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1.
Am J Nurs ; 121(5): 24-25, 2021 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-33872258

RESUMO

Cabenuva-an injectable formulation of cabotegravir and rilpivirine and the first injectable complete therapy for adults with HIV-1-is now approved.It is administered once a month as two intramuscular injections following a month of treatment with the oral forms of these drugs.


Assuntos
Fármacos Anti-HIV/normas , Antirretrovirais/normas , Infecções por HIV/tratamento farmacológico , Piridonas/normas , Rilpivirina/normas , Adulto , Fármacos Anti-HIV/uso terapêutico , Antirretrovirais/uso terapêutico , Aprovação de Drogas , Combinação de Medicamentos , Humanos , Injeções Intramusculares , Piridonas/uso terapêutico , Rilpivirina/uso terapêutico , Estados Unidos , United States Food and Drug Administration
3.
Bioanalysis ; 11(13): 1243-1254, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31397579

RESUMO

Aim: Hypidone hydrochloride (YL-0919) was a novel combined selective serotonin reuptake inhibitor and 5-hydroxytryptamine receptor agonist for treatment of major depressive disorder. Quantitation of YL-0919 in plasma samples was critical for evaluation of its pharmacokinetics in clinical studies. Methodology & results: An ultra HPLC-MS/MS method has been developed and validated. Plasma samples were extracted by SPE method and then chromatographed on an Acquity BEH C18 column. Detection was performed on an API-5500 tandem mass spectrometer using positive ESI. Conclusion: A sensitive and robust method was developed and validated for quantitative analysis of YL-0919 in human plasma samples for the first time. And this novel method was successfully applied to investigate pharmacokinetic profiles of YL-0919 in Chinese healthy subjects.


Assuntos
Cromatografia Líquida de Alta Pressão , Piperidinas/sangue , Piridonas/sangue , Espectrometria de Massas em Tandem , Cromatografia Líquida de Alta Pressão/normas , Meia-Vida , Humanos , Limite de Detecção , Piperidinas/isolamento & purificação , Piperidinas/normas , Piridonas/isolamento & purificação , Piridonas/normas , Controle de Qualidade , Reprodutibilidade dos Testes , Inibidores Seletivos de Recaptação de Serotonina/sangue , Inibidores Seletivos de Recaptação de Serotonina/isolamento & purificação , Inibidores Seletivos de Recaptação de Serotonina/normas , Extração em Fase Sólida , Espectrometria de Massas em Tandem/normas
4.
Medicina (Kaunas) ; 55(8)2019 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-31390809

RESUMO

Background and Objectives: Idiopathic pulmonary fibrosis (IPF) is a chronic condition leading to lung damage and deterioration in lung function. Following the availability of two new drugs, nintedanib and pirfenidone, a number of network meta-analyses (NMAs) of randomised controlled trials have been published which have conducted indirect comparisons on the two drugs. Differing recommendations from these studies are potentially confusing to clinicians and decision-makers. We aimed to systematically review published NMAs of IPF treatments, to compare their findings and summarise key recommendations. Materials and Methods: We systematically reviewed (PROSPERO: CRD42017072876) six eligible NMAs and investigated the differences in their findings with respect to key endpoints. We focused on differences in head-to-head comparisons between nintedanib and pirfenidone. Results: The NMAs were broadly consistent, with most differences being explained by model choice, endpoint definitions, inclusion of different studies, different follow-up durations, and access to unpublished data. A substantive difference remained, however, in the change from baseline forced vital capacity (FVC). One NMA favoured nintedanib, another found no statistical difference, whilst others did not conduct the analysis. These differences can be attributed to the choice of methodology, the use of the standardised mean difference (SMD) scale, and population heterogeneity. Conclusions: NMA methods facilitated the comparison of nintedanib and pirfenidone in the absence of a head-to-head trial. However, further work is needed to determine whether the trial populations are homogeneous and whether the SMD is appropriate in this population. Differences in patient characteristics may obscure the difference in treatment effects. To assist decision-makers, an exploration of efficacy in real-world populations may be prudent.


Assuntos
Fibrose Pulmonar Idiopática/tratamento farmacológico , Projetos de Pesquisa/normas , Resultado do Tratamento , Viés , Humanos , Indóis/normas , Indóis/uso terapêutico , Piridonas/normas , Piridonas/uso terapêutico , Projetos de Pesquisa/estatística & dados numéricos
5.
Intern Emerg Med ; 14(8): 1259-1270, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31073827

RESUMO

Patients with non-valvular atrial fibrillation (NVAF) and chronic kidney disease (CKD) are at increased risk of stroke and bleeding. Although direct oral anticoagulant (DOAC) trials excluded patients with severe CKD, a growing portion of CKD patients have been starting DOACs and limited data from real-world outcome in this high-risk setting are available. The INSigHT registry included 632 consecutive NVAF patients that started apixaban (256 patients, 41%), dabigatran (245, 39%) and rivaroxaban (131, 20%) between 2012 and 2015. Based on creatinine clearance, two sub-cohorts were defined: (1) non-CKD group (CrCl 60-89 mL/min, 413 patients) and (2) CKD group (15-59 ml/min, 219). Compared to non-CKD patients, those with CKD, were at higher ischemic (CHA2DS2-VASc 4.5 vs 2.9, p < 0.001) and hemorrhagic risk (HAS-BLED 2.4 vs 1.8, p < 0.001). At 2-year follow-up, the overall ISTH-major bleeding and thromboembolic event rates were 5.2% and 2.3% and no significant difference between non-CKD and CKD patients for both efficacy and safety endpoints were observed. In non-CKD patients, the 2-year ISTH-major bleeding rates were higher in rivaroxaban group (HR 2.9, 95% CI 1.1-7.3; p = 0.047) while dabigatran showed non-significant excess in thromboembolic events (HR 4.3, 95% CI 0.9-20.8; p = 0.068). In CKD patients, a significantly higher rate of thromboembolic events was observed in rivaroxaban (HR 6.3, 95% CI 1.1-38.1; p = 0.044). This real-world, non-insurance database registry shows remarkable 2-year safety and efficacy profile of DOACs even in patients with moderate to severe CKD. Head to head differences between DOACs are exploratory, hypothesis generating and warrant further investigation in larger studies.


Assuntos
Fibrilação Atrial/tratamento farmacológico , Insuficiência Renal Crônica/complicações , Resultado do Tratamento , Administração Oral , Idoso , Fibrilação Atrial/fisiopatologia , Dabigatrana/normas , Dabigatrana/uso terapêutico , Inibidores do Fator Xa/normas , Inibidores do Fator Xa/uso terapêutico , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Pirazóis/normas , Pirazóis/uso terapêutico , Piridonas/normas , Piridonas/uso terapêutico , Sistema de Registros/estatística & dados numéricos , Rivaroxabana/normas , Rivaroxabana/uso terapêutico , Estatísticas não Paramétricas
6.
Orthop Nurs ; 38(1): 43-52, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30676577

RESUMO

Anticoagulants serve as the primary strategy for the prevention and treatment of both arterial and venous thromboembolism. Anticoagulants disrupt coagulation by interfering at various points in the coagulation cascade. This class of medications does not lyse clots that already exist; rather, it prevents thrombus formation and prevents or slows the extension of an existing clot. For decades, the standard therapy for patients requiring oral anticoagulation was warfarin. However, due to some of the shortcomings of warfarin, including the need for continuous routine monitoring, longtime onset and offset of anticoagulation effect, major food and drug interactions, and high incidence of bleeding, newer agents, termed direct oral anticoagulants, or DOACs were developed. This article will provide a review of clinically important information regarding the most commonly used anticoagulants and their reversal agents.


Assuntos
Anticoagulantes/normas , Anticoagulantes/classificação , Benzamidas/classificação , Benzamidas/normas , Dabigatrana/classificação , Dabigatrana/normas , Humanos , Pirazóis/classificação , Pirazóis/normas , Piridinas/classificação , Piridinas/normas , Piridonas/classificação , Piridonas/normas , Rivaroxabana/classificação , Rivaroxabana/normas , Tiazóis/classificação , Tiazóis/normas , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/prevenção & controle , Varfarina/classificação , Varfarina/normas
7.
J Chromatogr Sci ; 55(9): 899-910, 2017 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-28505230

RESUMO

The present study focus on ICH prescribed stress degradation of ciclopirox olamine after precolumn derivatization. For establishing stability-indicating assay, the reaction solutions in which different degradation products were formed were mixed, and the separation was optimized by applying principle of QbD. A risk-analysis tools based on cause-effect risk assessment matrix with control-noise-experimentation (CNX) approach was utilized for identifying the high risk variable affecting the analytical attributes. Plackett Burman and central composite design was then used to screen and optimize experimental variables for DOE studies to resolve ciclopirox olamine and four of its degradation related impurities with good peak asymmetry and theoretical plates using C18 column. The method was validated according to ICH and ISO guidelines. To ensure reliability of the result, evaluation of risk profile, combined standard uncertainty and expanded uncertainty were also studied. One process related and four unknown degradation products were identified and characterized by LC-MS/MS study. The degradation pathways of degradants were proposed based on m/z values.


Assuntos
Piridonas/análise , Piridonas/química , Cromatografia Líquida/métodos , Ciclopirox , Contaminação de Medicamentos , Estabilidade de Medicamentos , Limite de Detecção , Modelos Lineares , Piridonas/normas , Reprodutibilidade dos Testes , Espectrometria de Massas em Tandem/métodos
9.
Mater Sci Eng C Mater Biol Appl ; 62: 596-604, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26952463

RESUMO

Zinc oxide nanocrystals-methylene blue nanocomposites were developed by electrodeposition of methylene blue onto the thin films of zinc oxide nanocrystals deposited onto SnO2/F coated glass substrates for in vitro sensing of anti-thalassemic drug i.e. deferiprone. Detailed morphological, electrochemical, structural and optical characterizations of ZnONC-MB/FTO electrode were done using XRD, SEM, EIS, FTIR, LSV, and CV and show quick response time (within 5 s), linearity as 1 × 10(-3) to 10(3) µM and shelf life of about 10 weeks under refrigerated conditions. Attempts have been made to utilize this electrode for estimation of deferiprone in urine samples. The developed sensor exhibited high reproducibility and good storage stability.


Assuntos
Técnicas Eletroquímicas , Quelantes de Ferro/análise , Nanopartículas Metálicas/química , Azul de Metileno/química , Óxido de Zinco/química , Calibragem , Deferiprona , Técnicas Eletroquímicas/normas , Eletrodos , Galvanoplastia , Flúor/química , Quelantes de Ferro/normas , Limite de Detecção , Microscopia Eletrônica de Varredura , Piridonas/análise , Piridonas/normas , Espectroscopia de Infravermelho com Transformada de Fourier , Compostos de Estanho/química , Difração de Raios X
10.
Skin Pharmacol ; 4(2): 89-94, 1991.
Artigo em Inglês | MEDLINE | ID: mdl-1831626

RESUMO

This report presents original methods to assess the bioavailability of an antifungal drug from a varnish preparation in finger nails. For the studies with human volunteers a ciclopirox 8% nail lacquer was used to determine its efficacy in the treatment of onychomycoses. In vivo studies were performed on the fingernails of healthy volunteers by determining the total amount of ciclopirox penetrated per milligram of nail and the partition of the drug in the plate of the nails (technically divided into four layers). Ciclopirox concentrations were evaluated by measuring the inhibition of Candida pseudotropicalis growth in vitro. The ciclopirox concentration after 30 days treatment was determined as 3.35 +/- 0.82 micrograms/mg nail material. This is a sufficient amount to kill the fungal pathogens. In addition, in vitro penetration experiments were carried out with excised pig skin. Lacquer formulations from 0.5 to 8% were used to inhibit the growth of Trichophyton mentagrophytes. Formulations from 2 to 8% led to a strong to total inhibition of the dermatophyte after 30 min treatment time.


Assuntos
Antifúngicos/administração & dosagem , Cosméticos/administração & dosagem , Unhas/efeitos dos fármacos , Piridonas/administração & dosagem , Pele/efeitos dos fármacos , Administração Tópica , Animais , Antifúngicos/farmacocinética , Antifúngicos/normas , Transporte Biológico/efeitos dos fármacos , Candida/crescimento & desenvolvimento , Ciclopirox , Cosméticos/farmacocinética , Cosméticos/normas , Relação Dose-Resposta a Droga , Dermatoses da Mão/tratamento farmacológico , Unhas/metabolismo , Onicomicose/tratamento farmacológico , Piridonas/farmacocinética , Piridonas/normas , Pele/metabolismo , Suínos , Trichophyton/crescimento & desenvolvimento
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