| Object:To evaluate the long-term antihypertensive effect and syndrome effect of Bushen Hemai Granule on grade 1 Isolated Systolic hypertension(ISH)kidney deficiency syndromeMethods:A prospective,completely randomized,double blind,double dummy,single-center clinical trial was designed for 24 weeks,the outcome measures were Clinic Blood Pressure(CBP),Home Blood Pressure(HBP),Ambulatory Blood Pressure(ABP)and kidney-qi Deficiency Syndrome,to evaluate the clinical efficacy and safety of Bushen Hemai granule placebo+perindopril(Control Group,n=31)and Bushen Hemai granule+perindopril placebo(Test Group,n=29).Result:The baseline characteristics,CBP,HBP,ABP and syndrome scores of the two groups before treatment were not different(P>0.05),and there were no significant differences in the three blood pressure parameters between the groups at 12 weeks of treatment(P>0.05);compared with the control group After 24 weeks of treatment,the systolic blood pressure in the CBP and HBP parameters of the experimental group further decreased by 4~6 mmHg,and the pulse pressure further decreased by 4~5 mmHg.The difference was significant(P<0.05).Nocturnal mean systolic blood pressure and nocturnal pulse pressure(average 4~6mmHg).Compared with the control group,the syndrome score of the test group decreased significantly at 12 weeks of treatment(P<0.05),and the syndrome score of the test group further decreased at 24 weeks of treatment(P<0.01).No serious adverse events occurred in the two groups during the test.Conclus ion:For the grade 1 ISH kidney deficiency syndrome,compared with perindopril,Bushen Hemai Granule may have similar antihypertensive effect at 12 weeks of treatment,and Bushen Hemai Granule at 24 weeks of treatment may further reduce contraction Pressure and pulse pressure,its curative effect is to better control the night systolic pressure and pulse pressure.Compared with perindopril,Bushen Hemai granule may improve the syndrome score faster at 12 weeks of treatment,and continue to improve the syndrome score at 24 weeks of treatment. |