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[PMID]:28858705
[Au] Autor:Biandolino F; Parlapiano I; Faraponova O; Prato E
[Ad] Endereço:CNR-IAMC, Institute for Coastal Marine Environment, Taranto, Italy. Electronic address: francesca.biandolino@iamc.cnr.it.
[Ti] Título:Effects of short- and long-term exposures to copper on lethal and reproductive endpoints of the harpacticoid copepod Tigriopus fulvus.
[So] Source:Ecotoxicol Environ Saf;147:327-333, 2018 Jan.
[Is] ISSN:1090-2414
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:The long-term exposure provides a realistic measurement of the effects of toxicants on aquatic organisms. The harpacticoid copepod Tigriopus fulvus has a wide geographical distribution and is considered as an ideal model organism for ecotoxicological studies for its good sensitivity to different toxicants. In this study, acute, sub-chronic and chronic toxicity tests based on lethal and reproductive responses of Tigriopus fulvus to copper were performed. The number of moults during larval development was chosen as an endpoint for sub-chronic test. Sex ratio, inhibitory effect on larval development, hatching time, fecundity, brood number, nauplii/brood, total newborn production, etc, were calculated in the chronic test (28d). Lethal effect of copper to nauplii showed the LC50-48h of 310 ± 72µgCu/L (mean ± sd). It was observed a significant inhibition of larval development at sublethal copper concentrations, after 4 and 7 d. After 4d, the EC50 value obtained for the endpoint in "moult naupliar reduction" was of 55.8 ± 2.5µgCu/L (mean ± sd). The EC50 for the inhibition of naupliar development into copepodite stage, was of 21.7 ± 4.4µgCu/L (mean ± sd), after 7 days. Among the different traits tested, copper did not affect sex ratio and growth, while fecundity and total nauplii production were the most sensitive endpoints. The reproductive endpoints offer the advantage of being detectable at very low pollutant concentrations.
[Mh] Termos MeSH primário: Copépodes/efeitos dos fármacos
Cobre/toxicidade
Monitoramento Ambiental/métodos
Poluentes Químicos da Água/toxicidade
[Mh] Termos MeSH secundário: Animais
Copépodes/crescimento & desenvolvimento
Determinação de Ponto Final
Fertilidade/efeitos dos fármacos
Dose Letal Mediana
Reprodução/efeitos dos fármacos
Razão de Masculinidade
Fatores de Tempo
Testes de Toxicidade Aguda
Testes de Toxicidade Crônica
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Water Pollutants, Chemical); 789U1901C5 (Copper)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180309
[Lr] Data última revisão:
180309
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170901
[St] Status:MEDLINE


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[PMID]:28459387
[Au] Autor:Jenkins RG; Moore BB; Chambers RC; Eickelberg O; Königshoff M; Kolb M; Laurent GJ; Nanthakumar CB; Olman MA; Pardo A; Selman M; Sheppard D; Sime PJ; Tager AM; Tatler AL; Thannickal VJ; White ES; ATS Assembly on Respiratory Cell and Molecular Biology
[Ti] Título:An Official American Thoracic Society Workshop Report: Use of Animal Models for the Preclinical Assessment of Potential Therapies for Pulmonary Fibrosis.
[So] Source:Am J Respir Cell Mol Biol;56(5):667-679, 2017 05.
[Is] ISSN:1535-4989
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Numerous compounds have shown efficacy in limiting development of pulmonary fibrosis using animal models, yet few of these compounds have replicated these beneficial effects in clinical trials. Given the challenges associated with performing clinical trials in patients with idiopathic pulmonary fibrosis (IPF), it is imperative that preclinical data packages be robust in their analyses and interpretations to have the best chance of selecting promising drug candidates to advance to clinical trials. The American Thoracic Society has convened a group of experts in lung fibrosis to discuss and formalize recommendations for preclinical assessment of antifibrotic compounds. The panel considered three major themes (choice of animal, practical considerations of fibrosis modeling, and fibrotic endpoints for evaluation). Recognizing the need for practical considerations, we have taken a pragmatic approach. The consensus view is that use of the murine intratracheal bleomycin model in animals of both genders, using hydroxyproline measurements for collagen accumulation along with histologic assessments, is the best-characterized animal model available for preclinical testing. Testing of antifibrotic compounds in this model is recommended to occur after the acute inflammatory phase has subsided (generally after Day 7). Robust analyses may also include confirmatory studies in human IPF specimens and validation of results in a second system using in vivo or in vitro approaches. The panel also strongly encourages the publication of negative results to inform the lung fibrosis community. These recommendations are for preclinical therapeutic evaluation only and are not intended to dissuade development of emerging technologies to better understand IPF pathogenesis.
[Mh] Termos MeSH primário: Congressos como Assunto
Modelos Animais de Doenças
Fibrose Pulmonar/terapia
Sociedades Médicas
[Mh] Termos MeSH secundário: Animais
Determinação de Ponto Final
Feminino
Seres Humanos
Masculino
Organismos Geneticamente Modificados
Reprodutibilidade dos Testes
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1707
[Cu] Atualização por classe:180216
[Lr] Data última revisão:
180216
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170502
[St] Status:MEDLINE
[do] DOI:10.1165/rcmb.2017-0096ST


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[PMID]:29176897
[Au] Autor:Bauters C; Dubois E; Porouchani S; Saloux E; Fertin M; de Groote P; Lamblin N; Pinet F
[Ad] Endereço:University of Lille, Inserm U1167, Institut Pasteur, University Hospital of Lille, Lille, France.
[Ti] Título:Long-term prognostic impact of left ventricular remodeling after a first myocardial infarction in modern clinical practice.
[So] Source:PLoS One;12(11):e0188884, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The association of left ventricular remodeling (LVR) after myocardial infarction (MI) with the subsequent risk of heart failure (HF) and death has not been studied in patients receiving optimal secondary prevention. METHODS AND RESULTS: We performed a long-term clinical follow-up of patients included in 2 prospective multicentric studies on LVR after first anterior MI. At 1-year echocardiography, LVR (≥20% increase in end-diastolic volume from baseline to 1 year) occurred in 67/215 (31%) patients in cohort 1 and in 87/226 (38%) patients in cohort 2. The prescription rate of secondary prevention medications was very high (ß-blockers at 1 year: 90% and 95% for cohorts 1 and 2, respectively; angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (ACE-I/ARB) at 1 year: 93% and 97% for cohorts 1 and 2, respectively). Median clinical follow-up after LVR assessment was 11.0 years in cohort 1 and 7.8 years in cohort 2. In both cohorts, LVR patients had a progressive increase in the risk of cardiovascular death or hospitalization for HF (p = 0.0007 in cohort 1 and 0.009 in cohort 2) with unadjusted hazard ratios of 2.52 [1.45-4.36] and 2.52 [1.23-5.17], respectively. Similar results were obtained when cardiovascular death was considered as an isolated endpoint. After adjustement on baseline characteristics including ejection fraction, the association with the composite endpoint was unchanged. CONCLUSION: In a context of a modern therapeutic management with a large prescription of evidence-based medications, LVR remains independently associated with HF and cardiovascular death at long-term follow-up after MI.
[Mh] Termos MeSH primário: Infarto do Miocárdio/fisiopatologia
Padrões de Prática Médica
Remodelação Ventricular
[Mh] Termos MeSH secundário: Estudos de Coortes
Ecocardiografia
Determinação de Ponto Final
Feminino
Seguimentos
Insuficiência Cardíaca/diagnóstico por imagem
Insuficiência Cardíaca/fisiopatologia
Hospitalização
Seres Humanos
Estimativa de Kaplan-Meier
Masculino
Meia-Idade
Infarto do Miocárdio/diagnóstico por imagem
Prognóstico
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1712
[Cu] Atualização por classe:171219
[Lr] Data última revisão:
171219
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171128
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0188884


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[PMID]:29223428
[Au] Autor:Seifert HA; Malik RE; Bhattacharya M; Campbell KR; Okun S; Pierce C; Terkowitz J; Turner JR; Krucoff MW; Powell GE
[Ad] Endereço:Vaccine Clinical Safety and Pharmacovigilance, GlaxoSmithKline Vaccines, King of Prussia, PA. Electronic address: harry.a.seifert@gsk.com.
[Ti] Título:Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank.
[So] Source:Am Heart J;194:107-115, 2017 Dec.
[Is] ISSN:1097-6744
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:This white paper provides a summary of the presentations and discussions from a think tank on "Enabling Social Listening for Cardiac Safety Monitoring" trials that was cosponsored by the Drug Information Association and the Cardiac Safety Research Consortium, and held at the White Oak headquarters of the US Food and Drug Administration on June 3, 2016. The meeting's goals were to explore current methods of collecting and evaluating social listening data and to consider their applicability to cardiac safety surveillance. Social listening is defined as the act of monitoring public postings on the Internet. It has several theoretical advantages for drug and device safety. First, these include the ability to detect adverse events that are "missed" by traditional sources and the ability to detect adverse events sooner than would be allowed by traditional sources, both by affording near-real-time access to data from culturally and geographically diverse sources. Social listening can also potentially introduce a novel patient voice into the conversation about drug safety, which could uniquely augment understanding of real-world medication use obtained from more traditional methodologies. Finally, it can allow for access to information about drug misuse and diversion. To date, the latter 2 of these have been realized. Although regulators from the Food and Drug Administration and the United Kingdom's Medicines and Healthcare Products Regulatory Agency participated in the think tank along with representatives from industry, academia, and patient groups, this article should not be construed to constitute regulatory guidance.
[Mh] Termos MeSH primário: Pesquisa Biomédica
Fármacos Cardiovasculares/uso terapêutico
Doenças Cardiovasculares/tratamento farmacológico
Monitoramento de Medicamentos/métodos
Determinação de Ponto Final/métodos
Coração/efeitos dos fármacos
[Mh] Termos MeSH secundário: Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Cardiovascular Agents)
[Em] Mês de entrada:1712
[Cu] Atualização por classe:171215
[Lr] Data última revisão:
171215
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171211
[St] Status:MEDLINE


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[PMID]:28985945
[Au] Autor:Rahman L; Jacobsen NR; Aziz SA; Wu D; Williams A; Yauk CL; White P; Wallin H; Vogel U; Halappanavar S
[Ad] Endereço:Environmental Health Science and Research Bureau, Health Canada, Ottawa, Canada.
[Ti] Título:Multi-walled carbon nanotube-induced genotoxic, inflammatory and pro-fibrotic responses in mice: Investigating the mechanisms of pulmonary carcinogenesis.
[So] Source:Mutat Res;823:28-44, 2017 Nov.
[Is] ISSN:1873-135X
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:The International Agency for Research on Cancer has classified one type of multi-walled carbon nanotubes (MWCNTs) as possibly carcinogenic to humans. However, the underlying mechanisms of MWCNT- induced carcinogenicity are not known. In this study, the genotoxic, mutagenic, inflammatory, and fibrotic potential of MWCNTs were investigated. Muta™Mouse adult females were exposed to 36±6 or 109±18µg/mouse of Mitsui-7, or 26±2 or 78±5µg/mouse of NM-401, once a week for four consecutive weeks via intratracheal instillations, alongside vehicle-treated controls. Samples were collected 90days following the first exposure for measurement of DNA strand breaks, lacZ mutant frequency, p53 expression, cell proliferation, lung inflammation, histopathology, and changes in global gene expression. Both MWCNT types persisted in lung tissues 90days post-exposure, and induced lung inflammation and fibrosis to similar extents. However, there was no evidence of DNA damage as measured by the comet assay following Mitsui-7 exposure, or increases in lacZ mutant frequency, for either MWCNTs. Increased p53 expression was observed in the fibrotic foci induced by both MWCNTs. Gene expression analysis revealed perturbations of a number of biological processes associated with cancer including cell death, cell proliferation, free radical scavenging, and others in both groups, with the largest response in NM-401-treated mice. The results suggest that if the two MWCNT types were capable of inducing DNA damage, strong adaptive responses mounted against the damage, resulting in efficient and timely elimination of damaged cells through cell death, may have prevented accumulation of DNA damage and mutations at the post-exposure time point investigated in the study. Thus, MWCNT-induced carcinogenesis may involve ongoing low levels of DNA damage in an environment of persisting fibres, chronic inflammation and tissue irritation, and parallel increases or decreases in the expression of genes involved in several pro-carcinogenic pathways.
[Mh] Termos MeSH primário: Carcinogênese/efeitos dos fármacos
Dano ao DNA/efeitos dos fármacos
Pulmão/efeitos dos fármacos
Nanotubos de Carbono/toxicidade
Fibrose Pulmonar/patologia
[Mh] Termos MeSH secundário: Animais
Líquido da Lavagem Broncoalveolar/citologia
Proliferação Celular/efeitos dos fármacos
Fenômenos Químicos
Ensaio Cometa
Determinação de Ponto Final
Feminino
Pulmão/citologia
Camundongos
Pneumonia/induzido quimicamente
Pneumonia/patologia
Fibrose Pulmonar/induzido quimicamente
Proteína Supressora de Tumor p53/genética
Proteína Supressora de Tumor p53/metabolismo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Nanotubes, Carbon); 0 (Tumor Suppressor Protein p53)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171019
[Lr] Data última revisão:
171019
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171008
[St] Status:MEDLINE


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[PMID]:28964455
[Au] Autor:Sussell J; Bognar K; Schwartz TT; Shafrin J; Sheehan JJ; Aubry W; Scanlon D
[Ad] Endereço:Precision Health Economics, Oakland, CA, USA, at the time the research was conducted. Electronic address: jesse.sussell@precisionhealtheconomics.com.
[Ti] Título:Value-Based Payments and Incentives to Improve Care: A Case Study of Patients with Type 2 Diabetes in Medicare Advantage.
[So] Source:Value Health;20(8):1216-1220, 2017 Sep.
[Is] ISSN:1524-4733
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVES: To estimate the impact of increased glycated hemoglobin (A1C) monitoring and treatment intensification for patients with type 2 diabetes (T2D) on quality measures and reimbursement within the Medicare Advantage Star (MA Star) program. METHODS: The primary endpoint was the share of patients with T2D with adequate A1C control (A1C ≤ 9%). We conducted a simulation of how increased A1C monitoring and treatment intensification affected this end point using data from the National Health and Nutrition Examination Survey and clinical trials. Using the estimated changes in measured A levels, we calculated corresponding changes in the plan-level A quality measure, overall star rating, and reimbursement. RESULTS: At baseline, 24.4% of patients with T2D in the average plan had poor A1C control. The share of plans receiving the highest A1C rating increased from 27% at baseline to 49.5% (increased monitoring), 36.2% (intensification), and 57.1% (joint implementation of both interventions). However, overall star ratings increased for only 3.6%, 1.3%, and 4.8% of plans, respectively, by intervention. Projected per-member per-year rebate increases under the MA Star program were $7.71 (monitoring), $2.66 (intensification), and $10.55 (joint implementation). CONCLUSIONS: The simulation showed that increased monitoring and treatment intensification would improve A1C levels; however, the resulting average increases in reimbursement would be small.
[Mh] Termos MeSH primário: Diabetes Mellitus Tipo 2/tratamento farmacológico
Hemoglobina A Glicada/análise
Hipoglicemiantes/administração & dosagem
Medicare/economia
Reembolso de Incentivo/economia
[Mh] Termos MeSH secundário: Simulação por Computador
Diabetes Mellitus Tipo 2/economia
Determinação de Ponto Final
Seres Humanos
Motivação
Inquéritos Nutricionais
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Glycated Hemoglobin A); 0 (Hypoglycemic Agents)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171002
[St] Status:MEDLINE


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[PMID]:28953953
[Au] Autor:Thomas LM; Jorgenson ZG; Brigham ME; Choy SJ; Moore JN; Banda JA; Gefell DJ; Minarik TA; Schoenfuss HL
[Ad] Endereço:Aquatic Toxicology Laboratory, St. Cloud State University, St. Cloud, Minnesota, United States of America.
[Ti] Título:Contaminants of emerging concern in tributaries to the Laurentian Great Lakes: II. Biological consequences of exposure.
[So] Source:PLoS One;12(9):e0184725, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The Laurentian Great Lakes contain one fifth of the world's surface freshwater and have been impacted by human activity since the Industrial Revolution. In addition to legacy contaminants, nitrification and invasive species, this aquatic ecosystem is also the recipient of Contaminants of Emerging Concern (CECs) with poorly understood biological consequences. In the current study, we documented the presence, concentrations, and biological effects of CECs across 27 field sites in six Great Lakes tributaries by examining over 2250 resident and caged sunfish (Lepomis ssp.) for a variety of morphological and physiological endpoints and related these results to CEC occurrence. CEC were ubiquitous across studies sites and their presence and concentrations in water and sediment were highest in effluent dominated rivers and downstream of municipal wastewater treatment plant discharges. However, even putative upstream reference sites were not free of CEC presence and fish at these sites exhibited biological effects consistent with CEC exposure. Only the Fox River exhibited consistent adverse biological effects, including increased relative liver size, greater prominence of hepatocyte vacuoles and increased plasma glucose concentrations. Canonical Redundancy Analysis revealed consistent patterns of biological consequences of CEC exposure across all six tributaries. Increasing plasma glucose concentrations, likely as a result of pollutant-induced metabolic stress, were associated with increased relative liver size and greater prominence of hepatocyte vacuoles. These indicators of pollutant exposure were inversely correlated with indicators of reproductive potential including smaller gonad size and less mature gametes. The current study highlights the need for greater integration of chemical and biological studies and suggests that CECs in the Laurentian Great Lakes Basin may adversely affect the reproductive potential of exposed fish populations.
[Mh] Termos MeSH primário: Monitoramento Ambiental
Lagos/química
Poluentes Químicos da Água/análise
[Mh] Termos MeSH secundário: Determinação de Ponto Final
Estradiol/análise
Sedimentos Geológicos/química
América do Norte
Água/química
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Water Pollutants, Chemical); 059QF0KO0R (Water); 4TI98Z838E (Estradiol)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171024
[Lr] Data última revisão:
171024
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170928
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0184725


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[PMID]:28923832
[Au] Autor:Thompson A
[Ad] Endereço:Division of Cardiovascular and Renal Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland Aliza.Thompson@fda.hhs.gov.
[Ti] Título:Rethinking End Points in Clinical Trials of Renoprotective Medication.
[So] Source:Clin J Am Soc Nephrol;12(10):1561-1562, 2017 10 06.
[Is] ISSN:1555-905X
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Ensaios Clínicos como Assunto
Determinação de Ponto Final
[Mh] Termos MeSH secundário: Seres Humanos
[Pt] Tipo de publicação:EDITORIAL; COMMENT
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171025
[Lr] Data última revisão:
171025
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170920
[St] Status:MEDLINE
[do] DOI:10.2215/CJN.09040817


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[PMID]:28916286
[Au] Autor:Pénzes Á; Mahmud Abdelwahab EM; Rapp J; Péteri ZA; Bovári-Biri J; Fekete C; Miskei G; Kvell K; Pongrácz JE
[Ad] Endereço:PannonPharma Ltd., Biological Control Laboratory, 1 Pannonpharma Str., H-7720, Pécsvárad, Hungary.
[Ti] Título:Toxicology studies of primycin-sulphate using a three-dimensional (3D) in vitro human liver aggregate model.
[So] Source:Toxicol Lett;281:44-52, 2017 Nov 05.
[Is] ISSN:1879-3169
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Primycin-sulphate is a highly effective compound against Gram (G) positive bacteria. It has a potentially synergistic effect with vancomycin and statins which makes primycin-sulphate a potentially very effective preparation. Primycin-sulphate is currently used exclusively in topical preparations. In vitro animal hepatocyte and neuromuscular junction studies (in mice, rats, snakes, frogs) as well as in in vitro human red blood cell experiments were used to test toxicity. During these studies, the use of primycin-sulphate resulted in reduced cellular membrane integrity and modified ion channel activity. Additionally, parenteral administration of primycin-sulphate to mice, dogs, cats, rabbits and guinea pigs indicated high level of acute toxicity. The objective of this study was to reveal the cytotoxic and gene expression modifying effects of primycin-sulphate in a human system using an in vitro, three dimensional (3D) human hepatic model system. Within the 3D model, primycin-sulphate presented no acute cytotoxicity at concentrations 1µg/ml and below. However, even at low concentrations, primycin-sulphate affected gene expressions by up-regulating inflammatory cytokines (e.g., IL6), chemokines (e.g., CXCL5) and by down-regulating molecules of the lipid metabolism (e.g., peroxisome proliferator receptor (PPAR) alpha, gamma, etc). Down-regulation of PPAR alpha cannot just disrupt lipid production but can also affect cytochrome P450 metabolic enzyme (CYP) 3A4 expression, highlighting the need for extensive drug-drug interaction (DDI) studies before human oral or parenteral preparations can be developed.
[Mh] Termos MeSH primário: Imagem Tridimensional
Macrolídeos/toxicidade
Sulfatos/toxicidade
[Mh] Termos MeSH secundário: Sobrevivência Celular/efeitos dos fármacos
Quimiocina CXCL5/genética
Quimiocina CXCL5/metabolismo
Técnicas de Cocultura
Citocromo P-450 CYP3A/genética
Citocromo P-450 CYP3A/metabolismo
Relação Dose-Resposta a Droga
Regulação para Baixo
Determinação de Ponto Final
Células Hep G2
Hepatócitos/efeitos dos fármacos
Hepatócitos/metabolismo
Seres Humanos
Interleucina-6/genética
Interleucina-6/metabolismo
Metabolismo dos Lipídeos/efeitos dos fármacos
Análise em Microsséries
Modelos Moleculares
PPAR alfa/genética
PPAR alfa/metabolismo
PPAR gama/genética
PPAR gama/metabolismo
Regulação para Cima
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (CXCL5 protein, human); 0 (Chemokine CXCL5); 0 (IL6 protein, human); 0 (Interleukin-6); 0 (Macrolides); 0 (PPAR alpha); 0 (PPAR gamma); 0 (Sulfates); EC 1.14.13.67 (CYP3A4 protein, human); EC 1.14.14.1 (Cytochrome P-450 CYP3A); M3Y14N50DX (primycin)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171106
[Lr] Data última revisão:
171106
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170917
[St] Status:MEDLINE


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[PMID]:28914116
[Au] Autor:de Kleuver M; Faraj SSA; Holewijn RM; Germscheid NM; Adobor RD; Andersen M; Tropp H; Dahl B; Keskinen H; Olai A; Polly DW; van Hooff ML; Haanstra TM
[Ad] Endereço:a Department of Orthopedic Surgery , Radboud University Medical Center , Nijmegen , the Netherlands.
[Ti] Título:Defining a core outcome set for adolescent and young adult patients with a spinal deformity.
[So] Source:Acta Orthop;88(6):612-618, 2017 Dec.
[Is] ISSN:1745-3682
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Background and purpose - Routine outcome measurement has been shown to improve performance in several fields of healthcare. National spine surgery registries have been initiated in 5 Nordic countries. However, there is no agreement on which outcomes are essential to measure for adolescent and young adult patients with a spinal deformity. The aim of this study was to develop a core outcome set (COS) that will facilitate benchmarking within and between the 5 countries of the Nordic Spinal Deformity Society (NSDS) and other registries worldwide. Material and methods - From August 2015 to September 2016, 7 representatives (panelists) of the national spinal surgery registries from each of the NSDS countries participated in a modified Delphi study. With a systematic literature review as a basis and the International Classification of Functioning, Disability and Health framework as guidance, 4 consensus rounds were held. Consensus was defined as agreement between at least 5 of the 7 representatives. Data were analyzed qualitatively and quantitatively. Results - Consensus was reached on the inclusion of 13 core outcome domains: "satisfaction with overall outcome of surgery", "satisfaction with cosmetic result of surgery", "pain interference", physical functioning", "health-related quality of life", "recreation and leisure", "pulmonary fatigue", "change in deformity", "self-image", "pain intensity", "physical function", "complications", and "re-operation". Panelists agreed that the SRS-22r, EQ-5D, and a pulmonary fatigue questionnaire (yet to be developed) are the most appropriate set of patient-reported measurement instruments that cover these outcome domains. Interpretation - We have identified a COS for a large subgroup of spinal deformity patients for implementation and validation in the NSDS countries. This is the first study to further develop a COS in a global perspective.
[Mh] Termos MeSH primário: Consenso
Determinação de Ponto Final/métodos
Procedimentos Ortopédicos/métodos
Satisfação do Paciente
Qualidade de Vida
Curvaturas da Coluna Vertebral/cirurgia
[Mh] Termos MeSH secundário: Adolescente
Adulto
Técnica Delfos
Feminino
Seres Humanos
Masculino
Estudos Retrospectivos
Países Escandinavos e Nórdicos
Curvaturas da Coluna Vertebral/psicologia
Inquéritos e Questionários
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171109
[Lr] Data última revisão:
171109
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170916
[St] Status:MEDLINE
[do] DOI:10.1080/17453674.2017.1371371



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