| BackgroundThe incidence rate of atopic dermatitis (AD) is increasing with an onset age of mainly children and young people. Its lingering and refractory course of disease has affected the psychological state of children's growth and development and also created a heavy financial burden to the family as well as the society. Yet, the current treatment of AD remains as a major challenge to both the clinical practice and academic dermatology. External use of medicine is still the main treatment to alleviate acute onset and to reduce the recurrence of skin lesions. Due to the present western external medicine which is mainly the glucocorticoid and calcineurin inhibitor, there are problems of drug dependence, withdrawal rebound, poor compliance, as well as the impact of system absorption after long-term use which causes side effects on children's growth and development. Therefore, research on how to develop a safe, effective and also of long-term usage external medicine in children and adolescents has become an emphasis on the hot AD research.As an optional treatment, the efficacy and advantages of Traditional Chinese Medicine are getting more and more attention from Dermatology doctors and experts in China and abroad. Our academic division leader, Professor Chen Da-can has gradually formed a "hilling and clearing away heart-fire" theory after a long-term clinical practice in the diagnosis and treatment of atopic dermatitis. According to the "insufficient spleen, sufficient heart" of AD pathogenesis, Professor Chen Da-can summarizes the external treatment of AD Chinese medicine prescription——anti-inflammatory moisturizing washing formula. Using the "dispersing wind heat and dampness, nourishing spleen and yin" as treatment rules, it has achieved a certain effect in infants with eczema and AD, both acute and remission.At present there is no research about Chinese Medicine on external treatment of AD overseas, while the research remains at experience summarization in China. The lack of rigorous research design and involvement in theoretical research make it hard to evaluate on the efficacy and mechanism on the external use of Chinese Medicine.ObjectiveThe purpose and innovation point of this topic lies in the standardized clinical design on the development of a new Chinese medicine for external use and the evaluation of efficacy and safety by anti-inflammatory moisturizing washing formula for treatment of AD. At the same time focusing on the two main components of the AD pathogenesis——skin barrier dysfunction and microbial infections. It preliminarily discuss the impact of the anti-inflammatory moisturizing washing formula to the Staphylococcus aureus colonization density in AD skin lesions and to the function of AD skin barrier which lay a certain foundation for further development of traditional Chinese medicine.Methods1. The efficacy evaluation of AD by anti-inflammatory moisturizing washing formula external treatmentSelect 23 similar severity cases of lesions on the limbs as well as distribute symmetrically as research objects for the study. Randomly select a typical skin lesions on the left (or right) upper (or lower limbs) as target lesion. Apply anti-inflammatory moisturizing washing formula to wash and wet packing the skin lesions, leaving the corresponding contralateral skin lesions as a blank control.2 weeks as a course of treatment. Then use the same basic moisturizing treatment on both sides of the skin lesions while receiving "hilling and clearing away heart-fire" medicine orally and health education guidance. Record the target lesion and the control lesions to score on skin severity, pruritus and systemic SCORAD.2. The research on the mechanism of AD by anti-inflammatory moisturizing washing formula external treatment(1) The impact of the Staphylococcus aureus colonization density in AD skin lesions Detection of the above-mentioned 23 cases of Staphylococcus aureus colonization density AD patients, as well as its comparison between the target lesions and the control lesions after treatment.(2) The impact of the function of AD skin barrierUse soft5.5 Skin parameters to detect the biological parameters of the targeted skin lesions of 11 cases of AD patients, including the stratum corneum water content, skin PH value, sebum, temperature, flexibility, and skin parameters value before and after the treatment for comparison. 3. Detect 48 cases of AD lesions of Staphylococcus aureus colonization and sensitivity analysis to explore the biological characteristics of Staphylococcus aureus as well as in AD pathogenesis in the AD skin lesions.Results1. The efficacy evaluation of AD by anti-inflammatory moisturizing washing formula external treatmentFrom the 23 cases of AD patients by anti-inflammatory moisturizing decocted-free washing formula, there were 11 moderate and severe cases respectively, each with 47.85% while only 22 cases were bring into statistic because of a failed case. After 2 weeks, the score of the treatment target lesions and the control lesions had significant statistical difference (P= 0.001), both the scores of the local pruritus had significant statistical difference (P=0.008) which indicated that the anti-inflammatory moisturizing washing formula could effectively improve the skin lesions and pruritus. The total score and the pruritus score of target lesions decreased more significantly than the control lesions. Within the 2 weeks course of treatment, the lesions score and pruritus score decreased more apparently where it was most effective with the lowest score in the second week. Target lesions of acute and chronic lesions compared with total score was significant (P=0.012), which shows the acute lesions improved more as compared with the chronic lesions. Suggesting response of using anti-inflammatory moisturizing washing formula in acute inflammatory was better. The SCORAD values before and after treatment was statistical significant (P=0.001), shows that systemic treatment (Qing-Xin-Pei-Tu prescription orally, anti-inflammatory moisturizing washing formula and basic moisturizing treatment and health education) have the exact effect in the treatment of atopic dermatitis. 2. The research on the mechanism of AD by anti-inflammatory moisturizing washing formula external treatment(1)The treatment of Staphylococcus aureus colonization density of target lesions and the control lesions was statistically significant (P=0.010), shows that the anti-inflammatory moisturizing washing formula can effectively inhibit the Staphylococcus aureus colonization and infection in AD skin lesions.(2)After treatment, the water content in the stratum corneum, of the target lesions increased significantly. The water content in the stratum corneum before and after treatment was statistical significant (P=0.014), shows that there are a certain extent in repairing the skin barrier by using the anti-inflammatory moisturizing washing formula. While there were no statistical significant in skin sebum, elasticity, temperature and PH value before and after the treatment of the target lesions (P=0.564, P=0.083, P=0.301, P=0.084).3.The bacteria detection rate of AD lesion was 85.4%, Staphylococcus aureus detection rate was 75%. The least density of Staphylococcus aureus colonization is 56CFU cm-2, the most to 1×108 CFU cm-2, the average density of 1X107 CFU cm-2. Whether or not the AD skin lesions are detected of Staphylococcus aureus are closely related to its severity, derived lesions (r=-0.601, P<0.001; r=0.615, P<0.001). Susceptibility of Staphylococcus aureus showed resistance to many antibiotics, and the detection rate of MRSA was high and accounting for 19.5%.ConclusionBy random and autocontrol experiment, it could better eliminate the factors of individual differences, oral administration of drug, disease severities and objectively assess the effectiveness of anti-inflammatory moisturizing washing formula in treating atopic dermatitis. It was statistical significant when compared to the control lesions. The results showed that the anti-inflammatory moisturizing washing formula could improve the scores of the target lesions and pruritus lesions significantly in 2 weeks while using the Qin-Xin-Pei-Tu prescription orally together with the anti-inflammatory moisturizing washing formula in treating moderate to severe AD, the SCORAD score decreased significantly in 2 weeks. Through clinical observation, the anti-inflammatory moisturizing washing formula could significantly reduce the redness, swelling and effusion in acute exacerbation of AD patients. It could effectively relieve the dryness of the skin and pruritus in AD remission and applicable to children and young people safely. Therefore, it is worth of further clinical research, promotion and usage. According to the declination research results of the Staphylococcus aureus colonization density of both lesions and the significantly increased of water content in the stratum corneum before treatment, it is considered that the main mechanism of the washing fomula is by antibacterial, anti-inflammatory and the rebuild function of the skin barrier. |
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