RESUMO
Objetivos: Gosserrelina é indicada para mulheres com leiomioma, por reduzir o risco associado às complicações clínicas. Este trabalho realizou uma análise de custo-utilidade comparando o uso e o não uso de gosserrelina em pacientes com leiomioma sob a perspectiva do Sistema Único de Saúde. Métodos: Um modelo de árvore de decisão foi estruturado para reproduzir o impacto clínico e econômico do uso de gosserrelina antes da miomectomia, cujo comparador seria o não uso de gosserrelina em pacientes elegíveis. Foram considerados: custos médicos diretos e eventos clínicos como complicações intra-hospitalares e tempo de internação. A razão de custo-utilidade incremental é representada pelo custo incremental da gosserrelina por anos de vida ajustado pela qualidade (QALY). Resultados: Em um cenário em que o acesso à gosserrelina é de 51% das pacientes, o custo incremental foi de R$ 629,08. Pacientes no grupo gosserrelina apresentaram um incremento de 0,0261 no QALY. A razão de custo-utilidade incremental foi de R$ 24.019,26 por QALY, ficando abaixo do limiar adotado pelo Ministério da Saúde. Ao variar o percentual de pacientes que recebem gosserrelina para 80% antes de um procedimento cirúrgico, houve um aumento de QALY para 0,5013, reduzindo custos de complicações e a razão de custo-utilidade incremental para R$ 10.581,07 por QALY. No cenário em que 100% das pacientes utilizam gosserrelina, há um aumento de QALY para 0,8290, reduzindo custos de complicações e a razão de custo-utilidade incremental para R$ 10.288,28 por QALY. Conclusão: O uso de gosserrelina possui custo-utilidade favorável, considerando os parâmetros utilizados nesta modelagem econômica. Quando o acesso à gosserrelina é maior, há um decremento expressivo no custo por QALY.
Objectives: Goserelin is indicated for women with leiomyoma to reduce the risk associated with clinical complications. This study conducted a cost-utility analysis comparing the use and non-use of goserelin in patients with leiomyoma from the perspective of the Brazilian Unified Health System. Methods: A decision tree model was structured to reproduce the clinical and economic impact of using goserelin before myomectomy, compared to not using it in eligible patients. Direct medical costs and clinical events such as in-hospital complications and length of stay were considered. The incremental cost-utility ratio is represented by the incremental cost of goserelin per quality-adjusted life year (QALY). Results: In a scenario where access to goserelin is 51% of patients, the incremental cost was R$ 629.08. Patients in the goserelin group showed an increase of 0.0261 in QALY. The incremental cost-utility ratio was R$ 24,019.26 per QALY, below the threshold adopted by the Ministry of Health. When the percentage of patients receiving goserelin was increased to 80% before surgery, there was an increase in QALY to 0.5013, reducing complication costs and the incremental cost-utility ratio to R$ 10,581.07 per QALY. In the scenario where 100% of patients use goserelin, QALY increased to 0.8290, reducing complication costs and the incremental cost-utility ratio to R$ 10,288.28 per QALY. Conclusions: The use of goserelin has a favorable cost utility, considering the parameters used in this economic modeling. When access to goserelin is higher, there is a significant decrease in the cost per QALY.
Assuntos
Análise Custo-Benefício , Gosserrelina , LeiomiomaRESUMO
RESUMEN Introducción: Los leiomiomas uterinos son los tumores ginecológicos benignos más comunes; son causa de anemia, infertilidad, alteración en la implantación embrionaria, pérdida gestacional recurrente, parto prematuro e incontinencia urinaria. Su transformación maligna es excepcional. La afectación a la fertilidad, se asocia con miomas entre el 3 % y el 31 % y depende de su ubicación y tamaño, sobre todo en los que distorsionan la cavidad uterina. Objetivo: Describir las opciones terapéuticas para una joven nulípara con un mioma uterino intramural gigante. Caso Clínico: Paciente de 30 años de edad, con antecedentes de mioma uterino intramural, de 5 años de evolución, además anemia ferripriva. Aqueja menstruaciones abundantes y dolorosas, incontinencia urinaria y constipación. El tratamiento fue escalonado, mediante el uso de acetato de goserelina, embolización selectiva de las arterias uterinas y posterior miomectomía. Conclusiones: El tratamiento del mioma uterino en la mujer joven, nulípara, depende del tamaño, localización, sintomatología asociada, edad de la paciente y deseo de engendrar descendencia.
ABSTRACT Introduction: Uterine leiomyomas are the most common benign gynecological tumors; they are a cause of anemia, infertility, altered embryo implantation, recurrent gestational loss, premature delivery and urinary incontinence. Their malignant transformation is exceptional. Fertility impairment is associated with myomas in between 3 % and 31 % and depends on their location and size, especially in those that distort the uterine cavity. Objective: To describe the therapeutic options for a nulliparous girl with a giant intramural uterine fibroid. Clinical Case: A 30-year-old patient with a 5-year history of intramural uterine fibroid, in addition to iron deficiency anemia. She complains of heavy and painful periods, urinary incontinence and constipation. Treatment was staggered, using goserelin acetate, selective embolization of the uterine arteries, and subsequent myomectomy. Conclusions: The treatment of uterine fibroid in young, nulliparous women depends on the size, location, associated symptoms, age of the patient and desire to have offspring.
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BACKGROUND: Testosterone suppression is the standard treatment for advanced prostate cancer, and it is associated with side-effects that impair patients' quality of life, like sexual dysfunction, osteoporosis, weight gain, and increased cardiovascular risk. We hypothesized that abiraterone acetate with prednisone (AAP) and apalutamide, alone or in combination, can be an effective hormonal therapy also possibly decreasing castration-associated side effects. METHODS: Phase II, open-label, randomized, efficacy trial of abiraterone acetate plus prednisone (AAP) and Androgen Deprivation Therapy (ADT) versus apalutamide versus the combination of AAP (without ADT) and apalutamide. Key eligibility criteria are confirmed prostate adenocarcinoma; biochemical relapse after definitive treatment (PSA ≥ 4 ng/ml and doubling time less than 10 months, or PSA ≥ 20 ng/ml); newly diagnosed locally advanced or metastatic prostate cancer; asymptomatic to moderately symptomatic regarding bone symptoms. Patients with other histology besides adenocarcinoma or previous use of hormonal therapy or chemotherapy were excluded. DISCUSSION: There is an urgent need to study and validate regimens such as new hormonal agents that may add benefit to castration with an acceptable safety profile. We aim to evaluate if apalutamide in monotherapy or in combination with AAP is an effective and safety hormonal treatment that can spare patients of androgen deprivation therapy. TRIAL REGISTRATION: This trial was registered in ClinicalTrials.gov on October 16, 2017, under Identifier: NCT02867020.
Assuntos
Acetato de Abiraterona/uso terapêutico , Adenocarcinoma/tratamento farmacológico , Antagonistas de Receptores de Andrógenos/uso terapêutico , Antineoplásicos Hormonais/uso terapêutico , Gosserrelina/uso terapêutico , Prednisona/uso terapêutico , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Tioidantoínas/uso terapêutico , Acetato de Abiraterona/administração & dosagem , Antagonistas de Receptores de Andrógenos/administração & dosagem , Antineoplásicos Hormonais/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica , Intervalo Livre de Doença , Gosserrelina/administração & dosagem , Humanos , Masculino , Medidas de Resultados Relatados pelo Paciente , Prednisona/administração & dosagem , Qualidade de Vida , Testosterona/sangue , Tioidantoínas/administração & dosagem , Resultado do TratamentoRESUMO
El objetivo de la investigación fue determinar la utilidad del tratamiento con goserelina en la tasa de embarazos en pacientes con infertilidad debida a endometriosis leve-moderada. Se realizó un estudio prospectivo, en el que se incluyó a 76 mujeres con diagnóstico de infertilidad y endometriosis leve-moderada que asistieron al Hospital Central Dr. Urquinaona. El grupo de estudio (grupo A; n = 42 pacientes) que fueron tratadas con goserelina de depósito por vía subcutánea, una vez al mes por 3 meses. Al reiniciar los ciclos menstruales, se realizó hiperestimulación ovárica controlada / inseminación intrauterina. En el grupo de control (grupo B; n = 34 pacientes) solo se realizó hiperestimulación ovárica controlada / inseminación intrauterina. Se analizó la tasa de embarazos. La tasa de embarazos en el grupo A fue de 35,7 % por paciente y 24,5 % por ciclo estimulado. En el grupo B, la tasa fue de 32,3 % por paciente y del 23,9 % por ciclo estimulado. La tasa en el grupo de pacientes tratadas con goserelina fue más alta en el grupo de pacientes no tratadas, pero estas diferencias no son estadísticamente significativas (p = ns). Se concluye que el tratamiento con goserelina por 3 meses no es útil en pacientes con infertilidad debida a endometriosis leve-moderada, ya que no produce un aumento significativo en la tasa de embarazos.
The objective of research was to determine the usefulness of goserelin in the pregnancy rate in patients with infertility due mild - moderate endometriosis. A prospective study was conducted in which 76 women with a diagnosis of infertility and mild-moderate endometriosis was included, who attended the Central Hospital Dr. Urquinaona. The study group (group A; n = 42 patients) were treated with goserelin depot subcutaneously once monthly for 3 months. Upon restarting menstrual cycles, controlled ovarian hyperstimulation / intrauterine insemination was performed. In the control group (group B, n = 34 patients), only controlled ovarian hyperstimulation / intrauterine insemination was performed. The pregnancy rate was analyzed. The pregnancy rate in group A was 35,7 % per patient and 24,5 % per stimulated cycle. In group B, the rate was 32,3 % per patient and 23,9 % per stimulated cycle. The rates in the group of patients treated with goserelin were higher in the group of untreated patients, but these differences were not statistically significant (p = ns). It is concluded that treatment with goserelin for 3 months is not useful in patients with infertility due mild - moderate endometriosis, as it does not produce a significant increase in the rate of pregnancy.
Assuntos
Humanos , Feminino , Gravidez , Síndrome de Hiperestimulação Ovariana , Gosserrelina , Endometriose , Infertilidade Feminina , Venezuela , InseminaçãoRESUMO
Nas células musculares lisas atípicas características da linfangioleiomiomatose (LAM) encontram-se receptores de estrogênio e progesterona, de modo que o tratamento anti-hormonal pode ser considerado uma opção, mas ainda com resultados controversos. O objetivo deste trabalho foi avaliar retrospectivamente parâmetros hormonais e espirométricos em nove mulheres com LAM após o tratamento com goserelina por um ano. Houve um aumento médio de 80 mL e 130 mL, respectivamente, em VEF1 e CVF, assim como bloqueio hormonal efetivo. Ainda não se pode excluir um potencial efeito favorável da utilização de análogos de hormônio liberador de gonadotrofina em pacientes com LAM, reforçando a necessidade de ensaios randomizados.
In the atypical smooth muscle cells that are characteristic of lymphangioleiomyomatosis (LAM), there are estrogen and progesterone receptors. Therefore, anti-hormonal therapy, despite having produced controversial results, can be considered a treatment option. The objective of this retrospective study was to evaluate hormonal and spirometric data for nine women with LAM after one year of treatment with goserelin. The mean increase in FEV1 and FVC was 80 mL and 130 mL, respectively. There was effective blockage of the hormonal axis. It is still not possible to exclude a potential beneficial effect of the use of gonadotropin-releasing hormone analogues in LAM patients, which underscores the need for randomized trials.