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依那普利对类风湿关节炎女性动脉僵硬度的影响:一项随机临床试验。

Enalapril Influence on Arterial Stiffness in Rheumatoid Arthritis Women: A Randomized Clinical Trial.

作者信息

Perez-Vazquez Felipe, Bäck Magnus, Chavarria-Avila Efrain, Gomez-Bañuelos Eduardo, Ramos-Becerra Carlos G, Pizano-Martínez Óscar, Salazar-Páramo Mario, Grover-Páez Fernando, Nava-Zavala Arnulfo H, Cardona-Muñoz Ernesto G, Cardona-Müller David, Duran-Barragán Sergio, Mera-Riofrio Valeria N, Prado-Bachega Natalia, Vazquez-Del Mercado Monica

机构信息

Instituto de Investigación en Reumatología y del Sistema Músculo Esquelético, Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Mexico.

Department of Cardiology and Center for Molecular Medicine, Karolinska University Hospital, Stockholm, Sweden.

出版信息

Front Med (Lausanne). 2020 Jan 29;6:341. doi: 10.3389/fmed.2019.00341. eCollection 2019.

Abstract

Cardiovascular parameters disruption can be found in patients at early stages of rheumatoid arthritis (RA). The primary endpoint of this study was the reduction of arterial stiffness in RA patients without traditional cardiovascular risk factors or previous comorbidities, measured by cardio-ankle vascular index (CAVI) through the enalapril intervention. The secondary endpoints were the enalapril influence on carotid femoral pulse wave velocity (cfPWV), carotid intima media thickness (cIMT), carotid artery distensibility (cDistensibility), Young's incremental elastic modulus (Einc)]. Fifty-three patients were enrolled in a clinical, randomized, closed-label trial. The subjects were randomly assigned into two groups: One receiving 5 mg of enalapril (27) or placebo (26), both twice a day. The drug was acquired at Victory Enterprises®. The placebo was kindly provided by the Universidad de Guadalajara (UdeG), as well as the blinding into two groups: A and B. Enalapril and placebo were packed into bottles without labeling. Clinical assessment included a structured questionnaire to gather demographic and clinical variables as well as determination of CAVI, cfPWV, cIMT, carotid artery distensibility and Einc. The whole set of evaluations were analyzed at the baseline and at the end of 12 weeks of intervention. The CAVI measurement at baseline was 7.1 ± 1.4 and increased up to 7.5 ± 1.2 at the end of 12 weeks. Meanwhile, the enalapril group was as follows: 7.4 ± 1.2 and at the of intervention, reduced to 7.1 ± 0.9. A reduction in delta CAVI of 0.21 in the enalapril intervention group was found. In contrast, an increase of 0.39 was observed in the placebo group. The delta CAVI reduction was not influenced by age or peripheral systolic blood pressure (pSBP). Enalapril seems to be effective in CAVI reduction in RA patients. The effect of enalapril intervention on arterial stiffness translated to the clinical context might be interpreted as a reduction of 6.4 years of arterial aging. The protocol was approved by the Institutional Review Board with the register CI-0117 from UdeG, and 0211/18 from Hospital Civil "Dr. Juan I. Menchaca", Secretaría de Salud Jalisco: DGSP/DDI/D.INV.28/18 and retrospectively registered at ClinicalTrials.gov Protocol Registration and Results System: NCT03667131.

摘要

在类风湿关节炎(RA)患者的早期阶段即可发现心血管参数紊乱。本研究的主要终点是通过依那普利干预,使用心-踝血管指数(CAVI)测量无传统心血管危险因素或既往合并症的RA患者动脉僵硬度的降低情况。次要终点是依那普利对颈股脉搏波速度(cfPWV)、颈动脉内膜中层厚度(cIMT)、颈动脉扩张性(cDistensibility)、杨氏增量弹性模量(Einc)的影响。53例患者参加了一项临床随机双盲试验。受试者被随机分为两组:一组接受5mg依那普利(27例),另一组接受安慰剂(26例),均每日两次。药物购自Victory Enterprises®。安慰剂由瓜达拉哈拉大学(UdeG)提供,并将受试者分为A组和B组进行双盲。依那普利和安慰剂均装在无标签的瓶子中。临床评估包括一份结构化问卷,以收集人口统计学和临床变量,以及测定CAVI、cfPWV、cIMT、颈动脉扩张性和Einc。在基线和干预12周结束时对所有评估进行分析。基线时CAVI测量值为7.1±1.4,12周结束时增至7.5±1.2。同时,依那普利组基线时为7.4±1.2,干预结束时降至7.1±0.9。依那普利干预组的CAVI变化值降低了0.21。相比之下,安慰剂组增加了0.39。CAVI变化值的降低不受年龄或外周收缩压(pSBP)的影响。依那普利似乎对降低RA患者的CAVI有效。依那普利干预对动脉僵硬度的影响在临床背景下可解释为动脉老化减少6.4年。该方案已获得机构审查委员会批准,登记号为UdeG的CI-0117以及哈利斯科州卫生部“胡安·I·门查卡医生”公民医院的0211/18:DGSP/DDI/D.INV.28/18,并在ClinicalTrials.gov协议注册和结果系统中进行了回顾性注册:NCT03667131。

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