To confirm the safety and efficacy of a low-calorie mayonnaise supplemented with phytosterol esters (PEM) at a daily consumption dose of 884 mg given for 12 weeks with the goal of lowering serum low-density lipoprotein (LDL) cholesterol levels, we conducted a double-blind comparative study in healthy adults with marginally high serum levels of LDL cholesterol and total cholesterol using a mayonnaise without phytosterol esters supplementation (CM) as the control food. Serum LDL cholesterol levels decreased significantly in the PEM group as compared with the CM group during the 12-week intervention period (136.3 ± 16.4 vs. 145.0 ± 19.3 mg/dL at Week 8 (P < 0.05) and 135.0 ± 17.4 mg/dL vs. 144.9 ± 17.5 mg/dL at Week 12; P < 0.05). No observable adverse effects were observed due to the ingestion of PEM in this study. The safety of PEM was again confirmed by an additional clinical study in which healthy adult subjects ingested a 3-fold greater amount of PEM (2,652 mg of phytosterol esters as a daily dose) for 4 weeks. Thus, we concluded that PEM is effective in lowing serum levels of LDL cholesterol and is safe and well tolerated without any clinical problems.

The influence of exercise on the endogenous levels of both β-endorphin (BE) and corticosteroid (CS) in the hypothalamus and plasma was examined in rats. F344 male rats, five weeks of age, were divided into three groups: involuntary exercised (IE), non-exercised (NE) and control (C) groups. Rats in the IE group were exercised every day for one hour at the speed of 20 m mm n for 7 to 28 days. After training, the hypothalamus and plasma were obtained from rats. BE levels in water soluble extracts of hypothalamus were examined by rat BE ELISA test kits; and CS contents in plasma was examined by RIA. The amount of BE in the hypothalamus obtained from rats in the IE group was much higher than that in the NE and C groups. Although there was no significant difference between rats exercised for 7, 14, and 21 days, BE levels in the hypothalamus from rats exercised for 28 days was significantly higher than for 7 days. The amount of BE in the hypothalamus of NE rats was nearly identical to that of C rats. On the other hand, there were no significant changes in plasma CS levels. These results may suggest that exercise, especially running, causes on increase in BE levels in the hypothalamus.

The influence of exercise on the endogenous levels of both β-endorphin (BE) and corticosteroid (CS) in the hypothalamus and plasma was examined in rats. F344 male rats, five weeks of age, were divided into three groups: involuntary exercised (IE), non-exercised (NE) and control (C) groups. Rats in the IE group were exercised every day for one hour at the speed of 20 m mm n for 7 to 28 days. After training, the hypothalamus and plasma were obtained from rats. BE levels in water soluble extracts of hypothalamus were examined by rat BE ELISA test kits; and CS contents in plasma was examined by RIA. The amount of BE in the hypothalamus obtained from rats in the IE group was much higher than that in the NE and C groups. Although there was no significant difference between rats exercised for 7, 14, and 21 days, BE levels in the hypothalamus from rats exercised for 28 days was significantly higher than for 7 days. The amount of BE in the hypothalamus of NE rats was nearly identical to that of C rats. On the other hand, there were no significant changes in plasma CS levels. These results may suggest that exercise, especially running, causes on increase in BE levels in the hypothalamus.

Two cases that were surgically treated with atherosclerotic aortic aneurysm, followed by innominate artery aneurysm are reported. The causes of these aneurysms were determined to be arteriosclerosis and idiopathic inflammation. Blood flow reconstruction surgery using grafts was performed on these two patients. In one case, we also employed an internal shunt technique to prevent brain ischemia. It was speculated that this type of aneurysm develops not only in cases of inflammation, but also in multifocal arteriosclerotic vascular diseases. This type of aneurysm will probably increase in the future.

The liver mitochondrial redox state (the liver mitochondrial free NAD+/NADH ratio), which indicates hepatic energy charge, is known to parallel the ketone body ratio (acetoacetate/3-hydroxybutyrate) in liver tissue. Since the ketone body ratio in arterial blood was reported to correlate with that in liver tissue; the arterial ketone body ratio (AKBR) has been widely accepted as a useful measure of the liver function reserve. The liver mitochondrial redox state is known to decrease with the oxidation of ethanol in alcohol abusers. To evaluate whether AKBR reflected the effect of alcohol intake on the liver, AKBR was measured in normal controls (n=8), and patients with alcoholic liver injuries (n=14) and chronic active hepatitis (n=15). The mean AKBRs in the normal control subjects, in patients with chronic active viral hepatitis, and in those with alcoholic liver disease were 1.68±0.77, 2.22±1.02, and 1.55±0.79, respectively. Though the AKBR in patients with alcoholic liver disease tended to be lower than the other groups, there was no significant difference in AKBR among those three groups. In conclusion, this study demonstrated that AKBR was doubtful as an accurate parameter to estimate the changes in the liver mitochondrial redox state by alcoholic intake.

OBJECTIVE: This open-label study examined the effects of ramelteon on cognitive functions in 10 outpatients with schizophrenia. METHODS: Ramelteon (8 mg/day) was administered to 10 patients with schizophrenia for six months. The verbal fluency test, Trail-Making Test, the Wisconsin Card Sorting Test, the Stroop Test, the Digit Span Distraction Test, Iowa Gambling Task, the Rey Auditory Verbal Learning Test were evaluated at baseline and 6 months after treatment with ramelteon. RESULTS: Ramelteon improved significantly the scores of Rey Auditory Verbal Learning Test. Additionally, ramelteon exerted improvements in the verbal fluency and Iowa Gambling Task in 4 patients. CONCLUSION: Ramelteon could be a potential therapeutic drug, in adjunctive treatment of learning and memory deficits seen in patients with schizophrenia.
Gambling ; Humans ; Iowa ; Learning ; Memory Disorders ; Outpatients ; Schizophrenia* ; Stroop Test ; Verbal Learning ; Wisconsin

In the 20th century, free tissue transfers have been successfully introduced using microvascular anastomosis techniques. Transplants not only include whole organs such as the kidney, liver and lung, but also bone, muscle and skin. However, there are a limited number of organs available for transplantation. This leads to the patient not only suffering from the malfunctioning tissue or organ, but also from the psychological trauma of an indefinite waiting period. The rapidly evolving field of tissue engineering is beginning to have an impact on free tissue transfers including organ. Small biopsy specimens can be grown into a large number of cells. These cultured cells can then be seeded onto biodegradable polymers, which serve several purposes. Firstly, the polymers function as a cell delivery system that enables the transplantation of a large numbers of cells into an organism. Secondly, they create a three-dimensional space for cell growth and serve as a template, thereby providing a structure for the extracellular matrix. These approaches have been demonstrated as practical strategies for the reconstruction of many tissues such as the liver, intestines, heart valve leaflets, bone and cartilage.
Animal ; Biomedical Engineering/trends* ; Bone and Bones ; Capillaries ; Cartilage ; Heart Valves ; Human ; Intestine, Small/physiopathology ; Liver, Artificial ; Regeneration

OBJECTIVES: Glucocorticoid (GC) treatment inhibits activation of runt-related transcription factor 2 (Runx2), which is essential for osteoblast differentiation from stem cells. As a result, GC treatment results in bone loss, GC-induced osteoporosis (GIO), elevated fracture risk, and delayed bone healing. Bisphosphonates such as alendronate (ALN) are recommended for treating or preventing GIO, and lowintensity pulsed ultrasound (LIPUS) facilitates fracture healing and maturation of regenerated bone. Combined therapy with ALN and LIPUS may stimulate cancellous bone healing in GIO rats. Here, we examined the effect of ALN and LIPUS on cancellous bone osteotomy repair in the proximal tibia of GIO rats. METHODS: Prednisolone (10 mg/kg body weight/day) was administered for 4 weeks to induce GIO in 6-month-old female Sprague-Dawley rats. Tibial osteotomy was then performed and daily subcutaneous injection of ALN (1-µg/kg body weight) was subsequently administered alone or in combination with LIPUS (20 min/day) for 2 or 4 weeks. RESULTS: ALN significantly increased bone mineral density (BMD) at 2 and 4 weeks, and ALN + LIPUS significantly increased BMD at 4 weeks. Bone union rates were significantly increased after 2 and 4 weeks ALN and ALN + LIPUS treatment. Lastly, ALN and ALN + LIPUS significantly increased the proportion of Runx2 positive cells at 4 weeks. CONCLUSIONS: ALN monotherapy and combined ALN and LUPUS treatment augmented BMD and stimulated cancellous bone repair with increased Runx2 expression at the osteotomy site in GIO rats. However, the combined treatment had no additional effect on cancellous bone healing compared to ALN monotherapy.
Alendronate* ; Animals ; Bone Density ; Bone Diseases, Metabolic* ; Diphosphonates ; Female ; Fracture Healing ; Humans ; Infant ; Injections, Subcutaneous ; Osteoblasts ; Osteoporosis ; Osteotomy* ; Prednisolone ; Rats* ; Rats, Sprague-Dawley ; Stem Cells ; Tibia* ; Transcription Factors ; Ultrasonic Waves*

The Standardized Structured Medical record Information eXchange (SS-MIX) was started in 2006 as the project supported by the Ministry of Health, Labour and Welfare (MHLW) for promoting the exchange of the standardized medical information. Free soft wares developed in the project allow the storage of medical information to receive HL7 messages for prescription, laboratory test results, diagnoses and patient demographics in the hospital information system (HIS). We encourage the use of the SS-MIX standardized storage for postmarketing surveys and clinical studies. The recommendations consist of the following 7 parts. [1] In surveys and clinical studies, the information of drugs and laboratory test results in the SS-MIX standardized storage can be directly transferred to the electronic questionnaire and the investigators may obtain the information with high accuracy and granularity. [2] The SS-MIX standardized storage works as the backup system for the HIS because it can provide the minimum information essential in patient care even under the disastrous condition like earthquake or unexpected network failure. [3] The SS-MIX standardized storage may be useful to conduct a good pharmacoepidemiology study not only because it provides the information in the storage efficiently but also it can be used to identify “new users” who started the drug after some period of non-use.The “new user” design is often essential to have the unbiased results. [4] When the drug company conducts postmarketing surveys according to the current regulation, the use of the SS-MIX standardized storage will facilitate the fast and efficient collection of data to develop the timely measure to minimize the drug-related risk. With the SS-MIX standardized storage, it is also expected that many types of study design can be employed and the quality of data is improved in the survey. [5] The SS-MIX standardized storage maybe also useful to evaluate the risk minimization action plan by comparing the prescription pattern or incidence of the targeted adverse event between two periods before and after the implementation of the action plan. [6] In planning clinical trials, the SS-MIX standardized storage may be used to estimate the size of eligible patients. The storage may also allow conducting cross-sectional studies to know characteristics of diseases or drug treatment. In addition, cohorts of those who had coronary artery angiography, new users of a drug and those with a rare disease may be readily identified. Using such cohorts, investigators can initiate a case-control study nested within the cohort, pharmacogenomic studies and comparative effectiveness researches. [7] The SS-MIX standardized storage may be used as the formal data source in clinical trials in the future when some conditions are satisfied. For instance, the formal agreement should be reached between industry, government and academia on the use of standards of data structure in Clinical Data Interchange Standards Consortium (CDISC) and on the operation of computerized system validation (CSV) in the clinical trials.

STUDY DESIGN: Retrospective and comparative study. PURPOSE: We assessed surgical treatment outcomes in patients with thoracic myelopathy due to ossification of the ligamentum flavum (OLF), and OLF combined with ossification of the posterior longitudinal ligament (OPLL) or vertebral fracture (VF) at the same level. OVERVIEW OF LITERATURE: OLF and OPLL cause severe thoracic myelopathy. Osteoporotic VF commonly occurs at the thoracolumbar junction. There have been no investigations of thoracic myelopathy due to OLF and VF. METHODS: Forty patients were divided among three groups: the OLF group (n=23): myelopathy due to OLF, the OLF+OPLL group (n=12): myelopathy due to OLF and OPLL, and the OLF+VF group (n=5): myelopathy due to OLF and VF. We recorded OLF, OPLL, and VF sites and operative procedures. Each patient’s neurological status, according to the Japanese Orthopaedic Association (JOA) score, and walking ability were evaluated pre- and postoperatively. RESULTS: Patients in the OLF+OPLL group were significantly younger than those in the other two groups. The preoperative JOA score was significantly lower in the OLF+VF than OLF group. The final JOA score was significantly lower in the OLF+VF than OLF and OLF+OPLL groups. The JOA score recovery rate was significantly lower in the OLF+VF than OLF group. Final walking ability was significantly worse in the OLF+OPLL and OLF+VF groups than in the OLF group and significantly worse in the OLF+VF than OLF+OPLL group. CONCLUSIONS: Thoracic myelopathy due to OLF+VF occurs primarily in older females, who also exhibit worse preoperative and postoperative neurological status, and worse walking ability, than patients with thoracic myelopathy due to OLF or OLF+OPLL.