Deger G
Am J Med. 1986 May 23;80(5B):62-7. doi: 10.1016/0002-9343(86)90854-5.
In a multicenter, double-blind, placebo-controlled study, the efficacy and safety of terazosin and prazosin were compared in patients with mild to moderate essential hypertension. Patients were randomly assigned to one of three treatment groups: terazosin administered once daily, prazosin administered twice daily, or placebo. After a two-week placebo lead-in period, each patient received increasing doses of terazosin or prazosin at two-week intervals until the supine diastolic blood pressure was decreased by 7 mm Hg or more compared with baseline, or until the maximum dose was reached. Patients in the placebo treatment group were similarly "titrated." A patient continued taking the selected dose for the remainder of the 14-week study. A total of 174 patients entered the active treatment period of the study; 155 were included in the efficacy analysis. Once-daily administration of terazosin resulted in significant (p less than or equal to 0.05) decreases in supine and standing diastolic blood pressure (-7.6 mm Hg and -8.3 mm Hg, respectively) when compared with placebo (-4.1 mm Hg and -2.2 mm Hg). The mean decrease in supine diastolic blood pressure resulting from twice-daily administration of prazosin (-4.9 mm Hg) was not significant when compared with placebo, whereas the decrease in mean standing diastolic blood pressure observed in the prazosin-treated group (-6.1 mm Hg) was significantly greater than that observed with placebo. Similar numbers of patients in all three groups reported adverse experiences of a subjective nature. In conclusion, once-daily administration of terazosin appears to be as safe and at least as effective as twice-daily administration of prazosin for the treatment of mild to moderate hypertension.
在一项多中心、双盲、安慰剂对照研究中,比较了特拉唑嗪和哌唑嗪对轻至中度原发性高血压患者的疗效和安全性。患者被随机分配到三个治疗组之一:每日一次服用特拉唑嗪、每日两次服用哌唑嗪或服用安慰剂。在为期两周的安慰剂导入期后,每位患者每隔两周接受递增剂量的特拉唑嗪或哌唑嗪,直至仰卧位舒张压较基线水平降低7mmHg或更多,或直至达到最大剂量。安慰剂治疗组的患者也进行类似的“滴定”。患者在为期14周的研究剩余时间内持续服用选定的剂量。共有174名患者进入研究的积极治疗期;155名患者纳入疗效分析。与安慰剂组(仰卧位舒张压降低4.1mmHg,站立位舒张压降低2.2mmHg)相比,每日一次服用特拉唑嗪导致仰卧位和站立位舒张压显著降低(分别为7.6mmHg和8.3mmHg,p≤0.05)。每日两次服用哌唑嗪导致的仰卧位舒张压平均降低值(4.9mmHg)与安慰剂组相比无显著差异,而哌唑嗪治疗组观察到的站立位舒张压平均降低值(6.1mmHg)显著大于安慰剂组。三组中报告主观性质不良经历的患者数量相似。总之,对于轻至中度高血压的治疗,每日一次服用特拉唑嗪似乎与每日两次服用哌唑嗪一样安全,且至少同样有效。