Bonnet G
Hôpital Dupuytren, Draveil, France.
Am Heart J. 1991 Jan;121(1 Pt 2):335-40. doi: 10.1016/0002-8703(91)90868-i.
This study was designed to assess the efficacy and tolerance of doxazosin in patients with mild, moderate, or severe essential hypertension in a general practice setting. Ninety-six adults of a mean age of 55 1/2 years took part in the 14-week study, consisting of a placebo phase (2 weeks), a dose-adjustment phase with doxazosin (8 weeks), and a maintenance phase (4 weeks). Doxazosin, at a final mean daily dose of 3.4 mg, produced a significant (p less than 0.05) reduction in blood pressure at all points of measurement during the study. The mean change in sitting blood pressure at the end of treatment was -15.4/-15.8 mm Hg. Of the 85 patients who could be categorized as a success or failure, 78 (92%) were considered a therapeutic success; 78 (89%) of the 88 efficacy-evaluable patients demonstrated an improvement in the severity category of their hypertension. Treatment with doxazosin produced a reduction in serum cholesterol (-3.1%) and triglyceride (-3.8%) levels, although these changes did not attain statistical significance. The calculated probability of developing coronary heart disease in 10 years (according to the Framingham equation) was significantly (p less than 0.001) reduced by 22%, from 16.7 chances per 100 (baseline) to 14.3 chances per 100 (final visit). Twenty-six patients (27.1%) reported side effects that were possibly related to treatment, the most prevalent of which were vertigo (7.3%) and headache (6.3%). In four (4.2%) patients the dose of doxazosin was reduced and two (2.1%) were withdrawn prematurely. The investigator's assessments of tolerance was reduced and two (2.1%) were considered to be excellent or good in 85 (88%) patients.
本研究旨在评估在普通医疗环境中,多沙唑嗪对轻度、中度或重度原发性高血压患者的疗效及耐受性。96名平均年龄为55.5岁的成年人参与了这项为期14周的研究,研究包括一个安慰剂阶段(2周)、一个多沙唑嗪剂量调整阶段(8周)和一个维持阶段(4周)。在研究期间,多沙唑嗪最终平均每日剂量为3.4毫克,在所有测量点均使血压显著降低(p<0.05)。治疗结束时,坐位血压的平均变化为-15.4/-15.8毫米汞柱。在85名可归类为成功或失败的患者中,78名(92%)被认为治疗成功;在88名可评估疗效的患者中,78名(89%)高血压严重程度类别有所改善。多沙唑嗪治疗使血清胆固醇水平降低了3.1%,甘油三酯水平降低了3.8%,尽管这些变化未达到统计学意义。根据弗雷明汉方程计算的10年内患冠心病的概率显著降低(p<0.001),从每100人中有16.7次发病机会(基线)降至每100人中有14.3次发病机会(末次随访)。26名患者(27.1%)报告了可能与治疗相关的副作用,其中最常见的是眩晕(7.3%)和头痛(6.3%)。4名(4.2%)患者减少了多沙唑嗪剂量,2名(2.1%)患者提前退出研究。研究者对耐受性的评估显示,85名(88%)患者为一般或良好,2名(2.1%)患者为优秀。