de Roa E Rodríguez, Botero R, Octavio J A, Berrizbeitia M L, Mayorca E, Castro P, Miranda R, Valecillo E, Aroca G, Aza G, González M
Servicio de Cardiología, Hospital Dr. José Ignacio Baldó, Caracas, Venezuela.
Am J Ther. 2007 Mar-Apr;14(2):140-6. doi: 10.1097/01.pap.0000249913.05896.3f.
Controlled clinical studies have clearly established the advantages of blood pressure (BP) reduction. However, optimal control of BP in the population is still not adequate. Monotherapy is ineffective in the majority of hypertensive patients, and multidrug therapy increases costs.
The objective of the study was to assess to what extent and how uniformly BP can be controlled with two different 24-hour drug-releasing formulations of nifedipine, used as monotherapy.
One hundred ninety-two patients of both genders, aged 18 to 65 years, with mild to moderate (Stage 1 and 2) essential hypertension with systolic BP <200 mm Hg and diastolic BP between 90 and 115 mm Hg were randomized in a double-blind, double-dummy fashion to receive sustained-release formulations of 30 mg nifedipine/day either as microgranules (NMG) or via osmotic pump (NOP) for 8 weeks. Office BP was measured at baseline (after 2 weeks of placebo) and after the third to fourth week of treatment. If at the third to fourth week the systolic BP/diastolic BP did not reach values of <140/<90 mm Hg, the dose was doubled to 60 mg/day. Monotherapy that did not yield these BP values at 8 weeks was considered a failure. Ambulatory monitoring of blood pressure (AMBP) was also performed after the placebo period and at the end of treatment. Smoothness index (SI) and trough/peak ratio (T/P) were calculated and their correlation was checked.
The initial systolic/diastolic BP values were similar at baseline and decreased significantly after the third to fourth week of treatment, with no difference between the groups. The proportions of patients reaching the goal BP (<140/<90 mm Hg) were similar in the two groups: NMG, 71%, and NOP, 78% (P = 0.12). There were no changes in the heart rate in either group. There was no difference between groups in the reduction in mean arterial pressure measured by AMBP. The frequency of SI values >1.4 and T/P ratios of >0.5 was similar in both groups. An important correlation was found between the SI and T/P values. The incidence of adverse effects was low and similar in both groups.
Target BP was reached in more than 70% of patients receiving monotherapy with either formulation. Both formulations were tolerated well.
对照临床研究已明确证实降低血压（BP）的益处。然而，人群中血压的最佳控制仍不充分。单一疗法对大多数高血压患者无效，而联合用药会增加成本。
本研究的目的是评估两种不同的硝苯地平24小时控释制剂作为单一疗法在多大程度上以及在何种程度上能均匀地控制血压。
192名年龄在18至65岁之间、患有轻度至中度（1期和2期）原发性高血压、收缩压<200 mmHg且舒张压在90至115 mmHg之间的男女患者，采用双盲、双模拟方式随机分组，接受30 mg硝苯地平/天的缓释制剂，剂型为微粒（NMG）或渗透泵（NOP），治疗8周。在基线（安慰剂治疗2周后）以及治疗第3至4周后测量诊室血压。如果在第3至4周时收缩压/舒张压未达到<140/<90 mmHg的值，则将剂量加倍至60 mg/天。在8周时未达到这些血压值的单一疗法被视为失败。在安慰剂期后和治疗结束时也进行了动态血压监测（AMBP）。计算平滑指数（SI）和谷峰比（T/P）并检查它们的相关性。
两组患者在基线时的初始收缩压/舒张压值相似，在治疗第3至4周后显著下降，两组之间无差异。两组达到目标血压（<140/<90 mmHg）的患者比例相似：NMG组为71%，NOP组为78%（P = 0.12）。两组患者的心率均无变化。通过AMBP测量的平均动脉压降低值在两组之间无差异。两组中SI值>1.4和T/P比值>0.5的频率相似。发现SI和T/P值之间存在重要相关性。不良反应的发生率较低，两组相似。
接受任一制剂单一疗法的患者中，超过70%达到了目标血压。两种制剂的耐受性都很好。
