BACKGROUND & AIMS:
OBJECTIVE:Iron deficiency anemia (IDA) in patients with heart disease is correlated with decreased exercise capacity and poor health-related quality of life, and predicts worse cardiovascular outcomes, especially for elderly patients. IDA can worsen cardiac function that can be monitored with Heart Rate Variability (HRV) analysis, providing important information about cardiac health. In a recent study we explored the effect and the tolerability of the administration of Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel Forte®) in "frailty" patients with secondary anemia and low kidney failure, by analysing the HRV frequency domain. The aim of the present study is the further confirmation of the safety of the already evaluated intervention, by analysing non-linear domain of HRV.
PATIENTS AND METHODS:In this pilot study we enrolled 52 "frailty" elderly patients, with a recent diagnosis of secondary anemia due to iron deficiency, with Class II New York Heart Association (NYHA) hypertensive heart disease, low kidney failure, and atherosclerosis. The patients were divided in 2 groups: Group A (N=23 patients) received oral administration of Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel Forte®) 2 tabs/day, containing 60 mg of Fe3+, for 24 days; Group B (N=29 patients) received intravenous administration of ferrous gluconate 63 mg/day added to saline solution, while they were hospitalized (15±5 days). We evaluated laboratory values of hemoglobin (Hb) and sideremia levels. Furthermore, we measured ECG signals before and after treatment, using non-linear analysis techniques.
RESULTS:Both intravenous and oral treatments evaluated in this study, were effective and safe about the cardiovascular risk in "frailty" elderly patients, as resulted from non-linear HRV analysis. Efficacy results showed that hemoglobin and sideremia levels after treatments are significantly increased. The HRV non-linear analysis showed that all parameters evaluated, except for the SD1 values in the Group A, were not affected by treatments, confirming the absence of cardiovascular risk of the therapy.
CONCLUSIONS:Non-linear HRV evaluation confirmed that oral administration of Ferric Sodium EDTA, in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel forte®) did not impact the cardiovascular risk, without causing adverse events typically reported with other iron supplementation therapies, both oral and intravenous.
背景与目标:
目的:心脏病患者缺铁性贫血(IDA)与运动能力下降和健康相关的生活质量下降相关,并预测心血管疾病的恶化,尤其是对于老年患者。 IDA可使心脏功能恶化,可通过心率变异性(HRV)分析进行监测,从而提供有关心脏健康的重要信息。在最近的研究中,我们探讨了EDTA铁钠与维生素C,叶酸,葡萄糖酸铜,葡萄糖酸锌和硒代蛋氨酸(FerachelForte®)联用对继发性贫血和低肾脏的“脆弱”患者的治疗效果和耐受性通过分析HRV频域来确定故障。本研究的目的是通过分析HRV的非线性域,进一步确认已经评估过的干预措施的安全性。
患者与方法:在这项前瞻性研究中,我们招募了52名“脆弱”的老年患者,这些患者最近被诊断为铁缺乏引起的继发性贫血,并伴有II级纽约心脏协会(NYHA)高血压心脏病,低肾功能衰竭和动脉粥样硬化。将患者分为2组:A组(N = 23名患者)接受口服EDTA铁钠联合维生素C,叶酸,葡萄糖酸铜,葡萄糖酸锌和硒代蛋氨酸(FerachelForte®)2片/天,含60 mg的Fe3,持续24天; B组(N = 29例患者)在住院期间(15±5天)接受了静脉滴注63 mg /天的葡萄糖酸葡萄糖酸亚铁静脉注射。我们评估了血红蛋白和血铁蛋白水平的实验室值。此外,我们使用非线性分析技术测量了治疗前后的ECG信号。
结果:本研究评估的静脉和口服治疗均有效且安全,这是由于非线性HRV分析导致的“虚弱”老年患者的心血管风险。疗效结果显示,治疗后血红蛋白和铁血含量显着增加。 HRV非线性分析表明,除A组中的SD1值外,所有评估的参数均不受治疗的影响,从而证实了该治疗方法无心血管风险。
结论:非线性HRV评估证实,口服EDTA铁钠与维生素C,叶酸,葡萄糖酸铜,葡萄糖酸锌和硒代蛋氨酸(Ferachelforte®)联合使用不会影响心血管疾病的风险,而不会引起通常报道的不良事件以及其他口服和静脉补铁疗法。