| Objective:To investigate the efficacy, safety and life quality of two treatment protocols of different antihypertensive drugs in management of middle or high risk hypertensive patients.Method:120 middle or high risk hypertensive patients were recruited and randomly assigned to group A or B. Group A were administered with amlodipine 2.5mg and 1/2 tablet fixed-dose combination of amiloride (amiloridel.25mg+ hydrochloro thiazidel2.5mg); Group B were treated with amlodipine 2.5mg and telmisartan 40mg. Another 1/2 tablet fixed-dose combination of amiloride (groupA) and telmisartan 40mg (groupB) could be added if blood pressure beyond 140/90mmHg at end of 2-week. Amlodipine could be added if blood pressure was still more than 140/90mmHg after 4 weeks follow-up. At the beginning and end of 24 weeks following-up, the quality of life was evaluated by using SF-36 questionnaires. Clinical parameters, laboratory data and adverse events were recorded during the whole process.Result:1. The scores of eight aspects from SF36 questionnaires showed as following:physiological function(PF) 68.4±22.2; society function (SF): 73.9±20.4; Role of physiological(RP):68.3±42.4; body pain(BP):70.1±21.4; mental health (MH):51.4±17.6; role of emotion(RE): 72.3±32.7; vitality(VT):42.6±18.1; global health (GH):41.5±19.3. All scores were statistically higher compared to norm (P<0.05).2. The efficacy and safety were not significant different between two treatment protocols of anti-hypertension. After 24-week's treatment, the reduction in systolic blood pressures (group A:32.0±13.2 vs group B: 28.8±12.1) and in diastolic blood pressures (15.0±9.5 vs 15.7±9.9) was similar in two groups. The efficacy of deduction of blood pressure was 84.7% in group A and 83.1% in group B (P>0.05), and the percentage of blood control were 78.9% vs 79.3% (P>0.05). The adverse events appeared to be 8.7% in group A and 6.8% in group B, respectively (P>0.05).3. After 24-week's treatment, scores of physiological function (PF) (68±22.78 vs 75.98±19.38) and that of vitality(VT) (65.13±18.67 and 68.78±17.42) were significant different between two groups (P<0.05). The total scores of SF36 questionnaire were significant higher compared to the baseline (P<0.05) in both groups.Conclusion:this clinical trial showed that Amlodipine combined with telmisartan resulted in a better life quality of hypertension patients compared as the patients co-administered with amiloride. Both treatment protocols significantly deducted blood-pressure, and the former demonstrated a better effect for hypertensive patients on early stage. Both two combination protocols improved quality of life of patients and is safe and well-tolerated. |