托伐普坦治疗低钠血症疗效及安全性的Meta分析

Efficacy and safety of tolvaptan for hyponatremia:a Meta-analysis

目的:系统评价托伐普坦治疗低钠血症患者的疗效与安全性。方法:计算机检索中国期刊全文数据库(CNKI)、万方数据知识服务平台、中文科技期刊数据库(VIP)、Pub Med、Web of Science、Springer等数据库,检索时间为2000至2015年6月,纳入关于托伐普坦治疗低钠血症患者疗效及安全性的随机对照试验(randomized controlled trials,RCTs),由2名评价者按照纳入与排除标准,独立筛选文献,提取资料并用Jadad量表评价纳入研究的方法学质量,采用R3.1.3软件进行Meta分析。结果:纳入14篇RCTs,包含低钠血症患者1 324例(托伐普坦组678例,对照组646例)。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对照组,WMD=3.33 mmol/L(90%CI=2.90~3.75,Z=12.95,P=0.000);血清钠浓度恢复正常率高于对照组,RR=2.61(90%CI=2.13~3.21,Z=7.70,P=0.000);24 h尿量多于对照组,WMD=812.82 ml(90%CI=534.90~1 090.75,Z=4.81,P=0.000);净液体平衡变化(尿量与液体摄入量差值)多于对照组,WMD=750.54 ml(90%CI=464.44~1 036.63,Z=4.32,P=0.000);2安全性:托伐普坦组与对照组的不良反应发生率和死亡率无统计学差异,RR分别为0.99(90%CI=0.86~1.13,Z=-0.184,P=0.854)和1.15(90%CI=0.78~1.69,Z=0.582,P=0.561)。结论:托伐普坦可显著提高血清钠浓度、血清钠恢复正常率,增加24 h尿量、净液体平衡变化,且不增加不良反应发生率及死亡率。

Objective:To systematically review the efficacy and safety of tolvaptan for the patients with hyponatremia. Methods:Databases of china national knowledge infrastructure(CNKI),wanfang,VIP,Pub Med,Web of Science,Springer were electronically searched for randomized controlled trials from 2000 to June 2015,which were about the efficacy and safety of tolvaptan for the hyponatremia patients. Two reviewers independently screened literature,extracted data according to the inclusion and exclusion criteria and assessed the methodological quality of the included studies by using Jadad scale. Then,Meta-analysis was performed using R3.1.3 software. Results:Fourteen trials involving 1 324 patients were included(tolvaptan group:678 patients;control group:646 patients).The results of Meta-analysis showed that tolvaptan group was more effective than control group in increasing the serum sodium concentration,WMD=3.33 mmol/L(90%CI=2.90-3.75,Z=12.95,P=0.000),in serum sodium normal rate(RR=2.61,90%CI=2.13-3.21,Z=7.70,P=0.000);in urine output in 24 hours WMD=812.82 ml(90%CI=534.90-1 090.75,Z=4.81,P=0.000);in net fluid balance changes,WMD=750.54 ml(90%CI=464.44-1 036.63,Z=7.733,P=0.000). There was no significant difference in the adverse events and mortality between tolvaptan and control group and RR were respectively 0.99(90%CI=0.86-1.13,Z=-0.184,P=0.854)and 1.15(90%CI=0.78-1.69,Z=0.582,P=0.561). Conclusion:Tolvaptan significantly increases serum sodium concentration,serum sodium normal rate,urine output in 24 hours and net fluid balance changes without increasing the adverse events and mortality.