| Objective:To assess the efficacy and safety of Um’bilical Medicine Pot Therapy in the treatment of chronic urticaria(CU)with wind-cold phenotype by means of detecting the serum levels of IgE and IL-6 before treatment and after treatment.Furthermore,to explore the possible mechanisms of therapeutic effect preliminarily.Methods:In this randomized controlled trial,all of the cases were treated in outpatient department of Dermatology the third Affiliated Hospital of Beijing University of Chinese Medicine during June 2017 to July 2018,meeting the inclusion criteria with chronic urticaria of wind-cold phenotype,by completing the ’The clinical observation table of Umbilical Medicine Pot Therapy in the treatment of chronic urticaria with wind-cold phenotype syndrome’,after the symptoms and other related informations of the patients were be collected,the eligible were included in the study.40 patients with chronic urticaria of wind-cold phenotype who met the inclusion criteria were randomly divided into two groups:the treatment group and the control group with 20 cases in each.The treatment group was treated with Umbilical Medicine Pot Therapy(lOmin/time every other day)combined oral Ioratadine Tablets(10mg/qn),and the control group was only treated with Ioratadine Tablets(10mg/qn)orally,both groups were treated for 4 weeks as a course of treatment,respectively.Urticaria Activity Score(UAS)and Traditional Chinese Medecine(TCM)syndrome score were evaluated before treatment,after 2 weeks treatment,4 weeks treatment and during follow-up(the 4th week after treatment).Serum LgE and IL-6 levels were detected before treatment and ending of the treatment,the indicators were compared and the efficacy was evaluated.Results:The clinical study included 40 patients with treatment group and control group with 20 cases in each group,the baseline data was no significant difference between the two groups of patients in gender,age,disease duration,the symptom scores before treatment and serum LgE and IL-6 levels(P>0.05),were comparable.To compare the effect of two groups,the total effective rate of treatment group was 95%,control group total effective rate was 75%(P=0.18>0.05).Although there was no obvious difference in the total effective rate between the two groups,the more treatment(recovery+effect)rate of 90%in the treatment group was significantly higher than 55%in the control group,with statistically significant difference(P=0.034<0.05),the treatment group had better clinical effect.Compared with the UAS of the two groups,the treatment group were lower than that of the control group at the ending of the treatment and follow-up,and the differences between the two groups were statistically significant(P<0.01).As for the scores of TCM syndrome in the two groups,the treatment group were lower than control group at the ending of the treatment and follow-up,and the differences between the two groups were statistically significant(P<0.01).Compared with the laboratory indicators of the two groups,there was no difference in IgE level(p=0.91>0.05)between the two groups at the ending of the treatment,and the difference in IL-6 level between the two groups was statistically significant(p=0.036<0.05).During the treatment,the two groups of patients had good compliance,no one detached from the clinical trial and no serious adverse events occurred.Conclusion:Umbilical Medicine Pot Therapy combined with Ioratadine Tablets in the treatment of chronic urticaria with wind-cold phenotype can effectively reduce the UAS and TCM symptom score in patients,improve the wheals,pruritus and quality of life in the short-term and forward Furthermore,the long-term effectiveness is more durable and stable.The treatment effectivenss could be related to the reduced IL-6 level,no significant relationship between the changed IgE level,the mechanism need more samples,longer treatment course and further explored.Umbilical Medicine Pot therapy combined with oral Ioratadine Tablets may be useful in the treatment of chronic urticaria with wind-cold phenotype,and is safe,reliable,easily accepted.Hence,Umbilical Medicine Pot Therapy is worthy of clinical promotion. |
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