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, open-label 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 significantly 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 （χ2 = 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 （χ2 = 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 （χ2 = 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: BCG-PSN