Charansonney O L, Lièvre M, Laville M, Lion L, Derobert E, Visèle N, Decourt S, de Rusunan M P, Luciani J, Vasmant D, Boissel J P, Grünfeld J P
Laboratoires Hoechst, Paris La Défense, France.
Therapie. 1997 May-Jun;52(3):169-77.
This study compares the loop diuretic piretanide 6 mg in a slow-release formulation (PIR) with hydrochlorothiazide 25 mg (HCT) and the fixed combination altizide 15 mg-spironolactone 25 mg (ALT-SP) in hypertension. 1105 mild to moderate hypertensive patients entered a three-week placebo wash-out period; 899 were randomized in a 6-month, double-blind, parallel group treatment phase; 800 completed the study. Primary end-points; serum potassium concentration and quality of life at one month; secondary end-points: ionic, renal and metabolic variables; blood pressure (BP) measurements. HCT and ALT-SP were compared only to PIR using Dunnett's or chi 2 tests.
No difference was found for the overall quality of life. No change of serum potassium concentration at one month was found in PIR while small decreases were detected with ALT-SP (-0.1 mM) and HCT (-0.26 mM). Serum creatinine concentration increased significantly in ALT-SP when compared to PIR. All the drugs were effective in reducing BP: HCT had a higher rate of responders than PIR with similar mean BP falls and ALT-SP induced greater falls in blood pressure.
PIR proves to be a potent antihypertensive drug without significant effect on serum electrolytes, plasma glucose and lipids. HCT was slightly more potent but induced a fall in serum potassium concentration with a significant risk of hypokalaemia. The addition of SP to ALT led to a more potent diuretic with a higher level of serum potassium and plasma creatinine disturbances.
本研究比较了缓释制剂中6毫克的布美他尼(PIR)与25毫克氢氯噻嗪(HCT)以及固定复方制剂15毫克阿利吉仑-25毫克螺内酯(ALT-SP)在高血压治疗中的效果。1105例轻度至中度高血压患者进入为期三周的安慰剂洗脱期;899例患者被随机分为6个月的双盲平行组治疗阶段;800例患者完成了研究。主要终点:1个月时的血清钾浓度和生活质量;次要终点:离子、肾脏和代谢变量;血压(BP)测量。仅使用Dunnett检验或卡方检验将HCT和ALT-SP与PIR进行比较。
总体生活质量未发现差异。PIR组1个月时血清钾浓度无变化,而ALT-SP组(-0.1 mM)和HCT组(-0.26 mM)有小幅下降。与PIR相比,ALT-SP组血清肌酐浓度显著升高。所有药物在降低血压方面均有效:HCT的有效率高于PIR,平均血压下降幅度相似,而ALT-SP导致的血压下降幅度更大。
PIR被证明是一种有效的降压药物,对血清电解质、血糖和血脂无显著影响。HCT的降压效果稍强,但会导致血清钾浓度下降,有显著的低钾血症风险。ALT中加入SP导致利尿作用更强,但血清钾和血浆肌酐紊乱程度更高。