Licata G, Scaglione R, Ganguzza A, Parrinello G, Costa R, Merlino G, Corrao S, Amato P
Department of Medical Pathology, University of Palermo, Italy.
Eur J Clin Pharmacol. 1993;45(4):307-11. doi: 10.1007/BF00265946.
In this study the efficacy and safety of short-term amlodipine administration on renal haemodynamics were evaluated in mild to moderate hypertensive subjects. Our final goal was to evaluate whether the reduced blood pressure induced by treatment was associated with maintenance of renal function. After a run-in period with placebo, 30 hypertensive patients without cardiac or renal diseases were randomly allocated to a double-blind 4 weeks controlled study with amlodipine 10 mg once a day (15 patients) or placebo (15 patients). Renal haemodynamic measurements included effective renal plasma flow (ERPF) and glomerular filtration rate (GFR) by radionuclide study using 131I-hippuran and 99mTc, with methods described by Schlegel and Gates, respectively. In addition, effective renal blood flow [ERBF = ERPF/(1-Ht)], filtration fraction (FF = GFR/ERPF) and renal vascular resistance (RVR = MBP x 80/ERBF) were calculated. Plasma renin activity (PRA), serum aldosterone (ALD) and urinary excretion of sodium (NaU) were evaluated. At the end of amlodipine administration a significant decrease (P < 0.001) in SBP, DBP and MBP from baseline values was observed. A significant decrease (P < 0.01) in RVR and significant increases (P < 0.05) in ERPF, ERBF and in NaU were also found, without relevant changes in GFR, FF, PRA and ALD. No significant variation in clinical and renal measurements was observed in the placebo group. No relevant side effects were observed in either group. In conclusion, amlodipine was effective in lowering blood pressure in mild to moderate hypertension and exerted favourable effects on renal haemodynamics and function.
在本研究中,我们评估了短期服用氨氯地平对轻至中度高血压患者肾脏血流动力学的疗效和安全性。我们的最终目标是评估治疗引起的血压降低是否与肾功能的维持相关。在服用安慰剂的导入期后,30名无心脏或肾脏疾病的高血压患者被随机分配到一项双盲4周对照研究中,其中15名患者每日服用一次10mg氨氯地平,另外15名患者服用安慰剂。肾脏血流动力学测量包括使用131I-马尿酸和99mTc通过放射性核素研究测定有效肾血浆流量(ERPF)和肾小球滤过率(GFR),方法分别由施莱格尔和盖茨描述。此外,还计算了有效肾血流量[ERBF = ERPF/(1-Ht)]、滤过分数(FF = GFR/ERPF)和肾血管阻力(RVR = MBP x 80/ERBF)。评估了血浆肾素活性(PRA)、血清醛固酮(ALD)和尿钠排泄量(NaU)。在服用氨氯地平结束时,观察到收缩压、舒张压和平均血压较基线值显著降低(P < 0.001)。还发现肾血管阻力显著降低(P < 0.01),有效肾血浆流量、有效肾血流量和尿钠排泄量显著增加(P < 0.05),而肾小球滤过率、滤过分数、血浆肾素活性和醛固酮无相关变化。安慰剂组在临床和肾脏测量方面未观察到显著变化。两组均未观察到相关副作用。总之,氨氯地平在降低轻至中度高血压患者血压方面有效,并对肾脏血流动力学和功能产生有利影响。