A traditional Chinese medicine composition for treating perianal eczema and anal itching

Abstract

The application discloses a traditional Chinese medicine composition for treating perianal eczema and anal itching and application thereof. The traditional Chinese medicine composition is composed of gypsum, cnidium seed, kadsura fruit, astragalus root, sophora flavescens, borneol, phellodendron, atractylodes, periostracum cicadae, thistle seed, Sichuan pepper, schizonepeta, saposhnicovia divaricata, angelica sinensis and raw rehmannia. The traditional Chinese medicine composition for treating perianal eczema and anal itching can be prepared into preparations. The traditional Chinese medicine composition and the preparations can be used for preparing medicines for treating perianal eczema and anal itching.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceuticals, specifically relating to a traditional Chinese medicine composition for treating perianal eczema and anal itching. Background Technology

[0002] Perianal eczema is a common disease in proctology, characterized by a long course and high recurrence rate. This inflammatory or allergic disease severely impacts patients' quality of life, clinically manifesting as itching, dampness, oozing, redness, lichenification, and peeling of the skin around the anus. It primarily occurs in the perianal area but can extend to the perineum, scrotum, and labia. The etiology of perianal eczema is complex, and its pathogenesis is not fully understood. Modern medical research suggests that it may be caused by a combination of factors, including allergic reactions, local infections, endocrine disorders, and contact with metallic substances.

[0003] Current treatments for perianal eczema include topical medication, phototherapy, oral medication, and surgery. Topical medication is the most common method, including topical corticosteroids, antifungal drugs, and antibiotics. These medications can relieve symptoms and reduce inflammation and itching, but long-term use of corticosteroids may lead to side effects such as thinning of the skin, pigmentation, and telangiectasia. The use of antifungal drugs and antibiotics may also lead to drug resistance. Phototherapy treats perianal eczema by irradiating it with specific wavelengths of light. Phototherapy can reduce inflammation and itching, but multiple treatments are required to see results, and it may cause side effects such as photosensitivity and dry skin. Oral medication mainly includes antihistamines, immunomodulators, and antibiotics. These medications can regulate the immune system and reduce inflammatory responses, but may cause gastrointestinal discomfort, immunosuppression, and antibiotic resistance. Surgical treatment is mainly suitable for severe cases or patients who have not responded to other treatments. Surgery can remove diseased tissue or repair the perianal area, but it carries significant risks, potentially leading to postoperative complications and recurrence. Therefore, there is an urgent need to find safe, effective, and non-toxic treatment methods. Summary of the Invention

[0004] To address the shortcomings of existing technologies, the present invention aims to provide a traditional Chinese medicine composition for treating perianal eczema and anal itching. The traditional Chinese medicine composition of the present invention has the effects of clearing heat and dampness, dispelling wind and relieving itching, and nourishing blood and moisturizing the skin, and can effectively treat perianal diseases such as perianal eczema and anal itching caused by damp-heat accumulation.

[0005] The objective of this invention is achieved through the following technical solution:

[0006] A traditional Chinese medicine composition for treating perianal eczema and anal pruritus, comprising the following components by weight: 10-30 parts gypsum, 10-30 parts Cnidium monnieri, 10-30 parts Kochia scoparia, 10-20 parts Astragalus membranaceus, 10-30 parts Sophora flavescens, 5-15 parts borneol, 10-30 parts Phellodendron chinense, 10-20 parts Atractylodes lancea, 10-20 parts Cicadae periostracum, 10-20 parts Arctium lappa, 10-20 parts Zanthoxylum bungeanum, 10-30 parts Schizonepeta tenuifolia, 10-30 parts Saposhnikovia divaricata, 10-20 parts Angelica sinensis, and 10-20 parts Rehmannia glutinosa.

[0007] Preferably, the traditional Chinese medicine composition for treating perianal eczema and anal pruritus comprises, by weight, the following components: 10-20 parts gypsum, 10-20 parts Cnidium monnieri, 10-20 parts Kochia scoparia, 10-15 parts Astragalus membranaceus, 10-20 parts Sophora flavescens, 5-10 parts borneol, 10-20 parts Phellodendron chinense, 10-15 parts Atractylodes lancea, 10-15 parts Cicadae periostracum, 10-15 parts Arctium lappa, 10-15 parts Zanthoxylum bungeanum, 10-20 parts Schizonepeta tenuifolia, 10-20 parts Saposhnikovia divaricata, 10-15 parts Angelica sinensis, and 10-15 parts Rehmannia glutinosa.

[0008] More preferably, the traditional Chinese medicine composition for treating perianal eczema and anal pruritus comprises, by weight, the following components: 10-15 parts gypsum, 10-15 parts Cnidium monnieri, 10-15 parts Kochia scoparia, 10-15 parts Astragalus membranaceus, 10-15 parts Sophora flavescens, 5-10 parts borneol, 10-15 parts Phellodendron chinense, 10-15 parts Atractylodes lancea, 10-15 parts Cicadae periostracum, 10-15 parts Arctium lappa, 10-15 parts Zanthoxylum bungeanum, 10-15 parts Schizonepeta tenuifolia, 10-15 parts Saposhnikovia divaricata, 10-15 parts Angelica sinensis, and 10-15 parts Rehmannia glutinosa.

[0009] In this formula, gypsum, Cnidium monnieri, Kochia scoparia, and Astragalus membranaceus serve as the principal herbs. Gypsum is sweet, pungent, and very cold in nature, and can clear heat, purge fire, detoxify, and reduce swelling. Cnidium monnieri is bitter, pungent, and warm in nature, and can dry dampness, kill parasites, and relieve itching. Kochia scoparia is bitter, pungent, and cold in nature, and can clear heat, dry dampness, dispel wind, and relieve itching. Astragalus membranaceus is sweet and slightly warm in nature, and can tonify qi, raise yang, consolidate the exterior, stop sweating, resist external pathogens, and promote the repair of damaged skin. The internal connection between the four principal herbs encompasses multiple TCM theories and mechanisms, including the pathogenesis of heat-dampness, qi and blood regulation, the relationship between exterior and interior, and immune regulation. Gypsum has the function of clearing heat and detoxifying, while Cnidium monnieri and Kochia scoparia can both dry dampness. The combination of the three herbs clears heat and dries dampness, improving the external damp-heat pathogenesis. The causes of perianal eczema and anal itching are often related to internal factors. Astragalus has the effects of replenishing qi and regulating immunity. By enhancing the body's qi and blood function, it can improve the condition of insufficient qi and blood and abnormal immune function. It works synergistically with gypsum, Cnidium monnieri and Kochia scoparia to treat perianal eczema and anal itching from multiple angles.

[0010] Sophora flavescens, borneol, Phellodendron chinense, Atractylodes lancea, Cicadae periostracum, Arctium lappa, and Zanthoxylum bungeanum are used as assistant herbs. Sophora flavescens is bitter and cold in nature, and enters the heart, liver, and stomach meridians. Its main function is to clear heat and dry dampness, and kill parasites. Borneol is bitter, pungent, and slightly cold in nature, and enters the heart, spleen, and lung meridians. It is more inclined to clear heat and relieve pain, and reduce itching and pain. The "Huangdi Neijing Suwen·Zhizhen Yaoda Lun" states that "all pain, itching, and sores belong to the heart." When the heart meridian is hot and the qi and blood are stagnant, itching and pain occur. The combination of the two herbs is mainly used to treat the heat toxicity, itching, and pain of perianal eczema and anal itching. The symptoms have a good synergistic and auxiliary effect on the principal drug; Phellodendron bark is bitter and cold in nature, clearing heat, drying dampness and detoxifying; Atractylodes rhizome is bitter and slightly warm in nature, with the functions of dispelling dampness and dispersing cold; Cicadae periostracum is sweet and cold in nature, with the functions of dispersing wind-heat, promoting rash and relieving itching; Arctium lappa is pungent and neutral in nature, which can disperse wind-heat, clear heat and detoxify; Zanthoxylum bungeanum is pungent and warm in nature, mainly attacking insects and relieving itching. The combination of Cicadae periostracum, Arctium lappa and Zanthoxylum bungeanum enhances the effects of the principal drug in dispelling wind, relieving itching and detoxifying, and helps to improve the symptoms of redness and inflammation of the perianal skin.

[0011] Schizonepeta, Saposhnikovia, Angelica sinensis, and Rehmannia glutinosa are used as adjuvant herbs. Schizonepeta is pungent and slightly warm, and has the functions of dispelling wind and relieving exterior symptoms, promoting rash eruption and eliminating sores. Saposhnikovia is pungent and slightly warm, and also dispels wind and relieves exterior symptoms. Both Schizonepeta and Saposhnikovia have pungent and warm properties, and their interaction can neutralize cold pathogens, making patients feel more gentle and comfortable. Angelica sinensis is pungent, sweet, and warm, and has the function of nourishing blood and moisturizing the skin. Rehmannia glutinosa is sweet, bitter, and cold, and can clear heat, cool blood, nourish yin and blood. The combination of the two can regulate local qi and blood stagnation, nourish yin and moisturize the skin, and improve skin lesions.

[0012] The traditional Chinese medicine composition used to treat perianal eczema and anal itching has the effects of clearing heat and dampness, dispelling wind and relieving itching, and nourishing blood and moisturizing the skin. It can effectively treat perianal diseases such as perianal eczema and anal itching.

[0013] Compared with the prior art, the present invention has the following advantages:

[0014] 1. The traditional Chinese medicine composition described in this invention, through a rational combination of principal, assistant, and adjuvant herbs, comprehensively treats perianal eczema, especially suitable for patients with perianal eczema of the damp-heat syndrome type. The synergistic effect of the principal, assistant, and adjuvant herbs optimizes the therapeutic effect, making it gentle yet effective, and reducing adverse reactions and side effects. Compared to single-herb traditional Chinese medicine or traditional prescriptions, it can improve the cure rate and prevent recurrence, playing a positive role in the overall recovery of patients.

[0015] 2. The traditional Chinese medicine composition described in this invention also has the following characteristics: The combined use of Sophora flavescens and borneol enhances the effects of clearing heat, drying dampness, and relieving itching, solving the two main problems of perianal eczema: damp heat and itching. Borneol, as a cold-natured medicine, can quickly lower the skin temperature, producing a cooling sensation to effectively reduce itching and burning sensations at the eczema site, bringing significant relief to the patient. Its cold nature also helps to constrict blood vessels, reducing local inflammatory exudation and redness. Sophora flavescens contains various active ingredients, primarily matrine, which has anti-inflammatory properties and can inhibit inflammatory responses to reduce redness and pain. Matrine also has certain antibacterial and antifungal effects, which are crucial for preventing secondary infections at the eczema site, helping to protect the local skin from bacterial and fungal infections. Phellodendron amurense and gypsum can cool the blood and reduce swelling, alleviating symptoms such as skin redness and itching caused by eczema. Schizonepeta, cicada slough, burdock fruit, cnidium fruit, kochia fruit, and Sichuan pepper have the effects of dispelling wind and relieving itching, which can soothe the itching of eczema patients and reduce secondary infections caused by repeated scratching. At the same time, astragalus, saposhnikovia, atractylodes, angelica, and rehmannia can also strengthen the body's defenses, replenish qi and promote blood circulation, thereby improving the constitution of eczema patients and enhancing the skin's resistance and repair capabilities.

[0016] 3. The traditional Chinese medicine composition described in this invention is mild in nature and has the characteristics of innovative combination, comprehensive treatment, reduced side effects, improved quality of life for patients and clinical efficacy. It is suitable for long-term sitz baths and fumigation. Detailed Implementation

[0017] The present invention will be further described below with reference to the embodiments, but the present invention is not limited to the embodiments.

[0018] Example 1

[0019] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 15g gypsum, 15g Cnidium monnieri, 15g Kochia scoparia, 10g Astragalus membranaceus, 20g Sophora flavescens, 10g borneol, 15g Phellodendron chinense, 10g Atractylodes lancea, 10g Cicadae periostracum, 15g Arctium lappa, 10g Zanthoxylum bungeanum, 25g Schizonepeta tenuifolia, 10g Saposhnikovia divaricata, 10g Angelica sinensis, and 10g Rehmannia glutinosa. Example 2

[0020] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 10g gypsum, 15g Cnidium monnieri, 15g Kochia scoparia, 10g Astragalus membranaceus, 25g Sophora flavescens, 10g borneol, 20g Phellodendron chinense, 10g Atractylodes lancea, 15g Cicadae periostracum, 10g Arctium lappa, 15g Zanthoxylum bungeanum, 25g Schizonepeta tenuifolia, 10g Saposhnikovia divaricata, 10g Angelica sinensis, and 10g Rehmannia glutinosa. Example 3

[0021] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 15g gypsum, 10g Cnidium monnieri, 10g Kochia scoparia, 10g Astragalus membranaceus, 30g Sophora flavescens, 5g borneol, 30g Phellodendron chinense, 10g Atractylodes lancea, 15g Cicadae periostracum, 10g Arctium lappa, 15g Zanthoxylum bungeanum, 20g Schizonepeta tenuifolia, 10g Saposhnikovia divaricata, 10g Angelica sinensis, and 10g Rehmannia glutinosa. Example 4

[0022] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 15g gypsum, 10g Cnidium monnieri, 10g Kochia scoparia, 10g Astragalus membranaceus, 20g Sophora flavescens, 5g borneol, 20g Phellodendron chinense, 10g Atractylodes lancea, 10g Cicadae periostracum, 10g Arctium lappa, 15g Zanthoxylum bungeanum, 20g Schizonepeta tenuifolia, 10g Saposhnikovia divaricata, 10g Angelica sinensis, and 10g Rehmannia glutinosa. Example 5

[0023] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 10g gypsum, 10g Cnidium monnieri, 10g Kochia scoparia, 10g Astragalus membranaceus, 20g Sophora flavescens, 5g borneol, 15g Phellodendron chinense, 15g Atractylodes lancea, 15g Cicadae periostracum, 10g Arctium lappa, 15g Zanthoxylum bungeanum, 20g Schizonepeta tenuifolia, 10g Saposhnikovia divaricata, 10g Angelica sinensis, and 10g Rehmannia glutinosa. Example 6

[0024] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 10g gypsum, 15g Cnidium monnieri, 15g Kochia scoparia, 10g Astragalus membranaceus, 20g Sophora flavescens, 5g borneol, 15g Phellodendron chinense, 15g Atractylodes lancea, 15g Cicadae periostracum, 10g Arctium lappa, 15g Zanthoxylum bungeanum, 20g Schizonepeta tenuifolia, 10g Saposhnikovia divaricata, 10g Angelica sinensis, and 10g Rehmannia glutinosa. Example 7

[0025] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 10g gypsum, 15g Cnidium monnieri, 15g Kochia scoparia, 10g Astragalus membranaceus, 30g Sophora flavescens, 10g borneol, 20g Phellodendron chinense, 15g Atractylodes lancea, 15g Cicadae periostracum, 10g Arctium lappa, 15g Zanthoxylum bungeanum, 15g Schizonepeta tenuifolia, 10g Saposhnikovia divaricata, 10g Angelica sinensis, and 10g Rehmannia glutinosa. Example 8

[0026] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 10g gypsum, 15g Cnidium monnieri, 15g Kochia scoparia, 10g Astragalus membranaceus, 30g Sophora flavescens, 10g borneol, 20g Phellodendron chinense, 15g Atractylodes lancea, 10g Cicadae periostracum, 15g Arctium lappa, 15g Zanthoxylum bungeanum, 20g Schizonepeta tenuifolia, 15g Saposhnikovia divaricata, 10g Angelica sinensis, and 10g Rehmannia glutinosa. Example 9

[0027] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 20g gypsum, 15g Cnidium monnieri, 15g Kochia scoparia, 10g Astragalus membranaceus, 25g Sophora flavescens, 10g borneol, 20g Phellodendron chinense, 15g Atractylodes lancea, 10g Cicadae periostracum, 15g Arctium lappa, 15g Zanthoxylum bungeanum, 20g Schizonepeta tenuifolia, 15g Saposhnikovia divaricata, 15g Angelica sinensis, and 15g Rehmannia glutinosa. Example 10

[0028] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 30g gypsum, 15g Cnidium monnieri, 15g Kochia scoparia, 10g Astragalus membranaceus, 25g Sophora flavescens, 5g borneol, 30g Phellodendron chinense, 15g Atractylodes lancea, 10g Cicadae periostracum, 15g Arctium lappa, 10g Zanthoxylum bungeanum, 20g Schizonepeta tenuifolia, 15g Saposhnikovia divaricata, 15g Angelica sinensis, and 15g Rehmannia glutinosa. Example 11

[0029] A traditional Chinese medicine composition for treating perianal eczema and anal itching, comprising the following components: 10g gypsum, 10g Cnidium monnieri, 10g Kochia scoparia, 10g Astragalus membranaceus, 10g Sophora flavescens, 5g borneol, 10g Phellodendron chinense, 10g Atractylodes lancea, 10g Cicadae periostracum, 10g Arctium lappa, 10g Zanthoxylum bungeanum, 10g Schizonepeta tenuifolia, 10g Saposhnikovia divaricata, 10g Angelica sinensis, and 10g Rehmannia glutinosa. Example 12

[0030] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 20g gypsum, 20g Cnidium monnieri, 20g Kochia scoparia, 15g Astragalus membranaceus, 20g Sophora flavescens, 10g borneol, 20g Phellodendron chinense, 15g Atractylodes lancea, 15g Cicadae periostracum, 15g Arctium lappa, 15g Zanthoxylum bungeanum, 20g Schizonepeta tenuifolia, 20g Saposhnikovia divaricata, 15g Angelica sinensis, and 15g Rehmannia glutinosa. Example 13

[0031] A traditional Chinese medicine composition for treating perianal eczema and anal itching, comprising the following components: 30g gypsum, 30g Cnidium monnieri, 30g Kochia scoparia, 20g Astragalus membranaceus, 30g Sophora flavescens, 15g borneol, 30g Phellodendron chinense, 20g Atractylodes lancea, 20g Cicadae periostracum, 20g Arctium lappa, 20g Zanthoxylum bungeanum, 30g Schizonepeta tenuifolia, 30g Saposhnikovia divaricata, 20g Angelica sinensis, and 20g Rehmannia glutinosa. Example 14

[0032] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 10g gypsum, 15g Cnidium monnieri, 20g Kochia scoparia, 18g Astragalus membranaceus, 30g Sophora flavescens, 5g borneol, 15g Phellodendron chinense, 15g Atractylodes lancea, 18g Cicadae periostracum, 20g Arctium lappa, 10g Zanthoxylum bungeanum, 15g Schizonepeta tenuifolia, 20g Saposhnikovia divaricata, 17g Angelica sinensis, and 20g Rehmannia glutinosa. Example 15

[0033] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 15g gypsum, 20g Cnidium monnieri, 25g Kochia scoparia, 20g Astragalus membranaceus, 10g Sophora flavescens, 8g borneol, 20g Phellodendron chinense, 18g Atractylodes lancea, 20g Cicadae periostracum, 10g Arctium lappa, 12g Zanthoxylum bungeanum, 20g Schizonepeta tenuifolia, 25g Saposhnikovia divaricata, 20g Angelica sinensis, and 10g Rehmannia glutinosa. Example 16

[0034] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 20g gypsum, 25g Cnidium monnieri, 30g Kochia scoparia, 10g Astragalus membranaceus, 15g Sophora flavescens, 10g borneol, 25g Phellodendron chinense, 20g Atractylodes lancea, 10g Cicadae periostracum, 12g Arctium lappa, 15g Zanthoxylum bungeanum, 25g Schizonepeta tenuifolia, 30g Saposhnikovia divaricata, 10g Angelica sinensis, and 12g Rehmannia glutinosa. Example 17

[0035] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 25g gypsum, 30g Cnidium monnieri, 10g Kochia scoparia, 13g Astragalus membranaceus, 20g Sophora flavescens, 12g borneol, 30g Phellodendron chinense, 10g Atractylodes lancea, 12g Cicadae periostracum, 15g Arctium lappa, 18g Zanthoxylum bungeanum, 30g Schizonepeta tenuifolia, 10g Saposhnikovia divaricata, 13g Angelica sinensis, and 15g Rehmannia glutinosa. Example 18

[0036] A traditional Chinese medicine composition for treating perianal eczema and anal itching comprises the following components: 30g gypsum, 10g Cnidium monnieri, 15g Kochia scoparia, 15g Astragalus membranaceus, 25g Sophora flavescens, 15g borneol, 10g Phellodendron chinense, 12g Atractylodes lancea, 15g Cicadae periostracum, 18g Arctium lappa, 20g Zanthoxylum bungeanum, 10g Schizonepeta tenuifolia, 15g Saposhnikovia divaricata, 15g Angelica sinensis, and 18g Rehmannia glutinosa. Example 19

[0037] A traditional Chinese medicine composition for treating perianal eczema and anal itching is prepared by weighing the medicinal materials according to the weight of any one of the traditional Chinese medicine compositions described in Examples 1-18 and following the steps below: after mixing all the medicinal materials, soak them in 10 times their weight of water for 1 hour, then decoct them twice with water for 30 minutes each time, combine the two decoctions, filter them and the liquid preparation can be obtained.

[0038] Application Example 1 – Clinical Study of the Traditional Chinese Medicine Composition of the Invention for the Treatment of Perianal Eczema

[0039] 1. Materials and Methods

[0040] 1.1 Research Subjects

[0041] The study subjects were selected from 80 patients with subacute perianal eczema in our hospital, including 56 females and 24 males; their ages ranged from 24 to 80 years, with a mean age of (49.6±12.8) years. The duration of disease ranged from 1 to 48 months, with a mean duration of (14.4±11.4) months. The 80 patients were randomly divided into a control group and a treatment group, with 40 patients in each group. There were no statistically significant differences between the two groups in terms of gender, age, and duration of disease. P (>0.05), making them comparable.

[0042] 1.2 Diagnostic criteria for perianal eczema

[0043] 1.2.1 Western Medicine Diagnostic Criteria

[0044] According to the "Guidelines for the Diagnosis and Treatment of Eczema" formulated by the Immunology Group of the Dermatology and Venereology Branch of the Chinese Medical Association, eczema is divided into three stages: acute, subacute, and chronic, based on its clinical manifestations. (1) Acute stage: erythema, edema, millet-sized papules, papulovesicles, vesicles, erosions, and exudation. The center of the lesion is often more severe, gradually spreading to the periphery. There are scattered papules and papulovesicles on the periphery, so the borders are unclear. (2) Subacute stage: redness, swelling, and exudation are reduced, and the eroded surface crusts and desquamates. (3) Chronic stage: roughness, thickening, lichenification, and may be accompanied by pigmentation changes. If eczema occurs in the perianal area, it is diagnosed as perianal eczema.

[0045] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria

[0046] Referring to the TCM syndrome differentiation and diagnosis of perianal eczema in the "Guidelines for Diagnosis and Treatment of Common Diseases in TCM Anorectal Surgery" published by the China Association of Traditional Chinese Medicine in 2012, it is divided into three syndromes: damp-heat syndrome, blood deficiency and wind-dryness syndrome, and spleen deficiency and dampness syndrome.

[0047] (1) Damp-heat syndrome: Symptoms include flushed, swollen, eroded, and oozing sebum, spreading in patches, itching, crusting, local tenderness, constipation, frequent and scanty urination, red and moist tongue, yellow and greasy tongue coating, and slippery and rapid pulse. (2) Blood deficiency and wind-dryness syndrome: Mainly characterized by redness, swelling and itching. Symptoms include flushed and moist skin, papules and scales, red tongue, white tongue coating, and rapid pulse. (3) Spleen deficiency and dampness syndrome: Symptoms include thickened and purplish-dark skin around the anus, or peeling and cracking, or slightly red skin, which erodes, oozes, and crusts when scratched. The condition is stubborn and recurs frequently, often accompanied by fatigue, loss of appetite, white and greasy tongue coating, and weak and thready pulse.

[0048] 1.3 Screening Criteria

[0049] 1.3.1 Inclusion Criteria

[0050] (1) Patients with perianal eczema of the damp-heat syndrome type who meet the above diagnostic criteria of traditional Chinese and Western medicine; (2) Patients aged 18-80 years; (3) Patients who are willing to participate and cooperate with the study and sign the informed consent form.

[0051] 1.3.2 Exclusion Criteria

[0052] (1) Pregnant or lactating women; (2) Patients with diabetes, low immune function, or mental illness; (3) Patients with primary perianal diseases such as anal fistula or condyloma acuminata who have not undergone surgical treatment; (4) Patients who have used corticosteroids, immunomodulators, antihistamines, or other drugs that affect the treatment effect within the past two weeks.

[0053] 1.4 Methods

[0054] (1) Control group: 250 mL of hemorrhoid wash solution (main ingredients: Sophora flavescens, Phellodendron chinense, Galla chinensis, Cnidium monnieri, Scutellaria baicalensis, Sophora japonica, borneol, hospital preparation, [Executive standard: Yunnan ZJGF-454-2019, approval number: Yunnan Pharmaceutical Preparation (Z) 20082299A]) was diluted with 9 times the amount of warm water and used for sitz baths for 15 minutes, once in the morning and once in the evening. One course of treatment was 7 days, and a total of 2 courses of treatment were given.

[0055] (2) Treatment group: The herbal composition described in Example 3 was used to prepare the sitz bath solution according to the method described in Example 19. One dose was taken daily, with each dose being 1000 mL. Before use, the solution was heated to about 37-40°C. The anus was immersed in the sitz bath solution for 15 minutes, twice a day. One course of treatment was 7 days, and a total of 2 courses of treatment were performed. The efficacy was observed after the treatment was completed.

[0056] 1.5 Efficacy Criteria

[0057] According to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines," the efficacy evaluation criteria are as follows: Symptom score improvement = (Total symptom and sign score before treatment - Total symptom and sign score after treatment) / Total symptom and sign score before treatment × 100%. Total score = Perianal itching severity score + Perianal itching duration score + Perianal skin lesion area score. Cure: Symptom score improvement rate ≥ 95%; Significant effect: 70% ≤ Symptom score improvement rate < 95%; Effective: 50% ≤ Symptom score improvement rate < 70%; Ineffective: Symptom score improvement rate < 50%. Total effective rate (%) = [(Number of cured cases + Number of cases with significant effect + Number of effective cases) ÷ Total number of cases] × 100%.

[0058] 1.6 Statistical Analysis

[0059] In this study, quantitative data were expressed as mean ± standard deviation, qualitative data were described as percentages, and categorical data were expressed as χ². 2 test.

[0060] 2 Results

[0061] 2.1 Therapeutic Results

[0062] After two courses of treatment, in the control group, 5 patients were clinically cured, 10 showed significant improvement, 13 showed improvement, and 12 showed no improvement, with a clinical cure rate of 12.5% ​​and a total effective rate of 70.0%. In the treatment group, 12 patients were clinically cured, 18 showed significant improvement, 8 showed improvement, and 2 showed no improvement, with a clinical cure rate of 30.0% and a total effective rate of 95.0%. The clinical cure rate and total effective rate of the treatment group were significantly higher than those of the control group (see Table 1). A comparison of the total scores before and after treatment in both groups is shown in Table 2.

[0063]

[0064]

[0065] As shown in Table 2, there was no statistically significant difference in the total scores before treatment between the treatment group and the control group. P >0.05); the total score after treatment was significantly different between the treatment group and the control group. P <0.05). The results show that the traditional Chinese medicine composition of the present invention is significantly effective in treating perianal eczema.

[0066] Application Example 2 – Clinical Study of the Traditional Chinese Medicine Composition of the Invention for the Treatment of Anal Pruritus

[0067] 1. Materials and Methods

[0068] 1.1 Research Subjects

[0069] The study subjects were 40 patients with anal pruritus from our hospital, including 26 females and 14 males; their ages ranged from 25 to 78 years, with a mean age of (52.1±13.1) years. The duration of illness ranged from 1 to 24 months, with a mean duration of (7.1±5.5) months. The 40 patients were divided into a control group and a treatment group, with 20 patients in each group. There were no statistically significant differences between the two groups in terms of gender, age, and duration of illness. P (>0.05), making them comparable.

[0070] 1.2 Diagnostic criteria for anal pruritus

[0071] 1.2.1 Western Medicine Diagnostic Criteria

[0072] According to the diagnostic criteria for anal pruritus in "Chinese Journal of Colorectal Diseases": (1) subjective itching of the perianal area, such as the feeling of ants crawling or insects crawling; (2) the itching worsens at night or after eating spicy and irritating foods, accompanied by mental tension, anxiety, and sleep disorders; (3) in the early stage, the perianal skin itching is more severe, sometimes mild and sometimes severe, intermittent or continuous, and there is stinging and burning pain after scratching with the hand. As it gradually develops, it becomes unbearably itchy, and papules, erythema, erosion, scratch marks and crusts, thickened and enlarged skin folds or accompanied by lichenification, depigmentation or deposition of the skin, and fissures may also occur.

[0073] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria

[0074] Based on the "Guidelines for the Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine Proctology" published by the China Association of Traditional Chinese Medicine in 2012 and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" published by the State Drug Administration in 2000, the following TCM syndrome type for anal pruritus is defined as damp-heat accumulation in the lower jiao: anal itching, swelling of the skin in the anal folds, accompanied by local weeping and oozing, often with a fishy odor. Patients often experience restlessness and even insomnia due to severe itching and inability to stop scratching. The tongue is red with a yellow coating, and the pulse is wiry and slippery. Accompanying secondary symptoms include: dry stools or constipation; dry throat and bitter taste in the mouth; and yellow urine.

[0075] 1.3 Screening Criteria

[0076] 1.3.1 Inclusion Criteria

[0077] (1) Patients with anal pruritus of the damp-heat syndrome type who meet the above diagnostic criteria of traditional Chinese and Western medicine; (2) Patients aged 18-80 years; (3) Patients who are willing to participate and cooperate with the study and sign the informed consent form.

[0078] 1.3.2 Exclusion Criteria

[0079] (1) Pregnant or lactating women; (2) Patients with diabetes, low immune function, or mental illness; (3) Patients with primary perianal diseases such as anal fistula or condyloma acuminata who have not undergone surgical treatment; (4) Patients who have used corticosteroids, immunomodulators, antihistamines, or other drugs that affect the treatment effect within the past two weeks.

[0080] 1.4 Methods

[0081] (1) Control group: Hemorrhoid washing solution (main ingredients: Sophora flavescens, Phellodendron chinense, Galla chinensis, Cnidium monnieri, Scutellaria baicalensis, Sophora japonica, Borneol, hospital preparation, [Executive standard: Yunnan ZJGF-454-2019, approval number: Yunnan Pharmaceutical Preparation (Z) 20082299A] 250mL, diluted with 9 times the amount of warm water, for sitz bath for 15 minutes, once in the morning and once in the evening. 7 days is one course of treatment, for a total of 2 courses.

[0082] (2) Treatment group: The herbal composition described in Example 6 was used to prepare the sitz bath solution according to the method described in Example 19. One dose was taken daily, with each dose being 1000 mL. Before use, the solution was heated to about 37-40°C. The anus was immersed in the sitz bath solution for 15 minutes, twice a day. One course of treatment lasted 7 days, and a total of 2 courses were performed. The efficacy was observed after the treatment was completed.

[0083] 1.5 Efficacy Criteria

[0084] According to the "Standards for Diagnosis and Efficacy Evaluation of Diseases and Syndromes in Traditional Chinese Medicine", a point-based method was used: n = (Score before treatment - Score after treatment) / Score before treatment × 100%. Total score = Score for severity of perianal itching + Score for duration of perianal itching. Cured: n ≥ 90%; Significantly effective: 70% ≤ n < 90%; Effective: 30% ≤ n < 70%; Ineffective: n < 30%. Total effective rate (%) = [(Number of cured cases + Number of cases with significant improvement + Number of cases with effectiveness) ÷ Total number of cases] × 100%.

[0085] 1.6 Statistical Analysis

[0086] In this study, quantitative data were expressed as mean ± standard deviation, qualitative data were described as percentages, and categorical data were expressed as χ². 2 test.

[0087] 2 Results

[0088] 2.1 Therapeutic Results

[0089] After two courses of treatment, in the control group, 3 patients were clinically cured, 2 showed significant improvement, 5 showed improvement, and 10 showed no improvement, with a clinical cure rate of 15.0% and a total effective rate of 50.0%. In the treatment group, 11 patients were clinically cured, 5 showed significant improvement, 3 showed improvement, and 1 showed no improvement, with a clinical cure rate of 55.0% and a total effective rate of 95.0%. The clinical cure rate and total effective rate of the treatment group were significantly higher than those of the control group (see Table 3). A comparison of the total scores before and after treatment in both groups is shown in Table 4.

[0090]

[0091]

[0092] As shown in Table 4, there was no statistically significant difference in the total scores before treatment between the treatment group and the control group. P >0.05); the total score after treatment was significantly different between the treatment group and the control group. P <0.05). The results show that the traditional Chinese medicine composition of the present invention has a certain therapeutic effect on anal pruritus.

Claims

1. A traditional Chinese medicine composition for treating perianal eczema and anal pruritus, comprising, by weight, the following raw materials: 10-30 parts gypsum, 10-30 parts Cnidium monnieri, 10-30 parts Kochia scoparia, 10-20 parts Astragalus membranaceus, 10-30 parts Sophora flavescens, 5-15 parts borneol, 10-30 parts Phellodendron chinense, 10-20 parts Atractylodes lancea, 10-20 parts Cicadae periostracum, 10-20 parts Arctium lappa, 10-20 parts Zanthoxylum bungeanum, 10-30 parts Schizonepeta tenuifolia, 10-30 parts Saposhnikovia divaricata, 10-20 parts Angelica sinensis, and 10-20 parts Rehmannia glutinosa.

2. The traditional Chinese medicine composition for treating perianal eczema and anal pruritus according to claim 1, by weight, is made from the following raw materials: 10-20 parts gypsum, 10-20 parts Cnidium monnieri, 10-20 parts Kochia scoparia, 10-15 parts Astragalus membranaceus, 10-20 parts Sophora flavescens, 5-10 parts borneol, 10-20 parts Phellodendron chinense, 10-15 parts Atractylodes lancea, 10-15 parts Cicadae periostracum, 10-15 parts Arctium lappa, 10-15 parts Zanthoxylum bungeanum, 10-20 parts Schizonepeta tenuifolia, 10-20 parts Saposhnikovia divaricata, 10-15 parts Angelica sinensis, and 10-15 parts Rehmannia glutinosa.

3. The traditional Chinese medicine composition for treating perianal eczema and anal pruritus according to claim 2, by weight, is made from the following raw materials: 10-15 parts gypsum, 10-15 parts Cnidium monnieri, 10-15 parts Kochia scoparia, 10-15 parts Astragalus membranaceus, 10-15 parts Sophora flavescens, 5-10 parts borneol, 10-15 parts Phellodendron chinense, 10-15 parts Atractylodes lancea, 10-15 parts Cicadae periostracum, 10-15 parts Arctium lappa, 10-15 parts Zanthoxylum bungeanum, 10-15 parts Schizonepeta tenuifolia, 10-15 parts Saposhnikovia divaricata, 10-15 parts Angelica sinensis, and 10-15 parts Rehmannia glutinosa.

4. The preparation of the traditional Chinese medicine composition for treating perianal eczema and anal pruritus according to any one of claims 1 to 3, characterized in that, The preparation is made by adding pharmaceutically acceptable excipients to the traditional Chinese medicine composition used to treat perianal eczema and anal itching.

5. The preparation of the traditional Chinese medicine composition for treating perianal eczema and anal pruritus according to claim 4, characterized in that, The formulation is a liquid formulation.

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

7. The application of the traditional Chinese medicine composition of claim 4 in the preparation of a medicament for treating perianal eczema and anal pruritus.

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