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.

Background/Aims: Appropriate tissue tension and clear visibility of the dissection area using traction are essential for effective and safe endoscopic submucosal dissection (ESD). In this study, we developed a retractable robot-assisted traction device and evaluated its performance in colorectal ESD. Methods: An experienced endoscopist performed ESD 18 times on an ex vivo porcine colon using the robot and 18 times using the conventional method. The outcome measures were procedure time, dissection speed, procedure-related adverse events, and blind dissection rate. Results: Thirty-six colonic lesions were resected from ex vivo porcine colon samples. The total procedure time was significantly shorter in robot-assisted ESD (RESD) than in conventional ESD (CESD) (20.1±4.1 minutes vs 34.3±8.3 minutes, p<0.05). The submucosal dissection speed was significantly faster in the RESD group than in the CESD group (36.8±9.2 mm 2 /min vs 18.1±4.7 mm 2 /min, p<0.05). The blind dissection rate was also significantly lower in the RESD group (12.8%±3.4% vs 35.1%±3.9%, p<0.05). In an in vivo porcine feasibility study, the robotic device was attached to a colonoscope and successfully inserted into the proximal colon without damaging the colonic wall, and ESD was successfully performed. Conclusions The dissection speed and safety profile improved significantly with the retractable RESD. Thus, our robotic device has the potential to provide simple, effective, and safe multidirectional traction during colonic ESD.

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: 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/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

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*

The aim of our work was to analyze the bibliographical characteristics of 9 North Korean medical journals and articles. All journals show only ten pieces of information, such as publication dates and table of contents, and do not provide submission guidelines and journal policy. Most of the journals were published four times a year. Editorials often share government policy. Research articles are very short and compressed. The journals often publish articles on oriental medicine and medical information useful to the public. In conclusion, the journals were published in their own unique style and format, which are far from the global standard.
Democratic People's Republic of Korea ; Medicine, East Asian Traditional ; Publications

PURPOSE: Germline mutations in the BRCA1 and BRCA2 genes confer increased risks for breast cancers. However, the clinical presentation of breast cancer among women who are carriers of the BRCA1 or BRCA2 (BRCA1/2 carriers) mutations is heterogenous. We aimed to identify the effects of the reproductive histories of women with the BRCA1/2 mutations on the clinical presentation of breast cancer. METHODS: We retrospectively analyzed clinical data on women with proven BRCA1 and BRCA2 mutations who were recruited to the Korean Hereditary Breast Cancer study, from 2007 to 2014. RESULTS: Among the 736 women who were BRCA1/2 mutation carriers, a total of 483 women had breast cancers. Breast cancer diagnosis occurred at significantly younger ages in women who experienced menarche at ≤14 years of age, compared to those who experienced menarche at >14 years of age (37.38±7.60 and 43.30±10.11, respectively, p<0.001). Additionally, the number of full-term pregnancies was significantly associated with the age of diagnosis, especially in women with the BRCA2 mutation. The prevalence of advanced stages (stage II or III vs. stage I) of disease in parous women was higher than in nulliparous women (68.5% vs. 55.2%, p=0.043). This association was more pronounced in women with the BRCA2 mutation (hazard ratio, 2.67; p=0.014). CONCLUSION: Our results suggest that reproductive factors, such as the age of onset of menarche and the presence of parity, are associated with the clinical presentation patterns of breast cancer in BRCA1/2 mutation carriers.
Age of Onset ; Breast Neoplasms* ; Breast* ; Diagnosis ; Female ; Genes, BRCA1 ; Genes, BRCA2 ; Germ-Line Mutation ; Humans ; Menarche ; Parity ; Pregnancy ; Prevalence ; Reproductive History ; Retrospective Studies

Barium sulfate is an inert material used as a radiographic contrast medium during upper gastrointestinal contrast studies for evaluation of patients with dysphagia. Oral barium aspiration is an uncommon but well-reported complication of this procedure. While barium aspiration of small amounts may not cause any symptoms, massive barium aspiration can be life-threatening, particularly in elderly patients with multiple comorbidities. In this case report, we describe an elderly patient with multiple comorbidities who presented with thyrotoxicosis and dysphagia, and then died after massive barium aspiration. Despite administration of intensive medical care with ventilator support and therapeutic bronchoalveolar lavage to remove the aspirated barium, the patient died of multiple organ failure 9 days after barium aspiration. Clinicians should pay attention to elderly patients with predisposing factors for aspiration in whom upper gastrointestinal barium contrast studies are indicated, and should consider other diagnostic tools for evaluation of dysphagia in this population.
Aged* ; Barium Sulfate* ; Barium* ; Bronchoalveolar Lavage ; Causality ; Comorbidity ; Deglutition Disorders* ; Humans ; Multiple Organ Failure ; Thyrotoxicosis ; Ventilators, Mechanical