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Doctoral Thesis
DOI
Document
Author
Full name
Marcelo Augusto Duarte Silveira
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2019
Supervisor
Committee
Andrade, Lucia da Conceição (President)
Abensur, Hugo
Costa, André Falcão Pedrosa
Santos, Daniel Rinaldi dos
Title in Portuguese
Efeitos da própolis verde brasileira sobre a proteinúria e função renal em pacientes com doença renal crônica: um estudo clínico randomizado, duplo-cego, placebo-controlado
Keywords in Portuguese
Estresse oxidativo
Inflamação
Insuficiência renal crônica
Própole
Proteinúria
Abstract in Portuguese
A Doença Renal Crônica (DRC) é um importante problema de saúde pública ao redor do mundo e a proteinúria é um marcador de progressão da doença bem estabelecido. A própolis, uma resina natural produzida por abelhas a partir de resíduos e seivas de diferentes partes de plantas, possui propriedades anti-inflamatória, imunomoduladora, anti-câncer, anti-oxidante, bem como demonstrou ter efeito antiproteinúrico em modelo experimental de DRC. O objetivo deste estudo foi avaliar o efeito do extrato de Própolis verde brasileiro na proteinúria e ritmo de filtração glomerular estimada (RFG) em pacientes com DRC. Este foi um estudo clínico, randomizado, duplo-cego, controlado por placebo que reuniu pacientes com DRC de etiologias diabética e não-diabética, com idade entre 18 e 90 anos, com RFG estimado entre 25-70 ml/min/1.73 m2 e proteinúria (excreção urinária de proteína > 300mg/dia) ou microalbuminúria ou macroalbuminúria (taxa urinária de albumina-creatinina > 30mg/g Cr ou > 300mg/g Cr, respectivamente). Nós pesquisamos 148 pacientes e selecionamos randomicamente 32 para receberam, por 12 meses, extrato de própolis verde brasileiro na dose de 500mg/dia (n=18) ou placebo (n=14). No final do tratamento, a proteinúria foi significantemente menor no grupo Própolis do que no grupo Placebo--695 mg/24 h (IC de 95%, 483 a 999) x 1403 mg/24 h (IC de 95%, 1031 a 1909); P=0.004--independente de variações no RFG e pressão arterial, os quais não foram diferentes entre os grupos. O subgrupo de pacientes com DRC de etiologia diabética que recebeu Própolis apresentou redução significativa da albuminúria ao final do estudo (de 981 mg/g uCr [IC de 95%, 223 a 1739] para 476 mg/g uCr [IC de 95%, -282 a 1235]; p= 0,031), ao passo que o subgrupo de diabéticos que recebeu Placebo apresentou elevação da albuminúria (de 1261 mg/g uCr [IC de 95%, 569 a 1953] para 1451 mg/g uCr [IC de 95%, 758 a 2143]; p = 0,999). O Monocyte Chemoattractant Protein-1 (MCP-1) urinário também foi menor no grupo Própolis do que no grupo Placebo ao final do tratamento -- 58 pg/mg Cr [IC de 95%, 36 a 95] x 98 pg/mg Cr [IC de 95%, 62 a 155]; P=0.038. O extrato de própolis verde brasileiro foi seguro e bem tolerado, bem como reduziu significativamente a proteinúria em pacientes com DRC de etiologia diabética e não-diabética
Title in English
Effects of Brazilian green propolis on proteinuria and renal function in patients with chronic kidney disease: a randomized, double-blind clinical study, placebo-controlled
Keywords in English
Inflammation
Oxidative stress
Propolis
Proteinuria
Renal insufficiency chronic
Abstract in English
Chronic kidney disease (CKD) is a public health problem worldwide, and proteinuria is a well-established marker of disease progression. Propolis, a natural resin produced by bees from residues and sap of different parts of plants, has anti-inflammatory, immunomodulatory, anti-cancer, anti-oxidant properties, as well as having been shown to have an antiproteinuric effect in experimental CKD. The aim of this study was to evaluate the effect that Brazilian green propolis extract has on proteinuria and on the estimated glomerular filtration rate (eGFR). This was a randomized, double-blind, placebo-controlled study including patients with CKD caused by diabetes or non-diabetic etiology, 18-90 years of age, with an eGFR of 25-70 ml/min per 1.73 m2 and proteinuria (urinary protein excretion > 300 mg/day) or micro- or macro-albuminuria (urinary albumin-to-creatinine ratio > 30 mg/g or > 300 mg/g, respectively). We screened 148 patients and selected 32, randomly assigning them to receive 12 months of Brazilian green propolis extract at a dose of 500 mg/day (n=18) or 12 months of a placebo (n=14). At the end of treatment, proteinuria was significantly lower in the propolis group than in the placebo group--695 mg/24 h (95% CI, 483 to 999) vs. 1403 mg/24 h (95% CI, 1031 to 1909); P=0.004--independent of variations in eGFR and blood pressure, which did not differ between the groups during follow-up. The subgroup of patients with CKD of diabetic ethiology who received Propolis presented a significant reduction of albuminuria at the end of the study (from 981 mg / g uCr [95% CI, 223 to 1739] to 476 mg / g uCr [95% CI, (P = 0.031), whereas the subgroup of diabetics receiving Placebo presented elevation of albuminuria (from 1261 mg / g uCr [95% CI, 569 to 1953] to 1451 mg / g uCr [CI 95%, 758 to 2143], p = 0.999). Urinary Monocyte Chemoattractant Protein-1 (MCP-1) was also significantly lower in the propolis group than in the placebo group -- 58 pg/mg creatinine (95% CI, 36 to 95) vs. 98 pg/mg creatinine (95% CI, 62 to 155); P=0.038. Brazilian green propolis extract was found to be safe and well tolerated, as well as to reduce proteinuria significantly in patients with diabetic and non-diabetic CKD
 
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Publishing Date
2019-08-08
 
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