State Key Laboratory of Oral Diseases, Sichuan University, Chengdu, Sichuan 610041, China.
J Oral Pathol Med. 2009 Aug;38(7):551-8. doi: 10.1111/j.1600-0714.2009.00796.x. Epub 2009 May 26.
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.
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.
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).
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.
目前，局部细胞介导的免疫紊乱可能在口腔扁平苔藓（OLP）的发病机制中起重要作用，这一观点已被广泛接受。因此，我们从各种免疫调节剂中筛选出卡介苗多糖核酸（BCG-PSN）的多糖核酸部分，以评估局部注射卡介苗多糖核酸（BCG-PSN）治疗糜烂性 OLP 的短期疗效和临床安全性。
将 56 例 OLP 患者随机分为两组，每组 28 例。实验组局部注射 0.5ml BCG-PSN，每两天一次；对照组局部注射 10mg 曲安奈德（TA），每周一次，共两周。治疗结束后，对已治愈的患者进行 3 个月的随访。另外两名研究人员在治疗开始和结束时分别测量糜烂面积并记录视觉模拟评分（VAS）。同时记录不良反应和复发间隔。
治疗 2 周后，实验组 27 例（87.1%）和对照组 22 例（88.0%）患者均痊愈。两组糜烂面积（27.86+/-27.97 比 25.68+/-34.65，P=0.801）和 VAS 评分（2.45+/-1.64 比 2.40+/-1.38，P=0.946）差异均无统计学意义。实验组 3 例（9.7%）和对照组 2 例（8.0%）患者出现肿胀或灼热感（P=0.827）。共有 49 例患者完成了随访。复发率（33.3%比 45.5%，P=0.386）和复发间隔（80.89+/-26.83 比 73.48+/-28.11，P=0.419）差异均无统计学意义。
局部注射卡介苗多糖核酸（BCG-PSN）治疗糜烂性 OLP 与曲安奈德（TA）同样有效，提示局部注射卡介苗多糖核酸（BCG-PSN）可能成为治疗糜烂性 OLP 的一种有前途的替代方法，尤其适用于对糖皮质激素不敏感甚至耐药的患者。
