetus*
;
Humans
;
Mandible
;
Maxilla
;
Mesoderm
;
Parturition
;
Physiology
;
Skull Base
;
Tongue*
8.Safety and Efficacy of Modern Insulin Analogues.
Hye Jin YOO ; Keun Yong PARK ; Kang Seo PARK ; Kyu Jeung AHN ; Kyung Wan MIN ; Jeong Hyun PARK ; Sang Ah CHANG ; Bong Soo CHA ; Dong Jun KIM ; Yong Seong KIM ; Tae Keun OH ; Suk CHON ; Il Seong NAM-GOONG ; Mi Jin KIM ; Hye Soon KIM ; Young Sik CHOI ; You Hern AHN ; Sora LEE ; Sei Hyun BAIK
Diabetes & Metabolism Journal 2013;37(3):181-189
BACKGROUND: A1chieve(R) was a noninterventional study evaluating the clinical safety and efficacy of biphasic insulin aspart 30, insulin detemir, and insulin aspart. METHODS: Korean type 2 diabetes patients who have not been treated with the study insulin or have started it within 4 weeks before enrollment were eligible for the study. The patient selection and the choice of regimen were at the discretion of the physician. The safety and efficacy information was collected from the subjects at baseline, week 12, and week 24. The number of serious adverse drug reactions (SADRs) was the primary endpoint. The changes of clinical diabetic markers at week 12 and/or at week 24 compared to baseline were the secondary endpoints. RESULTS: Out of 4,058 exposed patients, 3,003 completed the study. During the study period, three SADRs were reported in three patients (0.1%). No major hypoglycemic episodes were observed and the rate of minor hypoglycemic episodes marginally decreased during 24 weeks (from 2.77 to 2.42 events per patient-year). The overall quality of life score improved (from 66.7+/-15.9 to 72.5+/-13.5) while the mean body weight was slightly increased (0.6+/-3.0 kg). The 24-week reductions in glycated hemoglobin, fasting plasma glucose and postprandial plasma glucose were 1.6%+/-2.2%, 2.5+/-4.7 mmol/L, and 4.0+/-6.4 mmol/L, respectively. CONCLUSION: The studied regimens showed improvements in glycemic control with low incidence of SADRs, including no incidence of major hypoglycemic episodes in Korean patients with type 2 diabetes.
Biphasic Insulins
;
Body Weight
;
Diabetes Mellitus, Type 2
;
Drug Toxicity
;
Fasting
;
Glucose
;
Hemoglobins
;
Humans
;
Incidence
;
Insulin
;
Insulin Aspart
;
Insulin, Isophane
;
Insulin, Long-Acting
;
Patient Selection
;
Plasma
;
Quality of Life
;
Republic of Korea
;
Treatment Outcome
;
Insulin Detemir
9.Relationship between Metabolic Syndrome and MTHFR Polymorphism in Colorectal Cancer.
Bong Su KANG ; Dae Ho AHN ; Nam Keun KIM ; Jong Woo KIM
Journal of the Korean Society of Coloproctology 2011;27(2):78-82
PURPOSE: There have been studies on the relations between metabolic syndrome and colorectal cancer or on the relations between methylenetetrahydrofolate reductase (MTHFR) polymorphism and colorectal cancer, but reports on the relationship between metabolic syndrome, MTHFR polymorphism and colorectal cancer all together are rare. The aim of this study is to find the interrelation between metabolic syndrome and MTHFR polymorphism in colorectal cancer. METHODS: This study investigated 255 colorectal cancer patients (cancer group) who underwent surgery in our hospital from March 2003 to December 2008 and compared those patients to 488 healthy patients (control group). The diagnostic criterion for metabolic syndrome was based on the National Cholesterol Education Program-Adult Treatment Panel III (NCEP ATP III), and the MTHFR 677 polymorphism was analyzed. RESULTS: When colorectal cancer patients and patients in the control group were classified as MTHFR 677 subtypes, there was no difference between the two groups: CC 87 (34.1%), CT 134 (52.6%), and TT 34 (13.3%) for the cancer group and CC 145 (32.4%), CT 238 (53.1%), and TT 65 (14.5%) for the control group. Distributions of MTHFR 677C/T genotype and allele frequencies in the individuals with and without metabolic syndrome in the cancer group showed no differences. Moreover, we could find no differences in distributions of MTHFR 677C/T genotypes in the clinical and the biomedical variables of individuals with and without metabolic syndrome in the cancer group. CONCLUSION: Our results show no relation between metabolic syndrome and MTHFR polymorphism in colorectal cancer. However, a further prospective study, based on a precise diagnostic criterion for metabolic syndrome, is needed.
Adenosine Triphosphate
;
Cholesterol
;
Colorectal Neoplasms
;
Gene Frequency
;
Genotype
;
Humans
;
Methylenetetrahydrofolate Reductase (NADPH2)
10.Clinical Considerations of the Surgical Treatments of the Pressure Sore.
Keun Cheol LEE ; Joo Bong MOON ; Yong Seok KWON ; Byung Hoon CHA ; Seok Kwun KIM
Journal of the Korean Society of Plastic and Reconstructive Surgeons 2007;34(5):574-579
PURPOSE: The number of sore patients are increasing steadily, especially in old ages, chronic disease and paralytic patients. Most of patients need to surgical treatment. The aim of this paper is to assess clinical analysis of surgical treatment and to consider operative methods, complications, and recurrences. METHODS: We reviewed the data from 82 consecutive patients with 101 pressure sores from March 2003 to May 2006 to discuss the occurrence rate and recurrence rate according to the site on the basis of the presence or absence of paraplegic and its etiology-the patients were categorized into three diagnostic groups: traumatic paraplegics(TP), nontraumatic paraplegics (NTP), and nontraumatic nonparaplegics(NTNP). We examined the sites and sizes of each lesions, patient's state, primary causes of pressure sore, operative methods as each sites and groups, occurrence of complications and recurrences on each groups. RESULTS: In 82 patients, 52 patients were male, 30 patients were female. The male to female ratio was 1.7 :1. Mean age was 55.8 years. 27 patients were in TP group, 35 in NTP group, and 20 in NTNP group, respectively. The common site of sore were sacral area (50.5%), greater trochanteric area(15.8%) and ischial area(13.9%). In each group, incidence rate of recurrence and complication were 11.1%, 40.7% in TP, 5.7%, 5.7% in NTP and 15%, 45% in NTNP. CONCLUSION: Surgeons must consider the general condition of the patient and possibility of recurrence and returning of daily life. We propose that cutaneous flap, fasciocutaneous flap or skin graft as well as musculocutaneous flap be useful to repair of sore site as each patient's state.
Chronic Disease
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Female
;
Femur
;
Humans
;
Incidence
;
Male
;
Myocutaneous Flap
;
Pressure Ulcer*
;
Recurrence
;
Skin
;
Transplants

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