目的:评价托伐普坦对充血性心力衰竭的治疗效果及安全性.方法:通过检索Pubmed、中国生物医学文献等数据库,手工检索已纳入的相关文献,对符合随机对照条件的研究经质量评估、数据提取,进行meta分析.结果:纳入10项随机、双盲、安慰剂对照研究.共计5 086例病例,4 958例完成研究设计随访.Meta分析结果显示, 治疗组体质量(单位:0.1 kg)减轻[加权均数差(WMD)=-8.29, 95%CI:-9.38~-7.20, P<0.001],尿量(单位:100 mL)增加(WMD=14.58, 95%CI:8.22~20.95,P<0.001),血钠(单位:mmol/L)增加(WMD=2.83, 95%CI:1.66~4.01, P<0.01);与安慰剂比较,长期治疗的主要不良反应为口渴、口干和尿频;亚组分析显示,短期(1周)治疗,不良事件发生率无明显增加(WMD=1.35, 95%CI:0.61~2.97, P=0.46).托伐普坦对死亡率和再住院率无明显影响.结论:充血性心力衰竭患者选择性使用托伐普坦(30 mg/d)可以减轻体液潴留、纠正低钠血症,长期用药可能出现口渴、口干和尿频.%Objective:To assess the efficacy and safety of tolvaptan in patients with congestive heart failure.Methods:We performed a systemic search and identification in the Pubmed, CBM databases and et al to collect randomized controlled trials (RCT) study.The reference literature were retrieved manually.After quality assessment and data extraction, all the studies were given meta-analysis.Results:We enrolled 10 RCT studies with a total of 5 086 patients, of whom 4 958 were followed over.The results showed that the body weight (unit: 0.1 kg) decreased (WMD=-8.29, 95%CI=-9.38~-7.20, P<0.001) while the urine volume (unit: 100 mL) (WMD=14.58, 95%CI:8.22~20.95, P<0.001) and serum sodium (unit: mmol/L) (WMD=2.83, 95%CI:1.66~4.01, P<0.01) increased significantly in tolvaptan group compared with control group.The main adverse events of long-term treatment were thirst, dry mouth and frequent micturition compared with placebo.In subgroup, the adverse events were similar to the control during short-term (1 week) treatment (WMD=1.35, 95%CI=0.61~2.79, P=0.46).There was no difference in death and rehospitalization between two groups.Conclusions:Selective use of tolvaptan (30 mg/d) in patients with congestive heart failure can reduce fluid retention and correct hyponatremia.Long-term use may result in thirst, dry mouth and frequent micturition.
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