Spinar J, Vítovec J
II. interní klinika FN U sv. Anny LF MU, Brno.
Vnitr Lek. 1998 Jun;44(6):332-5.
A twelve-week open trial investigating the effect and tolerance of ramipril in 685 patients with mild to moderate hypertension in 88 clinics mostly of general practitioners (list with the author). The antihypertensive effect was investigated after 4, 8 and 12 weeks. The trial was terminated consistent with the protocol by 501 (73.1%) patients, 36 (5.3%) were eliminated early and in 148 (21.6%) the prescribed protocol was not respected. 413 patients (82.4%) terminated the trial on monotherapy, the remaining 88 (17.6%) had combined treatment from the 8th week onwards. When the trial with monotherapy was terminated the drop of blood pressure was more marked already during the 4th week and this trend proceeded during the 8th and 12th week, while in patients who had combined treatment from the 8th week the authors did not observe a drop of the blood pressure between the 4th and 8th week. The investigated laboratory indicators displayed insignificant changes within the range of normal values. The preparation was well tolerated, the total number of undesirable effects was 11% (three patients discontinued because of a cough). The effectiveness was evaluated by the attending physician as very good in 88%, the tolerance in 97%.
一项为期12周的开放性试验,在88家主要由全科医生组成的诊所中,对685例轻至中度高血压患者使用雷米普利的疗效和耐受性进行了研究(作者名单)。在第4、8和12周后研究其降压效果。该试验按照方案提前终止,501例(73.1%)患者,36例(5.3%)提前退出,148例(21.6%)未遵守规定方案。413例患者(82.4%)以单一疗法结束试验,其余88例(17.6%)从第8周起采用联合治疗。当单一疗法试验结束时,血压下降在第4周时就已较为明显,并在第8周和第12周持续,而对于从第8周起采用联合治疗的患者,作者未观察到第4周和第8周之间血压下降。所研究的实验室指标在正常范围内变化不显著。该制剂耐受性良好,不良反应总数为11%(3例患者因咳嗽停药)。主治医生评估其有效性为88%非常好,耐受性为97%。