应用随机双盲法评价补肾和脉方治疗老年单纯收缩期高血压的临床研究  

Bushen Hemai formula for elderly patients with isolated systolic hypertension: a randomized double-blind trial

作　　者：姜北[1] 胡元会[2] 杜柏[2] 孟莉[3] 房玉涛[2] 孟昊[2] 贾岱琳[2] 

机构地区：[1]中国中医科学院广安门医院南区,北京102618 [2]中国中医科学院广安门医院,北京100053 [3]北京市丰台区南苑医院,北京100076

出　　处：《北京中医药》2014年第8期563-567,共5页Beijing Journal of Traditional Chinese Medicine

基　　金：国家"十一五"科技支撑计划资助项目(2007BAI20B071)

摘　　要：目的探讨补肾和脉方联合规范化抗高血压药物治疗老年单纯收缩期高血压的疗效及安全性。方法采用随机双盲对照研究方法,将65例患者按照分层区组随机化分为试验组和对照组。试验组采用中药复方颗粒联合规范化抗高血压药物治疗,对照组采用安慰剂颗粒联合规范化抗高血压药物治疗。2组均治疗12周,研究分为导入期和随机化治疗期,观察疗效性指标。结果试验组降压有效率94.3%(33/35),对照组87.5%(26/30),组间比较差异无统计学意义(χ2=1.119,P>0.05)。试验组降压达标率88.6%(31/35),对照组80%(24/30),组间比较差异有统计学意义(χ2=17.515,P<0.01)。治疗前后脉压的降低幅度相比,2组间差异有统计学意义(t=3.248,P<0.01)。结论补肾和脉方联合规范化抗高血压药物治疗可有效、平稳地控制老年单纯收缩期高血压患者的血压,改善其临床症状,具有良好的安全性和耐受性。ABSTRACT Objective To explore the antihypertensive effect and safety of Bushen Hemai formula combined with normalized antihypertensive drug for elderly isolated systolic hypertension. Methods The randomized controlled double-blind trial was performed by using stratified blocked randomization method. The treatment group was treated with TCM compound granules combined with normalized antihypertensive drug, while the control group was treated with placebo granules combined with normalized antihypertensive drug. This trial consisted of recruitment period and randomized-treatment period. Results The effective rate of anti-hypertension was 94. 3 % （33/ 35） in the treatment group and 87. 5% （26/30） in the control group, which was not significantly different （X^2 = 1. 119, P 〉0. 05） ; the achieved rate of anti-hypertension 88. 6% （31/35） in the treatment group and 80% （24/30） in the control group, which was significantly different （X^2 = 17. 515, P 〈0. 01 ） ; as for the reducing range of pulse pressure before and after treatment, the difference between two groups was significantly different （t = 3. 248, P 〈 0. 01 ）. Condusion Bushen Hemai formula combined with normalized antihypertensive drug could control the elderly isolated systolic hypertension effectively and stably and improve the clinical symptoms with good safety and tolerance.

关 键 词：老年单纯收缩期高血压 补肾和脉方 动态血压 偶测血压 

分 类 号：R544.1[医药卫生—心血管疾病]