复方依那普利片剂治疗原发性高血压的临床研究

Clinical Effects of Enalapril Compound in the Treatment of Essential Hypertension

采用单盲、随机和交叉法,对比研究了受试药复方依那普利片（马来酸依那普利+氢氯噻嗪）和进口同类对照药Vaseretic（成份同复方依那普利片）对30例轻、中度原发性高血压患者的降压效果及不良反应。治疗4周后,复方依那普利片可使平均坐位收缩压及舒张压分别下降17.4％和14.0％,Vaseretic分别下降14.5％和14.0％,显效率均为96.7％。结果显示,复方依那普利片和Vaseretic的临床疗效无显著性差异,每d1次,两药均可较平稳地控制24h血压。复方依那普利治疗后6个月,患者疗效保持稳定,并有逆转肥厚心肌、改善血流动力学的作用。常见的不良反应如干咳等在服药过程中逐渐减轻,无因不良反应而终止试验者。结果提示:复方依那普利片的临床疗效和药物不良反应与Vaseretic类似,具有长期用药安全,耐受性好,疗效稳定等优点,是较好的抗高血压药物之一。

The antihypertensive effects and safety profiles of Enalapril compound were compared with Vaseretic in single blind, randomized and cross controlled clinical trials in 30 patients with mild-to-moderate essential hypertension. Vaseretic is analogous to Enalapril compound, both of them are composed of Enalapril and hydrochlorothiazide. After 4 weeks of therapy, mean sitting systolic blood pressure and dias-tolic blood pressure were reduced by 17. 4% and 14.0%, respectively in Enalapril compound group, 14. 5% and 14. 0% in Vaseretic group. The results showed that there was no significant difference in the efficiency between Enalapril compound and Vaseretic (96. 7 % vs 96. 7 %), the antihypertensive effects could last for over 24 h if one of them was given once daily. After 6 months treatment with Enalapril compound, the blood pressure of the patients remained within normal limits, the left ventricular hypertrophy was reversed and the hemodynamics improved. The commonest adverse effect in the two groups was dry cough which could be moderated during the period of treatment. No patients withdrew from the treatment due to adverse reactions. The results suggest that the antihypertensive effects and safety profiles of Enalapril compound are similar to those of Vaseretic. Enalapril compound is a drug with good effect and well tolerated by patients with mild-to-moderate hypertension.