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Background and study aims: The gastrointestinal (GI) tract is the most common site of extra-nodal involvement for non-Hodgkin's lymphoma (NHL). The features of GI NHLs remain unclear. The aim of this study was to clarify endoscopic characteristics of GI NHLs. Patients and methods: We retrospectively analyzed the morphological characteristics of 63 GI malignant lymphomas other than mucosa-associated lymphoid tissue lymphoma. Lesions were diagnosed between 2005 and 2020. Macroscopic findings were classified into five subtypes: superficial (S); protruding without ulcer (P); protruding with ulcer (PU); fungating (F); and multiple nodules (MN). Results: Thirty-one lesions in the stomach were classified as S type in 3 cases (9.6%), P type in 6 (19%), PU type in 13 (42%), and F type in 9 (29%). In the stomach, the ulcerated phenotype was more frequent for diffuse large B-cell lymphoma (DLBCL) (89.5%) than for other histological types (41.7%; P = 0.01). In the intestine, 23 tumors were classified as S type in 4 cases (17%), P type in 1 (4%), PU type in 6 (26%), F type in 1 (4%), and MN in 11 (48%). Eleven of the 14 cases (78.6%) of intestinal follicular lymphoma lesions showed MN type. In the colon, eight tumors were classified as S type in 2 cases (25%), P type in 2 (25%), PU type in 1 (13%), and F type in 3 (38%). Conclusion: We have clarified the endoscopic features of GI NHL using macroscopic classifications. The ulcerated phenotype was the most frequent endoscopic finding for DLBCL.
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Neoplasias Gastrointestinales , Linfoma de Células B de la Zona Marginal , Linfoma de Células B Grandes Difuso , Neoplasias Gastrointestinales/diagnóstico , Neoplasias Gastrointestinales/patología , Humanos , Linfoma de Células B de la Zona Marginal/diagnóstico , Linfoma de Células B de la Zona Marginal/patología , Linfoma de Células B Grandes Difuso/patología , Estudios Retrospectivos , ÚlceraRESUMEN
Dermatologists should consider Achenbach syndrome in the differential diagnosis for patients with purpura on the fingers. The patient should be monitored following appropriate examination and invasive tests, such as skin biopsy or angiography, should be avoided unless necessary.
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Hematoma , Púrpura , Diagnóstico Diferencial , Dedos , Humanos , Masculino , Púrpura/diagnóstico , Púrpura/etiología , SíndromeRESUMEN
Objective: Gastric inhibitory polypeptide plays a role in glucose and lipid metabolism and is associated with obesity and insulin resistance. The objective of this study is to confirm the anti-obesity effects of the gastric inhibitory polypeptide receptor antagonist, SKL-14959, on diet-induced obesity mice. Method: Diet-induced obesity mice at 20 weeks of age were administered with or without SKL-14959 for 96 d. Body weight and food intake were monitored throughout the experiment. Mice were sacrificed, and physiological and biochemical markers were measured, and then histochemical and gene expression analyses were also performed. In further studies, mice were orally gavaged with [14C]-oleic acid to investigate the excursion of digested lipids. Results: SKL-14959 significantly suppressed weight gain without affecting food intake, decreased triacylglycerol contents in the liver and the muscle and the intensity stained with oil-red in the liver. It also improved plasma glutamic pyruvic transaminase and 3-hydroxybutyrate levels in addition to notably down-regulated relative gene expression of srebf1 and dgat1 in the liver despite not altering in the adipose tissue. Furthermore, SKL-14959 showed remarkable inhibition of lipid uptake in the adipose tissue after the oil challenge. Conclusion: SKL-14959 inhibited lipids uptake and improved lipids metabolism, results in suppression of body-weight gain.
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OBJECTIVE: The impact of religious/spiritual activities on clinical outcomes in patients with serious mental illnesses remains controversial, which was addressed in this international cross-sectional study. METHOD: Three-hundred sixty-nine subjects were recruited from Austria (n = 189) and Japan (n = 180), consisting of 112 outpatients with paranoid schizophrenia, 120 with bipolar I disorder (DSM-IV), and 137 healthy controls. Religiosity was assessed in terms of attendance and importance of religious/spiritual activities, while resilience was assessed using the 25-item Resilience Scale. General linear models were used to test whether higher religiosity will be associated with higher resilience, higher social functioning, and lower psychopathology. The association between levels of spiritual well-being and resilience was also examined. RESULTS: Attendance of religious services (F[4,365] = 0.827, P = 0.509) and importance of religion/spirituality (F[3,365] = 1.513, P = 0.211) did not show significant associations with resilience. Regarding clinical measures, a modest association between higher importance of religion/spirituality and residual manic symptoms was observed in bipolar patients (F[3,118] = 3.120, P = 0.029). In contrast to the findings regarding religiosity, spiritual well-being showed a strong positive correlation with resilience (r = 0.584, P < 0.001). CONCLUSION: The protective effect of religiosity in terms of resilience, social functioning, and psychopathology was not evident in our sample. Spiritual well-being appears more relevant to resilience than religiosity.
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Trastorno Bipolar/psicología , Religión , Resiliencia Psicológica , Esquizofrenia Paranoide/psicología , Espiritualidad , Adulto , Austria , Estudios Transversales , Femenino , Humanos , Japón , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND: Health-related quality of life (HRQOL) is significantly affected in individuals with schizophrenia or bipolar I disorder (BD-I). The current study investigated whether symptomatic remission and resilience might differently impact HRQOL in these patients. METHODS: Fifty-two patients with schizophrenia and 60 patients suffering from BD-I from outpatient mental health services as well as 77 healthy control subjects from the general community were included into a cross-sectional study. HRQOL and resilience were assessed using the WHOQOL-BREF and the Resilience Scale. In patients, psychopathology was quantified by the Positive and Negative Syndrome Scale or the Montgomery Asberg Depression Rating Scale and the Young Mania Rating Scale, respectively. RESULTS: Notably, both patient groups showed lower HRQOL and resilience compared to control subjects, non-remitted patients indicated lower HRQOL than remitted ones. The effect of remission on HRQOL was significantly larger in patients with BD-I than in those with schizophrenia but did not explain the difference in HRQOL between groups. Resilience predicted HRQOL in all three groups. When accounting for the effect of resilience among remitted patients, only the difference in HRQOL between schizophrenia patients and control subjects was significant. CONCLUSION: These findings demonstrate the impact of symptomatic remission and resilience on HRQOL of both patients suffering from schizophrenia and BD-I and indicate that these factors are especially relevant for HRQOL of patients with BD-I.
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Trastorno Bipolar/psicología , Calidad de Vida , Psicología del Esquizofrénico , Adulto , Estudios Transversales , Femenino , Humanos , Masculino , Remisión Espontánea , Resiliencia PsicológicaRESUMEN
BACKGROUND AND PURPOSE: In patients with metastatic brain tumors after gamma knife radiosurgery, the superiority of PET using 11C-methionine for differentiating radiation necrosis and recurrent tumors has been accepted. To evaluate the feasibility of MR permeability imaging, it was compared with PET using 11C-methionine, FDG-PET, and DWI for differentiating radiation necrosis from recurrent tumors. MATERIALS AND METHODS: The study analyzed 18 lesions from 15 patients with metastatic brain tumors who underwent gamma knife radiosurgery. Ten lesions were identified as recurrent tumors by an operation. In MR permeability imaging, the transfer constant between intra- and extravascular extracellular spaces (/minute), extravascular extracellular space, the transfer constant from the extravascular extracellular space to plasma (/minute), the initial area under the signal intensity-time curve, contrast-enhancement ratio, bolus arrival time (seconds), maximum slope of increase (millimole/second), and fractional plasma volume were calculated. ADC was also acquired. On both PET using 11C-methionine and FDG-PET, the ratio of the maximum standard uptake value of the lesion divided by the maximum standard uptake value of the symmetric site in the contralateral cerebral hemisphere was measured (11C-methionine ratio and FDG ratio, respectively). The receiver operating characteristic curve was used for analysis. RESULTS: The area under the receiver operating characteristic curve for differentiating radiation necrosis from recurrent tumors was the best for the 11C-methionine ratio (0.90) followed by the contrast-enhancement ratio (0.81), maximum slope of increase (millimole/second) (0.80), the initial area under the signal intensity-time curve (0.78), fractional plasma volume (0.76), bolus arrival time (seconds) (0.76), the transfer constant between intra- and extravascular extracellular spaces (/minute) (0.74), extravascular extracellular space (0.68), minimum ADC (0.60), the transfer constant from the extravascular extracellular space to plasma (/minute) (0.55), and the FDG-ratio (0.53). A significant difference in the 11C-methionine ratio (P < .01), contrast-enhancement ratio (P < .01), maximum slope of increase (millimole/second) (P < .05), and the initial area under the signal intensity-time curve (P < .05) was evident between radiation necrosis and recurrent tumor. CONCLUSIONS: The present study suggests that PET using 11C-methionine may be superior to MR permeability imaging, ADC, and FDG-PET for differentiating radiation necrosis from recurrent tumors after gamma knife radiosurgery for metastatic brain tumors.
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Neoplasias Encefálicas/diagnóstico por imagen , Neuroimagen/métodos , Traumatismos por Radiación/diagnóstico por imagen , Adulto , Anciano , Neoplasias Encefálicas/patología , Radioisótopos de Carbono , Diagnóstico Diferencial , Femenino , Humanos , Imagen por Resonancia Magnética/métodos , Masculino , Persona de Mediana Edad , Necrosis/diagnóstico por imagen , Recurrencia Local de Neoplasia/diagnóstico por imagen , Tomografía de Emisión de Positrones/métodos , Curva ROC , Radiocirugia/efectos adversosRESUMEN
The aim of this study was the development of an innovative biocompatible sealant composed of Alaska pollock-derived gelatin partially modified with a dodecyl group (C12-ApGltn) and a poly(ethylene glycol)-based crosslinker, pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate. The burst strength of the developed sealants was measured using porcine aorta and rat lungs. The maximum burst strength of a C12-ApGltn-based sealant against the porcine aorta was 4-fold higher than that of an original ApGltn (Org-ApGltn)-based sealant. No significant increase in the burst strength was observed between C12-ApGltn-based sealants with 4.2 and 8.9 mol% modification ratios. From histological observation after burst strength measurement, tissue tearing was observed when a C12-ApGltn-based sealant was applied. In contrast, the Org-ApGltn-based sealant was peeled away from the aorta surface due to cohesion failure. Similar to the porcine aorta, the burst strength of C12-ApGltn-based sealants applied on a rat lung defect was 3-fold higher than that of an Org-ApGltn-based sealant. The curing time of the C12-ApGltn-based sealant measured by a simple mixing method was shorter (2.6 ± 0.1 s) than that of the Org-ApGltn-based sealant (4.1 ± 0.3 s). The swelling ratio of the C12-ApGltn-based sealant (23.7 ± 3.1) was significantly lower than that of the Org-ApGltn-based sealant (32.3 ± 1.1). The C12-ApGltn-based sealant was completely degraded within 28 days after implantation in the backs of rats without a severe inflammation reaction. However, the Org-ApGltn-based sealant disappeared within 14 days. These results indicated that hydrophobically-modified ApGltn has an effective sealing effect on moist tissues and biocompatibility in vivo.
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Materiales Biocompatibles/química , Gadiformes , Gelatina/química , Glutaratos/química , Polietilenglicoles/química , Adhesivos Tisulares/química , Alaska , Animales , Materiales Biocompatibles/uso terapéutico , Reactivos de Enlaces Cruzados/química , Reactivos de Enlaces Cruzados/uso terapéutico , Gadiformes/metabolismo , Gelatina/uso terapéutico , Glutaratos/uso terapéutico , Interacciones Hidrofóbicas e Hidrofílicas , Polietilenglicoles/uso terapéutico , Ratas , Porcinos , Resistencia a la Tracción , Adhesivos Tisulares/uso terapéuticoRESUMEN
Removable prosthodontics are often associated with mechanical troubles in daily use, such as fracture or deformation. These troubles render prostheses unusable and reduce wearers' QOL. Various reinforcements are used to prevent such problems, but consensus on reinforcement has not been reached. This review aimed to summarise the effects of reinforcement and to propose favourable reinforcement based on material, design and position in the prostheses. Initially, 139 articles were selected by electronic and manual searches. After exclusion of 99 articles based on the exclusion criteria, 40 articles were finally included in the review. Electronic searches were performed for articles published from 2005 to 2015 in PubMed, EMBASE, MEDLINE and Cochrane Library, and manual searches were performed in 10 journals relevant to the topic of removable prosthodontics. For in vitro studies, certain dental alloys and fibres were mainly used. Their forms were different, including complicated forms in dental alloys and various forms in fibres. The materials were examined for mechanical properties like fracture strength, flexural strength and elastic modulus and compared with one another or without reinforcement. There were a few clinical studies and one longitudinal study. Cast metal reinforcement seemed to be most favourable in terms of fracture toughness and stiffness. The most favourable forms differed depending on the prostheses, but placement around thin and deformable areas was effective. However, randomised or longitudinal clinical reports and comparative clinical studies on the use of reinforcement were still lacking and such studies are necessary in the future.
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Materiales Dentales/química , Fracaso de la Restauración Dental/estadística & datos numéricos , Ensayo de Materiales/métodos , Prostodoncia , Resinas Acrílicas , Análisis de Varianza , Aleaciones Dentales , Diseño de Prótesis Dental , Bases para Dentadura , Vidrio , Humanos , Prostodoncia/instrumentación , Prostodoncia/tendencias , Estrés Mecánico , Propiedades de Superficie , Resistencia a la TracciónRESUMEN
BACKGROUND: Impaired exercise capacity and muscle weakness are important characteristics of liver transplantation recipients. Perioperative rehabilitation has been introduced to promote early mobilization of patients and to prevent postoperative pulmonary complications. However, it is unknown how physical status recovers during the hospital stay after a liver transplant. The purpose of this study was to evaluate the changes in clinical indicators that represent the functional exercise capacity and muscle strength before and after living donor liver transplantation (LDLT). METHODS: We retrospectively reviewed 21 consecutive patients who underwent LDLT with perioperative rehabilitation from April 2014 to December 2015. Twelve patients who were tested for 6-minute walk distance, hand-grip strength, and isometric knee extensor muscle strength before and 4 weeks after LDLT were enrolled. RESULTS: At the preoperative baseline, the 6-minute walk distance significantly correlated with the Model for End-stage Liver Disease score and pulmonary functions (vital capacity, forced vital capacity, and forced expiratory volume in 1 second of predictive values). Comparisons between the preoperative and postoperative values revealed significant decreases in weight, Barthel Index, hand-grip strength, and isometric knee extensor muscle strength. Changes in hand-grip strength and isometric knee extensor muscle strength after LDLT correlated with the preoperative Model for End-stage Liver Disease score. CONCLUSIONS: Physical functional status had not been fully recovered 4 weeks after LDLT. Further investigation regarding developing a strategy for prevention of muscle atrophy before LDLT and recovery of physical fitness after LDLT would be helpful.
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Cirrosis Hepática/fisiopatología , Trasplante de Hígado/rehabilitación , Donadores Vivos , Fuerza Muscular , Prueba de Paso , Adulto , Anciano , Femenino , Volumen Espiratorio Forzado , Fuerza de la Mano , Humanos , Rodilla/fisiopatología , Cirrosis Hepática/rehabilitación , Cirrosis Hepática/cirugía , Trasplante de Hígado/métodos , Masculino , Persona de Mediana Edad , Fuerza Muscular/fisiología , Aptitud Física/fisiología , Periodo Posoperatorio , Periodo Preoperatorio , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Capacidad VitalRESUMEN
Disseminated histiocytic sarcoma (HS) was diagnosed on post-mortem examination of a 1.5-year-old African hedgehog (Atelerix albiventris) that was presented in poor physical condition and with diarrhoea. Leucocytosis and a hypoechoic abdominal mass were noted on haematological and ultrasonographical examinations. Gross pathological, histopathological, immunohistochemical and ultrastructural evaluation of the mass supported a diagnosis of disseminated HS. To our knowledge, this report represents the first documentation of disseminated HS in this species.
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Erizos , Sarcoma Histiocítico/veterinaria , Animales , FemeninoRESUMEN
OBJECTIVE: Improving quality of life (QoL) is an important objective in the treatment of schizophrenia. The aim of the current study was to examine to what extent resilience, self-esteem, hopelessness, and psychopathology are correlated with QoL. METHOD: We recruited 52 out-patients diagnosed with schizophrenia according to DSM-IV criteria and 77 healthy control subjects from the general community. In patients, psychopathology was quantified by the Positive and Negative Syndrome Scale. The following scales were used in both patients and control subjects: the Berliner Lebensqualitätsprofil, the Resilience Scale, the Rosenberg Self-Esteem Scale, and the Beck Hopelessness Scale to assess QoL, resilience, self-esteem, and hopelessness respectively. RESULTS: Patients with schizophrenia presented with significantly less QoL, resilience, self-esteem, and hope compared to healthy control subjects. In patients, QoL correlated moderately with resilience, self-esteem, and hopelessness and weakly with symptoms. With respect to the latter, particularly depression and positive symptoms were negatively correlated with QoL. CONCLUSION: Our results highlight the complex nature of QoL in patients suffering from schizophrenia. They underscore that significant efforts are necessary to enhance resilience and self-esteem and to diminish hopelessness as well as affective and positive symptoms in patients with schizophrenia.
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Resiliencia Psicológica , Esquizofrenia/diagnóstico , Autoimagen , Adulto , Estudios Transversales , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Escalas de Valoración Psiquiátrica , Calidad de Vida , Psicología del EsquizofrénicoRESUMEN
AIMS: For women with congenital heart defects (CHD), pregnancy may pose a health risk. Sexually active women with CHD without the desire for own children or for whom pregnancy would imply considerable health risks require adequate counselling regarding appropriate contraception. This study gathers data on the contraceptive behaviour of women with CHD from three different cultural regions. METHODS AND RESULTS: 634 women with CHD from Germany, Hungary and Japan were surveyed regarding contraception and contraceptive methods (CM) used. The patients were divided into groups according to different criteria such as pregnancy associated cardiovascular risk or "safety" of the contraceptive methods used. 59% of the study participants had already gained experience with CM. The average age at the first time of use was 18.4 years; the German patients were significantly younger at the first time of using a CM than those from Hungary and Japan. Overall the condom was the method used the most (38%), followed by oral contraceptives (30%) and coitus interruptus (11%). The range of CM used in Japan was much smaller than that in Germany or Hungary. Unsafe contraceptives were currently, or had previously been used, by 29% of the surveyed patients (Germany: 25%, Hungary: 37%, Japan: 32%). CONCLUSION: Most women with CHD use CM. There are differences between the participating countries. Adequate contraceptive counselling of women with CHD requires considering the individual characteristics of each patient, including potential contraindications. For choosing an appropriate CM, both the methods' "safety", as well as the maternal cardiovascular risk, are important.
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Anticoncepción/métodos , Cardiopatías Congénitas/fisiopatología , Adulto , Anticoncepción/instrumentación , Anticoncepción/estadística & datos numéricos , Conducta Anticonceptiva/estadística & datos numéricos , Dispositivos Anticonceptivos/estadística & datos numéricos , Femenino , Alemania , Humanos , Hungría , Japón , Educación del Paciente como Asunto , Factores de Riesgo , Adulto JovenRESUMEN
The polarizer is one of the critical components in a high-power millimeter-wave transmission line. It requires full and highly efficient coverage of any polarization states, high-power tolerance, and low-loss feature. Polarizers with rounded shape at the edge of the periodic groove surface are designed and fabricated by the machining process for a mega-watt long-pulse millimeter-wave transmission line of the electron cyclotron resonance heating system in the large helical device. The groove shape of λ/8- and λ/4-type polarizers for an 82.7 GHz transmission line is optimally designed in an integral method developed in the vector theories of diffraction gratings so that the efficiency to realize any polarization state can be maximized. The dependence of the polarization states on the combination of the two polarizer rotation angles (Φλ/8, Φλ/4) is examined experimentally in a low-power test with the newly developed polarization monitor. The results show that the measured polarization characteristics are in good agreement with the calculated ones.
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A control system for a fast steering mirror has been newly developed for the electron cyclotron heating (ECH) launchers in the large helical device. This system enables two-dimensional scan during a plasma discharge and provides a simple feedback control function. A board mounted with a field programmable gate array chip has been designed to realize feedback control of the ECH beam position to maintain higher electron temperature by ECH. The heating position is determined by a plasma diagnostic signal related to the electron temperature such as electron cyclotron emission and Thomson scattering.
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In order to evaluate the electron cyclotron (EC) heating power inside the Large Helical Device vacuum vessel and to investigate the physics of the interaction between the EC beam and the plasma, a direct measurement system for the EC beam transmitted through the plasma column was developed. The system consists of an EC beam target plate, which is made of isotropic graphite and faces against the EC beam through the plasma, and an IR camera for measuring the target plate temperature increase by the transmitted EC beam. This system is applicable to the high magnetic field (up to 2.75 T) and plasma density (up to 0.8 × 10(19) m(-3)). This system successfully evaluated the transmitted EC beam profile and the refraction.
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BACKGROUND: Posttransplant lymphoproliferative disorder (PTLD) is a life-threatening complication of organ transplantation that results from immunosuppression therapy. Most cases of PTLD derive from the B-cell lineage. T-cell PTLD, particularly natural killer (NK)/T-cell PTLD, is quite rare; only a few cases have been described. CASE REPORT: A 42-year-old woman received a living-related renal allograft from her father. Sixteen years after transplantation, the patient presented with a 1-week history of low-grade fever and epigastralgia. Computed tomography revealed intestinal masses and a right upper lung lobe mass. Gallium scintigraphy showed uptake in the abdominal mass. Epstein-Barr virus-related antibody was not detected in the patient's serum sample. We performed extirpation of the jejunum and ileum tumors. The pathologic findings showed that these 2 tumors were NK/T-cell lymphoma. After the operation, the lung mass rapidly enlarged, and right upper lobectomy was performed. The right upper lung lobe tumor showed the same histopathologic findings as the small bowel tumor. The final histologic diagnosis was established as multiple extranodal NK/T cell type PTLD of the small bowel and right upper lung lobe. CONCLUSIONS: After reduction of the immunosuppressive agent, no recurrence of PTLD has been observed for the past 9 years.
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Inmunosupresores/efectos adversos , Trasplante de Riñón , Linfoma Extranodal de Células NK-T/complicaciones , Trastornos Linfoproliferativos/inducido químicamente , Adulto , Linfocitos B/patología , Femenino , Humanos , Neoplasias del Íleon/complicaciones , Neoplasias del Íleon/patología , Neoplasias del Yeyuno/complicaciones , Neoplasias del Yeyuno/patología , Neoplasias Pulmonares/complicaciones , Neoplasias Pulmonares/patología , Inducción de Remisión , Tomografía Computarizada por Rayos XRESUMEN
The aim of this paper was to determine whether weather factors including atmospheric pressure are associated with the occurrence of ruptured abdominal aortic aneurysm (RAAA). We investigated our institutional experiences of RAAA in more than 150 patients during 8 years. Further, we performed a meta-analysis of published studies reporting the influence of atmospheric pressure on RAAA. We retrospectively evaluated 152 patients who underwent surgery for RAAA (including ruptured iliac arterial aneurysm) at our institute between 1 January 2006 and 31 December 2013. Daily regional meteorological data (in the nearest weather station located 3.5 km from the hospital) were obtained online from Japan Meteorological Agency. To identify comparative studies of mean atmospheric pressure on the day with RAAA versus that on the day without RAAA, MEDLINE and EMBASE were searched through January 2014 using Web-based search engines (PubMed and OVID). Mean sea level atmospheric pressure, delta mean atmospheric pressure (difference between mean sea level atmospheric pressure on the day and that on the previous day), and sunshine duration on the day with RAAA were significantly lower than those on the day without RAAA: 1012.43±7.44 versus 1013.71±6.49 hPa, P=0.039, -1.18±5.15 versus 0.05±5.62 hPa, P=0.005; and 4.76±3.76 versus 5.47±3.88 h, P=0.026; respectively. A pooled analysis of 8 studies (including our institutional study) demonstrated that mean atmospheric pressure on the day with RAAA was significantly lower than that on the day without RAAA: standardized mean difference, -0.09; 95% confidence interval, -0.14 to -0.04; P=0.0009. Atmospheric pressure on the day with RAAA appears lower than that on the day without RAAA. Atmospheric pressure may be associated with the occurrence of RAAA.
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Aneurisma de la Aorta Abdominal , Rotura de la Aorta , Presión Atmosférica , Adulto , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/epidemiología , Aneurisma de la Aorta Abdominal/etiología , Aneurisma de la Aorta Abdominal/cirugía , Rotura de la Aorta/epidemiología , Rotura de la Aorta/etiología , Rotura de la Aorta/cirugía , Femenino , Humanos , Japón/epidemiología , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Estadística como Asunto , Procedimientos Quirúrgicos Vasculares/estadística & datos numéricosRESUMEN
BACKGROUND AND PURPOSE: To assess the long-term safety and efficacy of pramipexole as a once-daily (q.d.) extended-release oral formulation in early or advanced Parkinson's disease (PD). METHODS: In two double-blind (DB) studies of early PD and one of advanced PD,active-treatment arms received pramipexole immediate release (IR) or extended release (ER), with exposure lasting up to 33 weeks. In open-label (OL) extensions that followed immediately, subjects took ER q.d. for up to 80 weeks, with dosage adjustment permitted (range 0.375-4.5 mg q.d.). RESULTS: Of 590 subjects completing an early-PD DB study, 511 entered the early-PD OL extension; 408 completed it. Reported adverse events (AEs) with incidence ≥10.0% were somnolence (15.1%), peripheral edema (11.7%) and back pain (10.6%). Of 465 subjects completing the advanced-PD DB study, 391 entered the advanced-PD OL extension; 329 completed it. Reported AEs with incidence ≥10.0%were dyskinesia (27.4%) and somnolence (13.6%). Impulse control disorders were identified by semi-structured interview in 13 subjects (1.4% of 902). In exploratory analyses, adjusted mean Unified Parkinson's Disease Rating Scale (UPDRS) PartsII + III scores (excluding ex-placebo recipients) remained substantially improved from DB baseline scores prior to pramipexole introduction, at -6.6 and -6.3 points amongst ex-DB-ER and ex-DB-IR recipients after 113 weeks of pramipexole (33 DB plus 80 OL) in early PD, and -11.5 and -9.1 after up to 113 weeks (up to 33 DB plus 80 OL) in advanced PD. CONCLUSIONS: These results support the long-term safety and efficacy of pramipexole ER in early and advanced PD. AEs were typical for dopaminergic medications, and UPDRS scores suggested sustained symptomatic benefit.