Pharmacological Treatment
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Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Tim Hundscheid ◽  
Rogier Donders ◽  
Wes Onland ◽  
Elisabeth M. W. Kooi ◽  
Daniel C. Vijlbrief ◽  

Abstract Background Controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Although both pharmacological and/or surgical treatment are effective in PDA closure, this has not resulted in an improved neonatal outcome. In most preterm infants, a PDA will eventually close spontaneously, hence PDA treatment potentially increases the risk of iatrogenic adverse effects. Therefore, expectant management is gaining interest, even in the absence of convincing evidence to support this strategy. Methods/design The BeNeDuctus trial is a multicentre, randomised, non-inferiority trial assessing early pharmacological treatment (24–72 h postnatal age) with ibuprofen versus expectant management of PDA in preterm infants in Europe. Preterm infants with a gestational age of less than 28 weeks and an echocardiographic-confirmed PDA with a transductal diameter of > 1.5 mm are randomly allocated to early pharmacological treatment with ibuprofen or expectant management after parental informed consent. The primary outcome measure is the composite outcome of mortality, and/or necrotizing enterocolitis Bell stage ≥ IIa, and/or bronchopulmonary dysplasia, all established at a postmenstrual age of 36 weeks. Secondary short-term outcomes are comorbidity and adverse events assessed during hospitalization and long-term neurodevelopmental outcome assessed at a corrected age of 2 years. This statistical analysis plan focusses on the short-term outcome and is written and submitted without knowledge of the data. Trial registration NTR5479. Registered on October 19, 2015, with the Dutch Trial Registry, sponsored by the United States National Library of Medicine NCT02884219 (registered May 2016) and the European Clinical Trials Database EudraCT 2017-001376-28.

2021 ◽  
Virgilio Galvis ◽  
Alejandro Tello ◽  
Jaime Larrea ◽  
Carlos J. Rodríguez ◽  
Sergio E. Serrano ◽  

Abstract Purpose To describe the results of topical atropine 1% weekly combined with a fixed combination of ocular hypotensives (dorzolamide + timolol), versus ocular hypotensives alone, in children and adolescents. Methods A retrospective review of medical records of myopic children and adolescents from September 2003 to June of 2019. The unit of analysis of the data was the change in the magnitude of myopia in a given eye between two consecutive visits (CMCV) and were divided in three groups: “non-adherent”, “hypotensive” and “atropine”, and classified according to the magnitude of myopia progression. Results There were statistically significant differences in the percentages of the CMVC analysis units included in the “completely controlled myopia” classification (higher for the “Atropine” group) and in the “moderate progression” and “severe progression” classifications (lower for the “Atropine” group). Mean progression rate of the CMCV analysis units included in the “atropine” group was significantly lower (-0.13 ± 0.41 Diopters/year) than in the “hypotensives” group (-0.41 ± 0.54 Diopters/year), and in the “non-adherent” group (-0.59 ± 0.57 Diopters/year). Conclusions In a group of myopic children and adolescents in Colombia during the periods of time in which they received 1% atropine, one drop weekly, in combination with dorzolamide + timolol, every 12 hours, showed better control of the progression of myopia, than in the time periods in which they received only ocular hypotensives or were not adherent to pharmacological treatment. Further research is warranted.

Hepatology ◽  
2021 ◽  
Nobuharu Tamaki ◽  
Kento imajo ◽  
Suzanne Sharpton ◽  
Jinho Jung ◽  
Nobuyoshi Kawamura ◽  

James Larkin ◽  
Ivana Pericin ◽  
Brian Osborne ◽  
Philip Dodd ◽  
Claire Collins

Abstract Background General practitioners are the gatekeepers of Irish healthcare and they offer continuity of care to patients. Irish general practice is therefore considered appropriate for preventing, diagnosing and managing most mental health problems. Aims This study sought to establish the coding frequency, consultation frequency, patient characteristics and pharmacological treatment of patients with severe mental disorders (SMDs) in Irish general practice. Methods A cross-sectional design was used. A finder tool embedded in the practice software assisted general practitioners (GPs) coding adult patients with SMDs. Eleven practices uploaded anonymous data on 2,203 patients. Variables analysed included disease code, consultations, prescriptions, sex, patient status and age. Results Overall, 2.9% (n = 2,337) of patients had ever been coded with a SMD, 2.4% (n = 1,964) coded with depressive disorder ever and 0.26% (n = 209) and 0.3% (n = 233) with bipolar disorder and schizophrenia, respectively. Overall, 68.0% (n = 1,336) of patients with depressive disorder were female, and 74.0% (n = 171) of patients with schizophrenia were public patients. The median consultation rate in the previous 3 years was highest for schizophrenia patients at 24.5 visits. Conclusions Coding of SMDs in Irish general practice appears incomplete. Patients with SMDs have high consultation rates. Patients with depressive disorder are more likely to be female and public patients. This research suggests that the improvement of coding in Irish general practice is the first practical step required to detecting prevalence rates.

Carrie A.M. Wegh ◽  
Desiree F. Baaleman ◽  
Merit M. Tabbers ◽  
Hauke Smidt ◽  
Marc A. Benninga

2021 ◽  
Monika Dmitrzak-Weglarz ◽  
Aleksandra Szczepankiewicz ◽  
Janusz Rybakowski ◽  
Paweł Kapelski ◽  
Karolina Bilska ◽  

Abstract Introduction This study aimed to find the expression biomarkers of pharmacological treatment response in a naturalistic hospital setting. Through gene expression profiling, we were able to find differentially-expressed genes (DEGs) in unipolar (UD) and bipolar (BD) depressed women. Methods We performed gene expression profiling in hospitalized women with unipolar (n=24) and bipolar depression (n=32) who achieved clinical improvement after pharmacological treatment (without any restriction). To identify DEGs in peripheral blood mononuclear cells (PBMCs), we used the SurePrint G3 Microarray and GeneSpring software. Results After pharmacological treatment, UD and BD varied in the number of regulated genes and ontological pathways. Also, the pathways of neurogenesis and synaptic transmission were significantly up-regulated. Our research focused on DEGs with a minimum fold change (FC) of more than 2. For both types of depression, 2 up-regulated genes, OPRM1 and CELF4 (p=0.013), were significantly associated with treatment response (defined as a 50% reduction on the Hamilton Depression Rating Scale [HDRS]). We also uncovered the SHANK3 (p=0.001) gene that is unique for UD and found that the RASGRF1 (p=0.010) gene may be a potential specific biomarker of treatment response for BD. Conclusion Based on transcriptomic profiling, we identified potential expression biomarkers of treatment outcomes for UD and BD. We also proved that the Ras-GEF pathway associated with long-term memory, female stress response, and treatment response modulation in animal studies impacts treatment efficacy in patients with BD. Further studies focused on the outlined genes may help provide predictive markers of treatment outcomes in UD and BD.

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