螺内酯在射血分数中等范围心力衰竭及射血分数保留心力衰竭中的疗效与安全性：一项随机临床试验的荟萃分析
Efficacy and safety of spironolactone in the heart failure with mid-range ejection fraction and heart failure with preserved ejection fraction: A meta-analysis of randomized clinical trials.
作者信息
Xiang Yajie, Shi Wenhai, Li Zhuolin, Yang Yunjing, Wang Stephen Yishu, Xiang Rui, Feng Panpan, Wen Li, Huang Wei
机构信息
Department of Cardiology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Geisel School of Medicine at Dartmouth, Hanover, NH.
出版信息
Medicine (Baltimore). 2019 Mar;98(13):e14967. doi: 10.1097/MD.0000000000014967.
BACKGROUND
Recent studies have shown the efficacy for using spironolactone to treat heart failure with reduced ejection fraction (HFrEF), but the efficacy of spironolactone for heart failure with mid-range ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF) is unclear. This meta-analysis investigated the efficacy and safety of spironolactone in patients with HFmrEF and HFpEF.
METHODS AND RESULTS
We searched several databases including PubMed and the Cochrane Collaboration, for randomized controlled trials (RCTs) that assessed spironolactone treatment in HFmrEF and HFpEF. Eleven RCTs including 4539 patients were included. Spironolactone reduced hospitalizations (odds ratio [OR], 0.84; 95% confidence interval [CI], 0.73-0.95; P = .006), improved New York Heart Association functional classifications (NYHA-FC) (OR, 0.35; 95% CI, 0.19-0.66; P = .001), decreased the levels of brain natriuretic peptide (BNP) (mean difference [MD], - 44.80 pg/mL; 95% CI, -73.44--16.17; P = .002), procollagen type I C-terminal propeptide (PICP) (MD, -27.04 ng/mL; 95% CI, -40.77--13.32, P < .001) in HFmrEF and HFpEF. Besides, it improved 6-minute walking distances (6-MWD) (standard weighted mean difference [SMD], 0.45 m; 95% CI, 0.27-0.64; P < .001), decreased amino-terminal peptide of procollagen type-III (PIIINP) (SMD, -0.37 μg/L; 95% CI, -0.59--0.15; P = .001) in HFpEF only. The risks of hyperkalemia (P<.001) and gynecomastia (P<.001) were increased.
CONCLUSION
Patients with HFmrEF and HFpEF could benefit from spironolactone treatment, with reduced hospitalizations, BNP levels, improved NYHA-FC, alleviated myocardial fibrosis by decreasing serum PICP in HFmrEF and HFpEF, decreased PIIINP levels and increased 6-MWD only in HFpEF. The risks of hyperkalemia and gynecomastia were significantly increased with the spironolactone treatment.
背景
近期研究已显示使用螺内酯治疗射血分数降低的心力衰竭（HFrEF）的疗效，但螺内酯用于射血分数中等范围的心力衰竭（HFmrEF）和射血分数保留的心力衰竭（HFpEF）的疗效尚不清楚。本荟萃分析探讨了螺内酯在HFmrEF和HFpEF患者中的疗效和安全性。
方法与结果
我们检索了包括PubMed和Cochrane协作网在内的多个数据库，以查找评估螺内酯治疗HFmrEF和HFpEF的随机对照试验（RCT）。纳入了11项RCT，共4539例患者。螺内酯降低了住院率（比值比[OR]，0.84；95%置信区间[CI]，0.73 - 0.95；P = 0.006），改善了纽约心脏协会功能分级（NYHA - FC）（OR，0.35；95% CI，0.19 - 0.66；P = 0.001），降低了HFmrEF和HFpEF患者的脑钠肽（BNP）水平（平均差值[MD]， - 44.80 pg/mL；95% CI， - 73.44 - - 16.17；P = 0.002）、I型前胶原C端前肽（PICP）水平（MD， - 27.04 ng/mL；95% CI， - 40.77 - - 13.32，P < 0.001）。此外，它改善了6分钟步行距离（6 - MWD）（标准加权平均差值[SMD]，0.45 m；95% CI，0.27 - 0.64；P < 0.001），仅在HFpEF中降低了III型前胶原氨基端肽（PIIINP）水平（SMD， - 0.37 μg/L；95% CI， - 0.59 - - 0.15；P = 0.001）。高钾血症（P < 0.001）和男性乳房发育症（P < 0.001）的风险增加。
结论
HFmrEF和HFpEF患者可从螺内酯治疗中获益，住院率、BNP水平降低，NYHA - FC改善，HFmrEF和HFpEF中通过降低血清PICP减轻心肌纤维化，仅在HFpEF中PIIINP水平降低且6 - MWD增加。螺内酯治疗显著增加了高钾血症和男性乳房发育症的风险。
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