| BackgroundThe anti-inflammatory and relieving itching creme,which was developed by the famous Professor XuanGuowei(as well as the academic leader in the dermatology department of Guangdong Provincial hospital of Traditional Chinese Medicine,) for fourty years,as a medical prescription for treating eczema,cutaneous pruritus and other skin disorders,the curative effect was determined,steroids ointment accounted for a prodigious proportion in the external used medicine for treating eczema at present.Although the steroids showed a good clinical effect in anti-inflammatory,relieving itching and decreasing exudation,,the disease recurred when the drug withdrew,and what's more,other side effects would arised such as pachylosis,enlarged pore, pigmentation after a long term usage.There were various treatment methods in traditional chinese medicine,but the external used medicine was limited,in addition to,other defects were also exist such as lagged dosage form, inconvenient to use,poor transdermal absorption and bioavailability, caducous and aesthetic problems,so how to develope efficient,easy-to-use external formulations was an urgent need.in view of this,we have studied the following aspects:literature searchEczema was an acute or chronic skin inflammation which result from various internal and external factors.In the acute stage,the Symptoms were red rash, herpes Hill pleomorphic damage and they have exudational tendency;while in the chronic phase,hypertrophy and Lichenoid skin are change-oriented,often recurrentin many years and intense itching.The causes are very complicated, for example,the external factors such as sunlight,ultraviolet radiation,cold, heat,drying,scratch and all kinds of animal fur,plants,chemical substances,that can aggravate the eczema,and the internal factors such as chronic digestive system diseases,gastrointestinal disorders,mental tension, insomnia,fatigue,focal infections,endocrine dysfunction,that may also worsen the disease.As for the pathogenesis,with both foreign-related research, we mainly focus on the genetic,allergic source of infection,immunization, and other neuropsychiatric research,it is generally acknowledged the pathogenesis was mainly caused by the complicated internal and external factors of a delayed hypersensitivity.Currently,the main treatment of the disease was to relieve the Symptoms.The main methods are anti-allergic,anti-inflammatory,antipruritic and so on.but there are some problems in use,suchas:(1) antihistamines aere generally significant in the acute phase,but their effect declined with time in the chronic phase;long-term application of antihistamines may be dependent on drugs and mental effects.In the same time,sudden withdrawal may result in obvious adverse drug reaction;and what's more,antihistamine drugs have obvious central inhibition and other side effects.(2) Although Glucocorticoid can control symptoms rapidly,but the drug is easy to relapse even worsen in general,and taking it by oral is not suggested.(3)The adverse reactions of immunomodulators are obvious,such as long-term use or excessive doses of cyclosporine can lead to renal toxicity;azathioprine may cause severe bone marrow suppression,neutropenia,aplastic anemia,even toxic hepatitis and other serious adverse reactions.Chinese medicine has a long history of be familiar with the eczema,the disease belong to "immersed sores," "wet wound","Hydrangea Wind," "Spin sore ears";chronic eczema is equivalent to "stubborn ringworm" in Chinese medicine. Chinese medicine practitioners believe that the occurrence of eczema are because of dysplasia and wind,moisture,thermal are Mixed in the skin,and intemperance of taking food,over-eating spicy and Smelly food due to spleen injury,Kin Yun-loss Secretary humid endogenous,internal and external pathogens involved,rheumatic fever immersed skin caused by this evil disease. The treatment of the eczema were recorded in document before the Ming and Qing dynasties are prior to external-oriented major,physicians have come to realize all above will be not enough to cure the diseas fundamentally,and begin to retrieve the disordered state of the body in the Ming and Qing Dynasties:At the same time,people start using acupuncture and physical therapy to cure the disease,and the methods of treatment gradually enriched; Now the Chinese medicine has done a large number of clinical and experimental research in the treatment of this disease,covering many aspects,and the current clinical researches focuse on simple Syndrome differentiation, specific drug research,pure external research and the intergration of internal-external therapy,the efficacy was various,by summarizing the cases, the efficiency is more than 80%,and some even 100%,which demonstrates the beautiful future of the treatment of eczema by the Chinese medicine.However,according to their clinical experience,different doctors carry on different researches,because of regional differences and personal factors, modern medicine has diffrent understanding about eczema;it is difficult to make a unified objective evaluation,the results of these studies encounter great difficulties when they are used to guide clinical work.animal experiment researchPharmacodynamic Study:we carried out six animal experiments in all:(1)we coated DNCB in the inner ear of guinea pigs so as to sensitize,stimulate and prepare the eczema model,while local administration of the auricle and observe drugs effect on the ear Profile swelling values and the impact of pathological changes simultaneously.(2)DNCB skin sensitization and ear to stimulate delayed-typehypersensitivity model preparation,abdominal skin of localized drug delivery to observe the impact of drugs on ear edema of guinea pigs and immune organs such as spleen,thymus.(3) the guineapig itching model were acquired through Oroupammonia(HA) method,and we observed The drugs effect on the HA of guineapig itch threshold by local administration;(4)using carrageenin to induce guinea pig feet proinflammatory,then observe the drugs effect on foot swelling rates by local administration(5)p-xylene-induced ear inflammation,observing the impact of drugs on guinea pig ear edema NIH value the capillary permeability were measured by Evansblue,and the drugs effect on animal skin Evansblue exudation volume were observed by local skin administrationThe animal experimental research shows that:(1)The anti-inflammatory and relieving itching gel has a significant effect to relieve itching reduced ear edema model inguinea pigs eczema values and dermal infiltration of inflammatory cells,auricleepi dermal thickening,dermal inflammatory cellinfiltrationina,and decrease invascularendothelial cells swelling significantly.(2) The anti-inflammatory and relieving itching gel can relieve DNCB-induced delayed-type hypersensitivity;this shows that the gel have the therapeutic effects on eczema.(3)The anti-inflammatory and relieving itching gel enhances itching threshold inguineapigs induced by histamine significantly,which means that it has antipruritic effect.(4)The anti-inflammatory and relieving itching gel can be significantly reduced carrageenan-induced rat foot swelling rate and xylene-induced mouse ear edema values this means the gel has anti-inflammatory effects.(5)The anti-inflammatory and relieving itching gel can reduce medication partial skin graft in rats lixivium in the concentration of Evansblue that has reduced the role of capillary permeability.Conclusion:The animal experiments confirmed that The anti-inflammatory and relieving itching gel has anti-inflammatory,antiallergic,antipruritic effects.Drug Toxicology study:We carried out the following four tests:(1)with 8%sodium sulfide to the back of the spine on both sides of the rabbit hair removal,with an area equal to about 10%of body surface area,so as to conduct acute toxicity test on the intact and damaged skin.(2)The anti-inflammatory and relieving itching gel pharmacognostic considerable amount of 0.91g/g and 3.64g/g two concentrations by 0.91g/kg and 3.64g/kg to rabbit skin and damaged skin integrity of local administration,drug-coated thickness of about for 0.1mm,the daily administration of one times,to maintain six hours,a total of 3 months of administration,observe two weeks after drug withdrawal,both sides of shearing on guinea pig back,with an area of each side of the 3×3cm~2,complete allergic skin tests,observe local medication when anaphylactic reaction on the skin.(4)rabbit spine on both sides of the back hair removal,with an area equal to about 10%of body surface area,inact and damaged skin irritation tests were conducted afterwards. Drug Toxicology Results:(1)The local administration of rabbit skin and damaged skin,we did not observe that local skin and animal acute toxicity:(2)The anti-inflammatory and relieving itching gel has no significant effect on animal behavior,activity,fur,urine,diet,drinking water and eye,nose,oral cavity;one week after administration of local damaged skin scab,after two weeks decrustation:it has no significant effect on animal body weight,organcoefficient,and histopathology;it has no significant effect on peripheral blood cells,blood biochemistry and liver and kidney function.(3)Skin contact sensitization of guinea pigs was 0%,suggesting that the anti-inflammatory and relieving itching gel has no hypersensitization.(4)The anti-inflammatory and relieving itching gel has no obvious stimulus on skin and damaged skin of rabbit.Conclusion:the anti-inflammatory and relieving itching gel has no toxicity,hypersensitization,and skin stimulation in our acute,long-term toxicity,skin allergies and local stimulation animal experiment. Clinical ResearchObjective:To objectively evaluate the the effectiveness and safety of anti-inflammatory and relieving itching gel in treating subacute and chronic eczema.Methods:120 patients sufferring from subacute or chronic eczema we recollected and randomly divided into treatment group and control group;the treatment group:anti-inflammatory relieving itching gel,topical,coverring the affected area 2-3 times daily by appropriate dose(about 0.1 grams /cm~2). Control group:Eloson paste,external use,take appropriate amount(about 0.1 grams/cm2) coating the affected area 2-3 times daily.The period of Treatment is 4 weeks,they may have been recovered in advance for less than four weeks; During the period of treatment,other treatment of the disease-related drugs can not be combined,we observe the situation of skin itching(pruritus grading, the degree of itching,pruritus frequency),lesions traits(dry,dander, scratch and blood scab,Papules and moss),lesions size,and observe the local and systemic adverse events.Results:the cure rate and total effective rate were 37.5%and 91.07%;In the control group,the cure rate and total effective rates were 47.27%and 94.54%,The treatment group Compared with the control group,both of them was not significant(P＞0.05).Antipruritic effect of two groups,lesion area reducement were not significant(P＞0.05).Clinical adverse events did not occur.Conclusion:The results showed that the clinical efficacy of anti-inflammatory and relieving itching gel was more positive, clinical use was safe.Conclusion:(1)Experimental research suggests that The anti-inflammatory and relieving itching gel are good at anti-inflammatory,antipruritic,anti-allergic effect and so on;(2)Clinical research shows that the anti-inflammatory and relieving itching gel have an outstanding effect in treating chronic eczema.(3)Security study shows that The gel has no acute and long-term toxicity to the animals,no irritation to the skin,and other side effects;the side effects was not observed in the process of clinical trials.Both the experimental and clinical study suggest that The anti-inflammatory and relieving itching gel is worthy of further research and development.
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