Background: It is well known that a large number of patients with diabetes also have dyslipidemia, which significantly increases the risk of cardiovascular disease (CVD). This study aimed to evaluate the efficacy and safety of combination drugs consisting of metformin and atorvastatin, widely used as therapeutic agents for diabetes and dyslipidemia. Methods: This randomized, double-blind, placebo-controlled, parallel-group and phase III multicenter study included adults with glycosylated hemoglobin (HbA1c) levels >7.0% and <10.0%, low-density lipoprotein cholesterol (LDL-C) >100 and <250 mg/dL. One hundred eighty-five eligible subjects were randomized to the combination group (metformin+atorvastatin), metformin group (metformin+atorvastatin placebo), and atorvastatin group (atorvastatin+metformin placebo). The primary efficacy endpoints were the percent changes in HbA1c and LDL-C levels from baseline at the end of the treatment. Results: After 16 weeks of treatment compared to baseline, HbA1c showed a significant difference of 0.94% compared to the atorvastatin group in the combination group (0.35% vs. −0.58%, respectively; P<0.0001), whereas the proportion of patients with increased HbA1c was also 62% and 15%, respectively, showing a significant difference (P<0.001). The combination group also showed a significant decrease in LDL-C levels compared to the metformin group (−55.20% vs. −7.69%, P<0.001) without previously unknown adverse drug events. Conclusion The addition of atorvastatin to metformin improved HbA1c and LDL-C levels to a significant extent compared to metformin or atorvastatin alone in diabetes and dyslipidemia patients. This study also suggested metformin’s preventive effect on the glucose-elevating potential of atorvastatin in patients with type 2 diabetes mellitus and dyslipidemia, insufficiently controlled with exercise and diet. Metformin and atorvastatin combination might be an effective treatment in reducing the CVD risk in patients with both diabetes and dyslipidemia because of its lowering effect on LDL-C and glucose.

Purpose: This study evaluated the effectiveness of different surveillance intensities on morbidity and mortality in women with breast cancer. Methods: This retrospective study included patients who had undergone breast cancer surgery in the Republic of Korea between 2009 and 2011. The patients were divided into two groups based on the intensity of their postsurgical surveillance: intensive surveillance group (ISG) and less-intensive surveillance group. Surveillance intensity was measured based on the frequency and type of follow-up diagnostic tests conducted, including mammography, ultrasonography, computed tomography, magnetic resonance imaging, bone scans, and positron emission tomography scans. Results: We included 1,356 patients with a median follow-up period of 121.2 months (range, 12.8–168.0 months). The analysis revealed no significant difference in the overall survival (OS) between the two groups within five years of surgery. However, patients with ISG exhibited significantly better breast cancer-specific survival (BCSS) and distant metastasisfree survival (DMFS) within the same period. Five years after surgery, the differences in survival outcomes between the groups were not statistically significant. Conclusion Intensive surveillance did not demonstrate a significant improvement in OS for patients with breast cancer beyond five years postoperatively. However, within the first five years, intensive surveillance was associated with better BCSS and DMFS. These findings suggest that personalized surveillance strategies may benefit specific patient subsets, particularly in the early years after treatment. Further nationwide randomized studies are warranted to refine surveillance guidelines and optimize outcomes in patients with breast cancer.

Objectives: Alcohol is metabolized to acetaldehyde by alcohol dehydrogenase enzyme in the liver and then acetaldehyde is metabolized to acetone by aldehyde dehydrogenase (ALDH) in the liver. There are two main ALDH enzymes which metabolize the acetaldehyde produced during ethanol oxidation. In particular, in the presence of the ALDH2 1*2 allele, the activity of the ALDH 2 enzyme is lowered. As a result, acetaldehyde metabolism is slowed down and acetaldehyde accumulates in the body compared to the ALDH2 1*1 allele. There are many studies that have investigated the blood acetaldehyde concentration according to the ALDH2 genotype, but there are few studies to compare this with age. So we investigated the blood acetaldehyde concentration according to ALDH2 genotype, age and gender. Methods: According to the ALDH2 genotype, we divided the group by gender and age. We divided the age group in to three groups which ranged from 20 to 34 years old, from 35 to 49 years old, and lastly from 50 to 64 years old. And then we collected blood samples after 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr and 15 hr of after drinking to measure the blood acetaldehyde concentration. Results: In ALDH2 1*2 allele group, there are significant differences of the blood acetaldehyde concentration between the age groups. In ALDH2 1*2 allele and male group, there are significant differences of the blood acetaldehyde concentration between the age groups. Conclusions There are significant differences of the blood acetaldehyde concentration between the age groups according to ALDH2 genotype. Also, there are significant differences of the blood acetaldehyde concentration between the age groups with male gender and ALDH2 1*2 allele. Studies about other factors that may influence the blood acetaldehyde concentration are needed.

Objective: This study was performed to evaluate the efficacy and safety of lurasidone (160 mg/day) compared to quetiapine XR (QXR; 600 mg/day) in the treatment of acutely psychotic patients with schizophrenia. Methods: Patients were randomly assigned to 6 weeks of double-blind treatment with lurasidone 160 mg/day (n=105) or QXR 600 mg/day (n=105). Primary efficacy measure was the change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions severity (CGI-S) score. Adverse events, body measurements, and laboratory parameters were assessed. Results: Lurasidone demonstrated non-inferiority to QXR on the PANSS total score. Adjusted mean±standard error change at week 6 on the PANSS total score was -26.42±2.02 and -27.33±2.01 in the lurasidone and QXR group, respectively. The mean difference score was -0.91 (95% confidence interval -6.35–4.53). The lurasidone group showed a greater reduction in PANSS total and negative subscale on week 1 and a greater reduction in end-point CGI-S score compared to the QXR group. Body weight, body mass index, and waist circumference in the lurasidone group were reduced, with significantly lower mean change compared to QXR. Endpoint changes in glucose, cholesterol, triglycerides, and low-density lipoprotein levels were also significantly lower. The most common adverse drug reactions with lurasidone were akathisia and nausea. Conclusion Lurasidone 160 mg/day was found to be non-inferior to QXR 600 mg/day in the treatment of schizophrenia with comparable efficacy and tolerability. Adverse effects of lurasidone were generally tolerable, and beneficial effects on metabolic parameters can be expected.

Purpose: To report a case of late-onset bleb-associated endophthalmitis caused by streptococcus cristatus (S. cristatus) after trabeculectomy.Case summary: A 59-year-old woman presented with left ocular pain and visual disturbance. She had undergone trabeculectomy of the left eye 2 years ago. At the initial visit, she was only able to count fingers from the left eye. Whitish thin bleb, conjunctival injection, and inflammation were observed in the left anterior chamber, and the fundus could not be visualized. Despite administering topical and systemic antibiotics, the chamber reaction worsened, and hypopyon and inflammatory membrane were noticed the next day. Vitrectomy with phacoemulsification and intravitreal antibiotic injection was performed, and the intravitreal antibiotic injections were repeated over the next two days. Bacterial culture of vitreous fluid showed a growth of S. cristatus 5 days after the surgery, and inflammation improved after 7 days. One month later, she was still only able to count fingers from the left eye, but there were no signs of endophthalmitis. Conclusions Postoperative endophthalmitis after glaucoma filtering surgeries caused by S. cristatus has not been reported previously from Korea. To the best of our knowledge, this is the first Korean case of late-onset bleb-associated endophthalmitis caused by S. cristatus. If gram-positive cocci are grown in samples from the patients with endophthalmitis after trabeculectomy, resident oral microflora such as S. cristatus should be considered as the causative pathogen.

BACKGROUND: We aimed to investigate the effectiveness and safety of adding basal insulin to initiating dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin and/or sulfonylurea (SU) in achieving the target glycosylated hemoglobin (HbA1c) in patients with type 2 diabetes mellitus (T2DM). METHODS: This was a single-arm, multicenter, 24-week, open-label, phase 4 study in patients with inadequately controlled (HbA1c ≥7.5%) T2DM despite the use of DPP-4 inhibitor and metformin. A total of 108 patients received insulin glargine while continuing oral antidiabetic drugs (OADs). The primary efficacy endpoint was the percentage of subjects achieving HbA1c ≤7.0%. Other glycemic profiles were also evaluated, and the safety endpoints were adverse events (AEs) and hypoglycemia. RESULTS: The median HbA1c at baseline (8.9%; range, 7.5% to 11.1%) decreased to 7.6% (5.5% to 11.7%) at 24 weeks. Overall, 31.7% subjects (n=33) achieved the target HbA1c level of ≤7.0%. The mean differences in body weight and fasting plasma glucose were 1.2±3.4 kg and 56.0±49.8 mg/dL, respectively. Hypoglycemia was reported in 36 subjects (33.3%, 112 episodes), all of which were fully recovered. There was no serious AE attributed to insulin glargine. Body weight change was significantly different between SU users and nonusers (1.5±2.5 kg vs. −0.9±6.0 kg, P=0.011). CONCLUSION: The combination add-on therapy of insulin glargine, on metformin and DPP-4 inhibitors with or without SU was safe and efficient in reducing HbA1c levels and thus, is a preferable option in managing T2DM patients exhibiting dysglycemia despite the use of OADs.
Blood Glucose ; Body Weight ; Body Weight Changes ; Diabetes Mellitus, Type 2 ; Fasting ; Hemoglobin A, Glycosylated ; Humans ; Hypoglycemia ; Hypoglycemic Agents ; Insulin Glargine ; Insulin ; Metformin ; Morinda

BACKGROUND/AIMS: Endoscopic assistive devices have been developed to reduce the complexity and improve the safety of surgeries involving the use of endoscopes. We developed an assistive robotic arm for endoscopic submucosal dissection (ESD) and evaluated its efficiency and safety in this in vitro pilot study. METHODS: ESD was performed using an auxiliary transluminal endoscopic robot. An in vitro test bed replicating the intra-abdominal environment and pig stomachs were used for the experiment. Participants were divided into skilled operators and unskilled operators. Each group performed ESD 10 times by using both conventional and robot-assisted methods. The perforation incidence, operation time, and resected mucous membrane size were measured. RESULTS: For the conventional method, significant differences were noted between skilled and unskilled operators regarding operation time (11.3 minutes vs 26.7 minutes) and perforation incidence (0/10 vs 6/10). Unskilled operators showed a large decrease in the perforation incidence with the robot-assisted method (conventional method vs robot-assisted method, 6/10 vs 1/10). However, the operation time did not differ between the conventional and robot-assisted methods. On the other hand, skilled operators did not show differences in the operation time and perforation incidence between the conventional and robot-assisted methods. Among both skilled and unskilled operators, the operation time decreased with the robot-assisted method as the experiment proceeded. CONCLUSIONS: The surgical safety of unskilled operators greatly improved with robotic assistance. Thus, our assistive robotic arm was beneficial for ESD. Our findings suggest that endoscopic assistive robots have positive effects on surgical safety.
Arm ; Endoscopes ; Endoscopy ; Hand ; In Vitro Techniques ; Incidence ; Methods ; Mucous Membrane ; Pilot Projects ; Self-Help Devices ; Stomach ; Surgery, Computer-Assisted

PURPOSE: Predicting lymph node metastasis (LNM) risk is crucial in determining further treatment strategies following endoscopic resection of T1 colorectal cancer (CRC). This study aimed to establish a new prediction model for the risk of LNM in T1 CRC patients. MATERIALS AND METHODS: The development set included 833 patients with T1 CRC who had undergone endoscopic (n=154) or surgical (n=679) resection at the National Cancer Center. The validation set included 722 T1 CRC patients who had undergone endoscopic (n=249) or surgical (n=473) resection at Daehang Hospital. A logistic regression model was used to construct the prediction model. To assess the performance of prediction model, discrimination was evaluated using the receiver operating characteristic (ROC) curves with area under the ROC curve (AUC), and calibration was assessed using the Hosmer-Lemeshow (HL) goodness-of-fit test. RESULTS: Five independent risk factors were determined in the multivariable model, including vascular invasion, high-grade histology, submucosal invasion, budding, and background adenoma. In final prediction model, the performance of the model was good that the AUC was 0.812 (95% confidence interval [CI], 0.770 to 0.855) and the HL chi-squared test statistic was 1.266 (p=0.737). In external validation, the performance was still good that the AUC was 0.771 (95% CI, 0.708 to 0.834) and the p-value of the HL chi-squared test was 0.040. We constructed the nomogram with the final prediction model. CONCLUSION: We presented an externally validated new prediction model for LNM risk in T1 CRC patients, guiding decision making in determining whether additional surgery is required after endoscopic resection of T1 CRC.
Adenoma ; Area Under Curve ; Calibration ; Colorectal Neoplasms ; Decision Making ; Discrimination (Psychology) ; Humans ; Logistic Models ; Lymph Nodes ; Neoplasm Metastasis ; Nomograms ; Risk Factors ; ROC Curve

BACKGROUND: Patients who survive an acute phase of stroke are at risk of falls and fractures afterwards. However, it is largely unknown how frequent fractures occur in the Asian stroke population. METHODS: Patients with acute (< 7 days) ischemic stroke who were hospitalized between January 2011 and November 2013 were identified from a prospective multicenter stroke registry in Korea, and were linked to the National Health Insurance Service claim database. The incidences of fractures were investigated during the first 4 years after index stroke. The cumulative incidence functions (CIFs) were estimated by the Gray's test for competing risk data. Fine and Gray model for competing risk data was applied for exploring risk factors of post-stroke fractures. RESULTS: Among a total of 11,522 patients, 1,616 fracture events were identified: 712 spine fractures, 397 hip fractures and 714 other fractures. The CIFs of any fractures were 2.63% at 6 months, 4.43% at 1 year, 8.09% at 2 years and 13.00% at 4 years. Those of spine/hip fractures were 1.11%/0.61%, 1.88%/1.03%, 3.28%/1.86% and 5.79%/3.15%, respectively. Age by a 10-year increment (hazard ratio [HR], 1.23; 95% confidence interval [CI], 1.17–1.30), women (HR, 1.74; 95% CI, 1.54–1.97), previous fracture (HR, 1.72; 95% CI, 1.54–1.92) and osteoporosis (HR, 1.44; 95% CI, 1.27–1.63) were independent risk factors of post-stroke fracture. CONCLUSION: The CIFs of fractures are about 8% at 2 years and 13% at 4 years after acute ischemic stroke in Korea. Older age, women, pre-stroke fracture and osteoporosis raised the risk of post-stroke fractures.
Accidental Falls ; Asian Continental Ancestry Group ; Epidemiology ; Female ; Hip Fractures ; Humans ; Incidence ; Korea ; National Health Programs ; Osteoporosis ; Prospective Studies ; Risk Factors ; Spine ; Stroke

BACKGROUND: Cases of low-energy-induced distal radius fracture (DRF) are increasing. Sarcopenia is considered to be an independent risk factor for fragility fractures. We compared body appendicular lean muscle mass (ALM) and bone mineral density (BMD) in patients with DRF and a comparable control population. This study aimed to investigate the correlation between skeletal muscle mass and DRF. METHODS: We performed a retrospective review of patients diagnosed with fragility DRF. The DRF group included 87 patients treated at our institute. The control group comprised data for 87 individuals in the general population from among 2,124 selected using nearest-neighbor propensity scoring, based on age, weight, height, and body mass index. All medical conditions and past history were also compared between the two groups. RESULTS: The relative overall ALM, combining arm and leg lean body mass divided by height squared, was not significantly different (DRF group, 6.093 kg/m²; controls, 5.945 kg/m²). T-score, a parameter of BMD, was significantly different between groups (DRF, −2.42; controls, −2.05). The proportion of patients with osteoporosis was significantly different (DRF, 44 [50.6%] vs. control, 29 [33.3%], respectively). CONCLUSIONS: Patients with DRF did not have significantly lower average lean body mass. BMD was significantly lower in patients with DRF than in controls.
Arm ; Body Mass Index ; Bone Density ; Humans ; Leg ; Muscle, Skeletal ; Osteoporosis ; Osteoporotic Fractures ; Propensity Score* ; Radius Fractures* ; Radius* ; Retrospective Studies ; Risk Factors* ; Sarcopenia*