PDE5 inhibitor sildenafil in the treatment of heart failure: A meta-analysis of randomized controlled trials
PDE5 inhibitor sildenafil in the treatment of heart failure: A meta-analysis of randomized controlled trials
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PDE5抑制剂西地那非治疗心力衰竭：随机对照试验的荟萃分析
DOI：
10.1016/j.ijcard.2014.01.102
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发表时间：
2014-04-01
影响因子：
3.5
通讯作者：
Du, Zhi-Min
中科院分区：
文献类型：
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作者：
Zhuang, Xiao-Dong;Long, Ming;Du, Zhi-Min
背景：临床试验已经评估了磷酸二酯酶（PDE） 5抑制剂西地那非作为治疗心力衰竭（HF）的潜在辅助药物的使用，结果好坏参半。因此，我们进行了一项荟萃分析，以评估西地那非在心力衰竭中的临床可行性。方法：在MEDLINE和EMBASE数据库中检索并鉴定相关研究。比较西地那非与安慰剂在心力衰竭患者中的随机临床试验（RCT），报告了至少一个感兴趣的结果。提取有关特征和临床结果的数据。结果：我们纳入了9项随机对照试验，纳入612例HF患者。西地那非组与安慰剂组的不良事件无显著差异（RR = 1.10, 95% CI = 0.74 ~ 1.65, P = 0.41），而西地那非治疗与HF射血分数降低（HFrEF）患者血流动力学参数峰值VO2 （MD = 3.25, 95% CI = 2.07 ~ 4.42, P < 0.00001）的显著改善相关，但与HF射血分数保持（HFpEF）患者无显著改善相关。此外，与安慰剂相比，西地那非治疗改善了HF患者在无氧阈下的VO2 (at) （MD = 3.47, 95% CI = 1.68 ~ 5.27, P = 0.0002）、VE/VCO2斜率（MD = -7.06, 95% CI = -8.93 ~ -5.19, P < 0.00001）和左室射血分数（MD = 5.43, 95% CI = 3.66 ~ 7.20, P < 0.00001），对血压和心率没有影响。对于生活质量（情绪功能、疲劳和呼吸困难），两组之间没有显著差异。结论：与安慰剂相比，西地那非改善了血流动力学参数，特别是HFrEF患者，但没有增加不良事件。西地那非治疗耐受性良好，对生活质量无影响。2014爱思唯尔爱尔兰有限公司版权所有。
Background: Clinical trials have evaluated the use of phosphodiesterase (PDE) 5 inhibitors sildenafil as a potential adjunct in the treatment of heart failure (HF) with mixed results. Thus, we undertook a meta-analysis to evaluate the clinical viability of sildenafil in HF.Methods: Relevant studies were searched and identified in the MEDLINE and EMBASE databases. Randomized clinical trials (RCT) comparing sildenafil to placebo, in heart failure patients, reporting at least one outcome of interest were included. Data were extracted regarding the characteristics and clinical outcomes.Results: We identified 9 RCTs enrolling 612 HF patients. There were no significant differences in adverse events between sildenafil group and placebo group (RR = 1.10, 95% CI = 0.74 to 1.65, P = 0.41), whereas sildenafil therapy was associated with a marked improvement in hemodynamic parameter peak VO2 (MD = 3.25, 95% CI = 2.07 to 4.42, P < 0.00001) in HF with reduced ejection fraction (HFrEF) patients but not in HF with preserved ejection fraction (HFpEF) patients. Also, sildenafil therapy improved VO2 at anaerobic threshold (AT) (MD = 3.47, 95% CI = 1.68 to 5.27, P = 0.0002), VE/VCO2 slope (MD = -7.06, 95% CI = -8.93 to -5.19, P < 0.00001) and LV ejection fraction (MD = 5.43, 95% CI = 3.66 to 7.20, P < 0.00001) compared to placebo in HF patients, which had no impact on blood pressure and heart rate. For quality of life (emotional function, fatigue and breathlessness), there was no significant difference between the two groups.Conclusions: Sildenafil improved hemodynamic parameters particularly in HFrEF patients when compared to placebo, with no increase in adverse events. Sildenafil treatment was well tolerated and had no impact on quality of life. (C) 2014 Elsevier Ireland Ltd. All rights reserved.