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[PMID]: 28526167 [Au] Autor: Park JY; Seong SJ; Kim TJ; Kim JW; Bae DS; Nam JH [Ad] Endereço: Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea. [Ti] Título: Significance of body weight change during fertility-sparing progestin therapy in young women with early endometrial cancer. [So] Source: Gynecol Oncol;146(1):39-43, 2017 Jul. [Is] ISSN: 1095-6859 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: OBJECTIVE: To evaluate the influence of body weight change during fertility-sparing progestin therapy on oncologic and reproductive outcomes in young women with early-stage endometrial cancer who did not complete child bearing. METHODS: This multicenter, retrospective study included 154 young patients with well-differentiated, endometrium-confined endometrioid endometrial adenocarcinoma on magnetic resonance imaging who received fertility-sparing progestin therapy. RESULTS: The mean body weight and body mass index (BMI) at baseline and progestin therapy completion was 65.3±16.2 and 66.5±15.9kg (P=0.044), respectively, and 25.51±5.99 and 25.99±5.94kg/m (P=0.034), respectively. During progestin therapy, 51 (33.1%), 29 (18.8%), and 74 patients (48.1%) had weight loss, no weight change, and weight gain, respectively, of which 11 (7.1%) had 10% weight loss and 30 (19.5%) had 10% weight gain. A pretreatment BMI of ≥25kg/m was significantly associated with a lower complete response rate to progestin therapy (P=0.003) and a high recurrence rate (P=0.033). A posttreatment BMI of ≥25kg/m was also a significant factor for high recurrence rate (P=0.049). However, weight change during therapy was not significantly associated with complete response or recurrence rate. Pre and posttreatment BMIs and weight change were not associated with pregnancy and live birth rates. CONCLUSION: Weight change during progestin therapy has little influence on complete response, recurrence, pregnancy, and live birth rates. However, pre and posttreatment BMIs of ≥25kg/m were significant predictors for poor treatment response and high recurrence. Therefore, it is important to maintain patients' normal BMIs during progestin therapy. [Mh] Termos MeSH primário: Antineoplásicos Hormonais/administração & dosagem Peso Corporal/efeitos dos fármacos Neoplasias do Endométrio/tratamento farmacológico Neoplasias do Endométrio/fisiopatologia Preservação da Fertilidade/métodos Progestinas/administração & dosagem [Mh] Termos MeSH secundário: Adulto Índice de Massa Corporal Neoplasias do Endométrio/patologia Feminino Seres Humanos Acetato de Medroxiprogesterona/administração & dosagem Acetato de Megestrol/administração & dosagem Estadiamento de Neoplasias Gravidez Resultado da Gravidez Taxa de Gravidez Estudos Retrospectivos [Pt] Tipo de publicação: JOURNAL ARTICLE; MULTICENTER STUDY [Nm] Nome de substância: 0 (Antineoplastic Agents, Hormonal); 0 (Progestins); C2QI4IOI2G (Medroxyprogesterone Acetate); TJ2M0FR8ES (Megestrol Acetate) [Em] Mês de entrada: 1707 [Cu] Atualização por classe: 170713 [Lr] Data última revisão: 170713 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 170521 [St] Status: MEDLINE

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[PMID]: 28353144 [Au] Autor: Moradan S; Nikkhah N; Mirmohammadkhanai M [Ad] Endereço: Gynecologist, Abnormal Uterine Bleeding Research Center, Semnan University of Medical Sciences, Semnan, Iran. [Ti] Título: Comparing the Administration of Letrozole and Megestrol Acetate in the Treatment of Women with Simple Endometrial Hyperplasia without Atypia: A Randomized Clinical Trial. [So] Source: Adv Ther;34(5):1211-1220, 2017 May. [Is] ISSN: 1865-8652 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: INTRODUCTION: The present study was conducted as a pilot to compare the therapeutic effects and the potential side effects of oral Megestrol acetate and Letrozole in the treatment of simple hyperplasia in perimenopausal women. METHODS: The participants of this randomized clinical trial consisted of two groups of 25 women aged 44-50 presenting with abnormal uterine bleeding diagnosed with simple endometrial hyperplasia without cytologic atypia confirmed by transvaginal ultrasonography and biopsy. The first group received 40-mg doses of Megestrol acetate for 2 weeks per month for a total period of 2 months. The second group received 2.5-mg daily doses of Letrozole for a total period of 2 months. The differences in terms of quantitative measurements were analyzed using the independent two-sample t test and the paired t test. To compare the two groups in terms of the distribution of the categorical variables, Pearson's Chi square and Fisher's Exact tests were used at the significance level of 0.05 by Stata-9.2. RESULTS: Although the intervention led to significant improvements in both groups (P < .001), there was no difference between the groups in terms of accomplishing resolution (P = .74) [seven (28%) patients in the Letrozole group and five (20%) in the Megestrol group], while two patients in the Letrozole group and nine in the Megestrol group suffered from side effects, suggesting significantly lower side effects in the Letrozole group (P = .02). CONCLUSION: Letrozole and Megestrol acetate seem to have similar effects on the treatment of simple endometrial hyperplasia, the only difference being that Letrozole presents fewer side effects than Megestrol acetate in patients with this condition. FUNDING: Abnormal Uterine Bleeding Research Center of Semnan University of Medical Sciences, Semnan, Iran. TRIAL REGISTRATION: IRCT2015031011504N5. [Mh] Termos MeSH primário: Hiperplasia Endometrial/tratamento farmacológico Acetato de Megestrol/uso terapêutico Nitrilos/uso terapêutico Triazóis/uso terapêutico [Mh] Termos MeSH secundário: Administração Oral Adulto Feminino Seres Humanos Meia-Idade Projetos Piloto [Pt] Tipo de publicação: COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL [Nm] Nome de substância: 0 (Nitriles); 0 (Triazoles); 7LKK855W8I (letrozole); TJ2M0FR8ES (Megestrol Acetate) [Em] Mês de entrada: 1710 [Cu] Atualização por classe: 171010 [Lr] Data última revisão: 171010 [Sb] Subgrupo de revista: T [Da] Data de entrada para processamento: 170330 [St] Status: MEDLINE [do] DOI: 10.1007/s12325-017-0509-8

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[PMID]: 28026855 [Au] Autor: Greenwald ZR; Huang LN; Wissing MD; Franco EL; Gotlieb WH [Ad] Endereço: Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada. [Ti] Título: Does hormonal therapy for fertility preservation affect the survival of young women with early-stage endometrial cancer? [So] Source: Cancer;123(9):1545-1554, 2017 May 01. [Is] ISSN: 1097-0142 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: BACKGROUND: The incidence of endometrial cancer among young women is increasing. Some patients with low-grade endometrial cancer receive hormone therapy (HT) before surgery to preserve fertility. It is unclear whether this adversely affects survival. METHODS: Patients with localized, low-grade endometrial cancer who were aged <45 years were selected from the Surveillance, Epidemiology, and End Results database between 1993 and 2012. Propensity score matching was used to select comparable groups receiving HT or primary surgery. Cancer-specific and overall survival were measured using Kaplan-Meier methods. Hazard ratios and 95% confidence intervals (95% CIs) were estimated using Cox models adjusted for age, period of diagnosis, marital status, race, tumor grade, morphology, and previous radiotherapy. RESULTS: A total of 6339 women were included in the current study cohort, 161 of whom initially received HT and 6178 of whom received primary surgery. After 15 years of follow-up, all-cause mortality did not differ between the groups (HT group: 14.1% [95% CI, 6.7%-28.4%] and propensity score-matched primary surgery group: 9.3% [95% CI, 4.1%-20.5%]). Cancer-specific mortality appeared higher in patients treated with HT compared with those treated with primary surgery (9.2% [95% CI, 3.4%-24.0%] vs 2.1% [95% CI, 1.5%-2.8%]). However, this difference was driven by 3 late deaths in the HT group. Sensitivity analyses using a broader definition of cancer-specific mortality provided no statistical evidence of a survival difference between the treatment groups. The hazard ratio for the overall risk of death was 1.45 (95% CI, 0.44-4.74). CONCLUSIONS: Based on this population-based cohort, young patients with low-grade endometrial cancer appear to have excellent survival, regardless of the primary therapy chosen (HT vs primary surgery). The current selection of patients for HT to preserve fertility, which is managed carefully by experienced clinicians, does not appear to significantly worsen clinical outcomes. Cancer 2017;123:1545-1554. © 2017 American Cancer Society. [Mh] Termos MeSH primário: Antineoplásicos Hormonais/uso terapêutico Carcinoma Endometrioide/tratamento farmacológico Neoplasias do Endométrio/tratamento farmacológico Preservação da Fertilidade/métodos Histerectomia [Mh] Termos MeSH secundário: Adulto Carcinoma Endometrioide/mortalidade Causas de Morte Estudos de Coortes Neoplasias do Endométrio/mortalidade Feminino Seres Humanos Estimativa de Kaplan-Meier Medroxiprogesterona/uso terapêutico Acetato de Medroxiprogesterona/uso terapêutico Acetato de Megestrol/uso terapêutico Gradação de Tumores Pontuação de Propensão Modelos de Riscos Proporcionais Programa de SEER Fatores de Tempo Estados Unidos [Pt] Tipo de publicação: JOURNAL ARTICLE; OBSERVATIONAL STUDY [Nm] Nome de substância: 0 (Antineoplastic Agents, Hormonal); C2QI4IOI2G (Medroxyprogesterone Acetate); HSU1C9YRES (Medroxyprogesterone); TJ2M0FR8ES (Megestrol Acetate) [Em] Mês de entrada: 1708 [Cu] Atualização por classe: 170811 [Lr] Data última revisão: 170811 [Sb] Subgrupo de revista: AIM; IM [Da] Data de entrada para processamento: 161228 [St] Status: MEDLINE [do] DOI: 10.1002/cncr.30529

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[PMID]: 27670256 [Au] Autor: Falcone F; Laurelli G; Losito S; Di Napoli M; Granata V; Greggi S [Ad] Endereço: Gynecologic Oncology Surgery, National Cancer Institute of Naples-IRCCS "Fondazione G. Pascale", Naples, Italy. [Ti] Título: Fertility preserving treatment with hysteroscopic resection followed by progestin therapy in young women with early endometrial cancer. [So] Source: J Gynecol Oncol;28(1):e2, 2017 Jan. [Is] ISSN: 2005-0399 [Cp] País de publicação: Korea (South) [La] Idioma: eng [Ab] Resumo: OBJECTIVE: To report our 15-year institutional experience of fertility-sparing treatment in young patients with early endometrial cancer (EC) treated by combined hysteroscopic resection and progestin therapy. METHODS: Twenty-eight patients (stage IA, G1 and 2 endometrioid EC) wishing to preserve their fertility were enrolled into this prospective study. Hysteroscopic resection was used to resect the tumor, endometrium adjacent to the tumor and myometrium underlying the tumor. Adjuvant hormonal therapy consisted of oral megestrol acetate or levonorgestrel intrauterine device for 6 months or more. RESULTS: After 3 months from the progestin start date, 25 patients (89.3%) showed a complete regression (median time to complete regression, 3 months [range, 3-9 months]), two (7.1%) showed persistent disease, while one patient (3.6%) presented with progressive disease and underwent definitive surgery (stage IA, G3 endometrioid). At 6 months, one of the two patients with persistent disease underwent definitive surgery (stage IA, G1 endometrioid), while the other one was successfully re-treated. Two recurrences were observed (7.7%) both involving the endometrium and synchronous ovarian cancer. The median duration of complete response was 94.5 months (range, 8-175 months). More than half of the responders (57.7%) attempted to conceive with 93.3% and 86.6% pregnancy and live birth rates, respectively. CONCLUSION: The addition of a standardized three-step resectoscopy to progestin would seem to improve the efficacy of progestin alone. High pregnancy and live birth rates were observed in women attempting to conceive. [Mh] Termos MeSH primário: Antineoplásicos Hormonais/administração & dosagem Neoplasias do Endométrio/terapia Preservação da Fertilidade/métodos Histeroscopia Acetato de Megestrol/administração & dosagem Progestinas/uso terapêutico [Mh] Termos MeSH secundário: Adulto Quimioterapia Adjuvante Terapia Combinada Neoplasias do Endométrio/patologia Feminino Seres Humanos Dispositivos Intrauterinos Levanogestrel/administração & dosagem Gravidez Estudos Prospectivos Adulto Jovem [Pt] Tipo de publicação: JOURNAL ARTICLE [Nm] Nome de substância: 0 (Antineoplastic Agents, Hormonal); 0 (Progestins); 5W7SIA7YZW (Levonorgestrel); TJ2M0FR8ES (Megestrol Acetate) [Em] Mês de entrada: 1707 [Cu] Atualização por classe: 170817 [Lr] Data última revisão: 170817 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 160928 [St] Status: MEDLINE [do] DOI: 10.3802/jgo.2017.28.e2

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[PMID]: 27639080 [Au] Autor: Guk J; Son H; Chae DW; Park K [Ad] Endereço: Department of Pharmacology, Yonsei University College of Medicine, Seoul, Korea. [Ti] Título: Quantitative Assessment of Food Effect on the Pharmacokinetics of Nano-Crystallized Megestrol Acetate. [So] Source: Basic Clin Pharmacol Toxicol;120(3):270-277, 2017 Mar. [Is] ISSN: 1742-7843 [Cp] País de publicação: England [La] Idioma: eng [Ab] Resumo: Megestrol acetate, an appetite stimulant with low bioavailability, shows increased bioavailability when taken together with food. However, the pharmacokinetic characteristics of megestrol acetate and its relation with food are not well understood. This study aimed to investigate the food effect on the pharmacokinetics (PK) of the recently developed nano-crystallized megestrol acetate (NCMA), using a model-based approach. Data were obtained from an NCMA PK study consisting of a single dose in fasting (39 individuals) and fed conditions (40 individuals). Plasma concentrations were measured up to 120 hr after dosing. With the incorporation of body-weight via allometry, NONMEM 7.3 was used to develop a PK model, which was then used to simulate an optimal fasting dose yielding an area under concentration (AUC) and maximum concentration (C ) of NCMA close to those obtained with the fed dose. NCMA concentrations were best characterized by a two-compartment model with first-order absorption linked to a recycling compartment to account for the multiple concentration peaks observed. Food increased bioavailability 2.2 times and decreased the absorption rate constant 0.58 times. Recycling event times were estimated to be 3.56, 7.99 and 24.0 hr. The optimal fast dose was 2.0 times higher than the fed dose, and the resulting difference in drug exposure between the fasting and fed dose was 7.5%. This work suggests that the PK model developed can be applied to an optimal dosage regimen design for NCMA treatment. [Mh] Termos MeSH primário: Estimulantes do Apetite/administração & dosagem Estimulantes do Apetite/farmacocinética Interações Alimento-Droga Acetato de Megestrol/administração & dosagem Acetato de Megestrol/farmacocinética Modelos Biológicos [Mh] Termos MeSH secundário: Administração Oral Adulto Estimulantes do Apetite/uso terapêutico Disponibilidade Biológica Caquexia/tratamento farmacológico Estudos Cross-Over Sistemas de Liberação de Medicamentos/métodos Cálculos da Dosagem de Medicamento Ingestão de Alimentos Jejum Voluntários Saudáveis Seres Humanos Masculino Acetato de Megestrol/uso terapêutico Nanopartículas República da Coreia Adulto Jovem [Pt] Tipo de publicação: CLINICAL TRIAL; JOURNAL ARTICLE [Nm] Nome de substância: 0 (Appetite Stimulants); TJ2M0FR8ES (Megestrol Acetate) [Em] Mês de entrada: 1703 [Cu] Atualização por classe: 170302 [Lr] Data última revisão: 170302 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 160918 [St] Status: MEDLINE [do] DOI: 10.1111/bcpt.12677

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[PMID]: 27343306 [Au] Autor: Gungor T; Cetinkaya N; Yalcin H; Zergeroglu S; Erkaya S [Ad] Endereço: Zekai Tahir Burak Women's Health Education and Research Hospital, Department of Gynecologic Oncology, Ankara, Turkey. [Ti] Título: Clinicopathologic characteristics and treatment features of women with the incidental diagnosis of endometrial adenocarcinoma during infertility follow-up in Ankara, Turkey. [So] Source: Taiwan J Obstet Gynecol;55(3):309-13, 2016 Jun. [Is] ISSN: 1875-6263 [Cp] País de publicação: China (Republic : 1949- ) [La] Idioma: eng [Ab] Resumo: OBJECTIVE: The aim of this study was to investigate the clinical and laboratory features of patients with the incidental diagnosis of endometrial adenocarcinoma (EC) during infertility work-up, with special attention given to treatment approaches, recurrence rate, and fertility outcome. MATERIAL AND METHODS: The medical records of 577 patients who were diagnosed with EC and treated between 2007 and 2013 were included in the study. Out of 577 EC patients, 5.1% (n = 30) were ≤ 40 years of age. However, 10 patients had a history of infertility and had been diagnosed during evaluation for infertility. Patients' clinical and laboratory data were reviewed retrospectively. RESULTS: The mean age at diagnosis was 34.3 ± 4.5 years and the mean duration of infertility was 5.1 ± 4.7 years. Immediate staging surgery was performed on three patients. The others were treated with oral megestrol acetate and/or a levonorgestrel-containing intrauterine device (IUD) for 6 months. The mean duration of postoperative or postdiagnostic follow-up was 44.7 ± 25.9 months. The disease persistence and recurrence rates were 11.1% and 22.2%, respectively. Two patients achieved pregnancy naturally or by assisted reproductive technology (ART) trial. CONCLUSION: The investigation of patients during infertility work-up provides an opportunity to evaluate the endometrium and its malignancies in young women, when the disease is in its early stage and symptom free. The standard surgical treatment for early-stage EC is total hysterectomy with bilateral salpingo-oophorectomy. However, conservative management of early stage EC with progestational drugs, especially in young patients who wish to preserve their fertility, is acceptable with the possibility of future pregnancies. [Mh] Termos MeSH primário: Adenocarcinoma/patologia Adenocarcinoma/terapia Neoplasias do Endométrio/patologia Neoplasias do Endométrio/terapia Infertilidade Feminina/complicações Recidiva Local de Neoplasia/patologia [Mh] Termos MeSH secundário: Adenocarcinoma/complicações Adulto Antineoplásicos Hormonais/uso terapêutico Neoplasias do Endométrio/complicações Feminino Preservação da Fertilidade Seres Humanos Achados Incidentais Dispositivos Intrauterinos Medicados Levanogestrel/administração & dosagem Acetato de Megestrol/uso terapêutico Gradação de Tumores Estadiamento de Neoplasias Gravidez Taxa de Gravidez Estudos Retrospectivos Turquia [Pt] Tipo de publicação: JOURNAL ARTICLE [Nm] Nome de substância: 0 (Antineoplastic Agents, Hormonal); 5W7SIA7YZW (Levonorgestrel); TJ2M0FR8ES (Megestrol Acetate) [Em] Mês de entrada: 1704 [Cu] Atualização por classe: 170418 [Lr] Data última revisão: 170418 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 160626 [St] Status: MEDLINE

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[PMID]: 27218795 [Au] Autor: Nanjappa S; Thai C; Shah S; Snyder M [Ad] Endereço: Departments of Internal Medicine, Moffitt Cancer Center, Tampa, FL 33612, USA. Sowmya.Nanjappa@Moffitt.org. [Ti] Título: Pharmacy Report: Megestrol Acetate-Induced Adrenal Insufficiency. [So] Source: Cancer Control;23(2):167-9, 2016 Apr. [Is] ISSN: 1526-2359 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: A man aged 65 years with metastatic renal cell carcinoma presented for evaluation after a recent fall. A thorough workup of the case was performed and secondary adrenal insufficiency induced by the administration of megestrol acetate was determined to be the cause. Adrenal insufficiency is a serious disorder that is a potential adverse event of megestrol acetate, a medication used to help patients with cancer cachexia increase their appetite and gain weight. This association is not well recognized in clinical practice, so this case highlights the importance of distinguishing possible endocrine complications induced by the long-term administration or sudden discontinuation of megestrol acetate. [Mh] Termos MeSH primário: Insuficiência Adrenal/etiologia Acetato de Megestrol/efeitos adversos [Mh] Termos MeSH secundário: Idoso Seres Humanos Masculino Acetato de Megestrol/farmacologia [Pt] Tipo de publicação: JOURNAL ARTICLE [Nm] Nome de substância: TJ2M0FR8ES (Megestrol Acetate) [Em] Mês de entrada: 1703 [Cu] Atualização por classe: 170310 [Lr] Data última revisão: 170310 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 160525 [St] Status: MEDLINE

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[PMID]: 27191767 [Au] Autor: Chae DW; Son H; Guk J; Park C; Park K [Ti] Título: Pharmacokinetics of a nanocrystal-containing megestrol acetate formulation: a single-dose, randomized, open-label, 2-part, 2-period crossover study in healthy Korean subjects. [So] Source: Int J Clin Pharmacol Ther;54(9):698-704, 2016 Sep. [Is] ISSN: 0946-1965 [Cp] País de publicação: Germany [La] Idioma: eng [Ab] Resumo: UNLABELLED: OBJECTIVE: The conventional suspension of megestrol acetate contains micronized megestrol acetate, which was recently discovered to have a disadvantage of decreasing bioavailability when taken in a fasting state. Since megestrol acetate is taken to increase appetite, this property becomes a discouraging factor. To improve upon this, an advanced formulation was developed using a nanocrystal drug-delivery system. This study was conducted to compare the safety and pharmacokinetic characteristics between the conventional formulation of megestrol acetate and a generic version of the advanced formulation containing nanocrystals. METHODS: This was a randomized, open-label, 2-period, 2-treatment, crossover, single-dose, 2-part study (part 1 fasting and part 2 fed), conducted in healthy males aged between 20 and 50 years with weight within ± 20% of ideal body weight having no congenital abnormalities or chronic diseases. Different subjects were used in part 1 and part 2, but subjects received a single dose of the reference and test drugs separated by a 14-day washout period. Blood sampling was performed up to 120 hours after dosing using a pre-specified sampling time scheme. Primary pharmacokinetic parameters were Cmax and AUClast of the test and reference formulations of megestrol acetate. Bioequivalence evaluation was based on the standard criterion of 80 - 125% for the 90% confidence interval of geometric mean ratios of test to reference drugs calculated for the pharmacokinetic parameters. To monitor adverse events, both subject interviews and physical examinations were done on a regular time basis. RESULTS: 80 subjects (n = 40 each part) were enrolled, and 79 completed the study. The 90% CIs of the geometric mean ratios of Cmax and AUClast were 4.4625 - 5.6018 and 1.3602 - 1.6418, respectively, for part 1, and 0.9793 - 1.1327 and 0.7721 - 0.8431, respectively, for part 2. No significant difference was discovered in the incidence of adverse events (AEs) when test and reference treated groups were compared. CONCLUSIONS: Our findings suggest that the test formulation of megestrol-acetate-containing nanocrystals is better absorbed and has higher bioavailability compared to the reference formulation in a fasting state. This should allow for a lower dose and better patient compliance. ClinicalTrials.gov identifier: NCT02446353. [Mh] Termos MeSH primário: Estimulantes do Apetite/farmacocinética Medicamentos Genéricos/farmacocinética Acetato de Megestrol/farmacocinética Nanopartículas [Mh] Termos MeSH secundário: Adulto Estimulantes do Apetite/administração & dosagem Área Sob a Curva Grupo com Ancestrais do Continente Asiático Disponibilidade Biológica Estudos Cross-Over Sistemas de Liberação de Medicamentos Medicamentos Genéricos/administração & dosagem Medicamentos Genéricos/efeitos adversos Jejum Seres Humanos Masculino Acetato de Megestrol/administração & dosagem Acetato de Megestrol/efeitos adversos Meia-Idade Equivalência Terapêutica Adulto Jovem [Pt] Tipo de publicação: COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL [Nm] Nome de substância: 0 (Appetite Stimulants); 0 (Drugs, Generic); TJ2M0FR8ES (Megestrol Acetate) [Em] Mês de entrada: 1701 [Cu] Atualização por classe: 170203 [Lr] Data última revisão: 170203 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 160519 [Cl] Clinical Trial: ClinicalTrial [St] Status: MEDLINE [do] DOI: 10.5414/CP202574

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[PMID]: 27038209 [Au] Autor: Hua J; Han J; Wang X; Guo Y; Zhou B [Ad] Endereço: State Key Laboratory of Freshwater Ecology and Biotechnology, Institute of Hydrobiology, Chinese Academy of Sciences, Wuhan 430072, China; University of Chinese Academy of Sciences, Beijing 100049, China. [Ti] Título: The binary mixtures of megestrol acetate and 17α-ethynylestradiol adversely affect zebrafish reproduction. [So] Source: Environ Pollut;213:776-784, 2016 Jun. [Is] ISSN: 1873-6424 [Cp] País de publicação: England [La] Idioma: eng [Ab] Resumo: Synthetic progesterones and estrogens are broadly used bioactive pharmaceutical agents and have been detected in aquatic environments. In the present study, we investigated the combined reproductive effects of megestrol acetate (MTA) and 17α-ethinylestradiol (EE2) on zebrafish. Adult zebrafish were exposed to MTA (33, 100 or 333 ng/L), EE2 (10 ng/L) or a mixture of both (MTA + EE2: 33 + 10, 100 + 10 or 333 + 10 ng/L) for 21 days. Results demonstrated that egg production was significantly reduced by exposure to 10 ng/L EE2, but not MTA. However, a combined exposure to MTA and EE2 caused further reduction of fish fecundity compared to EE2 exposure alone, suggesting an additive effect on egg production when EE2 is supplemented with MTA. Plasma concentrations of 17ß-estradiol and testosterone in the females and 11-ketotestosterone in the males were significantly decreased in the groups exposed to EE2 or MTA alone compared with the solvent control, and the plasma concentrations of the three hormones were further reduced in the co-exposure groups relative to the MTA exposure group, but not the EE2 exposure group. These data indicate that the inhibitory effects on plasma concentrations in the co-exposures were predominantly caused by EE2. Furthermore, exposure to MTA and EE2 (alone or in combination) led to histological alterations in the ovaries (decreased vitellogenic/mature oocytes), but not in the testes. This study has important implications for environmental risk assessment of synthetic hormones that are concurrently present in aquatic systems. [Mh] Termos MeSH primário: Etinilestradiol/toxicidade Acetato de Megestrol/toxicidade Reprodução/efeitos dos fármacos Poluentes Químicos da Água/toxicidade Peixe-Zebra/crescimento & desenvolvimento [Mh] Termos MeSH secundário: Animais Relação Dose-Resposta a Droga Sinergismo Farmacológico Feminino Fertilidade/efeitos dos fármacos Hormônios Esteroides Gonadais/sangue Masculino Ovário/efeitos dos fármacos Ovário/patologia Testículo/efeitos dos fármacos Testículo/patologia Testosterona/análogos & derivados Testosterona/toxicidade Peixe-Zebra/sangue [Pt] Tipo de publicação: JOURNAL ARTICLE [Nm] Nome de substância: 0 (Gonadal Steroid Hormones); 0 (Water Pollutants, Chemical); 3XMK78S47O (Testosterone); 423D2T571U (Ethinyl Estradiol); KF38W1A85U (11-ketotestosterone); TJ2M0FR8ES (Megestrol Acetate) [Em] Mês de entrada: 1701 [Cu] Atualização por classe: 170802 [Lr] Data última revisão: 170802 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 160403 [St] Status: MEDLINE

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[PMID]: 27016228 [Au] Autor: Myers AP; Filiaci VL; Zhang Y; Pearl M; Behbakht K; Makker V; Hanjani P; Zweizig S; Burke JJ; Downey G; Leslie KK; Van Hummelen P; Birrer MJ; Fleming GF [Ad] Endereço: Dana Farber Cancer Institute, Boston, MA, United States. Electronic address: andrea.myers@novartis.com. [Ti] Título: Tumor mutational analysis of GOG248, a phase II study of temsirolimus or temsirolimus and alternating megestrol acetate and tamoxifen for advanced endometrial cancer (EC): An NRG Oncology/Gynecologic Oncology Group study. [So] Source: Gynecol Oncol;141(1):43-8, 2016 Apr. [Is] ISSN: 1095-6859 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: OBJECTIVE: Rapamycin analogs have reproducible but modest efficacy in endometrial cancer (EC). Identification of molecular biomarkers that predict benefit could guide clinical development. METHODS: Fixed primary tissue and whole blood were collected prospectively from patients enrolled on GOG 248. DNA was isolated from macro-dissected tumors and blood; next-generation sequence analysis was performed on a panel of cancer related genes. Associations between clinical outcomes [response rate (RR) 20%; progression-free survival (PFS) median 4.9months] and mutations (PTEN, PIK3CA, PIK3R1, KRAS, CTNNB1, AKT1, TSC1, TSC2, NF1, FBXW7) were explored. RESULTS: Sequencing data was obtained from tumors of 55 of the 73 enrolled pts. Mutation rates were consistent with published reports: mutations in PTEN (45%), PIK3CA (29%), PIK3R1 (24%), K-RAS (16%), CTNNB1 (18%) were common and mutations in AKT1 (4%), TSC1 (2%), TSC2 (2%), NF1 (9%) and FBXW7 (4%) were less common. Increased PFS (HR 0.16; 95% CI 0.01-0.78) and RR (response difference 0.83; 95% CI 0.03-0.99) were noted for AKT1 mutation. An increase in PFS (HR 0.46; 95% CI 0.20-0.97) but not RR (response difference 0.00, 95% CI -0.34-0.34) was identified for CTNNB1 mutation. Both patients with TSC mutations had an objective response. There were no statistically significant associations between mutations in PIK3CA, PTEN, PIK3R1, or KRAS and PFS or RR. CONCLUSIONS: Mutations in AKT1, TSC1 and TSC2 are rare, but may predict clinical benefit from temsirolimus. CTNNB1 mutations were associated with longer PFS on temsirolimus. [Mh] Termos MeSH primário: Neoplasias do Endométrio/genética Acetato de Megestrol/administração & dosagem Mutação Sirolimo/análogos & derivados Tamoxifeno/administração & dosagem [Mh] Termos MeSH secundário: Classe I de Fosfatidilinositol 3-Quinases Neoplasias do Endométrio/tratamento farmacológico Neoplasias do Endométrio/mortalidade Feminino Seres Humanos PTEN Fosfo-Hidrolase/genética Fosfatidilinositol 3-Quinases/genética Estudos Prospectivos Proteínas Proto-Oncogênicas c-akt/genética Sirolimo/administração & dosagem Sirolimo/uso terapêutico Proteínas Supressoras de Tumor/genética [Pt] Tipo de publicação: CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL; RESEARCH SUPPORT, NON-U.S. GOV'T [Nm] Nome de substância: 0 (Tumor Suppressor Proteins); 0 (tuberous sclerosis complex 1 protein); 094ZI81Y45 (Tamoxifen); 624KN6GM2T (temsirolimus); EC 2.7.1.- (Phosphatidylinositol 3-Kinases); EC 2.7.1.137 (Class I Phosphatidylinositol 3-Kinases); EC 2.7.1.137 (PIK3CA protein, human); EC 2.7.11.1 (AKT1 protein, human); EC 2.7.11.1 (Proto-Oncogene Proteins c-akt); EC 3.1.3.67 (PTEN Phosphohydrolase); EC 3.1.3.67 (PTEN protein, human); TJ2M0FR8ES (Megestrol Acetate); W36ZG6FT64 (Sirolimus) [Em] Mês de entrada: 1608 [Cu] Atualização por classe: 171116 [Lr] Data última revisão: 171116 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 160327 [St] Status: MEDLINE

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