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1.
Article in English | MEDLINE | ID: mdl-38901607

ABSTRACT

Trochleitis is clinically and/or radiologically evidenced inflammation of the trochlea or orbital pulley. Clinically it is characterized by pain and hypersensitivity in the superomedial orbital angle, which is increased or triggered by direct palpation of the area and/or eye movements. During the REM (rapid eye movements) phase of sleep, patients with trochleitis suffer from nocturnal micro-awakenings that impede their rest, and pain is often associated with visual symptoms (diplopia or Brown's syndrome). The lack of common guidelines for diagnosis and treatment of this disease, its low prevalence and the lack of knowledge of the different entities associated with trochlear pain, leads to underdiagnosis or misdiagnosis. It is essential to know the characteristics of this pathology and to diagnose it correctly, differentiating it from other trochlear pain entities, in order to be able to carry out an adequate therapeutic and prognostic approach. The lack of consensus on the therapeutic protocol means that various treatments are used, in different order and often with a combination of several without a firm scientific basis. This comprehensive review of previous studies concludes that nonsteroidal anti-inflammatory drugs (NSAIDs) achieve an overall complete cure rate of 77%, although this rate decreases to 30% in case of motility restriction or diplopia. Intratrochlear corticosteroid injection achieves an overall complete cure rate of 86%, even in the worst prognosis trochleitis, being the only effective option in NSAID-refractory trochleitis and currently being questioned as the first treatment option.

2.
Gac Sanit ; 37: 102272, 2023.
Article in Spanish | MEDLINE | ID: mdl-36542890

ABSTRACT

OBJECTIVE: To describe the impact of diagnosis delay in rare diseases and analyze psychosocial needs related to this delay in patients. METHOD: The qualitative approach has been used by conducting online group interviews with patients and family members in the Valencian Region (Spain) and a content analysis has been carried out. Two categories were differentiated: with diagnostic delay of 1 year or more and without diagnostic delay. Five interviews were conducted with a total of 25 participants. RESULTS: The content analysis showed unequal aspects vs. common aspects, in persons with or without diagnostic delay. People with delay expressed the need to feel supported in order to live with continuous uncertainty. People without delay verbalized the importance of adequate communication between patients and professionals. The problems by the COVID-19 were common in both groups; the participants expressed that they did not feel unattended in their disease by the health services. CONCLUSIONS: High resilience and coping capacity has been identified in people with rare disease, regardless of whether they have suffered diagnostic delay or not. The professional psychosocial support during the diagnostic process of these rare diseases is essential.


Subject(s)
COVID-19 , Delayed Diagnosis , Humans , Rare Diseases/diagnosis , COVID-19/diagnosis , Adaptation, Psychological , Fear , Qualitative Research , COVID-19 Testing
3.
Gac. sanit. (Barc., Ed. impr.) ; 37: 102272, 2023. tab
Article in Spanish | IBECS | ID: ibc-217767

ABSTRACT

Objetivo: Describir el impacto de la demora diagnóstica de enfermedades raras y analizar las necesidades psicosociales de las personas afectadas en relación con dicha demora. Método: Se ha empleado el enfoque cualitativo mediante la realización de entrevistas grupales online a pacientes y familiares en la Comunitat Valenciana (España) y se ha efectuado un análisis de contenido. Se diferenciaron dos categorías: con demora diagnóstica de 1 año o más y sin demora diagnóstica. Se realizaron cinco entrevistas en las que participaron un total de 25 personas. Resultados: El análisis mostró aspectos desiguales frente a aspectos comunes, en personas con o sin demora diagnóstica. Las personas con demora manifestaron la necesidad de sentirse «sostenidas» para convivir con una incertidumbre continua. Las personas sin demora verbalizaron la importancia de una adecuada comunicación entre pacientes y profesionales. Los problemas surgidos por la COVID-19 fueron comunes en ambos grupos, y las personas participantes expresaron no sentirse desatendidas en su enfermedad por los servicios sanitarios durante la pandemia. Conclusiones: Se ha observado una gran capacidad de resiliencia y afrontamiento en las personas con enfermedades raras, independientemente de si han sufrido demora diagnóstica o no. El apoyo psicosocial profesionalizado durante el proceso de diagnóstico de estas enfermedades minoritarias es esencial. (AU)


Objective: To describe the impact of diagnosis delay in rare diseases and analyze psychosocial needs related to this delay in patients. Method: The qualitative approach has been used by conducting online group interviews with patients and family members in the Valencian Region (Spain) and a content analysis has been carried out. Two categories were differentiated: with diagnostic delay of 1 year or more and without diagnostic delay. Five interviews were conducted with a total of 25 participants. Results: The content analysis showed unequal aspects vs. common aspects, in persons with or without diagnostic delay. People with delay expressed the need to feel supported in order to live with continuous uncertainty. People without delay verbalized the importance of adequate communication between patients and professionals. The problems by the COVID-19 were common in both groups; the participants expressed that they did not feel unattended in their disease by the health services. Conclusions: High resilience and coping capacity has been identified in people with rare disease, regardless of whether they have suffered diagnostic delay or not. The professional psychosocial support during the diagnostic process of these rare diseases is essential. (AU)


Subject(s)
Humans , Pandemics , Coronavirus Infections/epidemiology , Coronavirus Infections/diagnosis , Delayed Diagnosis , Spain , Rare Diseases/diagnosis , Qualitative Research , Adaptation, Psychological , Fear
4.
Dalton Trans ; 50(9): 3315-3323, 2021 Mar 09.
Article in English | MEDLINE | ID: mdl-33595035

ABSTRACT

Solar perovskites have received phenomenal attention and success over the past decade, due to their high power conversion efficiencies (PCE), ease of fabrication and low cost which has enabled the prospect of them being a real commercial contender to the traditional silicon technology. In one of the several developments on the archetypal MAPbI3 perovskite absorber layer, FAPbI3 was found to obtain a higher PCE, likely due to its more optimum band gap, with doping strategies focusing on the inclusion of MA+/Cs+ cations to avoid the unfavourable phase transformation to a photoinactive phase. To better understand the phase change from the photoactive cubic (Pm3[combining macron]m) black (α) phase to the unwanted photoinactive (P63/mmc) yellow (δ) phase, we make use of variable temperature Raman spectroscopy to probe the molecular species and its relationship to the inorganic framework. We show for the first time there to be no Raman active modes for the α phase up to 4000 cm-1, which can be correlated to the Pm3[combining macron]m cubic symmetry of that phase. Our detailed studies suggest that previous reports of the observation of Raman peaks for this phase are likely associated with degradation reactions from the localised laser exposure and the formation of Raman active lead oxide. In addition, we have identified water as a contributing factor to the transformation, and observed a corresponding signal in the Raman spectra, although confirmation of its exact role still remains inconclusive.

5.
Rev. cir. (Impr.) ; 73(1): 50-58, feb. 2021. tab
Article in Spanish | LILACS | ID: biblio-1388788

ABSTRACT

Resumen Introducción: El síndrome compartimental del miembro inferior tiene el potencial de causar morbilidad devastadora en los pacientes y altos riesgos médico-legales para los médicos involucrados en su tratamiento. Una vez instaurado, la fasciotomía se constituye como el único tratamiento efectivo. La pérdida de la extremidad afectada es su complicación con mayor carga de enfermedad. Existen pocas descripciones sobre factores de riesgo para la necesidad de amputación de miembro inferior luego de haber sido sometido a fasciotomía en pacientes con lesiones traumáticas. Materiales y Método: Se realizó un estudio retrospectivo, observacional, analítico en el cual se recolectó información de pacientes con traumatismo de miembro inferior que requirieron fasciotomía de muslo o pierna durante un periodo de 10 años en busca de factores que pudieron influir en la pérdida de la extremidad. Resultados: 21 pacientes cumplían los criterios de inclusión de los cuales 6 (28,57%) fueron amputados y 2 fallecieron (9,52%). La mayoría de los individuos fueron menores de 30 años y casi la totalidad del sexo masculino. Encontramos que el porcentaje de amputación parece verse afectado de manera estadísticamente significativa por factores como un International Severity Score (ISS) elevado (media de 24), las parestesias al ingreso, la realización de fasciotomía tardía (> 6 h), la reactividad muscular al momento de la cirugía, la infección del sitio operatorio y la reintervención por trombosis del injerto vascular. Conclusiones: Existen factores de riesgo que pueden indicar la pérdida de la extremidad inferior luego de ser sometido a fasciotomía en el contexto de trauma. Un seguimiento prospectivo y un mayor número de pacientes podrían permitir dilucidar más de dichos factores.


Introduction: The lower limb compartment syndrome has the potential to cause devastating morbidity in patients and high legal medical risks for doctors involved in its treatment. Once established, fasciotomy is the only effective treatment. The loss of the affected limb is the complication with a greater burden of disease. There are few descriptions of risk factors for the need for lower limb amputation after having undergone fasciotomy in patients with traumatic injuries. Materials and Method: A retrospective, observational, analytical study was conducted in which information was collected from patients with lower limb trauma that required thigh or leg fasciotomy for a period of 10 years in search of factors that could influence limb loss. Results: 21 patients met the inclusion criteria of which 6 (28.57%) were amputated and 2 died (9.52%). The majority of the individuals were under 30 years old and almost all of the male sex. We found that the percentage of amputation seems to be affected statistically significantly by factors such as a high ISS (mean of 24), paresthesia at admission, performing late fasciotomy (> 6 h), muscle reactivity at the time of surgery, postoperative SSI and reintervention by vascular graft thrombosis. Conclusions: We found risk factors that may indicate the loss of the lower limb after being subjected to fasciotomy in the context of trauma. A prospective follow-up and a greater number of patients could make it possible to elucidate more of these factors.


Subject(s)
Humans , Male , Female , Adult , Lower Extremity/surgery , Fasciotomy/adverse effects , Fasciotomy/methods , Risk Factors , Compartment Syndromes/surgery , Compartment Syndromes/etiology
6.
Philos Trans A Math Phys Eng Sci ; 379(2192): 20200232, 2021 Mar 08.
Article in English | MEDLINE | ID: mdl-33455549

ABSTRACT

Combined effects of the damping and forcing in the underdamped time-delayed Duffing oscillator are considered in this paper. We analyse the generation of a certain damping-induced unpredictability due to the gradual suppression of interwell oscillations. We find the minimal amount of the forcing amplitude and the right forcing frequency to revert the effect of the dissipation, so that the interwell oscillations can be restored, for different time delay values. This is achieved by using the delay-induced resonance, in which the time delay replaces one of the two periodic forcings present in the vibrational resonance. A discussion in terms of the time delay of the critical values of the forcing for which the delay-induced resonance can tame the dissipation effect is finally carried out. This article is part of the theme issue 'Vibrational and stochastic resonance in driven nonlinear systems (part 1)'.

7.
Phys Rev E ; 101(6-1): 062212, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32688505

ABSTRACT

We use the Hénon-Heiles system as a paradigmatic model for chaotic scattering to study the Lorentz factor effects on its transient chaotic dynamics. In particular, we focus on how time dilation occurs within the scattering region by measuring the time with a clock attached to the particle. We observe that the several events of time dilation that the particle undergoes exhibit sensitivity to the initial conditions. However, the structure of the singularities appearing in the escape time function remains invariant under coordinate transformations. This occurs because the singularities are closely related to the chaotic saddle. We then demonstrate using a Cantor-like set approach that the fractal dimension of the escape time function is relativistic invariant. In order to verify this result, we compute by means of the uncertainty dimension algorithm the fractal dimensions of the escape time functions as measured with an inertial frame and a frame comoving with the particle. We conclude that, from a mathematical point of view, chaotic transient phenomena are equally predictable in any reference frame and that transient chaos is coordinate invariant.

8.
Comput Methods Programs Biomed ; 189: 105322, 2020 Jun.
Article in English | MEDLINE | ID: mdl-31954235

ABSTRACT

BACKGROUND AND OBJECTIVE: The aims of this study are (i) to assess the predictive reliability of the physiologically based software PhysPK versus the well-known population approach software NONMEM for the cited semi-mechanistic PK model, (ii) to determine whether these modelling approaches are interchangeable and (iii) to compare acausal with causal modelling approaches in the framework of semi-mechanistic PK models. METHODS: A semi-mechanistic model was proposed, which assumed oral administration of a solid dosage form with a peripheral compartment and two active metabolites. The model incorporates intestinal transit, dissolution limited by solubility, variable efflux transporter expression along the gut and linear and non-linear metabolism in the gut and liver. Four different approximations to the theoretical model were developed in order to validate both the new software and modelling methodology. RESULTS: Plasmatic concentrations correlation plots as well as relative errors in AUC0-48 and Cmax predictions revealed the accuracy of PhysPK in the prediction of these exposition parameters. Physiological and acausal object oriented version systematically under-estimated AUC0-48 and Cmax of the parent drug, whereas metabolites were over-estimated when taking the semi-mechanistic and extraction-based metabolism version as the reference. CONCLUSIONS: PhysPK has been properly validated, where differences are related to numerical precision of integrators and solvers. A systematic bias for the parent drug and active metabolites was predicted when a semi-mechanistic approach including extraction-based metabolism was compared to the physiologic and acausal approach, showing that interchangeability might be possible when intrinsic-clearance metabolism is implemented in the semi-mechanistic approach. The acausal and object-oriented methodology allows for defining the semi-mechanistic model through its local mechanisms and relationships among entities, without the need to build the final set of Ordinary Differential Equations.


Subject(s)
Models, Biological , Pharmacokinetics , Software/standards , Area Under Curve , Reproducibility of Results , Solubility
9.
Rev. colomb. gastroenterol ; 34(1): 10-16, ene.-mar. 2019. tab, graf
Article in Spanish | LILACS | ID: biblio-1003832

ABSTRACT

Resumen Objetivo: describir el comportamiento clínico y quirúrgico de los pacientes con pancreatitis aguda manejados en un centro hospitalario de cuarto nivel. Método: se realizó un estudio descriptivo retrospectivo analítico de los pacientes con diagnóstico de pancreatitis aguda que ingresaron al Hospital Universitario de Neiva en el período comprendido entre el 1 de enero del 2015 al 31 de julio del 2017. Resultados: se identificaron 138 pacientes que ingresaron con impresión diagnóstica de pancreatitis aguda, de los cuales se confirmó el diagnóstico en 130 pacientes y se excluyeron 21 pacientes por no cumplir con los criterios de inclusión. Según la clasificación de Atlanta 2012, 73 (67 %) pacientes cursaban con una pancreatitis leve, 17 (16 %) con pancreatitis moderadamente severa y 19 (17 %) con pancreatitis severa. La principal causa de pancreatitis encontrada fue la biliar. La prueba de chi cuadrado (χ2) mostró una significancia estadística para la edad como factor de riesgo para pancreatitis severa (p = 0,04). De la totalidad de pacientes, en 8 pacientes se documentó necrosis pancreática, de los cuales 5 fueron manejados quirúrgicamente, con un abordaje por laparotomía en 3 pacientes y 2 por laparoscopia, con una mortalidad del 37,5 % en los pacientes con necrosis pancreática manejados quirúrgicamente. De los 109 pacientes incluidos en el estudio, 100 pacientes (91,74 %) resolvieron su cuadro de pancreatitis y egresaron vivos de la institución, para una mortalidad reportada en 9 pacientes (8,25 %), quienes cursaron con pancreatitis aguda severa. Conclusión: el estudio presentado es de tipo descriptivo estableciendo las características demográficas y el curso de la enfermedad de los pacientes con pancreatitis aguda incluidos las complicaciones y el manejo de estas. Con este estudio no se pretende estandarizar causalidad ni manejo de la patología descrita, solo se describe la experiencia realizada en un hospital de cuarto nivel tratando de contribuir con el desarrollo de estudios de cohortes y ensayos clínicos que permitan establecer guías de manejo con el fin de mejorar los desenlaces de los pacientes con pancreatitis aguda.


Abstract Objective: Our objective was to describe the clinical and surgical behavior of patients with acute pancreatitis managed at a fourth level hospital center. Method: This is a descriptive, retrospective and analytical study of patients diagnosed with acute pancreatitis who entered the University Hospital of Neiva in the period from January 1, 2015 to July 31, 2017. Results: We identified 138 patients who had been admitted with a diagnosis of acute pancreatitis. Of these, the diagnosis was confirmed for 130 patients, but 21 patients were excluded because they did not meet the inclusion criteria. According to the 2012 Atlanta classification, 73 (67%) patients had mild pancreatitis, 17 (16%) had moderately severe pancreatitis, and 19 (17%) had severe pancreatitis. The main cause of pancreatitis was biliary. The chi-square test showed statistical significance for age as a risk factor for severe pancreatitis (p = 0.04). Pancreatic necrosis was documented in 8 patients, five of whom were managed surgically. This included three laparotomies and two laparoscopic operations. The mortality rate for patients with surgically managed pancreatic necrosis was 37.5%. Of the 109 patients included in the study, the resolved their pancreatitis of 100 patients (91.74%) was resolved and they left the institution alive. Nine patients (8.25%), all of whom had severe acute pancreatitis, died. Conclusion: This descriptive study established the demographic characteristics and clinical course of patients with acute pancreatitis including complications and management of complications. This study is not intended to standardize causality or management of acute pancreatitis, but rather only describes the experience of a fourth level hospital in order to contribute to the development of cohort studies and clinical trials that will allow establishment of management guidelines to improve the outcomes of patients with acute pancreatitis.


Subject(s)
Humans , Male , Female , Pancreatitis , Pancreatitis, Acute Necrotizing , Patients , Records , Classification
10.
Clin Exp Immunol ; 196(2): 226-236, 2019 05.
Article in English | MEDLINE | ID: mdl-30693467

ABSTRACT

Systemic lupus erythematosus (SLE) is a complex autoimmune disorder whose pathology involves multiple immune cell types, including B and T lymphocytes as well as myeloid cells. While it is clear that autoantibody-producing B cells, as well as CD4+ T cell help, are key contributors to disease, little is known regarding the role of innate lymphoid cells such as natural killer (NK) cells in the pathogenesis of SLE. We have characterized the phenotype of NK cells by multi-color flow cytometry in a large cohort of SLE patients. While the overall percentage of NK cells was similar or slightly decreased compared to healthy controls, a subset of patients displayed a high frequency of NK cells expressing the proliferation marker, Ki67, which was not found in healthy donors. Although expression of Ki67 on NK cells correlated with Ki67 on other immune cell subsets, the frequency of Ki67 on NK cells was considerably higher. Increased frequencies of Ki67+ NK cells correlated strongly with clinical severity and active nephritis and was also related to low NK cell numbers, but not overall leukopenia. Proteomic and functional data indicate that the cytokine interleukin-15 promotes the induction of Ki67 on NK cells. These results suggest a role for NK cells in regulating the immune-mediated pathology of SLE as well as reveal a possible target for therapeutic intervention.


Subject(s)
Interleukin-15/metabolism , Ki-67 Antigen/metabolism , Killer Cells, Natural/metabolism , Lupus Erythematosus, Systemic/metabolism , Nephritis/metabolism , Adolescent , Adult , Aged , CD56 Antigen/metabolism , Cells, Cultured , Female , Humans , Immunity, Innate/immunology , Killer Cells, Natural/immunology , Leukopenia/immunology , Leukopenia/metabolism , Lupus Erythematosus, Systemic/immunology , Male , Middle Aged , Nephritis/immunology , Proteomics/methods , Young Adult
11.
Rev. esp. salud pública ; 93: 0-0, 2019. tab
Article in Spanish | IBECS | ID: ibc-189549

ABSTRACT

OBJETIVO: La Enfermedad de Wilson (EW) es una patología rara congénita y hereditaria que se produce por acumulación de cobre en el organismo, degeneración crónica hepática, neurológica o lenticular. En ocasiones es incapacitante por lo que influye en la calidad de vida de afectados y familiares. El objetivo de este trabajo fue identificar las necesidades médicas, sociales y emocionales de pacientes y familiares. MÉTODOS: Con metodología cualitativa se realizaron en la Comunitat Valenciana (CV), en 2015-2016, 5 entrevistas a profesionales sanitarios y 2 grupos de discusión, uno con familiares y otro con afectados. Se elaboró un guión estructurado en: diagnóstico, tratamiento, atención sanitaria y calidad de vida. La información se recogió en audio/video, previa autorización y se transcribió literalmente. Se realizó un análisis del discurso (profesionales vs. familiares/afectados) determinando necesidades y demandas concretas. RESULTADOS: Los profesionales se mostraron emocionalmente distantes de las necesidades emocionales de afectados y familiares y consideraron necesario disponer de mayor información para facilitar el diagnóstico precoz. Las familias expresaron preocupación sobre la adherencia al tratamiento, especialmente en adolescentes, y confusión sobre la importancia de seguir una dieta baja en cobre. Los afectados reconocieron tener dudas sobre la funcionalidad de la medicación. Los afectados neurológicamente se sintieron estigmatizados por las secuelas físicas de la enfermedad. CONCLUSIONES: Los sanitarios consideran que tener un mayor conocimiento sobre esta enfermedad facilitaría una detección precoz. Familiares y afectados necesitan indicaciones claras y especificadas sobre las pautas de administración del tratamiento y sobre los alimentos que deben excluir de la dieta


OBJECTIVE: Wilson disease (WD) is a rare congenital disease that causes hepatic, neurological or lenticular degeneration due to the accumulation of copper. Sometimes it is incapacitating with implications in the quality of life of those affected and their families. The objective of this work was to identify the needs of medical staff and the social and emotional needs of patients with WD and their families. METHODS: A qualitative research was developed in the Valencian Region during 2015-2016, five interviews with medical staff and two focus groups were made, one with family members and another with patients using a script divided into: diagnosis, treatment, health care and quality of life. The information was collected in audio/video and transcribed. An analysis of discourse (professional vs family/affected) determining needs was made. RESULTS: Medical staff need more knowledge about this pathology. Better educational training for them would facilitate the diagnosis. Families and patients need more information about the guidelines for the treatment's administration and foods that should be excluded from the diet. The correct administration of the treatment will allow those affected to improve their quality of life with a total or partial recovery of their symptoms. CONCLUSIONS: Peru has made significant progress in reducing chronic malnutrition in children, but it still represents a health problem due to high prevalence in the sierra and expansion to jungles districts in 2016. Policies and programs should continue and enhance to avoid the high burden of disease that generates malnutrition in the development of children


Subject(s)
Humans , Male , Female , Child , Family Health , Hepatolenticular Degeneration/complications , Hepatolenticular Degeneration/psychology , Hepatolenticular Degeneration/therapy , Quality of Life , Family , Focus Groups , Medical Staff , Peru , Qualitative Research
12.
Eur J Clin Microbiol Infect Dis ; 37(8): 1475-1480, 2018 Aug.
Article in English | MEDLINE | ID: mdl-29756174

ABSTRACT

The aims of this study were to determine the correlation of mutations in the ftsI gene (coding for PBP3) of Haemophilus influenzae with aminopenicillin resistance and to evaluate the 2017 European Committee for Antibiotic Susceptibility Testing (EUCAST) guidelines for clinical categorization of ampicillin, amoxicillin, and amoxicillin-clavulanate for strains with mutated PBP3 conferring resistance (rPBP3). A panel of 91 H. influenzae isolates was genetically characterized by sequencing of the fstI gene. For all the studied isolates, a screening with benzylpenicillin 1U (BP1) was carried out and minimum inhibitory concentrations (MICs) of ampicillin, amoxicillin, and amoxicillin-clavulanate were tested and interpreted according to EUCAST recommendations. ftsI sequence analysis revealed a total of 14 different amino acid substitutions in PBP3. The substitution patterns most commonly observed were [D350N, M377I, A502V, N526K] among the bla-positive rPBP3 strains (37.5%) and [D350N, A502T, N526K] among the bla-negative rPBP3 strains (24.5%). Screening with BP1 was able to correctly categorize 100% of the bla-negative sPBP3 strains, 100% of the bla-positive strains, and 92% of the bla-negative rPBP3 ones. Only 29% of the bla-negative rPBP3 strains evaluated displayed ampicillin MICs above the current EUCAST resistant breakpoint defined at 1 µg/ml. The PBP3 substitution patterns of the strains evaluated are similar to the ones observed in previous Spanish and European studies. Although the screening with BP1 proved to be adequate in the detection of bla-negative rPBP3 strains, these cannot be reliably identified by current 2018 EUCAST breakpoints for ampicillin.


Subject(s)
Anti-Bacterial Agents/pharmacology , Genetic Variation , Haemophilus Infections/microbiology , Haemophilus influenzae/drug effects , Haemophilus influenzae/genetics , Penicillin-Binding Proteins/genetics , Phenotype , Amino Acid Substitution , Amoxicillin/pharmacology , Ampicillin/pharmacology , Drug Resistance, Bacterial , Haemophilus Infections/drug therapy , Haemophilus influenzae/isolation & purification , Humans , Microbial Sensitivity Tests , Mutation
13.
Eur J Pharm Sci ; 119: 200-207, 2018 Jul 01.
Article in English | MEDLINE | ID: mdl-29680456

ABSTRACT

Regulatory guidelines recommend that, when a level A IVIVC is established, dissolution specification should be established using averaged data and the maximum difference between AUC and Cmax between the reference and test formulations cannot be greater than 20%. However, averaging data assumes a loss of information and may reflect a bias in the results. The objective of the current work is to present a new approach to establish dissolution specifications using a new methodology (individual approach) instead of average data (classical approach). Different scenarios were established based on the relationship between in vitro-in vivo dissolution rate coefficient using a level A IVIVC of a controlled release formulation. Then, in order to compare this new approach with the classical one, six additional batches were simulated. For each batch, 1000 simulations of a dissolution assay were run. Cmax ratios between the reference formulation and each batch were calculated showing that the individual approach was more sensitive and able to detect differences between the reference and the batch formulation compared to the classical approach. Additionally, the new methodology displays wider dissolution specification limits than the classical approach, ensuring that any tablet from the new batch would generate in vivo profiles which its AUC or Cmax ratio will be out of the 0.8-1.25 range, taking into account the in vitro and in vivo variability of the new batches developed.


Subject(s)
Delayed-Action Preparations/chemistry , Drug Liberation , Models, Biological , Computer Simulation , Monte Carlo Method , Tablets , Therapeutic Equivalency
14.
Appl Radiat Isot ; 134: 470-476, 2018 Apr.
Article in English | MEDLINE | ID: mdl-28838724

ABSTRACT

A methodology including software tools for analysing NORM building materials and residues by low-level gamma-ray spectrometry has been developed. It comprises deconvolution of gamma-ray spectra using the software GALEA with focus on the natural radionuclides and Monte Carlo simulations for efficiency and true coincidence summing corrections. The methodology has been tested on a range of building materials and validated against reference materials.

15.
J Arthroplasty ; 32(10): 3126-3133.e1, 2017 10.
Article in English | MEDLINE | ID: mdl-28690040

ABSTRACT

BACKGROUND: The microorganisms that most frequently cause prosthetic joint infection are methicillin-resistant Staphylococcus aureus and gram-negative aerobic bacillus. Studies have documented the efficacy of mixing antibiotics with polymethyl methacrylate, but that of antifungal drugs has not received much attention. The objective of this in vitro study was to characterize the elution profile and bioactivity of ceftazidime and fluconazole when incorporated into bone cement in proportions intended for prophylaxis and treatment of bone infections. METHODS: Antibiotic-loaded bone cement cylinders in a proportion of 1:40 and 4:40 (ratio of grams of antibiotic to grams of cement) were assayed. Drug delivery was investigated in a flow-through dissolution apparatus (SotaxCE7). To assess bioactivity, antibiotic concentrations were simulated in the joint space of 1000 patients. Antibacterial properties were evaluated by counting colony forming units and the inhibition-halo test. RESULTS: The ratio of released ceftazidime and fluconazole was 453% and 648%, respectively, higher when used for treatment proportions than prophylaxis proportions. A bioactivity simulation exercise showed that the efficacy of ceftazidime/fluconazole determined as the amount of drug is released at the active site in the first 3 days after surgery would depend on the sensitivity of the microorganism and would increase substantially after drain removal. The microbiology study showed that biofilm formation by Pseudomonas aeruginosa could be a problem when ceftazidime was used in treatment or prophylaxis proportions. CONCLUSION: Our in vitro findings suggest that ceftazidime and fluconazole can be added into polymethyl methacrylate for the prevention/treatment of infections associated to joint surgery. Their efficacy depends on the sensitivity of the microorganism causing the infection.


Subject(s)
Antifungal Agents/pharmacokinetics , Bone Cements , Ceftazidime/pharmacokinetics , Fluconazole/pharmacokinetics , Prosthesis-Related Infections/prevention & control , Anti-Bacterial Agents , Antifungal Agents/therapeutic use , Arthroplasty , Biological Availability , Ceftazidime/therapeutic use , Fluconazole/therapeutic use , Gram-Negative Bacteria , Humans , Methicillin-Resistant Staphylococcus aureus , Polymethyl Methacrylate
16.
J Dairy Sci ; 100(9): 7544-7548, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28711239

ABSTRACT

The objective of this study was to determine the correlation between the results obtained with the ELISA technique for antibodies to Mycobacterium avium ssp. paratuberculosis in serum and bulk tank milk at the herd level. For this purpose, 203 samples of bulk tank milk were analyzed with 2 commercial ELISA from dairy herds with a prevalence of seropositive animals that was also determined. In regard to the reference test (results in blood serum), the sensitivity of the bulk tank milk test to detect high-positive herds (≥10% seroprevalence) ranged from 85.7 to 71.4%. The specificity to detect herds with no seropositive animals ranged from 70.5 to 53%. In a quantitative approach, Pearson correlation coefficients, reported as a measure of the linear association between herd seroprevalences and transformed optical density values recorded in bulk tank milk, were 0.39 and 0.54 for the studied ELISA. Although the test results were relatively fairly correlated with the within-herd prevalence, the practical utility of bulk tank milk testing for Mycobacterium avium ssp. paratuberculosis seems limited, especially regarding specificity.


Subject(s)
Antibodies, Bacterial/analysis , Enzyme-Linked Immunosorbent Assay/veterinary , Milk/immunology , Mycobacterium avium subsp. paratuberculosis/immunology , Animals , Cattle , Cattle Diseases/epidemiology , Cattle Diseases/immunology , Enzyme-Linked Immunosorbent Assay/methods , Paratuberculosis/epidemiology , Paratuberculosis/immunology , Prevalence , Sensitivity and Specificity , Seroepidemiologic Studies
17.
Prog. obstet. ginecol. (Ed. impr.) ; 60(1): 79-81, ene.-feb. 2017.
Article in Spanish | IBECS | ID: ibc-164040

ABSTRACT

El síndrome de Sheehan se caracteriza por necrosis de la glándula hipofisaria tras un parto hemorrágico cursando con hipovolemia. Su frecuencia ha disminuido debido a la mejoría en el manejo de las complicaciones hemodinámicas que ocurren en el parto y postparto. La destrucción de las células hipofisarias cursa con grados variables de hipopituitarismo. Debe ser considerado en la evaluación postparto de pacientes con inestabilidad hemodinámica (AU)


Sheehan syndrome is characterize by necrosis of the pituitary gland after hemorrhagic labor with hypovolemia. Its frecuecy has decreased due to the improvement in the management of the hemodynamic complications that occur in childbirth and postpartum. Destruction of pituitary cells is associated with varying degrres of hypopituitarism. It should be considered in the postpartum evaluation of patients with hemodynamic instability (AU)


Subject(s)
Humans , Female , Pregnancy , Hypopituitarism/complications , Pregnancy Complications/diagnosis , Obstetric Labor Complications/blood , Hormone Replacement Therapy , Postpartum Hemorrhage/diagnosis , Pituitary-Adrenal Function Tests , Pituitary Diseases , Pituitary Gland/pathology , Pituitary Gland
19.
Pharmazie ; 72(8): 449-455, 2017 Aug 01.
Article in English | MEDLINE | ID: mdl-29441903

ABSTRACT

The aim of the present study was to explore the feasibility of obtaining an IVIVC by combination of data from two bioequivalence (BE) studies of carbamazepine (CBZ) in order to assess if the previously published dissolution media and conditions could be applicable to any other oral immediate release (IR) CBZ products with conventional excipients. Twenty-four healthy male subjects from two BE study received one IR dose of the test (test 1 or 2) or the reference formulation (Tegretol, 400 mg). Dissolution studies of the IR CBZ tablets were performed in two different laboratories. In order to develop IVIVC, individual or average data analysis were considered. A level C, level B and level A correlation have been successfully developed by combining data from different BE studies of CBZ immediate release drug products. A level A IVIVC was developed with all four datasets with a good R2 for all the combinations of in vivo and in vitro data. A dissolution medium containing 1% SLS has demonstrated its suitability as the universal biopredictive dissolution medium, even if different batches and in vivo/in vitro studies were combined.


Subject(s)
Anticonvulsants/administration & dosage , Carbamazepine/administration & dosage , Excipients/chemistry , Anticonvulsants/pharmacokinetics , Carbamazepine/pharmacokinetics , Chemistry, Pharmaceutical/methods , Cross-Over Studies , Drug Liberation , Feasibility Studies , Humans , Male , Single-Blind Method , Solubility , Tablets , Therapeutic Equivalency
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