中孚降压胶囊治疗高血压病阴虚阳亢证临床观察

作者	单位
寇秋爱	中国中医科学院西苑医院
于华萍	北京市门头沟区中医院
周国栋	中国中医科学院西苑医院
柏燕君	中国中医科学院西苑医院
涂秀华	中国中医科学院西苑医院

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中文摘要:

目的观察中孚降压胶囊治疗高血压病(阴虚阳亢证)的临床疗效及安全性。方法采用分层区组随机、双盲双模拟、阳性药平行对照、多中心临床试验的方法。试验组口服中孚降压胶囊(0.5g/粒,每次3粒,每天2次)及洛丁新片模拟剂(10mg/片,每次1片,每天1次);对照组口服洛丁新片(10mg/片,每次1片,每天1次)及中孚降压胶囊模拟剂(0.5g/粒,每次3粒,每天2次),4周为1个疗程,观察两组的降压效果及中医证候疗效。结果试验组降压显效率58.65%,总有效率79.81%;对照组分别为60.51%,78.34%;试验组中医证候显效率21.15%,总有效率78.85%;对照组为分别25.48%、86.62%,两组降压效果及中医证候比较,总有效率、显效率差异均无显著性(P>0.05)。结论中孚降压胶囊治疗高血压病疗效明显而且安全性良好。

英文摘要:

Objective To observe the efficacy and safety of Zhongfu Hypotension Capsule (ZHC) in treating hypertension of yin-deficiency with sthenic-yang syndrome type. Methods Adopting the stratified, block randomized, double-blinded, double-dummy, positive parallel controlled, multi-centered clinical trial method, the tested group was treated by orally taken 3 capsules of ZHC (0.5 g/capsule) twice a day, and the control group was treated by orally taken Lotensin Tablet 1 tablet (10 mg/tab.) once a day. And all received the adiaphorous drug with the dosage-form mimic to that used in the tested group. The therapeutic course was 4 weeks for both groups. Results The markedly effective rate and the total effective rate in reducing blood pressure was 58.65% and 79.81% respectively in the tested group,and 60.51% and 78.34% respectively in the control group; while the markedly effective rate and the total effective rate for alleviating TCM syndrome was 21.15% and 78.85% in the tested group, and 25.48% and 86.62% in the control group respectively. Comparisons between the two groups showed insignificant difference (P>0.05) .Conclusion ZHC has good efficacy and is safety in treating hypertension.

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