摘要
目的评价注射用丹参多酚酸盐治疗老年冠心病心绞痛患者的疗效和安全性。方法选择国内多中心、开放、自身对照的丹参多酚酸盐Ⅳ期临床研究中,年龄>75岁的506例慢性稳定性心绞痛患者(>75岁组)和≤75岁组1570例。分析丹参多酚酸盐200mg/d,静脉滴注10～14d后对减少心绞痛发作的疗效和安全性。结果与治疗前比较,治疗后>75岁组患者心绞痛发作次数由4.00(2.00,7.00)次/周下降至1.00(0.00,2.00)次/周(P<0.05),硝酸甘油用量由2.00(2.82,3.65)片/周下降至1.00(1.33,2.02)片/周(P<0.05),59%患者治疗后加拿大心绞痛分级下降1级以上。治疗期间,发生不良事件25例,其中症状性不良事件7例,实验室检查不良事件18例,不良反应发生率为1%。结论注射用丹参多酚酸盐对老年冠心病心绞痛患者治疗14d能有效减少心绞痛发作次数,不良反应发生率低。
Objective To assess the efficacy and safety of salvianolate injection in treatment of sta ble angina pectoris in elderly coronary artery disease patients. Methods A total of 2076 patients with chronic stable angina pectoris ongoing phase IV non-blinded and self-controlled salvianolate trial in a multicenter were included in this study. They were divided into 〉75 years old group（n： 506） and ≤75 years old group（n： 1570）,The patients were treated with intravenous salvianolate drip at the dose of 200mg/d for 10-14 days, and the efficacy and safety of salvianolate were then analyzed. Results The frequency of angina pectoris attack decreased from 4.00（2.00,7.00） times per week before treatment to 1.00（0.00,2.00） times per week after treatment（P〈0.05）. The number of nitroglycerin tablets used by the patients decreased from 2.00（2.82,3.65） per week before treatment to 1.00（1.33,2.02） per week after treatment（P〈0.05）. Canadian angina pecto- ris staging decreased one level or more in 59%of the patients. Twenty-five adverse events oc- curred during the treatment,including 7 symptomatic adverse events and 18 adverse events detec- ted in laboratory test with an adverse reaction rate of 1%. Conclusion Salvianolate injection for 14 days can effectively decrease the frequency of angina pectoris attack in elderly coronary heart disease patients with a low adverse reaction rate.
出处
《中华老年心脑血管病杂志》
CAS
北大核心
2013年第2期135-138,共4页
Chinese Journal of Geriatric Heart,Brain and Vessel Diseases
基金
上海市科学技术委员会"科技小巨人项目"(11HX1186200)
关键词
丹参注射液
心绞痛
冠心病
硝酸甘油
血小板聚集抑制剂
临床试验
Ⅳ期
DANSHEN INJECTION
angina pectoris
coronary disease
nitroglycerin
platelet ag-gregation inhibitors
clinical trial, phase 1V
