RESUMO
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.