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目的:与依那普利单药比较,评价2种规格的复方依那普利/氢氯噻嗪片治疗原发性高血压病的疗效和安全性。方法:409例原发性高血压患者(坐位舒张压SeDBP 95~115mmHg),经2周洗脱期后随机分入A,B,C三组,分别每日1次口服复方依那普利(E)10mg/氢氯噻嗪(HCTZ)6.25mg,E10mg/HCTZ12.5mg或E10mg,治疗4周末诊室血压SeDBP≥90mmHg者剂量加倍,SeDBP<90mmHg者按原剂量治疗,继续治疗4周,共治疗8周。以SeDBP评价治疗8周的疗效,同时评价药物的安全性。结果:治疗8周后,三组血压均有明显下降(P<0.001)。A组(n=110)SeDBP下降(14.05±6.55)mmHg,总有效率81.82%;B组(n=106)分别为(14.01±6.66)mmHg, 83.02%;C组(n=96)分别为(10.82±6.33)mmHg,69.79%。A,B两组8周总有效率组间比较无统计学差异,但均优于C组(P<0.05)。三组总不良反应发生率分别为19.26%,21.90%和21.90%,组间比较无统计学差异。结论:复方依那普利/氢氯噻嗪治疗中国原发性高血压患者的降压疗效明显优于单药依邪普利,耐受性良好。氢氯噻嗪6.25mg与依那普利组成复方制剂时剂量组合尤佳。
OBJECTIVE: To compare the efficacy and safety of two enoxapril / hydrochlorothiazide tablets in the treatment of essential hypertension with enalapril monotherapy. Methods: Four hundred and ninety-nine patients with essential hypertension (SeDBP, sitting position 95-115 mmHg) were randomly divided into three groups A, B and C after two weeks of elution. Patients were given oral enalapril once a day E) 10mg / hydrochlorothiazide (HCTZ) 6.25mg, E10mg / HCTZ12.5mg or E10mg, 4 weeks after treatment clinic blood pressure SeDBP≥90mmHg were doubled dose, SeDBP <90mmHg were treated according to the original dose, continued treatment for 4 weeks for a total of 8 weeks . SeDBP evaluation of the efficacy of treatment for 8 weeks, while evaluating the safety of drugs. Results: After 8 weeks of treatment, blood pressure decreased significantly in all three groups (P <0.001). SeDBP in group A (n = 110) decreased (14.05 ± 6.55) mmHg with a total effective rate of 81.82%; group B (n = 106) was (14.01 ± 6.66) mmHg, 02%; Group C (n = 96) were (10.82 ± 6.33) mmHg, 69.79% respectively. There was no significant difference between the two groups in the total effective rate of 8 weeks (P <0.05), but both of them were superior to those in C (P <0.05). The total incidence of adverse reactions in the three groups were 19.26%, 21.90% and 21.90%, respectively, with no significant difference between the two groups. CONCLUSION: The antihypertensive efficacy of the compound enalapril / hydrochlorothiazide therapy in patients with essential hypertension in China is significantly better than that of monotherapy and yuzpril. Hydrochlorothiazide 6.25mg and enalapril composition of the compound dosage combination is particularly preferred.