Wu Yun, Zhou Gang, Zeng Hong, Xiong Chun-rong, Lin Mei, Zhou Hong-mei
State Key Laboratory of Oral Disease, West China College of Stomatology, Sichuan University, Chengdu, Sichuan and Wuhan, Hubei, China.
Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Aug;110(2):188-95. doi: 10.1016/j.tripleo.2010.03.034.
The objective of this study was to evaluate the short-term efficacy and safety of topical thalidomide for erosive oral lichen planes (OLP) in a prospective randomized, positive-control, double-blind clinical trial.
Sixty-nine patients with erosive OLP received thalidomide 1% paste (n = 37) or dexamethasone 0.043% paste (n = 32) for 1 week. Patients without erosions after initial 1-week treatment were followed for recurrence, whereas those with ongoing erosions received an additional 3-week treatment. Outcome measures included size of erosive area, visual analog scale (VAS) scores, 3-month recurrence rates, and adverse effects at 1 year.
After 1-week application, both groups showed significant reductions in erosive areas and VAS scores (P < .001). Complete healing occurred in 18 (54.5%) of 33 thalidomide-treated and 17 (56.7%) of 30 dexamethasone-treated patients. Erosive area size (P = .420) and VAS scores (P = .498) were similar between groups. After 1 month of treatment, 24 patients receiving thalidomide (66.7%) and 22 receiving dexamethasone (73.3%) fully healed. There was no difference between groups in recurrence at the 3-month follow-up. Only 2 patients in each group experienced discomfort with treatment, and no adverse reactions were observed over 1 year of follow-up.
Topical thalidomide appears as effective as dexamethasone for erosive OLP.
本研究的目的是在一项前瞻性随机、阳性对照、双盲临床试验中评估局部使用沙利度胺治疗糜烂性口腔扁平苔藓（OLP）的短期疗效和安全性。
69例糜烂性OLP患者接受1%沙利度胺糊剂（n = 37）或0.043%地塞米松糊剂（n = 32）治疗1周。初始1周治疗后无糜烂的患者随访复发情况，而仍有糜烂的患者接受额外3周的治疗。观察指标包括糜烂面积大小、视觉模拟量表（VAS）评分、3个月复发率以及1年时的不良反应。
应用1周后，两组的糜烂面积和VAS评分均显著降低（P <.001）。33例接受沙利度胺治疗的患者中有18例（54.5%）完全愈合，30例接受地塞米松治疗的患者中有17例（56.7%）完全愈合。两组之间的糜烂面积大小（P =.420）和VAS评分（P =.498）相似。治疗1个月后，24例接受沙利度胺治疗的患者（66.7%）和22例接受地塞米松治疗的患者（73.3%）完全愈合。3个月随访时两组的复发情况无差异。每组仅2例患者在治疗过程中出现不适，随访1年未观察到不良反应。
局部使用沙利度胺治疗糜烂性OLP似乎与地塞米松一样有效。
