| Objectives1. To assess the effectiveness and safty of the traditional chinese formula of QINGXINPEITU for atopic dermatitis with Scoring of atopic dermatitis index (SCORAD),life quality index (LQI)(dermatology life quality index (DLQI) and The Children dermatology of quality life index (CDLQI) for groups of different scope of ages),Main Symptom scale of Atopic Dermatitis ((MSSAD)) the Symptom scale of traditional Chinese medicine, the Investior's Global Assessment (IGA),the Patient's Global Assessment (PGA)2. TO explorate the establish of the multi-dimension evaluation about the treatment with traditional Chinese medicine for atopic dermatitis initially by investgating and screenning various efficacy endpoints on deferent observation points.MethodsThis trial is a multicenter, randomized, prospective study.249moderate-to-Severe AD patients between the age of5to25years will be enrolled and undergo two different treatments:oral administration group of special chinese formula QINGXINPEITU (group A) and a conventional standard therapy(group B). The duration of the study include12weeks treatment and24weeks follow up. The SCORAD and The Dermatology Life Quality Index (LQI including DLQI and CDLQI),Main Symptom scale of Atopic Dermatitis (MSSAD), the Symptom scale of traditional Chinese medicine,the Investior's Global Assessment (IGA), the Patient's Global Assessment (PGA) Score will be assessed as an clinical activity index. All adverse events occurring on the study were recorded. Physical and laboratory assessments were performed at the screening visit, and the end of the trentment(week12). Results110Patients with AD in this multicenter randomized controlled clinical trial were assigned to oral administration group of QINGXINPEITU (group A) and a conventional standard therapy(group B)1. As time extended, All index of the two groups had a tendency of descend with significant difference (P<0.01). However no significant difference could be found after the12weeks treatment(P>0.05), the significant difference were shown in the period of follow-up (P<0.05). There was a rebound during the follow-up (P<0.05) in group B.2. No adverse events happened A except few cases of slight diarrhea and vomit in Group. Some cases were found somnolence and folliculitis in Group B. There is no derangement in haematological or biochemical parameters (renal and liver functions) after treatment.3.The responsibility analysis:After intervention by the treatment, the index of SCORAD and LQI were shown good responsibility at all observation points (P<0.05). The difference happened in the the index of MSSAD^the Symptom scale of traditional Chinese medicine-. IGA and PGA between the two groups. The index of the Symptom scale of traditional Chinese medicine was shown good responsibility at the weeks8and12(P<0.05).4. The correlation analysis:SCORAD had no significant correlation with PGA (r<0.3), but the positive correlation with other index(0<r≤+1, P<0.05), and the higest correlation coefficient was shown with IGA(0.5<r<0.8). The Symptom scale of traditional Chinese medicine had the positive correlation with SCORAD, LQI and MSSAD(0<r≤+1, P<0.05), but the degree of correlation was lower (r<0.5). MSSAD had the positive correlation with SCORAD and the Symptom scale of traditional Chinese medicine (0<r≤+1, P<0.05), and no significant correlation with LQI(r<0.3).Conclusions1. The formula of QINGXINPEITU has confirmative therapeutic effect and safty on AD patients. This therapeutic could degree the index of skin serious, improve quality of life and patient's global assessment. The effection was tantamount with conventional standard therapy in the short-term and had the trend of preventing relapse for AD.2. SCORAD and LQI had shown the characteristic of stabilization and reliability in this study. 3. The Symptom scale of traditional Chinese and MSSAD can show the chang of effect in a certain extent treated with TCM, but would been imptoved and perfected. |
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