Martsevitch S Yu, Kutishenko N P, Deev On Behalf Of The Kvazar Study A D
National Research Center for Preventive Medicine, Moscow, Russia.
Kardiologiia. 2016 Oct;56(10):30-34.
to demonstrate impact of addition of nicorandil to standard treatment in patients with stable ischemic heart disease (IHD) on clinical manifestations of the disease and safety of conducted therapy.
We included in this double-blind placebo controlled study with parallel groups 120 patients with verified IHD and stable effort angina. During the entire study all patients received metoprolol (100 mg/day). Patients of main group were given nicorandil (10 mg twice a day for 2 weeks and 20 mg twice a day thereafter); patients of control group were given placebo. Study duration was 6 weeks.
Addition of nicorandil was associated with significant reduction of number of anginal attacks both compared with control period and addition of placebo. Consumption of short acting nitrates significantly decreased on both nicorandil doses compared with control period. Adverse events were registered in 10 of 61 and 7 of 59 patients (16.4 and 11.9%) taking nicorandil and placebo, respectively (n.s.). Three patients withdrew from the study because of headache.
Addition of nicorandil to standard therapy in patients with chronic IHD and stable effort angina promoted significant reduction of number of angina attacks. Good tolerability of nicorandil was also demonstrated.
证明在稳定型缺血性心脏病(IHD)患者的标准治疗中加用尼可地尔对该疾病临床表现及所实施治疗安全性的影响。
我们将120例确诊为IHD且患有稳定劳力型心绞痛的患者纳入这项双盲、安慰剂对照的平行组研究。在整个研究过程中,所有患者均接受美托洛尔(100毫克/天)治疗。主要组患者给予尼可地尔(前2周每天2次,每次10毫克,之后每天2次,每次20毫克);对照组患者给予安慰剂。研究持续时间为6周。
与对照期及加用安慰剂相比,加用尼可地尔与心绞痛发作次数显著减少相关。与对照期相比,两种尼可地尔剂量下短效硝酸盐的消耗量均显著降低。服用尼可地尔和安慰剂的患者中,分别有10例(16.4%)和7例(11.9%)记录到不良事件(无显著性差异)。3例患者因头痛退出研究。
在慢性IHD和稳定劳力型心绞痛患者的标准治疗中加用尼可地尔可显著减少心绞痛发作次数。尼可地尔还表现出良好耐受性。