Sperzel W D, Luther R R, Glassman H N
Am J Med. 1986 May 23;80(5B):25-8. doi: 10.1016/0002-9343(86)90848-x.
Terazosin has been studied in a variety of clinical trials conducted in hypertensive patients with supine diastolic blood pressures of 95 mm Hg or greater before treatment. Blood pressure, pulse rate, body weight, clinical laboratory variables, and adverse experience data were evaluated periodically throughout each study. Patients generally were seen at weekly or biweekly intervals. Total daily doses of terazosin ranged from 1 to 40 mg. Terazosin was administered alone and in combination with other antihypertensive agents. Clinical trials consisted of double-blind, controlled studies and long-term, follow-up studies. The controlled clinical trials employed three principal designs: studies in which the dose was titrated according to blood pressure response; studies in which the dose was increased to a fixed level regardless of blood pressure response; and randomized withdrawal studies. Efficacy evaluations were based on mean blood pressure changes from baseline to the final visit and on the distribution of patient responses, which were categorized from excellent to inadequate. Safety evaluations were based principally on comparisons of specific safety parameters before and after the study.
特拉唑嗪已在多种临床试验中进行了研究，这些试验针对的是治疗前仰卧位舒张压为95毫米汞柱或更高的高血压患者。在每项研究中，定期评估血压、脉搏率、体重、临床实验室指标以及不良事件数据。患者一般每周或每两周就诊一次。特拉唑嗪的每日总剂量范围为1至40毫克。特拉唑嗪单独给药以及与其他抗高血压药物联合给药。临床试验包括双盲对照研究和长期随访研究。对照临床试验采用了三种主要设计：根据血压反应调整剂量的研究；无论血压反应如何将剂量增加到固定水平的研究；以及随机撤药研究。疗效评估基于从基线到最后一次就诊时的平均血压变化以及患者反应的分布情况，患者反应分为优到差。安全性评估主要基于研究前后特定安全参数的比较。
