阅读说明：本技术 当归细辛液体药剂在制备治疗慢性湿疹的药物中的应用 (Application of angelica sinensis asarum liquid medicament in preparation of medicament for treating chronic eczema ) 是由 王新锋 邓安远 余玛俐 涂华新 李萌 樊伊娜 彭虎 张伟伟 于 2019-09-30 设计创作，主要内容包括：本发明提供了当归细辛液体药剂在治疗慢性湿疹中的应用。本发明首次将当归细辛药剂(当归细辛酒或当归细辛汤)用于治疗慢性湿疹。实验表明,在口服中药汤剂的基础上,外敷当归细辛酒(皮损者用当归细辛汤代替),在慢性湿疹治疗的皮损EASI评分方面优势明显,临床疗效显著,有利于慢性湿疹患者的快速康复。(The invention provides an application of angelica sinensis asarum liquid medicament in treating chronic eczema. The invention firstly uses angelica asarum medicament (angelica asarum wine or angelica asarum soup) for treating chronic eczema. Experiments show that on the basis of oral administration of the traditional Chinese medicine decoction, the Chinese angelica asarum wine is externally applied (a person with skin damage is replaced by the Chinese angelica asarum soup), has obvious advantages in the aspect of evaluation of the EASI for treating the skin damage of chronic eczema and obvious clinical curative effect, and is beneficial to rapid rehabilitation of patients with chronic eczema.)

1. Application of Chinese angelica and asarum liquid medicament in preparing medicament for treating chronic eczema is provided.

2. The use according to claim 1, wherein the chronic eczema is caused by blood deficiency and cold-dampness.

3. The use of claim 1, wherein said Angelica sinensis Asarum liquid medicament is an external preparation.

4. The use of claim 1, wherein the Angelica sinensis Asarum liquid medicament is Angelica sinensis wine and/or Angelica sinensis Asarum decoction.

5. The use of claim 1, wherein the angelica and asarum liquid medicament is prepared from a traditional Chinese medicine composition comprising 30-45g of angelica, 30-45g of divaricate saposhnikovia root, 30-45g of asarum, 10-35g of prepared monkshood and 20-35g of ephedra.

6. The use of claim 2, wherein the angelica and asarum liquid medicament is prepared from a traditional Chinese medicine composition comprising 45g of angelica, 45g of divaricate saposhnikovia root, 45g of asarum, 10g of prepared aconite root and 35g of ephedra herb.

7. The use according to any one of claims 1 to 6, wherein the medicament further comprises an oral medicament for the treatment of chronic eczema.

8. The use of claim 7, wherein the oral medicament is a four-substance wind-dispelling drink.

9. The use of claim 4, wherein the Angelica sinensis Asarum wine is prepared by the steps of:

(1) crushing the medicinal materials in the prescription, putting the medicinal materials into a gauze bag, tying the gauze bag, and soaking the gauze bag into a container filled with 1800ml of wine with alcohol content of more than 53 degrees for more than 7 days;

(2) sealing the container, boiling in water, boiling for 15-25 min, extinguishing, naturally cooling, and storing in shade.

10. The use of claim 4, wherein the Angelica sinensis Asarum decoction is prepared by the steps of:

(1) soaking the medicines in the prescription in 1200-1800ml of cold water for 1-2 hours;

(2) after soaking, boiling with strong fire, decocting with slow fire for 35-50 min, and removing residue.

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to application of Chinese angelica and asarum liquid medicament in treating chronic eczema.

Background

Chronic eczema is developed from acute and subacute eczema, has long course of disease and is difficult to heal repeatedly. Clinically, the skin is dry, desquamation, erythema and pruritus are often marked, scratches and erosion are often caused, and the life quality and physical and psychological health of patients are seriously affected.

Western medicine is mainly treated by glucocorticoid and immunomodulator through external application, and patients with severe symptoms often take antihistamine, immunosuppressant and the like through oral administration, so that the long-term curative effect is not ideal, and the diseases are easy to relapse after the medicine is stopped. Meanwhile, the long-term external use of hormone has the problems of large side effect, easy local telangiectasis, folliculitis, skin thickening, pigmentation and the like.

The traditional Chinese medicine method (including oral administration, external treatment and acupuncture) has a long history of treating eczema, and has obvious advantages in the aspects of relieving the disease condition, preventing relapse, maintaining long-term stability of the disease condition, improving the life quality of patients and the like. However, in clinical application, the existing traditional Chinese medicine means has poor curative effect when aiming at the coexistence of blood deficiency factors and cold-dampness factors of chronic eczema patients, which may be related to air and water pollution, air conditioning and abuse of antibiotics in recent years. Therefore, there is a need to develop new regimens for treating chronic eczema.

Disclosure of Invention

Through the intensive research of the inventor, the angelica sinensis asarum wine and/or the angelica sinensis asarum soup are used for treating the chronic eczema for the first time. Therefore, the invention provides the application of the angelica sinensis asarum liquid medicament in preparing the medicament for treating the chronic eczema.

In the application of the invention, the chronic eczema is preferably chronic eczema caused by blood deficiency factors and cold-dampness factors.

In the application of the invention, the angelica sinensis asarum liquid medicament is preferably an external preparation.

In the application of the invention, the angelica asarum liquid medicament is angelica asarum wine and/or angelica asarum soup.

In the application of the invention, the Chinese angelica and asarum liquid medicament is prepared from a traditional Chinese medicine composition comprising 30-45g of Chinese angelica, 30-45g of divaricate saposhnikovia root, 30-45g of asarum, 10-35g of prepared monkshood and 20-35g of ephedra. Further, in the application of the invention, the angelica sinensis and asarum herb wine is prepared from a traditional Chinese medicine composition comprising 45g of angelica sinensis, 45g of divaricate saposhnikovia root, 45g of asarum herb, 10g of prepared monkshood and 35g of ephedra herb.

In one embodiment of the application of the invention, the invention also comprises an oral medicament for treating chronic eczema; preferably, the oral medicine is a four-herb wind-dispelling decoction. In this embodiment, the angelica sinensis asarum liquid medicament is for external application on an eczema wound to assist in the treatment of chronic eczema.

In the application of the invention, the preparation method of the angelica sinensis asarum wine comprises the following steps:

(1) crushing the medicinal materials in the prescription, putting the medicinal materials into a gauze bag, tying the gauze bag, and soaking the gauze bag into a container filled with 1800ml of wine with alcohol content of more than 53 degrees for more than 7 days;

(2) sealing the container, boiling in water, boiling for 15-25 min, extinguishing, naturally cooling, and storing in shade.

In the application of the invention, the preparation method of the angelica sinensis and asarum decoction comprises the following steps:

(1) soaking the medicinal materials in the prescription with cool water 1200-;

(2) after soaking, boiling with strong fire, decocting with slow fire for 35-50 min, and removing residue.

Experiments show that the angelica sinensis asarum wine prepared by the invention is externally applied on the basis of oral traditional Chinese medicine decoction (for example, four-herb wind-dispelling decoction), the advantage in the aspect of skin injury EASI scoring is obvious, and the clinical results show that the difference has statistical significance; there was an advantage in the degree of itching, but the difference was not statistically significant.

The angelica sinensis and asarum wine is from the holy-economical bibliography, has the effects of activating blood circulation to expel wind, dispelling cold and relieving pain, and is used for treating wind-cold-dampness arthralgia and limb pain. The inventor finds in clinical practice that the angelica sinensis and asarum sieboldii wine can be used for treating chronic eczema, is reliable in curative effect, provides an effective traditional Chinese medicine treatment scheme for treating chronic eczema, and avoids side effects caused by the use of western medicines.

In addition, the Chinese angelica and asarum liquid medicament can be externally applied to the affected part of eczema to treat chronic eczema, is convenient to take, does not suffer from the bad taste of the Chinese medicaments, and improves the medication compliance. More excellent clinical curative effect is obtained by externally applying the angelica sinensis asarum liquid medicament. .

Detailed Description

In order to verify the effect of the angelica sinensis asarum liquid medicament in treating chronic eczema, the inventor carries out clinical tests on chronic eczema patients who are diagnosed in the department of medicine and meet inclusion standards in the recovery and caress hospital in Tanghe county in Nanyang city of Henan province from 11 months in 2017 to 4 months in 2019, and the clinical tests are described as follows.

First, case selection

(ii) diagnostic criteria

Referring to clinical research guiding principles diagnostic standard related to chronic eczema treated by new traditional Chinese medicines in clinical research guiding principles (trial) of new traditional Chinese medicines, the following diagnostic standard of chronic eczema is drawn up:

1. it can be caused by the recurrence of acute or subacute stages, or chronic eczema at the beginning.

2. The skin lesions are localized at one or more sites, and have a brownish or brownish pigmentation with a small amount of scales or lichenification.

3. A chronic course, but often with acute episodes.

(II) inclusion case criteria

1. Meets the diagnosis standard of the chronic eczema.

2. The age is 18-60 years, male and female are not limited, and the patients have independent behavior ability.

3. Before treatment, patients do not take medicines orally within 30 days or take medicines related to the disease externally within 7 days.

4. The patient signs an informed consent, the informed consenter.

(III) criteria for excluding cases

1. Pregnant or lactating women.

2. Allergic constitution or allergic to the test medicament and certain components thereof.

3. Serious cardiovascular and cerebrovascular, liver, kidney, metabolic diseases, autoimmune diseases, psychosis, etc.;

4. corticosteroids and other immunosuppressive agents (such as Tripterygium wilfordii) are taken within about 1 month or other antihistamines are taken within 7 days.

5. Are participating in clinical trials with other drugs.

(IV) criteria for case exclusion

1. The compliance is poor, and people who take the medicine according to the specified method or receive other methods during the treatment process are not treated according to the specified method.

2. Serious adverse reactions or special physiological changes occur, and the patients should not be taken continuously.

3. The patient is left out of the treatment course for various reasons.

4. Incomplete data affects the judgment of validity and safety.

(V) case grouping

The time of signing the informed consent is used as the sequence, and the single-number arrival persons are classified into the control group and the double-number arrival persons are classified into the experimental group.

Second, treatment and observation methods

(one) treatment course

The patients are treated for 2 weeks continuously, and the follow-up is carried out 2 weeks and 6 weeks after the treatment is finished.

(II) non-drug treatment

Both control and experimental groups received non-drug treatment:

1. during medication period, all experimental patients pay attention to light diet, no smoking, no wine and the like.

2. No herbs with moving wind such as fishy smell, pungent and spicy taste are forbidden.

(III) pharmaceutical treatment

1. Control group

Referring to the traditional Chinese medicine science, the textbook of the department of traditional Chinese medicine, the treatment scheme is as follows:

the oral Chinese medicinal preparation, the four-herb wind-dispelling decoction, comprises the following components:

the prescription composition is as follows: radix rehmanniae 15g Angelicae sinensis l0g Schizonepeta tenuifolia l0g ledebouriella seseloides l0g

Radix Paeoniae Rubra 15g rhizoma Ligustici Chuanxiong l0g cortex Dictamni Radicis 15g periostracum Cicadae l0g

Radix Angelicae Pubescentis l0g bupleuri l0g fructus Jujubae 2 pieces (torn) herba Menthae l0g (back lower)

Tribulus terrestris L0g for severe pruritus, Concha Margaritifera 30g and semen Ziziphi Spinosae l0g for those with pruritus and insomnia, and herba Dendrobii L0g and radix scrophulariae 15g for those with dry mouth and throat.

The decocting method comprises the following steps:

1) soaking the medicines (except the mint) in 1500ml of clear water at normal temperature for 30-40 minutes;

2) boiling with strong fire, decocting with slow fire for 30 min, and mixing with herba Menthae for two times (5 min before taking out herba Menthae from the pot during the second decoction).

The taking method comprises the following steps:

1) it is administered with empty stomach 60 min before meal, and after heating, 3 times daily, and one dose daily.

2) After the medicine is taken, the hot porridge or hot water can be taken frequently in small amount (with the effect of assisting the medicine); 3) after the medicine is taken, the wind is sheltered for 30 minutes, the patient slightly sweats, and the patient sweats at least once every day;

1 dose/day, taken warm in the morning, at noon and evening with empty stomach for three times.

2. Experimental group

On the basis of the treatment scheme of the control group, the Chinese angelica and asarum wine is used for external application, and the Chinese angelica and asarum soup is used for external application instead of the damaged part of the skin.

The external application method comprises the following steps: dipping an appropriate amount of radix Angelicae sinensis herba asari wine or radix Angelicae sinensis herba asari decoction (at a degree of no outflow) with 8 layers of gauze before sleeping every night, placing on the affected part, and wrapping and fixing with medical waterproof patch. The patient is removed after getting up in the morning.

Third, evaluation of safety

Patients are asked periodically during the administration period for local or systemic adverse reactions. The local adverse reactions comprise allergic reactions such as pruritus, pain, burning, red swelling and the like of the rash part; the general adverse reactions include gastrointestinal reaction, dizziness, palpitation, tinnitus, abnormal sleep and the like. The occurrence and duration of adverse reactions, clinical manifestations, severity, drug relevance, measures taken and outcome of patients are recorded in detail.

Fourth, evaluation of therapeutic efficacy

Efficacy was evaluated in terms of the wet epidemic Area And Severity Index (EASI, Eczema Area And Severity Index) score And the itch score.

(one) EASI scoring

1. Division of severity of eczema

The severity of each eczema was divided according to the severity in table 1.

TABLE 1 Classification of severity of eczema

The severity of each clinical presentation was scored on a scale of 0-3, 0 being none, 1 being light, 2 being medium and 3 being heavy. The score for each symptom may be scored halfway, i.e., 0.5.

2. Calculation of eczema area

The whole body can be divided into 4 parts: head/neck (H), Upper Limb (UL), torso (T), Lower Limb (LL) (where upper limb includes the lateral axilla and hands, torso includes the mid-axilla and groin, and lower limb includes hip and feet). According to the new nine divisions of China, the four parts occupy approximately 10%, 20%, 30% and 40% of the whole body area.

And then the proportion score of the area of the part according to the eczema is 7 grades: 0 is no rash on the part, 1 is that the area of the part of eczema accounts for less than 10 percent of the area of the part, and the rest is 10 to 19 percent of 2, 20 to 49 percent of 3, 50 to 69 percent of 4, 70 to 89 percent of 5 and 90 to 100 percent of 6.

Calculation of EASI score

The total eczema affected parts were counted and the score calculated with reference to table 2, in combination with the severity classification of each eczema affected part in table 1.

TABLE 2 evaluation chart of eczema area and severity

(II) evaluation of degree of itching

For each eczema, the affected area was graded and scored according to table 3. And after statistics, adding the results to obtain a itching degree score result.

TABLE 3 evaluation of pruritus

(III) observation points for treatment

To understand the pre-and post-treatment status of both groups of patients, the experiment performed an EASI score and a itch score at 4 observation points before (0 weeks), after (2 weeks), and 2 weeks after (4 weeks total), 6 weeks after (8 weeks total).

Fifth, analysis of experimental data

The experiment is included in 90 cases, and 45 cases are respectively included in a control group and an experimental group. Wherein, the control group drops 3 cases, and the dropping rate is 6.6%; the experimental group fell off 2 cases, and the falling off rate was 4.4%, which did not affect the overall evaluation.

Before treatment

1. Age, disease course

The basic cases of the two groups of patients are shown in table 4, and independent sample t-test is adopted for statistics.

TABLE 4 age, course of disease

As can be seen from Table 4, the difference between the ages and the courses of the two groups of patients was small and was not statistically significant.

EASI scoring and itch degree scoring

The EASI and itch degree scores were performed for each patient using the methods in Table 1, Table 2, and Table 3, and the mean and standard deviation were calculated, as shown in Table 5, and the statistics were performed using independent sample t-test.

TABLE 5 Preserve EASI score and Prurity score

As can be seen from Table 5, the EASI and itch scores of both groups of patients before treatment were very small and not statistically significant.

(II) after treatment

1. Comparison of EASI scores for skin lesions

Following treatment, the lesion EASI scores for both groups of patients are shown in table 6, and the statistics were performed using independent sample t-tests.

TABLE 6EASI scoring sheet

As can be seen from Table 6, the EASI scores of the two groups of patients were statistically significant in the 3 observation points after treatment, 2 weeks after treatment, and 6 weeks after treatment.

2. Comparison of degree of itching

After treatment, the itch scores of both groups of patients are shown in table 7, and the statistics were performed using independent sample t-tests.

TABLE 7 evaluation of degree of pruritus

As can be seen from the data in Table 7, the degree of itching in both groups of patients was superior, but not statistically significant, in the experimental group at 3 observation points after treatment, 2 weeks after treatment, and 6 weeks after treatment.

(III) safety index

TABLE 8 adverse reactions table

As can be seen from Table 8, the adverse reactions in the experimental groups were high, mainly due to the burning caused by the stimulation of external application.

Sixth, conclusion

(one) therapeutic effect

As shown in Table 6, when the Chinese angelica and asarum liquid medicament is used for treating chronic eczema, the Chinese angelica and asarum liquid medicament has obvious advantages in the aspect of scoring of the lesion EASI, and the difference has statistical significance.

As shown in Table 7, the Dang Gui Xixin liquid preparation has a preponderance in the degree of itching when used for treating chronic eczema, but the difference has no statistical significance.

The Chinese angelica and asarum wine or the Chinese angelica and asarum soup is used for treating chronic eczema, so that the skin damage condition of a patient can be obviously improved, the itching degree of a eczema affected part is low in the treatment process, the bad feeling of the patient is reduced, and the patient can easily accept the Chinese angelica and asarum wine or the Chinese angelica and asarum soup. The angelica sinensis asarum wine or the angelica sinensis asarum soup can also be independently used for treating mild chronic eczema through external application and used for after-treatment after normal treatment of chronic eczema.

(II) evaluation of safety

As can be seen from Table 8, the adverse reactions in the experimental group were higher than those in the control group, which was mainly due to the addition of the topical treatment regimen, and the local burning caused by the irritation when the Danggui Manchurian wildginger wine (or Danggui Manchurian wildginger wine soup) was applied externally. However, these mild adverse effects have little effect on the final therapeutic effect and are within acceptable limits.

Clinical cases of typical cases 1

Wangzhi, male, 47 years old, worker in the bedroom of Henan Nanyang city, and diagnosed in 2018 in 2 months. The skin becomes dry, desquamation and pruritus within 15cm below the inner groin of the thigh on both sides after bathing in the evening, and a small amount of liquid flows out after scratching. No treatment was given.

Deep pulse, wiry and weak pulse. Pale tongue with side teeth marks and sublingual vessels. The eyelids were pale.

The four wind-dispelling decoction is taken orally, and the angelica sinensis and asarum wine is applied externally every night (the damaged part of the skin is changed into the angelica sinensis and asarum decoction for external application, and the specific application method is shown in the experimental group treatment method part in the specific embodiment).

After two weeks of continuous treatment, the affected part has smooth skin, no dryness and basically no pruritus (pruritus caused by fatigue and water leakage at the affected part). The visit was repeated six weeks after treatment, and all were normal.

Clinical case 2

Guo in a man, 7 years old, Nanyang city Fang Cheng county, 1 month in 2018. The skin at the elbow and popliteal fossa is hypertrophic and dry, and has erythema, scratch, and scabbing. The parent generation is as follows: repeated itching at the elbow and popliteal fossa in the last half year, and the itching is relieved after oral administration of Tongrentang angelica and lightyellow sophora root pills and external use of the monasone furoate trimyriasis, but relapse is easy after the medicine is stopped.

The tongue is proper, the coating is proper, and the eyelid is pale.

The four wind-dispelling decoction is taken orally, and the angelica sinensis and asarum wine is applied externally every night (the damaged part of the skin is changed into the angelica sinensis and asarum decoction for external application, and the specific application method is shown in the experimental group treatment method part in the specific embodiment).

After one week of continuous treatment, the itching of the affected part disappears. After two weeks of continuous treatment, each symptom disappeared. The visit was repeated six weeks after treatment, and all were normal.

According to clinical cases, the Chinese angelica and asarum wine and/or the Chinese angelica and asarum decoction are used for the adjuvant treatment of chronic eczema for the first time, and good clinical effects are achieved.