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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 investigate the efficacy and safety of “Xueyang Jiangya Decoction” combined with western medicine antihypertensive drugs in the treatment of hypertension (hyperactivity of the liver-yang hyperactivity syndrome) who have undergone the treatment of antihypertensive drugs with western medicine but whose blood pressure has not reached the standard. METHODS: A randomized, double-blind, placebo-controlled and multicenter clinical trial was conducted in 240 subjects (160 in trial group and 80 in control group) through 6 clinical trial centers. Antihypertensive tablets 4, tid, treatment for 8 weeks. Control group oral sunflower antihypertensive tablets simulant 4, tid. Observe the efficacy and safety of the drug. Results: The effective rates of lowering blood pressure in experimental group and control group were 63.23% and 31.65%, respectively. The effective rates of TCM syndromes were 48.39% and 20.25% respectively. There was significant difference between the two groups (P <0.05). There were no serious adverse events in both groups. All the indexes of laboratory tests changed, and the investigators all judged that they had nothing to do with the test drugs. Conclusion: The decoction of sunflower combined with western medicine antihypertensive drugs “has been western medicine antihypertensive drug system, but the blood pressure has not yet reached the standard” of hypertensive disease (liver Yang hyperactivity), has good curative effect and safety Sex.