CAJ | 학술논문

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。
목적：：고찰천규강압편연합서약강압약치료“이경과서약강압약계통치료단혈압잉미체표자”적고혈압병(간양상항증)적료효급안전성。방법：채용수궤、쌍맹、안위제평행대조、다중심림상시험,경6가림상시험중심대240례수시자(시험조160례,대조조80례)진행림상시험,시험조구복천규강압편4편,tid,료정8주。대조조구복천규강압편모의제4편, tid。관찰약물적료효화안전성。결과：시험조화대조조적강혈압료효현효솔분별위63.23%화31.65%,중의증후료효현효솔분별위48.39%화20.25%；량조차이균유통계학의의(P<0.05)。량조균무엄중불량사건발생；실험실검사각항지표변화,연구자균판정여시험약물무관。결론：천규강압편연합서약강압약치료“이경과서약강압약물계통치료단혈압잉미체표자”적고혈압병(간양상항증),구유교호적료효화안전성。
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 multicenter clinical trials were performed on 240 subjects (160 in the ex-periment group and 80 in the control group) in 6 clinical trial centers. Tiankui antihypertension tablets and the placebo were respec-tively 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 efficien-cy and effective rate of the traditional Chinese medicine (TCM) syndrome of the experimental group was 48. 39% and 20. 25%, re-spectively, while that of the control group was 20. 25% and 36. 71%, respectively. All of the studied clinical indicators showed signifi-cant differences between the two groups (P<0. 05). No severe adverse reaction was shown in the two groups. Conclusion:Tiankui an-tihypertension 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.