Taylor S H, Frais M A, Lee P, Verma S P, Jackson N, Silke B
Br J Clin Pharmacol. 1985;20 Suppl 1(Suppl 1):135S-138S. doi: 10.1111/j.1365-2125.1985.tb05156.x.
The dose-response effects of oral nicardipine on the systemic blood pressure were examined in 54 patients with uncomplicated essential hypertension (DBP greater than or equal to 100 mm Hg). The study was designed in four sequential stages. A 2 week single-blind placebo run-in period was followed by dose titration with nicardipine at 2 week intervals. Patients achieving the target DBP less than or equal to 95 mm Hg were then crossed over to placebo for 2 weeks, following which the previous dose of nicardipine was readministered for 6 weeks. Forty-eight patients completed the dose-titration phase. The target DBP 95 mm Hg was achieved in 33; in eight after 10 mg three times daily, in 21 after 20 mg three times daily, in three after 30 mg three times daily and in one after 40 mg three times daily. In the 48 patients, systolic blood pressure was reduced from 188 +/- 25 to 158 +/- 21 mm Hg (P less than 0.001) and diastolic blood pressure from 111 +/- 9 to 93 +/- 13 mm Hg (P less than 0.001); heart rate increased from 81 +/- 7 to 87 +/- 13 beats min-1 (P less than 0.01). Thirty-one of the 33 patients completed the crossover to placebo, which was accompanied by a significant increase towards pretreatment blood pressure levels. Reinstitution of nicardipine at the previous dose resulted in a reduction of SBP and DBP to levels not significantly different from those at the end of the dose-titration stage.(ABSTRACT TRUNCATED AT 250 WORDS)
在54例无并发症的原发性高血压患者(舒张压大于或等于100 mmHg)中研究了口服尼卡地平对全身血压的剂量-反应效应。该研究按四个连续阶段设计。先有2周的单盲安慰剂导入期,随后每隔2周用尼卡地平进行剂量滴定。达到目标舒张压小于或等于95 mmHg的患者接着接受2周的安慰剂治疗,之后重新给予先前剂量的尼卡地平治疗6周。48例患者完成了剂量滴定阶段。33例患者达到了95 mmHg的目标舒张压;8例患者每日三次服用10 mg后达到目标,21例患者每日三次服用20 mg后达到目标,3例患者每日三次服用30 mg后达到目标,1例患者每日三次服用40 mg后达到目标。在这48例患者中,收缩压从188±25 mmHg降至158±21 mmHg(P<0.001),舒张压从111±9 mmHg降至93±13 mmHg(P<0.001);心率从81±7次/分钟增至87±13次/分钟(P<0.01)。33例患者中有31例完成了向安慰剂的交叉治疗,随后血压显著回升至治疗前水平。重新给予先前剂量的尼卡地平后,收缩压和舒张压降至与剂量滴定阶段结束时无显著差异的水平。(摘要截短至250字)