Evaluation Method And Clinical Study On The Benefit And Risk Of Chinese And Western Medicine Combined Intervention In Elderly Isolated Systolic Hypertension

Objective1.Based on the optimized multi-criteria decision analysis(MCDA)model,explore the benefit and risk evaluation method of combining Chinese and Western drugs in the intervention of elderly simple systolic hypertension.2.Verify the feasibility of the benefit and risk evaluation method of combining Chinese and Western drugs in the intervention of elderly simple systolic hypertension through clinical trials.Method1.Search Pub Med and Co Chrane Library,Embase,CNKI database,Wanfang database and VIP database: a randomized controlled clinical study on the intervention of elderly simple systolic hypertension with Chinese traditional medicine combined with long-acting calcium antagonist(CCB)or renin-angiotensin-aldosterone system blocker(ACEI or ARB).The retrieval period is from the establishment of the database to December 31,2019.The literature was screened according to inclusion and exclusion criteria,and frequency analysis method was used to screen the benefit and risk indicators of Chinese and Western combined drugs in the intervention of elderly simple systolic hypertension.2.Based on the benefit risk indicators determined by screening,the intervention measures included in the literature were selected as long-acting CCB and long-acting CCB+TCM clinical studies,and Meta analysis(subgroup analysis according to the course of treatment)was used to collect and process indicator data.Hiview 3 software and Crystal Ball software were used to optimize the MCDA model for index scoring,weight assignment,scoring and determination,sensitivity analysis and sensitivity analysis,to explore the benefit risk evaluation method of Chinese and Western drug combination in the intervention of elderly simple systolic hypertension.3.A total of 40 elderly patients with simple systolic hypertension diagnosed by Western medicine in the Department of Cardiology,The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from January 2021 to October 2021 were randomly divided into control group(n=20,treated with long-acting CCB)and treatment group(n=20,treated with long-acting CCB+Nourishing Serum Brain granules).The treatment course lasted for 4 weeks.The differences in clinic blood pressure,24 h ambulate blood pressure,TCM syndrome score,TCM symptom score,SF-36 quality of life scale and safety were compared between the two groups after treatment.By comparing the consistency of conventional RCT analysis results with the comprehensive benefit risk evaluation results of the application of the optimized MCDA model,the feasibility of the benefit risk evaluation method of combining Chinese and Western drugs in the intervention of elderly simple systolic hypertension was verified.Results1.A total of 38 literatures were included.The results showed that the clinical systolic pressure(7.04%),anti-hypertensive effective rate(6.31%),TCM syndrome effect(6.31%),clinic diastolic pressure(5.56%),nighttime mean systolic pressure(3.28%),24-hour mean systolic pressure(3.03%),daytime mean systolic blood pressure(3.03%),TCM syndrome score(3.03%),pulse pressure difference(2.78%),daytime diastolic pressure(2.78%)and nighttime diastolic pressure(2.78%),Risk indicators of liver function(4.29%),renal(4.29%),routine blood(4.04%),routine urine(3.79%),the incidence of adverse reactions(3.54%).2.Combined with the actual situation of the included literature,Eventually determine the Chinese and western medicine combined intervention effectiveness in senile patients with simple systolic hypertension risk indicators respectively step-down efficient,clinic blood pressure(systolic pressure,diastolic blood pressure,pulse pressure difference),24 hours ambulatory blood pressure(daytime mean systolic blood pressure,average systolic blood pressure at night,daytime mean diastolic pressure,average diastolic blood pressure at night),TCM syndrome integral,and the incidence of adverse drug reactions(incidence face blushing,The optimized MCDA model was used to evaluate the benefit and risk of TCM combined with long-acting CCB in the intervention of elderly simple systolic hypertension.The results showed that the total benefit and risk of treatment course=4weeks was better than that of treatment course=2 weeks(P<0.05).Treatment course=2weeks was better than treatment course>4weeks(P>0.05).91.6%of patients with treatment course=4 weeks had better benefit-risk than treatment course>4weeks(P>0.05).3.A total of 40 patients were included in the clinical trial,and there were no statistically significant differences in gender,age,duration of hypertension,blood pressure in the pre-test room and resting heart rate between the two groups(P>0.05).3.1 Anti-hypertensive effective rate: after 2 weeks of treatment,the anti-hypertensive effective rate was 100% in the treatment group and 95% in the control group;after 4 weeks of treatment,the anti-hypertensive effective rate was 100% in both groups;There was no statistical difference between the two groups(P>0.05).3.2 Blood pressure in the clinic:(1)Systolic blood pressure(SBP): after treatment,SBP in the two groups was lower than that before treatment(P<0.01),and the treatment for4 weeks was better than that for 2 weeks(P<0.01);After 2 weeks of treatment,the efficacy of SBP reduction in the treatment group was better than that in the control group(P<0.05),and after 4 weeks of treatment,the efficacy of SBP reduction in the two groups was similar(P>0.05).(2)Diastolic blood pressure(DBP): After treatment,DBP in the treatment group was lower than that before treatment(P<0.05),but there was no significant difference in DBP in the control group(P> 0.05);The effect of DBP reduction in treatment group was better than that in control group(P<0.05).(3)Difference of pulse pressure: after treatment,the difference of pulse pressure in both groups was significantly reduced(P<0.05),and the effect of 4 weeks was better than that of 2 weeks(P<0.05);There was no statistical difference between the two groups(P > 0.05).3.3 24 hours ambulatory blood pressure: 24 hours ambulatory blood pressure in the two groups after treatment in the 24 hours mean systolic blood pressure,24-hour average diastolic blood pressure,mean arterial pressure,and 24 hours day average systolic blood pressure,daytime average diastolic blood pressure,mean arterial pressure in the day and night,on average,systolic blood pressure,average diastolic blood pressure at night,the night mean arterial pressure,pulse pressure difference 24 hours,and 24 hours arterial pressure standard deviation treatment Predecreased(P<0.05);The treatment group was superior to the control group in reducing 24-hour pulse pressure difference,standard deviation of nighttime diastolic pressure and standard deviation of nighttime arterial pressure(P<0.05).(1)TCM syndrome score: after treatment,the TCM syndrome score in the treatment group was lower than that before treatment(P<0.01),and the curative effect of 4 weeks was better than that of 2 weeks(P<0.01),while there was no statistical difference in the control group before and after treatment(P>0.05);The curative effect of reducing TCM syndrome score in the treatment group was better than that in the control group(P<0.05).(2)Scores of single symptom in TRADITIONAL Chinese medicine: after treatment,scores of dizziness and headache in the treatment group were lower than those before treatment(P<0.05),and the efficacy of 4 weeks was better than that of 2 weeks(P<0.01),while there was no statistical difference in scores of single symptom in the control group compared with before treatment(P>0.05).After 2 weeks of treatment,the effect of vertigo and headache in the treatment group was significantly better than that in the control group(P<0.05),and after 4weeks of treatment,the effect of vertigo,headache and insomnia in the treatment group was significantly better than that in the control group(P<0.05).(3)Scores of SF-36 Quality of Life Scale: After treatment,scores of physical function(PF),physical function(RP),body pain(BP)and total pain(GH)of SF-36 quality of life scale in the treatment group were increased compared with those before treatment(P<0.05),and scores of PF and RP in the control group were increased compared with those before treatment(P<0.05).After 2 weeks of treatment,the treatment group was better than the control group in improving THE SCORES of PF and social function(SF)(P<0.05).After 4 weeks of treatment,the scores of PF,RF,BP,GH and SF in the treatment group were higher than those in the control group(P<0.05).3.5 Safety evaluation: There were no statistically significant differences in hematuria routine,liver and kidney function and other physical and chemical indexes between the two groups before and after treatment(P>0.05),and no serious adverse events occurred.Conclusions1.Based on the optimized MCDA model,this study applied the data of clinical randomized controlled trials and conducted frequency analysis and meta-analysis.The results showed that benefit indexes(effective rate of hypotension,blood pressure in clinic,24 hours ambulatory blood pressure and TCM syndrome score)and risk indexes(incidence of adverse drug reactions)could be used to evaluate the benefit and risk of TCM combined with long-acting CCB in the treatment of elderly simple systolic hypertension.2.TCM Yangxuanao Granule combined with long-acting CCB can effectively improve the antihypertensive efficiency and TCM syndrome score of elderly patients with simple systolic hypertension,reduce the clinic blood pressure and 24 hours ambulate blood pressure,without increasing the incidence of adverse drug reactions;It is suggested that benefit indexes(effective rate of hypotension,blood pressure in clinic,24 hours ambulatory blood pressure and TCM syndrome score)and risk indexes(incidence of adverse drug reactions)can be used to evaluate the benefit and risk of TCM combined with long-acting CCB in elderly patients with simple systolic hypertension.