硒治疗对恰加斯心脏病心脏功能的影响：STCC随机试验结果
Effects of Selenium treatment on cardiac function in Chagas heart disease: Results from the STCC randomized Trial.
作者信息
Holanda Marcelo T, Mediano Mauro F F, Hasslocher-Moreno Alejandro M, Gonzaga Beatriz M S, Carvalho Anna Cristina C, Ferreira Roberto R, Garzoni Luciana R, Pereira-Silva Fernanda S, Pimentel Luis O, Mendes Marcelo O, Azevedo Marcos J, Britto Constança, Moreira Otacilio C, Fernandes Alice G, Santos Carolina M, Constermani Jéssica, Paravidino Vitor B, Maciel Erica R, Carneiro Fernanda M, Xavier Sérgio S, Sperandio da Silva Gilberto M, Santos Priscila F, Veloso Henrique H, Brasil Pedro E A A, de Sousa Andrea S, Bonecini-de-Almeida Maria G, da Silva Paula S, Sangenis Luiz Henrique C, Saraiva Roberto M, Araujo-Jorge Tania C
机构信息
Laboratory of Clinical Research in Chagas Disease, Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, Brazil.
Laboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute (LITEB-IOC/Fiocruz), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro 21040-360, Brazil.
出版信息
EClinicalMedicine. 2021 Aug 28;40:101105. doi: 10.1016/j.eclinm.2021.101105. eCollection 2021 Oct.
BACKGROUND
Chagas disease (caused by infection) evolves to chronic chagasic cardiomyopathy (CCC) affecting 1.8 million people worldwide. This is the first randomized, placebo-controlled, double-blinded, clinical trial designed to estimate efficacy and safety of selenium (Se) treatment in CCC.
METHODS
66 patients with CCC stages B1 (left ventricular ejection fraction [LVEF] > 45% and no heart failure; = 54) or B2 (LVEF < 45% and no heart failure; = 12) were randomly assigned to receive 100 mcg/day sodium selenite ( = 32) or placebo ( = 34) for one year (study period: May 2014-September 2018). LVEF changes over time and adverse effects were investigated. Trial registration number: NCT00875173 (clinicaltrials.gov).
FINDINGS
No significant differences between the two groups were observed for the primary outcome: mean LVEF after 6 (β +1.1 = 0.51 for ) and 12 months (β +2.1; = 0.23). In a subgroup analysis, statistically significant longitudinal changes were observed for mean LVEF in the stage B2 subgroup (β= +10.1; = 0.02 for [ = 4] [ = 8]). Se treatment was safe for CCC patients, and the few adverse effects observed were similarly distributed across the two groups.
INTERPRETATION
Se treatment did not improve cardiac function (evaluated from LVEF) in CCC. However, in the subgroup of patients at B2 stage, a potential beneficial influence of Se was observed. Complementary studies are necessary to explore diverse Se dose and/or associations in different CCC stages (B2 and C), as well as in A and B1 stages with longer follow-up.
FUNDING
Brazilian Ministry of Health, Fiocruz, CNPq, FAPERJ.
背景
恰加斯病（由感染引起）会发展为慢性恰加斯心肌病（CCC），全球有180万人受其影响。这是第一项旨在评估硒（Se）治疗CCC疗效和安全性的随机、安慰剂对照、双盲临床试验。
方法
66例B1期（左心室射血分数[LVEF]＞45%且无心力衰竭；n = 54）或B2期（LVEF＜45%且无心力衰竭；n = 12）的CCC患者被随机分配接受100微克/天的亚硒酸钠（n = 32）或安慰剂（n = 34），为期一年（研究期：2014年5月至2018年9月）。研究LVEF随时间的变化及不良反应。试验注册号：NCT00875173（clinicaltrials.gov）。
研究结果
两组在主要结局方面未观察到显著差异：6个月（亚硒酸钠组β +1.1；P = 0.51）和12个月（β +2.1；P = 0.23）后的平均LVEF。在亚组分析中观察到，B2期亚组的平均LVEF有统计学意义的纵向变化（亚硒酸钠组β = +10.1；P = 0.02，n = 4；安慰剂组n = 8）。硒治疗对CCC患者是安全的，观察到的少数不良反应在两组中的分布相似。
解读
硒治疗并未改善CCC患者的心脏功能（根据LVEF评估）。然而，在B2期患者亚组中，观察到了硒的潜在有益影响。有必要进行补充研究，以探索不同CCC阶段（B2和C）以及A和B1期不同硒剂量和/或联合用药，并进行更长时间的随访。
资金来源
巴西卫生部、奥斯瓦尔多·克鲁兹基金会、国家科学技术发展委员会、里约热内卢州研究资助基金会。
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