Chrysant S G, Stimpel M
Oklahoma Cardiovascular and Hypertension Center, University of Oklahoma, Oklahoma City 73132-4904, USA.
J Cardiovasc Pharmacol. 1998 Mar;31(3):384-90. doi: 10.1097/00005344-199803000-00009.
The antihypertensive and metabolic effects of a fixed combination of very low dose of moexipril (MO), an angiotensin-converting enzyme (ACE) inhibitor, and hydrochlorothiazide (HCTZ) were tested in a multicenter, placebo (PBO) controlled, double-blind, parallel study of men (M) and women (W) with mild to moderate essential hypertension. After 4 weeks of PBO treatment, 223 patients with sitting diastolic blood pressure (SDBP) of 95-114 mm Hg and sitting systolic blood pressure (SSBP) < or =200 mm Hg, inclusive, were randomized to PBO (114 patients: M, 56; W, 58) and MO/HCTZ 3.75/6.25 mg (109 patients: M, 58; W, 51) given once daily and followed up for 12 weeks. The fixed combination MO/HCTZ, 3.75/6.25 mg, reduced SSBP/SDBP -7.6/-7.6 mm Hg (M, -8.5/-8.0; W, -6.3/-7.0), versus PBO, +0.2/-3.9 mm Hg (M, -1.9/-3.4; W, +1.1/-4.4); p < 0.05. Also, 54% of patients receiving MO/HCTZ, 3.75/6.25 mg/day, had good blood pressure response (SDBP < or =90 mm Hg, or > or =10 mm Hg decrease from baseline), versus 28% for PBO (p < 0.001). The clinical and metabolic side effects were minor and not different between MO/HCTZ and PBO. The results of this study indicate (a) a once-daily very low dose fixed combination of MO/HCTZ is effective and well tolerated by men and women with mild to moderate essential hypertension; (b) it is almost devoid of clinical and metabolic side effects; and (c) the safety profile was similar in men and women.
在一项针对患有轻度至中度原发性高血压的男性和女性的多中心、安慰剂对照、双盲、平行研究中,测试了极低剂量的血管紧张素转换酶(ACE)抑制剂莫昔普利(MO)与氢氯噻嗪(HCTZ)的固定组合的降压和代谢作用。在安慰剂治疗4周后,将223例坐位舒张压(SDBP)为95 - 114 mmHg且坐位收缩压(SSBP)≤200 mmHg(含)的患者随机分为安慰剂组(114例患者:男性56例;女性58例)和莫昔普利/氢氯噻嗪3.75/6.25 mg组(109例患者:男性58例;女性51例),每日给药一次,并随访12周。莫昔普利/氢氯噻嗪3.75/6.25 mg的固定组合使收缩压/舒张压降低7.6/7.6 mmHg(男性为8.5/8.0;女性为6.3/7.0),而安慰剂组为升高0.2/降低3.9 mmHg(男性为降低1.9/降低3.4;女性为升高1.1/降低4.4);p < 0.05。此外,每日服用莫昔普利/氢氯噻嗪3.75/6.25 mg的患者中有54%血压反应良好(坐位舒张压≤90 mmHg,或较基线降低≥10 mmHg),而安慰剂组为28%(p < 0.001)。临床和代谢副作用轻微,莫昔普利/氢氯噻嗪组与安慰剂组之间无差异。本研究结果表明:(a)莫昔普利/氢氯噻嗪的极低剂量每日一次固定组合对患有轻度至中度原发性高血压的男性和女性有效且耐受性良好;(b)它几乎没有临床和代谢副作用;(c)男性和女性的安全性相似。