Background and objective:Substandard long-term control of blood pressure often leads to ventricular remodeling,in which obese hypertension occurs earlier than the general patient.Soluble growth stimulation expressed gene 2 protein(sST2)is a novel cardiac marker,when the heart muscle cells are stimulated by traction to undergo ventricular remodeling,sST2 will be secreted into the peripheral blood,so it is often used for chronic heart failure,coronary heart disease and primary hypertension and other heart-related damage evaluation and clinical efficacy QGZSF has been clinically proven to be effective in improving glycolipid metabolism and assisting in lowering blood pressure,but the effect on serum sST2 expression in obese and hypertensive patients is not clear,and the purpose of this clinical study is to explore the effect of QGZSF on serum sST2 expression in obese and hypertensive patients on the basis of Western medicine blood pressure reduction standards.Methods:A total of 54 cases of obese hypertension patients who met the evidence of hyperhepatic hyperactivity or yin deficiency and yang hyperactivity were included in the cardiology outpatient clinic,hypertension research institute and ward of Jiangsu Provincial Hospital of Traditional Chinese Medicine(Affiliated Hospital of Nanjing University of Traditional Chinese Medicine)from June 2020 to August 2021,and they were randomly divided into 27 cases in the experimental group and 27 cases in the control group,of which 2 cases fell off in the experimental group,25 cases in the experimental group and 27 cases in the control group who finally completed two follow-up visits.This study protocol is present at the China Clinical Trials Registry(www.medresman.org)completed the registration(registration number ChiCTR1800018074)and was approved by the Ethics Committee of the Affiliated Hospital of Nanjing University of Chinese Medicine(batch number 2018NL-081-02).Both groups of patients were treated with valsartan capsules(80 mg/capsule)+amlodipine besulfonate tablets(5 mg/tablet)to control blood pressure,and the experimental group added QGZSF(1 dose per day,concentrated decoction,1 time/day)on the basis of Western medicine.The patients were followed up after the initial diagnosis and intervention for 3 months,serum sST2 was measured by ELISA method,and LVIDd,IVSd,LVPWd,LVEF,E/A were examined by routine twodimensional echocardiography,and the effects of liver and kidney cleansing on serum sST2,heart structure and function,blood pressure,TCM syndrome integrals and safety indicators were observed.Results:1.Pearson-related analysis showed a correlation between serum sST2 baseline and the course of hypertension in patients(p<0.05),which was statistically significant,and there was no obvious correlation with sex,age,BMI,systolic blood pressure,diastolic blood pressure,mean arterial pressure,LVIDd,IVSd,LVPWD,LVMI,E/A,EF,and TCM syndrome integrals(p>0.05),of which there was a very weak negative correlation with sex and age,and a very weak positive correlation with other indicators,but none of them were statistically significant.2.Before treatment,there was no difference in sST2 levels between the experimental and control groups(22.87±7.76ng/ml vs 21.47±7.48ng/ml,p>0.05).After three months of treatment,the serum sST2 levels of the trial group decreased significantly compared with the control group,and there was a statistically significant difference(15.37±5.93 vs 22.14±8.25,p<0.05).After treatment,the average decrease in sST2 in the experimental group was 0.67 ng/ml,and the average increase in sST2 in the control group was 7.50 ng/ml,and the difference between the difference between the experimental group and the control group before and after the intervention was significantly significant(p<0.01).The serum sST2 levels of the two groups were not statistically significant compared with before treatment(p>0.05).3.① The left ventricular mass index of the two groups before and after treatment decreased from 91.59±50.34 g/m2,87.29±42.51 g/m2 to 86.16±14.20 g/m2,82.57±11.49 g/m2,and the change was not statistically significant(p>0.05).The left ventricular mass index was higher in the preand post-treatment trial group than in the control group,but the difference between the two groups was not statistically significant(p>0.05).The sST2 concentration in the post-treatment trial group was strongly positively correlated with the left ventricular mass index and the control group was extremely weakly negatively correlated,but the difference was not statistically significant(r=0.023,-0.114,p>0.05).② The ejection fractions of the patients before and after treatment increased from 65.91±2.68%,66.17±2.87%to 66.52±2.92%,67.49±3.23%,respectively,and the difference was not statistically significant(p>0.05).The ejection fractions of the pre-and post-treatment experimental groups were higher than those of the control group,but the difference between the groups was not statistically significant(p>0.05).After treatment,the sST2 concentration was inversely correlated with the ejection fraction in the experimental group and the extremely weak positive correlation in the control group,and the difference was not statistically significant(r=-0.232,0.045,p>0.05).③The E/A values of the two groups before and after treatment increased from 1.06±0.34,1.04±0.23 to 1.15±0.40,1.15±0.23,respectively,with statistical differences(p<0.05).The E/A values of the experimental group before and after treatment were higher than those in the control group(p<0.05),and the difference was statistically significant,of which the E/A values of the two groups before treatment(p<0.01)were statistically significant.After treatment,the sST2 concentration and E/A values were positively correlated with the E/A values in both the experimental and control groups,and the difference was not statistically significant(r=0.321,0.187,p>0.05).4.After three months of treatment,the systolic blood pressure value,diastolic blood pressure value,and mean arterial pressure value were compared with the baseline blood pressure value,and the test group decreased from 143.44±15.94,94.26±11.62,110.75±13.38 to 131.91±7.00,83.50±4.54,99.64±4.52,and the control group decreased from 142.52±16.45,91.44±12.37,108.47±13.02,respectively 136.49±10.46,84.89±7.34,102.09±8.02,the difference between the two groups was not statistically significant(p>0.05);the correlation analysis was found that the sST2 concentration in the experimental group was extremely weakly positively correlated with diastolic and mean arterial pressure,and the difference was not statistically significant(r=-026,0.029,0.006,both p>0.05);the ST2 concentration in the control group was extremely weak and negatively correlated with systolic blood pressure.Both diastolic and mean arterial pressure were positively correlated,and the difference was not statistically significant,(r=0.137,0.069,0.102,both p>0.05).5.Comparing the TCM syndrome scores before and after treatment between the two groups,the total TCM syndrome scores of the experimental group and the control group showed significant improvement(p<0.01),but the difference between the two groups was not statistically significant(p>0.05).6.In this clinical trial,the three major routines of hematuria and feces,electrocardiogram,electrolytes,liver and kidney function and other safety indicators before and after treatment of two groups of patients were detected.The results showed that the relevant results before and after the patient’s treatment were basically similar,and no obvious abnormalities were seen.Conclusion:QGZSF can effectively reduce the expression of serum sST2 in obese and hypertensive patients,and can alleviate myocardial remodeling to a certain extent,with good safety and can be further promoted and used in clinical practice. |