| Background and purposeAtopic dermatitis(AD)is a common skin disease during infancy and65% of cases occurring during the first 18 months.Its clinical presentation in infants typically involves the face,scalp,trunk and extensor surfaces of the extremities,accompanied by severe itching,dry skin.and making a severe impact on the growth of body and quality of life for children.The early onset of AD indicated an increased odds ratio of developing asthma,allergic rhinitis and conjunctivitis.Although its exact pathogenesis still remains unclear,it is well established that AD depends on a combination of genetic and environmental factors.Therefore,the current principle of treatment is to control symptoms,improve the disease.Topical corticosteroids remain the most important treatment for AD.But,topical corticophobiais is a frequent concern for atopic dermatitis patients and/or their parents.According to the survey.67.5%~80.8% of people worriedabout using topical corticosteroids on their own or their child’s skin,and38.3% of the caregivers were reluctant to use TCS on their children’s skin.This fear could be the main cause of poor therapeutic adherence and consequently poor treatment response for many patients.Chushizhiyang ointment that is made up of 13 kinds of traditional Chinese medicine,with the function of antibacterial,anti-inflammatory,anti-pruritic.It has been recommended as a treatment of subacute eczema by the expert in 2014,and it has been widely used in the treatment of eczema,atopic dermatitis.To evaluate efficiency and safety of Chushizhiyang ointment in the therapy of mild to moderate atopic dermatitis in infancy,a randomized,parallel controlled trial was designed.MethodsThe study included 80 cases were randomly divided into the treatment group and control group.Respectively,visiting in the first week and the second week,syndromes changes were observed and clinical score sheets were filled out.If the patients recovered within 2 weeks of discontinuation,the efficacy evaluation for the cured cases.Emollient,topical and system use of antihistamines and corticosteroids are disabled during treatment.ResultsIn all 80 cases were brought into the research and 79 cases completed the study.The results were as follows,1.EASI: At the first visit,there was no significant difference between the test group and the control group,theirrespective values :3.45±1.746 V 3.154±1.596(P>0.05);Day 7,their respective EASI values :1.52 ± 1.402 V 1.023 ± 1.148(P > 0.05),Significantly improved compared with before(P < 0.05);Day 14,their respective EASI values :0.69±0.892 V 0.359±0.605(P>0.05).2.BSA: at the first visit,The BSA value of the test group and the control group were4.15±1.805 V 3.821±1.467(P>0.05);Day 7,there was no significant difference between the test group(1.975 ± 1.405)and the control group(1.359±1.246);Day 14,there was no significant difference between the test group(0.80 ± 1.159)and the control group(0.538 ± 0.845).but,significant improvements in BSA values were seen in both of the group compared with the first visit.3.After a week,the effective rate of the control group was significantly higher than the test group(74.4%,52.50%)(P<0.05),but there was no significant difference between the test group and control group(87.50% v 89.74%)(P>0.05).After 2 weeks,the lower limit of 95%CI:-13.95%,demonstrating that Chushizhiyang ointment group was non-inferior to Hydrocortisone Butyrate Ointment group in the efficiency rate.4.Both of the IDLQI and itch value were significantly improved after 2 weeks of treatment,and there was no significant difference between the test group and the control group(P > 0.05).5.In the entire course of treatment,there were 15 cases of side-effect,6 cases in test group,the main side-effect were peeling,recurrence and worsening,9 cases in the control group,including hypopigmentation,telangiectasia,pigmentation and recurrence.ConclusionCompared with Hydrocortisone Butyrate Ointment,Chushizhiyang Ointment with slow effect.The efficiency of Chushizhiyang Ointment in the trement of mild to moderate atopic dermatitis in infancy was non-inferior to Hydrocortisone Butyrate Ointment,which is effective and safe. |
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