A randomized double-blind, positive-control trial of topical thalidomide in erosive oral lichen planus
A randomized double-blind, positive-control trial of topical thalidomide in erosive oral lichen planus
复制标题
一项外用沙利度胺治疗糜烂性口腔扁平苔藓的随机双盲阳性对照试验。
DOI：
10.1016/j.tripleo.2010.03.034
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发表时间：
2010-08-01
期刊：
影响因子：
--
通讯作者：
Zhou, Hong-mei
中科院分区：
文献类型：
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作者：
Wu, Yun;Zhou, Gang;Zhou, Hong-mei
Objective.本研究的目的是评估短期疗效和安全性的局部沙利度胺糜烂性口腔扁平苔藓（OLP）的前瞻性随机，阳性对照，双盲临床试验。69例糜烂型OLP患者分别用1%沙利度胺糊剂（n = 37）和0.043%地塞米松糊剂（n = 32）治疗1周。最初1周治疗后无糜烂的患者随访复发情况，而持续糜烂的患者接受额外3周治疗。结果测量包括糜烂面积的大小、视觉模拟量表（VAS）评分、3个月复发率和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 <0.001）。沙利度胺组33例中18例（54.5%）完全愈合，地塞米松组30例中17例（56.7%）完全愈合。两组的勃起面积大小（P = 0.420）和VAS评分（P = 0.498）相似。治疗1个月后，沙利度胺组24例（66.7%）和地塞米松组22例（73.3%）完全愈合。在3个月随访时，两组之间的复发率没有差异。两组均仅2例患者出现治疗不适，随访1年以上未见不良反应。对于糜烂型OLP，局部应用沙利度胺似乎与地塞米松一样有效。(Oral《口腔外科医学》《口腔病理学》《口腔放射学》，2010年; 110：188-195）
Objective. 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.Study design. 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.Results. 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.Conclusion. Topical thalidomide appears as effective as dexamethasone for erosive OLP. (Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2010; 110: 188-195)