| l.Objective:To observe the efficacy, safety, cost-effectiveness analysis (CEA) and recurrence of Longmu decoction in the treatment of Atopic dermatitis(AD).2.Method:2.1The method of random parallel control was used in this clinical trial.2.2Patients selection:2.2.1Diagnostic CriteriaWestern Medicine Diagnostic Criteria:Hanifin and Rajka AD Diagnostic Criteria.Traditional Chinese Medicine Diagnostic Criteria:Syndrome of blood deficiency and wind-dryness in Si Wan Feng according to Guiding Principles of Cinical Researches on New Drugs of Traditional Chinese Medicine.2.2.2Inclusion Criteria(1)In accordence with Western Medicine Diagnostic Criteria (2) In accordence with Traditional Chinese Medicine Diagnostic Criteria (3)age from2to40.(4)The patients who were informed and signed consent to participate.(5) The patients whose routine blood examination, routine urine examination, ALT, Cr and BUN were nomal. Exclusion Criterion:(1)The patients who are allergic to the medicine.(2)Pregnancy or breast-feeding women.(3)The patients who used steroids and anti-allergy in the past2weeks.(4)Immunosuppressed patients (such as lymphoma) or in patients with a history of malignant disease.(5)The patients whose occupations are dangeroussuch as pilot and so on.2.3Treatment Methods2.3.1Treatment groupThe patients of treatment group take Longmu decoction orally twice a day for2months. At the same time, the affected area applied with Longmu decoction externally. Component of Longmu decoction:Os Draconis(Longgu)30g, Concha Ostreae(Muli)30g, Rhizoma Drynariae (Gusuibu)10g, Radix Rehmanniae Recens(Shengdihuang)10g, Fructus Koch/ae(Difuzi)10g.2.3.2Contol groupThe patients of control group take Loratadine tablets orally once at night and Hydrocortisone Butyrate cream twice a day for external use for2months.Visits are scheduled on preliminary diagnosis (before treatment),2,4,8,12,24weeks after treatment. 2.4Observation items2.4.1evaluation indexThe severity of skin was evaluated by the index of scoring atopic dermatitis (SCORAD) which was proposed by European Task Force on Atopic Dermatitis (ETFAD). The SCORAD index includes the change of symptoms and the physical signs, lesion area of skin, disease severity, pruritus degree,etc.2.4.2Measurement formulaThe treatment rate=(pre-treatment SCORAD score—post-treatment SCORAD score)/pre-treatment SCORAD score×100%2.4.3Evaluation of quality of lifeThe effects of atopic dermatitis on the quality of life of patients was evaluated by dermatology life quality index (DLQI)(age over12), the Children’s dermatology life quality index (CDLQI)(age from7to12), the infants’dermatology life quality index (IDLQI)(age from2to7)2.4.4. Cost-effectiveness analysisThe Cost-effectiveness analysis (CEA) of the experimental group and the control group was evaluated after2months treatment.2.4.5Analysis of recurrenceAfter3,6months follow-up, the recurrence were recorded by using the SCORAD index.2.4.6. Safety evaluationThe patients’routine blood examination, routine urine examination, ALT, Cr and BUN were measured before and after treatment. The adverse events during the treatment were recorded.2.5Statistical AnalysisStatistical analyses were performed by SAS9.2. Test oft andX2statistical methods were used to evaluate the difference between the two groups. COX regression and Wald test were used to evaluate the recurrence.The signicicance was determined as P<0.05.ResultThere were64cases included in this trial. All the cases came from the dermatologists of Xiyuan Hospital of China Academy of Chinese Medical Sciences. The number of patients of treatment group and control group was both32, but2cases of control group were lost after the first treatment. There was separately1case lost in both group after the2weeks of treatment and we used LOCF(Last Observation Carried Forward, LOCF)to evaluate the date. We made the ITT (intention to treat, ITT) Analysis after the experiment. There were13men and19women in the treatment group and16men and14women in the control group. There is no significant difference of sex between experimental group and control group.The treatment group aged2to33years old, average age10.50±5.97. The control group aged2to36years old, average age10.52±5.76. There is no significant difference of age between the two groups.There is no significant difference between treatment group and control group of the total scores of symptoms and signs before the test (P>0.05).There is no significant difference between two groups of DLQI/CDLQI/IDLQI scores (P>0.05).Both treatment group and control group experience significant improvement respectively in the total scores of symptoms and signs including scores of lesion area of skin, scores of disease severity, scores of pruritus degree and SCORAD score (P<0.05).There is no significant difference between treatment group and control group of the total scores of symptoms and signs(P>0.05).Both treatment group and control group experience significant improvement respectively in symptoms and feelings, daily activities, leisure and total DLQI scores, but there is no significant difference between two groups (P>0.05).The efficacy rates are81.25%and83.33%for treatment group and control group respectively,with non-significance difference between them (P>0.05).Among patients of treatment group there are1cases and7cases of recurrence at the third and sixth months follow-up respectively. Among patients of control group there are11cases and7cases of recurrence after3,6months follow-up respectively. The recurrence risk of control group is3.14times to the treatment group.There is no significant difference of safty between the two groups, and Longmu decoction cost lower.Conclusion:Longmu decoction in the treatment of Atopic dermatitis is effective and safe. At the same time, Longmu decoction can significantly lower relapse rate, prolonge time to relapse and cost lower. |
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