Maroko P R, McDevitt J T, Fox M J, Silber S A, Young M D, Beg M, Rockhold F W, Free S M, Herron J R, Gray J M
Smith Kline & French Laboratories, Philadelphia, Pennsylvania.
Clin Ther. 1989;11(1):94-119.
A large, multicenter, randomized, placebo-controlled, double-blind trial was carried out to determine the effects of the lowest dose of commercially available hydrochlorothiazide. Thus, Dyazide (which contains 25 mg of hydrochlorothiazide and 50 mg of triamterene in an approximately 50% bioavailable form), one capsule, was given daily to patients with either mild or moderate hypertension (supine diastolic blood pressure of 95 to 115 mmHg) for eight weeks. At the end of this eight-week period, supine diastolic blood pressure (SDBP) fell by 11.3 +/- 6.7 mmHg (mean +/- SD) in the Dyazide-treated compared to 4.6 +/- 6.9 mmHg in the placebo-treated group (P less than 0.001). In two thirds of the patients receiving active treatment the fall in SDBP was more than 10 mmHg, and in over half SDBP was completely normalized (ie, SDBP less than 90 mmHg). Supine systolic blood pressure fell by 14.7 +/- 12.3 mmHg in the Dyazide-treated group compared to 5.3 +/- 11.6 mmHg in the placebo-treated group (P less than 0.001). Approximately 80% of the antihypertensive effect occurred within two weeks and after four weeks there was no further significant reduction. Mildly (SDBP = 95 to 104 mmHg) and moderately (SDBP = 105 to 115 mmHg) hypertensive patients responded similarly to treatment. All studied subpopulations responded to treatment with a reduction of SDBP of at least an average of 10 mmHg; the best responders were blacks, women, the elderly (greater than 65 years old), and patients weighing less than 170 lbs. Side effects were mild and infrequent. In conclusion, by examining the effects of Dyazide (one capsule/day), this investigation demonstrated the effectiveness of low-dose hydrochlorothiazide in antihypertensive therapy and quantified it both in the general population and in clinically relevant subpopulations.
开展了一项大型、多中心、随机、安慰剂对照、双盲试验，以确定市售最低剂量氢氯噻嗪的效果。因此，给轻度或中度高血压患者（仰卧位舒张压为95至115 mmHg）每日服用一粒Dyazide（其含有25 mg氢氯噻嗪和50 mg氨苯蝶啶，生物利用度约为50%），持续八周。在这八周结束时，Dyazide治疗组的仰卧位舒张压（SDBP）下降了11.3±6.7 mmHg（均值±标准差），而安慰剂治疗组下降了4.6±6.9 mmHg（P<0.001）。在接受积极治疗的患者中，三分之二的患者SDBP下降超过10 mmHg，超过一半的患者SDBP完全恢复正常（即SDBP<90 mmHg）。Dyazide治疗组的仰卧位收缩压下降了14.7±12.3 mmHg，而安慰剂治疗组下降了5.3±11.6 mmHg（P<0.001）。约80%的降压效果在两周内出现，四周后无进一步显著降低。轻度（SDBP = 95至104 mmHg）和中度（SDBP = 105至115 mmHg）高血压患者对治疗的反应相似。所有研究的亚组对治疗的反应均为SDBP平均至少降低10 mmHg；反应最佳的是黑人、女性、老年人（大于65岁）以及体重低于170磅的患者。副作用轻微且不常见。总之，通过研究Dyazide（每日一粒胶囊）的效果，本研究证明了低剂量氢氯噻嗪在抗高血压治疗中的有效性，并在一般人群和临床相关亚组中进行了量化。
