Terapia hormonal para criptorquidia com hormônio gonadotrofina coriônica humana (HCG): ensaio clínico randomizado duplo-cego placebo controlado
Arquivos
Data
2006
Autores
Henna, Marcia Riromi 
Orientadores
Schettini, Sérgio Tomaz
Tipo
Tese de doutorado
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Objetivo: O objetivo deste estudo foi comparar o efeito do tratamento hormonal do hormônio
Gonadotrofina Coriônica Humana (HCG), em dois esquemas posológicos diferentes, ao
placebo quanto sua efetividade e segurança no tratamento da Criptorquidia. Métodos: Este
estudo é um ensaio clínico randomizado, duplo-cego, placebo-controlado de 14 semanas. A
amostra de 92 pacientes que foram randomizados para o grupo-HCG dias alternados,
denominados de Grupo G1 (N = 29), para o grupo HCG a cada quatro dias, denominados
Grupo G4 (N= 33) e o grupo-placebo, denominados como Grupo O(N = 30). 2. Os
desfechos clínicos primários para este estudo foram 1) Cura, 2) Melhora, 3) Não Cura. Os
desfechos complementares foram: 4) Efeitos adversos, 5) Níveis séricos hormonais.
Resultados: Não existiram diferenças entre os grupos HCG dias alternados, HCG a cada
quatro dias e placebo para as medidas dos desfechos primários. 1) Cura: G1: 3/29(3,3%), G4:
4/33(4,3%) e O: 3/30(3,3%) 2) Melhora: G1:3/29(3,3%), G4: 1/33(1,1%) e O: 3/30(3,3%). 3)
Não Cura: G1: 23/29(25%), G4: 28/33(30,4%) e O: 24/30(26,1%) p=0,815. 4) Os efeitos
adversos mais freqüentes em nossa amostra foram: Aumento do numero de ereções: não foi
possível avaliar. 5) Níveis séricos hormonais: Testosterona sérica: G1: de 34,15 ± 5,8ng/ml;
G4: 49,6± 5,6 ng/ml e O: 7,5± 3,5ng/ml. Hormônio Luteinizante (LH): G1: 0,22± 0,2 , G4:
0,07±0,1 e O: 0,08±0,02
Hormônio Folículo Estimulante (FSH): G1: 0,88±0,16, G4: 0,3±0,1 e O 1,15±0,6.
Conclusão: Não foi encontrada nenhuma diferença estatística no tratamento com HCG,
independente da posologia adotada, e placebo. Os autores concluem a hormonioterapia com
HCG não demonstrou superioridade na eficácia e ou segurança no tratamento da criptorquidia
ao placebo.
Objective: The objective of this study is to compare the effect of hormone treatment with Human Chorionic Gonadotropin (HCG) with two different posological schemes compared to placebo treatment regarding its effectiveness and safety in the treatment of cryptorchidism. Methods: This study is a 14-day double-blind, placebo-controlled, randomized clinic assay. Ninety two patients were randomized into a group-HCG alternate days, identified as G1 Group (N=29); a group HCG every other four days, identified as G4 Group (N=33); and a placebo group, identified as Group O (N = 30). The primary clinical findings of this study were: 1) Cure, 2) Improvement, 3) Uncured. The complementary findings were: 4) Adverse effects, 5) Hormone serum levels. Results: There were no differences between the HCG alternate days, hCG every other 4 days, and the placebo groups for the primary findings. 1) Cure: G1: 3/29(3.3%), G4: 4/33(4.3%) and O: 3/30(3.3%) 2) Improvement: G1:3/29(3.3%), G4: 1/33(1.1%) and O: 3/30(3.3%). 3) Uncured: G1: 23/29(25%), G4: 28/33(30.4%) and O: 24/30(26.1%) p=0.815. 4). The most frequent adverse effects in our sample were: increase in the number of erections: impossible to assess. 5) Hormone serum levels: Serum testosterone: G1: 34.15 ± 5.8ng/ml; G4: 49.6± 5.6 ng/ml and O: 7.5± 3.5ng/ml. Luteinizing Hormone (LH): G1: 0.22± 0.2, G4: 0.07±0.1 and O: 0.08±0.02. Follicle-Stimulating Hormone (FSH): G1: 0.88±0.16, G4: 0.3±0.1 and O 1.15±0.6. Conclusion: No differences were found in the treatment with HCG independently of the posology employed and placebo. The authors concluded that hormone therapy with HCG was not effective in cryptorchidism treatment in relation to placebo.
Objective: The objective of this study is to compare the effect of hormone treatment with Human Chorionic Gonadotropin (HCG) with two different posological schemes compared to placebo treatment regarding its effectiveness and safety in the treatment of cryptorchidism. Methods: This study is a 14-day double-blind, placebo-controlled, randomized clinic assay. Ninety two patients were randomized into a group-HCG alternate days, identified as G1 Group (N=29); a group HCG every other four days, identified as G4 Group (N=33); and a placebo group, identified as Group O (N = 30). The primary clinical findings of this study were: 1) Cure, 2) Improvement, 3) Uncured. The complementary findings were: 4) Adverse effects, 5) Hormone serum levels. Results: There were no differences between the HCG alternate days, hCG every other 4 days, and the placebo groups for the primary findings. 1) Cure: G1: 3/29(3.3%), G4: 4/33(4.3%) and O: 3/30(3.3%) 2) Improvement: G1:3/29(3.3%), G4: 1/33(1.1%) and O: 3/30(3.3%). 3) Uncured: G1: 23/29(25%), G4: 28/33(30.4%) and O: 24/30(26.1%) p=0.815. 4). The most frequent adverse effects in our sample were: increase in the number of erections: impossible to assess. 5) Hormone serum levels: Serum testosterone: G1: 34.15 ± 5.8ng/ml; G4: 49.6± 5.6 ng/ml and O: 7.5± 3.5ng/ml. Luteinizing Hormone (LH): G1: 0.22± 0.2, G4: 0.07±0.1 and O: 0.08±0.02. Follicle-Stimulating Hormone (FSH): G1: 0.88±0.16, G4: 0.3±0.1 and O 1.15±0.6. Conclusion: No differences were found in the treatment with HCG independently of the posology employed and placebo. The authors concluded that hormone therapy with HCG was not effective in cryptorchidism treatment in relation to placebo.
Descrição
Citação
Henna, Marcia Riromi. Terapia hormonal para criptorquidia com hormônio gonadotrofina coriônica humana (HCG): ensaio clínico randomizado duplo-cego placebo controlado. 2006. 73 f. Tese (Doutorado em Ciências) - Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, 2006.