黄连素凝胶治疗轻型复发性阿弗他溃疡的临床疗效研究

Study on clinical effect of berberine gel on the treatment of minor recurrent aphthous ulcer

目的本研究探讨自制黄连素凝胶对轻型阿弗他溃疡(minor recurrentaphthous ulcer,MiRAU)的治疗效果。方法 47例受试者,分为黄连素凝胶组24例和对照组23例。采用随机、双盲、对照的临床研究方法,每天用黄连素凝胶(5 mg/g)或者安慰剂涂布溃疡处4次,连续使用5 d。在第1、2、4、6天观察溃疡情况,包括溃疡的疼痛程度、溃疡面积大小、充血红晕带的颜色和渗出物多少,评价治疗效果。结果在第2、4、6天,治疗组溃疡疼痛评分分别下降15.8%、41.27%和80.58%,对照组分别下降5.56%、19.60%和51.25%,两组之间差异有统计学意义(P<0.05);治疗组溃疡面积分别减小28.36%、48.63%和72.72%,对照组分别减小11.41%、25.77%和50.92%,两组之间差异有统计学意义(P<0.05);在第4,6天,治疗组溃疡充血程度较对照组得以减轻(P<0.05),渗出水平明显减少(P<0.05)。没有发现明显的不良反应。结论黄连素凝胶可促进MiRAU的溃疡愈合、减轻疼痛,具有良好的临床疗效。

Objective This study aims to determine the effects of application of berberine gelatin on the treatment of minor RAU （MiRAU）. Methods A randomized, double-blind, placebo-controlled, clinical trial was performed. The gelatin containing berberine （ 5 mg/g） or placebo only was applied 4 times per day for 5 days. Clinical evaluation included pain level, size, erythema, and exudation of certain ulcers on 1st, 2nd, 4th and 6th days. Results A total of 47 subjects including 24 subjects in treatment group and 23 subjects in the control group fulfilled the study without obvious side effects. On 2rid, 4th and 6th days, the ulcer pain score of the treatment group decreased by 15.8%, 41.27% and 80.58%, respectively, while the control group decreased by 5.56%, 19.60% and 51.25%. Berberine gelatin treatment reduced the ulcer pain score compared with control group and there was significant difference between the two groups（P〈0.05）. The ulcer size of treatment group decreased by 28.36%, 48.63% and 72.72%,respectively, while the control group decreased by 11.41%, 25.77% and 50.92%. The ulcer size was significantly reduced in treatment group （P〈0.05）. On the 2nd day, there was no difference in congestion and exudation between two groups （P〉0.05）.On 4th and 6th days, the erythema and exudation of the treatment group significantly reduced （P〈0.05） compared with control group. No obvious adverse reaction was found. Conclusion Berberine gelatin can promote the healing of MiRAU and relieve the pain. It has good clinical effects and may be a safe and effective local administration for MiRAU.