盐酸雷诺嗪缓释片治疗稳定型心绞痛的临床观察  

Clinical Observation of Ranolazine Hydrochloride Sustained-release Tablets in the Treatment of Stable Angina Pectoris

作　　者：王高频[1] 周长宇 

机构地区：[1]辽宁医学院附属第一医院心内科,辽宁锦州121000 [2]辽阳市中心医院心内科,辽宁辽阳111000

出　　处：《中国药房》2012年第26期2455-2458,共4页China Pharmacy

摘　　要：目的:观察不同剂量盐酸雷诺嗪缓释片对稳定型心绞痛患者的临床症状、心电图及肝、肾功能的影响。方法:90例冠心病稳定型心绞痛患者随机分为对照组、盐酸雷诺嗪缓释片500mg组和盐酸雷诺嗪缓释片1000mg组,每组30例,在常规治疗(阿司匹林、调脂药、美托洛尔)的基础上,分别加用安慰剂、盐酸雷诺嗪缓释片500mg(每日2次)和盐酸雷诺嗪缓释片1000mg(每日2次),治疗8周。观察心绞痛发作频率、每次发作持续时间、硝酸甘油用量、心电图NST和∑ST变化,并记录临床总有效率、不良反应及检测肝、肾功能,评估盐酸雷诺嗪缓释片的安全性。结果:对心绞痛症状的影响:与治疗前比较,3组心绞痛发作频率、每次发作持续时间、硝酸甘油用量均明显减少(P<0.01);与对照组比较,盐酸雷诺嗪缓释片500mg组和盐酸雷诺嗪缓释片1000mg组心绞痛发作频率显著减少,每次发作持续时间缩短,硝酸甘油用量减少(P<0.01或P<0.05),盐酸雷诺嗪缓释片1000mg组较盐酸雷诺嗪缓释片500mg组改善更明显(P<0.05)。对心电图的影响:与治疗前比较,3组心电图NST和∑ST均改善(P<0.01或P<0.05);与对照组比较,盐酸雷诺嗪缓释片500mg组和盐酸雷诺嗪缓释片1000mg组对心电图NST和∑ST均改善(P<0.05),但盐酸雷诺嗪缓释片500mg组与盐酸雷诺嗪缓释片1000mg组组间比较差异无统计学意义(P>0.05)。不良反应及安全性:与对照组比较,盐酸雷诺嗪缓释片500mg组和盐酸雷诺嗪缓释片1000mg组肝、肾功能变化及不良反应差异无统计学意义(P>0.05)。结论:盐酸雷诺嗪缓释片治疗慢性稳定型心绞痛有效、安全性高,且呈剂量依赖性。OBJECTIVE： To observe the effects of different dosages of Ranolazine hydrochloride sustained-release tablets on clinical symptoms, electrocardiogram, liver and renal function in patients with stable angina pectoris. METHODS ： 90 coronary heart disease （CHD） patients with stable angina pectoris were randomized into control group, Ranolazine hydrochloride sustained release tablets 500 mg group and Ranolazine hydrochloride sustained-release tablets 1 000 mg group with 30 patients in each group. Based on conventional therapy （aspirin, cholesterol lowering agents, metoprolol） , 3 groups received placebo, Ranolazine hydrochloride sustained-release tablets 500 mg and 1 000 mg for 8 weeks respectively. Angina attack frequency, the duration of each attack, nitroglycerin consumption, ECG NST and ∑ ST, clinical total effective rate, ADR and detection of liver and kidney function were observed and determined to evaluate the safety of Ranolazine hydrochloride sustained-release tablets. RESULTS： Effects of tablets on symptom： compared with before therapy, angina attack frequency, duration of each attack, nitroglycerin consumption were significantly reduced in 3 groups （P〈0.01） ; compared with control group, angina seizure frequency, the duration of each attack and nitroglycerin consumption in Ranolazine hydrochloride sustained release tablets 500 mg and 1 000 mg groups were significantly decreased （P〈 0.01 or P（0.05）, and the improvement of Ranolazine hydrochloride sustained-release tablets 1 000 mg group was more significant than that of 500 mg group （P〈0.05）. Effects of tablets on ECG： compared with before therapy, ECG NST and ∑ ST in 3 groups were significantly improved （P〈0.01 or P〈0.05） ; compared with control group, ECG NST and ∑ ST in Ranolazine groups were significantly improved （P〈0.05）, but there were no significant difference between Ranolazine hydrochloride sustained-release tablets 500 mg group and 1 000 mg group （P〉0.05）. ADR and safety： compared w

关 键 词：盐酸雷诺嗪 稳定型心绞痛 冠心病 药品不良反应 

分 类 号：R972.3[医药卫生—药品] R969.4[医药卫生—药学]