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.

BACKGROUND: Bioactive glass-ceramics have the ability to directly bind to bones and have been widely used as bone graft substitutes due to their high osteoconductivity and biocompatibility. CaO-SiO2-P2O5-B2O3 glass-ceramics are known to have good osteoconductivity and are used as bone graft extenders. METHODS: This study aimed to evaluate the effects of the resorbing properties of glass-ceramics in bone fusion after producing and analyzing three types of CaO-SiO2-P2O5-B2O3 glass-ceramics with high osteoconductivity that had enhanced resorption by having an increased B2O3 content. The three types of CaO-SiO2-P2O5-B2O3 glass-ceramics with B2O3 contents of 8.0, 9.0, and 9.5 weight % were designated and grouped as P20B80, P10B90, and P5B95, respectively. Glass-ceramic types were tested for fusion rates and bone formation by employing the lumbar 5-6 intertransverse process fusion model in 51 New Zealand male rabbits. Bioactivity was assessed by soaking in simulated body fluid (SBF). RESULTS: In vitro study results showed sufficient hydroxycarbonate apatite layer formation occurred for P20B80 in1 day, for P10B90 in 3 days, and for P5B95 in 5 days after soaking in SBF. For the rabbit lumbar spine posterolateral fusion model, the autograft group recorded a 100% fusion rate with levels significantly higher than those of P20B80 (29.4%), P10B90 (0%), and P5B95 (14.3%), with high resorbing properties. Resorbing property differences among the three glass-ceramic groups were not significant. Histological results showed new bone formation confirming osteoconductivity in all three types of glass-ceramics. Radiomorphometric results also confirmed the resorbing properties of the three glass-ceramic types. CONCLUSIONS: The high resorbing properties and osteoconductivity of porous glass-ceramics can be advantageous as no glass-ceramics remain in the body. However, their relatively fast rate of resorption in the body negatively affects their role as an osteoconductive scaffold as glass-ceramics are resorbed before bony fusion.
Animals ; Bone Resorption ; Bone Substitutes/adverse effects/*therapeutic use ; Ceramics/adverse effects/*therapeutic use ; Electric Conductivity ; Lumbosacral Region/*surgery ; Male ; Rabbits ; Spinal Fusion/*methods

Foreign bodies in the upper esophagus should be removed as soon as possible to avoid serious complications. These foreign bodies can penetrate the bowel wall and cause severe complications. The peristalsis of the esophagus is not strong enough to prevent it from retaining swallowed objects. Hence, perforation from a foreign body is more likely to occur in the esophagus than in the rest of the gastrointestinal tract. A razor blade is a rare foreign body of the esophagus. Its sharpness and large size make it difficult to remove. A razor blade was very firmly impacted in the esophageal wall in our case, and the razor blade had not moved from the upper esophagus. A standard overtube has limitations to remove a razor blade inside the overtube's lumen. We report here on a case of using a wedge resected overtube made it possible to successfully extract a razor blade and no serious complications occurred after extraction of the razor blade.
Esophagus ; Foreign Bodies ; Gastrointestinal Tract ; Peristalsis

Ischemic colitis is generally considered a disease of the elderly. The causes of ischemic colitis include low-flow states due to cardiac dysfunction or hypovolemia and certain medications including estrogen. Here we report a case of ischemic colitis in a 26-year-old woman. She had no specific medical history except taking oral-contraceptives for a long time. The mechanism of estrogen-induced ischemic colitis is not clearly understood. But we recommend that oral-contraceptives should be considered as a cause of ischemic colitis in young women.
Adult ; Aged ; Colitis, Ischemic ; Contraceptives, Oral ; Estrogens ; Female ; Humans ; Hypovolemia

Maternal alcohol abuse is thought to be the common cause of mental retardation. Even moderate maternal alcohol consumption may produce fetal alcohol effects with behavioral and learning difficulties, if the drinking is associated with malnutrition. Especially, continuous alcohol consumption during critical period of brain development is very likely to produce fetal alcohol effects. The aims of this study are to investigate whether exogenous thyroxine treatment to alcohol -fed dams may ameliorate the detrimental effects of alcohol on the postnatal development of BDNF -containing Purkinje cell of the cerebellar cortex of the offspring. The morphological features of the growth and maturation were observed at 0, 7, 14, 21, 28 postnatal days via immunohistochemistry. In addition, electron microscopic finding of BDNF -containing Purkinje cell at P14 was also examined. Time -pregnant rats were divided into three groups. Alcohol -fed group received 35 calories of liquid alcohol diet daily from gestation day 6; control pair -fed group was fed a liquid diet in which dextrin replaced alcohol isocalorically; alcohol +/-T4 group received 35 calories liquid alcohol diet and exogenous thyroxine subcutaneously. As a result, a similar developmental pattern of BDNF -immunoreactive Purkinje cells was observed in control pair - fed and alcohol+/-T4 group on and after P14. These cells of alcohol -fed group showed immature features. Single -layer arrangement of these cells in alcohol -fed group was not completely achieved throughout postnatal life. Electron microscopic observations of BDNF -immunoreactive Purkinje cells at P14 revealed large nucleus, small cytoplasm, small amount of ribosomal collection and rudimentary cytoplasmic organelles in alcohol -fed group. The morphology of BDNF -immunoreactive Purkinje cell in alcohol +/-T4 group was similar to that in control pair -fed group. It was characterized by numerous short segments of rough endoplasmic reticulum, many of which showed a tendency of parallel alignment that suggested an attempt at Nissl body configuration. The cytology of Golgi complexes was also found within the cytoplasm in perinuclear location. Those observed differences of postnatal maturation patterns between alcohol -fed and alcohol +/-T4 group may indicate the beneficial effects on the postnatal development of BDNF -containing Purkinje cells in cerebellar cortex in the pups of thyroxine -treated alcohol -exposed dams. These results suggest that the increase of BDNF synthesis during early postnatal life caused by maternal administration of exogenous thyroxine may ameliorate fetal alcohol effects as a result of the dysthyroid state following maternal alcohol abuse.
Alcohol Drinking ; Alcoholism ; Animals ; Brain ; Brain-Derived Neurotrophic Factor ; Cerebellar Cortex ; Cerebellum* ; Critical Period (Psychology) ; Cytoplasm ; Diet ; Drinking ; Endoplasmic Reticulum, Rough ; Golgi Apparatus ; Immunohistochemistry ; Intellectual Disability ; Learning ; Malnutrition ; Organelles ; Pregnancy ; Purkinje Cells ; Rats* ; Thyroxine*

STUDY DESIGN: A comparative in vivo study between ceramics with different compositions. OBJECTIVES: To compare the biodegradation and osteoconduction properties of CaO-SiO2- P2O5- B2O3 glass-ceramics and Cerabone(R)-AW. Summary of Literature Review: Bioglass ceramics can be used as bone graft substitutes. However, no study has been undertaken to investigate the possibility of CaO-S i O2-P2O5-B2O3 glass-ceramics as a bone graft substitute. MATERIALS AND METHODS: Porous CSPB2 implants (44.07% CaO, 40.28% SiO2, 8.1% P2O5 and 5.0% B2O3), porous CSPB3 implants (43.76% CaO, 43.41% SiO2, 4.05% P2O5 and 7.5% B2O3) and porous Cerabone(R)-AW were prepared by the polymer sponge method. Single-level posterolateral spinal fusions were performed on sixty New Zealand white male rabbits. The animals were divided into four groups (9 of autograft, 17 per 3 kind of porous implant group) according to the implant material used: autograft, CSPB2, CSPB3 and Cerabone(R)-AW. Radiographs were performed every two weeks. All animals were sacrificed 12 weeks after surgery. Manual palpation and uniaxial tensile strength were determined. The proportion of the area occupied by the ceramics in the final compared to the initial radiographs was calculated. Decalcified and undecalcified histological sections were evaluated by light microscopy. RESULTS: Fifty one rabbits were evaluated. The union rates were 100 (9 out of 9), 80 (8 out of 8), 81.1 (9 out of 11) and 90.9% (10 out of 11) in the autograft, Cerabone(R)-AW, CSPB2 and CSPB3 groups, respectively. The proportion of the area occupied by Cerabone(R)-AW (90.8 % +/- 14.0) was significantly higher than for CSPB2 (73.1% +/- 11.5) and CSPB3 (73.5% +/- 10.0)(p=0.0011). The mean values of the tensile strengths of Cerabone(R)-AW (214. +/- 57.3N), CSPB2 (214. +/- 57.3 N) and CSPB3 (217 +/- 70.1 N) were not significantly different (p>0.05). CONCLUSION: CSPB2 and CSPB3 had similar tensile strengths and fusion rates of the fusion masses as those of Cerabone(R)-AW; however, they degraded more rapidly than Cerabone(R)-AW. These findings suggest that CSPB2 and CSPB3 grafts can be used as a more ideal new bone graft substitutes than Cerabone(R)-AW.
Animals ; Autografts ; Bone Regeneration ; Ceramics ; Humans ; Lumbar Vertebrae* ; Male ; Microscopy ; New Zealand ; Palpation ; Polymers ; Porifera ; Rabbits ; Spinal Fusion ; Tensile Strength ; Transplants

PURPOSE: To evaluate the osseointegration of different dense ceramics. MATERIALS AND METHODS: Twenty-eight New Zealand white male rabbits were divided into 4 groups by implant materials: Cerabone(R)-AW, CaO-SiO2- B2O3 glass ceramics (CS10B), CaO-SiO2- B2O3 glass (CS5B glass) and Cerabone(R)- A W + A l2O3 glass ceramics. We implanted the dense ceramics into the tibia of rabbits with external fixator and checked the radiographs every 4 weeks. The union rate, histology and SEM were evaluated 8 weeks after surgery. RESULTS: The union rates were 85.7% (6 of 7) in Cerabone(R)-AW, 85.7% (6 of 7) in CS10B, 71.4% (5 of 7) in CS5B glass and 28.6% (2 of 7) in Cerabone(R)-AW+Al2O3 by simple radiographs. The union rates of Cerabone (R)-AW and CS10B were statistically higher than that of Cerabone(R)-AW+Al2O3 (p=0.031). Histologically, the Cerabone(R)-AW had fused with tibia without biodegradation, CS10B, CS5B glass had fused with tibia in some portion but resorbed in others. Cerabone(R)-AW+Al2O3 had not fused with bony tissue. CONCLUSION: We confirmed the osseointegration and insolubility of Cerabone(R)-AW. We also confirmed the osseointegration and partial solubility of CaO-SiO2-B2O3 glass ceramics. These findings suggest that Cerabone (R)-AW can be used as an insoluble artificial bone and CaO-SiO2-B2O3 glass ceramics as biodegradable bone replacement materials.
Bone Substitutes ; Ceramics* ; External Fixators ; Glass ; Humans ; Male ; New Zealand ; Osseointegration* ; Rabbits ; Solubility ; Tibia

PURPOSE: To evaluate the possibility of using porous beta-calcium pyrophosphate (beta-CPP) as a bone graft substitute by comparing its osteoconduction and degradation with porous hydroxyapatite (HA). MATERIALS AND METHODS: Porous HA and porous beta-CPP were implanted in the proximal tibia of 7 dogs. Two animals were sacrificed at 8weeks and 5 animals were sacrificed at 20 weeks after surgery. Radiographs and histologic sections were evaluated. RESULTS: The mean period required for the radiolucent zone to disappear was 7.1+/-1.1 weeks in HA and 6.4+/-1.1 weeks in beta-CPP. By serial radiography, resorption was more prominent in porous beta-CPP than in porous HA at 8 weeks (p=0.04) and at 20 weeks. The proportion of bony tissue in the pore was 16.8% in HA and 29.7% in -CPP. The proportion of pores with bony tissue was 70.2% in HA and 62.5% in beta-CPP at 8 weeks. CONCLUSION: In beta-CPP, the new bone growth was as vigorous as in HA, but the degradation was more rapid than in HA. These results suggest that beta-CPP is a more ideal new bone graft substitute.
Animals ; Bone Development ; Bone Regeneration ; Dogs ; Durapatite ; Radiography ; Tibia ; Transplants*

PURPOSE: To compare the biodegradation and osteoconduction properties of CaO-SiO2-B2O3 glass-ceramics (CS10B), hydroxyapatite(HA), and tricalcium phosphate (TCP). MATERIALS AND METHODS: Porous CS10B implants were prepared by the polymer sponge method. Single-level posterolateral spinal fusions were performed on thirty rabbits. The animals were divided into three groups by implant material: HA, TCP and CS10B. Radiographs were performed every two weeks. All animals were sacrificed 12 weeks after surgery. The proportion of the area occupied by the ceramicsin the final over the initial radiographs was calculated. Uniaxial tensile strength was determined from 7 cases in each group. RESULTS: The proportion of the area occupied by HA (88.7+/-16.1%) was significantly higher than the others (p<0.05), and the proportion of the area occupied by CS10B (28.2+/-9.3%) was significantly lower than those of HA and TCP (37+/-9.6%) (p<0.05). The mean values of the tensile strengths of HA (191.4+/-33.5 N) and CS10B (182.7+/-19.9 N) were significantly higher (p<0.05) than those of TCP (141.1+/-28.2 N). CONCLUSION: CS10B had similar tensile strengths of the fusion masses as HA, however, it degraded more rapidly than HA or TCP. These findings suggest CS10B grafts as possible bone replacement materials.
Animals ; Bone Regeneration ; Bone Substitutes ; Durapatite ; Lumbar Vertebrae* ; Polymers ; Porifera ; Rabbits ; Spinal Fusion ; Tensile Strength ; Transplants

PURPOSE: The purpose of the present study was to compare the osteoconduction in porous bodies made of various compositions of calcium phosphate compounds and other porous artificial bones. MATERIALS AND METHODS: Single-level posterolateral spinal fusions were performed on ninety rabbits. The animals were divided into nine groups by graft materials: autograft (positive control), implantation of HA, TCP, CPP, HA/TCP composite, TCP/CPP composite, Lubboc(R) and Calcium sulfate pellet (CSP), no-graft after decortication (negative control). Serial radiography, serum calcium and phosphorus levels were checked. All animals were sacrificed 12 weeks after surgery and the fusion masses were compared by manual palpation, uniaxial tensile strength measurement and histological evaluation. RESULTS: Autografted and CPP implanted groups showed significantly higher fusion ratio than TCP, TCP/CPP composite, and no-graft groups. Meanwhile, HA and HA/TCP groups showed no significant difference with other groups in fusion ratio. From the radiological examination, TCP and CPP groups seemed to show more rapid absorption of implant than HA group. The mean values of tensile strength of autografted and CPP group were significantly larger than those of TCP, TCP/CPP composite, and no-graft groups. The result of direct inspection and microscopic examination showed the TCP-contained implants lost their porous structure, whereas the other implants did not. On the light microscopy, both HA and CPP groups showed more abundant new bone growth into the pores than TCP-contained groups, but the pore size of CPP became larger than that of the HA, which manifested more rapid absorption of CPP in the living body. CONCLUSION: The porous CPP implant is considered to be more desirable bone graft substitute because it has satisfactory osteoconductive ablility and better biodegradation than porous HA. And the maintenance of porous structure is considered to be indispensable for osteoconduction.
Absorption ; Animals ; Autografts ; Bone Development ; Bone Regeneration ; Calcium Sulfate ; Calcium* ; Lumbar Vertebrae* ; Microscopy ; Palpation ; Phosphorus ; Rabbits ; Radiography ; Spinal Fusion ; Tensile Strength ; Transplants