| Background:Chronic urticaria is a common dermatosis which etiology is complex.For most patients it is difficult to find a clear cause.The second-generation H1-antihistamine is the first choice for the clinical treatment.However,clinical efficacy of the single-drug treatment is not very satisfactory.Although the symptoms can be temporarily alleviated,the rash is easily recurrence when the drug retreat.Chronic urticaria brought great pain to the patient's life and seriously affected the patients'life quality.It is important to find a safety and effective therapy in the treatment of chronic urticaria.BCG-PSN,as an immunomodulator,can regulate the body's humoral and cellular immunity,inhibit the production of IgE and reduce the release of histamine and other inflammatory mediators.Olopatadine hydrochloride is a novel antihistamine which is potent and highly selective second-generation H1-receptor antagonist,and it may treat chronic urticaria by inhibiting the release of histamine and some other inflammatory mediators.The two drugs have been proven to be effective in the treatment of chronic urticaria,but the combination of these two drugs is not widely used in the treatment of chronic urticaria.Only one report can be searched in CNKI in China,but the number of cases is relatively few.In this study,172 patients with chronic urticaria were treated by BCG-PSN combined with olopatadine hydrochloride.The clinical efficacy was evaluated,and the total serum IgE level and peripheral blood eosinophil count(EOS)were detected,and the patients'life quality was assessed before and after treatment.Objective:To evaluate the efficacy and security of BCG-PSN combined with olopatadine hydrochloride in the treatment of chronic urticaria,and study the effect of serum total IgE level,eosinophil count and the quality of life in patients.Methods:From January 2016 to September 2017,172 patients with chronic urticaria who visited the Department of Dermatology,the Second Affiliated Hospital of Dalian Medical University were enrolled.Patients'history was collected in detail.172patients were randomly divided into treatment group and control group,and there are 86cases respectively in each group.In the treatment group,olopatadine hydrochloride was taken orally twice a day,everytime 5mg for 8 weeks.BCG-PSN was injected 2ml every2 days for 8 weeks.In the control group,only olopatadine hydrochloride was taken orally,the usage and dosage were as same as the treatment group.The efficacy was evaluated respectively before treatment,at 2nd week,the 4th week,the 6th week,and the 8th week,and the adverse reactions were recorded.Serum total IgE level,eosinophil count were detected and dermatology life quality index score were evaluated before treatment and at the 8th week.4 weeks after the treatment,the recurrence rate was evaluated of the two groups.Statistical analysis was dealt with SPSS version 20.0statistical software.The effective rate and recurrence rate between the two groups were compared by Chi-square test.The serum total IgE level,eosinophil count and quality of life scores were measured by t-test,P<0.05 was considered statistically significant,P<0.01 as significant difference.Results:In this study of 172 patients,3 cases dropped out and 2 cases interrupted treatment in the treatment group.In the control group,5 cases dropped out and 1 cases interrupted treatment.The remaining 161 patients completed the treatment and follow-up.1.At the 2nd,4th,6th,8th week,the total effective rate of treatment group and control group were 50.62%,41.25%(?~2=1.42);64.20%,50.0%(?~2=3.91);72.84%,56.25%(?~2=4.84);86.42%,70.0%(?~2=6.38).There was no statistically significant of the total effective rate between the two groups at the 2nd week(?~2=1.42,P>0.05).There were significant differences of the total effective rate between the two groups at the 4th,6th,and 8th week(?~2=3.91,4.84,6.38,P<0.05),the total effective rate was significantly higher in the treatment group than the control group.2.9 patients among 70 patients who were cured or markedly cured in the treatment group relapsed at4 weeks after the end of treatment,so the recurrence rate was 12.86%.16 patients among 56 patients who were cured or markedly cured in the control group relapsed,so the recurrence rate was 28.57%.The recurrence rate of the control group was significantly higher than the treatment group(?~2=4.83,P<0.05),and the difference was statistically significant.3.In the treatment group,1 patient interrupted because of serious somnolence after olopatadine hydrochloride treatment.1 patient interrupted because of intramuscular injection of pain after BCG-PSN injection.There was mild somnolence in 9 patients.There was dry mouth in 5 patients.There was intramuscular injection site swelling in 2 patients.There was intramuscular injection site induration in1 patient.Applied hot comprss,the swelling and induration can gradually subside.In the control group,1 patient interrupted because of serious somnolence after olopatadine hydrochloride treatment.There was mild somnolence in 11 patients.There was dry mouth in 4 patients.No serious adverse reactions were found in both two groups.4.After 8 weeks,serum total IgE level,eosinophil count and life quality scores of both groups were lower than those before treatment,and the difference between the treatment group and the control group was considered statistically significant.Conclusion:BCG-PSN combined with olopatadine in the treatment of chronic urticaria shows definite curative effect,which can significantly improve the efficiency,reduce recurrence rate,decrease serum total IgE level and eosinophil count,and improve patient life quality.The adverse reactions were minor.Therefore,this therapy is effective and safe,and it can be applied in clinic. |
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