A Randomized，Double-blind，Multi-center Clinical Trial of Tengfu Jiangya Tablets Combined with Valsartan/Amlodipine in Treatment of Grade 2 Hypertension with Hyperactivity of Liver Yang / 中国实验方剂学杂志

ABSTRACT

ObjectiveTo observe the clinical efficacy and safety of Tengfu Jiangya tablets combined with valsartan/amlodipine in the treatment of grade 2 hypertension with liver Yang hyperactivity syndrome. MethodAccording to a randomized，double-blind，and placebo parallel control method，288 patients with grade 2 hypertension with liver Yang hyperactivity from 7 subcenters were included. They were randomly divided into an observation group （144 cases） and a control group （144 cases），and then treated with Tengfu Jiangya tablets combined with valsartan/amlodipine and placebo combined with valsartan/amlodipine，respectively. The efficacy was evaluated after four weeks of intervention. During the experiment，the safety indicators and adverse reaction events of the subjects were recorded for safety evaluation，and the efficacy indicators and TCM syndrome scores were recorded for effectiveness evaluation. Sensitivity analysis was also conducted on the statistical results of the main efficacy indicators such as blood pressure （BP） compliance rate to ensure the accuracy of the analysis results. 88 groups of blood samples from each of the treatment and control groups were included as test subjects. Fasting blood samples were collected from the patients in the clinical trial on the day before and after medication，and enzyme linked immunosorbent assay （ELISA） was performed on the treated serum. The levels of arachidonic acid （AA），thromboxane B2 （TXB2），and prostaglandin E2 （PGE2） in the serum of the patients before and after treatment were measured to explore the regulation of inflammatory factors in the body by Tengfu Jiangya tablets. ResultA total of 271 patients （133 in the observation group and 138 in the control group） completed the trial. There was no statistically significant difference before and after treatment in such safety indicators as the blood routine （white blood cells，red blood cells，and platelets），urine routine （urinary protein and urinary red blood cells），alanine aminotransferase，aspartate aminotransferase，creatinine，urea，and abnormal electrocardiogram，and no serious adverse reactions were observed. After four weeks，the systolic blood pressure （SBP） difference and diastolic blood pressure （DBP） difference of patients in the observation group were greater than those in the control group（P<0.01）. According to the criteria for determining the antihypertensive effect，the overall response rate in the observation group［89.47%（119/133）］ was higher than that in the control group［57.97%（80/138）］ （Z=2.593，P<0.01）. The SBP compliance rate was 61.65%（82/133） and 37.68%（52/138） in the observation group and control group， respectively. The DBP compliance rate in the observation group was 78.20%（104/133），while in the control group it was 55.07%（76/138）. The overall BP compliance rate in the observation group was 48.12%（64/133），while in the control group it was 23.19%（32/138）. The BP compliance rates in the observation group were all significantly higher than those in the control group（χ2=15.571，16.236，18.404，P<0.01）. According to the criteria for evaluating the therapeutic effect of TCM syndrome integration，the overall response rate of the observation group［57.89%（77/133）］ was higher than that of the control group［38.41%（53/133）］ （Z=-3.172，P<0.01）.Compared with those before treatment， the levels of serum AA and TXB2 in the two groups were significantly decreased after treatment （P<0.01）， and the level of PGE2 in the observation group was significantly increased （P<0.01）. Compared with those of the control group after treatment， the levels of AA and TXB2 in the observation group were significantly decreased， while the level of PGE2 was significantly increased （P<0.01）. The results suggest that Tengfu Jiangya tablets can effectively reduce inflammatory factors，reduce the production of inflammatory mediators，and thus prevent the occurrence of inflammatory reactions in the treatment of patients with grade 2 hypertension. ConclusionTengfu Jiangya tablets can more effectively reduce patients' SBP and DBP，improve their BP compliance rates，and improve their TCM syndromes in the treatment of grade 2 hypertension with liver Yang hyperactivity. Its clinical application is safe. Tengfu Jiangya tablets has outstanding clinical efficacy and can be used as an effective intervention method for the treatment of grade 2 hypertension with liver Yang hyperactivity syndrome.