Efficacy and Safety of Tolvaptan in the Treatment of Liver Cirrhosis Ascites with Hyponatremia:a Meta-analysis / 中国药房

ABSTRACT

OBJECTIVE:To evaluate the efficacy and safety of tolvaptan in the treatment of liver cirrhosis ascites with hyponatremia systematically,in order to provide reference for clinical drug use. METHODS:Retrieved from The Cochrane Library, PubMed,CNKI and Wanfang database,etc.,randomized controlled trials(RCTs)about tolvaptan combined with routine treatment plan(trial group)versus routine treatment plan with or without placebo(control group)in the treatment of liver cirrhosis ascites with hyponatremia were collected. The qualities of included studies were evaluated according to modified Jadad scale after extracting data. Meta-analysis was performed by using Rev Man 5.3 statistical software. RESULTS:A total of 16 RCTs were included, involving 1 271 patients.The results of Meta-analysis showed that serum sodium concentration[MD=6.51,95%CI(4.64,8.39),P<0.001],24 h urine volume [MD=1.36,95%CI(1.01,1.70),P<0.001],response rate of ascites and edema [RD=0.27,95%CI (0.20,0.35),P<0.001],body weight improvement[MD=-1.11,95%CI(-1.31,-0.91),P<0.001]and abdomen circumference improvement [MD=-2.13,95%CI(-2.96,-1.31),P<0.001] of trial group were significantly superior to those of control group, with statistical significance.There was no statistical significance in the levels of blood potassium,blood pressure,heart rate,TBiL,Scr or BUN between 2 groups before and after treatment(P>0.05). The level of ALT in trial group was significantly lower than control group,with statistical significance(P=0.003). Subgroup analysis showed that there was no statistical significance in 24 h urine volume when traditional diuretics were given only in control group or not used in two groups(P>0.05);the serum sodium concentration and 24 h urine volume of other subgroups were significantly higher than those of control group,with statistical significance(P<0.001). The incidence of ADR in trial group was higher than control group as dry mouth,thirst,frequent urination,insomnia,with statistical significance(P<0.05). Total incidence of ADR in trial group was slightly higher than control group,without statistical significance (P>0.05). CONCLUSIONS:Tolvaptan has good therapeutic efficacy for liver cirrhosis ascites with hyponatremia,can effectively improves serum sodium concentration,24 h urine volume,ascites and edema,body weight and abdomen circumference,but rarely affects blood potassium,heart rate,blood pressure,liver and renal function.However,ADR as thirst should be paid attention.