RESUMEN
Paricalcitol is approved for prevention and therapy of secondary hyperparathyroidism (sHPT) in patients with chronic kidney disease (CKD), with only short-term data in clinical routine settings. A 12-month observational study was conducted in Germany and Austria (90 centers, 761 patients) from 2008 to 2013. Laboratory values, demographical, and clinical data were documented in 629 dialysis patients and 119 predialysis patients. In predialysis patients, median intact parathormone (iPTH) was 180.0 pg/mL (n = 105) at the start of the study, 115.7 pg/mL (n = 105) at last documentation, and 151.8 pg/mL (n = 50) at month 12, with 32.4% of the last documented iPTH values in the KDOQI (Kidney Disease Outcomes Quality Initiative) target range. In dialysis patients, median iPTH was 425.5 pg/mL (n = 569) at study start, 262.3 pg/mL (n = 569) at last documentation, and 266.1 pg/mL (n = 318) at month 12, with 36.5% of dialysis patients in the KDOQI target range. Intravenous paricalcitol showed more homogenous iPTH control than oral treatment. Combined analysis of all dialysis patients indicated comparable and stable mean serum calcium and phosphate levels throughout the study. Clinical symptoms, such as itching, bone pain, and fatigue, were improved compared with study entry. The spectrum and frequency of adverse events mirrored the known pattern for patients on dialysis. Paricalcitol is efficacious and has a consistent safety profile in sHPT over 12 months.
Asunto(s)
Ergocalciferoles/uso terapéutico , Insuficiencia Renal Crónica/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Austria , Biomarcadores , Conservadores de la Densidad Ósea/uso terapéutico , Calcio/sangre , Femenino , Alemania , Humanos , Hiperparatiroidismo Secundario/tratamiento farmacológico , Hiperparatiroidismo Secundario/etiología , Fallo Renal Crónico/complicaciones , Fallo Renal Crónico/diagnóstico , Fallo Renal Crónico/tratamiento farmacológico , Pruebas de Función Renal , Masculino , Persona de Mediana Edad , Fósforo/sangre , Diálisis Renal/efectos adversos , Diálisis Renal/métodos , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/etiología , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Safety and efficacy of paricalcitol in hemodialysis patients with secondary hyperparathyroidism (sHPT) was investigated under routine clinical practice in German and Austrian dialysis centers. METHODS: Hemodialysis patients with sHPT initiating intravenous paricalcitol were enrolled in this noninterventional study regardless of concomitant sHPT treatment. Prior active vitamin D therapy was discontinued. Clinical laboratory values, including intact parathyroid hormone (iPTH), total serum calcium (Ca), phosphorus (P), Ca × P product, and alkaline phosphatase (AP), were recorded for 6 months following initiation of paricalcitol treatment. RESULTS: 1,313 patients (Austria, n = 280; Germany, n = 1,033) from 169 dialysis centers were enrolled. Most patients (n = 932; 79.1%) had received dialysis for ≥1 year. Median iPTH fell from 518.9 pg/ml [55.0 pmol/l] at baseline to 264.0 pg/ml [28.0 pmol/l] after 6 months (p < 0.0001). After 6 months of treatment, ≥30 and ≥60% reductions in iPTH were observed in 63.0 and 35.9% of patients, respectively. At 6 months, 27.2% of patients achieved iPTH levels between 150 and <300 pg/ml [15.9 and <31.8 pmol/l] compared with 9.7% at baseline. Ca, P, and Ca × P levels remained stable in the majority of patients. AP levels declined from a median of 98 U/l at baseline to 83 U/l (p < 0.0001) at 6 months. Monitoring of adverse events and clinical laboratory assessments identified no unexpected safety signals for paricalcitol. CONCLUSIONS: Paricalcitol is an effective and well-tolerated treatment option for the control of iPTH levels in hemodialysis patients with sHPT. The results of this study support the results of previous trials under real-time clinical practice conditions in Austria and Germany.
Asunto(s)
Conservadores de la Densidad Ósea/uso terapéutico , Ergocalciferoles/uso terapéutico , Hiperparatiroidismo Secundario/tratamiento farmacológico , Anciano , Fosfatasa Alcalina/sangre , Austria , Conservadores de la Densidad Ósea/efectos adversos , Calcimiméticos/uso terapéutico , Calcio/sangre , Cinacalcet , Ergocalciferoles/efectos adversos , Femenino , Alemania , Humanos , Hiperparatiroidismo Secundario/sangre , Hiperparatiroidismo Secundario/etiología , Masculino , Persona de Mediana Edad , Naftalenos/uso terapéutico , Hormona Paratiroidea/sangre , Fósforo/sangre , Estudios Prospectivos , Diálisis Renal , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/terapiaRESUMEN
According to the Multiple Arousal Theory, electrodermal activity (EDA) is not uniform across the body. However, the psychological meaning of a left or right-sided EDA dominance is still not clear. We explored EDA lateral asymmetry as a psychophysiological marker of optimistic and pessimistic attributional style regarding success and failure in a darts competition. Bilateral EDA pattern of 230 throws of a competing pair was measured by Obimon EDA including accelerometer measurements of movements. First, we confirmed that lateral asymmetry can be measured reliably based on EDA data from both wrists. Second, we assessed attributional styles related to lateral asymmetry based on 80 individual throws. We recorded participants' expectations regarding their upcoming performance, and their attribution of success and failure based on Seligman's definition as optimist (internal cause attributed to success, or external cause ascribed to failure) or pessimist. The ratio of optimist and pessimist attributions was significantly different for throws with right or left-sided EDA dominance (p = 0.001). Optimistic attribution characterized 84% of right dominant, while pessimist 63% of left-dominant EDA during throws. We replicated these findings on 50 throws from 10 more individuals (p = 0.034). All individuals were right-handed. We conclude that wrist EDA can be reliably measured during physical movements, such as in a darts game. Lateral EDA asymmetry is a consistent psychophysiological marker of the attitude toward success and failure in a competitive setting, suggesting that lateral asymmetry of emotional arousal may serve as a novel psychophysiological biomarker for attribution style. Results underlie the psychophysiological relevance of bilateral arousal assessment and provide evidence-based verification for the Multiple Arousal Theory.
RESUMEN
Interpersonal distance regulation is an essential element of social communication. Its impairment in autism spectrum disorder (ASD) is widely acknowledged among practitioners, but only a handful of studies reported empirical research in real-life settings, focusing mainly on children. Interpersonal distance in adults with ASD and related autonomic functions received less attention. Here, we measured interpersonal distance along with heart rate variability (HRV) in adults with ASD, and tested the modulatory effects of eye-contact and attribution. Twenty-two adults diagnosed with ASD and 21 matched neurotypical controls participated in our study from October 2019 to February 2020. Our experimental design combined the modified version of the stop distance paradigm with HRV measurement controlling for eye contact between the experimenter and the participant to measure interpersonal distance. Still, we did not detect significant modulatory effect of eye contact and attribution. Our results showed a greater preferred distance in ASD. Moreover, we found lower baseline HRV and reduced HRV reactivity in ASD; however, these autonomic measurements could not predict preferred interpersonal distance. Our study highlights the importance of interpersonal space regulation in ASD: it might be considered that people with ASD need individually variable, presumably greater interpersonal distance. In addition, regardless of the distance they may have reduced autonomic regulatory capacity in social situations. Our results could help shape future experiments with sophisticated designs to grasp the complexity and underlying factors of distance regulation in typical and atypical populations.
Asunto(s)
Trastorno del Espectro Autista , Adulto , Niño , Humanos , Frecuencia Cardíaca/fisiología , Atención , Comunicación , Comunicación no VerbalRESUMEN
Advances in mobile and wireless technology have expanded the scope of electrodermal research. Since traditional electrodermal measurement sites are not always suitable for laboratory research and are rarely appropriate for ambulatory measurements, there is a need to explore and contrast alternate measurement locations. We evaluated bilateral electrodermal activity (EDA) from five measurement sites (fingers, feet, wrists, shoulders, and calves). In a counterbalanced, randomized, within-subjects design study, participants (N = 115) engaged in a 4-min-long breathing exercise and were exposed to emotionally laden and neutral stimuli. High within-subject correlations were found between the EDA measured from fingers bilaterally (r = .89), between the left fingers and both feet (r = .72). Moderate correlations were found between EDA measured from the left fingers and wrists (r = .30 and r = .33), low correlations between the left fingers and the shoulders (r = -.03 and r = -.06) or calves (r = .05 and r = .14). Response latency was the shortest on the fingers while it was the longest on the lower body. Short response windows would miss some of the responses from the palmar surfaces and a substantial number from other evaluated locations. The fingers and the feet are the most reliable locations to measure from, followed by the wrists. We suggest setting site-specific response windows for different measurement locations. An investigation of repeatability showed that within-subject correlations, response frequencies, response amplitudes show a similar pattern from the first measurement time to a later one.
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Emociones/fisiología , Dedos/fisiología , Pie/fisiología , Respuesta Galvánica de la Piel/fisiología , Pierna/fisiología , Pruebas Neuropsicológicas , Hombro/fisiología , Muñeca/fisiología , Adolescente , Adulto , Femenino , Humanos , Masculino , Distribución Aleatoria , Adulto JovenRESUMEN
Electrodermal activity (EDA) provides the means to gauge the activity of the sympathetic nervous system. Assessment of EDA for research purposes requires measurement systems that are sensitive to small changes in arousal in the full measurement range, collecting, storing, and monitoring data. The objective behind designing a new open-source device was to be able to measure EDA simultaneously on many subjects, monitoring their activity in real time remotely and collecting high precision data suitable for analyses. To assure feasibility of simultaneous measurements on multiple subjects, the devices must be compact and wearable, without compromising data quality. Experiments were carried out using synchronized devices in group and single subject environments. Validity of EDA measurements of Obimon was demonstrated compared to a reference system (Nexus) during a breathing exercise, a short movie, and while exposed to loud computer-generated tones, using Pearson correlation, Passing-Bablok regression, and Bland-Altman analysis. Seamless management of several Obimons and real-time visualization of EDA via Android phone/tablet application from a large number of participants was demonstrated. Based on analyses of the data collected, we conclude that the Obimon device presented here is a valid and feasible tool for collecting EDA in single or multisubject environments.