Effect Of Compound Qima Capsule On HRV In Patients With Hypertension With Qi Deficiency And Turbidity Syndrome

ObjectiveTo observe the effect of compound Qima capsule on the clinical symptoms,circadian rhythm of blood pressure and heart rate variability of patients with hypertension with qi deficiency and phlegm syndrome,and further explore the preventive and therapeutic effects of compound Qima capsule on cardiovascular and cerebrovascuJ ar diseases.MethodsA prospective randomized controlled trial was conducted in which 118 patients with qi deficiency and phlegm syndrome with reduced heart rate variability who were randomized to the inclusion criteria were randomized into 59 patients in the observation group and the control group.The control group received antihypertensive treatment of Amlodipine besylate tablets.The observation group took Compound Qima Capsules on the basis of the control group,2 capsules each time,3 times a day f:or 8 weeks.The cardiovascular disease health education and diet were given to the two groups before the treatment began to minimize the adverse factors that may affect the patient's treatment effect;collect and record the patient's clinical symptoms and signs and fill in the TCM symptom quanti tative score table before and after treatment,collect the time-domain indicators of heart rate variability before and after treatment(SDNN,SDANN,rMSSD,pNN50),frequency domain indicators(VLF,LF,HF,LF/HF)and ambulatory blood pressure related data(dMSBP,nMSI3P,dMDBP,nMDBP,nMSBP decline rate(%),nDBP decline rate(%)),observe and record treatment Liver and kidney function and blood,urine and stool routine in the two groups before and after;baseline analysis of pre-treatment demographic and clinical data using SPSS21.0 statistical software Comparative analysis of TCM symptom scores,ambulatory blood pressure and heart rate variability before and after treatment.Resu ts1.Analysis of two groups of baseline study data:gender composition ratio,age,duration of disease,combined disease,office blood pressure,TCM symptom scores,and dynamic blood pressure related indicators(dMSBP,nMSBP,dMDBP,nMDBP,between the observation group and the control group before treatment)nMSBP decline rate(%),nDBP decline rate(%)),heart rate variability time domain indicators(SDNN,SDANN,r MSSD,pNN50)and frequency domain indicators(VLF,LF,HF,LF/HF),etc.,There was no significant difference(P>0.05),which was comparable.2.The efficacy of TCM syndromes was 91.07%in the observation group and 69.64%in the control group.The difference was statistically significant(JY0.01).After treatment,the TCM syndrome scores in the observation group(5.18±2.28)were lower than those in the control group(9.55±1.96).The difference between the two groups was statistically significant(P<0.01).The difference in the syndrome scores of the observation group was higher than that of the control group(P<0.01).3.Office blood pressure:After treatment,the systolic blood pressure of the two groups was significantly lower than that before treatment(P<00.01).The systolic blood pressure of the observation group was significantly lower than that of the control group(P<0.05).There was a significant difference between the two groups before and after treatment(P<0.01).The diastolic blood pressure of the two groups was significantly lower than that before treatment(P<0.01).The diastolic blood pressure of the observation group was significantly lower than that of the control group(P<0.05).There was significant difference between the two groups before and after treatment(P<0.05).4.Dynamic blood preshsure and blood pressure rhythm:? The comparison of systolic blood pressure and nighttime systolic blood pressure reduction rate:After treatment,the levels of dMSBP were signifieantly lower than those before treatment(P<0.01).The dMSBP of the observation group was significantly lower than that of the control group(P<0.01).There was significant difference between the two groups before and after treatment(P<0.01).After treatment,nMSBP was significantly lower than that before treatment(P<0.01).The nMSBP of the observation group was significantly lower than that of the control group(P<0.01).There was significant difference between the two groups before and after treatment(P<0.01).After treatment,the decrease rate(%)of nSBP in the observation group was significantly higher than that before treatment(P<0.01),and the decrease rate of nSBP in the control group(%)was not significantly different from that before treatment(P>0.05).The difference in nSBP decline rate(%)was significant(P<0.01).? Comparison of diastolic blood pressure and nighttime diastolic blood pressure drop rate:After treatment,dMDBP was significantly lower than that before treatment(P<0.01).The dMDBP of the observation group was significantly lower than that of the control group(P<0.01).There was a significant difference(P<0.01).After treatment,nMDBP was significantly lower than that before treatment(P<0.01).There was no significant difference between nMDBP and nMDBP before and after treatment(P>0.05).There was no significant difference in the rate of nDBP(%)between the two groups after treatment(P>0.05).There was no significant difference in the decrease rate of nDBP(%)between the two groups after treatment and before and after treatment(P>0.05).5.Heart rate variability index:? The comparison of(SDNN,SDANN,r MSSD,pNN50):after treatment,the SDNN of the two groups was significantly higher than that before treatment(P<0.01),and the SDNN of the observation group was more significant than the control group(P<0.01),there was no significant difference in the difference of SDNN between the two groups before and af'ter treatment(P>0.05).There was no significant difference between the two groups about SDANN(P>0.05).The rMSSD of the observation group was significantly higher than that before treatment(P<0.01),the control group had no significantly difference comparing with that before treatment(P>0.05).After treatment,the rMSSD was higher than that of the control group(P<0.01).There was a signi ficant difference in the di fference of r MSSD between the two groups before and after treatment(P<0.01).After treatment,the pNN50 of the two groups was significantly higher than that before treatment(P<0.01).The pNN50 of the observation group was significantly higher than that of the control group(P<0.01).There was a significant difference between the two groups before and after treatment(P<0.05).?The comparison of heart rate variability frequency domain indices(VLF,LF,HF,LF/HF)between the two groups:There was no significant difference in VLF between the two groups before and after treatment(P>0.05).After treatment,the LF of the observation group was significantly higher than that before the treatment(P<0.01),and the LF of the control group was higher than that before the treatment(P<0.05).There was no significant difference between the LF and the LF difference before and after treatment(P>0.05).After treatment,the HF in the observation group was significantly higher than that before treatment(P<0.01).There was no significant difference about the control group comparing with that before treatment(P>0.05).After treatment,the HF in the observation group was significantly higher than that in the control group(P<0.01),there was no significant difference in the observation group comparing with that before treatment(P>0.05)the HF in the observation group was significantly higher than that in the control group after treatment(P<0.01).There was no significant difference in the HF difference between the two groups before and after treatment(P>0.05).After treatment,the LF/HF ratio of the observation group was significantly lower than that before treatment(P<0.01).There was no significant difference between the LF/HF ratio of the control group and the pre-treatment group(P>0.05).The LF/HF ratio of the observation group after treatment.Compared with the control group,the difference was significantly lower(P<0.01).There was a significant difference in the difference of LF/HF ratio between the two groups before and after treatment(P<0.05).6.Safety evaluation:There were no serious adverse events in the treatment group.There were no obvious abnormalities in blood routine,urine analysis,stool routine,liver and kidney function,vital signs and other safety indicators before and after treatment.There are no serious side effects in the trial.ConelusionCompound Qima CapvSule can improve the clinical symptoms of patients with hypertension,qi deficiency and phlegm syncirome,better regulate blood pressure,restore normal circadian rhythm of blood pressure,and improve the overall function of autonomic nerve and improve vagal nerve tension in patients with hypertension qi deficiency and phlegm syndrome.Multi-target,multi-channel to improve target organ damage in hypertension,control or delay the progress of hypertension,and further reduce the occurrence of cardiovascular and cerebrovascular adverse events.