螺内酯治疗顽固性高血压的随机、单盲、对照试验

目的:评价螺内酯治疗顽固性高血压的疗效和安全性。方法:顽固性高血压患者随机分为观察组(58例)和对照组(66例),在常规三联抗高血压治疗的基础上观察组加用螺内酯20～40mg/d,对照组给予安慰剂,两组治疗均包括一种利尿剂,治疗第1周及1、3、6个月复查血钾、血肌酐、血压等。结果:螺内酯治疗1个月时显示出轻度的降压作用,以收缩压下降更为显著,随着疗程的延长,降压效果增强,治疗1、2、3个月两组收缩压(SBP)、舒张压(DBP)的变化值差异均有统计学意义(P均<0.05)。安全性方面,观察组血钾水平较对照组明显升高,治疗1、2、3个月两组血钾水平变化值差异均有统计学意义(P均<0.05)。治疗1、2、3个月观察组血肌酐水平有轻度上升,和对照组相比差异有统计学意义(P均<0.05),但均未超过正常上限。结论:螺内酯治疗顽固性高血压在严密监测下是有效的、安全的。

Effects of spironolactone on resistant hypertension: A randomized, single-blind and placebocontrolled clinical trial

Objective: To evaluate the efficacy and safety of spironolactone on resistant hypertension(RH).Methods: Patients with RH were enrolled and randomly divided into observation group(58 cases) and control group(66 cases) groups.Patients in observation group were treated with spironolactone,20-40 mg/d based on regular triple anti-hypertensive regimen,while those in the control group were given regular triple anti-hypertensive regimen plus placebo.All patients were treated with diuretics.Blood pressure,serum potassium and serum creatinine were checked the first week of treatment,1,3 and 6 months of treatment.Results: After 1 month of treatment,spironolactone showed slight depressurization,which gradually became obvious later.Changes in SBP and DBP were significant,after 1,2 and 3 months of treatment(P all <0.05).Serum K+ level of the observation group was significantly increased,significant difference in serum K+ level was observed between the two groups after 1,2,3 months of treatment(P all <0.05).But the creatinine level of the observation group slightly increased showing significant difference comparing with the control group although they were both in the normal rang(P all <0.05).Conclusions: Spironolactone is effective and safe for patients with resistant hypertension under regular follow-up and close monitoring.