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.Clinical Outcome of Endoscopic Submucosal Dissection for Papillary Type Early Gastric Cancer: A Multicenter Study
Hyun-Deok SHIN ; Ki Bae BANG ; Sun Hyung KANG ; Hee Seok MOON ; Jae Kyu SUNG ; Hyun Yong JEONG ; Dong Kyu LEE ; Ki Bae KIM ; Sun Moon KIM ; Seung Woo LEE ; Dong Soo LEE ; Young Sin CHO ; Il-Kwun CHUNG ; Ju Seok KIM
Gut and Liver 2024;18(3):426-433
Background/Aims:
Papillary adenocarcinoma is classified to differentiated-type gastric cancer and is indicated for endoscopic submucosal dissection. However, due to its rare nature, there are limited studies on it. The purpose of this study was to determine the outcome of endoscopic submucosal dissection in patients with papillary-type early gastric cancer and to find the risk factors of lymph node metastasis.
Methods:
Patients diagnosed with papillary-type early gastric cancer at eight medical centers, who underwent endoscopic submucosal dissection or surgical treatment, were retrospectively reviewed. The clinical results and long-term outcomes of post-endoscopic submucosal dissection were evaluated, and the risk factors of lymph node metastasis in the surgery group were analyzed.
Results:
One-hundred and seventy-six patients with papillary-type early gastric cancer were enrolled: 44.9% (n=79) in the surgery group and 55.1% (n=97) in the endoscopic submucosal dissection group. As a result of endoscopic submucosal dissection, the en bloc resection and curative resection rates were 91.8% and 86.6%, respectively. The procedure-related complication rate was 4.1%, and local recurrence occurred in 3.1% of patients. Submucosal invasion (odds ratio, 3.735; 95% confidence interval, 1.026 to 12.177; p=0.047) and lymphovascular invasion (odds ratio, 7.636; 95% confidence interval, 1.730 to 22.857; p=0.004) were the risk factors of lymph node metastasis in papillary-type early gastric cancer patients.
Conclusions
The clinical results of endoscopic submucosal dissection in papillary-type early gastric cancer were relatively favorable, and endoscopic submucosal dissection is considered safe if appropriate indications are confirmed by considering the risk of lymph node metastasis.
3.Newly Developed Sex-Specific Z Score Model for Coronary Artery Diameter in a Pediatric Population
Jeong Jin YU ; Hee Joung CHOI ; Hwa Jin CHO ; Sung Hye KIM ; Eun Jung CHEON ; Gi Beom KIM ; Lucy Youngmin EUN ; Se Yong JUNG ; Hyun Ok JUN ; Hyang-Ok WOO ; Sin-Ae PARK ; Soyoung YOON ; Hoon KO ; Ji-Eun BAN ; Jong-Woon CHOI ; Min Seob SONG ; Ji Whan HAN
Journal of Korean Medical Science 2024;39(16):e144-
Background:
This study aimed to generate a Z score calculation model for coronary artery diameter of normal children and adolescents to be adopted as the standard calculation method with consensus in clinical practice.
Methods:
This study was a retrospective, multicenter study that collected data from multiple institutions across South Korea. Data were analyzed to determine the model that best fit the relationship between the diameter of coronary arteries and independent demographic parameters. Linear, power, logarithmic, exponential, and square root polynomial models were tested for best fit.
Results:
Data of 2,030 subjects were collected from 16 institutions. Separate calculation models for each sex were developed because the impact of demographic variables on the diameter of coronary arteries differs according to sex. The final model was the polynomial formula with an exponential relationship between the diameter of coronary arteries and body surface area using the DuBois formula.
Conclusion
A new coronary artery diameter Z score model was developed and is anticipated to be applicable in clinical practice. The new model will help establish a consensus-based Z score model.
4.Endoscopist-Driven Sedation Practices in South Korea:Re-evaluation Considering the Nationwide Survey in 2019
Seon-Young PARK ; Jun Kyu LEE ; Chang-Hwan PARK ; Byung-Wook KIM ; Chang Kyun LEE ; Hong Jun PARK ; Byung Ik JANG ; Dong Uk KIM ; Jin Myung PARK ; Jae Min LEE ; Young Sin CHO ; Hyung Ku CHON ; Seung Young SEO ; Woo Hyun PAIK ; The Committees of Quality Management and Conscious Sedation of Korean Society of Gastrointestinal En
Gut and Liver 2022;16(6):899-906
Background/Aims:
This study aimed to determine changes in endoscopist-driven sedation practices 5 years after the first nationwide survey in 2014 by the Korean Society of Gastrointestinal Endoscopy (KSGE).
Methods:
A 59-item survey covering current practices was electronically mailed to all members of the KSGE in 2019.
Results:
In total, 955 (12.8%) out of 7,486 questionnaires were returned. A total of 738 (77.7%) out of 955 respondents attended dedicated sedation education programs. The American Society of Anesthesiologists class was recorded by 464 (51.2%) out of 907 respondents. The recording rate was higher in respondents who completed sedation education (p=0.014) and worked in general or tertiary hospitals (p<0.001). Compared to that reported in the previous survey, the reported use of propofol was higher in 2019. The respondents had higher satisfaction scores for propofol-based sedation compared with midazolam monotherapy (p<0.001). The rates of oxygen supplementation (p<0.001) and oxygen saturation level monitoring (p<0.001) during sedative endoscopy were higher in 2019 than in the previous survey. A total of 876 (98.4%) out of 890 respondents reported a separate recovery bay, and 615 (70.5%) out of 872 respondents reported that personnel were assigned solely to the recovery bay.
Conclusions
Endoscopist-driven sedation and monitoring practices in 2019 were significantly different than those in 2014. The respondents favored propofol-based sedation and utilized oxygen supplementation and monitoring of O2 saturation more frequently in 2019 than in 2014.
5.Oxidative Stress Modulates the Expression Pattern of Peroxiredoxin-6 in Peripheral Blood Mononuclear Cells of Asthmatic Patients and Bronchial Epithelial Cells
Hyun Jae SHIM ; So Young PARK ; Hyouk Soo KWON ; Woo Jung SONG ; Tae Bum KIM ; Keun Ai MOON ; Jun Pyo CHOI ; Sin Jeong KIM ; You Sook CHO
Allergy, Asthma & Immunology Research 2020;12(3):523-536
PURPOSE: Reduction-oxidation reaction homeostasis is vital for regulating inflammatory conditions and its dysregulation may affect the pathogenesis of chronic airway inflammatory diseases such as asthma. Peroxiredoxin-6, an important intracellular anti-oxidant molecule, is reported to be highly expressed in the airways and lungs. The aim of this study was to analyze the expression pattern of peroxiredoxin-6 in the peripheral blood mononuclear cells (PBMCs) of asthmatic patients and in bronchial epithelial cells (BECs).METHODS: The expression levels and modifications of peroxiredoxin-6 were evaluated in PBMCs from 22 asthmatic patients. Phosphorylated and acetylated peroxiredoxin-6 in hydrogen peroxide-treated human BECs was detected using immunoprecipitation analysis. The expression level of peroxiredoxin-6 was also investigated in BECs treated with hydrogen peroxide. Cycloheximide and proteasome inhibitors were used to determine whether peroxiredoxin-6 is degraded by proteasomes.RESULTS: Peroxiredoxin-6 expression was significantly reduced in the PBMCs of asthmatic patients compared to control subjects. Distinct modification patterns for peroxiredoxin-6 were observed in the PBMCs of asthmatic patients using 2-dimensional-electrophoresis. The levels of phosphorylated serine and acetylated lysine in peroxiredoxin-6 were significantly increased in the BECs following hydrogen peroxide treatment. The level of peroxiredoxin-6 expression was reduced in hydrogen peroxide-stimulated BECs, presumably due to proteasomes.CONCLUSIONS: The expression of peroxiredoxin-6, which is down-regulated in the immune cells of asthmatic patients and BECs, can be modified by oxidative stress. This phenomenon may have an effect on asthmatic airway inflammation.
Asthma
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Cycloheximide
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Epithelial Cells
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Homeostasis
;
Humans
;
Hydrogen
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Hydrogen Peroxide
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Immunoprecipitation
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Inflammation
;
Lung
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Lysine
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Oxidative Stress
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Proteasome Inhibitors
;
Protein Processing, Post-Translational
;
Serine
6.Evaluation of lymph node metastasis in a rabbit tumor model: correlations between contrast-enhanced ultrasound and pathologic findings
Shin-Woo HA ; Hyun-Je LEE ; Ae-Sin CHO ; Sung Il HWANG ; Hak Jong LEE
Ultrasonography 2020;39(1):60-69
Purpose:
The purpose of this study was to evaluate the ability of contrast-enhanced ultrasonography (CEUS) with microbubbles to detect metastatic lymph nodes (LNs) for treatment planning and prognosis.
Methods:
For the metastatic LN model, ground VX2 tumor tissues were injected subcutaneously in 12 rabbits, just below the right hind limb. The rabbits were classified into three groups based on the LN area: group A (n=4, >1.9 cm2 ), group B (n=4, 1-1.9 cm2 ), and group C (n=4, <1 cm2 ). The LNs were monitored on CEUS for 10 seconds after injecting 2.5 mL of microbubbles. The percent area of metastatic LNs was calculated on pathologic images and compared with CEUS images.
Results:
In group A, the mean percent area of metastasis was 40.7%±19.4%. In all cases of metastasis, round-shaped perfusion defects were clearly observed in CEUS images. The metastatic areas were strongly correlated with pathologic findings. The mean percent area in group B was 21.5%±14.4%. The CEUS findings showed multiple nodular perfusion defects, clearly revealing the metastatic areas. In group B, the CEUS and pathologic findings were concordant for three of the four cases. The mean percent area in group C was 9.1%±6.4%. However, in this group, CEUS only detected a small perfusion defect in one case.
Conclusion
CEUS has the potential to depict characteristic imaging features of metastatic LNs but still has limitations in early detection.
7.Immunogenicity and Optimal Timing of 13-Valent Pneumococcal Conjugate Vaccination during Adjuvant Chemotherapy in Gastric and Colorectal Cancer: A Randomized Controlled Trial
Wonyoung CHOI ; Jong Gwang KIM ; Seung-Hoon BEOM ; Jun-Eul HWANG ; Hyun-Jung SHIM ; Sang-Hee CHO ; Min-Ho SHIN ; Sin-Ho JUNG ; Ik-Joo CHUNG ; Joon Young SONG ; Woo Kyun BAE
Cancer Research and Treatment 2020;52(1):246-253
Purpose:
Pneumococcal vaccination (13-valent pneumococcal conjugate vaccine [PCV13]) is recommended to cancer patients undergoing systemic chemotherapy. However, the optimal time interval between vaccine administration and initiation of chemotherapy has been little studied in adult patients with solid malignancies.
Materials and Methods:
We conducted a prospective randomized controlled trial to evaluate whether administering PCV13 on the first day of chemotherapy is non-inferior to vaccinating 2 weeks prior to chemotherapy initiation. Patients were randomly assigned to two study arms, and serum samples were collected at baseline and 4 weeks after vaccination to analyze the serologic response against Streptococcus pneumoniae using a multiplexed opsonophagocytic killingassay.
Results:
Of the 92 patients who underwent randomization, 43 patients in arm A (vaccination 2 weeks before chemotherapy) and 44 patients in arm B (vaccination on the first day of chemotherapy) were analyzed. Immunogenicity was assessed by geometric mean and fold-increase of post-vaccination titers, seroprotection rates (percentage of patients with post-vaccination titers > 1:64), and seroconversion rates (percentage of patients with > 4-fold increase in post-vaccination titers). Serologic responses to PCV13 did not differ significantly between the two study arms according to all three types of assessments.
Conclusion
The overall antibody response to PCV13 is adequate in patients with gastric and colorectal cancer during adjuvant chemotherapy, and no significant difference was found when patients were vaccinated two weeks before or on the day of chemotherapy initiation.
8.Long-term Breastfeeding in the Prevention of Allergic Rhinitis: Allergic Rhinitis Cohort Study for Kids (ARCO-Kids Study)
Doo Hee HAN ; Jae Min SHIN ; Seokyung AN ; Jong Seung KIM ; Dong Young KIM ; Sungji MOON ; Jung Soo KIM ; Joong Saeng CHO ; Si Whan KIM ; Young Hyo KIM ; Hwan Jung ROH ; Woo Sub SHIM ; Ki Sang RHA ; Sang Wook KIM ; Seung Sin LEE ; Dae Woo KIM ; Kyu Sup CHO ; Hyo Jin YIM ; Sue K PARK ; Chae Seo RHEE
Clinical and Experimental Otorhinolaryngology 2019;12(3):301-307
OBJECTIVES: There is a great deal of interest in the possibility that environmental factors may influence the risk of developing allergic rhinitis (AR) in early life. We investigated the simultaneous effects of mode of delivery and duration of breastfeeding on the development of AR in children. METHODS: Data from 1,374 children participating in the Allergic Rhinitis Cohort Study for kids (ARCO-kids study) was analyzed. All subjects were divided into AR or non-allergic rhinitis (NAR) groups. Data on environmental factors, mode of delivery and duration of breastfeeding were collected using a questionnaire. RESULTS: Compared with short-term breastfeeding (<6 months), long-term breastfeeding (≥12 months) was significantly associated with a lower prevalence of AR (adjusted odds ratio [aOR], 0.54; 95% confidence interval [CI], 0.34 to 0.88). Children in the AR group also had a higher cesarean delivery rate than those in the NAR group (39.1% vs. 32.8%, P=0.05). Regarding the combined effects of mode of delivery and duration of breastfeeding, long-term breastfeeding with a vaginal delivery strongly suppressed the development of AR, compared to short-term breastfeeding with a cesarean delivery (aOR, 0.47; 95% CI, 0.30 to 0.73). CONCLUSION: Long-term breastfeeding (≥12 months) and a vaginal delivery are associated with a lower risk of developing childhood AR.
Breast Feeding
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Cesarean Section
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Child
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Cohort Studies
;
Delivery, Obstetric
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Female
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Humans
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Odds Ratio
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Pregnancy
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Prevalence
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Rhinitis
;
Rhinitis, Allergic
9.Frequency and Severity of Hypoglycemia in Type 2 Diabetes Mellitus Patients Treated with a Sulfonylurea-Based Regimen at University-Affiliated Hospitals in Korea: The Naturalistic Evaluation of Hypoglycemic Events in Diabetic Subjects Study
Yon Su KIM ; Be Long CHO ; Woo Sik KIM ; Sang Hyun KIM ; In Hyeon JUNG ; Won Yong SIN ; Dong Hoon CHOI ; Sang Jae LEE ; Chun Soo LIM ; Kyung Pyo KANG ; Byung Yeon YU ; Wonju JEUNG ; Chang Gyu PARK
Korean Journal of Family Medicine 2019;40(4):212-219
BACKGROUND: We assessed the frequency and severity of hypoglycemia in type 2 diabetes mellitus patients treated with sulfonylurea monotherapy or sulfonylurea+metformin. METHODS: We conducted a retrospective, observational, cross-sectional study in 2011 and 2012 including patients with type 2 diabetes mellitus aged ≥30 years who were treated with ≥6 months of sulfonylurea monotherapy or sulfonylurea+metformin at 20 university-affiliated hospitals in Korea. At enrollment, glycated hemoglobin (HbA1c) was assessed; participants completed self-reported questionnaires describing hypoglycemia incidents over the past 6 months. A review of medical records up to 12 months before enrollment provided data on demographics, disease history, comorbidities, laboratory results, and drug usage. RESULTS: Of 726 enrolled patients, 719 were included (55.6% male); 31.7% and 68.3% were on sulfonylurea monotherapy and sulfonylurea+metformin, respectively. Mean±standard deviation age was 65.9±10.0 years; mean HbA1c level was 7.0%±1.0%; 77.8% of patients had hypertension (89.4% used antihypertensive medication); 60.5% had lipid disorders (72.5% used lipid-lowering medication); and 52.0% had one or more micro- or macrovascular diseases. Among patients with A1c measurement (n=717), 56.4% achieved therapeutic goals (HbA1c <7.0%); 42.4% (305/719) experienced hypoglycemia within 6 months of enrollment; and 38.8%, 12.9%, 12.7%, and 3.9% of patients experienced mild, moderate, severe, and very severe hypoglycemia symptoms, respectively. Several reported hypoglycemia frequency as 1–2 times over the last 6 months. The mean number of very severe hypoglycemia episodes was 3.5±5.5. CONCLUSION: Among type 2 diabetes mellitus patients treated with sulfonylurea-based regimens, glycemic levels were relatively well controlled but hypoglycemia remained a prevalent side effect.
Comorbidity
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Cross-Sectional Studies
;
Demography
;
Diabetes Mellitus, Type 2
;
Hemoglobin A, Glycosylated
;
Humans
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Hypertension
;
Hypoglycemia
;
Korea
;
Medical Records
;
Metformin
;
Retrospective Studies
10.Comparison of Blood Loss between Intra-Articular and Intravenous Tranexamic Acid Following Primary Total Knee Arthroplasty.
Gwang Chul LEE ; Dong Hwi KIM ; Jung Woo LEE ; Sin Wook KANG ; Sung Won CHO
The Journal of the Korean Orthopaedic Association 2018;53(2):152-158
PURPOSE: To investigate the difference in blood loss between two injection methods, intravenous (IV) and intra-articular (IA) methods via drain tube. MATERIALS AND METHODS: A total of 183 patients who underwent total knee arthroplasty between October 2013 and March 2016 were included. The method of tranexamic acid (TXA) administration was intravenously injected before August 2015, and it was applied thereafter to the joint through a drainage tube post intra-articular suture. Our subjects were divided into the following groups: The intravenous unilateral (IVU), intravenous bilateral (IVB), intra-articular unilateral (IAU), and intra-articular bilateral (IAB) groups. Hemoglobin and hematocrit, drainage amount, transfusion frequency, mean transfusion volume, and blood loss, as well as complications were compared between the groups. RESULTS: Drainage amount was 558.08±296.29 ml in IVU, and 498.39±199.70 ml in IAU; there was less drainage in IAU than in IVU, but without significance (p=0.262). Moreover, the drainage amount was 1,110.39±396.23 ml in IVB and 827.14±282.47 ml in IAB, which was significantly lower in IAB (p=0.000). Transfusion frequency was 5 patients (10.0%) in IVU and 2 patients (4.5%) in IAU, but without significant difference (p=0.442). Moreover, the frequency was 16 patients (29.6%) in IVB and 1 patient (2.9%) in IAB, which was significantly lower in the IAB group (p=0.002). Mean transfusion volume was 44.80±144.71 ml in IVU and 21.80±106.86 ml in IAU, but without significant difference (p=0.389); the volume was 177.80±321.00 ml in IVB and 18.30±108.18 ml in IAB, with statistical significance (p=0.001). Blood loss was 1,318.70±724.20 ml in IVU and 963.28±454.03 ml in IAU, which was significantly lower in the IAU (p=0.006); blood loss was 1,837.40±699.70 ml in IVB, and 1,337.60±382.20 ml in IAB and it was significantly lower in IAB (p=0.000). Complications included deep vein thrombosis in one case in IVU. CONCLUSION: In TKA, IA injection of TXA significantly reduced blood loss compared with IV injection, especially in bilateral TKA.
Arthroplasty, Replacement, Knee*
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Blood Transfusion
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Drainage
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Hematocrit
;
Humans
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Joints
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Methods
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Sutures
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Tranexamic Acid*
;
Venous Thrombosis

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