| Objective: To construct a new pathogenesis theory of "hyperactivity of Yang Qi" of hypertension,start with the syndrome type of "hyperactivity of liver-Yang",evaluate the effectiveness and safety of "tengfujiangya tablet" in the treatment of hyperactivity of liverYang of grade 2 hypertension through clinical research,and detect and analyze the number of inflammatory factors in serum and circulating endothelial cells in whole blood of patients with grade 2 hypertension,Based on the results of clinical and basic research,this paper discusses the effect of "tengfujiangya tablet" on vascular endothelial dysfunction in patients with liver-yang hyperactivity syndrome of grade 2 hypertension,and explores a new idea of traditional Chinese medicine treatment of liver-yang hyperactivity syndrome of grade 2hypertension.Methods: 1.Clinical study(1)A multicenter,randomized,double-blind,placebo-controlled clinical trial was conducted.According to the inclusion and exclusion criteria,288 patients were randomly divided into treatment group and control group.They were treated with tengfujiangya tablet combined with valsartan / amlodipine and placebo combined with valsartan / amlodipine for4 weeks.During the experiment,the efficacy index and TCM syndrome score of the subjects were recorded for effectiveness evaluation,and the safety index and adverse reaction events of the subjects were recorded for safety evaluation.(2)Analyze the accuracy of key indicators such as blood pressure sensitivity and curative effect rate;The changes of family blood pressure were statistically analyzed to effectively supplement the main analysis results2、 Basic research(1)Due to the limited preservation conditions of serum in some sub centers,a total of 88 groups of blood samples in the treatment group and the control group were finally included as the test objects.Blood samples were gathered from the patients in clinical trial treatment.The treated serum was determined by enzyme-linked immunosorbent assay to detect AA and The contents of TXB2 and PGE2 were measured to explore the regulation of tengfujiangya tablet on inflammatory factors.(2)Due to the limitation of plasma preservation and experimental conditions,whole blood was collected in the sub center of the hospital.A total of 37 groups of blood samples were included in treatment group and the group.Blood samples were gathered from the patients in the clinical trial one day before taking the medicine and the first day after taking the medicine,and the peripheral blood circulating endothelial cells were detected by flow cytometry to verify the role of tengfujiangya tablet in antagonizing vascular endothelial injury.Results: 1.Clinical study(1)After 4 weeks of treatment,the systolic blood pressure difference was 24 mm Hg in the treatment group and 18 mm Hg in the control group;the diastolic blood pressure difference was 11 mm Hg in the treatment group and 8 mm Hg in the control group.According to the evaluation criteria of antihypertensive efficacy,55 patients(41.34%)in the treatment group were markedly effective,64(48.12%)were effective,and the total effective rate was89.47%;The effective rate is 76.81%.In accordance blood pressure compliance rate,the systolic blood pressure compliance rate of the treatment group was 61.65%,and the control group was 37.68%;the diastolic blood pressure compliance rate was 78.20% in the treatment group and 55.07% in the control group;the blood pressure compliance rate in the treatment group was 48.12%,and the control group was 23.19%.The difference of syndrome scores was 79 in the treatment group and 72.5 in the control group.According to the criteria for evaluating the efficacy of syndrome score,the treatment group total effective rate was 57.89%.In the control group,the total effective rate was38.41%.There were statistical differences before and after treatment,and the treatment group was better than the control group,which could improve the patients’ TCM syndromes,and the clinical application was safer.(2)The results of the clinical study also showed that after 4 weeks of treatment,the home blood pressure systolic blood pressure compliance rate was 76.83% in the treatment group and 57.14% in the control group;the family blood pressure diastolic blood pressure compliance rate It was 86.59% in the treatment group and 80.59% in the control group;the overall home blood pressure compliance rate was 75.61% in the treatment group and 53.57%in the control group.The treatment group could control the patient’s home blood pressure more effectively,and the monitoring of home blood pressure had a positive effect on enhancing the antihypertensive effect of drugs.2、 Basic research(1)The study confirmed that after 4 weeks of treating,the difference of arachidonic acid content before and after treatment was 65.70ng/ml in the treatment group and28.25ng/ml in the control group;thromboxane The difference of B2 content was360.12pg/ml in the treatment group and 200.26pg/ml in the control group.The difference of prostaglandin E2 content was 155.57ng/ml in the treatment group and 6.43ng/ml in the control group.The treatment group could more effectively reduce the levels of arachidonic acid(AA)and thromboxane B2(TXB2),increase the level of prostaglandin E2(PGE2),reduce inflammatory factors,reduce the production of inflammatory mediators,and effectively reduce the occurrence of inflammatory reactions.(2)The results of the study also showed that the content of circulating endothelial cells in peripheral blood before and after treatment decreased by an average of 0.23% in the treatment group and by 0.10% in the control group.Compared with the placebo group,Tengfujiangya Tablet effectively reduced the number of circulating endothelial cells detectable in peripheral blood after 4 weeks of treatment suggesting that Tengfujiangya Tablet can improve grade 2 hypertension.Endothelial function in hypertensive patients and reduce endothelial damage.Conclusion: Tengfujiangya tablet has good effectiveness and safety in the clinical treatment of liver-yang hyperactivity syndrome of grade 2 hypertension.It can regulate the body’s inflammatory factors and reduce the number of circulating endothelial cells in peripheral blood,suggesting that tengfujiangya tablet can effectively reduce the damage of vascular endothelium in the treatment of liver-yang hyperactivity syndrome of grade 2hypertension,it can antagonize endothelial dysfunction in patients with grade 2 hypertension with hyperactivity of liver-yang.At the same time,the number of vascular circulating endothelial cells in peripheral blood can be used as a marker of tengfujiangya tablet against endothelial dysfunction in grade 2 hypertension with hyperactivity of liver-yang.Studies have proved that tengfujiangya tablet plays a key role in the treatment of patients with liveryang hyperactivity syndrome of grade 2 hypertension and the protection of vascular target organs.It is an innovative method for the treatment of hypertension. |
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