Step-down Capsule Treatment Of Isolated Systolic Hypertension Clinical Study

Objective: To evaluate the clinical efficacy of Jiangya Capsule treating elderly isolated systolic hypertension (EISH) and to explore its potential mechanisms, meanwhile, to observe the effect on life quality of these patients with isolated systolic hypertension treated with the capsule.Methods: 110 cases who are consistent with ISH medical diagnostic standards and above 60 years old (including 60 years old) were divided randomly and double-blindly into treatment group (Jiangya Capsule) and the control group (Nimo-dipine Capsule), parallel comparison had been employed in the test, every group contained 55 patients, the test cycle was four weeks. All patients's symptoms, blood pressure, life quality and target organ of renal damage tests were contrasted between the two groups as well as their own control, the data was used to evaluate the clinic efficacy of Jiangya Capsule. At the same time, endothelial cell function (including NO,ET-1,TXA2 and PGI₂ ),peripheral artery stiffness ,vascular infection was detected in the test,which was used to explore potential mechanisms and channel of Jiangya Capsule in treatment of elderly isolated systolic hypertension.Results:1. Treat effect of systolic blood pressure reducing is 48.9% in treat group and 57.4% in control group. Although the effect in treat group is a little bit lower than that in the control group, there wasn't significant difference between them. The systolic blood pressure in the two groups came down comparing to that before the test (P< 0.05 ) , but the diastolic blood pressure in the two groups didn't change after treatment(P>0.05);Regarding automatic blood pressure motoring, it was shown that 24-hour mean systolic blood pressure, mean day and night systolic blood pressure between the two groups comparing to itself came down obviously (P<0.05) . The treat effect of the patients with yin-deficiency and yang-excess syndromes in EISH was higher than those without it in the treat group (P<0.01) ,while there was no difference in the control group (P>0.05) .2. There was some improvement on TCM symptoms in the treat group after treatment, especially on the symptoms of dizziness, headache, lumbago and knee weakness. Dizziness and headache improved much in the control group (P <0.05 ),but there was not so much improvement as that in the treat group. Lumbago and knee weakness didn't improve in the control group after treatment (P>0.05) .The overall scores of symptom in the two groups came down in their own control(P<0.05) , while the scores in the treat group after treatment was less than that inthe control group (P <0.01). The total efficiency was higher in treat group than that incontrol group, with 53.3% and 27.7% respectively(P<0.05). It indicated that the trialgroup was superior to the control group in TCM symptoms relief.3. There was statistical significant difference on physical function, role physical, body pain and general health of life quality in the two groups in their own control and between them (P<0.05); there wasn't statistical significant difference on vitality, social function, role emotion and mental health of life quality in their own control and between them (P>0.05);4. The Hs-CRP in treat group reduced much after treatment (P <0.01), while there was no any difference in control group comparing to that before treatment (P>0.05) . The TXB₂ and ET-1 in the treat group and control group was less after treatment than that before treatment (P <0.01,P<0.05, ) , but the NO and 6-Keto-PGF1αwas more than that before treatment (P<0.01) . It's shown that Jiangya Capsule could make endothelial cell function better judged from reducing ET-1 and TXB₂ and raising NO and 6-Keto -PGF1α.5. There wasn't statistical significant difference on left and right pulse wave velocity and ankle brachial index in their own control and between the two groups (P> 0.05); it indicated that Jiangya Capsule may not meliorate artery stiffness in a short time.6. mALB in treat group reduced markedly (P<0.05) , while mALB in control group reduced a little after treatment , and there was no much difference between before and after (P>0.05) . There wasn't statistical significant difference onβ₂-MG, IgU and NAG after treatment in their own control, and between the two groups (P>0.05);Conclusions:1. Jiangya Capsule may reduce systolic blood pressure of patients with elderly isolated systolic hypertension, especially patients with yin-deficiency and yang-excess syndromes of EISH.2. Jiangya Capsule could alleviate symptoms of patients with elderly isolated systolic hypertension and improve their life quality3. Jiangya Capsule protects kidneys in earlier renal damage.4. Jiangya Capsule may raise NO and PGI₂ , inhibit ET-1 and TXA₂, and reduce Hs-CRP. It indicates that it is its clinical mechanism via improving the endothelial cell function and allevating vascular infection5. Jiangya Capsule was a safe and effective drug and it hadn't toxic and side effect.