De Bruijn J H, Orofiamma B A, Pauly N C
De Stadsmaten Hospital, Enschede, The Netherlands.
J Cardiovasc Pharmacol. 1994;23 Suppl 4:S60-4.
This double-blind, placebo-controlled, dose-ranging study recruited 170 patients with mild-to-moderate hypertension from nine centers. After a 4-week, single-blind, placebo run-in phase, patients were randomized in a double-blind fashion to four parallel groups that received either placebo or 0.5, 1, or 2 mg trandolapril for 4 weeks. Treatment was administered as a once-daily dose in the morning and blood pressure was measured 24 h after drug intake. The primary criterion of efficacy was a decrease in supine diastolic blood pressure. At the end of the study, the lowest dose of trandolapril that consistently produced a significant difference from placebo in reducing blood pressure was 1 mg (-6.6 mm Hg for supine diastolic blood pressure). It was effective from around 2 weeks onward; the 2-mg dose differed significantly from placebo from around 1 week onward. At the end of the study, the 1- and 2-mg doses were equally effective. The lowest dose tested, 0.5 mg, showed some evidence of an effect on systolic blood pressure and may well prove to be a useful dose in patients who are highly sensitive to the effect of ACE inhibition. Tolerance throughout the study was good for all doses tested.
这项双盲、安慰剂对照、剂量范围研究从9个中心招募了170例轻至中度高血压患者。经过4周的单盲、安慰剂导入期后，患者以双盲方式随机分为4个平行组，分别接受安慰剂或0.5、1或2 mg群多普利治疗4周。治疗采用每日早晨一次给药，服药后24小时测量血压。疗效的主要标准是仰卧位舒张压降低。研究结束时，群多普利在降低血压方面始终与安慰剂有显著差异的最低剂量为1 mg（仰卧位舒张压降低6.6 mmHg）。从大约2周起开始有效；2 mg剂量从大约1周起与安慰剂有显著差异。研究结束时，1 mg和2 mg剂量同样有效。测试的最低剂量0.5 mg对收缩压有一定的作用迹象，对于对ACE抑制作用高度敏感的患者可能是一个有用的剂量。在整个研究过程中，所有测试剂量的耐受性都良好。
