Abstract: Wang Zhenhua, Yang Fanghong, Sun Yi, Wang Hui, Xue Feng. Department of Dermatology, Weifang People′s Hospital, Weifang 261041, Shandong, China Corresponding author: Wang Zhenhua, Email: wfzcwzh@126.com 【Abstract】 Objective To evaluate the effect of polysaccharide nucleic acid fraction of bacillus Calmette-Guerin （BCG-PSN） on peripheral blood CD4+CD25+Foxp3+ regulatory T （Treg） cells in patients with condyloma acuminatum （CA）. Methods Forty-two patients with first onset of CA were randomly assigned to receive either injection of BCG-PSN （0.35 mg every other day for 3 months） after fulguration （combination group, 26 patients）, or fulguration only （fulguration group, 16 patients）. Venous blood samples were obtained from all the patients at the initial visit and three months after the beginning of treatment, as well as from 30 healthy checkup examinees. The percentage of peripheral Treg cells in CD4+ T lymphocytes was determined by flow cytometry. The recurrence of CA was evaluated during the three months after the beginning of treatment. Results The percentage of peripheral Treg cells in CD4+ T lymphocytes was significantly higher in patients with CA than in the controls （8.31% ± 1.24% vs. 5.15% ± 0.72%, P < 0.01）, and in patients with clinical recurrence of CA than in those without （9.34% ± 0.72% vs. 7.45% ± 0.85%, P < 0.01）. The recurrence rate was significantly lower in the combination group than in the fulguration group（30.77% vs. 68.75%, P < 0.05）. After three months of treatment, the combination group showed lower percentage of Treg cells in CD4+ T cells compared with the fulguration group （5.87% ± 1.05% vs. 6.60% ± 0.75%, P < 0.05）. Conclusions The percentage of Treg cells has a close relationship with the progression of CA, i.e., the higher the percentage, the more frequent the relapse. BCG-PSN may enhance the antiviral immune response in patients with CA and improve their prognosis by reducing the number of Treg cells.

Key words: Condylomata acuminata, BCG-PSN, CD4-positive T-lymphocytes, FoxP3