国产盐酸特拉唑嗪片治疗原发性高血压的临床研究

Clinical study on domestic terazosin hydrochloride for treatment of essential hypertension

目的：评价国产盐酸特拉唑嗪片治疗原发性高血压（EH）的有效性及安全性。方法：采用单盲、随机对比的多中心临床试验方法，研究受试药国产特拉唑嗪片和进口同类对照药Hytrin对124例轻、中度EH患者的降压效果及不良反应。结果：治疗4周后，国产特拉唑嗪片可使平均坐位收缩压及舒张压下降16．4％和14．0％（均P＜0．01），Hytrin下降16．1％和15．2％（P＜0．01）；它们的降压疗效分别为88．5％和90．5％，无统计学差异（P＞0．05）。两药均能改善EH患者的脂质代谢。日服一次，国产特拉唑嗪可较平稳地控制24h血压。常见的不良反应为头晕等，在服药过程中逐渐减轻，无固不良反应而终止试验者。结论：国产特拉唑嗪的临床疗效和药物不良反应与Hytrin类似，降压作用肯定，维持时间长，可降低高血脂及不良反应轻，是一种治疗轻、中度EH患者较为理想的降压药。

Objective:To evaluate antihypertensive effect and safety of domestic Terazosin hydrochloride. Method: 124 patients with mild-to-moderate essential hypertension were treated withTerazosin and Hytrin,analogous to Terazosin in a multicenter,single-blind,randomized and parallelcontrolled clinical trials. Their efficiencies and the tolerance were comparaed. Results: After 4 weeksof therapy,mean systolic blood pressure and diastolic blood pressure were significantly reduced by16.4% and 14. 0% respectively in Terazosin group by 16. 1 % and 15. 2% respectively in Hytringroup(P＜0. 01 ). There was no significant difference in the efficiency between Terazosin andHytrin (88. 5 % vs 90. 5 % ). (P＞0. 05 ). Both of them might improve lipid metabolism in hypertensive patients. The antihypertensive effects of Terazosin could persist for more than 24 h when itwas given once daily. The commonest adverse effect in the two groups was dizziness and it could bemoderated during the period of treatment,no patients were withdrawn from the treatment due toadverse reactions. Conclusion: The antihypertensive effects and safety of Terazosin are similar tothose of Hytrin. Demestic Terazosin is well effective and tolerated by patients with mild-to-moderate hypertension.