BACKGROUND: Nowadays, it has been widely accepted that the local cell-mediated immunologic disorders may play an important role in the pathogenesis of oral lichen planus (OLP). Therefore, we sieved out polysaccharide nucleic acid fraction of bacillus Calmette-Guerin (BCG-PSN) from various immunomodulators to evaluate the short-term therapeutic efficacy and clinical safety of intralesional BCG-PSN injection for erosive OLP. METHODS: A total of 56 OLP patients were randomly assigned to receive either intralesional injection of 0.5 ml BCG-PSN every other day (31 of 56) or 10 mg triamcinolone acetonide (TA, a positive-controlled group, 25 of 56) every week for 2 weeks. After the cessation of treatment, those cured from erosion were followed up for 3 months. Another two researchers measured erosive areas and recorded visual analog scale (VAS) scores both at the start and the end of the treatment. We also registered adverse reactions and the recurrence intervals. RESULTS: After 2-week treatment, 27 of 31 BCG-PSN-treated patients (87.1%) and 22 of 25 TA-treated patients (88.0%) healed. There were no statistical differences between the two groups in erosive areas (27.86 +/- 27.97 vs. 25.68 +/- 34.65, P = 0.801) and VAS scores (2.45 +/- 1.64 vs. 2.40 +/- 1.38, P = 0.946). Three of 31 BCG-PSN-treated patients (9.7%) vs. 2 of 25 TA-treated patients (8.0%) experienced the swelling or burning sensation (P = 0.827). A total of 49 of 56 patients were followed up. There were no statistical differences in the recurrence rates (33.3% vs. 45.5%, P = 0.386) and intervals (80.89 +/- 26.83 vs. 73.48 +/- 28.11, P = 0.419). CONCLUSIONS:Topical intralesional BCG-PSN injection is as effective as TA for erosive OLP, which suggests that topical intralesional BCG-PSN injection can be a promising therapeutic alternative for erosive OLP, especially for those insensitive, or even resistant, to glucocorticoids.
RCT Entities:
BACKGROUND: Nowadays, it has been widely accepted that the local cell-mediated immunologic disorders may play an important role in the pathogenesis of oral lichen planus (OLP). Therefore, we sieved out polysaccharide nucleic acid fraction of bacillus Calmette-Guerin (BCG-PSN) from various immunomodulators to evaluate the short-term therapeutic efficacy and clinical safety of intralesional BCG-PSN injection for erosive OLP. METHODS: A total of 56 OLP patients were randomly assigned to receive either intralesional injection of 0.5 ml BCG-PSN every other day (31 of 56) or 10 mg triamcinolone acetonide (TA, a positive-controlled group, 25 of 56) every week for 2 weeks. After the cessation of treatment, those cured from erosion were followed up for 3 months. Another two researchers measured erosive areas and recorded visual analog scale (VAS) scores both at the start and the end of the treatment. We also registered adverse reactions and the recurrence intervals. RESULTS: After 2-week treatment, 27 of 31 BCG-PSN-treated patients (87.1%) and 22 of 25 TA-treated patients (88.0%) healed. There were no statistical differences between the two groups in erosive areas (27.86 +/- 27.97 vs. 25.68 +/- 34.65, P = 0.801) and VAS scores (2.45 +/- 1.64 vs. 2.40 +/- 1.38, P = 0.946). Three of 31 BCG-PSN-treated patients (9.7%) vs. 2 of 25 TA-treated patients (8.0%) experienced the swelling or burning sensation (P = 0.827). A total of 49 of 56 patients were followed up. There were no statistical differences in the recurrence rates (33.3% vs. 45.5%, P = 0.386) and intervals (80.89 +/- 26.83 vs. 73.48 +/- 28.11, P = 0.419). CONCLUSIONS: Topical intralesional BCG-PSN injection is as effective as TA for erosive OLP, which suggests that topical intralesional BCG-PSN injection can be a promising therapeutic alternative for erosive OLP, especially for those insensitive, or even resistant, to glucocorticoids.