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[PMID]:26772905
[Au] Autor:Coleman JS; Fuchs E; Aung WS; Marzinke MA; Bakshi RP; Spiegel HML; Robinson J; Hendrix CW
[Ad] Endereço:Johns Hopkins University School of Medicine, Department of Gynecology & Obstetrics; Johns Hopkins University School of Medicine Division of Clinical Pharmacology, Department of Medicine. Electronic address: colemanj@jhmi.edu.
[Ti] Título:Feasibility of radiolabeled small molecule permeability as a quantitative measure of microbicide candidate toxicity.
[So] Source:Contraception;93(4):331-336, 2016 Apr.
[Is] ISSN:1879-0518
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To determine the feasibility of using quantitative changes in vaginal permeability to small molecules as a measure of candidate microbicide toxicity. STUDY DESIGN: Controlled, open-labeled, prospective study. Seven healthy women received a single vaginal dose of hydroxyethylcellulose gel (HEC), nonoxynol-9 (N-9) or K-Y Jelly. Each gel was radiolabeled with a small molecule ((99m)Tc-DTPA) followed by 12-h blood and urine collection. Pharmacokinetic (PK) parameters of (99m)Tc-DTPA were calculated to compare the impact of each gel on vaginal permeability. Each woman served as her own control. The Friedman test with post hoc Wilcoxon test was used to detect differences among the gels. RESULTS: Vaginal permeability of (99m)Tc-DTPA was highest for the N-9 radiolabel. N-9 plasma area under the concentration curve was 2.7-fold higher (p=.04), and peak concentration was threefold higher (p=.04) compared to HEC. There were no significant PK parameter differences between HEC and K-Y Jelly or between N-9 and K-Y Jelly. Cumulative dose-adjusted median (interquartile range) 12-h timed urine gamma activity was 66.70 × 10(-4)µCi (27.90-152.00) following HEC dosing, 103.00 × 10(-4)µCi (98.20-684.00) following N-9 gel dosing and 20.30 × 10(-4)µCi (11.10-55.90) following K-Y gel dosing. The differences between urine HEC and K-Y Jelly (p=.047) and between N-9 and K-Y Jelly (p=.016) were statistically significant. CONCLUSIONS: It is feasible to measure differences in vaginal permeability among vaginal gels using a radiolabeled small molecule, though there are permeability differences that require a nuanced understanding of gel composition to interpret the results. IMPLICATIONS: Establishing the safety of both vehicle and active pharmaceutical ingredient is an essential task in microbicide development, to be determined as soon as possible. This study suggests that a combination of microbicide toxicity assessments, that is, cervicovaginal permeability, inspection and histopathology, may need to be studied simultaneously.
[Mh] Termos MeSH primário: Permeabilidade da Membrana Celular
Vagina/metabolismo
[Mh] Termos MeSH secundário: Adolescente
Adulto
Anti-Infecciosos
Celulose/administração & dosagem
Celulose/análogos & derivados
Celulose/farmacocinética
Feminino
Géis
Glicerol/administração & dosagem
Glicerol/farmacocinética
Infecções por HIV/prevenção & controle
Seres Humanos
Meia-Idade
Nonoxinol/administração & dosagem
Nonoxinol/farmacocinética
Fosfatos/administração & dosagem
Fosfatos/farmacocinética
Propilenoglicóis/administração & dosagem
Propilenoglicóis/farmacocinética
Estudos Prospectivos
Pentetato de Tecnécio Tc 99m/farmacocinética
Cremes, Espumas e Géis Vaginais/química
Cremes, Espumas e Géis Vaginais/farmacocinética
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Nm] Nome de substância:
0 (Anti-Infective Agents); 0 (Gels); 0 (K-Y jelly); 0 (Phosphates); 0 (Propylene Glycols); 0 (Vaginal Creams, Foams, and Jellies); 26027-38-3 (Nonoxynol); 9004-34-6 (Cellulose); 9004-62-0 (hydroxyethylcellulose); PDC6A3C0OX (Glycerol); VW78417PU1 (Technetium Tc 99m Pentetate)
[Em] Mês de entrada:1612
[Cu] Atualização por classe:170916
[Lr] Data última revisão:
170916
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160117
[St] Status:MEDLINE


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[PMID]:26552463
[Au] Autor:Park S; Hwang IW; Kim JS; Kang HC; Park SY; Gil HW; Song HY; Hong SY
[Ad] Endereço:Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.
[Ti] Título:The effects of nonyl phenoxypolyethoxyl ethanol on cell damage pathway gene expression in SK-NSH cells.
[So] Source:Korean J Intern Med;30(6):873-83, 2015 Nov.
[Is] ISSN:2005-6648
[Cp] País de publicação:Korea (South)
[La] Idioma:eng
[Ab] Resumo:BACKGROUND/AIMS: Most pesticide formulations contain both chief and additive ingredients. But, the additives may not have been tested as thoroughly as the chief ingredients. The surfactant, nonyl phenoxypolyethoxylethanol (NP40), is an additive frequently present in pesticide formulations. We investigated the effects of NP40 and other constituents of a validamycin pesticide formulation on cell viability and on the expression of genes involved in cell damage pathways. METHODS: The effects of validamycin pesticide ingredients on cell viability and of NP40 on the mRNA expression of 80 genes involved in nine key cellular pathways were examined in the human neuroblastoma SK-N-SH cell line. RESULTS: The chemicals present in the validamycin pesticide formulation were cytotoxic to SK-N-SH cells and NP40 showed the greatest cytotoxicity. A range of gene expression changes were identified, with both up- and down-regulation of genes within the same pathway. However, all genes tested in the necrosis signaling pathway were down-regulated and all genes tested in the cell cycle checkpoint/arrest pathway were up-regulated. The median fold-change in gene expression was significantly higher in the cell cycle checkpoint/arrest pathway than in the hypoxia pathway category (p = 0.0064). The 70 kDa heat shock protein 4 gene, within the heat shock protein/unfolded protein response category, showed the highest individual increase in expression (26.1-fold). CONCLUSIONS: NP40 appeared to be particularly harmful, inducing gene expression changes that indicated genotoxicity, activation of the cell death (necrosis signaling) pathway, and induction of the 70 kDa heat shock protein 4 gene.
[Mh] Termos MeSH primário: Inositol/análogos & derivados
Neurônios/efeitos dos fármacos
Nonoxinol/toxicidade
Praguicidas/envenenamento
Tensoativos/toxicidade
[Mh] Termos MeSH secundário: Idoso
Pontos de Checagem do Ciclo Celular/efeitos dos fármacos
Pontos de Checagem do Ciclo Celular/genética
Linhagem Celular Tumoral
Sobrevivência Celular/efeitos dos fármacos
Relação Dose-Resposta a Droga
Feminino
Regulação da Expressão Gênica/efeitos dos fármacos
Genes cdc
Proteínas de Choque Térmico HSP110/genética
Proteínas de Choque Térmico HSP110/metabolismo
Seres Humanos
Inositol/química
Inositol/envenenamento
Necrose
Neurônios/metabolismo
Neurônios/patologia
Nonoxinol/química
Praguicidas/química
RNA Mensageiro/metabolismo
Transdução de Sinais/efeitos dos fármacos
Tensoativos/química
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (HSP110 Heat-Shock Proteins); 0 (HSPA4 protein, human); 0 (Pesticides); 0 (RNA, Messenger); 0 (Surface-Active Agents); 26027-38-3 (Nonoxynol); 4L6452S749 (Inositol); 50642-14-3 (validamycins)
[Em] Mês de entrada:1610
[Cu] Atualização por classe:161230
[Lr] Data última revisão:
161230
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:151111
[St] Status:MEDLINE
[do] DOI:10.3904/kjim.2015.30.6.873


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[PMID]:26177352
[Au] Autor:Smith-McCune K; Chen JC; Greenblatt RM; Shanmugasundaram U; Shacklett BL; Hilton JF; Johnson B; Irwin JC; Giudice LC
[Ad] Endereço:Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, California, United States of America.
[Ti] Título:Unexpected Inflammatory Effects of Intravaginal Gels (Universal Placebo Gel and Nonoxynol-9) on the Upper Female Reproductive Tract: A Randomized Crossover Study.
[So] Source:PLoS One;10(7):e0129769, 2015.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Intravaginal anti-HIV microbicides could provide women with a self-controlled means for HIV prevention, but results from clinical trials have been largely disappointing. We postulated that unrecognized effects of intravaginal gels on the upper female reproductive tract might contribute to the lower-than-expected efficacy of HIV microbicides. Our objective was to study the effects of intravaginal gels on the immune microenvironment of the cervix and uterus. In this randomized crossover study, 27 healthy female volunteers used a nightly application of intravaginal nonoxynol-9 (N9) gel as a "failed" microbicide or the universal placebo gel (UPG) as a "safe" gel (intervention cycles), or nothing (control cycle) from the end of menses to the mid-luteal phase. At a specific time-point following ovulation, all participants underwent sample collection for measurements of T-cell phenotypes, gene expression, and cytokine/chemokine protein concentrations from 3 anatomic sites above the vagina: the cervical transformation zone, the endocervix and the endometrium. We used hierarchical statistical models to estimate mean (95% CI) intervention effects, for N9 and UPG relative to control. Exposure to N9 gel and UPG generated a common "harm signal" that included transcriptional up-regulation of inflammatory genes chemokine (C-C motif) ligand 20 (macrophage inflammatory factor-3alpha) and interleukin 8 in the cervix, decreased protein concentrations of secretory leukocyte protease inhibitor, and transcriptional up-regulation of inflammatory mediators glycodelin-A and osteopontin in the endometrium. These results need to be replicated with a larger sample, but underscore the need to consider the effects of microbicide agents and gel excipients on the upper female reproductive tract in studies of vaginal microbicides.
[Mh] Termos MeSH primário: Fármacos Anti-HIV/efeitos adversos
Colo do Útero/efeitos dos fármacos
Colo do Útero/imunologia
Nonoxinol/efeitos adversos
Útero/efeitos dos fármacos
Útero/imunologia
[Mh] Termos MeSH secundário: Administração Intravaginal
Adulto
Fármacos Anti-HIV/administração & dosagem
Microambiente Celular/efeitos dos fármacos
Microambiente Celular/imunologia
Colo do Útero/metabolismo
Estudos Cross-Over
Feminino
Géis
Seres Humanos
Inflamação/induzido quimicamente
Inflamação/genética
Inflamação/imunologia
Nonoxinol/administração & dosagem
Fenótipo
Placebos
Linfócitos T/efeitos dos fármacos
Linfócitos T/imunologia
Transcriptoma/efeitos dos fármacos
Útero/metabolismo
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Nm] Nome de substância:
0 (Anti-HIV Agents); 0 (Gels); 0 (Placebos); 26027-38-3 (Nonoxynol)
[Em] Mês de entrada:1604
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:150716
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0129769


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[PMID]:25818602
[Au] Autor:Fichorova RN; Mendonca K; Yamamoto HS; Murray R; Chandra N; Doncel GF
[Ad] Endereço:Laboratory of Genital Tract Biology, Department of Obstetrics, Gynecology and Reproductive Biology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. Electronic address: rfichorova@rics.bwh.harvard.edu.
[Ti] Título:A quantitative multiplex nuclease protection assay reveals immunotoxicity gene expression profiles in the rabbit model for vaginal drug safety evaluation.
[So] Source:Toxicol Appl Pharmacol;285(3):198-206, 2015 Jun 15.
[Is] ISSN:1096-0333
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Any vaginal product that alters the mucosal environment and impairs the immune barrier increases the risk of sexually transmitted infections, especially HIV infection, which thrives on mucosal damage and inflammation. The FDA-recommended rabbit vaginal irritation (RVI) model serves as a first line selection tool for vaginal products; however, for decades it has been limited to histopathology scoring, insufficient to select safe anti-HIV microbicides. In this study we incorporate to the RVI model a novel quantitative nuclease protection assay (qNPA) to quantify mRNA levels of 25 genes representing leukocyte differentiation markers, toll-like receptors (TLR), cytokines, chemokines, epithelial repair, microbicidal and vascular markers, by designing two multiplex arrays. Tissue sections were obtained from 36 rabbits (6 per treatment arm) after 14 daily applications of a placebo gel, saline, 4% nonoxynol-9 (N-9), and three combinations of the anti-HIV microbicides tenofovir (TFV) and UC781 in escalating concentrations (highest: 10% TFV+2.5%UC781). Results showed that increased expression levels of toll-like receptor (TLR)-4, interleukin (IL)-1ß, CXCL8, epithelial membrane protein (EMP)-1 (P<0.05), and decreased levels of TLR2 (P<0.05), TLR3 and bactericidal permeability increasing protein (BPI) (P<0.001) were associated with cervicovaginal mucosal alteration (histopathology). Seven markers showed a significant linear trend predicting epithelial damage (up with CD4, IL-1ß, CXCL8, CCL2, CCL21, EMP1 and down with BPI). Despite the low tissue damage RVI scores, the high-dose microbicide combination gel caused activation of HIV host cells (SLC and CD4) while N-9 caused proinflammatory gene upregulation (IL-8 and TLR4) suggesting a potential for increasing risk of HIV via different mechanisms depending on the chemical nature of the test product.
[Mh] Termos MeSH primário: Avaliação Pré-Clínica de Medicamentos
Ensaios de Proteção de Nucleases/métodos
Transcriptoma
Vagina/efeitos dos fármacos
[Mh] Termos MeSH secundário: Adenina/administração & dosagem
Adenina/efeitos adversos
Adenina/análogos & derivados
Animais
Fármacos Anti-HIV/administração & dosagem
Fármacos Anti-HIV/efeitos adversos
Modelos Animais de Doenças
Relação Dose-Resposta a Droga
Combinação de Medicamentos
Estudos de Avaliação como Assunto
Feminino
Interações Hospedeiro-Patógeno
Imuno-Histoquímica
Inflamação/patologia
Interleucina-1beta/genética
Interleucina-1beta/metabolismo
Interleucina-8/genética
Interleucina-8/metabolismo
Membrana Mucosa/efeitos dos fármacos
Membrana Mucosa/metabolismo
Nonoxinol/administração & dosagem
Nonoxinol/efeitos adversos
Oligopeptídeos/genética
Oligopeptídeos/metabolismo
Organofosfonatos/administração & dosagem
Organofosfonatos/efeitos adversos
Coelhos
Tenofovir
Receptor 4 Toll-Like/genética
Receptor 4 Toll-Like/metabolismo
Vagina/patologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Anti-HIV Agents); 0 (Drug Combinations); 0 (Interleukin-1beta); 0 (Interleukin-8); 0 (Oligopeptides); 0 (Organophosphonates); 0 (Toll-Like Receptor 4); 0 (valyl-seryl-tryptophyl-phenylalanyl-phenylalanyl-glutamic acid); 26027-38-3 (Nonoxynol); 99YXE507IL (Tenofovir); JAC85A2161 (Adenine)
[Em] Mês de entrada:1507
[Cu] Atualização por classe:151119
[Lr] Data última revisão:
151119
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:150331
[St] Status:MEDLINE


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[PMID]:25751199
[Au] Autor:Schwartz JL; Weiner DH; Lai JJ; Frezieres RG; Creinin MD; Archer DF; Bradley L; Barnhart KT; Poindexter A; Kilbourne-Brook M; Callahan MM; Mauck CK
[Ad] Endereço:CONRAD, Eastern Virginia Medical School, Arlington, Virginia; FHI 360, Durham, North Carolina; the California Family Health Council, Los Angeles, California; the University of Pittsburgh, Pittsburgh, Pennsylvania; Johns Hopkins Community Physicians, Baltimore, Maryland; the University of Pennsylvania, Philadelphia, Pennsylvania; Baylor College of Medicine, Houston, Texas; and PATH, Seattle, Washington. Dr. Creinin is currently affiliated with the University of California, Davis, Sacramento, California.
[Ti] Título:Contraceptive efficacy, safety, fit, and acceptability of a single-size diaphragm developed with end-user input.
[So] Source:Obstet Gynecol;125(4):895-903, 2015 Apr.
[Is] ISSN:1873-233X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To estimate contraceptive efficacy, safety, acceptability, and fit of a single-size diaphragm used with contraceptive gel. METHODS: We conducted a multicenter trial in which 450 couples used the single-size diaphragm, 300 randomized to acid-buffering gel and 150 to nonoxynol-9, for at least 190 days and six menstrual cycles. Visits were at enrollment and after menstrual cycles 1, 3, and 6. Study outcomes included pregnancy probability, safety, acceptability, and fit. Pregnancy and safety were compared with an historical control group who used a standard diaphragm with these gels. RESULTS: Most (439/450 [98%]) women could be fitted with the single-size diaphragm. A total of 421 of 450 (94%) provided follow-up. The 35 study pregnancies yielded 6-month Kaplan-Meier cumulative typical use pregnancy probabilities per 100 women with 95% confidence intervals (CIs) of 10.4 (6.9-14.0) for all users and 9.6 (5.5-13.6) and 12.5 (5.4-19.5) with acid-buffering gel and nonoxynol-9, respectively. Historical control analysis yielded a propensity score-adjusted estimate of this pregnancy probability for the single-size diaphragm of 11.3 compared with 10.7 per 100 women for the standard diaphragm ([rounded] difference 0.7, 95% CI -3.6 to 4.9). Approximately half (51%) reported at least one urogenital event but compared favorably to the standard diaphragm in historical control analysis. Most (282/342 [82%]) liked the diaphragm. Results suggest that if provided by a clinician, 94% (95% CI 92-96%) could insert, correctly position, and remove the diaphragm. CONCLUSION: The single-size diaphragm was safe, as effective as a standard diaphragm, and acceptable when used with contraceptive gel. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00578877.
[Mh] Termos MeSH primário: Dispositivos Anticoncepcionais Femininos
Gravidez/estatística & dados numéricos
Espermicidas
Cremes, Espumas e Géis Vaginais
[Mh] Termos MeSH secundário: Resinas Acrílicas/efeitos adversos
Adulto
Dispositivos Anticoncepcionais Femininos/efeitos adversos
Desenho de Equipamento
Feminino
Seres Humanos
Masculino
Nonoxinol/efeitos adversos
Satisfação do Paciente
Pontuação de Propensão
Espermicidas/efeitos adversos
Cremes, Espumas e Géis Vaginais/efeitos adversos
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, U.S. GOV'T, NON-P.H.S.
[Nm] Nome de substância:
0 (Acrylic Resins); 0 (BufferGel); 0 (Spermatocidal Agents); 0 (Vaginal Creams, Foams, and Jellies); 26027-38-3 (Nonoxynol)
[Em] Mês de entrada:1505
[Cu] Atualização por classe:150324
[Lr] Data última revisão:
150324
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:150310
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1097/AOG.0000000000000721


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[PMID]:25347518
[Au] Autor:Ensign LM; Lai SK; Wang YY; Yang M; Mert O; Hanes J; Cone R
[Ad] Endereço:Center for Nanomedicine, ‡Department of Ophthalmology, The Wilmer Eye Institute, ⊥Department of Biomedical Engineering, and â—‹Departments of Neurosurgery and Oncology, Johns Hopkins University, School of Medicine , Baltimore, Maryland, United States.
[Ti] Título:Pretreatment of human cervicovaginal mucus with pluronic F127 enhances nanoparticle penetration without compromising mucus barrier properties to herpes simplex virus.
[So] Source:Biomacromolecules;15(12):4403-9, 2014 Dec 08.
[Is] ISSN:1526-4602
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Mucosal drug delivery nanotechnologies are limited by the mucus barrier that protects nearly all epithelial surfaces not covered with skin. Most polymeric nanoparticles, including polystyrene nanoparticles (PS), strongly adhere to mucus, thereby limiting penetration and facilitating rapid clearance from the body. Here, we demonstrate that PS rapidly penetrate human cervicovaginal mucus (CVM), if the CVM has been pretreated with sufficient concentrations of Pluronic F127. Importantly, the diffusion rate of large polyethylene glycol (PEG)-coated, nonmucoadhesive nanoparticles (PS-PEG) did not change in F127-pretreated CVM, implying that F127 did not significantly alter the native pore structure of CVM. Additionally, herpes simplex virus type 1 (HSV-1) remains adherent in F127-pretreated CVM, indicating that the presence of F127 did not reduce adhesive interactions between CVM and the virions. In contrast to treatment with a surfactant that has been approved for vaginal use as a spermicide (nonoxynol-9 or N9), there was no increase in inflammatory cytokine release in the vaginal tract of mice after daily application of 1% F127 for 1 week. Pluronic F127 pretreatment holds potential as a method to safely improve the distribution, retention, and efficacy of nanoparticle formulations without compromising CVM barrier properties to pathogens.
[Mh] Termos MeSH primário: Muco do Colo Uterino/efeitos dos fármacos
Portadores de Fármacos/química
Poloxâmero/farmacologia
Vagina/efeitos dos fármacos
Vagina/virologia
[Mh] Termos MeSH secundário: Animais
Muco do Colo Uterino/virologia
Feminino
Seres Humanos
Camundongos
Nanopartículas/química
Nanotecnologia
Nonoxinol/farmacologia
Poloxâmero/química
Simplexvirus/patogenicidade
Tensoativos/farmacologia
Vagina/metabolismo
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Nm] Nome de substância:
0 (Drug Carriers); 0 (Surface-Active Agents); 106392-12-5 (Poloxamer); 26027-38-3 (Nonoxynol)
[Em] Mês de entrada:1508
[Cu] Atualização por classe:161019
[Lr] Data última revisão:
161019
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:141028
[St] Status:MEDLINE
[do] DOI:10.1021/bm501419z


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[PMID]:25333937
[Au] Autor:Fields S; Song B; Rasoul B; Fong J; Works MG; Shew K; Yiu Y; Mirsalis J; D'Andrea A
[Ad] Endereço:Biosciences Division, SRI International, Menlo Park, California, United States of America.
[Ti] Título:New candidate biomarkers in the female genital tract to evaluate microbicide toxicity.
[So] Source:PLoS One;9(10):e110980, 2014.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Vaginal microbicides hold great promise for the prevention of viral diseases like HIV, but the failure of several microbicide candidates in clinical trials has raised important questions regarding the parameters to be evaluated to determine in vivo efficacy in humans. Clinical trials of the candidate microbicides nonoxynol-9 (N9) and cellulose sulfate revealed an increase in HIV infection, vaginal inflammation, and recruitment of HIV susceptible lymphocytes, highlighting the need to identify biomarkers that can accurately predict microbicide toxicity early in preclinical development and in human trials. We used quantitative proteomics and RT-PCR approaches in mice and rabbits to identify protein changes in vaginal fluid and tissue in response to treatment with N9 or benzalkonium chloride (BZK). We compared changes generated with N9 and BZK treatment to the changes generated in response to tenofovir gel, a candidate microbicide that holds promise as a safe and effective microbicide. Both compounds down regulated mucin 5 subtype B, and peptidoglycan recognition protein 1 in vaginal tissue; however, mucosal brush samples also showed upregulation of plasma proteins fibrinogen, plasminogen, apolipoprotein A-1, and apolipoprotein C-1, which may be a response to the erosive nature of N9 and BZK. Additional proteins down-regulated in vaginal tissue by N9 or BZK treatment include CD166 antigen, olfactomedin-4, and anterior gradient protein 2 homolog. We also observed increases in the expression of C-C chemokines CCL3, CCL5, and CCL7 in response to treatment. There was concordance in expression level changes for several of these proteins using both the mouse and rabbit models. Using a human vaginal epithelial cell line, the expression of mucin 5 subtype B and olfactomedin-4 were down-regulated in response to N9, suggesting these markers could apply to humans. These data identifies new proteins that after further validation could become part of a panel of biomarkers to effectively evaluate microbicide toxicity.
[Mh] Termos MeSH primário: Citocinas/biossíntese
Genitália Feminina/efeitos dos fármacos
Fator Estimulador de Colônias de Granulócitos/biossíntese
Infecções por HIV/tratamento farmacológico
Mucina-5B/biossíntese
[Mh] Termos MeSH secundário: Administração Intravaginal
Animais
Anti-Infecciosos/efeitos adversos
Compostos de Benzalcônio/efeitos adversos
Biomarcadores/metabolismo
Celulose/efeitos adversos
Celulose/análogos & derivados
Feminino
Regulação da Expressão Gênica/efeitos dos fármacos
Genitália Feminina/metabolismo
Genitália Feminina/patologia
Infecções por HIV/metabolismo
Infecções por HIV/patologia
Seres Humanos
Camundongos
Nonoxinol/efeitos adversos
Coelhos
Vagina/efeitos dos fármacos
Vagina/metabolismo
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Nm] Nome de substância:
0 (Anti-Infective Agents); 0 (Benzalkonium Compounds); 0 (Biomarkers); 0 (Cytokines); 0 (Muc5b protein, mouse); 0 (Mucin-5B); 0 (OLFM4 protein, human); 0 (Pglyrp1 protein, mouse); 143011-72-7 (Granulocyte Colony-Stimulating Factor); 26027-38-3 (Nonoxynol); 9004-34-6 (Cellulose); 9032-43-3 (cellulose sulfate)
[Em] Mês de entrada:1512
[Cu] Atualização por classe:161019
[Lr] Data última revisão:
161019
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:141022
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0110980


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[PMID]:25243914
[Au] Autor:Chakraborty D; Maity A; Jha T; Mondal NB
[Ad] Endereço:Department of Chemistry, Indian Institute of Chemical Biology, Council of Scientific and Industrial Research, Jadavpur, Kolkata, West Bengal, India.
[Ti] Título:Spermicidal and contraceptive potential of desgalactotigonin: a prospective alternative of nonoxynol-9.
[So] Source:PLoS One;9(9):e107164, 2014.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Crude decoction of Chenopodium album seed showed spermicidal effect at MIC 2 mg/ml in earlier studies. Systematic isolation, characterization and evaluation revealed that the major metabolite Desgalactotigonin (DGT) is the most effective principle in both in vitro and in vivo studies. The in vitro studies comprises (a) rat and human sperm motility and immobilizing activity by Sander-Cramer assay; (b) sperm membrane integrity was observed by HOS test and electron microscopy; (c) microbial potential was examined in Lactobacillus broth culture, and (d) the hemolytic index was determined by using rat RBCs. The in vivo contraceptive efficacy was evaluated by intra uterine application of DGT in rat. Lipid peroxidation and induction of apoptosis by DGT on human spermatozoa were also studied. The minimum effective concentration (MEC) of DGT that induced instantaneous immobilization in vitro was 24.18 µM for rat and 58.03 µM for human spermatozoa. Microbial study indicated DGT to be friendly to Lactobacillus acidophilus. Implantation was prevented in DGT treated uterine horn while no hindrance occurred in the untreated contra lateral side. At the level of EC50, DGT induced apoptosis in human spermatozoa as determined by increased labeling with Annexin-V and decreased polarization of sperm mitochondria. Desgalactotigonin emerged 80 and 2×10(4) times more potent than the decoction and Nonoxynol-9 respectively. It possesses mechanism based detrimental action on both human and rat spermatozoa and spares lactobacilli and HeLa cells at MEC which proves its potential as a superior ingredient for the formulation of a contraceptive safer/compatible to vaginal microflora.
[Mh] Termos MeSH primário: Chenopodium album
Anticoncepcionais/farmacologia
Extratos Vegetais/farmacologia
Saponinas/farmacologia
Motilidade Espermática/efeitos dos fármacos
Espermicidas/farmacologia
Espermatozoides/efeitos dos fármacos
Esteroides/farmacologia
[Mh] Termos MeSH secundário: Animais
Apoptose/efeitos dos fármacos
Sobrevivência Celular/efeitos dos fármacos
Seres Humanos
Peroxidação de Lipídeos/efeitos dos fármacos
Masculino
Nonoxinol/farmacologia
Ratos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Contraceptive Agents); 0 (Plant Extracts); 0 (Saponins); 0 (Spermatocidal Agents); 0 (Steroids); 0 (degalactotigonin); 26027-38-3 (Nonoxynol)
[Em] Mês de entrada:1506
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:140923
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0107164


  9 / 586 MEDLINE  
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[PMID]:25160062
[Au] Autor:Rongxiu L; Guozheng L; Xiaoqun L; Huiyan T
[Ad] Endereço:Central Laboratory of Hebei Research Institute for Family Planning , Shijiazhuang, Hebei Province , China.
[Ti] Título:Spermicidal and antifertility effects of an imbibing and soluble nonoxynol-9 diaphragm (ISND) in rabbits.
[So] Source:Eur J Contracept Reprod Health Care;19(6):465-74, 2014 Dec.
[Is] ISSN:1473-0782
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To determine the minimum effective concentration (MEC) of an imbibing and soluble nonoxynol-9 (N-9) diaphragm (ISND) required for immobilisation of all spermatozoa in vitro and in vivo. The speed of semen absorbance, time of ISND to dissolution, and the antifertility effects were also investigated in rabbits. METHODS: In vitro spermicidal tests with ISND were conducted using fresh semen from humans and rabbits. Spermicidal and antifertility effects were observed in vivo after the ISND was placed directly into the vagina of rabbits. RESULTS: The MEC of N-9 required in the ISND to totally immobilise sperm within 20 seconds was 0.15 mg/ml for human sperm, and 0.5 mg/ml for rabbit sperm. The human semen was absorbed into the ISND in 45 minutes; the diaphragm dissolved in the vagina 3.5 hours later. In vivo, in rabbits, the MEC of N-9 required to immobilise sperm within five minutes of mating was 1 mg/kg in the ISND, and 10 mg/kg for the nonoxynol-9 film. The median effective dose of N-9 in the ISND was 1.07 mg/kg, whereas for the film it was 3.30 mg/kg. CONCLUSION: The spermicidal and antifertility activities of a low dose N-9 in the ISND were high, with properties of imbibition and solubility confirmed.
[Mh] Termos MeSH primário: Dispositivos Anticoncepcionais Femininos
Nonoxinol/administração & dosagem
Espermicidas/administração & dosagem
[Mh] Termos MeSH secundário: Animais
Feminino
Seres Humanos
Masculino
Nonoxinol/farmacologia
Coelhos
Sêmen
Motilidade Espermática/efeitos dos fármacos
Espermicidas/farmacologia
Espermatozoides/efeitos dos fármacos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Spermatocidal Agents); 26027-38-3 (Nonoxynol)
[Em] Mês de entrada:1508
[Cu] Atualização por classe:141121
[Lr] Data última revisão:
141121
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:140828
[St] Status:MEDLINE
[do] DOI:10.3109/13625187.2014.950729


  10 / 586 MEDLINE  
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[PMID]:25022144
[Au] Autor:Kyamwanga IT; Turyakira E; Kilbourne-Brook M; Coffey PS
[Ti] Título:Potential for revitalisation of the diaphragm for family planning in Uganda: a rapid assessment of the feasibility of introducing the SILCS Diaphragm.
[So] Source:Afr J Reprod Health;18(2):77-86, 2014 Jun.
[Is] ISSN:1118-4841
[Cp] País de publicação:Nigeria
[La] Idioma:eng
[Ab] Resumo:This health systems assessment evaluated the feasibility of introducing a new contraceptive device, the SILCS single-size diaphragm, into the existing family planning method mix in Uganda. A total of 26 focus group discussions with 201 female and 77 male potential users and 98 key informant interviews with policymakers and providers were conducted between June and August 2010. Potential users, providers, and policymakers recognised that the SILCS Diaphragm could fill a gap in the method mix and expressed eagerness to make the SILCS Diaphragm available, particularly because it is nonhormonal and woman initiated. The diaphragm was viewed by all stakeholders as a method that would increase choice and could improve women's reproductive health in Uganda. Like many countries, Uganda's family planning programme is financially stretched, and clear support for the SILCS Diaphragm by end-users will need to be demonstrated before the product will be considered for public-sector introduction.
[Mh] Termos MeSH primário: Dispositivos Anticoncepcionais Femininos
Serviços de Planejamento Familiar
[Mh] Termos MeSH secundário: Adolescente
Adulto
Feminino
Grupos Focais
Infecções por HIV/prevenção & controle
Seres Humanos
Masculino
Nonoxinol/administração & dosagem
Uganda
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, U.S. GOV'T, NON-P.H.S.
[Nm] Nome de substância:
26027-38-3 (Nonoxynol)
[Em] Mês de entrada:1408
[Cu] Atualização por classe:140715
[Lr] Data última revisão:
140715
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:140716
[St] Status:MEDLINE



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