口服β-胡萝卜素治疗非糜烂型口腔扁平苔藓的随机对照试验研究

Oral beta-carotene in the treatment of non-erosive oral lichen planus:a randomized controlled trial

目的设计并实施一项随机对照临床试验,以明确口服β-胡萝卜素治疗非糜烂型口腔扁平苔藓(OLP)的疗效及安全性。方法将74例临床表现为广泛白色病损的非糜烂型OLP患者随机分为2组。试验组(38例)口服β-胡萝卜素软胶囊,每次6 mg,每天1次;对照组(36例)口服维生素E软胶囊,每次100 mg,每天1次。2组的疗程均为6个月。于治疗前、用药3个月、用药6个月分别记录白色病损面积、角化程度、疼痛指数及不良反应。白色病损基本消退者进入复发观察阶段。结果用药3个月和6个月后,β-胡萝卜素组在改善白纹面积(3个月和6个月均P<0.001)及角化程度(3个月时P=0.018,6个月时P=0.001)方面均优于维生素E组,但在改善疼痛方面差异无统计学意义(P>0.05)。2组均未发生严重不良反应。2组复发率的差异无统计学意义(P>0.05)。结论β-胡萝卜素可以作为一种安全有效的替代药物治疗非糜烂型OLP。

Objective This study aims to illustrate the efficacy and safety of oral beta-carotene in the treatment of nonerosive oral lichen planus(OLP)by designing and conducting a randomized controlled clinical trial.Methods A total of74 patients with non-erosive OLP and widespread white lesions were randomized into the experimental group(n=38)who received oral beta-carotene soft capsules(6 mg p.o.q.d.)or the control group(n=36)who received oral vitamin E soft cap‐sules(100 mg p.o.q.d.)for 6 months continuously.Then,the white area,keratotic degree,pain level,and adverse effects were recorded at the first visit and after 3 and 6 months of treatment.If the white lesions disappeared,any recurrence du-ring the follow-up period was recorded.Results The final diminution in white lesion areas(both P<0.001)and keratotic degree scores(P=0.018,P=0.001)were significantly greater with beta-carotene than with vita‐min E after 3 and 6 months of treatment,respectively.However,the intergroup differences in the reduction of pain level were not significant(P>0.05).No severe adverse reactions were found in both groups.Recurrence rates did not significantly differ between groups(P>0.05).Conclusion Oral beta-carotene is an effective and safe alternative for the treatment of non-erosive OLP.