螺内酯在75岁以上老年收缩性心力衰竭患者中应用的安全性研究

Safety of spironolactone in patients with systolic heart failure aged 75 and over

目的探讨螺内酯在门诊≥75岁老年收缩性心力衰竭患者中应用的安全性。方法选择2011年12月至2013年6月就诊于我院门诊的≥75岁老年收缩性心力衰竭患者205例,随机分为2组。对照组（101例）给予常规治疗,螺内酯组（104例）在常规治疗的基础上加用螺内酯治疗,螺内酯组起始给予螺内酯20 mg/d口服,用药4周后,如血钾〈4.0 mmol/L且肾功能稳定,可增加螺内酯用量至40 mg/d。如监测期间血钾在5.0-5.5mmol/L,则减螺内酯用量为20 mg隔日1次。所有患者入选前及治疗后1周、1月以及随后的每3月监测血钾和肾功能。结果螺内酯应用的平均剂量为（22.78±9.33）mg。螺内酯组23例（22.1%）患者因不能耐受螺内酯治疗而停用,其中12例（11.5%）患者因高钾血症（血钾≥5.5 mmol/L）而停用。7例（6.7%）患者因肾功能恶化（血肌酐增长〉50%）而停用。螺内酯组出现严重高钾血症（血钾≥6.0 mmol/L）者4例,但研究中无患者因高钾血症而死亡。2组中均无因肾功能不全而需要透析者。螺内酯组4例（3.8%）患者发生低钾血症,而对照组有13例（12.9%）,2组比较差异有统计学意义（P〈0.05）。结论门诊≥75岁老年收缩性心力衰竭患者在严格监测血钾和肾功能的情况下,应用螺内酯20 mg/d是安全的,且可显著减少低钾血症的发生。

Objective To investigate the safty of spironolactone in outpatients with systolic heart failure aged≥75years old. Methods A toal of 205 outpatients with systolic heart failure aged 75 and over were enrolled in this study from December 2011 to June 2013. The patients in the control group received routine treatment and the patients in spironolactone intervention group received spironolactone 20 mg / d initially. After 4 weeks of treatment,if serum level of K＋ 4. 0mmol / L and renal function was stable,the dosage of spironolactone could be increased to 40 mg / d,and if serum level of K＋was 5. 0-5. 5 mmol / L,the dosage of spironolactone should be decreased to 20 mg every other day. All the patients underwent the detection of serum level of K＋and renal function before treatment,7 d,1 month and every 3 months after treatment. Results Average dosage of spironolactone was 22. 78 ± 9. 33 mg. The rate of spironolactone withdrawal was22. 1%（ 23 /104） in spironolactone group,12（ 11. 5%） cases with hyperkalemia and 7（ 6. 7%） cases with renal function deterioration. Severe hyperkalemia（ K^＋≥6. 0 mmol/L） occurred in 4 patients in spironolactone group,but no patient died.There was no patients receiving dialysis because of renal function failure in two groups. The incidence of hypokalemia was3. 8% in spironolactone group,which was significantly lower than that in control group（ P〈0. 05）. Conclusions It is safe to administrate spironolactone 20 mg / d for outpatients with systolic heart failure aged 75 and over by monitoring the serum level of K＋and renal function.