CN116270809A - Traditional Chinese medicine compound prescription for soothing nerves, relieving itching and strengthening spleen for treating atopic dermatitis and preparation method thereof - Google Patents
Traditional Chinese medicine compound prescription for soothing nerves, relieving itching and strengthening spleen for treating atopic dermatitis and preparation method thereof Download PDFInfo
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- CN116270809A CN116270809A CN202310354377.6A CN202310354377A CN116270809A CN 116270809 A CN116270809 A CN 116270809A CN 202310354377 A CN202310354377 A CN 202310354377A CN 116270809 A CN116270809 A CN 116270809A
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Abstract
The invention discloses a traditional Chinese medicine compound prescription for soothing nerves, relieving itching and strengthening spleen for treating atopic dermatitis and a preparation method thereof, wherein the traditional Chinese medicine compound prescription for soothing nerves, relieving itching and strengthening spleen for treating atopic dermatitis comprises 15-30 parts of raw dragon bone, 9-30 parts of calcined oyster, 10-30 parts of stir-fried medicated leaven, 9-30 parts of poria peel, 6-30 parts of fructus forsythiae and 3-9 parts of ephedra root by mass. The raw keels in the recipe are the effects of relieving the heart and soothing the nerves, fixing the five viscera, tonifying yin and yang of the calcined oyster, frying medicated leaven and strengthening the spleen, and the poria cocos Pi Lishi and the fructus forsythiae are used for clearing heat to relieve itching, and the ephedra root is used for guiding the drugs to the exterior. The whole prescription treats both with the functions of relieving heart and tranquillization, strengthening spleen and relieving itching. The prescription has ingenious medicine taking and is in accordance with the physique and pathogenesis characteristics of the children patients with atopic dermatitis. The traditional Chinese medicine composition is used for treating atopic dermatitis, provides "shape and spirit simultaneous treatment", and is different from the traditional single treatment methods such as shape and theory treatment, and the compatibility of medicines is matched with the physique and pathogenesis characteristics of children.
Description
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to a traditional Chinese medicine compound prescription for treating atopic dermatitis, which is used for soothing nerves, relieving itching and strengthening spleen and a preparation method thereof.
Background
Atopic dermatitis (atopic dermatitis, AD) is a skin lesion with various manifestations, which may be represented by pimples, erythema, lichenification, dryness, etc., and patients often feel severe itching, severely affecting the quality of life of the patient and its family members. AD has the highest incidence in infancy, mostly before age 7.
The external glucocorticoid for treating AD in modern medicine is first-line administration, and other treatment modes comprise external calcineurin inhibitor, wet pack therapy, systemic administration, phototherapy, biological preparation and the like. It plays an important role in the treatment of AD, and some new and promising advances have been made in recent years. However, the limitations of the application of therapeutic methods such as side effects of therapeutic drugs, systemic drugs and biological agents to subjects have led to AD as one of the refractory diseases of the dermatological department. Itching is one of the main characteristics of AD, seriously affects the life quality of a patient and is related to the symptoms such as attention deficit and the like of the patient, but the current treatment measures for treating AD itching and improving the combined symptoms such as attention deficit and the like of the patient are insufficient to meet the demands of the patient, and the continuous research of new medicines for improving the severity of AD skin damage and reducing the itching, improving the attention level and the like of the patient and combined cognitive symptoms are the current treatment key points and difficulties.
At present, improving AD pruritus and improving the accompanying attention deficit and the like combined cognitive symptoms are the current treatment key points and difficulties, AD is a shape-spirit co-morbid, but the corresponding effective treatment medicine for shape-spirit co-morbid is still lacking. The compatibility of traditional Chinese medicines for treating AD from heart and spleen theory still lacks better choices for improving attention and relieving AD symptoms aiming at the constitution of infants.
The information disclosed in this background section is only for enhancement of understanding of the general background of the invention and should not be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person of ordinary skill in the art.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine compound prescription for soothing nerves, relieving itching and strengthening spleen for treating atopic dermatitis and a preparation method thereof, which can solve the problem that the traditional Chinese medicine only treats AD from the aspect of relieving skin injury, and the Western medicine lacks a treatment method for improving the combined cognitive symptoms such as AD attention deficit and the like.
The invention provides a traditional Chinese medicine compound prescription for soothing nerves, relieving itching and strengthening spleen for treating atopic dermatitis, which comprises raw dragon bone, calcined oyster, stir-fried medicated leaven, poria peel, fructus forsythiae and ephedra root.
Preferably, the traditional Chinese medicine composition consists of 15-30 parts of raw dragon bone, 9-30 parts of calcined oyster, 10-30 parts of fried medicated leaven, 9-30 parts of poria cocos peel, 6-30 parts of fructus forsythiae and 3-9 parts of ephedra root according to mass parts.
Preferably, the concentration of the liquid medicine of the prescription for soothing nerves, relieving itching and strengthening spleen is 5.0g/ml.
The invention also provides a preparation method of the traditional Chinese medicine compound prescription for treating atopic dermatitis, which comprises the following steps:
(1) Soaking Os Draconis, concha Ostreae preparata, massa Medicata Fermentata preparata, exodermis Poria, fructus forsythiae and radix Ephedrae in water respectively;
(2) Decocting Os Draconis and Concha Ostreae Preparata for 30 min, wrapping the parched Massa Medicata Fermentata with gauze, decocting Os Draconis, concha Ostreae Preparata and Massa Medicata Fermentata with Poria cortex, fructus forsythiae and radix Ephedrae in water twice, decocting in water for 1.5 hr for 8 times, and decocting in water for 1 hr for 6 times;
(3) Filtering after decocting twice, mixing filtrates, concentrating to 5g crude drug content per 1ml, and making the drug concentration 5.0g/ml.
Compared with the prior art, the traditional Chinese medicine compound prescription for treating atopic dermatitis, which is used for soothing nerves, relieving itching and strengthening spleen and the preparation method thereof, have the following beneficial effects:
the raw keels in the recipe are the effects of relieving the heart and soothing the nerves, fixing the five viscera, tonifying yin and yang of the calcined oyster, frying medicated leaven and strengthening the spleen, and the poria cocos Pi Lishi and the fructus forsythiae are used for clearing heat to relieve itching, and the ephedra root is used for guiding the drugs to the exterior. The whole prescription treats both with the functions of relieving heart and tranquillization, strengthening spleen and relieving itching. The medicine is ingenious, and is in accordance with the physique and pathogenesis characteristics of the AD children patients. The traditional Chinese medicine composition is used for treating atopic dermatitis, provides "shape and spirit simultaneous treatment", and is different from the traditional single treatment methods such as shape and theory treatment, and the compatibility of medicines is matched with the physique and pathogenesis characteristics of children. The prescription for soothing nerves, relieving itching and strengthening spleen can obviously improve the skin damage condition of the atopic dermatitis model mouse and reduce the skin damage inflammation level. The prescription for soothing nerves, relieving itching and strengthening spleen has definite curative effect on treating the AD of the light and medium children, can reduce the itching degree and improve the sleep, can obviously improve the life quality and the attention of patients with the atopic dermatitis of the light and medium children, improves the cognitive ability of the patients, has good safety and has higher social popularization value.
Drawings
FIG. 1 is a technical roadmap for BALB/c mouse grouping, modeling and administration according to example 1 of the present invention;
FIG. 2 is a schematic time chart of the administration of the groups of the formula II dermatitis, of the formula II, with the effect of soothing nerves, relieving itching and strengthening the spleen, according to the establishment of a model of an atopic dermatitis mouse in example 1 of the present invention;
FIG. 3 is a schematic diagram of the atopic dermatitis skin-lesion score according to example 1 of the present invention;
FIG. 4 is a schematic diagram showing the back skin damage after the atopic dermatitis mouse model was established according to the present invention in example 1;
FIG. 5 is a comparative schematic of the appearance of skin lesions in groups of mice after treatment according to example 1 of the present invention;
FIG. 6 is a graph showing comparison of skin damage scores of groups of mice after treatment according to example 1 of the present invention;
FIG. 7 is a schematic representation of HE staining of skin lesions in groups of atopic dermatitis model mice following treatment according to example 1 of the present invention;
FIG. 8 is a schematic diagram of the subject entry into a group according to example 2 of the present invention;
FIG. 9 is a graphical representation of the change in SCORAD score before and after treatment according to example 2 of the present invention;
FIG. 10 is a graphical representation of score and total score of control and treatment groups SCORAD after 8 weeks of treatment according to example 2 of the invention;
fig. 11 is a graph showing the change in CDLQI scores of the control group and the treatment group before and after treatment according to example 2 of the present invention;
Fig. 12 is a graph showing CDLQI scores for the control and treatment groups after 8 weeks of treatment according to example 2 of the present invention;
FIG. 13 is a graphical representation of the distribution of scores from the numerical scratch scale after 8 weeks of treatment according to example 2 of the present invention;
FIG. 14 is a graphical representation of the distribution of scores of the numerical scratch scales before and after 8 weeks of treatment in treatment group according to example 2 of the present invention;
FIG. 15 is a graph showing the distribution of scores of the numerical scratch list before and after 8 weeks of control treatment according to example 2 of the present invention;
fig. 16 is a diagram showing an example of the skin before and after treatment of a part of a patient according to embodiment 2 of the present invention.
Detailed Description
The following detailed description of embodiments of the invention is, therefore, to be taken in conjunction with the accompanying drawings, and it is to be understood that the scope of the invention is not limited to the specific embodiments.
Throughout the specification and claims, unless explicitly stated otherwise, the term "comprise" or variations thereof such as "comprises" or "comprising", etc. will be understood to include the stated element or component without excluding other elements or components.
Atopic dermatitis (atopic dermatitis, AD) is often combined with other diseases, and in addition to asthma and allergic rhinitis, recent studies have shown that AD is also associated with hypertension, heart disease, diabetes and mental neuropathy, and that the severity of AD is positively correlated with these diseases.
Itching is one of the main symptoms of AD, whether it is light, moderate or severe AD, and is the symptom most noticeable to the patient and most worrying about it, bringing a great burden to the AD patient. The scratching caused by the itching causes the patients to be very painful, the night itching affects the sleeping of the patients, the physical and mental health of the patients can be affected, and the life quality of the patients is seriously affected. Studies have shown that the lack of sleep in AD patients due to itching increases the risk of combining attention deficit/hyperactivity disorder, anxiety and depression.
According to the clinical manifestations of AD eczematoid skin lesions and the characteristics of higher hereditary property, the Chinese medicine has close relation with the symptoms of tinea, four-bending wind and the like. The traditional Chinese medicine mainly adopts viscera syndrome differentiation, qi, blood and body fluids and six-excessive syndrome differentiation to treat AD, wherein the viscera syndrome differentiation is most applied, and different differentiation methods such as defensive qi, nutrient and blood, six-channel syndrome differentiation, evil-lying differentiation and triple-jiao syndrome differentiation are adopted. First, it is considered that wind, dampness and heat are the main causes of AD from the perspective of six exogenous pathogenic factors and five endogenous pathogenic factors, and modern doctors mostly consider that damp and heat can be exogenous pathogenic factors or endogenous dampness and internal heat caused by imbalance of yin and yang of viscera. Wherein wind evil is dominant in infancy, damp evil is dominant in childhood, and heat evil is dominant in adulthood. Secondly, the viscera diseases are treated by heart, spleen, lung and spleen, liver and kidney, and the viscera dysfunction can lead to AD. Thirdly, from the point of view of qi, blood and body fluids, the deficiency of defensive qi and consolidating the constitution and the deficiency of blood dryness, blood deficiency and body fluids are the main factors. The deficiency of the healthy qi is susceptible to pathogenic factors, chronic long-term illness, and the deficiency of blood and body fluids leads to dry and rough skin and lichen-like changes. Fourth, analyzing the course of disease from defensive qi, nutrient and blood, it should clear wind-heat and damp-heat in qi system, clear nutrient and cool blood in nutrient and blood system, and enrich blood and move blood in chronic stage. The upper-jiao, lung-defensive and middle-jiao, due to damp-heat in the spleen and stomach, and lower-jiao are mainly attributed to liver-kidney dysfunction. Therefore, the disease is repeatedly caused, so doctors consider the pathogenic factors as important factors of the disease, and the disease treatment process should be completed by eliminating the pathogenic factors. It is preferable to clear the interior Fu Rexie and dispel the pathogenic wind.
The pathogenesis of AD is mostly focused on the shape, but the characteristics of the same disease as the spirit are not considered. For example, from the heart-spleen theory, it is considered that its etiology is mainly due to congenital endowment intolerance and fetal toxicity and excessive heat, leading to heart fire and spleen deficiency, and the heart fire and spleen deficiency are mutually seen with each other, and deficiency and excess are mixed. Only heart-spleen viscera theory is adopted, and the influence of five-spirit heart spirit and spleen spirit on the AD disease process is not considered, and the treatment of attention deficit and other combined cognitive symptoms is not considered. For clearing away heart fire, fructus forsythiae and rush herb are used for clearing away heart fire, radix pseudostellariae, chinese yam and coix seed are used for strengthening spleen, and medicines for treating sleep disorder caused by restlessness of heart spirit and attention deficit caused by incoordination between spleen and the like of AD patients are not used.
With the development of research on AD, it is recognized that AD is a physical and mental disorder. For AD patients, the skin damage and pruritus symptoms of the AD patients are improved, and the attention of the AD patients and the combined cognitive symptoms of the AD patients are also very important. The traditional Chinese medicine has better curative effect and multi-target characteristics in treating AD, but most of the current treatments are single in pathogenesis, mostly only treat from the theory of 'shape', and lack of treatment from the two aspects of skin damage (shape) and attention deficit and the like combined with cognitive symptoms (spirit).
The invention is based on the theory of 'shape and spirit integration' of traditional Chinese medicine. The shape is the root of the spirit, the spirit is the purpose of the shape, and the shape is related to the physiology of the spirit and affects each other in pathology. Heart and spleen, heart spirit and spleen are important in disease onset. The traditional Chinese medicine considers that the heart is most closely related to the mind, the heart stores the mind and dominates all life activities, and the mind is most related to the emotion activities and is also dominated by the heart, so the heart plays an important role in the emotion activities. "meaning" refers to the spirit of spleen and is mainly focused. Abnormal heart mind may cause abnormal five zang organs, and abnormal spleen meaning may affect concentration. Therefore, in the long-term clinical and basic research work of atopic dermatitis, according to the basic theory of traditional Chinese medicine, the AD is considered as a shape-nerve homopathy, which is manifested by skin damage and viscera disorder, and is mainly characterized by heart and spleen; the psychosis manifests mental and cognitive symptoms such as depression anxiety, attention deficit, etc., and is mainly characterized by "mind and spleen meaning". Abnormal heart mind causes disturbance of vital activities, viscera disorder, skin damage and itching, and mental problems. Anxiety and depression are caused by restlessness of heart spirit of an AD patient, the sleep of the patient is seriously affected, and attention is often deficient due to failure of spleen to guard, so that the AD patient is difficult to concentrate on things. Therefore, the subject group proposes that the shape and spirit treat AD simultaneously, and treat the effects of relieving heart and tranquillization, strengthening spleen and relieving itching. The invention creates a prescription for soothing nerves, relieving itching and strengthening spleen by taking raw dragon bone, calcined oyster, stir-fried medicated leaven, poria peel, weeping forsythiae capsule and the like as main medicines on the basis of dragon-bone soup.
The invention aims to provide the traditional Chinese medicine compound granule for treating physical and mental stress, relieving heart and mental stress, strengthening spleen and relieving itching, treating atopic dermatitis, relieving the itching degree of patients, improving the life quality of the patients and improving the attention of the patients, and is compatible with the characteristics of the physique and pathogenesis of children in compatibility so as to fill the current AD treatment gap and meet the needs of medical activities. In the aspect of dialectical treatment and prescription dispatching of AD, from the heart-theory treatment, the traditional clinic mostly uses fructus forsythiae, rush and the like to clear heart fire, but the prescription uses raw dragon bone and calcined oyster to calm heart and tranquilize, nourish yin and suppress yang, thereby not only improving AD skin loss, but also improving the difficult problems of night pruritus and poor sleep of AD patients. In the traditional treatment, when the traditional Chinese medicines for strengthening spleen and eliminating dampness are selected for compatibility, the traditional Chinese medicines such as rhizoma atractylodis, poria cocos, radix scutellariae and the like are mostly selected, but the subject group considers that rhizoma atractylodis is warm and strong in nature, radix scutellariae is bitter and cold, children are young yin and young yang, are easy to be cold and easy to be hot, rhizoma atractylodis is easy to help to transform heat, radix scutellariae is easy to lose spleen and stomach, and therefore the poria cocos Pi Gan, light and mild products are selected for strengthening spleen and eliminating dampness, and meanwhile the skin treatment effect is considered.
According to the traditional Chinese medicine compound prescription for treating atopic dermatitis and the preparation method thereof, the invention is applied to the traditional Chinese medicine compound prescription for treating atopic dermatitis. Aiming at the difficulties of easy recurrence, pruritus, inattention and other combined symptoms in the current AD treatment, under the guidance of the theory of 'shape and spirit simultaneous treatment' of traditional Chinese medicine, a safe and effective prescription for improving pruritus, improving the concentration level, fitting the constitution and pathogenesis of children for soothing the nerves, relieving itching and strengthening the spleen is developed.
The traditional Chinese medicine compound prescription for soothing nerves, relieving itching and strengthening spleen for treating atopic dermatitis consists of, by mass, 15-30 parts of raw dragon bone, 9-30 parts of calcined oyster, 10-30 parts of fried medicated leaven, 9-30 parts of poria peel, 6-30 parts of fructus forsythiae, 3-9 parts of ephedra root and 6 traditional Chinese medicines. The medicine has the best effect when the concentration of the medicine liquid is controlled to be 5.0g/ml when 30 parts of raw dragon bone, 30 parts of calcined oyster, 30 parts of stir-fried medicated leaven, 30 parts of poria peel, 30 parts of weeping forsythiae capsule and 6 parts of ephedra root. The traditional Chinese medicine composition has definite curative effects on treating children with mild and moderate atopic dermatitis, restlessness of heart mind and spleen deficiency and dampness accumulation, can improve the severity of diseases, improve the life quality of patients, promote the attention of the patients, and has good safety. Meanwhile, the experimental research results show that the prescription for soothing nerves, relieving itching and strengthening spleen can improve the skin damage degree of the atopic dermatitis model mouse and reduce the inflammation level.
The innovation points and advantages of the method for treating the nerve calming, itching relieving and spleen strengthening are as follows: according to the treatment method of the traditional Chinese medicine 'shape and spirit simultaneous treatment', the method fills the blank that the traditional Chinese medicine lacks of simultaneous treatment from the aspects of 'shape' and 'spirit' and the Western medicine lacks of improvement of the combined cognitive symptoms such as the attention deficit of the AD.
The prescription compatibility of the prescription for soothing nerves, relieving itching and strengthening spleen has the following innovation points and advantages: according to the traditional Chinese medicine 'anti-heart tranquillization, spleen strengthening and itching relieving' treatment method,
The raw dragon bone in the recipe is a monarch drug for relieving heart and tranquillization and fixing five viscera. Raw Keel is neutral in nature, sweet and astringent in taste, enters foot shaoyang, jueyin and shaoyin meridians, and also enters hand-operated yangming and shaoyin meridians. "drug Property theory" states that it can calm heart, dispel pathogenic qi, and is commonly used in dream-disturbed dream 32429. While atopic dermatitis patients experience restlessness, accompanied by sleep disorders, which in turn can affect the cognition of the patient. Therefore, the raw keels can calm the mind, help the patient sleep and improve the cognitive abnormalities such as attention deficit of the patient. According to the record of ' Bie Lu ', sheng Ke can nourish spirit, calm soul and calm five zang organs ' and has important regulation and treatment effects on five gods and five zang organs, and can treat both physical and mental diseases.
Calcined oyster has the effects of nourishing yin and suppressing yang. Calcined oyster is salty in taste and cool in nature. The onset of atopic dermatitis is related to heart, heart is fire accumulation, multiple fever, excessive yang is heat, and heat is heat-induced to form sores and ulcers, so that the onset of atopic dermatitis is multi-bias heat syndrome, and calcined oyster can benefit yin and subdue yang, and regulate the balance of yin and yang of the body of a patient suffering from atopic dermatitis to calm the mind in a full shape. In addition, oyster powder can be applied externally to the affected part of the first stage of carbuncle and ulcer according to the record of "elbow rear" formula. Atopic dermatitis is a long term, and it is often caused by depression due to heart-blood dysfunction or phlegm-accumulation due to spleen dysfunction, and calcined oyster can dispel carbuncles and dissipate nodulation due to nodule skin lesions on skin.
The stir-fried medicated leaven can strengthen the spleen. The stir-baked medicated leaven is sweet and pungent in taste, warm in nature, enters spleen and stomach meridians, and has the effects of strengthening spleen and stomach, promoting digestion and resolving food stagnation and reinforcing acquired root. Sweet taste can enter spleen, dispel spleen and stomach qi stagnation in middle energizer, and also can help soil, invigorate spleen and promote digestion. According to Ben Cao Zheng (Ben Cao Zheng), shen qu qi is rotten and can dehumidify and remove heat. According to the book Ben Cao Zhen (materia Medica), doctors regulate the spleen and stomach of children with Massa Medica. Spleen strengthening is done to strengthen the mind, so Massa Medicata Fermentata is used in this recipe to strengthen the spleen and benefit the mind.
Poria cocos (wolf) bark, cortex Poria cocos, has the effect of promoting diuresis. Poria is listed as the upper grade in Shen nong Ben Cao Jing, and Poria is sweet in flavor, light in taste, flat in nature, and more suitable for children than the pungent and dry, bitter and cold herbs such as Zhu and Huang Qin, etc., and is not easy to help it to dispel cold and resolve heat. Poria skin can regulate the running of water on body surface skin, open striae, help body surface damp-heat go out, and promote water passage and remove damp-heat from lower energizer.
Fructus forsythiae has effects of clearing heat and relieving itching. Fructus forsythiae is a "sores" in the heart meridian of shaoyin and the pericardium meridian of jueyin. It is recorded in the theory of medicine that Lian Qiao can clear heat of heart and home, and it is recorded in Ri Hua Zi Ben Cao to treat furuncle and sore. Therefore, in this recipe, lian Qiao is used to clear heat from the heart to eliminate skin lesions of atopic dermatitis. In addition, according to the record of the ' Yi Ji Lun ' of the ' Ka Lun Ji Ying ', the weeping Forsythia Capsule drink taking weeping Forsythia as a monarch drug can be used for treating all heat of children, so that weeping Forsythia capsule is more suitable for treating children's atopic dermatitis.
The ephedra root directs the drugs to the exterior. Sweet in flavor and neutral in nature, it can guide other herbs to the skin of defensive organ. According to Qian jin Fang Yanyi, ma Huang Gen can dispel wind-damp, and can be made into Ma Huang Gen powder together with sulfur and rice flour for external application to treat sores and ulcers. Modern researches have shown that pseudoephedrine contained in ephedra can exert anti-inflammatory and antiallergic effects by inhibiting the release of allergic medium. Studies have shown that ephedra also has immunosuppressive effects on mouse cells.
The raw keels in the prescription are monarch drugs for relieving the heart and soothing the nerves, fixing the five viscera, ministerial drugs for calcining oyster, tonifying yin and suppressing yang, stir-baked medicated leaven for strengthening the spleen, poria cocos Pi Lishi and adjuvant drugs for clearing heat to achieve the effect of relieving itching, so that the Chinese ephedra root is led to the exterior by the drug. The whole prescription treats both with the functions of relieving heart and tranquillization, strengthening spleen and relieving itching. The medicine is ingenious, and is in accordance with the physique and pathogenesis characteristics of the AD children patients.
A preparation method of a traditional Chinese medicine compound prescription for treating atopic dermatitis for soothing nerves, relieving itching and strengthening spleen comprises the following steps:
(1) Soaking Os Draconis, concha Ostreae preparata, massa Medicata Fermentata preparata, exodermis Poria, fructus forsythiae and radix Ephedrae in water respectively;
(2) Decocting Os Draconis and Concha Ostreae Preparata for 30 min, parching Massa Medicata Fermentata, decocting with 3 drugs including exodermis Poria, fructus forsythiae and radix Ephedrae in water for 2 times;
(3) The first time of 8 times of water is added for decoction for 1.5 hours, the second time of 6 times of water is added for decoction for 1 hour, the two times of water are both filtered, the filtrates are combined and concentrated until each 1ml contains 5g of crude drug, and the concentration of the drug is 5.0g/ml.
EXAMPLE 1 animal Experimental study
1. Experimental materials
1.1 laboratory animals
SPF-class BALB/c mice, 50, weighing 18-22 g, purchased from Si Bei Fu (Beijing) Biotechnology Co., ltd., license number SCXK (Beijing) 2019-0010.
1.2 Main Experimental reagents and consumables
2, 4-Dinitrochlorobenzene (DNCB), sigma Aldrich trade Co., ltd., switzerland, lot number: BCBN7826V. Olive oil, shanghai Yi En chemical technologies limited, lot number: RH104398.
The traditional Chinese medicinal materials (raw dragon bone, talcum, calcined oyster shell, stir-fried medicated leaven, poria peel, fructus forsythiae and ephedra root) used in the experiment are all Chinese herbal medicine library medicines in the western radix astragali hospital of Chinese traditional medicine department.
2. Experimental method
2.1 preparation of sensitization solution
According to the previous study, acetone and olive oil are taken according to the following weight ratio of 4:1, preparing a mixed solution matrix according to the proportion; DNCB was dissolved in a mixture of acetone and olive oil to prepare a sensitizer (w/v) at a concentration of 0.2% and 2%, respectively.
2.2 preparation of the tranquillizing, antipruritic and spleen invigorating prescription and dermatitis No. II prescription, as shown in Table 1
(1) Dermatitis No. ii (control group) was: 20g of talcum powder, 20g of calcined oyster, 10g of fried medicated leaven, 10g of poria peel, 10g of fructus forsythiae and 5g of ephedra root. (75 g in total)
(2) The nerve-soothing itching-relieving spleen-strengthening prescription 1 comprises the following components: 20g of raw dragon bone, 20g of calcined oyster, 10g of stir-fried medicated leaven, 10g of poria peel, 10g of weeping forsythiae capsule and 5g of ephedra root (75 g in total)
(3) The nerve-soothing itching-relieving spleen-strengthening prescription 2 comprises the following components: 30g of raw dragon bone, 30g of calcined oyster, 30g of stir-fried medicated leaven, 30g of poria peel, 30g of fructus forsythiae and 6g of ephedra root. (156 g in total)
Table 1 composition of the formula for tranquillizing, relieving itching and strengthening spleen
The preparation process of the nerve-soothing itching-relieving spleen-strengthening prescription 1 and the nerve-soothing itching-relieving spleen-strengthening prescription 2 are respectively as follows: decocting Os Draconis and Concha Ostreae Preparata for 30 min, parching Massa Medicata Fermentata, decocting with 3 drugs such as Poria cortex with water for 2 times, decocting with 8 times of water for 1.5 hr for the first time, decocting with 6 times of water for 1 hr for the second time, filtering, mixing filtrates, and concentrating to obtain medicinal materials 2.5g and 5g per 1ml, respectively to obtain tranquilization, antipruritic and spleen invigorating prescription 1 and tranquilization, antipruritic and spleen invigorating prescription 2. The preparation process of the dermatitis II prescription is as follows: soaking the above materials except pulvis Talci in water, decocting Concha Ostreae preparata for 30 min, decocting pulvis Talci and Massa Medicata Fermentata preparata, mixing with 3 materials such as Poria, decocting with water for 2 times, decocting with 8 times of water for 1.5 hr for the first time, decocting with 6 times of water for 1 hr for the second time, filtering, mixing filtrates, and concentrating to obtain dermatitis II.
Finally, 100ml of medicinal liquid of the formula II, the formula 1 and the formula 2 are obtained, wherein the medicinal concentration is 2.5g/ml,2.5g/ml and 5.0g/ml respectively.
2.3 establishment of a mouse model for atopic dermatitis
All experimental animals were kept in a constant temperature and humidity clean-level environment for 3 days, and were externally coated with depilatory cream on the back, and depilated after partial rubbing with gauze, with an area of 3×4cm. On week 1, the remaining mice were back skin sensitized with 2% DNCB at 200 μl/week, 2 times/week, 3 days apart. The back skin was sensitized with 0.2% DNCB at 200 μl/time, 2 times/week, 3 days apart, on weeks 2-5. The back of the mice in the blank group is coated with the mixed liquid matrix, and the time, the dosage and the times are the same as those of the mice in the other groups.
2.4 grouping and administration
50 BALB/c mice were divided into 5 groups, each blank group (n=10), model group (n=10), dermatitis No. II group (n=10), nerve-soothing, itching-relieving and spleen-strengthening group 1 (n=10), nerve-soothing, itching-relieving and spleen-strengthening group 2 (n=10). The stomach is irrigated by administering different doses of solutions of the formula of soothing nerves, relieving itching and strengthening spleen and the formula of dermatitis II at the beginning of the experiment at the 3 rd week. The blank group and the model group are provided with purified water with the same volume for stomach irrigation, and the stomach irrigation volume is 0.1ml/10g.1 time per day, and the stomach is continuously irrigated for 21 days.
The average weight of the mice is 20g, namely 0.02kg, and the dosage of the gastric lavage liquid is 0.2 ml/time, namely 25g/kg. The average weight of 6-12 year old children is about 33.5kg. The clinical dosage of the dermatitis II prescription is about 2.2g/kg, so the dosage of the dermatitis II prescription for mice lavage is about 11 times of the clinical dosage; the clinical dosage of the nerve-soothing itching-relieving spleen-strengthening prescription 1 is about 2.2g/kg, so the dosage of the nerve-soothing itching-relieving spleen-strengthening prescription 2 used for the stomach irrigation of mice in the experiment is about 11 times of the clinical dosage; the clinical dosage of the nerve-soothing itching-relieving spleen-strengthening prescription 2 is about 4.66g/kg, so the dosage of the nerve-soothing itching-relieving spleen-strengthening prescription 2 used for the stomach irrigation of mice in the experiment is about 5 times of the clinical dosage.
2.5 technical roadmap
As shown in FIG. 1, 50 BALB/c mice were grouped and dosed on a technical route pattern.
2.6 time axis
As shown in fig. 2, an atopic dermatitis mouse model was established and a time chart of the administration of the dermatitis No. ii prescription was shown.
3. Observation index and method
3.1 evaluation of AD skin loss
The AD skin damage score for this experiment was developed based on previous studies and on the atopic dermatitis integral index (scoring atopic dermatitis index, SCORAD), as shown in fig. 3.
3.2 skin tissue pathology
The method comprises the following steps:
(1) The thickness of the cut skin tissue block is about 0.2-0.3 cm, and the size is about 1.5cm multiplied by 0.3cm. The harvested tissue blocks were fixed in 10% formalin for more than 48 h.
(2) Dewatering, embedding the tissue block and slicing are sequentially performed according to a predetermined flow.
(3) The slices were subjected to dewaxing. Sequentially placing the slices into xylene I and II for 20min respectively, and absolute ethyl alcohol II, absolute ethyl alcohol I, 95% absolute ethyl alcohol, 90% absolute ethyl alcohol, 85% absolute ethyl alcohol and 70% absolute ethyl alcohol for 5min respectively. Followed by a running water rinse.
(4) Hematoxylin Eosin (HE) staining: the sections are stained with hematoxylin for 3-8min, washed with tap water, differentiated with 1% hydrochloric acid alcohol for several seconds, rinsed with tap water, and rinsed with 0.6% ammonia water to turn blue. Then the slice is put into eosin dye solution for dyeing for 1-3min, and washed by running water.
(5) Dehydrating and sealing: sequentially placing the slices into 70% absolute ethyl alcohol and 80% absolute ethyl alcohol for 5min,90% absolute ethyl alcohol and 95% absolute ethyl alcohol for 3min, dehydrating and transparentizing the slices in absolute ethyl alcohol I, absolute ethyl alcohol II, xylene II and xylene I for 5min, taking out the slices from xylene, slightly airing the slices, and sealing the slices with neutral resin. And (5) observing and photographing.
The invention establishes an atopic dermatitis mouse model through 0.2% DNCB external coating back skin sensitization, and is specifically divided into a blank group, a model group, a control group (dermatitis II formula group), a nerve-soothing itching-relieving spleen-strengthening formula 1 group and a nerve-soothing itching-relieving spleen-strengthening formula 2 group (preferred proportion group). The animal experiments are mainly found by the following analysis:
1. the atopic dermatitis mouse model was successfully replicated.
Compared with the blank control group, the back of the mice in the model group has obvious desquamation, erythema, edema and crusting, partial areas have epidermis peeling and ulcers, and epidermis is scattered in the scratch distribution (shown in figure 4).
2. The prescription for soothing nerves, relieving itching and strengthening spleen can effectively improve the skin damage of the mice with atopic dermatitis.
After treatment, the appearance of skin lesions in each group of mice is shown in fig. 5; as shown in FIG. 6, the comparison between the groups was statistically different (P < 0.001). Compared with the blank group, the skin damage scores of the mice in the group 2 of the prescription with the functions of soothing nerves, relieving itching and strengthening spleen have no obvious statistical difference (P is more than 0.05), the scores of the other groups are higher than the blank group, and the difference has statistical significance (P is less than 0.001 and P is less than 0.05); compared with the model group, the skin damage scores of mice in the dermatitis II prescription group, the nerve-soothing, itching-relieving and spleen-strengthening prescription 1 group and the nerve-soothing, itching-relieving and spleen-strengthening prescription 2 group are lower than those of the mice in the model group, the skin damage scores of the mice in the dermatitis II prescription group and the skin damage scores in the model group have no obvious statistical difference (P > 0.05), and the skin damage scores in the nerve-soothing, itching-relieving and spleen-strengthening prescription 1 group and the skin damage scores in the nerve-soothing, itching-relieving and spleen-strengthening prescription 2 group have obvious statistical differences (P < 0.05 and P < 0.001); compared with the dermatitis II prescription, the skin damage scores of the mice in the tranquillizing, antipruritic and spleen strengthening prescription 1 and the mice in the tranquillizing, antipruritic and spleen strengthening prescription 2 are lower than those of the mice in the dermatitis II prescription, the tranquillizing, antipruritic and spleen strengthening prescription 1 and the mice in the dermatitis II prescription have no obvious statistical difference (P > 0.05), the tranquillizing, antipruritic and spleen strengthening prescription 2 and the mice in the dermatitis II prescription have obvious statistical difference (P < 0.01), and the results show that the tranquillizing, antipruritic and spleen strengthening prescription has obvious improvement effects on the skin damage of the mice with atopic dermatitis, and the tranquillizing, antipruritic and spleen strengthening prescription 2 (the preferable proportioning group) has the best effects, and is shown in table 2.
TABLE 2 comparison of skin loss scores (M (P25, P75), score for each group of mice after treatment
Note that: (1) blank group; m: a model group; PY2H: dermatitis No. II group; ASZYJP1, 1 group of nerve soothing, itching relieving and spleen strengthening formulas; ASZYJP2, group 2 of tranquillizing, antipruritic and spleen strengthening prescriptions; (2) The dermatitis was compared with that of the blank group, * P＜0.05， *** p is less than 0.001; in comparison with the set of models, # P＜0.05， ### p is less than 0.001; in comparison with the dermatitis No. II prescription group, ΔΔ P＜0.01
3. the prescription for soothing nerves, relieving itching and strengthening spleen can effectively reduce the skin injury inflammation level of the atopic dermatitis mice.
Each group of mouse tissues was observed under an optical microscope for HE-stained sections, and pathological changes of each group of skin tissues were evaluated, as shown in fig. 7. Compared with the blank control group, the model group mice have partial epidermis deletion, squamous epithelium thickening, acanthosis, partial skin ulcers, dermal fibroblast hyperplasia and massive inflammatory cell infiltration. Compared with the model group, the dermatitis II prescription group and the nerve soothing, itching relieving and spleen strengthening prescription group have reduced inflammatory cells in the dermis of each group of mice. Compared with the formula II of dermatitis, the formula II has the advantages that the inflammatory cells of mice in each group are reduced, the thickness of squamous epithelium and thorn layer is thinned, the thickening of epidermis is reduced, and the formula 2 of the formula II has the most obvious improvement.
The prescription for soothing nerves, relieving itching and strengthening spleen plays a role in treating AD mice by reducing skin damage of AD model mice and reducing inflammation of AD model mice.
After treatment, mice in each group of AD models were scored for skin loss: the blank group is less than the tranquillizing, itching relieving and spleen strengthening formula 2 is less than the tranquillizing, itching relieving and spleen strengthening formula 1 is less than the dermatitis II formula is less than the model group, so that the effect of the tranquillizing, itching relieving and spleen strengthening formula 2 on improving the skin damage of the AD model mice is better than the dermatitis II formula, and the effect of the tranquillizing, itching relieving and spleen strengthening formula 2 is better than the tranquillizing, itching relieving and spleen strengthening formula 1, so that the tranquillizing, itching relieving and spleen strengthening formula 2 is the optimal proportion of the tranquillizing, itching relieving and spleen strengthening formula.
After treatment, the pathology of each group of skin tissues showed the following degree of inflammation: the blank group < the tranquillizing, itching relieving and spleen strengthening formula 2 group < the tranquillizing, itching relieving and spleen strengthening formula 1 group < the dermatitis II formula < the model group, so that the tranquillizing, itching relieving and spleen strengthening formula 2 has better effect on the skin damage tissue inflammation of the AD model mice than the dermatitis II formula, and the tranquillizing, itching relieving and spleen strengthening formula 2 has better effect than the tranquillizing, itching relieving and spleen strengthening formula 1 group, so that the tranquillizing, itching relieving and spleen strengthening formula 2 is the optimal proportion of the tranquillizing, itching relieving and spleen strengthening formula.
Modern pharmacology suggests that the dragon bone has the effects of tranquilizing, soothing nerves, resisting viruses and improving organism immunity, and has good improvement effect on clinical symptoms such as pruritus, dysphoria and sleep deprivation caused by the pruritus of the AD infants. However, no research has shown that talcum can calm and calm the nerves, so that the effect of the dragon bone in treating the AD of the children is better than that of talcum powder. The medicated leaven can produce a large amount of active substances such as digestive enzymes, volatile oil, glycosides and the like through fermentation so as to promote secretion of digestive juice and increase gastrointestinal motility; meanwhile, different kinds of microorganismssuch as microzyme, mould and the like can be produced, and the microbial ecological balance of the intestinal tract system can be regulated and protected. The poria peel contains a large amount of poria triterpene, polysaccharide, sterols and other substances, and has the effects of promoting urination, resisting oxidation, inhibiting bacteria (especially the growth inhibition effect on staphylococcus aureus and escherichia coli), resisting inflammation, whitening, regulating immunity and the like. Studies have shown that the active ingredients extracted from the skin of Poria also have anti-inflammatory effects, and can inhibit iNOS and COX-2 expression by down-regulating NF-kappaB. Modern medicine considers that factors such as bacterial infection, immune imbalance and the like are possible pathogenesis of AD, and pharmacological research of forsythia suspensa shells suggests that the forsythia suspensa has antibacterial, anti-inflammatory, antioxidant and antiviral effects. In addition, research shows that the forsythin B extracted from the weeping forsythia can act on TRPV3 cation channels to inhibit the TRPV3 cation channels, so that the scratching behavior of mice with AD models is reduced, and the weeping forsythia has an antipruritic effect on atopic dermatitis. Pseudoephedrine contained in herba Ephedrae can exert antiinflammatory and antiallergic effects by inhibiting release of allergic medium. Studies have shown that ephedra also has immunosuppressive effects on mouse cells.
The prescription for soothing the nerves, relieving itching and strengthening the spleen takes raw keels as a monarch, and the prescription for dermatitis II takes talcum powder as a monarch, and according to modern pharmacological research, the keels have the function of soothing the nerves, but the talcum does not have, so the effect of treating AD by the keels is superior to that of the talcum, and the prescription for soothing the nerves, relieving itching and strengthening the spleen is one of the reasons that the effect of the prescription for soothing the nerves, relieving itching and strengthening the spleen is superior to that of the prescription for dermatitis II. In summary, the effect of the tranquillizing, antipruritic and spleen strengthening prescription for treating AD mice is better than that of the dermatitis II prescription, and the effect of the tranquillizing, antipruritic and spleen strengthening prescription 2 for treating AD mice is better than that of the tranquillizing, antipruritic and spleen strengthening prescription 1. Therefore, the formula 2 for soothing nerves, relieving itching and strengthening spleen is the optimal proportion of the invention.
EXAMPLE 2 clinical trial study
1. Study protocol
1.1 diagnostic criteria
Western medicine disease diagnosis standard
Reference is made to the Hanifen & Rajka (H & R) atopic dermatitis diagnostic standard (which is the gold standard for current diagnosis of AD). Meanwhile, the patient who meets the main characteristics and the secondary characteristics more than or equal to 3 can be diagnosed as AD.
As shown in table 3, the severity of the disease was graded: the score (Scoring atopic dermatitis Index, score) is classified into light, medium and heavy 3 grades according to the score of atopic dermatitis. (total score=a/5+7b/2+C)
TABLE 3 severity of atopic dermatitis grading
The study was included in patients with atopic dermatitis in the light and moderate range, i.e., with a score of 1-50 SCORAD.
Diagnostic/diagnostic criteria for TCM
The four-bend wind diagnosis standard in the traditional Chinese medicine disease diagnosis curative effect standard is taken as a reference to treat the syndrome of restlessness of heart spirit, spleen deficiency and dampness accumulation.
(1) Skin damage is characterized by dryness, roughness, hypertrophic lichenification, and can have acute or subacute dermatitis-like attacks, subjective itching;
(2) Skin injury is well developed on the elbow and knee joint flexion side, and also can be seen on the leg extension side, the face neck, the periphery of the mouth and other parts;
(3) Can have the medical history of infant's wet sore, repeated attack is continuous and is not healed;
(4) Has a tendency to hypersensitive, and family or principal often has a history of asthma, urticaria, etc.;
(5) Severe skin itch, dryness, roughness, occasional flushing, exudation, itching, dysphoria, difficult sleep onset, attention deficit, possibly accompanied by poor appetite, abdominal distention, loose stool, pale tongue, greasy or white coating, weak pulse or wiry and slippery pulse.
1.2 inclusion criteria
(1) Meets the H & R diagnosis standard of western medicine and the diagnosis/syndrome standard of Chinese medicine for atopic dermatitis;
(2) Age 6 to 12 years old;
(3) SCORAD scores light, moderate;
(4) Guardians sign informed consent (i.e. if not less than 8 years old);
(5) The compliance is good.
1.3 exclusion criteria
(1) Topical, oral or systemic treatments associated with atopic dermatitis, such as topical calcineurin inhibition, have been accepted within one week;
(2) Liver and kidney dysfunction (ALT, AST greater than 1.5 times, BUN, cr greater than 1 time) or other serious disease patients;
(4) Combining other dermatological patients who affect the judgment of the severity of the disease;
(5) The history of allergy to the test drugs (drugs in the recipe of soothing nerves, relieving itching and strengthening the spleen) is known;
(6) While taking part in other clinical trials.
1.4 stop criteria
(1) In the study, subject compliance was poor, or forbidden drugs prescribed using the study protocol;
(2) The treatment is stopped when the liquid seepage is more or the itch is difficult to endure after three days of combined treatment (cold boiled water wet compress, and the itch can be also carried out by orally taking loratadine tablet) is still serious or the itch is difficult to endure. Under the condition of respecting the intention of the subject and the guardian, please the dermatologist to take other treatment methods according to the specific illness state;
(3) Other serious disease patients should stop the clinical researchers immediately at the discretion of the doctor.
(4) Serious adverse reactions occur.
1.5 termination criteria
(1) The study shows that the therapeutic effect of the medicine is poor, and the disease of the subject is repeated or aggravated, so that the whole treatment is stopped;
(2) If a clinical study protocol is found to have a major error, causing injury or irreversible damage to the subject, terminating the whole study;
(3) Treatment is withdrawn by the regulatory authorities.
1.6 treatment of abscission cases
Cases of shedding: subjects who completed at least one primary efficacy index evaluation after study drug administration, but did not complete the prescribed observation period, were eligible to enter treatment after written informed consent and screened. The abscission cases should be recorded in detail with completed observations and the abscission causes and times recorded in the treatment history.
1.7 rejection criteria
(1) Failing to meet the standard, misincorporating into the researcher;
(2) One time without the study of the required drugs;
(3) After randomization no data were recorded.
2. Research method
2.1 case selection
The main source of the study subjects is that the patients with mild and moderate atopic dermatitis in the skin department of the aster hospital of the academy of Chinese traditional Chinese medicine are diagnosed from 2021, 3 to 2021, 12, 6 to 12 years old (the date of birth is between 1, 3, 1, and 31, 2015, 12, 31 days), 66 cases in total.
2.2 medicaments
The treatment group orally administrates the prescription for soothing nerves, relieving itching and strengthening spleen, and the control group orally administrates placebo granules, 1 dose per day for 8 weeks. (1 pouch in the morning and evening, 200ml boiled water brewing, and warm administration)
The prescription for soothing nerves, relieving itching and strengthening spleen comprises the following components: 30g of raw dragon bone, 30g of calcined oyster, 30g of stir-fried medicated leaven, 30g of poria peel, 30g of fructus forsythiae and 6g of ephedra root.
The nerve soothing, itching relieving and spleen strengthening formula of the treatment group medicine and the placebo granules of the control group are provided by Beijing Kang Rentang pharmaceutical industry Co.
3 observation index
(1) General data: the baseline assessment is described by including patient name, sex, year, month and age.
(2) The main curative effect index is as follows: SCORAD score.
(3) Secondary efficacy index: including quality of life assessment and attention assessment related indicators. The quality of life assessment index was scored using the child quality of life scale CDLQI (the child's s dermatology life quality index, CDLQI). Attention-assessment related indicators were derived from the numerical rating scale (Number Cancellation Test, NCT).
4 evaluation of efficacy
The main curative effect index is as follows: SCORAD score.
Evaluation criteria reference general principles of clinical research of New Chinese medicine
(1) And (3) healing: asymptomatic, score difference of 100% before and after treatment;
(2) The method is effective: obvious symptom relief, and a SCORAD score difference of more than 50% before and after treatment;
(3) Invalidation: symptom relief was not apparent or there was no relief, with a score difference of less than 50% for SCORAD before and after treatment.
Total effective rate = (effective number + recovery number)/total number of cases × 100%.
5 statistical analysis
The statistical software selects SPSS 26.0. Metering data: the average value + -standard deviation is chosen for the normal distributor 
) The comparison between the treatment group and the control group is performed by using two independent sample t-test, and the paired t-test is adopted before and after the treatment of the treatment group or the control group. Those not meeting normal distribution are represented by median (quartile spacing) M (P25, P75), and the comparison between the treatment group and the control group is tested by rank and symbol rank and test before and after treatment of the treatment group or the control group. Counting data: and (5) adopting chi-square test. All data P<A statistical difference was considered at 0.05, using a double-sided differential test.
6 results of the study
6.1 general data
The study included 66 subjects, 33 of which were treated and 33 of which were control. Wherein, the treatment group drops off 3 cases, the control group drops off 3 cases, and 1 case is removed. The final subjects completed the trial were 59, 30 in the treatment group and 29 in the control group. Subjects included the FAS set in 61 cases, with 32 in the treatment group and 29 in the control group. Treatment group men accounted for 18 (56.3%) and women accounted for 14 (43.75%). Control men were 10 (34.5%) and women were 19 (65.5%). The median age of the treatment group was 9 years and the median age of the control group was 8 years. See fig. 8.
Before treatment, the treatment group had no statistical difference (P > 0.05) in general data such as age, sex, and the like, SCORAD score, quality of life score, and NCT score, and the general data were comparable, as shown in Table 4.
TABLE 4 patient profile baseline comparison (FAS set)
6.2 analysis of efficacy
(1) SCORAD scoring analysis
As shown in fig. 9 and 10, 8 weeks after treatment, the score a (skin loss distribution range) was lower in the treated group than in the control group by comparison analysis between groups, and the difference was statistically significant (P < 0.05); treatment group score a decreased, differences were statistically significant (P < 0.001) as analyzed by intra-group treatment pre-post comparison; control group score a decreased compared to pre-treatment, the difference was statistically significant (P < 0.01).
After 8 weeks of treatment, the score B (skin loss severity) was lower in the treated group than in the control group, the difference was statistically significant (P < 0.01) by comparison analysis between groups; treatment group score B decreased, differences were statistically significant (P < 0.001) as analyzed by intra-group treatment pre-post comparison; the difference between control group score B compared to pre-treatment was not statistically significant (P > 0.05).
After 8 weeks of treatment, the score C (itching and sleep affecting) was lower in the treated group than in the control group, the difference was statistically significant (P < 0.01); treatment group score C decreased, differences were statistically significant (P < 0.001) as analyzed by intra-group treatment pre-post comparison; control group score C decreased compared to pre-treatment, differences were statistically significant (P < 0.001); the difference between the scores C before and after treatment is compared, the difference has statistical significance (P < 0.05), the descending score of the treatment group is larger than that of the control group, and the curative effect of improving AD itch and affecting the sleeping degree of the treatment group is better than that of the control group.
After 8 weeks of treatment, the overall score of SCORAD was lower in the treated group than in the control group, the difference was statistically significant (P < 0.01); the total score of the treatment group is reduced through the comparison analysis before and after the treatment in the group, and the difference has statistical significance (P < 0.001); the total score of the control group was reduced compared to that before treatment, and the difference was statistically significant (P < 0.01); the total score of SCORAD before and after treatment of the two groups is compared, the difference has statistical significance (P < 0.001), the descending score of the treatment group is larger than that of the control group, and the treatment effect of the treatment group on the AD is better than that of the control group.
(2) Quality of life analysis
As shown in fig. 11 and 12, 8 weeks after treatment, the average CDLQI score was lower in the treatment group than in the control group, and the difference was statistically significant (P < 0.001); the average score of CDLQI in the treatment group was reduced by comparison analysis before and after treatment in the group, and the difference was statistically significant (P < 0.001); the average score of CDLQI in the control group was statistically significant (P > 0.05) compared to the pre-treatment difference; the difference between CDLQI before and after treatment is compared, the difference has statistical significance (P < 0.001), and the drop score of the treatment group is larger than that of the control group, which indicates that the treatment group has better treatment effect of improving the quality of life than that of the control group.
(3) Attention related index analysis
As shown in fig. 13, 14 and 15, after 8 weeks of treatment, the NCT scores of the treatment groups were roughly divided, net divided higher than that of the control group, the omission rate and the error rate were lower than those of the control group, and the differences were statistically significant (P <0.05 or P < 0.01); the NCT score of the treatment group is roughly divided, the net score is increased, the omission is reduced, and the difference has statistical significance (P < 0.01) through the comparison analysis before and after the treatment in the group; the NCT scoring error rate of the treatment group is not obviously different from that of the treatment group before treatment (P is more than 0.05); the NCT score of the control group is roughly divided, net divided, leaky and error rate is not statistically significant (P > 0.05) compared with that before treatment; the net differences of NCT before and after treatment of the two groups are compared, the differences have statistical significance (P < 0.01), the increasing score of the treatment group is larger than that of the control group, and the curative effect of improving the attention of the treatment group is better than that of the control group.
6.3 effective analysis
The total of 32 treatment groups included FAS set, the effective number of the treatment groups was 21, and the effective rate was 65.6%. Of these, 15 cases were judged to be valid, and 6 cases were cured; the control group included 29 FAS sets, the number of effective cases was 3, and the effective rate was 10.4%. Among them, 3 cases were judged to be effective, and 0 cases were cured. The effective rate of the treatment group is obviously higher than that of the control group, and the difference has statistical significance (P < 0.001).
6.4 part of the study is shown in figure 16 for pre-treatment and post-treatment pictures.
6.5 Security analysis
No adverse events occurred in the treatment group. The adverse event incidence rate of the control group was 9.1%, wherein the appetite was poor 1, the cold was 1, and the allergy was 1 after vaccination. 19 is combined with the medicine for treating inappetence, and the oral solution of the lysine inositol vitamin B12 is taken for 3 days; the ibuprofen suspension is taken for 1 day due to the combined administration of the cold No. 18; the post-allergy skin lesions were ameliorated by the topical glucocorticoid used after the vaccination allergy of # 53 (this example knocked out). It is judged that obvious abnormality related to therapeutic drugs does not appear in safety examination of the conventional blood and urine, liver and kidney functions and the like of the subject.
7 knots
The itching symptoms of the atopic dermatitis patients are severe, and the AD patients often have cognition related symptoms such as attention deficit and the like due to the influence of the itching on sleep and the like, so that the life quality is seriously influenced. The study finds that the prescription for soothing nerves, relieving itching and strengthening spleen can effectively improve symptoms of an AD patient by observing SCORAD scores before and after treatment of a treatment group and a control group, can obviously improve life quality by observing life quality scale scores before and after treatment of the treatment group and the control group, and can improve attention level of the AD patient by observing consumption scale scores before and after treatment of the treatment group and the control group.
Symptoms of AD patients often manifest as repeated erythema, papules, exudation, crusting throughout the body, accompanied by severe itching, and often incorporate symptoms of "mental" disorders such as sleep disorders, attention deficit, and the like, in addition to these "physical" disorders. The traditional Chinese medicine has the effects of soothing the nerves, relieving itching, strengthening the spleen Fang Zhen, soothing the nerves, strengthening the spleen, relieving itching, effectively improving skin damage, relieving itching symptoms, improving sleep of a patient and improving attention level, and is a treatment for both physical and mental health.
In summary, the pharmaceutical preparation of the invention is used for treating atopic dermatitis, and provides "treating with the same therapeutic effect", and the therapeutic method is different from the prior single therapeutic method such as treating with the same therapeutic effect from the theory of shape, and the compatibility of medicines is matched with the physical and pathological characteristics of children. Proved by researches, the prescription for soothing nerves, relieving itching and strengthening spleen can obviously improve the skin damage condition of the atopic dermatitis model mice and reduce the skin damage inflammation level. The prescription for soothing nerves, relieving itching and strengthening spleen has definite curative effect on treating the AD of the light and medium children, can reduce the itching degree and improve the sleep, can obviously improve the life quality and the attention of patients with the atopic dermatitis of the light and medium children, improves the cognitive ability of the patients, has good safety and has higher social popularization value.
The foregoing descriptions of specific exemplary embodiments of the present invention are presented for purposes of illustration and description. It is not intended to limit the invention to the precise form disclosed, and obviously many modifications and variations are possible in light of the above teaching. The exemplary embodiments were chosen and described in order to explain the specific principles of the invention and its practical application to thereby enable one skilled in the art to make and utilize the invention in various exemplary embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims and their equivalents.
Claims (4)
1. The traditional Chinese medicine compound prescription for soothing nerves, relieving itching and strengthening spleen for treating atopic dermatitis is characterized by comprising raw dragon bone, calcined oyster shell, stir-fried medicated leaven, poria peel, fructus forsythiae and ephedra root.
2. The traditional Chinese medicine compound prescription for soothing nerves, relieving itching and strengthening spleen for treating atopic dermatitis according to claim 1, which is characterized by comprising, by mass, 15-30 parts of raw dragon bone, 9-30 parts of calcined oyster, 10-30 parts of stir-fried medicated leaven, 9-30 parts of poria peel, 6-30 parts of fructus forsythiae and 3-9 parts of ephedra root.
3. The traditional Chinese medicine compound prescription for treating atopic dermatitis according to claim 1, wherein the concentration of the liquid medicine of the prescription for tranquillizing, relieving itching and strengthening spleen is 5.0g/ml.
4. The preparation method of the traditional Chinese medicine compound prescription for treating atopic dermatitis, which is characterized by comprising the following steps:
(1) Soaking Os Draconis, concha Ostreae preparata, massa Medicata Fermentata preparata, exodermis Poria, fructus forsythiae and radix Ephedrae in water respectively;
(2) Decocting Os Draconis and Concha Ostreae Preparata for 30 min, wrapping the parched Massa Medicata Fermentata with gauze, decocting Os Draconis, concha Ostreae Preparata and Massa Medicata Fermentata with Poria cortex, fructus forsythiae and radix Ephedrae in water twice, decocting in water for 1.5 hr for 8 times, and decocting in water for 1 hr for 6 times;
(3) Filtering after decocting twice, mixing filtrates, concentrating to 5g crude drug content per 1ml, and making the drug concentration 5.0g/ml.
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Non-Patent Citations (2)
| Title |
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| 株洲市康复者量化研究发展基金会: "儿童湿疹案例分享八", pages 4, Retrieved from the Internet <URL:https://mp.weixin.qq.com/s?src=11×tamp=1713754781&ver=5215&signature=aNytAMqWQzVDmRorstUCGyT6*LiCDJQ9aL62zHYK-UFvlWoY6ndLGriyNjn9oHxFkK9xv8PawjFi5vdGRv4pKDD76Mt7ev4n45E0kBAL7-xDwDvntPGVUzrHEpaN3qZV&new=1> * |
| 王雄;郎娜;付中学;: "黄尧洲教授从心论治特应性皮炎经验介绍", 世界中西医结合杂志, vol. 12, no. 01, 28 January 2017 (2017-01-28), pages 40 * |
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