OBJECTIVE:To systematically review the efficacy and safety of mizolastine combined with H2 recepter antagonists in the treatment of chronic urticaria,and provide evidence-based reference for the clinical treatment. METHODS:Retrieved from PubMed,Cochrane Library,EMBase,CBM,CJFD,etc.,randomized controlled trials (RCT) or QRCT about mizolastine com-bined with H2 recepter antagonists(test group)versus mizolastine alone(control group)in the treatment of chronic urticaria. After quality evaluation and data extract,Meta-analysis was conducted by using Stata 12.0 statistics software. RESULTS:A total of 12 RCT were included,involving 1 188 patients. Results of Meta-analysis showed the effective rate [RR=1.23,95%CI(1.16,1.31), P<0.001] in test group was significantly higher than control group,subgroup analysis showed the the efficacies of different combi-nation of mizolastine and other drugs were significantly better than control group;there was no significant difference in the inci-dence of adverse reactions between 2 group[RR=1.01,95%CI(0.71,1.44),P>0.05]. CONCLUSIONS:The effective rate of mizo-lastine combined with H2 recepter antagonists is significantly higher than mizolastine in the treatment of chronic urticaria,with bet-ter safety. Due to the limit of methodological quality and sample size,it remains to be further verified with more rigorously de-signed and long-term follow-up of large-scale RCT.