国产卡维地洛治疗原发性高血压的临床研究

CLINICAL EFFECTS OF DOMESTIC CARVEDILOL IN TREATMENT OF ESSENTIAL HYPERTENSION

采用双盲双模拟、随机对照法，对比研究受试药卡维地洛片和对照药阿替洛尔对２０５例轻、中度原发性高血压患者的降压效果及药物不良反应。治疗４周后，卡维地洛使平均坐位收缩压及舒张压分别下降１０．８％和１２．７％，阿替洛尔分别下降１３．３％和１３．４％；两药总有效率分别为８５．１％及７８．８％。卡维地洛和阿替洛尔均能明显降低心率，但卡维地洛降低幅度较小。两药的临床疗效无显著性差异，日服一次，均可较平稳地控制２４ｈ血压。卡维地洛治疗后６个月，降压疗效保持，并有逆转肥厚心肌、改善血流动力学的作用。常见药物不良反应为乏力、头晕等，在服药过程中逐渐减轻，无因药物不良反应而终止试验者。结果提示，卡维地洛治疗原发性高血压，具有长期用药安全，耐受性好，疗效稳定等优点，与阿替洛尔比较，卡维地洛对心率和生化代谢影响小。

The antihypertensive effects and safety profiles of carvedilol(test)were compared with atenolol(control)in double-blind,randomized and controlled clinical trials with double-dummy technique in 205 patients with mild-to-moderate essential hypertension. After 4 weeks of therapy, mean sitting systolic blood pressure and diastolic blood pressure were reduced by 10.8% and 12.7%, respectively in carvedilol, 13.3% and 13.4% in atenolol. The results showed that there was no significant difference in the efficiency between carvedilol and atenolol ( 85.1% vs 78.8%). Their antihypertensive effects could persist for over 24 h when they were given once daily. After treatment with carvedilol for 6 months, the blood pressure of the patients were lowered to within normal limits, the left ventricular hypertrophy were reduced and the hemodynamics were improved. The common adverse effects of both drugs were fatigue and dizziness, which might become milder during the period of treatment. No patients withdrew from the treatment because of adverse reactions of the drugs. The results suggest that carvedilol is safe in its antihypertensive effects and is well tolerated by patients with mild_to_moderate hypertension. Compared with atenolol, the effects of carvedilol on the heart rate and biochemistry metabolism were slight.