| Objective: This article compares the efficacy of aminopolysaccharide quaternary ammonium salts with tacrolimus ointment in the treatment of erosive lichen planus then to provide theoretical basis for the clinical application of aminopolysaccharide quaternary ammonium salts in treating lichen planus.Methods: According to the inclusion criteria,78 patients with erosive oral lichen planus(Oral Lichen Planus,OLP)who were treated in the Department of Oral Medicine of the Second Hospital of Hebei Medical University from January 2019 to December 2019 were collected.At the same time,78 healthy volunteers were selected for hospital anxiety and depression Table(HADS)score comparison.Collect patient's basic information,design random tables using the SAS random system,and divide patients into three groups according to the random tables.The experimental group(group A)was treated with aminopolysaccharide quaternary ammonium salt topically;the control group(group B)was treated with tacrolimus;the saline group was used as placebo(group C).The trial was performed in a double-blind manner.The investigator performed a visual analog scale(VAS)pain score on the patient before and after treatment,and the area of the oral mucosal lesion was measured.The HADS score was determined for all patients with erosive OLP and healthy people.All subjects were enrolled and the data were unblinded after data compilation.The changes in pain degree and area of erosion surface before and after treatment in the three groups were analyzed,and the efficacy index(EI value)of the three groups was compared.Comparing HADS scores between erosive OLP patients and healthy people.SPSS21.0 statistical software was used for data analysis.Paired t test was used for pairwise comparison within the measurement data group,and rank sum test for non-normality;comparisons between groups were performed using analysis of variance,the rank sum test was used for non-normal and inconsistent variances;as well as the Kruskal-Wallis H test was used for the further pairwise comparison.The rank sum test was used for rank data.The test level was ?=0.05(two-sided),P<0.05 was having statistical significance.Results:1.Baseline characteristics: A total of 74 patients with erosive OLP completed the trial(including 25 patients in group A,24 patients in group B,and 25 patients in group C).A total of 4 patients were lost to follow-up..The 74 patients who completed the trial ranged in age from 24 to 72 years,with an average age of 52.4 years,including 59(79.7%)women and 15(20.3%)men.Of the 74 patients with erosive OLP,63(85.1%)had only buccal mucosa involvement,5(6.8%)had skin lesions in addition to oral mucosal involvement,4(5.4%)had lesions in the tongue,and 3(4.1%)cases with obvious lesions on buccal mucosa,tongue and lips at the same time,1(1.4%)had obvious erosion surface on the palate.There was no statistically significant difference in baseline characteristics between the three groups of patients(P>0.05).2.VAS pain score difference before and after treatment:(1)The VAS scores of patients in the three groups A,B,and C all decreased after treatment,and the difference was statistically significant(P<0.05).(2)The difference in VAS score before and after treatment in patients in groups A,B,and C was 2.24 ± 1.50,2.36 ± 1.43,and 0.27 ± 0.74,respectively.The degree of VAS reduction in patients in group A and group B was significantly higher than that in group C,and the difference was statistically significant(P<0.05).The difference between group A and B before and after treatment was not statistically significant(P>0.05).3.Area change of erosion surface:(1)The erosion surface of both groups A and B were reduced,the difference was statistically significant(P < 0.05);the area of erosion surface increased after treatment in group C,and there was no significant difference in group C(P>0.05);(2)The values were 0.21 ± 0.27,0.18 ± 0.18,and-0.02 ± 0.08 in group A,B,and C,respectively.The area of erosion surface reduction in patients in group A and B was larger than that in group C,and the difference was statistically significant(P <0.05).There was no significant difference in erosion surface changes between group A and group B(P> 0.05).4.Calculation of EI(efficacy index)value:(1)In group A moderate improvement in 2(8.0%)patients,mild improvement in 13(52.0%)patients,and no improvement in 10(40.0%)patients;(2)In group B,moderate improvement in 3(12.5%)patients,16(66.7 %)patients had mild improvement,and 5(20.8%)patients had no improvement;(3)In group C,only 2(8%)patients had mild improvement,and 23(92%)patients had no improvement.(4)The curative effect of the A and B groups was better than that of the C group,and there were statistical differences between the A,B and C groups(P<0.05).There was no significant difference between A and B groups(P>0.05).5.HADS score:(1)There was no significant difference in age and sex between the erosive OLP patients and healthy control group(P>0.05);(2)Anxiety score(A): Of the erosive OLP patients,24(30.8%)cases were asymptomatic,21(26.9%)cases were suspicious,and 33(42.3%)cases were confirmed;in the healthy control group,50(64.1%)cases were free of anxiety,11(14.1%)cases were suspected,and 17(21.8%)cases were confirmed.The number of suspicious and confirmed anxiety in erosive OLP patients was more than that in the healthy control group,and the difference was statistically significant(P<0.05);(3)Depression score(D): In erosive OLP group,9(11.5%)cases were asymptomatic,that is,no depression,18(23.1%)cases were suspicious,and 51(65.4%)cases were confirmed;in healthy control group,54(69.2%)cases without depression,12(15.4%)cases were suspicious,and 12(15.4%)cases were confirmed.There were more suspicious and positive depression in erosive OLP patients than that in healthy controls,and the difference was statistically significant(P<0.05).Conclusion:The topical application of aminopolysaccharide quaternary ammonium salt for the treatment of erosive lichen planus is definitely effective.Therefore,aminopolysaccharide quaternary ammonium salt can be used as a conventional medicine for treating erosive lichen planus.Patients with erosive oral lichen planus have a high incidence of anxiety and depression,and psychological counseling may be considered in clinical treatment. |
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