天葵降压片联合西药降压药治疗高血压病的随机、双盲、安慰剂对照、多中心临床试验  

Randomized,Double-blind,Placebo Control and Multicenter Clinical Trials for Tiankui Antihypertension Tablets Combined with Chemical Drugs in the Treatment of Hypertension

作　　者：王淑华 李泮海[2] 冉大强[2] 王晓峰 薛洁 陈兆光 

机构地区：[1]山东省药学科学院,济南250101 [2]山东省食品药品监督管理局审评认证中心 [3]新疆维吾尔自治区中医医院

出　　处：《中国药师》2015年第6期964-967,共4页China Pharmacist

基　　金：国家"重大新药创制"科技重大专项(编号:2009ZX09103-367)

摘　　要：目的:考察天葵降压片联合西药降压药治疗"已经过西药降压药系统治疗但血压仍未达标者"的高血压病(肝阳上亢证)的疗效及安全性。方法:采用随机、双盲、安慰剂平行对照、多中心临床试验,经6家临床试验中心对240例受试者(试验组160例,对照组80例)进行临床试验,试验组口服天葵降压片4片,tid,疗程8周。对照组口服天葵降压片模拟剂4片,tid。观察药物的疗效和安全性。结果:试验组和对照组的降血压疗效显效率分别为63.23%和31.65%,中医证候疗效显效率分别为48.39%和20.25%;两组差异均有统计学意义(P<0.05)。两组均无严重不良事件发生;实验室检查各项指标变化,研究者均判定与试验药物无关。结论:天葵降压片联合西药降压药治疗"已经过西药降压药物系统治疗但血压仍未达标者"的高血压病(肝阳上亢证),具有较好的疗效和安全性。Objective： To confirm the efficacy and safety of Tiankui antihypertension tablets combined with chemical drugs in the treatment of patients with hypertension whose blood pressure can ＇t reach the standard after the treatment only with chemical drugs. Methods： Randomized, double-blind, placebo control and muhieenter clinical trials were performed on 240 subjects （160 in the experiment group and 80 in the control group） in 6 clinical trial centers. Tiankui antihypertension tablets and the placebo were respectively given with 4 tablets per time and 3 times a day. The efficacy and safety were observed. Results： For the blood pressure control, the significant efficiency of the experimental group was 63.23%, while that of the control group was 31.65%. The significant efficiency and effective rate of the traditional Chinese medicine （TCM） syndrome of the experimental group was 48.39% and 20.25%, respectively, while that of the control group was 20.25% and 36.71%, respectively. All of the studied clinical indicators showed significant differences between the two groups （ P 〈 0.05 ）. No severe adverse reaction was shown in the two groups. Conclusion ： Tiankui antihypertension tablets combined with chemical drugs exhibits better curative effect and safety in the treatment of hypertension patients whose blood pressure can＇ t reach the standard after the treatment only with chemical drugs.

关 键 词：天葵降压片 高血压 安慰剂对照 多中心临床试验 

分 类 号：R285.6[医药卫生—中药学]