| In the dissertation, the main content includes three relevant parts:the literature review of Traditional Chinese Medicine (TCM) study on Atopic Dermatitis (AD), the follow-up study and immunomodulatory effects research of Formulation for Tranquilizing Heart and Mind (FTHM) in treating AD.1Literature review of TCM study on ADObjective In TCM study of AD, there are plenty of researches, however, lack of system reviewing. In this dissertation, the recent23years scientific papers and ancient books of TCM study on AD have been reviewed, analyzed and evaluated. The aim of this study is getting the common rules of TCM treatment on AD, which will provide available evidence to help the future clinical and research.Methods Relevant publications and writings about TCM study on AD were systematically gathered from databases such as PubMed, CNKI, CBM, VIP, Wanfang data and TCM ancient books, then analyzed. The quality of the publications was evaluated by randomized controlled trials according to the Cochrane handbook.Results1. In TCM ancient books, the feature of "the wind of four fossae","anemogenous sore" and "infantile eczema" is similar to AD.2. In recent23years publications, the syndrome of spleen deficiency and its related syndromes, the syndrome of accumulated dampness-heat and syndrome of wind and dryness due to blood deficiency are the most common clinical syndromes. The treatment of AD is composed of self-modified formulation, plused or reduced medicine form traditional formulation, TCM patent prescription, acupuncture, medicated bath, acupoint-injection, massage and combination of above methods. Commonly used drugs and formulations include that qi-supplementing drug, blood-supplementing drug, heart-clearing and dampness-drying drug, inducing dieresis for removing edema drug, xiaofeng powder, xiaofengdaochi powder, angelica yin zi, et al.3. Clinical researches of TCM in treating AD are at low methodological quality. The stricter designed, double-blind, randomized controlled, large sample trials are required to support and ensure the efficacy and safety of TCM.Conclusions TCM studies on AD are lack of unified standard syndrome, evaluation standard, reasonable designed and strict quality controlled clinical trials. 2The follow-up study of FTHM in treating ADObjective Evaluate the efficacy and safety of FTHM with the follow-up study on patients who had AD.Methods We designed and carried out a multicenter, randomized, controlled clinical trial. Patients with AD were randomized received an8week treatment twice-daily dosing of FTHM or loratadine tablets and0.1%hydrocortisone butyrate cream. After the trial,64patients with significantly improved were recruited to a24weeks follow-up study.45patients finished the whole24weeks follow-up study. The results of SCORAD score, lesion area of skin score, severity of lesion-skin score, pruritus degree score, Dermatology Life Quality Index (DLQI)/Children Dermatology Life Quality Index (CDLQI), and TCM syndrome score were assessed during the treatment and week4,12and24in the follow-up study. Adverse events, tolerability, haematological and biochemical parameters were monitored during the study.Results1. The effect of trial drug64patients were recruited for the follow-up study. For over8weeks, the mean SCORAD score decrease from40.03to11.33in treatment group (n=31, P=0.0001), and from37.83to10.18in control group (n=33, P=0.0001). However, the results have no significant difference between two groups at the corresponding time. Lesion area of skin score, severity of lesion-skin score, pruritus degree score and DLQI/CDLQI were all improved after the treatment. There was no significant difference in these results too. No serious adverse effects were observed in both the groups. In treatment group,13patients were diagnosed as the syndrome of wind-damp stagnating in skin and18patients were diagnosed as the syndrome of wind and dryness due to blood deficiency. In control group,6patients were diagnosed as the syndrome of wind-damp stagnating in skin and27patients were diagnosed as the syndrome of wind and dryness due to blood deficiency. In TCM syndromes, only hyperpigmentation and dermatauxe were not improved heavily.2. The follow-up studyOver24weeks’follow-up study,45patients accomplished the whole trial which including26from treatment group and19from control group. SCORAD score, lsion area of skin score, severity of lesion-skin score, pruritus degree score and DLQI/CDLQI, and TCM syndrome score were stable in treatment group. However, SCORAD score increased from12.59to19.83in control group, which indicates some patients have a recurrence of AD. There were significant differences of erythema score, papule score and effusion score between two groups. There were also significant differences DLQI/CDLQI between patients’age below12in two groups. In treatment group,13patients were diagnosed as the syndrome of wind-damp stagnating in skin and13patients were diagnosed as the syndrome of wind and dryness due to blood deficiency. Erythema score of some patients was higher than at the beginning of the follow-up study. In control group,5patients were diagnosed as the syndrome of wind-damp stagnating in skin and14patients were diagnosed as the syndrome of wind and dryness due to blood deficiency. Dry skin score, pruritus score and total score were higher than at beginning of the follow-up study. Adverse events, tolerability, haematological and biochemical parameters were monitored during follow-up study.Conclusions FTHM is efficacious in improving clinical symptoms, the quality of life and reducing recurrence in patients with AD. The formulation was safe and well tolerated, but more research of FTHM still needed to reinforce this conclusion.3Research of immunomodulatory effects of FTHM in treating AD.Objective To study various of cytokines and chemokines in the peripheral blood of patients with AD and explore the immunomodulatory effects of FTHM in AD patients.Methods The serum level of IL-4, IL-12, MDC, Eotaxin-2, IL-17A, IL-21and β-EP were detected by enzyme-linked immunosorbent assay (ELISA) before and after treatment by FTHM.20patients and20healthy volunteers were recruited.Results1. The serum level of IL-4, IL-17A and MDC in AD patients was significant higher than controls. The serum level of Eotaxin-2in AD patients was significant lower than controls. There was no significant difference in the serum level of IL-12, IL-21and P-EP between AD patients and controls.2. The serum level of IL-4and IL-17A in patients with the syndrome of wind-damp stagnating in skin was significant higher than patients with the syndrome of wind and dryness due to blood deficiency. The serum level of IL-12and MDC in patients with the syndrome of wind-damp stagnating in skin was significant lower than patients with the syndrome of wind and dryness due to blood deficiency. There was no significant difference in the serum level of Eotaxin-2, IL-21and β-EP between the two TCM syndromes. 3. Relevant analysis indicated that the serum level of IL-4, MDC and IL-17A was positively related to the SCORAD scores, and the serum level of IL-12was negatively related to the SCORAD scores. There was no linear relationship between the serum level of Eotaxin-2, IL-21and p-EP and SCORAD scores.4. After the treatment of FTHM, the serum level of IL-12and p-EP rose up and the serum level of MDC fell down. There was no significant difference in the serum level of IL-12, MDC and P-EP between AD patients and controls.5. The influence of FTHM on the serum level of IL-4, Eotaxin-2, IL-17A and IL-21was not significant. After treatment, the serum level of IL-4, IL-17A and IL-21was still higher than controls. There was no significant difference between AD patients and controls at the serum level of Eotaxin-2.Conclusions FTHM plays a bidirectional immunomodulatory effects in treating patients with AD. MDC is the suppressive target. IL-12, Eotaxin-2, IL-21and P-EP are the promoting targets. |
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