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1.
BMC Cancer ; 20(1): 594, 2020 Jun 26.
Artículo en Inglés | MEDLINE | ID: mdl-32586289

RESUMEN

BACKGROUND: Patients with cancer have an increased risk of malnutrition which is associated with poor outcome. The Mini Nutritional Assessment (MNA®) is often used in older patients with cancer but its relation to outcome is not known. METHODS: Four databases were systematically searched for studies relating MNA-results with any reported outcome. Two reviewers screened titles/abstracts and full-texts, extracted data and rated the risk of bias (RoB) independently. RESULTS: We included 56 studies which varied widely in patient and study characteristics. In multivariable analyses, (risk of) malnutrition assessed by MNA significantly predicts a higher chance for mortality/poor overall survival (22/27 studies), shorter progression-free survival/time to progression (3/5 studies), treatment maintenance (5/8 studies) and (health-related) quality of life (2/2 studies), but not treatment toxicity/complications (1/7 studies) or functional status/decline in (1/3 studies). For other outcomes - length of hospital stay (2 studies), falls, fatigue and unplanned (hospital) admissions (1 study each) - no adjusted results were reported. RoB was rated as moderate to high. CONCLUSIONS: MNA®-result predicts mortality/survival, cancer progression, treatment maintenance and (health-related) quality of life and did not predict adverse treatment outcomes and functional status/ decline in patients with cancer. For other outcomes results are less clear. The moderate to high RoB calls for studies with better control of potential confounders.


Asunto(s)
Desnutrición/diagnóstico , Neoplasias/mortalidad , Estado Nutricional , Progresión de la Enfermedad , Humanos , Tiempo de Internación/estadística & datos numéricos , Desnutrición/etiología , Neoplasias/complicaciones , Neoplasias/terapia , Evaluación Nutricional , Admisión del Paciente/estadística & datos numéricos , Pronóstico , Supervivencia sin Progresión , Calidad de Vida , Factores de Riesgo , Factores de Tiempo
2.
Int J Colorectal Dis ; 35(5): 847-857, 2020 May.
Artículo en Inglés | MEDLINE | ID: mdl-32103326

RESUMEN

PURPOSE: Anastomotic leak and other infectious complications are septic complications of rectal cancer surgery caused by bacteria. Data from registry analysis show a beneficial effect of local antimicrobial administration on anastomotic leaks, but data are inconsistent in recent clinical trials. Therefore, our aim was to study the efficacy of topical antibiotic treatment on the incidence of anastomotic leaks in rectal cancer surgery. METHODS: A prospective, randomized, double-blind and placebo-controlled, single center trial was conducted. Patients received either placebo and amphotericin B or decontamination with polymyxin B, tobramycin, vancomycin, and amphotericin B four times per day starting the day before surgery until postoperative day 7. If a protective ileostomy was created, a catheter was placed transanally and the medication was administered locally to the anastomotic site. All patients received an intravenous perioperative antibiotic prophylaxis. RESULTS: The trial had to be stopped for ethical reasons after first interim analysis with 80 patients instead of the initially planned 280 patients. Of the 40 patients randomized to receive placebo, eight (20%) developed anastomotic leak compared to only 2 (5%) in the treatment group of 40 patients (decontamination) with significant difference in the χ2 test (p = 0.0425). Twenty percent of the placebo group and 12.5% in the treatment group developed infectious complications not associated with anastomotic leak (p = 0.5312). One patient (2.5%) in the placebo group died (p = 0.3141). CONCLUSION: Local decontamination with polymyxin, tobramycin, vancomycin, and amphotericin B is safe and effective in the prevention of anastomotic leak in rectal cancer surgery.


Asunto(s)
Fuga Anastomótica/tratamiento farmacológico , Fuga Anastomótica/prevención & control , Antibacterianos/uso terapéutico , Descontaminación , Neoplasias del Recto/cirugía , Fuga Anastomótica/etiología , Antibacterianos/farmacología , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Placebos , Estudios Prospectivos , Resultado del Tratamiento
3.
J Affect Disord ; 229: 193-198, 2018 03 15.
Artículo en Inglés | MEDLINE | ID: mdl-29324366

RESUMEN

BACKGROUND: Major Depression is mainly related to structural and functional alterations in brain networks involving limbic and prefrontal regions. Reduced olfactory sensitivity in depression is associated with reduced olfactory bulb (OB) volume. We determined if the OB volume reduction is a specific biomarker for depression and whether its diagnostic accuracy allows its use as a valid biomarker to support its diagnosis. METHODS: 84 in-patients with mixed mental disorders and 51 age-matched healthy controls underwent structural MR imaging with a spin-echo T2-wheighted sequence. Individual OB volume was calculated manually (interrater-reliability = .81, p < .001) and compared between groups. Multiple regression analysis with OB volume as dependent variable and Receiver Operator Characteristic analysis to obtain its diagnostic accuracy for depression were ruled out. RESULTS: Patients exhibited a 13.5% reduced OB volume. Multiple regression analysis showed that the OB volume variation was best explained by depression (ß = -.19), sex (ß = -.31) and age (ß = -.29), but not by any other mental disorder. OB volume attained a diagnostic accuracy of 68.1% for depression. LIMITATIONS: The patient group mainly contained highly comorbid patients with mostly internalizing disorders which limits the generalisability of the results of the regression analysis. CONCLUSION: The OB may serve as a marker for depression. We assume that reduced neural olfactory input to subsequent limbic and salience processing structures moderates this relation. However, the OB was in an inferior position compared to conventional questionnaires for diagnosis of depression. Combination with further structural or functional measurements is suggested.


Asunto(s)
Depresión/diagnóstico por imagen , Imagen por Resonancia Magnética , Bulbo Olfatorio/patología , Adulto , Biomarcadores , Estudios de Casos y Controles , Depresión/patología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Bulbo Olfatorio/diagnóstico por imagen , Tamaño de los Órganos , Curva ROC , Análisis de Regresión , Reproducibilidad de los Resultados
4.
Blood Cells Mol Dis ; 67: 14-17, 2017 09.
Artículo en Inglés | MEDLINE | ID: mdl-28087247

RESUMEN

Von Willebrand Factor (VWF) has a central role in primary hemostasis. Its biological activity is related to the size of VWF multimers, spontaneously binding to platelets and inducing circulating microthrombi formation. This process is down-regulated by the VWF cleaving protease ADAMTS13 (A Disintegrin and Metalloprotease with ThromboSpondin motif). To date, information regarding the levels of ADAMTS13 in neonates and preterm infants is scarce. Our aim was to study ADAMTS13, VWF antigen (Ag) and Ristocetin cofactor (RiCof) activity in neonates and evaluate potential correlations with perinatal complications. Our cohort consisted of 128 (48/128: born preterm) neonates, born in Sheba Medical Center and followed until hospital discharge. Control group consisted of 20 healthy adults. As expected, a significant elevation of VWF:Ag was observed in preterm and term infants compared to adults. VWF:Ag levels were highest in full term infants (Median 129.0 IQR 33.8) and lowest in adults (Median 119.0 IQR 58.5) (p<0.05), and RiCoF levels in neonates were higher than in adults. ADAMTS13 was significantly (p<0.05) higher in preterm babies in comparison to full term and adult controls. Neonates that underwent stressful conditions or experienced vascular complications such as IUGR, ROP, NEC, had lower levels of ADAMTS13 in our study. Further studies are required to validate and asses potential significance of these findings.


Asunto(s)
Proteína ADAMTS13/sangre , Recien Nacido Prematuro/sangre , Nacimiento Prematuro/sangre , Factor de von Willebrand/análisis , Proteína ADAMTS13/metabolismo , Adulto , Estudios de Cohortes , Femenino , Humanos , Recién Nacido , Recien Nacido Prematuro/metabolismo , Persona de Mediana Edad , Embarazo , Nacimiento Prematuro/metabolismo , Adulto Joven , Factor de von Willebrand/metabolismo
5.
J Matern Fetal Neonatal Med ; 30(4): 402-405, 2017 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-27071421

RESUMEN

OBJECTIVES: To evaluate perinatal morbidity and mortality among preterm neonates who were born to overweight and obese mothers compared to preterm neonates who were born to mothers with normal pre-pregnancy body mass index (BMI). METHODS: Retrospective recordings of medical charts of 110 preterm infants born to overweight (n = 68) and obese (n = 42) mothers at gestational age (GA) 28-34 weeks, as well as 110 controls matched for GA and birth weight. All infants were born at the Sheba Medical Center between 2007 and 2014. Data regarding maternal pre-pregnancy weight and height were recorded, as well as maternal and neonatal complications and feeding methods. RESULTS: Obese mothers had more pregnancy-induced hypertension (52.4% versus 21.4%, p = 0.006) and caesarean section deliveries (81% versus 52.4%, p = 0.018). Overweight mothers had more gestational diabetes (20.6% versus 2.9%, p = 0.001). The study and control groups were similar on all neonatal outcome parameters. No differences between the groups were recorded throughout hospitalization with respect to Apgar score, respiratory distress and support, hypotension, cardiac manifestations, brain pathologies, infection, feeding type and total hospitalization days. CONCLUSIONS: Although the maternal complications are greater among obese and overweight women, it seems that preterm infants born to these women are not at increased risk for neonatal complications.


Asunto(s)
Recien Nacido Prematuro , Obesidad/complicaciones , Complicaciones del Embarazo , Resultado del Embarazo/epidemiología , Análisis de Varianza , Peso al Nacer , Estudios de Casos y Controles , Cesárea/estadística & datos numéricos , Diabetes Gestacional/etiología , Femenino , Edad Gestacional , Humanos , Hipertensión Inducida en el Embarazo/etiología , Recién Nacido , Masculino , Obesidad/epidemiología , Embarazo , Complicaciones del Embarazo/epidemiología , Nacimiento Prematuro , Estudios Retrospectivos
6.
J Perinatol ; 36(9): 739-43, 2016 09.
Artículo en Inglés | MEDLINE | ID: mdl-27195981

RESUMEN

OBJECTIVE: Premature delivery and prolonged hospitalization of infants in the neonatal intensive care unit (NICU) are very stressful for parents. As technology has advanced, short message services (SMS) have been used increasingly in the medical disciplines. To date, the use of SMS for updating patients and families regarding medical information has not been reported. We implemented the SMS technique to daily update the parents regarding the health status of their preterm infant. The objective of this study was to evaluate the use of SMS technology and to assess its impact on the parents and the nursing staff. STUDY DESIGN: Parents and nurses completed questionnaires at two time periods: pre-SMS implementation (pre-SMSi) and post-SMS implementation (post-SMSi). The parent questionnaires included statements about medical information delivery, communication and trust between parents and medical staff, parental anxiety and overall satisfaction. The nurse questionnaires included statements about the expected and actual impact on their workload. RESULTS: Comparison of the parents' responses at the two time periods indicated that in the post-SMSi time period, they felt that the physician was more available when needed (P=0.002), they were more comfortable about approaching the physician (P=0.001) and more satisfied with the medical information provided by the staff (P=0.03). In the post-SMSi period, 78.1% of the nurses noted that the SMS communication is a convenient and user-friendly method. CONCLUSIONS: SMS updating is an easy and user-friendly technology that enriches the modalities of information delivery to parents of hospitalized preterm infants. It is a complementary and useful tool for encouraging and improving personal communication between parents and medical staff and should be considered part of quality improvement in health care.


Asunto(s)
Comunicación , Cuidado Intensivo Neonatal/métodos , Padres/psicología , Relaciones Profesional-Familia , Envío de Mensajes de Texto/estadística & datos numéricos , Adulto , Femenino , Humanos , Recién Nacido , Recien Nacido Prematuro , Unidades de Cuidado Intensivo Neonatal , Israel , Masculino , Enfermeras y Enfermeros , Satisfacción Personal , Mejoramiento de la Calidad , Encuestas y Cuestionarios
7.
J Perinatol ; 36(9): 775-8, 2016 09.
Artículo en Inglés | MEDLINE | ID: mdl-27101390

RESUMEN

OBJECTIVE: To determine the prevalence, risk factors and diseases associated with isolated lenticulostriate vasculopathy (LSV) among preterm infants. STUDY DESIGN: Medical records of 84 preterm infants (gestational age (GA) 25 to 34 weeks) with isolated LSV in a case-control retrospective study over a period of 6.5 years were reviewed and compared with matched control infants. LSV was defined as 'early' if it was documented in head ultrasound (HUS) before or on the fifth day of life and 'late' if it was not present in the first HUS and recorded later during neonatal hospitalization. RESULTS: A 3.9% prevalence of LSV was recorded among preterm infants (GA⩽34 weeks). Study and control groups were similar for all maternal parameters, neonatal outcomes and length of hospitalization. Infants with late LSV had more neonatal complications than control infants and were born with younger GA and lower birth weight in comparison to infants with early LSV. More infants with late LSV needed mechanical ventilation, were diagnosed with bronchopulmonary dysplasia and were hospitalized longer in comparison to infants with early LSV. Urine cytomegalovirus was negative in the entire study group. CONCLUSIONS: No risk factors or specific associated morbidities were identified among preterm infants with early isolated LSV. Infants with late isolated LSV were younger and had overall increased associated morbidities. Long-term outcome studies are needed to determine LSV impact.


Asunto(s)
Enfermedad Cerebrovascular de los Ganglios Basales/diagnóstico por imagen , Recien Nacido Extremadamente Prematuro , Síndrome de Dificultad Respiratoria del Recién Nacido/complicaciones , Enfermedad Cerebrovascular de los Ganglios Basales/complicaciones , Peso al Nacer , Estudios de Casos y Controles , Ecoencefalografía , Femenino , Edad Gestacional , Humanos , Lactante , Recién Nacido , Israel , Tiempo de Internación , Modelos Logísticos , Masculino , Respiración Artificial , Síndrome de Dificultad Respiratoria del Recién Nacido/terapia , Estudios Retrospectivos , Factores de Riesgo
8.
Environ Sci Pollut Res Int ; 22(2): 1160-74, 2015 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-25119278

RESUMEN

In the European registration procedure for pesticides, microcosm and mesocosm studies are the highest aquatic experimental tier to assess their environmental effects. Evaluations of microcosm/mesocosm studies rely heavily on no observed effect concentrations (NOECs) calculated for different population-level endpoints. Ideally, a power analysis should be reported for the concentration-response relationships underlying these NOECs, as well as for measurement endpoints for which significant effects cannot be demonstrated. An indication of this statistical power can be provided a posteriori by calculated minimum detectable differences (MDDs). The MDD defines the difference between the means of a treatment and the control that must exist to detect a statistically significant effect. The aim of this paper is to expand on the Aquatic Guidance Document recently published by the European Food Safety Authority (EFSA) and to propose a procedure to report and evaluate NOECs and related MDDs in a harmonised way. In addition, decision schemes are provided on how MDDs can be used to assess the reliability of microcosm/mesocosm studies and for the derivation of effect classes used to derive regulatory acceptable concentrations. Furthermore, examples are presented to show how MDDs can be reduced by optimising experimental design and sampling techniques.


Asunto(s)
Ecosistema , Monitoreo del Ambiente/normas , Plaguicidas/análisis , Contaminantes Químicos del Agua/análisis , Monitoreo del Ambiente/métodos , Reproducibilidad de los Resultados
9.
J Perinatol ; 34(12): 906-8, 2014 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-25058747

RESUMEN

OBJECTIVE: To evaluate whether Rh-positive preterm newborn infants born to Rh-negative mothers treated with prophylactic anti-D immunoglobulins exhibited signs of hemolytic reaction, including anemia and hyperbilirubinemia. STUDY DESIGN: Retrospective data were collected for 94 Rh-positive preterm newborns born at gestational age (GA) 28 to 34 weeks to 76 Rh-negative mothers and for matched controls. RESULT: We found 11.7% positive Coombs' tests among infants in the study group and slightly higher bilirubin levels at birth and on the following 3 days. No differences were recorded between the study and the control groups for hematocrit levels throughout hospitalization, maximal bilirubin level, phototherapy treatment or the need for blood transfusion. CONCLUSION: Among preterm Rh-positive newborn infants born to Rh-negative mothers, there appears to be no evidence of significant hemolytic reaction derived from placental anti-D transfer. Further prospective studies are needed to confirm these findings in order to support anti-D administration close to preterm birth.


Asunto(s)
Hemólisis/efectos de los fármacos , Recien Nacido Prematuro , Globulina Inmune rho(D)/uso terapéutico , Adulto , Bilirrubina/sangre , Prueba de Coombs , Eritroblastosis Fetal/prevención & control , Femenino , Hematócrito , Humanos , Recién Nacido , Modelos Logísticos , Masculino , Embarazo , Resultado del Embarazo
10.
Lupus ; 23(10): 986-93, 2014 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-24729280

RESUMEN

OBJECTIVE: YB current affiliation: Department of Pediatrics, Hadassah-Hebrew University Medical Center, Mount Scopus, Israel YB and MJS contributed equally to the study and should be regarded as joint first authors on this manuscript. Antiphospholipid syndrome (APS) may present with thrombosis and persistently elevated titers of antiphospholipid antibodies (aPL) in the neonatal period. Our aim was to investigate the course and impact of elevated titers of aPL in a cohort of infants presenting with either perinatal arterial ischemic stroke (PAS) or cerebral sinus vein thrombosis (CSVT) during the perinatal period. STUDY DESIGN: Sixty-two infants with clinically and radiologically confirmed PAS or CSVT presenting in the neonatal period underwent thrombophilia workup that included Factor V Leiden (FVL), PII20210A mutation, MTHFR 677T polymorphism, protein C, protein S, aPL namely either circulating lupus anticoagulant (CLA), anticardiolipin antibodies (aCL) or anti-ß2-glycoprotein-1 (ß2GP1). Mothers also underwent thrombophilia workup. RESULTS: Twelve infants with persistently elevated aPL were prospectively followed. Infants with positive aPL showed no concordance with presence of maternal aPL. All children were followed for a median of 3.5 years (range: nine months to 19 years) with repeated aPL testing every three to six months. Anticoagulant therapy initiation and therapy duration varied at the physician's discretion. In 10/12 cases aPL decreased to normal range within 2.5 years; one female with complex thrombophilia risk factors required indefinite prolonged anticoagulation. None of the infants showed recurrent thrombosis or any other APS manifestations, despite lack of prolonged anticoagulation. CONCLUSIONS: The presence of aPL may be important in the pathogenesis of cerebral thrombosis in neonates. Nevertheless, the nature of thrombophilia interactions in this period and their therapeutic impact warrants further investigation.


Asunto(s)
Anticuerpos Antifosfolípidos/sangre , Síndrome Antifosfolípido/inmunología , Isquemia Encefálica/inmunología , Enfermedades del Recién Nacido/inmunología , Trombosis de los Senos Intracraneales/inmunología , Accidente Cerebrovascular/inmunología , Adolescente , Anticoagulantes/uso terapéutico , Síndrome Antifosfolípido/sangre , Síndrome Antifosfolípido/clasificación , Síndrome Antifosfolípido/diagnóstico , Síndrome Antifosfolípido/tratamiento farmacológico , Biomarcadores/sangre , Isquemia Encefálica/sangre , Isquemia Encefálica/clasificación , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/prevención & control , Niño , Preescolar , Femenino , Estudios de Seguimiento , Humanos , Lactante , Recién Nacido , Enfermedades del Recién Nacido/sangre , Enfermedades del Recién Nacido/clasificación , Enfermedades del Recién Nacido/diagnóstico , Enfermedades del Recién Nacido/tratamiento farmacológico , Israel , Masculino , Estudios Prospectivos , Recurrencia , Sistema de Registros , Factores de Riesgo , Trombosis de los Senos Intracraneales/sangre , Trombosis de los Senos Intracraneales/clasificación , Trombosis de los Senos Intracraneales/diagnóstico , Trombosis de los Senos Intracraneales/prevención & control , Accidente Cerebrovascular/sangre , Accidente Cerebrovascular/clasificación , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/prevención & control , Trombofilia/sangre , Trombofilia/diagnóstico , Trombofilia/inmunología , Factores de Tiempo , Resultado del Tratamiento , Regulación hacia Arriba , Adulto Joven
11.
J Perinatol ; 34(1): 39-42, 2014 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-24113397

RESUMEN

OBJECTIVE: When rectal bleeding occurs in an otherwise asymptomatic child, it can be classified as isolated rectal bleeding (IRB). Among the different etiologies suggested for IRB, one of the most common is a hypersensitivity reaction of the bowel mucosa to digested antigens. The objective of this study was to assess the long-term outcomes and the risk of developing hypersensitivity syndromes among infants following an IRB event. STUDY DESIGN: A historical prospective comparative study was carried out. The study compared 77 infants who were born at the Sheba Medical Center in Israel during the period 2002 to 2009 and who experienced a neonatal IRB event to 77 infants with the same gestational age, but without IRB. Data were obtained from hospital records and from phone interviews with the parents regarding hypersensitivity syndrome between the ages of 3 and 10 years. RESULT: The IRB group was not at an increased risk of developing a hypersensitivity syndrome or gastrointestinal symptoms compared to the control group. Longer duration of breast-feeding was found to be related to a lower incidence of hypersensitivity symptoms. CONCLUSION: An IRB event in the neonatal period does not increase the risk of developing hypersensitivity syndromes or food allergies during childhood.


Asunto(s)
Hemorragia Gastrointestinal/complicaciones , Hipersensibilidad/etiología , Enfermedades del Prematuro , Asma/etiología , Peso al Nacer , Lactancia Materna , Estudios de Casos y Controles , Femenino , Hipersensibilidad a los Alimentos/etiología , Edad Gestacional , Humanos , Recién Nacido , Recien Nacido Prematuro , Masculino , Estudios Prospectivos , Recto , Factores de Riesgo
13.
Semin Fetal Neonatal Med ; 16(6): 301-4, 2011 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-21810548

RESUMEN

Hemostasis is a dynamic process and physiologic concentrations of coagulation proteins gradually increase with gestational age. Nevertheless, the risk for bleeding in term neonates is counterbalanced by the protective effects of physiologic deficiencies of the inhibitors of coagulation. Although laboratory diagnosis of coagulation disorders in infants may be difficult to establish, due to the need to adapt all assays for small amounts of blood and the age-related interpretation required for test results - evaluation of infants with secondary hemostatic defects is quite feasible, whereas laboratory assessment of primary hemostasis in neonates remains a challenge. While platelet number and volume are similar in neonates as compared to adult values, neonatal platelets certainly exhibit hyporesponsiveness. Analysis of platelet function may include aggregation studies or flow cytometry assays, using fluorescence-stained monoclonal antibodies against platelet membranes and cellular antigens. Data on platelet function in correlation with gestational age are scarce and the duration of platelet hyporeactivity and its clinical significance have not yet been completely elucidated. Whole-blood-based platelet function assays have shown in neonates as well as in premature infants progressive improvement of clot formation with gestational age. This article reviews platelet function, assessed by various techniques, and its development in the premature as well as healthy term neonate.


Asunto(s)
Trastornos de las Plaquetas Sanguíneas/fisiopatología , Plaquetas/fisiología , Recién Nacido/sangre , Recien Nacido Prematuro/sangre , Agregación Plaquetaria/fisiología , Factores de Edad , Trastornos de las Plaquetas Sanguíneas/diagnóstico , Hemostasis/fisiología , Humanos , Pruebas de Función Plaquetaria/métodos
14.
Haemophilia ; 17(4): 625-9, 2011 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-21299743

RESUMEN

Recent reports have raised concerns regarding potential risk factors for inhibitor development. In Israel, all haemophilia patients (n = 479) are followed by the National Hemophilia Center. Most children are neonatally exposed to factor concentrate (due to circumcision performed at the age of 8 days). The impact of early exposure and recombinant FVIII products (rFVIII) administration (approved in Israel since 1996) upon inhibitor occurrence in our cohort of haemophilia A (HA) patients was analysed. Two hundred ninety-two consecutive paediatric cases with a first symptomatic onset of HA were enrolled and followed over a median time of 7 years [min-max: 9 months to 17 years]. Study endpoint was inhibitor development against factor VIII. In addition, the treatment regimens applied, i.e. bolus administration or 'continuous infusion' and the family history of inhibitor development were investigated. During the follow-up period 31/292 children (10.6%) developed high titre inhibitors. Inhibitors occurred in 14/43 (32.5%) HA patients neonatally exposed to rFVIII, as compared to 22/249 previously treated with Plasma Derived (PD) products (8.8%). The odds ratio for inhibitor formation in rFVIII treated HA patients was 3.43 (95% CI: 1.36-8.65). Transient inhibitor evolved among 2/43 paediatric HA patients, only among those treated with rFVIII. The risk of inhibitor detection significantly increased among HA children treated by continuous infusion (P = 0.025). Our experience shows that the risk of inhibitor formation may be increased by early exposure to recombinant concentrates. The multiple variables affecting inhibitor incidence deserve further attention by larger prospective studies.


Asunto(s)
Autoanticuerpos/sangre , Inhibidores de Factor de Coagulación Sanguínea/metabolismo , Factor VIII/efectos adversos , Hemofilia A/tratamiento farmacológico , Hemofilia A/inmunología , Proteínas Recombinantes/efectos adversos , Adolescente , Niño , Preescolar , Estudios de Cohortes , Factor VIII/uso terapéutico , Femenino , Humanos , Lactante , Israel , Masculino , Proteínas Recombinantes/uso terapéutico
15.
Klin Padiatr ; 222(3): 154-7, 2010 May.
Artículo en Inglés | MEDLINE | ID: mdl-20514619

RESUMEN

OBJECTIVE: In a recent pilot study, platelet function of 4 neonates born to mothers with pregnancy-induced hypertension (PIH) was found to display lower platelet adhesion compared to healthy neonates. The present study aimed at confirming and validating these findings. STUDY DESIGN: Platelet adhesion was measured using a Cone Platelet Analyzer (CPA). The platelet function in the cord blood of 35 term infants born to mothers with PIH or gestational diabetes (GD) was compared with the platelet function of 196 infants born to healthy mothers. All neonates were monitored for perinatal complications until hospital discharge. RESULTS: Neonates born to mothers with PIH and with GD displayed poorer platelet function, with decreased platelet surface coverage as tested by CPA (control group 8.53+/-3.81%; PIH: 5.9+/-3.91%, p=0.003; GD: 6.64+/-3.64%, p=0.005). No association was found between CPA values and post-natal complications. CONCLUSIONS: Maternal PIH or GD is associated with impaired platelet function in neonates. The clinical impact of these findings is yet to be studied.


Asunto(s)
Diabetes Gestacional/sangre , Hipertensión Inducida en el Embarazo/sangre , Adhesividad Plaquetaria/fisiología , Peso al Nacer , Femenino , Sangre Fetal/citología , Humanos , Recién Nacido , Masculino , Proyectos Piloto , Pruebas de Función Plaquetaria , Embarazo , Valores de Referencia
16.
Zentralbl Chir ; 135(2): 143-8, 2010 Apr.
Artículo en Alemán | MEDLINE | ID: mdl-20379945

RESUMEN

BACKGROUND: The Surgical Department of the University Hospital Grosshadern has been making a systematic record of complications since 2005. With respect to the ongoing problem of under-financing from DRG reimbursements, an analysis of the relationship between surgical cases with severe complications and insufficient reimbursement warranted a detailed analysis. MATERIAL AND METHODS: Out of 16 762 in-house patients during 2005-2007 we assigned 6707 cases into four divisions - hepato-pancreato-biliary, colorectal, minimal invasive and general abdominal surgery as well as 1469 cases of thoracic surgery, for costs and reimbursement. In all groups patients with mandatory treament of complications were compared to the remaining cases without complications. Within these, further subgroups were analysed: patients with a need for artificial ventilation (partition A of the G-DRG system), cases with excessive loss (underfunding above 10 000 Euro) and their intersections. RESULTS: With the exception of minimal invasive surgery, each division featured 10-15 % of serious complications. Losses for these cases ranged from 159 % (thoracic surgery) to 102 % (other abdominal surgery) of the overall loss in each division. Cases with excessive losses, representing 1.5 % of all patients, caused 80 % to 100 % of this deficit. Complicated cases alloted to DRGs for artificial ventilation still represented 50 % of the under-fund-ing. CONCLUSION: Cases with mandatory complication treatment can be discerned as separate economic entities. They are considerably overlapping cases with excessive underfunding, so further analysis might lead to an improved reimbursement policy. In addition, the connection between quality management and economic efficiency is highlighted.


Asunto(s)
Grupos Diagnósticos Relacionados/economía , Procedimientos Quirúrgicos del Sistema Digestivo/economía , Programas Nacionales de Salud/economía , Complicaciones Posoperatorias/economía , Procedimientos Quirúrgicos Torácicos/economía , Costos y Análisis de Costo , Tabla de Aranceles , Alemania , Costos de Hospital/estadística & datos numéricos , Humanos , Clasificación Internacional de Enfermedades/economía , Mecanismo de Reembolso/economía , Respiración Artificial/economía , Servicio de Cirugía en Hospital/economía , Atención no Remunerada/economía
17.
Thromb Haemost ; 103(2): 344-50, 2010 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-20076842

RESUMEN

Evaluation of clot formation in neonates is troublesome. Our aim was to investigate cord blood clot formation of pre-term versus full-term infants and adults, using rotating thromboelastogram (ROTEM), Pentafarm, Munich, Germany). ROTEM was investigated in cord blood of 184 full-term and 47 pre-term infants. Measurements of the clotting time (CT), clot formation time (CFT) and maximal clot firmness (MCF) were obtained in order to asses reference values for this age group, and compare between full-term and pre-term neonates and compared to adult controls. For each infant demographic information and data regarding pregnancy and delivery were gathered. Infants were prospectively followed until discharge. CT and CFT were significantly shorter among pre-term and term infants as compared to adults [median CT: 185, 194, 293 seconds respectively, p pound0.001, CFT: 80, 76, 103 seconds respectively, p pound0.001). MCF was lower in pre-term and term as compared to adults (p pound0.001) with significantly lower values in pre-term as compared to full-term neonates (p=0.004). Clotting time and MCF correlated with gestational age (R=0.132, p=0.045, R= 0.259, p<0.001, respectively). No association was found between any ROTEM values and the occurrence of post-natal complications in infants of our study group. This is the first study assessing clot formation by ROTEM in pre-term infants. Clot formation parameters of term and premature infants correlated with gestational age. The predictive value of clot formation tests in neonates deserves further attention.


Asunto(s)
Coagulación Sanguínea , Edad Gestacional , Tromboelastografía/normas , Adulto , Sangre Fetal/fisiología , Humanos , Recién Nacido , Recien Nacido Prematuro , Valor Predictivo de las Pruebas , Valores de Referencia
18.
Int J Pharm ; 385(1-2): 181-6, 2010 Jan 29.
Artículo en Inglés | MEDLINE | ID: mdl-19854253

RESUMEN

Therapeutic peptides are highly potent and specific in their functions, but difficulties in their administration require parallel development of viable delivery systems to improve their bioavailability. In this study the potential of a novel lipid-based colloidal delivery system for improving the absorption of nasally and intestinally administered salmon calcitonin (sCT) was investigated. Two types of delivery vehicles based on Pheroid technology was prepared and characterized. Liposome-like bilayer vesicles had a mean diameter of 1.0 microm and microsponges were 1.6 microm. Doses of 10 IU/kg and 500 IU/kg bodyweight sCT were administered intranasally and intestinally to rats, respectively. The obtained absorption enhancement with Pheroid vesicles and Pheroid microsponges were also compared with the absorption enhancement obtained with N-trimethyl chitosan chloride (TMC). With the inclusion of 0.5% (w/v) TMC the maximum plasma concentration (C(max)) of sCT increased from 72.6+/-6.1 pg/ml to 478.5+/-6.1 pg/ml after nasal administration. Pheroid vesicles and Pheroid microsponges increased the C(max) values of sCT to 262.64+/-17.1 pg/ml and 202.66+/-28.6 pg/ml, respectively. The time to reach the maximum concentration (T(max)) was also significantly decreased from 35 min to approximately 14 min. Intestinal administration of Pheroid formulations increased the C(max) of sCT from 249.1+/-21.5 pg/ml to 386.2+/-45.5 and 432.1+/-18.9 pg/ml, respectively for Pheroid vesicles and Pheroid microsponges. TMC increased the C(max) of sCT to 738.9+/-277.1 pg/ml. TMC and Pheroid technology could offer the potential to significantly improve intranasal and intestinal absorption of sCT and reduce the variability in absorption.


Asunto(s)
Calcitonina/administración & dosificación , Quitosano/química , Portadores de Fármacos , Ácidos Grasos/química , Absorción Intestinal , Yeyuno/metabolismo , Administración Intranasal , Administración Oral , Animales , Calcitonina/sangre , Calcitonina/química , Calcitonina/farmacocinética , Química Farmacéutica , Coloides , Formas de Dosificación , Liposomas , Masculino , Tamaño de la Partícula , Ratas , Ratas Sprague-Dawley , Tecnología Farmacéutica/métodos
19.
Neuropediatrics ; 38(5): 219-27, 2007 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-18330835

RESUMEN

BACKGROUND: In infants with hypoxic-ischaemic encephalopathy (HIE), prediction of the prognosis is based on clinical, neuro-imaging and neurophysiological parameters. METHODS: EEG, cranial ultrasound, MRI and follow-up findings of 23 infants (GA 35-42 weeks) with HIE were studied retrospectively to assess 1) the contribution of ultrasound, MRI and EEG in predicting outcome, 2) the accuracy of ultrasound as compared to MRI, and 3) whether patterns of brain damage and EEG findings are associated. RESULTS: An abnormal EEG background pattern was highly predictive of adverse outcome [positive predictive value (PPV) 0.88]. If combined with diffuse white and deep and/or cortical grey matter changes on ultrasound or MRI, the PPV increased to 1.00. Abnormal neuro-imaging findings were also highly predictive of adverse outcome. Abnormal signal intensity in the posterior limb of the internal capsule, and diffuse cortical grey matter damage were associated with adverse outcome. MRI showed deep grey matter changes more frequently than ultrasound. Severely abnormal neuro-imaging findings were always associated with abnormal EEG background pattern. CONCLUSIONS: Both early EEG and neuro-imaging findings are predictive of outcome in infants with HIE. The predictive value of EEG is strengthened by neuro-imaging.


Asunto(s)
Asfixia Neonatal/diagnóstico , Ecoencefalografía , Electroencefalografía , Hipoxia Encefálica/diagnóstico , Imagen por Resonancia Magnética , Examen Neurológico , Peso al Nacer , Encéfalo/patología , Parálisis Cerebral/diagnóstico , Femenino , Estudios de Seguimiento , Edad Gestacional , Humanos , Recién Nacido , Masculino , Embarazo , Pronóstico , Estudios Retrospectivos
20.
Radiologe ; 46(4): 309-16, 2006 Apr.
Artículo en Alemán | MEDLINE | ID: mdl-16550355

RESUMEN

BACKGROUND: Morphologic and dynamic assessment of respiratory chest kinetics was performed in patients with pectus excavatum deformity (PE) using dynamic MRI: cine MRI. MATERIAL AND METHODS: Seven consecutive patients with PE (aged 20.3 years+/-4.0) and ten healthy volunteers of comparable age underwent real-time cine MRI of the chest during breathing on a 1.5 T MR scanner (Magnetom Sonata, Siemens Medical Systems, Erlangen, Germany) using a standard phased array body coil and a half-Fourier single-shot turbo spin echo sequence (HASTE) for dynamic imaging. During deep inspiration and expiration, single-shot sequences were performed in one slice level over 20 s at a frequency of 1 image/s covering the entire thoracic cage in three orientations. Morphology and chest kinetics in patients with PE were analyzed and compared with normal values, and typical patterns of chest kinetics were noted. RESULTS: Three different types of chest morphology in PE were identified: (1) the generally flattened thoracic cage, (2) the "tilted" sternum, and (3) the focally deepened sternum. Three patterns of motion correspond to these morphological types: (1) elevation of the sternum and the anterior thoracic wall, (2) angulated elevation of the parasternal rib cage with persistent deepening of the sternum resembling a "wing beat" movement, and (3) increased diaphragmatic movements with limited chest wall dynamics. CONCLUSIONS: Cine MRI is an adequate radiation-free diagnostic modality for the dynamic imaging of both chest morphology and chest wall kinetics in patients with PE. The pectus severity index can easily be determined and three typical movement patterns of chest wall kinetics identified.


Asunto(s)
Tórax en Embudo/patología , Tórax en Embudo/fisiopatología , Interpretación de Imagen Asistida por Computador/métodos , Imagen por Resonancia Cinemagnética/métodos , Imagen por Resonancia Magnética/métodos , Tórax/patología , Tórax/fisiopatología , Adolescente , Adulto , Femenino , Humanos , Masculino , Reproducibilidad de los Resultados , Sensibilidad y Especificidad
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