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The EIVIC project was launched in 2020, and the main goal was the organisation of a European intercomparison of in-vivo monitoring laboratories dealing with direct measurements of gamma-emitting radionuclides incorporated into the body of exposed workers. This project was organised jointly by members of EURADOS Working Group 7 on internal dosimetry (WG7), the Federal Office for Radiation Protection (BfS, Germany) and the Radioprotection and Nuclear Safety Institute (IRSN, France). The objective was to assess the implementation of individual-monitoring requirements in EU Member States on the basis of in-vivo measurements and to gain insight into the performance of in-vivo measurements using whole-body counters. In this context, a total of 41 in-vivo monitoring laboratories from 21 countries, together with JRC (EC) and IAEA participated. The results were submitted in terms of activity (Bq) of the radionuclides identified inside phantoms that were circulated to all participants. The measured data were compared with reference activity values to evaluate the corresponding bias according to the standards ISO 28218 and ISO 13528. In general, the results of the different exercises are good, and most facilities are in conformity with the criteria for the bias and z-scores in the ISO standards. Furthermore, information about technical and organisational characteristics of the participating laboratories was collected to test if they had a significant influence on the reported results.
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Laboratórios , Monitoramento de Radiação , Humanos , Radiometria/métodos , Radioisótopos , França , Padrões de ReferênciaRESUMO
Several studies suggest that patients with psoriasis have a higher incidence of neoplasms, especially of the skin, which could be associated with the use of therapies to treat psoriasis. Furthermore, the evidence available on the safety profile of some treatments in this context, and the management of these patients is scarce, which is why clinical practice guidelines with recommendations on the management of psoriasis in cancer patients are ambiguous. This study provides recommendations on the management and use of the therapies currently available for these patients. They are the result of a Delphi consensus reached by 45 dermatologists of the Spanish Academy of Dermatology and Venereology Psoriasis Working Group, whose goal is to help specialists in the field in their decision-making processes.
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Neoplasias , Psoríase , Humanos , Psoríase/terapia , Psoríase/tratamento farmacológico , Neoplasias/terapia , Neoplasias/complicações , Técnica Delphi , Espanha , Dermatologia/normas , ComorbidadeRESUMO
Several studies suggest that patients with psoriasis have a higher incidence of neoplasms, especially of the skin, which could be associated with the use of therapies to treat psoriasis. Furthermore, the evidence available on the safety profile of some treatments in this context, and the management of these patients is scarce, which is why clinical practice guidelines with recommendations on the management of psoriasis in cancer patients are ambiguous. This study provides recommendations on the management and use of the therapies currently available for these patients. They are the result of a Delphi consensus reached by 45 dermatologists of the Spanish Academy of Dermatology and Venereology Psoriasis Working Group, and their goal is to help specialists in the field in their decision-making processes.
Assuntos
Neoplasias , Psoríase , Humanos , Psoríase/tratamento farmacológico , Psoríase/terapia , Neoplasias/complicações , Neoplasias/terapia , Técnica Delphi , Espanha , Dermatologia/normas , ComorbidadeRESUMO
AIM: Ileal pouch-anal anastomosis (IPAA) should be delayed to a second stage in patients with ulcerative colitis and prolonged exposure to medical therapy. However, there is still discussion about whether a modified two-stage approach is preferable to a three-stage approach. Recently, a transanal approach has been introduced to overcome the well-known difficulties of laparoscopic pelvic surgery. This paper presents short-term outcomes of transanal IPAA (Ta-IPAA) according to a modified two-stage approach. METHODS: Data from all patients who underwent a modified two-stage Ta-IPAA for ulcerative colitis refractory to medical therapy were retrieved retrospectively from a prospective database. A comprehensive complication index was used for 90-day postoperative complications. Conversion, duration of surgery, hospital stay and reoperation were considered. A logistic regression model was used to assess risk factors for peri-pouch sepsis. RESULTS: Seventy-five (68.8%) patients were identified from 109 consecutive IPAAs. Median operation time was 159 min. Conversion rate was 4%. Mean comprehensive complication index was 7. All anastomotic leaks (10.6%) were treated with diverting ileostomy. Additionally, active rescue with transanal drainage and early resuturing of the anastomotic gap was performed in six patients. Ileostomy closure occurred after a median period of 5.4 months. At univariable analysis, factors associated with peri-pouch sepsis were male gender and age at IPAA construction. CONCLUSIONS: A modified two-stage Ta-IPAA is safe and feasible. Standardization and reproducibility of the technique are reflected in few conversions and intra-operative complications. Finally, morbidity and anastomotic leak do not differ from those reported in previous Ta-IPAA series with a variable proportion of multistage procedures.
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Colite Ulcerativa , Bolsas Cólicas , Proctocolectomia Restauradora , Anastomose Cirúrgica/efeitos adversos , Colite Ulcerativa/cirurgia , Bolsas Cólicas/efeitos adversos , Humanos , Masculino , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Proctocolectomia Restauradora/efeitos adversos , Reprodutibilidade dos Testes , Estudos Retrospectivos , Centros de Atenção Terciária , Resultado do TratamentoRESUMO
BACKGROUND: Anastomotic leak (AL) is the most feared complication in colorectal surgery. Indocyanine green (ICG) fluorescence angiography allows for real-time intraoperative evaluation of bowel perfusion. This study aimed to assess the impact of ICG on perioperative outcomes in patients treated with transanal total mesorectal excision (TaTME) for rectal cancer. METHODS: Comparative study based on a retrospective analysis of prospectively collected data, to validate the use of ICG assessment (ICGA) during TaTME (November/2011-June/2018). The primary outcome was the clinical AL rate. The secondary outcomes included modification of proximal colonic transection, anastomotic redo, additional surgical maneuvers and surgical morbidity. RESULTS: Two hundred and eighty-four patients were included, 204 (71.8%) in non-ICG group and 80 (28.2%) in ICG group. No significant differences were found in patient and tumor features. Mean anastomotic height was 4.85 cm vs. 5.04 cm (p = 0.500), diverting stoma was constructed in 205 patients (72.1% vs. 72.5%; p = 0.941). Fluorescence angiography modified the surgical plan in 23 patients (28.7%). AL was diagnosed in 23 patients (11.3%) in the non-ICG group and in two patients (2.5%) in the ICG group (p = 0.020). Postoperative intraabdominal collection was diagnosed in 19 patients (7.4% vs. 5.1%; p = 0.490), and reintervention was needed in 24 patients (10.8% vs. 7.6%; p = 0.420). Median length of hospital stay was 6.0 (IQR 5.0-9) vs. 4.0 (IQR 3.0-8.5) (p = 0.005). ICGA was found as independent protective factor for AL in the multivariate analysis of the whole cohort (n = 284) (OR 0.142; 95% CI 0.032-0.633; p = 0.010). CONCLUSION: ICG fluorescence angiography modified the proximal colonic transection in more than one-quarter of patients, leading to a significant decrease of AL rate.
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Fístula Anastomótica/etiologia , Angiofluoresceinografia/métodos , Neoplasias Retais/diagnóstico por imagem , Feminino , Humanos , Masculino , Neoplasias Retais/cirurgia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Capillary malformation-arteriovenous malformation (CM-AVM) syndrome is a rare syndrome with characteristic skin lesions that are associated with fast-flow vascular malformations (FFVMs) in one-third of patients. Few case series have been described, and none in Spain. AIM: To identify the prevalence of dermatological parameters, FFVMs and associated features in a large series of patients with CM-AVM. METHODS: We conducted an observational study of patients with CM-AVM syndrome diagnosed in 15 Spanish hospitals over 3 years. The main clinical, radiological, genetic findings and associated diseases were analysed. RESULTS: In total, 64 patients were assessed. In 26.5% of cases, the diagnosis was incidental. In 75% of patients, there was one significantly larger macule, which we termed the 'herald patch'. FFVMs were detected in 34% of the patients, with 30% located on the skin, 7.8% in the brain and in 1.5% in the spine. There was a positive family history in 65% of the 64 patients. Genetic analysis was performed for RASA1 mutations in 57 patients, of whom 42 (73%) had a positive result. All 4 patients tested for EPHB4 mutations had a positive result. No tumour lesions were detected in the series, except for five infantile haemangiomas. CONCLUSIONS: Our data on clinical lesions, associated FFVM, family history and genetics are similar to those previously published in the literature. An extensive data analysis failed to demonstrate any statistically significant association between the presence of an FFVM and any clinical, familial or genetic parameter that could predict its onset, although a link between the presence of a herald patch on the midline face and the presence of a brain FFVM was observed. We did not detect any genotype-phenotype correlation.
Assuntos
Malformações Arteriovenosas/patologia , Encéfalo/patologia , Capilares/anormalidades , Mancha Vinho do Porto/patologia , Pele/patologia , Coluna Vertebral/patologia , Malformações Vasculares/patologia , Adulto , Malformações Arteriovenosas/diagnóstico , Malformações Arteriovenosas/epidemiologia , Malformações Arteriovenosas/genética , Encéfalo/irrigação sanguínea , Capilares/patologia , Criança , Pré-Escolar , Análise de Dados , Feminino , Estudos de Associação Genética , Humanos , Achados Incidentais , Lactente , Masculino , Mutação , Mancha Vinho do Porto/diagnóstico , Mancha Vinho do Porto/epidemiologia , Mancha Vinho do Porto/genética , Prevalência , Receptor EphB4/genética , Pele/irrigação sanguínea , Espanha/epidemiologia , Coluna Vertebral/irrigação sanguínea , Malformações Vasculares/diagnóstico , Malformações Vasculares/genética , Proteína p120 Ativadora de GTPase/genéticaRESUMO
AIM: To evaluate in a laboratory setting the antibiofilm activity of several irrigating protocols including conventional irrigation, ultrasonic activation and XP-endo Finisher, with a mixture of sodium hypochlorite and etidronic acid in infected isthmuses and root canals of extracted human mandibular molar teeth. METHODOLOGY: Fifty-six mesial roots of mandibular molars, half of them with a continuous isthmus from the cervical to the apical third between the two root canals (type 1), and the other half with a continuous isthmus from the cervical to the middle third and one canal in the apical third (type 2), were included. The root canals were contaminated for 7 days with an Enterococcus faecalis suspension. There were three experimental groups plus a control group (n = 7 per type of root canal anatomy). All the root canals, except for the control group that was not treated, were chemomechanically prepared and then assigned to one of the experimental groups according to the final adjunctive procedure: conventional irrigation, ultrasonic activation or XP-endo Finisher activation. The irrigating solution used was a combination of 2.5% sodium hypochlorite and 9% etidronic acid, and the final protocols were applied for three cycles of 30 s with a 3 mL volume. The antibiofilm activity was evaluated at each location (root canal and isthmus) and third (cervical, middle and apical) using confocal laser scanning microscopy and the live/dead technique. Statistical analysis was performed using SPSS (descriptive statistics) and SUDAAN (P-value calculations). RESULTS: Root canals had significantly lower biovolume values than the isthmuses (P < 0.05). The biovolume in the root canals was significantly reduced in all the experimental groups in all the thirds except for conventional irrigation in the apical third (P > 0.05). In the cervical and middle thirds, ultrasonic activation was associated with the lowest biovolumes (P < 0.05), followed by XP-endo Finisher. In the isthmus, disinfection was similar in all the thirds for all the protocols. Conventional irrigation was associated with intermediate values with no significant differences from the control group or from the activated protocols (P > 0.05), although the latter were significantly different from the control group (P < 0.05). No differences were found between ultrasonic activation and XP-endo Finisher in the middle and apical thirds (P > 0.05) in the isthmuses. CONCLUSIONS: In this laboratory study on extracted teeth, the isthmus was more difficult to disinfect than root canals. In the root canals, ultrasonic activation and XP-endo Finisher had a greater effectiveness than conventional irrigation. In the isthmuses, no differences were observed between the two activation techniques and conventional irrigation.
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Cavidade Pulpar , Hipoclorito de Sódio , Desinfecção , Ácido Etidrônico , Humanos , Laboratórios , Irrigantes do Canal Radicular/farmacologia , Preparo de Canal Radicular , Hipoclorito de Sódio/farmacologia , Irrigação TerapêuticaRESUMO
BACKGROUND: In the PACIFIC trial, durvalumab significantly improved progression-free and overall survival (PFS/OS) versus placebo, with manageable safety, in unresectable, stage III non-small-cell lung cancer (NSCLC) patients without progression after chemoradiotherapy (CRT). We report exploratory analyses of outcomes by tumour cell (TC) programmed death-ligand 1 (PD-L1) expression. PATIENTS AND METHODS: Patients were randomly assigned (2:1) to intravenous durvalumab 10 mg/kg every 2 weeks or placebo ≤12 months, stratified by age, sex, and smoking history, but not PD-L1 status. Where available, pre-CRT samples were tested for PD-L1 expression (immunohistochemistry) and scored at pre-specified (25%) and post hoc (1%) TC cut-offs. Treatment-effect hazard ratios (HRs) were estimated from unstratified Cox proportional hazards models (Kaplan-Meier-estimated medians). RESULTS: In total, 713 patients were randomly assigned, 709 of whom received at least 1 dose of study treatment durvalumab (n = 473) or placebo (n = 236). Some 451 (63%) were PD-L1-assessable: 35%, 65%, 67%, 33%, and 32% had TC ≥25%, <25%, ≥1%, <1%, and 1%-24%, respectively. As of 31 January 2019, median follow-up was 33.3 months. Durvalumab improved PFS versus placebo (primary-analysis data cut-off, 13 February 2017) across all subgroups [HR, 95% confidence interval (CI); medians]: TC ≥25% (0.41, 0.26-0.65; 17.8 versus 3.7 months), <25% (0.59, 0.43-0.82; 16.9 versus 6.9 months), ≥1% (0.46, 0.33-0.64; 17.8 versus 5.6 months), <1% (0.73, 0.48-1.11; 10.7 versus 5.6 months), 1%-24% [0.49, 0.30-0.80; not reached (NR) versus 9.0 months], and unknown (0.59, 0.42-0.83; 14.0 versus 6.4 months). Durvalumab improved OS across most subgroups (31 January 2019 data cut-off; HR, 95% CI; medians): TC ≥ 25% (0.50, 0.30-0.83; NR versus 21.1 months), <25% (0.89, 0.63-1.25; 39.7 versus 37.4 months), ≥1% (0.59, 0.41-0.83; NR versus 29.6 months), 1%-24% (0.67, 0.41-1.10; 43.3 versus 30.5 months), and unknown (0.60, 0.43-0.84; 44.2 versus 23.5 months), but not <1% (1.14, 0.71-1.84; 33.1 versus 45.6 months). Safety was similar across subgroups. CONCLUSIONS: PFS benefit with durvalumab was observed across all subgroups, and OS benefit across all but TC <1%, for which limitations and wide HR CI preclude robust conclusions.
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Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Anticorpos Monoclonais , Antígeno B7-H1 , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/genética , Humanos , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/genéticaRESUMO
Active hybrid microspheres were prepared by blending aqueous solutions of gelatine and chitosan with different concentrations of copper nanoparticles (0) (CuNPs) using emulsion-based crosslinking synthesis to obtain hybrid microspheres. The incorporation of CuNPs slightly affected the physical and chemical properties of the films. Microscopic surface structure (SEM), energy dispersive X-ray (EDX) spectroscopy and X-ray diffraction (XRD) analysis confirmed the presence of elemental copper and the crystalline structure of the CuNPs in the hybrid matrix. The surface properties of CuNPs were studied by XPS analyses. The antimicrobial activity of CuNPs coated with chitosan (QO)/gelatine (GE) compared to the QO/GE matrix alone was investigated, using the agar diffusion and culture medium methods in Mueller-Hinton. The evaluation was performed using the Gram-negative bacterium E. coli and the Gram positive bacterium E. faecalis. The investigated microspheres showed antimicrobial activity. Hybrid microspheres with 40 mg of Cu, evaluated in liquid medium, inhibited the growth of E. coli by 56% and of E. faecalis by 40% compared to the matrix hybridised alone; in solid medium, the inhibition was 2.5-fold and 2.6-fold, respectively. Thus, these microspheres are a promising material for applications with medical uses.
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Nanopartículas Metálicas , Nanopartículas , Antibacterianos/farmacologia , Cobre/farmacologia , Escherichia coli , Microesferas , Difração de Raios XRESUMO
The purpose of this research was to investigate the possible variations to the pharmacokinetics of nimesulide by the effect of age using an animal model. An experimental, analytical, prospective and longitudinal study in five dogs, from birth to 730 days of age was carried out. Nimesulide blood levels were measured in different months; concentrations were determined by HPLC-UV. Pharmacokinetic parameters were calculated by using the WinNonlin software. There were statistically significant differences (p <0.05) in most of the pharmacokinetic parameters between study of 6 months against the other three studies in different ages. Changes in the pharmacokinetic parameters of nimesulide as a result of age, are determined by the growing and maturation of the animals. Resulting data suggest that nimesulide can be used safely as a long-term analgesic in dogs, but, the dosing regimens in humans should be different when administered at early age.
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Anti-Inflamatórios não Esteroides/farmacocinética , Sulfonamidas/farmacocinética , Animais , Cães , Estudos Longitudinais , Masculino , Estudos ProspectivosRESUMO
OBJECTIVE: We compare the effects of three different approved sources of supplemental zilpaterol on growth-performance responses and carcass characteristics of finishing lambs. METHODS: Twenty four Pelibuey×Katahdin lambs (46.75±2.43 kg) were used in a 33-day feeding trial. Lambs were fed a dry rolled corn-based finishing diet. Treatments consisted of the non-supplemental basal diet (Control) versus the basal diet supplemented with 125 mg zilpaterol/kg of diet (as fed basis) from three commercial sources marketed in Mexico: Zilmax (ZIL), Grofactor, and Zipamix. RESULTS: Compared to controls, zilpaterol (ZH) supplementation did not affect dry matter intake (DMI), but increased carcass adjusted daily weight gain (ADG, 36.7%), gain efficiency (34.2%), and dietary net energy (26.0%), and decreased (23.4%) the ratio of observed:expected DMI. Compared to controls, supplemental ZH increased hot carcass weight (6.4%), dressing percentage (3.2%), m. longissimus thoracis (LM) area (15.6%), and shoulder muscle:fat ratio (28.7%), but decreased kidney-pelvic-heart fat, and fat thickness. Supplemental ZH increased 10.9% and 14.3% whole cut weight of loin and leg, respectively, and the proportion (as percentage of cold carcass weight) of leg (4.3%). These increases were reflected in greater forequarter and hindquarter weights. Lambs fed ZH increased (4.6%) empty body weight (EBW) and reduced (14.7%) liver/spleen weight (as g/kg EBW). Likewise, ZH supplementation tended (p = 0.08) to lower (8.9%) visceral fat. Growth performance, energetic efficiency, hot carcass weight, dressing percentage, LM area and whole cuts were not different across supplemental ZH sources. However, compared with non-supplemented controls, only ZIL appreciably decreased carcass fat distribution, including fat thickness, percentage kidney pelvic and heart fat, shoulder fat, and visceral fat. CONCLUSION: Supplemental ZH increases ADG, gain efficiency, carcass dressing percentage, and LM area. The magnitude of these responses was similar among ZH sources. Nevertheless, compared with non-supplemented controls, only ZIL appreciably decreases carcass fat. The basis for this is uncertain, but indicative that some practical differences in zilpaterol bio-equivalency may exist across commercial sources tested.
RESUMO
Protein misfolding has been linked to numerous inherited diseases. Loss- and gain-of-function mutations (common features of genetic diseases) may cause the destabilization of proteins, leading to alterations in their properties and/or cellular location, resulting in their incorrect functioning. Misfolded proteins can, however, be rescued via the use of proteostasis regulators and/or pharmacological chaperones, suggesting that treatments with small molecules might be developed for a range of genetic diseases. This work describes the potential of these small molecules in this respect, including for the treatment of congenital disorder of glycosylation (CDG) due to phosphomannomutase 2 deficiency (PMM2-CDG).
Assuntos
Deficiências na Proteostase/tratamento farmacológico , Deficiências na Proteostase/etiologia , Animais , Ensaios Clínicos como Assunto , Descoberta de Drogas , Predisposição Genética para Doença , Glicosilação/efeitos dos fármacos , Humanos , Mitocôndrias , Mutação , Deficiências na Proteostase/diagnóstico , Deficiências na Proteostase/metabolismoRESUMO
Richieri-Costa-Pereira syndrome is a rare autosomal recessive acrofacial dysostosis that has been mainly described in Brazilian individuals. The cardinal features include Robin sequence, cleft mandible, laryngeal anomalies and limb defects. A biallelic expansion of a complex repeated motif in the 5' untranslated region of EIF4A3 has been shown to cause this syndrome, commonly with 15 or 16 repeats. The only patient with mild clinical findings harbored a 14-repeat expansion in 1 allele and a point mutation in the other allele. This proband is described here in more details, as well as is his affected sister, and 5 new individuals with Richieri-Costa-Pereira syndrome, including a patient from England, of African ancestry. This study has expanded the phenotype in this syndrome by the observation of microcephaly, better characterization of skeletal abnormalities, less severe phenotype with only mild facial dysmorphisms and limb anomalies, as well as the absence of cleft mandible, which is a hallmark of the syndrome. Although the most frequent mutation in this study was the recurrent 16-repeat expansion in EIF4A3, there was an overrepresentation of the 14-repeat expansion, with mild phenotypic expression, thus suggesting that the number of these motifs could play a role in phenotypic delineation.
Assuntos
Pé Torto Equinovaro/genética , RNA Helicases DEAD-box/genética , Fator de Iniciação 4A em Eucariotos/genética , Deformidades Congênitas da Mão/genética , Laringe/fisiopatologia , Deformidades Congênitas dos Membros/genética , Síndrome de Pierre Robin/genética , Adolescente , Adulto , Alelos , Brasil/epidemiologia , Criança , Pé Torto Equinovaro/epidemiologia , Pé Torto Equinovaro/fisiopatologia , Expansão das Repetições de DNA/genética , Inglaterra/epidemiologia , Extremidades/fisiopatologia , Feminino , Genótipo , Deformidades Congênitas da Mão/epidemiologia , Deformidades Congênitas da Mão/fisiopatologia , Humanos , Laringe/anormalidades , Deformidades Congênitas dos Membros/fisiopatologia , Masculino , Fenótipo , Síndrome de Pierre Robin/epidemiologia , Síndrome de Pierre Robin/fisiopatologia , Mutação Puntual/genética , Adulto JovemRESUMO
This study examines gene expression patterns in dairy heifers experimentally infected with N. caninum during on Day 110 of pregnancy with live foetuses at euthanasia, 42 days later. The study population was constituted of four non-infected controls and three infected dams. Gene expression was determined on gamma interferon (IFNγ), (Th1 pro-inflammatory cytokine), interleukin-4 (IL4) (Th2 pro-gestation cytokine) or interleukin-10 (IL10) (T regulatory cytokine) and the serine peptidase inhibitor SERPINA14 in intercaruncular, placental, uterine lymph node (UTLN) and luteal tissue samples. Intercaruncular SERPINA14 expression was negatively correlated with IFNγ expression in cotyledon samples and with IL4 expression in UTLN. No relationships were detected between cytokine gene expression at the foetal-maternal interface and SERPINA14 expression in the luteal samples. Our findings suggest that gene expression of the uterine serpin SERPINA14 correlates negatively with the expression of Th1 and Th2 cytokines at the foetal-maternal interface but not in the corpus luteum.
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Doenças dos Bovinos/parasitologia , Coccidiose/veterinária , Corpo Lúteo/metabolismo , Citocinas/metabolismo , Serpinas/metabolismo , Animais , Bovinos , Doenças dos Bovinos/metabolismo , Coccidiose/parasitologia , Feminino , Feto , Regulação da Expressão Gênica/fisiologia , Troca Materno-Fetal , Neospora , Gravidez , Complicações Parasitárias na Gravidez/veterinária , Serpinas/genética , Útero/metabolismoRESUMO
BACKGROUND: CT-P13 is a biosimilar of Remicade®, an agent approved in some countries for use in inflammatory bowel disease (IBD). Controlled clinical trials have demonstrated the efficacy and safety of CT-P13 in rheumatic diseases, but not in IBD. AIMS: To assess the effectiveness and safety of CT-P13 in IBD patients in real clinical practice. METHODS: This is a prospective observational study in patients with moderate to severe Crohn's disease or ulcerative colitis treated with CT-P13. The study was performed in one single center. Patients included were naive or switched to anti-TNF treatment from the reference infliximab (Remicade®) to CT-P13. Efficacy and safety were assessed in naive and switched patients who were in remission at the time of the switch at months 3 and 6 of therapy. RESULTS: 87.5 and 83.9% of switched CD patients who were in remission at the time of the switch continued in remission, and 66.7 and 50% of naive CD patients reached remission, at months 3 and 6. In UC switched cases, 92 and 91.3% of patients in remission at the time of the switch continued in remission, at 3 and 6 months. In naive UC patients, the remission rates were 44.4 and 66.7%, at months 3 and 6. Adverse events occurred in 7.5% of patients during 6 months of study. CONCLUSIONS: CT-P13 was efficacious and well tolerated in patients with CD or UC.
Assuntos
Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Adulto , Anticorpos Monoclonais/administração & dosagem , Esquema de Medicação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Indução de RemissãoRESUMO
AIM: To evaluate the antibiofilm activity of 2.5% sodium hypochlorite (NaOCl), 2% chlorhexidine (CHX), 2% alexidine (ALX) and 0.2% cetrimide (CTR) alone and in combination on mature polymicrobial root canal biofilms on human dentine using confocal laser scanning microscopy (CLSM). METHODOLOGY: Twenty-eight human dentine specimens were infected for 21 days with microbial samples collected from infected root canals of three volunteers. Antibiofilm activity of the irrigating solutions was evaluated after 3 min of contact time under CLSM. For quantification purposes, bioimage_L software was used. The variables evaluated were the log10 of total biovolume (µm3 ) and percentage of live cells (green) population. Statistical analysis of both variables was performed using an anova test and a post hoc Duncan test to determine significant clusters amongst groups. The variable green population percentage was previously subjected to the normalized Anscombe transformation. RESULTS: The NaOCl group had a total biovolume and percentage of live cells significantly lower than the other groups (P Ë 0.001). The addition of 0.2% CTR significantly increased the antimicrobial effect of 2% CHX (P Ë 0.001). There were no significant differences between 0.2% CTR, 2% ALX and the combination of both (P Ë 0.05). CONCLUSIONS: Overall, 2.5% NaOCl dissolved and killed bacteria significantly more efficiently when used against polymicrobial mature biofilm on human dentine. Cetrimide improved the antimicrobial activity of chlorhexidine and alexidine.
Assuntos
Antibacterianos/farmacologia , Biofilmes/efeitos dos fármacos , Dentina/microbiologia , Biguanidas/farmacologia , Cetrimônio , Compostos de Cetrimônio/farmacologia , Clorexidina/farmacologia , Humanos , Tratamento do Canal Radicular , Hipoclorito de Sódio/farmacologiaRESUMO
BACKGROUND: The decline in participation rates in surveys, including epidemiological surveillance surveys, has become a real concern since it may increase nonresponse bias. The aim of this study is to estimate the contribution of a complementary survey among a subsample of nonrespondents, and the additional contribution of paradata in correcting for nonresponse bias in an occupational health surveillance survey. METHODS: In 2010, 10,000 workers were randomly selected and sent a postal questionnaire. Sociodemographic data were available for the whole sample. After data collection of the questionnaires, a complementary survey among a random subsample of 500 nonrespondents was performed using a questionnaire administered by an interviewer. Paradata were collected for the complete subsample of the complementary survey. Nonresponse bias in the initial sample and in the combined samples were assessed using variables from administrative databases available for the whole sample, not subject to differential measurement errors. Corrected prevalences by reweighting technique were estimated by first using the initial survey alone and then the initial and complementary surveys combined, under several assumptions regarding the missing data process. Results were compared by computing relative errors. RESULTS: The response rates of the initial and complementary surveys were 23.6% and 62.6%, respectively. For the initial and the combined surveys, the relative errors decreased after correction for nonresponse on sociodemographic variables. For the combined surveys without paradata, relative errors decreased compared with the initial survey. The contribution of the paradata was weak. CONCLUSION: When a complex descriptive survey has a low response rate, a short complementary survey among nonrespondents with a protocol which aims to maximize the response rates, is useful. The contribution of sociodemographic variables in correcting for nonresponse bias is important whereas the additional contribution of paradata in correcting for nonresponse bias is questionable.
Assuntos
Coleta de Dados/métodos , Pesquisas sobre Atenção à Saúde/métodos , Saúde Ocupacional , Vigilância da População/métodos , Adolescente , Adulto , Idoso , Viés , França/epidemiologia , Humanos , Pessoa de Meia-Idade , Saúde Ocupacional/estatística & dados numéricos , Projetos Piloto , Saúde Pública/métodos , Saúde Pública/normas , Estudos de Amostragem , Inquéritos e Questionários , Adulto JovemRESUMO
BACKGROUND: Xerosis is an abnormally dry and flaky skin condition that is associated with a change in the packing behaviour of the lipid matrix in the stratum corneum (SC), the outermost layer of the skin. This skin condition can lead to an increase in transepidermal water loss (TEWL). As ultralong-chain fatty acids have a positive effect on maintaining the packing behaviour of the SC lipid matrix, a moisturizer which contains glycerides of ultralong-chain fatty acids could act as a semi-occlusive layer on the surface of the skin. This will lower the rate of water evaporation through the epidermis and consequently help prevent or improve skin xerosis. OBJECTIVE: To identify a novel source of ultralong-chain lipids and develop monoacylglycerols with mixed fatty acyl chain lengths that have occlusive properties superior to petrolatum. METHODS: Initially, Performacol 425, a mixture of very long-chain fatty alcohols, was fractionated using short path distillation to yield a fraction enriched with C22:0-C26:0 fatty alcohols. The fatty alcohol fraction was then oxidized using Jones reagent, and the resulting fatty acids were esterified with glycerol to yield the corresponding monoglycerides using Novozym 435. These were then evaluated using Fourier transform infrared spectroscopy, differential scanning calorimetry and water vapour transmission rate measurements. RESULTS: The monoacylglycerols enriched with C22:0-C26:0 displayed a melting point of 80°C and orthorhombic packing; packing behaviour mainly present in healthy SC. In addition, a phospholipid-structured emulsion containing 3% of the monoglycerides displayed occlusive properties superior to the vehicle containing 3% petrolatum jelly. CONCLUSIONS: Performacol 425 can be a potential source of fatty alcohols to synthesize monoacylglycerols that can improve the occlusive behaviour of phospholipid-structured emulsions.