动态血压监测比较复方依那普利与依那普利单药的疗效  

Comparison of two type of enalaprii/HCTZ compounds to enalapril alone in the treatment of hypertension

作　　者：华潞[1] 明广华[1] 汪芳[1] 蒋文[1] 王莉[1] 庞会敏[1] 成小如[1] 张阴凤[1] 李一石[1] 

机构地区：[1]中国医学科学院中国协和医科大学心血管病研究所暨阜外心血管病医院临床药理中心卫生部心血管药物临床研究重点实验室,北京100037

出　　处：《中国新药杂志》2006年第13期1106-1109,共4页Chinese Journal of New Drugs

基　　金：863国家攻关项目<临床试验关键技术及平台研究>(2002AA223411;2004AA223760)

摘　　要：目的:应用动态血压监测(ABPM)评价2种规格的复方依那普利片治疗高血压的疗效、谷/峰比值,并与依那普利单药比较,探讨中国人应用依那普利/氢氯噻嗪复方制剂的合适剂量组合。方法:经2周洗脱期,平均坐位舒张压(SeDBP)为95～114 mmHg,且ABPM检查平均舒张压≥82 mmHg的高血压患者,随机分为A,B,C三组,分别口服复方依那普利(E)10mg/氢氯噻嗪(HCTZ)12．5mg或E10mg/HCTZ 6．25mg或E10mg,qd。治疗4周末,诊室SeDBP≥90 mmHg者剂量加倍,SeDBP＜90 mmHg者按原剂量治疗,继续治疗4周。于洗脱期末及治疗8周末各行ABPM和实验室检查1次。结果:治疗8周末,三组24h,日间、夜间平均血压均较给药前明显下降,A组(n=24)降压幅度优于C组(n=23)(P＜0．05),略高于B组(n=26)(P＞0．05)。B组降压幅度高于C组,但无显著差异。A,B,C组的DBP谷峰比值分别为78．88%,70．23%和45．75%。结论:复方依那普利片每日一次口服可24 h平稳降压,且E 10 mg与HCTZ 6．25 mg剂量组合为佳。Objective：To assess the antihypertensive effect, T/P ratio of two type of enaiapriL/ hydrochlorothiazide （E/HCTZ）compounds versus enalapril alone in patients with essential hypertension by ambulatory blood pressure monitoring（ABPM）. And to study the appropriate dose combination of enalapril and HCTZ. Methods ：Patients with seated diastolic blood pressure （SeDBP） 95～ 114 mmHg and ambulatory diastolic blood pressure（ADBP） 〉182 mmHg were blinded and randomized to receive E/HCTZ （ 10/ 12.5 mg,n =24）E/HCTZ（10/6.25 mg,n =26）,or E（10 mg,n = 23） once daily for 4 weeks after they had a 2-week washout. The patients with SiDBP 〉190 mmHg at the end of the 4-week therapy were double dosed for additional 4 weeks. The patients with SeDBP 〈 90 mmHg at the end of the 4-week therapy remained the initial regimen for additional 4 weeks. Both ambulatory blood pressure monitoring （ABPM） and laboratory tests were performed after the wash out and at the end of the 8-week therapy. Results：All regimens showed significant reductions of the 24 hours-, day- and night blood pressures from baseline （P 〈 0.01 ）. The E/HCTZ（ 10/12.5 mg） showed a superiority of Bp reduction to the E （ 10 mg） （ P 〈 0. 05） but inferiority to E/HCTZ（ 10/6.25 rag） （ P 〉 0.05 ）. The E/HCTZ （ 10/6.25 rag） decreased Bp more than the E10 mg alone; the p value showed no statistical difference （P 〉 0.05）. The trough-peak ratios of DBP in the E/HCTZ （ 10/12.5 mg）, E/HCTZ （ 10/6. 25mg） and E （ 10mg） were 78.88%, 70.23% ,45.75%, respectively. Conclusion：Both two type of enalapril/HCTZ compounds once a day can decrease blood pressure smoothly 24 hours and the E/HCTZ（ 10/6.25mg）compound offered a best option for patients with hypertension.

关 键 词：高血压 依那普利 氢氯噻嗪 动态血压监测 

分 类 号：R972.4[医药卫生—药品] R969.4[医药卫生—药学]