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1.
Rev. Hosp. Ital. B. Aires (2004) ; 40(1): 34-38, mar. 2020. tab
Artigo em Espanhol | LILACS | ID: biblio-1102292

RESUMO

Las mujeres han sido tratadas por décadas con testosterona intentando aliviar una gran variedad de síntomas con riesgos y beneficios inciertos. En la mayoría de los países, la testosterona se prescribe "off-label", de modo que las mujeres están utilizando compuestos y dosis ideadas para tratamientos en hombres. En este sentido, varias sociedades médicas de distintos continentes adoptaron recientemente por consenso una toma de posición sobre los beneficios y potenciales riesgos de la terapia con testosterona en la mujer, explorar las áreas de incertidumbre e identificar prácticas de prescripción con potencial de causar daño. Las recomendaciones con respecto a los beneficios y riesgos de la terapia con testosterona se basan en los resultados de ensayos clínicos controlados con placebo de al menos 12 semanas de duración. A continuación se comentan las recomendaciones. (AU)


There are currently no clear established indications for testosterone replacement therapy for women. Nonetheless, clinicians have been treating women with testosterone to alleviate a variety of symptoms for decades with uncertainty regarding its benefits and risks. In most countries, testosterone therapy is prescribed off-label, which means that women are using testosterone formulations or compounds approved for men with a modified dose for women. Due to these issues, there was a need for a global Consensus Position Statement on testosterone therapy for women based on the available evidence from placebo randomized controlled trials (RCTs). This Position Statement was developed to inform health care professionals about the benefits and potential risks of testosterone therapy intended for women. The aim of the Consensus was to provide clear guidance as to which women might benefit from testosterone therapy; to identify symptoms, signs, and certain conditions for which the evidence does not support the prescription of testosterone; to explore areas of uncertainty, and to identify any prescribing practices that have the potential to cause harm. (AU)


Assuntos
Humanos , Feminino , Idoso , Testosterona/uso terapêutico , Pós-Menopausa/efeitos dos fármacos , Depressores do Apetite/efeitos adversos , Fenitoína/efeitos adversos , Placebos/administração & dosagem , Psicotrópicos/efeitos adversos , Tamoxifeno/efeitos adversos , Testosterona/administração & dosagem , Testosterona/análise , Testosterona/efeitos adversos , Testosterona/farmacologia , Fármacos Cardiovasculares/efeitos adversos , Indometacina/efeitos adversos , Hormônio Liberador de Gonadotropina/efeitos adversos , Pós-Menopausa/fisiologia , Ensaios Clínicos Controlados como Assunto , Antagonistas Colinérgicos/efeitos adversos , Anticoncepcionais Orais/efeitos adversos , Disfunções Sexuais Psicogênicas/etiologia , Disfunções Sexuais Psicogênicas/terapia , Danazol/efeitos adversos , Consenso , Inibidores da Aromatase/efeitos adversos , Uso Off-Label , Inibidores do Fator Xa/efeitos adversos , Anfetaminas/efeitos adversos , Antagonistas dos Receptores Histamínicos/efeitos adversos , Antagonistas de Androgênios/efeitos adversos , Androgênios/fisiologia , Cetoconazol/efeitos adversos , Entorpecentes/efeitos adversos
4.
Ann Allergy Asthma Immunol ; 122(1): 86-92, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30312677

RESUMO

BACKGROUND: Hereditary angioedema with C1 inhibitor deficiency (C1-INH-HAE) is a rare, potentially life-threatening disorder characterized by recurrent edematous attacks. The edema formation is the consequence of interaction of bradykinin and various vasoactive peptides with endothelium. Besides these agents, danazol, a modified testosterone derivative used in these patients to prevent edematous attacks, can also affect the function of the endothelium, because it shifts the blood lipid profile to a pro-atherogenic phenotype. OBJECTIVE: To assess the endothelial function in C1-INH-HAE patients and in healthy matched controls. METHODS: To evaluate the endothelial function, we used the flow-mediated dilation method measured in the region of the brachial artery in 33 C1-INH-HAE patients and in 30 healthy matched controls. Laboratory measurements of standard biochemical parameters were performed on computerized laboratory analyzers. RESULTS: No difference was found in endothelial function (reactive hyperemia, RH) between patients (median, 9.0; 25%-75% percentile, 6.3-12.9) and controls (median, 7.37; 25%-75% percentile, 4.52-9.93). Although we found elevated cardiovascular risk (high body mass index and low-density lipoprotein/high-density lipoprotein ratio) in danazol-treated C1-INH-HAE patients, RH values did not differ between danazol-treated and nontreated patients. Furthermore, risk factors correlated with the endothelial function only in healthy controls and patients not treated with danazol. CONCLUSION: In summary, our results did not indicate any signs of endothelial dysfunction in C1-INH-HAE patients. Moreover, the normal endothelial function in danazol-treated patients with pro-atherogenic lipid profile suggests that elevated bradykinin level or other factor(s) involved in the pathogenesis of edematous attacks may have a protective role against endothelial dysfunction and atherosclerosis.


Assuntos
Proteína Inibidora do Complemento C1/genética , Danazol/uso terapêutico , Células Endoteliais/metabolismo , Endotélio Vascular/fisiologia , Antagonistas de Estrogênios/uso terapêutico , Angioedema Hereditário Tipos I e II/tratamento farmacológico , Lipoproteínas HDL/sangue , Lipoproteínas LDL/sangue , Adulto , Aterosclerose/diagnóstico , Bradicinina/sangue , Estudos de Casos e Controles , Danazol/efeitos adversos , Progressão da Doença , Endotélio Vascular/citologia , Antagonistas de Estrogênios/efeitos adversos , Feminino , Angioedema Hereditário Tipos I e II/diagnóstico , Angioedema Hereditário Tipos I e II/patologia , Humanos , Masculino , Inquéritos e Questionários , Vasodilatação , Adulto Jovem
5.
Pak J Pharm Sci ; 31(3(Special)): 1157-1161, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29735467

RESUMO

Endometriosis is a common benign disease of Gynecology, which often causes symptoms of dysmenorrhea, pelvic pain and infertility. In this paper, we analyzed the effect of laparoscopy combined with mifepristone in the treatment of endometriosis. By observing the clinical efficacy and side effects of small dose mifepristone, we explored the feasibility of small dose mifepristone in the treatment of recurrent endometriosis. The results showed that the clinical symptoms of small dose mifepristone group and danazol group were improved to varying degrees. The improvement rate of mifepristone group was 96.7% for dysmenorrhea and 61.1% for non menstrual lower abdominal pain, respectively. In conclusion, small dose mifepristone is an effective treatment for recurrent endometriosis with high remission and good curative effect.


Assuntos
Endometriose/tratamento farmacológico , Endometriose/cirurgia , Laparoscopia/métodos , Mifepristona/efeitos adversos , Mifepristona/uso terapêutico , Adulto , Danazol/efeitos adversos , Danazol/uso terapêutico , Antagonistas de Estrogênios/efeitos adversos , Antagonistas de Estrogênios/uso terapêutico , Feminino , Antagonistas de Hormônios/efeitos adversos , Antagonistas de Hormônios/uso terapêutico , Humanos , Pessoa de Meia-Idade , Ovário/efeitos dos fármacos , Ovário/fisiologia , Adulto Jovem
6.
Clin Lymphoma Myeloma Leuk ; 18(2): e109-e113, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29268959

RESUMO

BACKGROUND: Allogeneic stem cell transplantation (ASCT) represents the only option with a potential cure rate of 30% to 50% in myelodysplastic syndrome (MDS); however, < 5% of patients are optimal candidates for this management. Therapeutic options are limited in patients unsuitable for ASCT. Evidence that androgens might be beneficial in MDS is controversial. We aimed to document the clinical outcomes of patients diagnosed with MDS treated with danazol as first-line therapy. PATIENTS AND METHODS: We retrospectively reviewed patients diagnosed in our center with MDS according to the World Health Organization 2008 criteria and treated with danazol between 2005 and 2015. Response was defined according to international working group criteria. RESULTS: We included 42 patients treated exclusively with danazol. Median dose was 400 mg/d (range, 100-600 mg/d). Median follow-up was 12 (range, 3-76) months. Twenty-four of these patients (60%) achieved clinical response. Median overall survival was 24 months (95% confidence interval, 5.1-42). Responders were older than nonresponders (P = .025) and had higher baseline hemoglobin concentration (P = .009). No patients discontinued danazol because of toxicity. Fifteen patients died (35.7%) and 5 progressed to acute myeloid leukemia. CONCLUSION: Danazol as first-line therapy is an acceptable treatment option with low side effects for patients with MDS who cannot receive ASCT.


Assuntos
Danazol/uso terapêutico , Síndromes Mielodisplásicas/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Danazol/efeitos adversos , Antagonistas de Estrogênios/efeitos adversos , Antagonistas de Estrogênios/uso terapêutico , Feminino , Gastroenteropatias/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Análise de Sobrevida , Resultado do Tratamento , Ganho de Peso/efeitos dos fármacos
7.
Hematology Am Soc Hematol Educ Program ; 2017(1): 96-101, 2017 12 08.
Artigo em Inglês | MEDLINE | ID: mdl-29222242

RESUMO

Despite significant progress in transplantation by the addition of alternative hematopoietic stem cell sources, many patients with inherited bone marrow failure syndromes are still not eligible for a transplant. In addition, the availability of sequencing panels has significantly improved diagnosis by identifying cryptic inherited cases. Androgens are the main nontransplant therapy for bone marrow failure in dyskeratosis congenita and Fanconi anemia, reaching responses in up to 80% of cases. Danazol and oxymetholone are more commonly used, but virilization and liver toxicity are major adverse events. Diamond-Blackfan anemia is commonly treated with corticosteroids, but most patients eventually become refractory to this treatment and toxicity is limiting. Growth factors still have a role in inherited cases, especially granulocyte colony-stimulating factor in congenital neutropenias. Novel therapies are warranted and thrombopoietin receptor agonists, leucine, quercetin, and novel gene therapy approaches may benefit inherited cases in the future.


Assuntos
Doenças da Medula Óssea/terapia , Doenças Genéticas Inatas/terapia , Androgênios/efeitos adversos , Androgênios/uso terapêutico , Doenças da Medula Óssea/genética , Doenças da Medula Óssea/metabolismo , Doença Hepática Induzida por Substâncias e Drogas , Danazol/efeitos adversos , Danazol/uso terapêutico , Feminino , Doenças Genéticas Inatas/genética , Doenças Genéticas Inatas/metabolismo , Terapia Genética , Humanos , Leucina/uso terapêutico , Oximetolona/efeitos adversos , Oximetolona/uso terapêutico , Quercetina/uso terapêutico , Transplante de Células-Tronco , Síndrome , Virilismo/induzido quimicamente
8.
Lancet Haematol ; 4(10): e487-e496, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28917657

RESUMO

BACKGROUND: Primary immune thrombocytopenia is a severe bleeding disorder. About 50-85% of patients achieve initial remission from first-line therapies, but optimal second-line treatment remains a challenge. All-trans retinoic acid (ATRA) has an immunomodulatory effect on haemopoiesis, making it a possible treatment option. We aimed to evaluate the efficacy and safety of ATRA plus danazol versus danazol in non-splenectomised patients with corticosteroid-resistant or relapsed primary immune thrombocytopenia. METHODS: We did a multicentre, randomised, open-label, phase 2 study of adult patients (≥18 years) with primary immune thrombocytopenia from five different tertiary medical centres in China. Those eligible were non-splenectomised, resistant to corticosteroid treatment or relapsed, and had a platelet count less than 30 × 109 per L. Masked statisticians used simple randomisation to assign patients (1:1) to receive oral ATRA (10 mg twice daily) plus oral danazol (200 mg twice daily) or oral danazol monotherapy (200 mg twice daily) for 16 weeks. Neither clinicians nor patients were masked to group assignments. All patients were assessed every week during the first 8 weeks of treatment, and at 2-week intervals thereafter. The primary endpoint was 12-month sustained response defined as platelet count of 30 × 109 per L or more and at least a doubling of baseline platelet count (partial response), or a platelet count of 100 × 109 per L or more (complete response) and the absence of bleeding without rescue medication at the 12-month follow-up. All randomly allocated patients, except for those who withdrew consent, were included in the modified intention-to-treat population and efficacy assessment, and all patients who received at least one dose of the study agents were included in the safety analysis. Study enrolment was stopped early because the trial results crossed the interim analysis efficacy boundary for sustained response. This trial is registered with ClinicalTrials.gov, number NCT01667263. FINDINGS: From June 1, 2012, to July 1, 2016, we screened 130 patients for eligibility; 34 were excluded and 96 were randomly assigned. 93 patients were included in the modified intention-to-treat analysis: 45 in the ATRA plus danazol group and 48 in the danazol group. At the 12-month follow-up, sustained response was achieved more frequently in patients receiving ATRA plus danazol than in those receiving danazol monotherapy (28 [62%] of 45 vs 12 [25%] of 48; odds ratio 4·94, 95% CI 2·03-12·02, p=0·00037). Only two grade 3 adverse events were reported: one (2%) patient receiving ATRA plus danazol with dry skin, and one (2%) patient receiving danazol monotherapy with liver injury. There was no grade 4 or worse adverse event or treatment-related death in either group. INTERPRETATION: Patients with primary immune thrombocytopenia given ATRA plus danazol had a rapid and sustained response compared with danazol monotherapy. This finding suggests that ATRA represents a promising candidate for patients with corticosteroid-resistant or relapsed primary immune thrombocytopenia. FUNDING: National Natural Science Foundation of China, Beijing Natural Science Foundation, Beijing Municipal Science and Technology Commission, and the National Key Research and Development Program of China.


Assuntos
Danazol/uso terapêutico , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Tretinoína/uso terapêutico , Adulto , Danazol/administração & dosagem , Danazol/efeitos adversos , Quimioterapia Combinada , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Razão de Chances , Contagem de Plaquetas , Púrpura Trombocitopênica Idiopática/diagnóstico , Púrpura Trombocitopênica Idiopática/mortalidade , Retratamento , Resultado do Tratamento , Tretinoína/administração & dosagem , Tretinoína/efeitos adversos , Adulto Jovem
9.
Orv Hetil ; 158(32): 1269-1276, 2017 Aug.
Artigo em Húngaro | MEDLINE | ID: mdl-28780879

RESUMO

INTRODUCTION: Attenuated androgens are used for the prevention of angioedema attacks of hereditary angioedema with C1-inhibitor deficiency. After prepuberty, their use can lead to growth retardation. AIM: We assessed the effect of danazol on the growth of pediatric patients with hereditary angioedema. METHOD: In the retrospective study on 42 patients diagnosed with hereditary angioedema, we calculated the deviation from the mid-parental target height, and analyzed it against the gender, the dose and duration of danazol treatment administered before the age of 21 years and before the age of 16 years. RESULTS: Regarding the deviation from the mid-parental target height, we did not find any significant difference between patients taking vs. not taking danazol, males vs. females taking danazol. The dose and the duration of danazol treatment did not influence that value neither before 21, nor before 16 years of age. CONCLUSIONS: Our findings suggest that treatment with the lowest effective doses of danazol does not influence growth. Orv Hetil. 2017; 158(32): 1269-1276.


Assuntos
Angioedemas Hereditários/tratamento farmacológico , Síndrome Linfoproliferativa Autoimune/tratamento farmacológico , Danazol/uso terapêutico , Antagonistas de Estrogênios/uso terapêutico , Transtornos do Crescimento/induzido quimicamente , Adolescente , Angioedemas Hereditários/genética , Síndrome Linfoproliferativa Autoimune/genética , Criança , Proteína Inibidora do Complemento C1/genética , Danazol/efeitos adversos , Antagonistas de Estrogênios/efeitos adversos , Feminino , Humanos , Masculino , Estudos Retrospectivos , Fatores de Risco
11.
Pediatrics ; 138(5)2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27940765

RESUMO

Hereditary angioedema (HAE) is a potentially life-threatening inherited disease characterized by attacks of skin swelling, severe abdominal pain, and upper airway swelling. Attacks typically begin in childhood, but the appropriate diagnosis is often missed. Attacks do not respond to epinephrine, antihistamines, or glucocorticoids. Recently, many effective drugs have been approved for treatment of adults with HAE, and the Medical Advisory Board of the HAE Patient's Association has developed and reported treatment recommendations for adults. Only 1 medication is approved for treatment of children <12 years of age, and there are no reported consensus recommendations for treatment of young children in the United States. The 11-member Medical Advisory Board, with extensive experience in the treatment of children, in concert with the leaders of the HAE Patient's Association, has developed these consensus recommendations to help in recognition, diagnosis, treatment of attacks, and prophylaxis of children with HAE.


Assuntos
Angioedemas Hereditários/tratamento farmacológico , Angioedemas Hereditários/prevenção & controle , Adolescente , Angioedemas Hereditários/diagnóstico , Anti-Inflamatórios não Esteroides/uso terapêutico , Antifibrinolíticos/uso terapêutico , Bradicinina/análogos & derivados , Bradicinina/uso terapêutico , Criança , Proteínas Inativadoras do Complemento 1/uso terapêutico , Proteína Inibidora do Complemento C1/uso terapêutico , Danazol/efeitos adversos , Testes Genéticos , Humanos , Equipe de Assistência ao Paciente , Educação de Pacientes como Assunto , Peptídeos/uso terapêutico , Proteínas Recombinantes/uso terapêutico , Ácido Tranexâmico/uso terapêutico
12.
Rinsho Ketsueki ; 57(8): 1026-31, 2016 08.
Artigo em Japonês | MEDLINE | ID: mdl-27599419

RESUMO

Peliosis hepatis (PH) is a condition involving benign tumors pathologically characterized by multiple blood-filled cavities, mostly affecting the liver and spleen. Androgenic-steroids are widely used in patients with bone marrow failure syndromes (e.g.: aplastic anemia) and these patients are at increased risk of developing PH. Although patients with PH are generally asymptomatic, PH can progress to liver failure and even fatal spontaneous intraabdominal hemorrhage. Therefore, early diagnosis is critical in order to prevent life-threatening complications of PH. We herein report a patient with PH which had been treated with danazol, who presented with liver dysfunction and multiple hepatic lesions on imaging studies at the time of diagnosis. Although the patient presented with disseminated intravascular coagulation (DIC), a bone marrow biopsy revealed no evidence of leukemic transformation. The patient was diagnosed as having danazol-induced PH, and these abnormalities spontaneously resolved after the discontinuation of danazol. PH is one of the most important complications of long-term administration of androgenic-steroids. Although the mechanisms remain unclear, the multiple blood-filled cavities characteristic of PH may be responsible for the development of DIC. Therefore, monitoring of coagulation markers might also be a key strategy for early diagnosis of PH.


Assuntos
Anemia Aplástica/etiologia , Doenças da Medula Óssea/etiologia , Danazol/efeitos adversos , Coagulação Intravascular Disseminada/etiologia , Hemoglobinúria Paroxística/etiologia , Peliose Hepática/induzido quimicamente , Idoso de 80 Anos ou mais , Transtornos da Insuficiência da Medula Óssea , Feminino , Humanos , Resultado do Tratamento
13.
Lima; s.n; sept. 2016.
Não convencional em Espanhol | LILACS, BRISA/RedTESA | ID: biblio-847823

RESUMO

INTRODUCCIÓN: Antecedentes: El presente dictamen responde a la solicitud de evaluación de tecnología sanitaria del uso fuera del petitorio de Eltrombopag en pacientes con aplasia medular severa, no tributarios a terapia triple inmunosupresora ni trasplante de médula ósea. Aspectos Generales: La trombopeyetina es un factor humoral o citoquina, el cual estimula la producción de trombocitos (plaquetas), proliferación de megacariocitos de la médula ósea y por ende liberación de plaquetas en un mecanismo llamado trombopoyesis. El rol principal de las plaquetas es proveer la interacción y activación de factores de coagulación en la cascada de coagulación. Los pacientes con anemia aplásica exhiben altos niveles de trombopoyetina y pero aún así presentan trombocitopenia debido a una supresión o falla por parte de la producción de plaquetas en la médula ósea. Tecnología Sanitaria de Interés: Eltrombopag (ETP), Revolade o Promacta (GlaxoSmithKline lnc) es un medicamento agonista del receptor de la trombopoyetina (TPOr) que promueve la diferenciación megacariocítica, la proliferación y la producción de plaquetas. Es un agente hematopoyético que actúa como agonista no peptídico del receptor de la trombopoyetina. Interacciona con el dominio transmembrana e induce a la proliferación y diferenciación de los megacariocitos produciendo, a consecuencia de ello, un incremento en el recuento plaquetario. METODOLOGÍA: Estrategia de Búsqueda: Se llevó a cabo una búsqueda sistemática de la literatura con respecto a la eficacia y seguridad de Eltrombopag en pacientes con aplasia medular severa, no tributarios a terapia triple inmunosupresora ni trasplante de médula ósea. Para la búsqueda primaria se revisó en primer lugar la información disponible por entes reguladoras y normativas de autorización comercial como la Administración de Drogas y Alimentos (FDA) de Estados Unidos, la Agencia de Medicamentos Europea (EMA) y la Dirección General de Medicamentos y Drogas (DIGEMID) en el Perú. Seguidamente, se emplearon los motores de búsqueda de los metabuscadores Translating Research into Practice (TRIPDATABASE), Epistemonikos y Health Systems Evidence (HSE). Asimismo, se buscó información generada por grupos internacionales que realizan revisiones sistemáticas, evaluaciones de tecnologías sanitarias y guías de práctica clínica, tales como el National Institute for Health and Care Excellence (NICE) del Reino Unido, National Guideline Clearinghouse (NGC) de Estados Unidos, Canadian Agency for Drugs and Technologies in Health (CADTH) de Canadá, Scottish Medicines Consortium (SMC) de Escocia, Haute Authorité de Santé (HAS) de Francia, el Instituto de Evaluación de Tecnologías Sanitarias (IETS) de Colombia, el Instituto de efectividad clínica y sanitaria (IECS) de Argentina. Finalmente, se realizó una búsqueda dentro de las bases de datos Pubmed, EMBASE, y The Web of Science que a su vez fue complementada con una búsqueda en www.clinicaltrials.gov y www.clinicaltrialsregister.eu. RESULTADOS: Sinopsis de la Evidencia: De acuerdo con la pregunta PICO, se llevó a cabo una búsqueda de evidencia científica relacionada al uso de eficacia y seguridad de eltrombopag en pacientes con aplasia medular severa, no tributarios a terapia triple inmunosupresora ni trasplante de médula ósea. En la presente sinopsis se describe la evidencia encontrada a la fecha. Guías de práctica clínica: No se encontraron guías de práctica clínica de buena calidad que recomienden eltrombopag en AAS. Evaluaciones de tecnologías sanitarias: El grupo evaluador de NICE revisó este año (2016) la evidencia disponible para AAS con eltrombopag. Sin embargo es observable que tanto la CADTH de Canada, la SMC de Escocia, el IECS Argentina, IETS Colombia, y la HAS de Francia los cuales son referentes internacionales de evaluaciones de tecnologías sanitarias, no han realizado aún evaluaciones ni han emitido recomendaciones para el uso de eltrombopag en AAS. Ensayos clínicos: Se encontraron los ensayos clínicos fase II de Olnes et al., 2012 y Desmond et al., 2014. Ensayos clínicos no-publicados: Se encontraron tres estudios en progreso en la página de clinicaltrials.gov que corresponden a NCT01891994, NCT 01703169, y NCT 02148133. Otros documentos adicionales: Documento de recomendación como Guía de la BCSH. CONCLUSIONES: El presente dictamen responde a la solicitud de evaluación de tecnología sanitaria del uso fuera del petitorio de Eltrombopag en pacientes con aplasia medular severa, no tributarios a terapia triple inmunosupresora ni trasplante de médula ósea. Se encontraron dos ensayos clínicos fase II, no-aleatorizados, abiertos y de un solo brazo y tres ensayos clínicos en proceso no-publicados, los cuales evaluaron la respuesta hematológica a eltrombopag en la población de interés. La evidencia generada por éstos contiene limitaciones severas para la interpretación y generalización de los resultados para la población de interés. El Instituto de Evaluación de Tecnologías en Salud e Investigación ­IETSI, aprueba el uso de Eltrombopag en pacientes con aplasia medular severa, no tributarios a terapia triple inmunosupresora ni trasplante de médula ósea. La vigencia del presente dictamen preliminar es de un año. En los subsiguientes meses a la publicación del presente dictamen, se evaluará la nueva evidencia publicada en la literatura internacional, y se analizarán los datos clínicos de todos aquellos pacientes que hayan recibido eltrombopag en el contexto del presente dictamen, con el fin de establecer el impacto del mismo. Esta información será tomada en cuenta para actualizar el presente dictamen al culminar su vigencia.


Assuntos
Humanos , Doenças da Medula Óssea/tratamento farmacológico , Ciclosporina/efeitos adversos , Danazol/efeitos adversos , Avaliação da Tecnologia Biomédica , Trombopoetina/administração & dosagem , Trombopoetina/agonistas
14.
J Vet Med Sci ; 78(10): 1611-1614, 2016 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-27320967

RESUMO

A 2-year-old female beagle was referred to our hospital for evaluation of anemia. Laboratory tests, including bone marrow cytology, revealed non-regenerative immune-mediated anemia (NRIMA). Although initial immunosuppressive multi-drug therapy was not effective, additional administration of danazol was successful in treating the anemia. However, hepatocellular carcinoma (HCC) developed about 20 months after the administration of danazol. In humans, several cases of development of HCC after the administration of danazol have been reported. The present report describes a case of HCC development in a dog after chronic administration of danazol in addition to other immunosuppressive drugs.


Assuntos
Carcinoma Hepatocelular/veterinária , Danazol/efeitos adversos , Doenças do Cão/induzido quimicamente , Imunossupressores/efeitos adversos , Neoplasias Hepáticas/veterinária , Anemia/tratamento farmacológico , Anemia/imunologia , Anemia/veterinária , Animais , Carcinoma Hepatocelular/induzido quimicamente , Carcinoma Hepatocelular/diagnóstico por imagem , Doenças do Cão/diagnóstico por imagem , Cães , Feminino , Neoplasias Hepáticas/induzido quimicamente , Tomografia Computadorizada por Raios X/veterinária
16.
Ann Allergy Asthma Immunol ; 114(4): 281-288.e7, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25707325

RESUMO

OBJECTIVE: To provide an objective basis for evaluating the risk-benefit ratio of long-term androgen use in patients with hereditary angioedema (HAE). DATA SOURCES: PubMed was searched with no time limitations using the keywords hereditary angioedema or angio-oedema combined with danazol, stanozolol, and androgen. STUDY SELECTION: Qualifying articles were English-language reports of androgen use in patients with HAE, with relevant safety and/or efficacy information. Reports were categorized according to level of evidence (LOE). RESULTS: The search process identified 153 citations, 63 of which contained relevant information; 2 additional publications were identified while other citations were being reviewed. Fifteen LOE 2 studies and multiple LOE 4 reports provided efficacy data, confirming a high level of prophylactic efficacy for androgen therapy in HAE, with occasional reports of poor prophylactic response. Common adverse events include weight gain, menstrual irregularities, virilization, headaches, myalgias or cramps, mood changes, and elevations in creatine phosphokinase level, liver function test results, and serum lipid level. The risk of adverse events is often correlated with dose and/or treatment duration. Rare cases of hepatic adenomas and hepatocellular carcinoma associated with long-term androgen use often had no preceding changes in liver function test results. CONCLUSION: Androgen therapy may be effective for most patients with HAE; however, potential risks and adverse effects must be carefully considered and discussed with patients when considering options for long-term HAE prophylaxis.


Assuntos
Androgênios/uso terapêutico , Angioedemas Hereditários/tratamento farmacológico , Danazol/uso terapêutico , Estanozolol/uso terapêutico , Androgênios/efeitos adversos , Animais , Danazol/efeitos adversos , Cálculos da Dosagem de Medicamento , Feminino , Humanos , Metabolismo dos Lipídeos/efeitos dos fármacos , Distúrbios Menstruais/etiologia , Obesidade/etiologia , Medição de Risco , Estanozolol/efeitos adversos , Fatores de Tempo , Virilismo/etiologia
19.
Orphanet J Rare Dis ; 9: 205, 2014 Dec 05.
Artigo em Inglês | MEDLINE | ID: mdl-25475444

RESUMO

BACKGROUND: Danazol, a drug extensively used in the management of hereditary angioedema due to C1 inhibitor deficiency (C1-INH-HAE), has various side effects. This study investigated the virilizing actions of this drug in 31 danazol-treated female patients with HAE-C1-INH. We compared our findings with those of healthy controls and with literature data. METHODS: The patients were interviewed individually about the type and severity of the virilizing effects, as well as about their satisfaction with danazol therapy. RESULTS: The average duration of danazol treatment was 10.31 years [2 to 23] and its mean daily dose was 131.7 mg [33 to 200]. The most common adverse effects were hirsutism (n=14), weight gain (n=13), and menstrual disturbances (n=8). The severity of danazol adverse effects did not differ by duration of treatment or by daily drug dose. The mean level of patient satisfaction with the treatment was high. The comparison of age-matched healthy controls and of HAE-C1-INH patients receiving danazol did not demonstrate a statistically higher incidence of any of the monitored symptoms in the danazol group. CONCLUSIONS: Our findings indicate that long-term danazol treatment - using the lowest effective dose - has only a mild virilizing effect.


Assuntos
Angioedemas Hereditários/diagnóstico , Angioedemas Hereditários/tratamento farmacológico , Danazol/efeitos adversos , Virilismo/induzido quimicamente , Virilismo/diagnóstico , Adulto , Idoso , Androgênios/administração & dosagem , Androgênios/efeitos adversos , Angioedemas Hereditários/sangue , Proteína Inibidora do Complemento C1/metabolismo , Danazol/administração & dosagem , Coleta de Dados/métodos , Relação Dose-Resposta a Droga , Antagonistas de Estrogênios/administração & dosagem , Antagonistas de Estrogênios/efeitos adversos , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos , Virilismo/sangue , Adulto Jovem
20.
Neth J Med ; 72(7): 380-2, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25178775

RESUMO

Hereditary angio-oedema is characterised by recurrent episodes of laryngeal, intra-abdominal, facial or peripheral oedema. Danazol can be used as prophylaxis for recurrent attacks. Hepatotoxicity is a recognised adverse effect of danazol. We report an exceptional case of a danazol-induced hepatocellular carcinoma in a 75-year-old patient with hereditary angio-oedema.


Assuntos
Angioedemas Hereditários/tratamento farmacológico , Carcinoma Hepatocelular/induzido quimicamente , Danazol/efeitos adversos , Antagonistas de Estrogênios/efeitos adversos , Neoplasias Hepáticas/induzido quimicamente , Idoso , Feminino , Humanos
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