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 real-world compliance with surgical treatment according to Korea's gastric cancer treatment guidelines. Materials and Methods: The 2018 Korean Gastric Cancer Treatment Guidelines were evaluated using the 2019 national survey data for surgically treated gastric cancer based on postoperative pathological results in Korea. In addition, the changes in surgical treatments in 2019 were compared with those in the 2014 national survey data implemented before the publication of the guidelines in 2018. The compliance rate was evaluated according to the algorithm recommended in the 2018 Korean guidelines. Results: The overall compliance rates in 2019 were 83% for gastric resection extent, 87% for lymph node dissection, 100% for surgical approach, and 83% for adjuvant chemotherapy, similar to 2014. Among patients with pathologic stages IB, II, and III disease who underwent total gastrectomy, the incidence of splenectomy was 8.08%, a practice not recommended by the guidelines. The survey findings revealed that 48.66% of the patients who underwent gastrectomy had pathological stage IV disease, which was not recommended by the 2019 guidelines. Compared to that in 2014, the rate of gastrectomy in stage IV patients was 54.53% in 2014. Compliance rates were similar across all regions of Korea, except for gastrectomy in patients with stage IV disease. Conclusions Real-world compliance with gastric cancer treatment guidelines was relatively high in Korea.

Purpose: Completion total gastrectomy (CTG) for remnant gastric cancer (RGC) is a technically demanding procedure and associated with increased morbidity. The present study aimed to evaluate postoperative complications and their risk factors following surgery for RGC after initial partial gastrectomy due to gastric cancer excluding peptic ulcer. Materials and Methods: We retrospectively reviewed the data of 107 patients who had previously undergone an initial gastric cancer surgery and subsequently underwent CTG for RGC between March 2002 and December 2020. The postoperative complications were graded using the Clavien-Dindo classification. Logistic regression analyses were used to determine the risk factors for complications. Results: Postoperative complications occurred in 34.6% (37/107) of the patients. Intraabdominal abscess was the most common complication. The significant risk factors for overall complications were multi-visceral resections, longer operation time, and high estimated blood loss in the univariate analysis. The independent risk factors were multivisceral resection (odds ratio [OR], 2.832; 95% confidence interval [CI], 1.094–7.333;P=0.032) and longer operation time (OR, 1.005; 95% CI, 1.001–1.011; P=0.036) in the multivariate analysis. Previous reconstruction type, minimally invasive approach, and current stage were not associated with the overall complications. Conclusions Multi-visceral resection and long operation time were significant risk factors for the occurrence of complications following CTG rather than the RGC stage or surgical approach. When multi-visceral resection is required, a more meticulous surgical procedure is warranted to improve the postoperative complications during CTG for RGC after an initial gastric cancer surgery.

BACKGROUND: The aim of this multicenter, randomized, double-blind study was to examine the effect of lobeglitazone, a novel thiazolidinedione, on the changes in bone mineral density (BMD) in patients with type 2 diabetes mellitus. METHODS: A 24-week, double-blinded phase was followed by a 28-week, open-label phase, in which the placebo group also started to receive lobeglitazone. A total of 170 patients aged 34 to 76 years were randomly assigned in a 2:1 ratio to receive lobeglitazone 0.5 mg or a matching placebo orally, once daily. BMD was assessed using dual-energy X-ray absorptiometry at week 24 and at the end of the study (week 52). RESULTS: During the double-blinded phase, the femur neck BMD showed decreasing patterns in both groups, without statistical significance (−0.85%±0.36% and −0.78%±0.46% in the lobeglitazone and placebo groups, respectively). The treatment difference between the groups was 0.07%, which was also not statistically significant. Further, minimal, nonsignificant decreases were observed in both groups in the total hip BMD compared to values at baseline, and these differences also did not significantly differ between the groups. During the open-label phase, the BMD was further decreased, but not significantly, by −0.32% at the femur neck and by −0.60% at the total hip in the lobeglitazone group, and these changes did not significantly differ compared with the original placebo group switched to lobeglitazone. CONCLUSION: Our results indicate that treatment with lobeglitazone 0.5 mg over 52 weeks showed no detrimental effect on the BMD compared to the placebo.
Absorptiometry, Photon ; Bone Density* ; Diabetes Mellitus, Type 2* ; Double-Blind Method ; Femur Neck ; Hip ; Humans ; Thiazolidinediones

BACKGROUND/AIMS: Delayed post-endoscopic submucosal dissection (ESD) bleeding (DPEB) is difficult to predict and there is controversy regarding the usefulness of prophylactic hemostasis during second-look endoscopy. This study evaluated the risk factors related to DPEB, the relationship between clinical outcomes and the Forrest classification, and the results of prophylactic hemostasis during second-look endoscopy. METHODS: Second-look endoscopy was performed on the day after ESD to check for recent hemorrhage or potential bleeding and the presence of artificial ulcers in all patients. RESULTS: DPEB occurred in 42 of 581 patients (7.2%). Multivariate analysis determined that a specimen size ≥40 mm (odds ratio [OR], 3.03; p=0.003), and a high-risk Forrest classification (Forrest Ib+IIa+IIb; OR, 6.88; p<0.001) were risk factors for DPEB. DPEB was significantly more likely in patients classified with Forrest Ib (OR, 24.35; p<0.001), IIa (OR, 12.91; p<0.001), or IIb (OR, 8.31; p<0.001) ulcers compared with Forrest III ulcers. There was no statistically significant difference between the prophylactic hemostasis and non-hemostasis groups (Forrest Ib, p=0.938; IIa, p=0.438; IIb, p=0.397; IIc, p=0.773) during second-look endoscopy. CONCLUSIONS: The Forrest classification of artificial gastric ulcers during second-look endoscopy seems to be a useful tool for predicting delayed bleeding. However, routine prophylactic hemostasis during second-look endoscopy seemed to not be useful for preventing DPEB.
Classification* ; Endoscopy* ; Hemorrhage ; Hemostasis ; Hemostasis, Endoscopic ; Humans ; Multivariate Analysis ; Risk Factors ; Stomach Neoplasms ; Stomach Ulcer ; Ulcer*

BACKGROUND/AIMS: There are few data supporting the diagnostic yield of brush cytology depending on the order of cytologic preparation method or the location or shape of tumors in biliary strictures. We investigated diagnostic yields and variations in brush cytology with direct smear and cell-block preparations according to sampling preparation sequence and tumor location and shape in biliary strictures. METHODS: Patients who had undergone ERCP with tissue sampling between August 2009 and April 2013 were analyzed retrospectively. Group A was examined using brush cytology with direct smear followed by cell-block with or without biopsy, while the reverse order was performed for group B. RESULTS: Among 138 enrolled patients, 92 patients (A: 36, B: 56) underwent both brush cytology with direct smear and cell-block preparations. No differences in sensitivity, specificity, or accuracy were observed according to the sampling preparation method and the location or shape of tumors in biliary strictures. The cellularity observed from brush cytology with direct smear was better than that from cell-block according to the location of the tumor (p<0.01). The diagnostic yield was increased in both groups with addition of an endobiliary biopsy. CONCLUSIONS: No difference in diagnostic accuracy was observed between the sequences of preparation for brush cytology with direct smear and cell-block techniques. Brush cytology showed better cellularity for diagnosis.
Aged ; Aged, 80 and over ; Bile Duct Neoplasms/*pathology ; Cholangiocarcinoma/pathology ; Cholangiopancreatography, Endoscopic Retrograde ; *Cytodiagnosis ; Female ; Gallbladder Neoplasms/pathology ; Humans ; Male ; Middle Aged ; Neoplasm Staging ; Pancreatic Neoplasms/pathology ; Retrospective Studies ; Sensitivity and Specificity

PURPOSE: Tracheostomy is used to aid airway management in perdiatric respiratory care. This study was designed to review causes and outcomes of pediatric tracheostomy. METHODS: We performed a retrospective chart review of 153 patients, less than 18 years of age, who underwent tracheostomy between January 1995 and July 2010. Age at tracheostomy, indications, durations, complications and mortality were evaluated. RESULTS: Subglottic stenosis (19%) was the most common indication for tracheostomy. The median age at tracheostomy was 1.3 years (range, 22 days to 17.8 years). Seventy-three (47.7%) tracheostomies were performed in children under 1 year of age. Respiratory diseases were significantly more prevalent in patients under 1 year of age, while neuromuscular disease were more frequently found in patients older than 1 year (P=0.013). Stoma or tracheal granuloma formation (36.6%) was the most common complication of pediatric tracheostomy. Decannulation was accomplished in 61 (39.9%) patients with median cannulation time of 141 days (range, 1 to 2,529 days). Overall mortality rate was 10.5% (n=16), but only one patient (0.7%) died from tracheostomy-related complications. CONCLUSION: Respiratory diseases, such as subglottic stenosis and neuromuscular disease, are the main cause of pediatric tracheostomy. Although complications, like stoma or tracheal granuloma formation occur, tracheostomy in children is a safe way to aid airway management.
Airway Management ; Catheterization ; Child ; Constriction, Pathologic ; Granuloma ; Humans ; Neuromuscular Diseases ; Retrospective Studies ; Tracheostomy

INTRODUCTION: This study examined the effect of cyclosporine A (CsA) on the allogenic cranial bone graft in the mice. MATERIALS AND METHODS: Twenty eight 12-week-old male ICR mice weighing 40 g were used. The experimental group was injected subcutaneously with CsA (10 mg/kg/day) diluted in Caster oil for 7 days prior to the graft until sacrifice. The control group was injected with the same solution without CsA. RESULTS: In the experimental group, fibrous connective tissues and small amounts of inflammatory cells were observed. At 2 weeks after the allograft in the experimental group, new bone formation in fibrous collagenous tissue and around the allogenic bone was noted. At 4 weeks after the allograft, new bone formation was active along and at the periphery of the mature allogenic bone. The proliferation of blood vessels increased in bone marrow. In the control group, fibrous tissues and inflammatory cells were observed around the allogenic bone and existing bone at 1 week. At 2 weeks after the allograft, the proliferation of blood vessels accompanied by inflammatory cells were scattered in the fibrous connective tissues. New bone formation around the allogenic and existing bone could be observed. At 4 weeks after the allograft, inflammatory cells were severely infiltrated around the allogenic bone. Osteoclasts were scattered along the allogenic bone and induced bone resorption. CONCLUSION: These results suggest that the daily administration of CsA (10 mg/kg/day) induces efficient immunosuppression without serious complications ,and this protocol might be useful for the experimental model of allogenic bone grafts.
Animals ; Blood Vessels ; Bone Marrow ; Collagen ; Connective Tissue ; Cyclosporine ; Humans ; Immunosuppression ; Male ; Mice ; Mice, Inbred ICR ; Models, Theoretical ; Osteoclasts ; Osteogenesis ; Transplantation, Homologous ; Transplants

OBJECTIVES: The primary aim of this study was to determine whether 18F-FDG-PET/CT (PET/CT) scans provide additional diagnostic information in addition to the direct laryngoscopic examination (L/E) and contrast-enhanced CT (CT) in patients with glottic cancer during the initial evaluation. METHODS: Fifty-five consecutive patients with glottic cancer of the larynx that had L/E, CT and PET/CT were enrolled. The diagnostic value of each modality was compared for their accuracy in predicting the extent of the primary tumors on sub-site based analysis and the final tumor staging. The reference standards were either the surgical pathology findings or clinical/radiological follow-up outcome. Changes in patient care based on PET/CT results were compared with the treatment decisions based on L/E with CT. RESULTS: For primary tumor sub-site based analysis, the sensitivity was significantly higher for L/E (92.8%) than for PET/CT (79.4%, P=0.028). The comparisons between L/E vs. CT and CT vs. PET/CT did not reach statistical significance. As an initial tumor-staging method the L/E had a diagnostic accuracy of 76.4%, compared to 61.8% for CT and 41.8% for PET/CT. The L/E and CT were better than the PET/CT (P=0.0009 and 0.049) for the initial TNM staging. PET/CT scanning changed the clinical decision-making based on the L/E with CT results in 12.7% of cases, of whom 5.5% had no additional PET/CT related benefit. CONCLUSION: Conclusion. The results of this study showed that PET/CT imaging added no clinical information benefit compared to the L/E and CT for the initial evaluation of patients with glottic cancer.
Fluorodeoxyglucose F18 ; Follow-Up Studies ; Glottis ; Humans ; Laryngeal Neoplasms ; Laryngoscopy ; Neoplasm Staging ; Pathology, Surgical ; Patient Care ; Positron-Emission Tomography

BACKGROUND: Studies using a transcranial Doppler (TCD) to establish cerebral vasoreactivity (CVR) have mostly focused on the anterior circulation. The purpose of this study is not only to evaluate the feasibility of the power motion mode Doppler (PMD) with a probes fixating device, but also to simultaneously measure the CVR between the middle cerebral artery (MCA) and the basilar artery (BA) during hypercapnea simulated by the rebreathing technique. METHODS: Twenty eight healthy volunteers were enrolled. Baseline hemodynamic values (heart rate, blood pressure) were measured while volunteers sat in a comfortable position for 5 minutes. The TCD was performed in two steps. First, velocities and spectra of the MCAs were simultaneously monitored. Then, the velocities and spectra of the MCA and BA were simultaneously monitored by a headset that included an anterior-posterior probes fixating device. The equation for CVR was ([maximum mean velocity baseline mean velocity] x 100/baseline mean velocity). RESULTS: Baseline mean velocities were revealed as follows: (64.0+/-13.7, 65.0+/-11.9 cm/s in right and left MCA; p>0.05; 67.3+/-12.2, -45.3+/-7.6 cm/s in dominant MCA and BA). CVR did not differ between the dominant MCA and the BA (46.1+/-12.1, 46.0+/-15.1%; p>0.05), nor between the right and left MCAs (46.9+/-15.2, 46.4+/-14.8%; p>0.05). There was a positive linear correlation between the CVR of the dominant MCA and that of the BA (r=0.856; p<0.001). CONCLUSIONS: PMD with a probes fixating device for accurate insonation is a useful tool for evaluating the relative CVR between the MCA and BA. Our study suggests that CVR values of the BA are similar to those of the MCA.
Basilar Artery ; Healthy Volunteers ; Hemodynamics ; Middle Cerebral Artery* ; Volunteers