Study On The Rurative Effect Characteristics Of Zhenzhu Tiaozhi Capsule In The Treatment Of Essential Hypertension Based On The Real-World Research

Blood pressure variability is a risk factor that increases the incidence of target organ injury and cardiovascular and cerebrovascular events independent of blood pressure.Research shows that the management of hypertension should ensure that blood pressure is controlled within a reasonable range,reduce blood pressure variability and reduce blood pressure fluctuation.At present,there is no specific drug to reduce blood pressure variability,and traditional Chinese medicine used in the treatment of essential hypertension can not only have good clinical efficacy,but also reduce blood pressure variability and adverse reactions.However,there is no systematic evaluation of the effect of traditional Chinese medicine on blood pressure variability.Clinical practice has found that the traditional Chinese medicine compound Zhenzhu Tiaozhi capsule（FTZ）can reduce the dosage of antihypertensive drugs in patients with hypertension,stabilize the blood pressure level and reduce the fluctuation of blood pressure,but its curative effect needs to be clarified.Real world research is based on real clinical practice and provides a good research means and perspective.Research method and purpose:This study intends to further carry out the meta-analysis of the regulatory effect of traditional Chinese medicine on blood pressure variability in patients with essential hypertension and the study on the efficacy characteristics of Zhenzhu Tiaozhi capsule in the treatment of essential hypertension based on the real world.Firstly,meta-analysis was carried out on the literature that met the acceptance criteria of this study in CNKI,VIP database,Wanfang database,Pub Med database and web of science database to systematically evaluate the regulatory effect of traditional Chinese medicine on blood pressure variability in patients with essential hypertension.Based on the real-world data,the information of patients with essential hypertension treated in the First Affiliated Hospital of Guangdong Pharmaceutical University from January 2016 to December 2021 was extracted.The natriuretic exclusion criteria were divided into FTZ group and Western medicine group,and the observation time was 3 months.Through propensity score matching（PSM）method 1:1 matching,t-test and rank sum test were used to compare the changes of blood pressure variability,blood pressure value,blood glucose,blood lipid and liver and kidney function between the two groups before and after treatment.To explore the efficacy and characteristics of FTZ in the treatment of essential hypertension.Research results:1.Meta analysis of the effect of traditional Chinese medicine on blood pressure variability of essential hypertensionAccording to the natriuretic exclusion criteria,a total of 28 randomized controlled trials and 3159 subjects were included.The results of meta-analysis showed that the curative effect of traditional Chinese medicine alone or traditional Chinese medicine combined with conventional western medicine was better than that of Western medicine.The efficacy of reducing the standard deviation of 24h systolic blood pressure(SD_{24h S})[WMD=-1.83（-2.19,-1.46）,p<0.00001],reducing the standard deviation of 24h diastolic blood pressure(SD_{24h D})[WMD=-1.10,95%（-1.37,-0.84）,p<0.00001],reducing the standard deviation of daytime systolic blood pressure(SD_DS)[WMD=-1.96,95%（-2.43,-1.50）,p<0.00001],reducing the standard deviation of daytime diastolic blood pressure(SD_DD)[WMD=-0.90,95%（-1.37,-0.43）,p=0.0002]Reducing the standard deviation of nocturnal systolic blood pressure(SD_NS)[WMD=-1.42,95%（-2.12,-0.73）,p<0.0001],reducing the standard deviation of nocturnal diastolic blood pressure(SD_ND)[WMD=-0.88,95%（-1.37,-0.40）,p=0.0001],reducing the coefficient of variation of 24h systolic blood pressure(CV_{24h S})[WMD=-4.79,95%（-7.59,-1.98）,p=0.0008],reducing the coefficient of variation of 24h diastolic blood pressure(CV_{24h D})[WMD=-2.27,95%（-54.44,-0.10）,p=0.04]Reduce the coefficient of variation of daytime systolic blood pressure(CV_DS)[WMD=-2.82,95%（-4.65,-0.99）,p<0.00001],reduce the coefficient of variation of daytime diastolic blood pressure(CV_DD)[WMD=-2.01,95%（-3.26,-0.76）,p=0.002],reduce the coefficient of variation of nighttime systolic blood pressure(CV_NS)[WMD=-3.27,95%（-6.01,-0.53）,p<0.00001],reduce the coefficient of variation of nighttime diastolic blood pressure(CV_ND)[WMD=-1.14,95%（-1.70,-0.58）,p=0.01].The quality of the included literature is not high,which may lead to some bias in the research results.More high-quality studies need to be included for further verification.2.Study on the efficacy characteristics of compound traditional Chinese medicine FTZ in the treatment of essential hypertension（1）Main outcome measures:after PSM matching,66 subjects were included in this study,with 33cases in each group.There was no significant difference in age,gender and combined medical history between the two groups at baseline.（1）After treatment,FTZ can significantly reduce the indexes of systolic and diastolic blood pressure variability in each period:the 24h systolic blood pressure standard deviation(SD_{24h S})decreased by 2mmhg,the 24h diastolic blood pressure standard deviation(SD_{24h D})decreased by 1mmhg,the daytime systolic blood pressure standard deviation(SD_DS)decreased by 3mm Hg,the daytime diastolic blood pressure standard deviation(SD_DD)decreased by2mmhg,and the nighttime systolic blood pressure standard deviation(SD_NS)decreased by 1mmhg.The differences were statistically significant（p<0.05）,There was significant difference between SD_{24h S}and SD_DSbefore and after treatment（p<0.01）.The standard deviation of blood pressure in the western medicine group had no difference before and after treatment.The comparison between groups showed that the effect of FTZ on reducing the standard deviation of blood pressure was better than that of Western medicine.（2）After treatment,the average blood pressure of the two groups decreased significantly（p<0.05）.After treatment,the mean systolic blood pressure and mean diastolic blood pressure in FTZ group decreased in each period:24h mean systolic blood pressure（24h M SBP）decreased by 7.97mmhg,24h mean diastolic blood pressure（24h M SBP）decreased by 4.28mmhg,daytime mean systolic blood pressure（DM SBP）decreased by 8.73mmhg,daytime mean diastolic blood pressure（DM SBP）decreased by 4.79mmhg,nighttime mean systolic blood pressure（NM SBP）decreased by 5.49mmhg and nighttime mean diastolic blood pressure（DM SBP）decreased by3.70mmhg,There was significant difference between before and after treatment（p<0.05）.（3）After treatment,the systolic and diastolic blood pressure load in FTZ group decreased by 25.20%in 24h,20.70%in 24h,25.90%in daytime,15.70%in daytime,25.00%in nighttime and 17.80%in nighttime（p<0.05）.（4）At baseline,the blood pressure of 19 patients in FTZ group did not reach the standard,and 10 patients reached the standard after treatment,with the standard rate of 52.63%;In FTZ group,there were 14 patients whose blood pressure reached the standard at baseline,and 12 patients whose blood pressure was still controlled at the normal level after treatment.The clinical control rate was 85.71%,and the overall blood pressure control rate was 66.67%.（2）Secondary outcome measures:（1）Glucose metabolism indexes:19 patients with FTZ combination and abnormal glucose metabolism,and 14 patients with blood glucose test results.Before and after treatment:fasting insulin decreased by an average of 1.49μIU/m L,p=0.07。The average blood glucose decreased by 0.48 mmol/L 2hours after meal,p=0.08.The median level of glycosylated hemoglobin was6.05%at baseline and 5.95%after treatment（p>0.05）.（2）There were 21 patients with abnormal lipid metabolism.Comparison before and after treatment:the average level of total cholesterol decreased by0.34 mmol/L,p<0.05.（3）FTZ group had significant effect on improving clinical symptoms and reducing TCM symptom score（p<0.01）.（4）Safety indicators:there was no increase in the number of cases with abnormal liver function（ALT,AST）and renal function（BUN,SCR）in FTZ group.The number of abnormal cases of AIT,AST,BUN and SCR before treatment was 4,2,0 and 1 respectively,and after treatment was 2,0,0 and 0respectively.Conclusion:Meta analysis showed that traditional Chinese medicine treatment can effectively reduce blood pressure variability in patients with essential hypertension.In the real world,Zhenzhu Tiaozhi capsule,a traditional Chinese medicine compound,has a good effect on reducing blood pressure and improving blood pressure variability in patients with essential hypertension,and can improve patients’clinical symptoms with good safety.