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巴西绿蜂胶提取物能否改善有症状的慢性冠状动脉疾病的功能能力?一项初步随机试验

Does Green Brazilian Propolis Extract Improve Functional Capacity in Symptomatic Chronic Coronary Disease?-A Pilot Randomized Trial.

作者信息

Figueiredo Clara Salles, Passos Luiz Carlos Santana, Cafezeiro Caio Rebouças Fonseca, de Melo Rodrigo Morel Vieira, Viana Tainá Teixeira, de Oliveira Eduardo Jorge Gomes, Berretta Andresa Aparecida, Silveira Marcelo Augusto Duarte

机构信息

Programa de Pós-Graduação em Medicina e Saúde (Graduate Program in Medicine and Health), Faculdade de Medicina da Bahia, Universidade Federal da Bahia, Salvador 40110-060, BA, Brazil.

Hospital Ana Nery, Salvador 40301-155, BA, Brazil.

出版信息

Pharmaceuticals (Basel). 2025 May 31;18(6):827. doi: 10.3390/ph18060827.

Abstract

Inflammation plays a critical role in the progression of coronary heart disease (CHD). Low-dose colchicine has shown promise in reducing cardiovascular events, and green Brazilian propolis extract (EPP-AF® (standardized Brazilian green propolis extract) was provided by Apis Flora Indl. Coml. Ltda, Ribeirão Preto, SP, Brazil), known for its anti-inflammatory properties, may offer additional therapeutic benefits. This pilot study aimed to evaluate whether six weeks of EPP-AF supplementation improves functional capacity assessed by treadmill exercise testing. : This was a randomized, double-blind, placebo-controlled pilot study conducted at a coronary disease clinic in Brazil. Patients aged ≥ 18 years with stable CHD receiving optimized medical therapy were randomized in a 2:1 ratio to receive either 200 mg of EPP-AF or placebo twice daily for six weeks. The primary outcome was the change in treadmill exercise duration (in seconds). Secondary outcomes included total exercise time, functional capacity (measured in metabolic equivalents of task [METs]), high-sensitivity C-reactive protein (hs-CRP) levels, the Seattle Angina Questionnaire (SAQ), and the Canadian Cardiovascular Society (CCS) angina classification. Statistical analysis was performed on an intention-to-treat basis. : A total of 59 patients were randomized, with a median follow-up of 6.5 weeks. There was no significant difference in the primary endpoint between groups: the median change in treadmill test time was 39 s in the EPP-AF group versus 30 s in the placebo group ( = 0.83). No improvements were observed in METs, hs-CRP levels, SAQ scores, or CCS class in the EPP-AF group. No major adverse cardiovascular events occurred during the study. EPP-AF did not improve functional capacity, inflammatory markers, or angina symptoms in patients with stable CHD compared to placebo.

摘要

炎症在冠心病(CHD)的进展中起关键作用。低剂量秋水仙碱已显示出降低心血管事件的前景,而以其抗炎特性闻名的巴西绿蜂胶提取物(EPP-AF®(标准化巴西绿蜂胶提取物)由巴西圣保罗州里贝朗普雷图的Apis Flora Indl. Coml. Ltda提供)可能会带来额外的治疗益处。这项初步研究旨在评估补充六周EPP-AF是否能改善通过跑步机运动测试评估的功能能力。:这是一项在巴西一家冠心病诊所进行的随机、双盲、安慰剂对照的初步研究。年龄≥18岁且接受优化药物治疗的稳定型CHD患者以2:1的比例随机分组,分别接受每日两次200毫克EPP-AF或安慰剂,为期六周。主要结局是跑步机运动持续时间的变化(以秒为单位)。次要结局包括总运动时间、功能能力(以任务代谢当量[METs]衡量)、高敏C反应蛋白(hs-CRP)水平、西雅图心绞痛问卷(SAQ)以及加拿大心血管学会(CCS)心绞痛分级。统计分析按意向性分析进行。:共有59名患者被随机分组,中位随访时间为6.5周。两组之间的主要终点无显著差异:EPP-AF组跑步机测试时间的中位变化为39秒,而安慰剂组为30秒(=0.83)。EPP-AF组在METs、hs-CRP水平、SAQ评分或CCS分级方面未观察到改善。研究期间未发生重大不良心血管事件。与安慰剂相比,EPP-AF未能改善稳定型CHD患者的功能能力、炎症标志物或心绞痛症状。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9ef/12196463/1cb00044f527/pharmaceuticals-18-00827-g001.jpg

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