CN117919318A

CN117919318A - Traditional Chinese medicine composition for treating perianal eczema and pruritus ani

Info

Publication number: CN117919318A
Application number: CN202410150370.7A
Authority: CN
Inventors: 陈琴; 彭栎帆; 娄龙; 张凤琼; 徐瑞; 朱云婴
Original assignee: Kunming Hospital of Traditional Chinese Medicine
Current assignee: Kunming Hospital of Traditional Chinese Medicine
Priority date: 2024-02-02
Filing date: 2024-02-02
Publication date: 2024-04-26

Abstract

The invention discloses a traditional Chinese medicine composition for treating perianal eczema and pruritus ani and application thereof. The traditional Chinese medicine composition for treating perianal eczema and pruritus ani can be prepared into a preparation. The traditional Chinese medicine composition and the preparation thereof can be used for preparing medicines for treating perianal eczema and pruritus ani.

Description

Traditional Chinese medicine composition for treating perianal eczema and pruritus ani

Technical Field

The invention belongs to the field of medicines, and particularly relates to a traditional Chinese medicine composition for treating perianal eczema and pruritus ani.

Background

Perianal eczema is a common disease of anorectal department, and has long disease course and high recurrence rate. The disease is an inflammatory or allergic disease which seriously affects the life quality of patients, and clinically presents symptoms such as itch, dampness, exudation, rash, rubeosis, lichenification, desquamation and skin removal of skin around anus. Mainly occurs in the perianal skin area, and can also extend to the perineum, scrotum, labia, etc. The pathogenesis of perianal eczema is very complex, the etiology mechanism of the perianal eczema is not completely defined at present, and modern medical research considers that the perianal eczema is possibly caused by a plurality of factors such as allergic reaction, local infection, endocrine disturbance, contact with metal substances and the like.

Current techniques for treating perianal eczema include topical medications, phototherapy, oral medications, surgical treatments, and the like. Topical drug treatment is the most commonly used method, including topical hormonal drugs, antifungal drugs, antibiotics, and the like. These drugs can relieve symptoms, reduce inflammation and itching, but long-term use of hormonal drugs can lead to side effects such as skin thinning, pigmentation, telangiectasia, etc. Resistance may also be developed using antifungal agents and antibiotics. Phototherapy is a method of treating perianal eczema by irradiating light of a specific wavelength. Phototherapy can reduce inflammation and itch, but multiple treatment methods are needed to take effect, and side effects such as light sensitivity and skin dryness can be caused. Oral drug therapy mainly includes antiallergic drugs, immunomodulators, antibiotics, and the like. These drugs can modulate the immune system, reduce inflammatory responses, but may cause problems with gastrointestinal distress, immunosuppression, and antibiotic resistance. Surgical treatment is mainly applicable to severe cases or patients who are not effective with other treatments. Surgery may remove diseased tissue or repair perianal areas, but is at greater risk and may lead to postoperative complications and recurrence. Therefore, there is an urgent need to find a safe, effective and non-toxic therapeutic method.

Disclosure of Invention

Aiming at the defects existing in the prior art, the invention aims to provide a traditional Chinese medicine composition for treating perianal eczema and pruritus ani. The traditional Chinese medicine composition has the effects of clearing heat and promoting diuresis, dispelling wind and relieving itching, nourishing blood and moisturizing skin, and can effectively treat perianal diseases such as perianal eczema, pruritus ani and the like caused by downward flow of damp-heat.

The invention aims at realizing the following technical scheme:

A traditional Chinese medicine composition for treating perianal eczema and pruritus ani comprises the following components in parts by weight: 10-30 parts of gypsum, 10-30 parts of fructus cnidii, 10-30 parts of fructus kochiae, 10-20 parts of radix astragali, 10-30 parts of radix sophorae flavescentis, 5-15 parts of borneol, 10-30 parts of cortex phellodendri, 10-20 parts of rhizoma atractylodis, 10-20 parts of periostracum cicadae, 10-20 parts of burdock, 10-20 parts of Sichuan pepper, 10-30 parts of herba schizonepetae, 10-30 parts of radix sileris, 10-20 parts of angelica sinensis and 10-20 parts of radix rehmanniae.

Preferably, the traditional Chinese medicine composition for treating perianal eczema and pruritus ani comprises the following components in parts by weight: 10-20 parts of gypsum, 10-20 parts of fructus cnidii, 10-20 parts of fructus kochiae, 10-15 parts of radix astragali, 10-20 parts of radix sophorae flavescentis, 5-10 parts of borneol, 10-20 parts of cortex phellodendri, 10-15 parts of rhizoma atractylodis, 10-15 parts of periostracum cicadae, 10-15 parts of burdock, 10-15 parts of Sichuan pepper, 10-20 parts of herba schizonepetae, 10-20 parts of radix sileris, 10-15 parts of angelica sinensis and 10-15 parts of radix rehmanniae.

More preferably, the traditional Chinese medicine composition for treating perianal eczema and pruritus ani comprises the following components in parts by weight: 10-15 parts of gypsum, 10-15 parts of fructus cnidii, 10-15 parts of fructus kochiae, 10-15 parts of radix astragali, 10-15 parts of radix sophorae flavescentis, 5-10 parts of borneol, 10-15 parts of cortex phellodendri, 10-15 parts of rhizoma atractylodis, 10-15 parts of periostracum cicadae, 10-15 parts of burdock, 10-15 parts of Sichuan pepper, 10-15 parts of herba schizonepetae, 10-15 parts of radix sileris, 10-15 parts of angelica sinensis and 10-15 parts of radix rehmanniae.

In the formula, gypsum, fructus cnidii, fructus kochiae and radix astragali are taken as monarch drugs, and gypsum has sweet and spicy taste and severe cold, and can clear heat, purge fire, detoxify and reduce swelling; fructus Cnidii is pungent and bitter in nature, warm in nature, dry in dampness, insecticidal and antipruritic; kochia scoparia is pungent and bitter in nature and cold in nature, and has the effects of clearing heat and drying dampness, dispelling wind and relieving itching; astragalus mongholicus is sweet and slightly warm in taste, can tonify qi, raise yang, strengthen superficies, arrest sweating, resist exogenous evils, and promote repair of damaged skin. The internal connection of four principal drugs covers a plurality of traditional Chinese medicine theories and mechanisms, including the aspects of heat-dampness pathogenesis, qi-blood conditioning, exterior-interior relationship, immunoregulation and the like. Gypsum Fibrosum has the effects of clearing heat and detoxicating, and fructus Cnidii and Kochiae are combined to clear heat and remove dampness and improve external damp-heat pathogenesis. The etiology of perianal eczema and pruritus ani is also often related to internal factors, astragalus has the functions of tonifying qi and regulating immunity, and by enhancing the qi and blood functions of the organism, the situations of qi and blood deficiency and abnormal immune functions of the organism are improved, and the perianal eczema and pruritus ani are comprehensively treated from multiple angles by being corresponding to the inside and outside of gypsum, fructus cnidii and fructus kochiae and being mutually cooperated.

The kuh-seng, borneol, phellodendron bark, rhizoma atractylodis, cicada slough, great burdock fruit and Sichuan pepper are taken as ministerial drugs, the kuh-seng is bitter and cold in nature, and is returned to heart, liver and stomach channels, the main effects of clearing heat and drying dampness, disinfestation, the borneol is bitter in nature, slightly cold, and is returned to heart, spleen and lung channels, the main effects of clearing heat and relieving pain are reduced, and the pain sensation of itching is relieved; huang Baixing are bitter and cold, clear heat, dry dampness and detoxify, the flavor of rhizoma atractylodis is slightly warm, the effects of dispelling dampness and dispelling cold are achieved, the nature of periostracum cicadae is sweet and cold, the effects of dispelling wind heat and promoting eruption and relieving itching are achieved, the nature of fructus arctii is Xin Ping, wind heat and heat can be evacuated, heat and detoxify, the nature of fructus zanthoxyli is pungent and warm, the effects of killing parasites and relieving itching are achieved, the effects of monarch drug of dispelling wind, relieving itching and detoxifying are achieved by combining the periostracum cicadae, fructus arctii and fructus zanthoxyli, and the effects of improving perianal local skin redness and swelling and inflammation symptoms are achieved in an assistance mode.

Herba schizonepetae, radix sileris, chinese angelica and dried rehmannia root are used as adjuvant drugs, and the herba schizonepetae is spicy and slightly warm in taste, has the effects of dispelling wind and relieving exterior syndrome, promoting eruption and eliminating sore, is spicy and slightly warm in flavor, has the property of dispelling wind and relieving exterior syndrome, and can neutralize cold evil through interaction, so that patients feel milder and more comfortable; the Chinese angelica is spicy and warm in nature, has the effects of nourishing blood and moisturizing skin, and the dried rehmannia root is sweet and bitter and cold in taste, can clear heat and cool blood, nourish yin and nourish blood, and has the effects of harmonizing local qi and blood, nourishing yin and moisturizing skin and improving skin loss when being combined.

The traditional Chinese medicine composition for treating perianal eczema and pruritus ani has the effects of clearing heat and promoting diuresis, dispelling wind and relieving itching, nourishing blood and moisturizing skin, and can effectively treat perianal diseases such as perianal eczema and pruritus ani.

Compared with the prior art, the invention has the beneficial effects that:

1. The traditional Chinese medicine composition disclosed by the invention comprehensively conditions and treats perianal eczema through reasonable compatibility of monarch, minister, assistant and guide medicines, and is especially suitable for perianal eczema patients with damp-heat downward flow type physique. The monarch, minister, assistant and guide medicines are matched with each other, so that the treatment effect is optimized, the method is mild and effective, and adverse reactions and side effects are reduced. Compared with single traditional Chinese medicine or traditional prescription, the traditional Chinese medicine can improve cure rate and prevent recurrence, and has positive effect on overall rehabilitation of patients.

2. The traditional Chinese medicine composition provided by the invention also has the following characteristics: the combination of the kuh-seng and the borneol enhances the effects of clearing heat, drying dampness and relieving itching, and solves two main problems of perianal eczema, namely damp-heat and itching. The borneol serving as a cold medicament can quickly reduce the temperature of skin and generate cool feel so as to effectively relieve itching and burning feel at the affected part of eczema and bring obvious relief to patients. The cold is mainly collected and the cold effect of the cold is also helpful for contracting blood vessels, alleviating local inflammatory exudation and redness. The radix Sophorae Flavescentis contains various active ingredients, wherein matrine is used as main ingredient, and has antiinflammatory effect, and can inhibit inflammatory reaction to relieve inflammation and pain. Matrine also has antibacterial and antifungal effects, and is very important for preventing secondary infection of eczema affected part, and helps to protect local skin from bacteria and fungi. Cortex Phellodendri and Gypsum Fibrosum can cool blood and detumescence, and can relieve skin red swelling and itching caused by eczema. Herba Schizonepetae, periostracum Cicadae, fructus Arctii, fructus Cnidii, kochiae fructus and fructus Zanthoxyli have effects of dispelling pathogenic wind and relieving itching, and can relieve itching of eczema patients, and reduce secondary infection caused by repeated scratching. Meanwhile, astragalus root, divaricate saposhnikovia root, rhizoma atractylodis, chinese angelica and dried rehmannia root can be used for tonifying and strengthening the exterior, tonifying qi and activating blood so as to improve the constitution of eczema patients and enhance the resistance and the repair capability of skin.

3. The traditional Chinese medicine composition disclosed by the invention is mild in property, has the characteristics of innovation combination, comprehensive treatment, reduction of side effects, improvement of life quality of patients and clinical curative effects, and is suitable for long-term hip bath fumigation.

Detailed Description

The present invention will be further described with reference to examples, but the present invention is not limited to the examples.

Example 1

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 15g of gypsum, 15g of fructus cnidii, 15g of fructus kochiae, 10 g of radix astragali, 20 g of radix sophorae flavescentis, 10 g of borneol, 15g of cortex phellodendri, 10 g of rhizoma atractylodis, 10 g of periostracum cicada, 15g of burdock, 10 g of Sichuan pepper, 25 g of herba schizonepetae, 10 g of radix sileris, 10 g of Chinese angelica and 10 g of radix rehmanniae.

Example 2

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 10 g of gypsum, 15g of fructus cnidii, 15g of fructus kochiae, 10 g of radix astragali, 25 g of radix sophorae flavescentis, 10 g of borneol, 20 g of cortex phellodendri, 10 g of rhizoma atractylodis, 15g of periostracum cicada, 10 g of burdock, 15g of Sichuan pepper, 25 g of herba schizonepetae, 10 g of radix sileris, 10 g of angelica and 10 g of radix rehmanniae.

Example 3

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 15g of gypsum, 10g of fructus cnidii, 10g of fructus kochiae, 10g of radix astragali, 30g of radix sophorae flavescentis, 5g of borneol, 30g of cortex phellodendri, 10g of rhizoma atractylodis, 15g of periostracum cicada, 10g of burdock, 15g of Sichuan pepper, 20g of herba schizonepetae, 10g of radix sileris, 10g of angelica and 10g of radix rehmanniae.

Example 4

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 15g of gypsum, 10g of fructus cnidii, 10g of fructus kochiae, 10g of radix astragali, 20g of radix sophorae flavescentis, 5g of borneol, 20g of cortex phellodendri, 10g of rhizoma atractylodis, 10g of periostracum cicada, 10g of burdock, 15g of Sichuan pepper, 20g of herba schizonepetae, 10g of radix sileris, 10g of angelica and 10g of radix rehmanniae.

Example 5

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 10g of gypsum, 10g of fructus cnidii, 10g of fructus kochiae, 10g of radix astragali, 20g of radix sophorae flavescentis, 5g of borneol, 15g of cortex phellodendri, 15g of rhizoma atractylodis, 15g of periostracum cicada, 10g of burdock, 15g of Sichuan pepper, 20g of herba schizonepetae, 10g of radix sileris, 10g of angelica and 10g of radix rehmanniae.

Example 6

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 10g of gypsum, 15g of fructus cnidii, 15g of fructus kochiae, 10g of radix astragali, 20g of radix sophorae flavescentis, 5g of borneol, 15g of cortex phellodendri, 15g of rhizoma atractylodis, 15g of periostracum cicada, 10g of burdock, 15g of Sichuan pepper, 20g of herba schizonepetae, 10g of radix sileris, 10g of angelica and 10g of radix rehmanniae.

Example 7

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 10 g of gypsum, 15g of fructus cnidii, 15g of fructus kochiae, 10 g of radix astragali, 30 g of radix sophorae flavescentis, 10 g of borneol, 20 g of cortex phellodendri, 15g of rhizoma atractylodis, 15g of periostracum cicada, 10 g of burdock, 15g of Sichuan pepper, 15g of herba schizonepetae, 10 g of radix sileris, 10 g of angelica and 10 g of radix rehmanniae.

Example 8

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 10 g of gypsum, 15g of fructus cnidii, 15g of fructus kochiae, 10 g of radix astragali, 30 g of radix sophorae flavescentis, 10 g of borneol, 20 g of cortex phellodendri, 15g of rhizoma atractylodis, 10 g of periostracum cicada, 15g of burdock, 15g of Sichuan pepper, 20 g of herba schizonepetae, 15g of radix sileris, 10 g of Chinese angelica and 10 g of radix rehmanniae.

Example 9

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 20 g of gypsum, 15g of fructus cnidii, 15g of fructus kochiae, 10 g of radix astragali, 25 g of radix sophorae flavescentis, 10 g of borneol, 20 g of cortex phellodendri, 15g of rhizoma atractylodis, 10 g of periostracum cicada, 15g of burdock, 15g of Sichuan pepper, 20 g of herba schizonepetae, 15g of radix sileris, 15g of Chinese angelica and 15g of radix rehmanniae.

Example 10

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 30g of gypsum, 15g of fructus cnidii, 15g of fructus kochiae, 10g of radix astragali, 25 g of radix sophorae flavescentis, 5g of borneol, 30g of cortex phellodendri, 15g of rhizoma atractylodis, 10g of periostracum cicada, 15g of burdock, 10g of Sichuan pepper, 20g of herba schizonepetae, 15g of radix sileris, 15g of Chinese angelica and 15g of radix rehmanniae.

Example 11

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 10g of gypsum, 10g of fructus cnidii, 10g of fructus kochiae, 10g of radix astragali, 10g of radix sophorae flavescentis, 5g of borneol, 10g of cortex phellodendri, 10g of rhizoma atractylodis, 10g of periostracum cicadae, 10g of burdock, 10g of Sichuan pepper, 10g of herba schizonepetae, 10g of radix sileris, 10g of angelica and 10g of radix rehmanniae.

Example 12

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 20 g of gypsum, 20 g of fructus cnidii, 20 g of fructus kochiae, 15g of radix astragali, 20 g of radix sophorae flavescentis, 10 g of borneol, 20 g of cortex phellodendri, 15g of rhizoma atractylodis, 15g of periostracum cicada, 15g of burdock, 15g of Sichuan pepper, 20 g of herba schizonepetae, 20 g of radix sileris, 15g of Chinese angelica and 15g of radix rehmanniae.

Example 13

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 30 g of gypsum, 30 g of fructus cnidii, 30 g of fructus kochiae, 20 g of radix astragali, 30 g of radix sophorae flavescentis, 15g of borneol, 30 g of cortex phellodendri, 20 g of rhizoma atractylodis, 20 g of periostracum cicada, 20 g of burdock, 20 g of pericarpium zanthoxyli, 30 g of schizonepeta, 30 g of radix sileris, 20 g of Chinese angelica and 20 g of radix rehmanniae.

Example 14

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 10g of gypsum, 15g of fructus cnidii, 20g of fructus kochiae, 18 g of astragalus, 30g of radix sophorae flavescentis, 5g of borneol, 15g of amur corktree bark, 15g of rhizoma atractylodis, 18 g of periostracum cicada, 20g of burdock, 10g of Sichuan pepper, 15g of herba schizonepetae, 20g of radix sileris, 17 g of Chinese angelica and 20g of dried rehmannia root.

Example 15

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 15g of gypsum, 20g of fructus cnidii, 25 g of fructus kochiae, 20g of astragalus, 10g of radix sophorae flavescentis, 8g of borneol, 20g of amur corktree bark, 18 g of rhizoma atractylodis, 20g of periostracum cicada, 10g of burdock, 12 g of Sichuan pepper, 20g of schizonepeta, 25 g of radix sileris, 20g of Chinese angelica and 10g of dried rehmannia root.

Example 16

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 20g of gypsum, 25g of fructus cnidii, 30g of fructus kochiae, 10g of radix astragali, 15g of radix sophorae flavescentis, 10g of borneol, 25g of cortex phellodendri, 20g of rhizoma atractylodis, 10g of periostracum cicada, 12g of burdock, 15g of Sichuan pepper, 25g of herba schizonepetae, 30g of radix sileris, 10g of Chinese angelica and 12g of radix rehmanniae.

Example 17

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 25 g of gypsum, 30 g of fructus cnidii, 10 g of fructus kochiae, 13 g of radix astragali, 20 g of radix sophorae flavescentis, 12 g of borneol, 30 g of cortex phellodendri, 10 g of rhizoma atractylodis, 12 g of periostracum cicada, 15g of burdock, 18 g of Sichuan pepper, 30 g of herba schizonepetae, 10 g of radix sileris, 13 g of angelica and 15g of radix rehmanniae.

Example 18

A Chinese medicinal composition for treating perianal eczema and pruritus ani comprises the following components: 30 g of gypsum, 10 g of fructus cnidii, 15g of fructus kochiae, 15g of radix astragali, 25 g of radix sophorae flavescentis, 15g of borneol, 10 g of cortex phellodendri, 12 g of rhizoma atractylodis, 15g of periostracum cicada, 18 g of burdock, 20 g of Sichuan pepper, 10 g of herba schizonepetae, 15g of radix sileris, 15g of angelica and 18 g of radix rehmanniae.

Example 19

A Chinese medicinal composition for treating perianal eczema and pruritus ani is prepared by weighing medicinal materials according to the weight of the Chinese medicinal composition in any one of embodiments 1-18, and preparing the Chinese medicinal composition by the following steps: mixing all the above materials, soaking in 10 times of water for 1 hr, decocting with water for 2 times for 30min, mixing 2 decoctions, and filtering to obtain liquid preparation.

Clinical study of application example 1-the Chinese medicinal composition of the invention for treating perianal eczema

1. Data and method

1.1 Study object

The study subjects were selected from 80 sub-acute perianal eczema patients, 56 female patients and 24 male patients; age 24-80 years, average (49.6+ -12.8) years. The disease course varies from 1 to 48 months, and the average (14.4+/-11.4) months. The 80 patients were randomly divided into control and treatment groups, 40 each, with no statistical differences in sex, age and course of disease (P > 0.05) for the two groups, comparable.

1.2 Diagnostic criteria for perianal eczema

1.2.1 Western diagnostic criteria

According to the diagnosis and treatment guidelines for eczema, which are formulated by the immunological group of the cutaneous classification of the Chinese medical society, the clinical manifestations of eczema are classified into acute, subacute and chronic three phases. (1) acute phase: on the basis of erythema and edema, large pimples, blisters, erosion and exudation are often heavy in the center of lesions, and gradually spread to the periphery, scattered pimples and pimples are arranged on the periphery, so that the boundaries are unclear. (2) subacute phase: the redness, swelling and exudation are reduced, and the erosion surface is scabbed and desquamated. (3) chronic phase: coarse hypertrophy and moss-like changes may be accompanied by pigment changes. Eczema occurs in the perianal region, and the perianal eczema is diagnosed.

1.2.2 Diagnostic criteria for TCM

Referring to the diagnosis and treatment of perianal eczema in the diagnosis and treatment guide of common diseases of anorectal diseases of traditional Chinese medicine published by the Chinese society of traditional Chinese medicine in 2012, the diagnosis and treatment of perianal eczema is classified into a downward flow of damp-heat syndrome, a blood deficiency and wind dryness syndrome and a spleen deficiency and dampness accumulation syndrome.

(1) Syndrome of downward flow of damp-heat: the symptoms are skin flushing, swelling, erosion, lipid water overflow, flooding into flakes, itching, crusting, local tenderness, constipation, short and rapid urine, ruddy tongue, yellow and greasy coating and slippery and rapid pulse. (2) blood deficiency and wind dryness syndrome: it is mainly red, swelling and itching. The symptoms are that the skin is flushed and infiltrated, pimples and scales are combined, the tongue is red, the coating is white, and the pulse is rapid. (3) spleen deficiency and dampness accumulation pattern: the symptoms are thickening of perianal skin, purple and dark color, or chapped skin, or reddish skin, erosion, liquid seepage, crusting, intractable illness and repeated attacks, and often accompanied with lassitude and hypodynamia, inappetence, white and greasy tongue fur, soft and thin pulse and weakness.

1.3 Screening criteria

1.3.1 Inclusion criteria

(1) Perianal eczema patients with damp-heat downward flow pattern meeting the diagnosis standards of the traditional Chinese medicine and the western medicine; (2) between 18 and 80 years of age; (3) Patients who voluntarily participated in and who were able to cooperate with the study and signed informed consent.

1.3.2 Exclusion criteria

(1) Pregnant or lactating women; (2) Patients with diabetes, immune dysfunction, and mental disorders; (3) Patients with anal fistula, condyloma acuminata and other perianal primary diseases are treated without operation; (4) Drugs affecting the therapeutic effect, such as corticosteroids, immunomodulators, antihistamines, etc., are used in the near 2 weeks.

1.4 Method

(1) Control group: adopts hemorrhoid-washing liquid (main components of kuh-seng, phellodendron bark, chinese gall, cnidium fruit, baikal skullcap root, pagodatree pod and borneol, and is an intracorporal preparation [ the execution standard is Yunnan ZJGF-454-2019, approval document is Yunnan medicine word-making (Z) 20082299A ]) 250mL, and the Chinese medicinal materials are diluted by 9 times of warm boiled water and then are subjected to hip bath for 15 minutes, 1 time each in the morning and evening. 7 days is a treatment course, and 2 treatment courses are taken.

(2) Treatment group: the medicinal liquid prepared according to the method described in example 19 was subjected to hip bath using the Chinese medicinal composition described in example 3, one dose per day, 1000mL per dose, and the anus was immersed in the medicinal liquid for 15 minutes by heating to about 37-40 ℃ before use. 7 days is a treatment course, 2 treatment courses are taken, and the curative effect is observed after the treatment is finished.

1.5 Standard of efficacy

And (3) setting a curative effect judgment standard according to the Chinese medicine new medicine clinical research guidelines, wherein symptom integral improvement= (total integral of pre-treatment symptom and total integral of post-treatment symptom and total integral of pre-treatment symptom and sign is multiplied by 100 percent). Total integral = perianal pruritus degree integral + perianal pruritus duration integral + perianal skin lesion area integral. And (3) healing: the symptom integral improvement rate is more than or equal to 95 percent; the effect is shown: the symptom integral improvement rate is more than or equal to 70% and less than 95%; the method is effective: the symptom integral improvement rate is more than or equal to 50 percent and less than 70 percent; invalidation: the symptom score improvement rate is less than 50 percent. Total effective rate (%) = [ (number of recovery cases + number of significant cases + number of effective cases)/(total cases ] ×100%).

1.6 Statistical treatment

The quantitative data of the study are expressed by mean ± standard deviation, the qualitative data are described by percentage, and the counting data are checked by χ ².

2 Results

2.1 Curative effect results

After 2 treatment courses, the control group patients are clinically cured by 5 cases, 10 cases are effectively cured by 13 cases, 12 cases are effectively cured by 12 cases, the clinical cure rate is 12.5%, and the total effective rate is 70.0%; the treatment group patients are clinically cured by 12 cases, 18 cases, 8 cases, 2 cases, 30.0% of clinical cure rate and 95.0% of total effective rate. The clinical cure rate and the total effective rate of the treatment group are obviously higher than those of the control group, and are shown in table 1. The total integration before and after treatment for both groups is compared and shown in Table 2.

As can be seen from table 2, the difference was statistically significant (P > 0.05) compared to the total integral prior to treatment in the treatment group and the control group; the difference was statistically significant (P < 0.05) compared to the total integral after treatment in the treatment group and the control group. The result shows that the traditional Chinese medicine composition provided by the invention has a remarkable curative effect on perianal eczema.

Clinical study of application example 2-the Chinese medicinal composition of the invention for treating pruritus ani

1. Data and method

1.1 Study object

The study subjects were selected from 40 patients with anal itching, 26 female patients and 14 male patients; age 25-78 years, average (52.1+ -13.1) years. The disease course varies from 1 to 24 months, and the average (7.1+/-5.5) months. The 40 patients were divided into a control group and a treatment group, 20 patients each, and the two groups of patients were comparable with no statistical differences in sex, age and course of disease (P > 0.05).

1.2 Diagnostic criteria for pruritus ani

1.2.1 Western diagnostic criteria

Reference is made to the diagnostic criteria for pruritus ani in "Chinese anorectal theory": (1) subjective perianal itching, such as ant walking, worm climbing; (2) Itching is aggravated at night or after the user eats spicy food, and mental stress, anxiety and sleep disorder are caused; (3) Early perianal skin itching is severe, the skin itching is light and heavy, intermittent or continuous, the hand is scratched and has stinging pain, burning pain, and severe itching and insanity are caused by gradual development, pimples, erythema, erosion, incrustation of scratch marks, hypertrophy and thickening of skin wrinkles or skin moss-like changes, pigment loss or pigmentation can be caused, and chapping can also occur.

1.2.2 Diagnostic criteria for TCM

The traditional Chinese medicine pattern of pruritus ani-damp-heat downward pouring pattern is formulated by referring to the diagnosis and treatment guide of common diseases of anorectal diseases of traditional Chinese medicine issued by the Chinese medical society in 2012 and the clinical study guidelines of new traditional Chinese medicine issued by the national drug administration in 2000: itching of the anus, swelling of the skin at the anal folds, localized wet rot and maceration of the skin, and often a fishy smell. The patients often suffer from dysphoria and restlessness due to severe itching and inability to self-stop scratching, even at night. A red tongue with yellow coating and a wiry and slippery pulse. Secondary symptoms associated therewith include: dry stool or constipation; dry throat and bitter taste; yellow urine.

1.3 Screening criteria

1.3.1 Inclusion criteria

(1) The anus pruritus patients with damp-heat downward flow pattern which meet the diagnosis standards of the traditional Chinese medicine and the western medicine; (2) between 18 and 80 years of age; (3) Patients who voluntarily participated in and who were able to cooperate with the study and signed informed consent.

1.3.2 Exclusion criteria

1.4 Method

(1) Control group: the hemorrhoids lotion (main components of kuh-seng, cortex phellodendri, chinese gall, cnidium monnieri, radix scutellariae, sophora fruit and borneol) is adopted, and the preparation in hospital is [ the execution standard is Yunnan ZJGF-454-2019, the approval document is Yunnan medicine preparation (Z) 20082299A ] 250mL, and the Chinese medicinal materials are diluted with 9 times of warm boiled water and then hip bath is carried out for 15 minutes, wherein 1.7 days in the morning and evening are a treatment course, and 2 treatment courses are taken.

(2) Treatment group: the medicinal liquid prepared according to the method described in example 19 was subjected to hip bath using the Chinese medicinal composition described in example 6, one dose per day, 1000mL per dose, and the anus was immersed in the medicinal liquid for 15 minutes by heating to about 37-40 ℃ before use. 7 days is a treatment course, 2 treatment courses are taken, and the curative effect is observed after the treatment is finished.

1.5 Standard of efficacy

According to quantification of the traditional Chinese medicine disease diagnosis curative effect standard, an integration method is adopted: n= (integration before treatment-integration after treatment)/integration before treatment x 100%. Total integral = perianal pruritus degree integral + perianal pruritus duration integral. And (3) healing: n is more than or equal to 90 percent; the effect is shown: n is more than or equal to 70% and less than 90%; the method is effective: n is more than or equal to 30% and less than 70%; invalidation: n is less than 30 percent. Total effective rate (%) = [ (number of recovery cases + number of significant cases + number of effective cases)/(total cases ] ×100%).

1.6 Statistical treatment

2 Results

2.1 Curative effect results

After 2 treatment courses, the control group patients are clinically cured by 3 cases, 2 cases are effectively treated by 5 cases, 10 cases are effectively treated by 10 cases, the clinical cure rate is 15.0%, and the total effective rate is 50.0%; the treatment group patients are clinically cured by 11 cases, 5 cases, 3 cases, 1 case, 55.0% of clinical cure rate and 95.0% of total effective rate. The clinical cure rate and total effective rate of the treatment group are obviously higher than those of the control group, and are shown in table 3. The total integration before and after treatment for both groups is compared and shown in Table 4.

As can be seen from table 4, the difference was statistically significant (P > 0.05) compared to the total integral prior to treatment in the treatment group and the control group; the difference was statistically significant (P < 0.05) compared to the total integral after treatment in the treatment group and the control group. The result shows that the traditional Chinese medicine composition has a certain curative effect for treating pruritus ani.

Claims

1. A traditional Chinese medicine composition for treating perianal eczema and pruritus ani comprises the following components in parts by weight: 10-30 parts of gypsum, 10-30 parts of fructus cnidii, 10-30 parts of fructus kochiae, 10-20 parts of radix astragali, 10-30 parts of radix sophorae flavescentis, 5-15 parts of borneol, 10-30 parts of cortex phellodendri, 10-20 parts of rhizoma atractylodis, 10-20 parts of periostracum cicadae, 10-20 parts of burdock, 10-20 parts of Sichuan pepper, 10-30 parts of herba schizonepetae, 10-30 parts of radix sileris, 10-20 parts of angelica sinensis and 10-20 parts of radix rehmanniae.

2. The traditional Chinese medicine composition for treating perianal eczema and pruritus ani according to claim 1, which comprises the following components in parts by weight: 10-20 parts of gypsum, 10-20 parts of fructus cnidii, 10-20 parts of fructus kochiae, 10-15 parts of radix astragali, 10-20 parts of radix sophorae flavescentis, 5-10 parts of borneol, 10-20 parts of cortex phellodendri, 10-15 parts of rhizoma atractylodis, 10-15 parts of periostracum cicadae, 10-15 parts of burdock, 10-15 parts of Sichuan pepper, 10-20 parts of herba schizonepetae, 10-20 parts of radix sileris, 10-15 parts of angelica sinensis and 10-15 parts of radix rehmanniae.

3. The traditional Chinese medicine composition for treating perianal eczema and pruritus ani according to claim 2, which comprises the following components in parts by weight: 10-15 parts of gypsum, 10-15 parts of fructus cnidii, 10-15 parts of fructus kochiae, 10-15 parts of radix astragali, 10-15 parts of radix sophorae flavescentis, 5-10 parts of borneol, 10-15 parts of cortex phellodendri, 10-15 parts of rhizoma atractylodis, 10-15 parts of periostracum cicadae, 10-15 parts of burdock, 10-15 parts of Sichuan pepper, 10-15 parts of herba schizonepetae, 10-15 parts of radix sileris, 10-15 parts of angelica sinensis and 10-15 parts of radix rehmanniae.

4. The preparation of the traditional Chinese medicine composition for treating perianal eczema and pruritus ani according to any one of claims 1 to 3, wherein the preparation is prepared by adding pharmaceutically acceptable auxiliary materials into the traditional Chinese medicine composition for treating perianal eczema and pruritus ani.

5. The formulation of a traditional Chinese medicine composition for treating perianal eczema and pruritus ani according to claim 4, wherein the formulation is a liquid formulation.

6. The use of a traditional Chinese medicine composition for treating perianal eczema and pruritus ani according to any one of claims 1 to 3, wherein the use of the traditional Chinese medicine composition for treating perianal eczema and pruritus ani in the preparation of a medicament for treating perianal eczema and pruritus ani.

7. The use of the preparation of the traditional Chinese medicine composition for treating perianal eczema and pruritus ani according to claim 4, wherein the use of the preparation of the traditional Chinese medicine composition for treating perianal eczema and pruritus ani in preparing medicines for treating perianal eczema and pruritus ani is disclosed.