螺内酯治疗老年慢性肺源性心脏病有效性和安全性的研究

Study on safety and efficacy of spironolactone in elderly patients with chronic cor pulmonale

目的螺内酯治疗老年慢性肺源性心脏病有效性和安全性。方法58例慢性肺源性心脏病患者,随机分为螺内酯组和对照组观察12周。两组都给予常规处理。螺内酯组给予螺内酯20mg,每天2次口服。临床效果在试验开始和试验第12周通过纽约心功能分级、足部水肿、肺部听诊、明尼苏达心衰生活问卷表记分、呼吸困难疲劳指数记分、肺动脉压等进行评估;安全性通过男性乳房发育、阳萎、性功能、高钾血症≥6.0mmol/L、血清钾、胃肠道反应表现进行评估。结果与对照组相比,实验12周后螺内酯组可以明显改善纽约心功能分级、足部水肿、肺部听诊,明尼苏达心衰生活问卷表记分、呼吸困难疲劳指数记分、肺动脉压。与对照组相比,螺内酯组的男性乳房发育、阳萎、性功能低下、胃肠道反应、血清钾、暂时性血浆肌酐有显著差异,但是无临床意义。结论小剂量的螺内酯治疗老年慢性肺心病临床有效而且安全。

Objective To investigate the effecacy and safety of spironolactone in elderly patients with chronic cor pulmonale. Methods Fifty eight patients with chronic cor pulmonale were randomly divided into spironolactone group and control group. Spironolactone was administered to patients 20 mg b. i. d in spironolactone group. Clinical effects were assessed by observing NYH, ankle edema, pulmonary auscultation, Minnesota Living With Heart Failure Questionnaire score, dyspnea-fatigue index score and pulmonary artery pressure at the beginning of the study and at week 12. Safety were assessed by detecting gynecomastia, impotance, sexual function, hyperkalemia ≥6.0 mmol/L,serum potassium and gastrointestinal tract adverse effects. Results Compared with control group, spironolactone remarkably improved NYHA,ankle edema,pulmonary auscultation,Minnesota Living With Heart Failure Questionnaire score, dyspnea-fatigue index score and pulmonary artery pressure at week 12. The status of gynecomastia, impotanee, sexual function, hyperkalemia ≥6.0 mmol/L, serum potassium and gastrointestinal tract adverse effects in spironolaetone group had obvious difference compared with control group,but had no clinical significance. Conclusion Low dose of spironolaetone have a clinical effect in treating elderly patients with chronic cor pulmonale,and it is safe.