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Clinical Observation The Therapeutic Effect, Safety And Mechanisms Of The Formula Of Hilling And Clearing Away Heart-fire On Atopic Dermatitis

Posted on:2008-05-17Degree:DoctorType:Dissertation
Country:ChinaCandidate:Y M LiaoFull Text:PDF
GTID:1104360215465434Subject:Traditional surgery
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BackgroundAtopic dermatitis is characterized by chronic and relapsing pruritus andskin lesions resulting in great impacts on the physical and psychologicalstatus of the patients, usually occurring in children and adolescent. Theprevalence of the disease has been increasing according to domestic andinternational epidemiological datas, with development of social economy andenvironmental changes. Despite equivocal theory of etiology and pathogenesisfor the disease, it seems that atopic dermatitis results from syntheticalaction involved in genetic, environmental, immunological, microbial,psychological factors and so on. Present guideline for atopic dermatitisproposes that the core of treatment of AD is to ameliorate symptoms and signs,control the recurrence, and prevent from deterioration and progression.Therefore, controls of episodes of symptoms represent new trends and viewpointsconsidered management of atopic dermatitis. The chineses medicine fortreatment of atopic dermatitis becomes the warm spots due to its uniquesuperiority. However, most researches in this field revolve around clinicalobservation of therapeutic effects of several empirical formulas whilethere're less therapeutic principles and mechanism discussions. For thisreason, the unique formula of hilling and clearing away heart-fire, stemedfrom advisor's long-term clinical practice, is further discussed in thisstudy, including its therapeutic effects and potential therapeutic mechanisms.Since most studies demonstrate that atopic dermatitis is associated withimmunological factors, it's warranted in this study for the choices of itemsof immunoglobulin E and eosinophil cationic protein. On the other hand, moreand more attentions were paid upon the theory of neuroendocrine-immune network,the new explanation for mechanism of the psychosomatic disease; nerve growth factor and substance P are regarded as another research focus in this studyfor their important role in the pathology and pathophysiology of atopicdermatitis.Objective1. Serum immunoglobulin E and eosinophil cationic protein are examined toexplore their role in the pathogenesis of atopis dermatitis.2. Therapeutic effects of advisor's empirical formula of hilling andclearing away heart-fire are evaluated through observation of changes ofSCORAD index before and after treatment.3. Influence on the serum LgE, ECP, NGF, and SP is studied to discusspotential therapeutic mechanisms of advisor's empirical formula for atopicdermatitis. The research methods and results may provide new direction forclinical practice and become basis of development of new medicine.Methods55 patients diagnosed atopic dermatitis are admitted to this clinical trial.Scores of SCORAD index are collected before treatment, 1 month and 3 monthsafter treatment respectively. At the meantime, 38 cases are randomly chosenout of those 55 patients, controlled by 15 cases of normal volunteers. CAPallergen test system (Pharmacia Ltd) is then used for examination of serumIgE and ECP and ELISA assay for determination of serum NGF and SP. Correlationanalysis is conducted to explore the association between the serum items andscores of SCORAD index.Results1. Risk factors of atopic dermatitis. Questionnaire research is made toscreen potential risk factors of atopic dermatitis in 55 admitted patients.The final outcomes indicate that the disease is associated with diet, climateand season changes, sentiment and emotion abnormality, and past allergichistory and family history. Among those, onset and episodes of the diseaseare correlated with diet factor in 27 cases (especial the sea food), thechanges of season in 50 cases without dominant season trend, sentiment factorin 9 cases and emotion factor in 32 cases (especial the strain mood). In 55cases, 30 cases have history of allergic rhinitis, ashma, or both of them,in which 9 casese suffered from the two diseases. Further study also findsthat their relatives of 34 cases have the history of allergic diseases,especial the allergic rhinitis. 2. Clinical observation of therapeutic effects. Management regimen isconsisited of oral medicine of empirical formula of the hilling and clearingaway heart-fire and external application of emollients. Therapeutic effectsare evaluated through SCORAD index. The mean values of SCORAD are55.458±15.051 before the treatmen, 49.410±12.331 1 month after treatment,and 34.684±8.824 3 month after treatment, respectively. Compared to thescores of SCORAD before treatment, the scores of SCORAD after treatment areboth statistically significant (P<0.01). The symptoms of pruritus and skinlesions are obvious improved and the quality of sleep is accordingly enhanced.The total effective rate, evaluated by Nimodipine method, is 92.75%,including excellence in 2 cases, improving in 49 cases, inefficacy in 4 cases.No adverse event was observed in the study. These preliminary outcomes of theclinical trial firtly demonstrated that the advisor's empirical formula isclinically practical in some degree.3. Examination of total serum IgE. The mean value of serum IgE is2175.162±1982.798KU/L before the treatment, higher than that of normalcontrol group (45.287±35.753 KU/L). The difference between them isstatistically significant (P<0.01). The mean value of serum IgE decreasesstatistically significant compared with that of before treatment (P<0. 01).The final results seems that although undergoing management, the serum IgEafter treatment is still higher than that of normal control group withstatistical significance (P<0.01). Correlation analysis indicates that thescore of SCORAD is positively associated with values of total serum IgE.4. Tests of serum ECP. The mean value of serum ECP is 29.953±42.752 ug/L,higher than that of normal control group (7.867±6.629ug/L). The differenceis statistically significant (P<0.05). The decrease of serum ECP aftertreatment is also statistically significant (P<0.01) compared to that ofbefore treatment and no statistical significance are found between serum IgEafter treatment and that of normal control group (P>0.05). Mild correlationis found between the score of SCORAD and value of serum ECP. However, suchassociation seems little important.5. Correlation of total serum IgE and ECP. Correlation analysis indicatesthat there's positive association between total serum IgE and ECP, whereasit becomes slightly significant after treatment. The correlation coefficientis 0.329 (P=0.044) before treatment and 0.124 (P=0.457) 3 months after treatment, respectively.6. The changes of serum NGF. The mean value of serum NGF is 251.914±216.054pg/ml, higher than that of normal control group (105.859±21.471 pg/ml) withstatistical significance (P<0.01). The patients are further assigned to 2groups including moderate (120.962±69.167) pg/ml and serious group(413.675±227.282)pg/ml according to Rajka scales system. Variaration betweengroups is statistically significant (P<0.01). Correlation analysisdemonstrates that the score of SCORAD is positively associated with the valueof serum NGF with statistical significance before treatment. Paired t-testanalysis is uses to demonstrate that the mean value of serum NGF after treatment(107.273±109.187 pg/ml) is statistically significantly lower than that ofbefore treatment (251.914±216.054 pg/ml) (P<0.01). On the contrary, nostatistical significance is found when it's compared to that of normal controlgroup (105.859±21.471 pg/ml) (P>0.05).7. Analysis of values of serum SP. The mean value of serum SP is 67.332±42.919 pg/ml, higher than that of normal control group (30. 987±7.909 pg/ml)with statistical significance (P<0.01). The patients are further assigned to2 groups including moderate (43.487±13.949 pg/ml) and serious group(96.787±48.459 pg/ml) according to Rajka scales system. Variaration betweengroups is statistically significant (P<0.01). Correlation analysisdemonstrates that the score of SCORAD is positively associated with the valueof serum SP with statistical significance before treatment. Paired t-testanalysis is uses to demonstrate that the mean value of serum SP after treatment(46.581±26.480 pg/ml) is statistically significantly lower than that ofbefore treatment (P<0.05). What's more, statistical significance is alsofound when it's compared to that of normal control group (30.987±7.909pg/ml) (P<0.01).8. Association of serum NCF and SP. The positive correlation is demonstratedbetween serum NGF and SP before treatment while such correlation becomes littlesignificant. The coeeficient correlation is 0.556 (P=0.000) before treatmentand 0.283 (0.085) respectively.Conclusions1. The empirical formula of hilling and clearing away heart-fire hasundoutable therapeutic effects for atopic dermatitis, illuminated by the factsthat the symptoms of pruritus, disturbance of sleep, and skin lesions are significantly enhanced after treatment. No case reports adverse events duringperiods of therapy and the regimen discussed in this study thus may bealternative management for atopic dermatitis in the future.2. The elevated serum IgE and ECP exsisted in patients of atopic dermatitisare demonstrated in this study again. No correlation is found between valuesof serum ECP and degree of severity of the disease but serum IgE. Therefore,it's reasonable to postulate that values of total serum IgE can be regardedas serum index for reflection of status of atopic dermatitis.3. Laboratory darns combined with clinical observation support thatneurogenic mechanism plays a key role in pathogenesis of atopic dermatitis.Compared to that of normal control group, the elevation of serum NGF and SPindicates that these factors is involved in the onset and flare of atopicdermatitis.4. The values of NGF and SP are associated with status of AD, based oncorrelation between serum NGF and SP, Rajka Index, and SCORAD scores.5. The empirical formula of hilling and clearing away heart-fire maygenerate its therapeutic effects through downregulating levels of serum totalIgE,ECP,NGF,SP. According to theses outcomes, it's proposed that therapeuticmechanism of the formula may be multi-target and associated with regulationof immunological and neurogenic factors.6. Development of neuropeptide antagonists and releasing regulators mayprovide new promise for treatment of atopic dermatitis in the future.
Keywords/Search Tags:Atopic Dermatitis, Nerve Growth Factor, Substance P, The Empirical Formula of Hilling and Clearing Heat-fire
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