复方依那普利/氢氯噻嗪片治疗原发性高血压Ⅱ期临床研究

Efficacy and safety of enalapril/HCTZ compounds versus Enalapril alone in Chinese subjects with primary hypertension

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 assess the efficacy and safety of enalapril/HCTZ （E/HCTZ） compound versus enalapril （E） alone in Chinese subjects with primary hypertension. Methods： Following after a 2-week washing-out period, 409 subjects with seated diastolic blood pressure （SeDBP） of 95 115 mmHg were randomized orally to receive either E/HCTZ 10 mg/6.25 mg（ n = 110） , 10 mg/12. 5 mg （n = 106） or E10mg alone （n =96） once daily for 4 weeks. The subjects with SeDBP≥90 mmHg were doubled the dosing of the study drug regimen at the end of 4-week treatment for additional 4 weeks, and the subjects with SeDBP 〈 90 mmHg remained the dosing the study drug regimen for additional 4 weeks. The primary endpoint was to measure the improvement of SeDBP at the end of 8-week treatment. Other endpoints included the assessment of efficacy and safety in the week 2, 4, 6 and 8 post the treatment. Results：All subjects experienced significant improvement of SeDBP at the end of the 8-week treatment （P 〈 0. 01 ）, showing the SeDBP reduction by （ 14.05±6.55 ） mmHg （ the response rate of 81.82 % ）in E/HCTZ （10mg/6.25 mg） group, （14.01±6.66）mmHg （the response rate of 83.02 %） in E/ HCTZ （10 mg/12.5 mg） group, and （10.82± 6.33）mmHg （the response rate of 69.79 % ） in E alone group, respectively. No significant difference was found between the two bi-regimen groups. A statistical difference was found between the bi-regimen and the mono-regimen groups （P 〈 0.05 ）. The incidence rate of adverse events was 19.26% , 21.90% and 21.90% , respectively; the p value showed no significant difference. Conclusion： The efficacy of the E/HCTZ compound is superior to the E alone in the treatment of primary hypertension.