Pessina A C
Cattedra di Medicina Interna, Università degli Studi di Padova.
Clin Ter. 1995 Jan;146(1):3-12.
This is an open non-comparative study to evaluate the efficacy and tolerability of doxazosin mesilate in 540 subjects with either history or newly diagnosed mild/moderate hypertension. In all adult subjects of both sexes enrolled in this study, the diastolic blood pressure (DBP) was in the range of 95-115 mmHg at two different measurements both in clino- and orthostatism, in the absence of any heart pathology. Those patients who, after one-week wash-out period, reported DPB > or = 95 mmHg, were given doxazosin as a single daily dose. The initial dosage was 1 mg for three days; afterwards, patients have been instructed to take a whole 2 mg tablet in the morning up to the following visit (i.e. 14 days after the first administration). In case < or = 90 mmHg DBP control could not be obtained, the dosage has been increased to 4 mg and if after the same interval of time (i.e. 14 days) DPB control could not be achieved, the dosage was increased up to 8 mg (2 x 4 mg tablets) and/or the concomitant administration of another antihypertensive drug was instituted. At the beginning and at the end of the study blood collection for lipid profile determinations (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides), routine tests and complete urinalysis were performed. The onset of side-effects was reported in 84 (15.5%) subjects and only 13 (2.4%) of them had to discontinue the therapy. A comparative analysis of the incidence of side-effects between the total number of patients and those aged > or = 65 yrs. has not shown a significant difference. At week 24, a total of 540 subjects had completed the treatment. BP value normalization has been achieved with a mean dosage of 3.1 +/- 1.2 mg/day of doxazosin. Doxazosin administration did not produce clinically significant effects on heart rate. Laboratory data have evidenced a statistically significant increase in HDL cholesterol (p < 0.0001) and a significant reduction of mean values of total cholesterol, LDL cholesterol and triglycerides (p < 0.0001) at week 24, with respect to baseline. In the group of patients aged > or = 65 yrs. (116 patients) only a delta/percentage variation of HDL cholesterol with respect to baseline has been evidenced, after 24 weeks of treatment.
这是一项开放性非对比研究，旨在评估甲磺酸多沙唑嗪对540例有高血压病史或新诊断为轻度/中度高血压患者的疗效和耐受性。在本研究纳入的所有成年男女受试者中，在临床和直立位两种不同测量情况下，舒张压（DBP）在95 - 115 mmHg范围内，且无任何心脏病变。那些在为期一周的洗脱期后报告DBP≥95 mmHg的患者，给予多沙唑嗪每日单次剂量。初始剂量为1 mg，连用三天；之后，指导患者在下次就诊（即首次给药后14天）前每天早晨服用整片2 mg片剂。如果无法将DBP控制在≤90 mmHg，剂量增至4 mg；若在相同时间间隔（即14天）后仍未实现DBP控制，则剂量增至8 mg（2片4 mg片剂）和/或开始联合使用另一种抗高血压药物。在研究开始和结束时，采集血样进行血脂谱测定（总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、甘油三酯）、常规检查和完整尿液分析。84例（15.5%）受试者报告出现副作用，其中仅13例（2.4%）不得不停止治疗。对患者总数与年龄≥65岁患者的副作用发生率进行比较分析，未显示出显著差异。在第24周时，共有540例受试者完成治疗。使用多沙唑嗪平均剂量3.1±1.2 mg/天实现了血压值正常化。多沙唑嗪给药对心率未产生临床显著影响。实验室数据表明，与基线相比，在第24周时高密度脂蛋白胆固醇有统计学显著升高（p<0.0001），总胆固醇、低密度脂蛋白胆固醇和甘油三酯平均值有显著降低（p<0.0001）。在年龄≥65岁的患者组（116例患者）中，治疗24周后，仅证明高密度脂蛋白胆固醇相对于基线有δ/百分比变化。
