Marcelo Augusto Duarte Silveira, Hayna Malta-Santos, Jéssica Rebouças-Silva, Flávio Teles, Erica Batista Dos Santos Galvão, Sergio Pinto de Souza, Fábio Ricardo Dantas Dutra, Marcel Miranda Dantas Gomes, Maurício Brito Teixeira, Luis Filipe Miranda Rebelo da Conceição, Carolina Sa Nascimento, Carolina Kymie Vasques Nonaka, Rodrigo Silva Cezar, Paulo Benigno Pena Batista, Andresa Aparecida Berretta, Valeria M Borges, Rogerio da Hora Passos
{"title":"标准巴西绿蜂胶提取物(EPP-AF®)对血液透析患者炎症的影响:一项临床试验。","authors":"Marcelo Augusto Duarte Silveira, Hayna Malta-Santos, Jéssica Rebouças-Silva, Flávio Teles, Erica Batista Dos Santos Galvão, Sergio Pinto de Souza, Fábio Ricardo Dantas Dutra, Marcel Miranda Dantas Gomes, Maurício Brito Teixeira, Luis Filipe Miranda Rebelo da Conceição, Carolina Sa Nascimento, Carolina Kymie Vasques Nonaka, Rodrigo Silva Cezar, Paulo Benigno Pena Batista, Andresa Aparecida Berretta, Valeria M Borges, Rogerio da Hora Passos","doi":"10.1155/2022/1035475","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Patients on haemodialysis (HD) present a significant inflammatory status, which has a pronounced negative impact on their outcomes. Propolis is a natural resin with anti-inflammatory and immunomodulatory properties. We assessed the safety and impact of a standardized Brazilian green propolis extract (EPP-AF®) on the inflammatory status in patients under conventional HD.</p><p><strong>Methods: </strong>Patients were assigned to receive 200 mg/day of EPP-AF® for 4 weeks followed by 4 weeks without the drug, and changes in plasma levels of interleukins (ILs), interferon gamma (IFN-<i>γ</i>), tumour necrosis factor-alpha (TNF-<i>α</i>), and high-sensitivityc-reactive protein (HsCRP) were measured. A heatmap was used to illustrate trends in data variation.</p><p><strong>Results: </strong>In total, 37 patients were included in the final analysis. Patients presented an exacerbated inflammatory state at baseline. During EPP-AF® use, there was a significant reduction in IFN-<i>γ</i> (<i>p</i>=0.005), IL-13 (<i>p</i>=0.04 2), IL-17 (<i>p</i>=0.039), IL-1ra (<i>p</i>=0.008), IL-8 (<i>p</i>=0.009), and TNF-<i>α</i> (<i>p</i> < 0.001) levels compared to baseline, and significant changes were found in Hs-CRP levels. The heatmap demonstrated a pattern of pronounced proinflammatory status at baseline, especially in patients with primary glomerulopathies, and a clear reduction in this pattern during the use of EPP-AF®. There was a tendency to maintain this reduction after suspension of EPP-AF®. No significant side effects were observed.</p><p><strong>Conclusion: </strong>Patients under haemodialysis presented a pronounced inflammatory status, and EPP-AF® was demonstrated to be safe and associated with a significant and maintained reduction in proinflammatory cytokines in this population. This trial is registered with Clinicaltrials.gov NCT04072341.</p>","PeriodicalId":14177,"journal":{"name":"International Journal of Nephrology","volume":null,"pages":null},"PeriodicalIF":1.7000,"publicationDate":"2022-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9708369/pdf/","citationCount":"2","resultStr":"{\"title\":\"Effects of Standardized Brazilian Green Propolis Extract (EPP-AF®) on Inflammation in Haemodialysis Patients: A Clinical Trial.\",\"authors\":\"Marcelo Augusto Duarte Silveira, Hayna Malta-Santos, Jéssica Rebouças-Silva, Flávio Teles, Erica Batista Dos Santos Galvão, Sergio Pinto de Souza, Fábio Ricardo Dantas Dutra, Marcel Miranda Dantas Gomes, Maurício Brito Teixeira, Luis Filipe Miranda Rebelo da Conceição, Carolina Sa Nascimento, Carolina Kymie Vasques Nonaka, Rodrigo Silva Cezar, Paulo Benigno Pena Batista, Andresa Aparecida Berretta, Valeria M Borges, Rogerio da Hora Passos\",\"doi\":\"10.1155/2022/1035475\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Patients on haemodialysis (HD) present a significant inflammatory status, which has a pronounced negative impact on their outcomes. Propolis is a natural resin with anti-inflammatory and immunomodulatory properties. We assessed the safety and impact of a standardized Brazilian green propolis extract (EPP-AF®) on the inflammatory status in patients under conventional HD.</p><p><strong>Methods: </strong>Patients were assigned to receive 200 mg/day of EPP-AF® for 4 weeks followed by 4 weeks without the drug, and changes in plasma levels of interleukins (ILs), interferon gamma (IFN-<i>γ</i>), tumour necrosis factor-alpha (TNF-<i>α</i>), and high-sensitivityc-reactive protein (HsCRP) were measured. A heatmap was used to illustrate trends in data variation.</p><p><strong>Results: </strong>In total, 37 patients were included in the final analysis. Patients presented an exacerbated inflammatory state at baseline. During EPP-AF® use, there was a significant reduction in IFN-<i>γ</i> (<i>p</i>=0.005), IL-13 (<i>p</i>=0.04 2), IL-17 (<i>p</i>=0.039), IL-1ra (<i>p</i>=0.008), IL-8 (<i>p</i>=0.009), and TNF-<i>α</i> (<i>p</i> < 0.001) levels compared to baseline, and significant changes were found in Hs-CRP levels. The heatmap demonstrated a pattern of pronounced proinflammatory status at baseline, especially in patients with primary glomerulopathies, and a clear reduction in this pattern during the use of EPP-AF®. There was a tendency to maintain this reduction after suspension of EPP-AF®. No significant side effects were observed.</p><p><strong>Conclusion: </strong>Patients under haemodialysis presented a pronounced inflammatory status, and EPP-AF® was demonstrated to be safe and associated with a significant and maintained reduction in proinflammatory cytokines in this population. This trial is registered with Clinicaltrials.gov NCT04072341.</p>\",\"PeriodicalId\":14177,\"journal\":{\"name\":\"International Journal of Nephrology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2022-11-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9708369/pdf/\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Nephrology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1155/2022/1035475\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Nephrology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1155/2022/1035475","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
Effects of Standardized Brazilian Green Propolis Extract (EPP-AF®) on Inflammation in Haemodialysis Patients: A Clinical Trial.
Background: Patients on haemodialysis (HD) present a significant inflammatory status, which has a pronounced negative impact on their outcomes. Propolis is a natural resin with anti-inflammatory and immunomodulatory properties. We assessed the safety and impact of a standardized Brazilian green propolis extract (EPP-AF®) on the inflammatory status in patients under conventional HD.
Methods: Patients were assigned to receive 200 mg/day of EPP-AF® for 4 weeks followed by 4 weeks without the drug, and changes in plasma levels of interleukins (ILs), interferon gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α), and high-sensitivityc-reactive protein (HsCRP) were measured. A heatmap was used to illustrate trends in data variation.
Results: In total, 37 patients were included in the final analysis. Patients presented an exacerbated inflammatory state at baseline. During EPP-AF® use, there was a significant reduction in IFN-γ (p=0.005), IL-13 (p=0.04 2), IL-17 (p=0.039), IL-1ra (p=0.008), IL-8 (p=0.009), and TNF-α (p < 0.001) levels compared to baseline, and significant changes were found in Hs-CRP levels. The heatmap demonstrated a pattern of pronounced proinflammatory status at baseline, especially in patients with primary glomerulopathies, and a clear reduction in this pattern during the use of EPP-AF®. There was a tendency to maintain this reduction after suspension of EPP-AF®. No significant side effects were observed.
Conclusion: Patients under haemodialysis presented a pronounced inflammatory status, and EPP-AF® was demonstrated to be safe and associated with a significant and maintained reduction in proinflammatory cytokines in this population. This trial is registered with Clinicaltrials.gov NCT04072341.
期刊介绍：
International Journal of Nephrology is a peer-reviewed, Open Access journal that publishes original research articles, review articles, and clinical studies focusing on the prevention, diagnosis, and management of kidney diseases and associated disorders. The journal welcomes submissions related to cell biology, developmental biology, genetics, immunology, pathology, pathophysiology of renal disease and progression, clinical nephrology, dialysis, and transplantation.
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