MEDIUM-TERM EFFECTS OF ENHANCED EXTERNAL COUNTERPULSATION ON OF GLYCEMIC CONTROL MARKERS IN PATIENTS WITH CHRONIC

Lishuta A.S., Slepova O.A., Nikolaeva N.A., Belenkov Yu.N.
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Abstract

Aim. To study the effects of complex therapy with the addition of enhanced external counterpulsation (EECP) on exercise tolerance, echocardiographic parameters, markers of glycemic control and clinical outcomes in patients with ischemic chronic heart failure (CHF) with concomitant type 2 diabetes mellitus (DM). Material and methods. Patients with ischemic CHF II-III functional class with type 2 DM were randomized into group 1 (n=20) – optimal medical therapy (OMT) and EECP (35 hours, 2 courses per year), group 2 (n=21) – OMT and EECP (35 hours, 1 course per year), control group (n=20) – OMT and placebo-counterpulsation (35 hours, 1 course per year). The primary endpoint was achieving an HbA1c level of ≤7%. Secondary endpoints included the development of a combined endpoint (CEP: cases of adverse outcomes, hospitalizations for CHF, new onsets of atrial fibrillation, decreased renal function), as well as an increase after 12 months in the distance covered in 6-minue walk test (6MWT) by 20% or more from the baseline. Results. After 12 months, the proportion of patients achieving an HbA1c level of ≤7% in group 1 increased by 30%, in group 2 – by 14.3%, and remained the same in the control group (p=0.005). The proportion of patients with an increase in distance traveled according to 6MWT data >20% after 12 months in the 1st, 2nd and control groups was 100%, 76.2% and 15.0%, respectively (p<0.001). The development of CEP was observed in 3 (15.0%) patients of the 1st group, 7 (33.3%) – of the 2nd group and 12 (60.0%) – of the control group (including 1 case of death), p =0.003. Conclusion. Over a 12-month study period in patients with ischemic heart failure and type 2 diabetes, the addition of EECP to OMT after 12 months demonstrated an improvement in the clinical status of patients, which was accompanied by a decrease in levels of markers of glycemic control and the incidence of adverse outcomes compared with the placebo counterpulsation group.
增强型体外反搏对慢性病患者血糖控制指标的中期影响
目的研究缺血性慢性心力衰竭(CHF)合并 2 型糖尿病(DM)患者在接受复合疗法的同时接受增强体外反搏(EECP)对运动耐量、超声心动图参数、血糖控制指标和临床预后的影响。缺血性慢性心力衰竭(CHF)II-III功能分级伴2型糖尿病患者被随机分为1组(20人)--最佳医疗疗法(OMT)和EECP(35小时,每年2个疗程),2组(21人)--OMT和EECP(35小时,每年1个疗程),对照组(20人)--OMT和安慰剂反搏(35小时,每年1个疗程)。主要终点是实现 HbA1c 水平≤7%。次要终点包括综合终点(CEP:不良后果病例、慢性阻塞性肺病住院病例、心房颤动新发病例、肾功能下降病例)的发展情况,以及 12 个月后 6 分钟步行测试(6MWT)覆盖距离比基线增加 20% 或更多。12 个月后,HbA1c 水平≤7% 的患者比例,第一组增加了 30%,第二组增加了 14.3%,而对照组保持不变(P=0.005)。12 个月后,根据 6MWT 数据,第 1 组、第 2 组和对照组中行走距离增加大于 20% 的患者比例分别为 100%、76.2% 和 15.0%(p<0.001)。第一组有 3 名患者(15.0%)、第二组有 7 名患者(33.3%)、对照组有 12 名患者(60.0%)(包括 1 例死亡病例)出现了 CEP,P =0.003。在对缺血性心力衰竭合并 2 型糖尿病患者进行的为期 12 个月的研究中,与安慰剂反搏组相比,在 OMT 基础上加用 EECP 12 个月后,患者的临床状况有所改善,同时血糖控制指标水平和不良后果发生率也有所下降。
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