托伐普坦治疗心力衰竭疗效和安全性的系统评价

Tolvaptan for heart failure：a systematic review

摘要:

目的：系统评价托伐普坦（tolvaptan，TOL）治疗心力衰竭（heart failure，HF）的疗效与安全性。方法：计算机检索PubMed、EMbase、Web of Science、The Cochrane Library、CBM、CNKI、VIP和WanFang Data，检索时限均从建库至2013年10月。由2名评价者按照纳入与排除标准以及Cochrane 协作网推荐的方法独立筛选文献、提取资料并评价纳入研究的方法学质量后，采用RevMan 5.2.3软件进行Meta 分析。结果：共纳入8个研究，4 908例患者。Meta分析结果显示：① 疗效：托伐普坦组治疗前后血清钠浓度差值大于安慰剂组（MD=2.99，95%CI=1.74～4.24，P＝0.000）；体质量差值大于安慰剂组（MD=-0.81，95%CI=-0.92～-0.70，P=0.000）。② 安全性：安慰剂组不良反应发生率明显低于托伐普坦组（OR=0.27，95%CI=0.20～0.38，P=0.000）。结论：托伐普坦治疗心力衰竭时能有效治疗及预防低钠血症，并且能够减轻体质量，虽然不良反应较多，但严重不良反应较少，患者耐受性好。

Abstract:

Objective：To systematically review the efficacy and safety of tolvaptan for the patients with heart failure. Methods：Databases of PubMed，Embase，Web of Science，The Cochrane Library，CBM，CNKI，VIP and WanFang Data were electronically searched for rel－evant studies from inception to October 2013. Two reviewers independently screened literature，extracted data，and assessed the meth-odological quality of the included studies according to the inclusion and exclusion criteria as well as the methods recommended by the Cochrane Collaboration. Then，Meta-analysis was performed using RevMan 5.2.3 software. Results：Eight trials involving 4 908 patients were included. The results of Meta-analysis showed that tolvaptan was more effective than placebo in increasing the serum sodium concentration（MD=3.63，95%CI=3.32 to 3.94，P=0.000），and in decreasing body weight（MD=-0.81，95%CI=-0.92 to -0.70，P=0.000）. In addition，the incidence of adverse events was significantly lower in the placebo group（OR=0.27，95%CI=0.20 to 0.38，P=0.000）. Conclusion：Tolvaptan is effective for patients with heart failure and hyponatremia and patients can tolerate the adverse events well.