Verho M, Rangoonwala B, Beloso M, Maass L, Bender R, Garduno D
Drugs Exp Clin Res. 1986;12(5):385-91.
In a randomized, double-blind parallel group study the 24-hour hypotensive effect of piretanide and its influence on biochemical variables were compared with those of placebo in patients with mild to moderate essential hypertension. Sixty patients entered the study, all of whom met the inclusion criteria (RRdiast between 95 and 120 mmHg). There was no drop-out during the study, so that the results of all 60 patients were statistically analysed. Piretanide produced a significant reduction of both systolic and diastolic blood pressure over 24 hours which was evident at four weeks and was maintained and further enhanced over the ensuing trial period. A mean maximal fall (at 12 weeks) of 10.7% (BPdiast supine) was observed. Placebo tablets did not produce any clinically relevant changes in systolic blood pressure, whereas a slight decrease was seen in diastolic blood pressure. This blood pressure reduction was significantly less in the placebo group than in the piretanide group at the end of the study (weeks 10 and 12). Dose doubling was needed in 13 of the 30 patients in the piretanide group, whereas as many as 20 out of 30 patients needed dose doubling in the placebo group. Pulse rate did not change relevantly during the trial in either group. A slight reduction in body weight was observed in the piretanide group. The mean values of serum potassium and sodium showed a slight decrease but remained within the normal range during the study period. A small increase in serum phosphorus was noted. None of these changes required any specific measures.(ABSTRACT TRUNCATED AT 250 WORDS)
在一项随机、双盲平行组研究中,将吡咯他尼的24小时降压效果及其对生化指标的影响与安慰剂在轻度至中度原发性高血压患者中的情况进行了比较。60名患者进入研究,所有患者均符合纳入标准(舒张压RR在95至120 mmHg之间)。研究期间无患者退出,因此对所有60名患者的结果进行了统计学分析。吡咯他尼在24小时内使收缩压和舒张压均显著降低,四周时明显,在随后的试验期内保持并进一步增强。观察到平均最大降幅(12周时)为10.7%(仰卧位舒张压)。安慰剂片对收缩压未产生任何临床相关变化,而舒张压略有下降。在研究结束时(第10周和第12周),安慰剂组的血压降低幅度明显小于吡咯他尼组。吡咯他尼组30名患者中有13名需要加倍剂量,而安慰剂组30名患者中有多达20名需要加倍剂量。两组试验期间脉搏率均无明显变化。吡咯他尼组观察到体重略有下降。血清钾和钠的平均值略有下降,但在研究期间仍在正常范围内。血清磷略有升高。这些变化均无需采取任何特殊措施。(摘要截断于250字)