Bacille calmette-guerin polysaccharide nucleic acid and mizolastine for the treatment of patients with chronic idiopathic urticaria:clinical efficacy and effect on skin prick test reactions

Abstract

Objective To estimate the effect of bacille calmette-guerin polysaccharide nucleic acid(BCG-PSN)on skin prick test(SPT)reactions,and to assess the clinical efficacy and therapeutic mechanism of BCG-PSN combined with mizolastine,in patients with chronic idiopathic urticaria.Methods A non-randomized,openlabel clinical trial was carried out.Totally,168 patients with chronic idiopathic urticaria were divided into 2 groups to be treated with mizolastine 10 mg once a day combined with BCG-PSN injection at a dose of 2 ml every other day(experiment group,n =85)or mizolastine 10 mg once a day only(control group,n =83).All the patients underwent SPT,and were evaluated by symptom score at the baseline and after 12 weeks of treatment.Statistical analysis was performed by using the SPSS 10.0 software,t test and Chi-square test were used to analyze the intra-and inter-group differences in symptom score reducing index(SSRI)and SPT results.Results After 12-week treatment,SSRI was significandy higher in the experiment group than in the control group(0.92 ± 0.33 vs.0.74 ± 0.35,t =2.39,P ＜ 0.05).In the experiment group,50 patients were cured,28 patients received a marked response,with a total response rate of 92.0％;meanwhile,32 patients were cured and 30 patients received a marked response in the control group with a total response rate of 74.6％;there was a significant difference in the total response rate between the experiment group and control group(x2 =5.62,P ＜ 0.05).The percentage of positive SPT to Dermatophagoides pteronyssinus and Dermatophagoides farinae was 24.7％ and 17.6％ respectively at the baseline,9.4％ and 5.9％ respectively after treatment,in the experiment group,24.1％ and 16.9％ respectively at the baseline,24.1％ and 15.7％ respectively after treatment,in the control group.Significant differences were observed in the percentage of positive SPT between the control group and experiment group after treatment(x2 =5.82,P ＜0.05),but not at the baseline.A statistical decrease in the percentage of positive SPT was induced by the combined therapy with BCG-PSN and mizolastine(x2 =4.56,P＜ 0.05),but not by mizolastine alone.Conclusions BCG-PSN combined with mizolastine appears superior to mizolastine alone in the treatment of chronic idiopathic urticaria,with a decrease in the percentage of positive SPT reactions and in the sensitivity to allergens. Key words: Urticaria; Skin tests; Mizolastine; BCG-PSN