Dauer A D
Am J Med. 1986 May 23;80(5B):29-34. doi: 10.1016/0002-9343(86)90849-1.
The safety and efficacy of once-daily terazosin as monotherapy were evaluated in five randomized, double-blind, placebo-controlled studies in which 351 patients with mild to moderate hypertension participated. The five studies included two dose-titration studies and three fixed-dose studies. In the dose-titration studies, terazosin doses were titrated at weekly intervals until supine diastolic blood pressure was below 90 mm Hg. In the fixed-dose studies, titration continued until a predetermined dosage level of terazosin or corresponding placebo was reached. The dose of terazosin ranged from 1 to 40 mg once daily, and responses were assessed after a four-week course of therapy at a constant dosage level. Terazosin administration resulted in significantly greater mean decreases in supine diastolic blood pressure in comparison with placebo in four of the five studies. Similar decreases were observed for supine systolic and standing blood pressures in selected studies. In all five studies, terazosin caused a significant decrease in supine and standing blood pressures from baseline to the final visit. Adverse experiences occurring with a significantly greater prevalence rate in terazosin-treated versus placebo-treated patients and 7 percent of placebo-treated patients), asthenia (17 percent of the terazosin group and 4 percent of the placebo group), and peripheral edema (10 percent of the terazosin group and 3 percent of the placebo group). On the basis of these studies, it appears that terazosin, when administered once daily as monotherapy, is both safe and effective for the treatment of mild to moderate hypertension.
在五项随机、双盲、安慰剂对照研究中,对351例轻至中度高血压患者进行了每日一次特拉唑嗪单药治疗的安全性和有效性评估。这五项研究包括两项剂量滴定研究和三项固定剂量研究。在剂量滴定研究中,特拉唑嗪剂量每周滴定一次,直至仰卧位舒张压低于90mmHg。在固定剂量研究中,滴定持续进行,直至达到特拉唑嗪或相应安慰剂的预定剂量水平。特拉唑嗪剂量范围为每日一次1至40mg,在恒定剂量水平治疗四周后评估反应。在五项研究中的四项中,与安慰剂相比,特拉唑嗪给药导致仰卧位舒张压平均下降幅度显著更大。在选定的研究中,仰卧位收缩压和站立位血压也有类似下降。在所有五项研究中,从基线到最后一次访视,特拉唑嗪均使仰卧位和站立位血压显著下降。与安慰剂治疗的患者相比,特拉唑嗪治疗的患者中发生率显著更高的不良事件有:头晕(特拉唑嗪组为12%,安慰剂组为7%)、乏力(特拉唑嗪组为17%,安慰剂组为4%)和外周水肿(特拉唑嗪组为10%,安慰剂组为3%)。基于这些研究,每日一次特拉唑嗪单药治疗似乎对轻至中度高血压的治疗既安全又有效。