Traditional Chinese medicine composition for treating leukoplakia vulvae

Abstract

The invention discloses a traditional Chinese medicine composition for treating leukoplakia vulvae, the traditional Chinese medicine composition is formed by combining an oral medicine and an external application medicine, the oral medicine is prepared from the following medicinal materials: angelica sinensis, ligusticum wallichii, radix paeoniae rubra, radix rehmanniae preparata, cassia twig, peach kernel, cortex moutan, poria cocos, Chinese yam, dogwood, safflower carthamus, radix bupleuri, herba epimedii, rhizoma curculiginis, morinda officinalis, radix aconiti carmichaeli and cynanchum paniculatum; the external application medicine is prepared from the following medicinal materials: radix angelicae sinensis, rhizoma chuanxiong, radix paeoniae rubra, radix rehmanniae preparata, cassia twig, peach kernel, cortex moutan, poria cocos, rhizoma dioscoreae, fructus corni, flos carthami, radix bupleuri, herba epimedii, rhizoma curculiginis, radix morindae officinalis, radix aconiti carmichaeli, radix cynanchi paniculati, fructus cnidii, cortex phellodendri, radix sophorae flavescentis, fructus kochiae and herba menthae. Clinical symptoms of a patient are effectively relieved, vulva skin lesion is effectively repaired, skin regeneration is promoted, vulva skin is recovered to a normal form, and the life quality of the patient is improved.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating vulvar leukoplakia. BACKGROUND

[0002] Vulvar leukoplakia, also known as vulvar leukoplakia or vulvar dystrophy, is a common gynecological chronic disease, mainly manifested as pigmentation, pruritus, pain, and even ulceration and atrophy of the skin and mucosa of the vulva. Its pathogenesis is not fully clear, and it may be related to genetic susceptibility, immune regulation abnormalities, endocrine disorders, infections, and local irritation. Pathological features include excessive keratinization of the epidermis, thickening of the prickle layer, and infiltration of lymphocytes in the superficial dermis. The main clinical manifestation is intractable pruritus, which is more severe at night, and may involve the clitoris, labia minora and other parts. Severe cases can lead to dyspareunia and vaginal stenosis.

[0003] At present, the etiology and pathogenesis of the disease has not been clearly defined. Many clinical studies suggest that the disease may be related to autoimmune, genetic predisposition, and low endogenous sex hormone levels. Various pathogenic factors cause nutritional disorders in the deep connective tissue of the vulva, and there is microcirculatory dysfunction in the local dermal microvessels and collagen fibers. The epithelium is caused by malnutrition, leading to degenerative changes, resulting in metabolic disorders in the normal skin of the vulva, microvessel hypoxia, and the role of tyrosinase is affected. The synthesis of melanin is affected, resulting in the occurrence of the disease in the vulvar mucosa and skin.

[0004] Reports show that 10% of patients develop malignant lesions due to delayed treatment or prolonged illness, and repeated attacks eventually develop into malignant lesions, seriously affecting the physical and mental health of patients and the quality of life. Vulvar leukoplakia has a long course and a high recurrence rate. The pathogenesis of Western medicine is not yet clear, and it is difficult to completely cure the disease.

[0005] At present, clinical treatment of Western medicine mainly applies topical glucocorticoids and other drugs, and cooperates with physical therapy. Ultrasonic, liquid nitrogen, and cryotherapy are also commonly used. However, such drugs have the problems of large adverse reactions after long-term use, and can cause great pain to patients. At the same time, there are problems of poor compliance and unsatisfactory long-term application effects, which further affect the prognosis of the disease. SUMMARY

[0006] The present application aims to provide a traditional Chinese medicine composition for treating vulvar leukoplakia, comprising oral medicine and external application medicine, the external application medicine of the present application directly reaches the disease site and is easily absorbed by the skin, the oral medicine is distributed to all tissues and organs of the body after entering the blood circulation, can regulate the internal environment of the body, enhance the overall resistance and regulation ability of the body, and the combination of the two can significantly improve the itching symptoms and atrophy degree of the patient, effectively relieve the clinical symptoms of the patient, effectively repair the vulvar skin damage, promote skin regeneration, restore the normal morphology of the vulvar skin, and improve the life quality of the patient.

[0007] To achieve the above-mentioned purpose, the technical solution adopted by the present application is: A traditional Chinese medicine composition for treating vulvar leukoplakia, the traditional Chinese medicine composition is combined by oral medicine and external application medicine, the oral medicine is made of traditional Chinese medicinal materials in the following weight parts: Angelica 15-30g, Chuanxiong 10-20g, Red peony root 15-30g, Prepared rehmannia 15-30g, Cassia twig 10-20g, Peach kernel 10-20g, Danpi 15-30g, Poria 15-30g, Shanyao 15-30g, Cornus 20-40g, Red flower 10-20g, Bupleurum 10-20g, Herba Epimedii 10-20g, Herba Cynomorii 10-20g, Aconite 10-20g, Xuchangqing 10-20g; The external application medicine is made of the following traditional Chinese medicinal materials: Angelica 15-30g, Chuanxiong 10-20g, Red peony root 15-30g, Prepared rehmannia 15-30g, Cassia twig 10-20g, Peach kernel 10-20g, Danpi 15-30g, Poria 15-30g, Shanyao 15-30g, Cornus 20-40g, Red flower 10-20g, Bupleurum 10-20g, Herba Epimedii 10-20g, Herba Cynomorii 10-20g, Aconite 10-20g, Xuchangqing 10-20g, Snakegall 15-30g, Amur cork tree 15-30g, Sophora flavescens 15-30g, Fructus Kochiae 15-30g, Herba Mentholis 10-20g.

[0008] Preferably, the oral medicine is in the following weight parts: Angelica 15g, Chuanxiong 10g, Red peony root 15g, Prepared rehmannia 15g, Cassia twig 10g, Peach kernel 10g, Danpi 15g, Poria 15g, Shanyao 15g, Cornus 20g, Red flower 10g, Bupleurum 10g, Herba Epimedii 10g, Herba Cynomorii 10g, Aconite 10g, Xuchangqing 10g.

[0009] Preferably, the external medicine comprises, by weight: Danggui 15g, Chuanxiong 10g, Chishao 15g, Shudihuang 15g, Guizhi 10g, Taoren 10g, Danpi 15g, Fuling 15g, Shanyao 15g, Shanzha 20g, Honghua 10g, Chaihu 10g, Yinyanghuo 10g, Xianmao 10g, Bajitian 10g, Fuzi 10g, Xuchangqing 10g, Shechuangzi 15g, Huangbai 15g, Kushen 15g, Diguozi 15g, and Bohe 10g.

[0010] The specific steps of the preparation method of the external medicine are as follows: S1: Danggui, Chuanxiong, Chishao, Shudihuang, Guizhi, Taoren, Danpi, Fuling, Shanyao, Shanzha, Honghua, Chaihu, Yinyanghuo, Xianmao, Bajitian, Fuzi, Xuchangqing, Shechuangzi, Huangbai, Kushen, Diguozi, and Bohe are washed, dried, mixed, ground into fine powder, and then used. The fine powder obtained in S1 is mixed with honey and sesame oil, and then stirred to obtain the external medicine.

[0011] Preferably, the ratio of the fine powder, honey, and sesame oil is 4:1.5:1.5.

[0012] Preferably, the specific steps of the preparation method of the oral medicine are as follows: Danggui, Chuanxiong, Chishao, Shudihuang, Guizhi, Taoren, Danpi, Fuling, Shanyao, Shanzha, Honghua, Chaihu, Yinyanghuo, Xianmao, Bajitian, Fuzi, Xuchangqing are washed, put into a pot, added with cold water to cover the medicine, and then boiled to obtain the boiled liquid.

[0013] Preferably, the mixture of medicinal materials is soaked for 0.5-2h before being boiled with water.

[0014] In the present application, the properties and effects of the traditional Chinese medicines used are as follows: Danggui: sweet, pungent, and warm, and is used to tonify blood, regulate menstruation, and relieve pain, and is used for blood deficiency, dizziness, irregular menstruation, and constipation.

[0015] Chuanxiong: pungent and warm, and is used to activate blood and relieve pain, and is used for chest pain, chest and hypochondriac pain, dysmenorrhea, and abdominal pain.

[0016] Chishao: bitter and cold, and is used to clear heat and cool blood, and is used for heat in blood, bleeding, and abdominal pain.

[0017] Rehmannia glutinosa (processed): Sweet, slightly warm. Enters the liver and kidney meridians. Nourishes blood and yin, replenishes essence and marrow. Used for blood deficiency and chlorosis, palpitations, irregular menstruation, metrorrhagia, liver and kidney yin deficiency, soreness and weakness of the lower back and knees, bone steaming fever, night sweats, seminal emission, internal heat and thirst, dizziness, tinnitus, and premature graying of hair.

[0018] Cinnamon twig: pungent, sweet, and warm. It enters the heart, lung, and bladder meridians. It promotes sweating and relieves muscle tension, warms and unblocks the meridians, assists yang qi transformation, and calms and descends qi. It is used for wind-cold common cold, abdominal pain due to cold, amenorrhea due to blood stasis, joint pain, phlegm retention, edema, palpitations, and sudden abdominal pain.

[0019] Moutan bark: Bitter, pungent, slightly cold. Enters the heart, liver, and kidney meridians. Clears heat and cools the blood, invigorates blood and removes blood stasis. Used for heat entering the blood level, febrile rashes, hematemesis, epistaxis, night fever with morning coolness, steaming bone without sweating, amenorrhea, dysmenorrhea, traumatic injuries, carbuncles, boils, and sores.

[0020] Poria cocos: Sweet, bland, and neutral. It enters the heart, lung, spleen, and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. It is used for edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0021] Yam: Sweet, neutral. Enters the spleen, lung, and kidney meridians. Tonifies the spleen and stomach, promotes the production of body fluids and benefits the lungs, tonifies the kidneys and astringes essence. Used for spleen deficiency with poor appetite, chronic diarrhea, lung deficiency with cough and asthma, kidney deficiency with seminal emission, leukorrhea, frequent urination, and thirst due to deficiency heat. Wheat bran-fried yam tonifies the spleen and stomach. Used for spleen deficiency with poor appetite, loose stools, and excessive leukorrhea.

[0022] Cornus officinalis: Sour, astringent, slightly warm. It enters the liver and kidney meridians. It tonifies the liver and kidneys, and astringes and consolidates the body. It is used for dizziness and tinnitus, lower back and knee pain, impotence and seminal emission, enuresis and frequent urination, metrorrhagia and leukorrhea, profuse sweating and collapse, and internal heat and thirst.

[0023] Safflower: Pungent, warm. Enters the heart and liver meridians. Invigorates blood circulation, regulates menstruation, disperses blood stasis, and relieves pain. Used for amenorrhea, dysmenorrhea, lochia retention, abdominal masses, chest pain, abdominal pain due to blood stasis, stabbing pain in the chest and ribs, traumatic injuries, and sores and swellings.

[0024] Bupleurum: Pungent, bitter, slightly cold. Enters the liver, gallbladder, and lung meridians. Disperses and reduces fever, soothes the liver and relieves stagnation, raises yang qi. Used for colds with fever, alternating chills and fever, chest and rib pain, irregular menstruation, uterine prolapse, and rectal prolapse.

[0025] Epimedium: pungent, sweet, and warm. It enters the liver and kidney meridians. It tonifies kidney yang, strengthens tendons and bones, and dispels wind and dampness. It is used for kidney yang deficiency, impotence, seminal emission, weakness of tendons and bones, rheumatic pain, numbness, and contractures.

[0026] Curculigo orchioides: pungent, hot; toxic. Enters the kidney, liver, and spleen meridians. Tonifies kidney yang, strengthens tendons and bones, dispels cold and dampness. Used for impotence, weak and flaccid muscles and bones, cold pain in the lower back and knees, and diarrhea due to yang deficiency.

[0027] Morinda officinalis: Sweet, pungent, slightly warm. Enters the kidney and liver meridians. Tonifies kidney yang, strengthens tendons and bones, dispels wind and dampness. Used for impotence, seminal emission, infertility due to cold uterus, irregular menstruation, lower abdominal pain due to cold, rheumatic pain, and weakness of tendons and bones.

[0028] Fuzi: acrid, sweet, extremely hot; toxic. Nourishes the heart, kidney and spleen meridians. Restores yang, supplements fire and yang, dispels cold and relieves pain. Used for yang deficiency, cold limbs, weak pulse, heart yang deficiency, chest pain, cold abdominal pain, kidney yang deficiency, impotence, cold uterus, cold edema, external cold, cold dampness and pain.

[0029] Xuchangqing: acrid, warm. Liver and stomach meridians. Dispels wind, removes dampness, relieves pain and itching. Used for wind-dampness arthralgia, stomach distention, toothache, lumbago, contusion pain, wind rash, eczema.

[0030] Tangren: bitter, sweet, neutral. Heart, liver and large intestine meridians. Activates blood and removes stasis, moistens the intestines and relieves constipation, relieves cough and asthma. Used for irregular menstruation, abdominal mass, lung and intestinal abscesses, contusion, dry intestines, constipation, cough and asthma.

[0031] Shechuangzi: acrid, bitter, warm; slightly toxic. Kidney meridian. Dries dampness and dispels wind, kills parasites and relieves itching, warms kidney and strengthens yang. Used for itching and leucorrhea, eczema, dampness and lumbago, kidney yang deficiency, impotence, cold uterus and infertility.

[0032] Huangbai: bitter, cold. Kidney and bladder meridians. Clears heat and dries dampness, purges fire and removes heat, detoxifies and treats sores. Used for damp-heat diarrhea, jaundice and red urine, leucorrhea and itching, hot stranguria, beriberi, bone heat, night sweating, spermatorrhea, sores and abscesses, eczema and dermatitis. Salt Huangbai nourishes yin and clears heat, used for yin deficiency and heat, night sweating and bone heat.

[0033] Kuhseng: bitter, cold. Heart, liver, stomach, large intestine and bladder meridians. Clears heat and dries dampness, kills parasites and diuretic. Used for heat diarrhea, hematochezia, jaundice and urinary retention, leucorrhea, itching and eczema, pruritus, scabies and leprosy; externally treats trichomonas vaginitis.

[0034] Difusizi: acrid, bitter, cold. Kidney and bladder meridians. Clears heat and dries dampness, dispels wind and relieves itching. Used for dysuria, leucorrhea, eczema, pruritus and itching.

[0035] Bohe: acrid, cool. Lung and liver meridians. Dispels wind-heat, clears the head and eyes, benefits the throat, breaks up rashes and soothes the liver and promotes qi flow. Used for wind-heat syndrome, wind-heat at the beginning, headache, red eyes, sore throat, aphthous ulcer, eczema, measles, chest and hypochondriac distention.

[0036] Compared with the prior art, the present application has the following advantages: (1) The present application takes red peony root and chuanmugua to activate blood and dredge collaterals, takes fleshy groundcherry, snakegalls, kuh-seng, Chinese cork tree, xuchangqing, and mint to clear heat and dry dampness, dispel wind and relieve itching, takes peach kernel and safflower to activate blood and resolve stasis, takes angelica and prepared rehmannia to nourish blood and regulate menstruation, takes caulis rhizomatosi, herba epimedii, and radix morindae officinalis to tonify kidney yang, dispel cold and dampness, takes cassia twig and aconite to warm yang and dispel cold, and takes peony to clear away pathogenic fire, and can also make cortex alpiniae oxyphyllae warm and astringe, poria to invigorate the spleen and eliminate dampness, and yam to tonify the spleen and help invigorate the spleen, and bupleurum to soothe the liver and gallbladder, and the drugs can cooperate to dispel white and relieve itching, activate blood and resolve stasis, nourish muscle and promote local mucous membrane blood circulation, so that the pigment loss of the lesion site returns to normal, thereby achieving the dual effects of treatment and conditioning of the body.

[0037] (2) The present application uses the external application drug to be applied to the external lesion site of the patient with vulvar leukoplakia, gently massages for 1-2 minutes, and then washes off the external application drug with warm water after 1 hour, twice a day, so that the drug effect directly reaches the lesion site and is directly absorbed, promotes the color and elasticity of the lesion skin to return to normal, and effectively improves the treatment effect and reduces the adverse reactions of the patient.

[0038] (3) The traditional Chinese medicine composition of the present application includes internal and external application drugs, the external application drug directly reaches the lesion site and is easily absorbed by the skin, the internal drug enters the blood circulation and is distributed to all tissues and organs of the body, can adjust the internal environment of the body, and enhance the overall resistance and regulation ability of the body, and the combination of the two can obviously improve the itching symptoms and atrophy degree of the patient, effectively alleviate the clinical symptoms of the patient, effectively repair the vulvar lesion, promote skin regeneration, make the vulvar skin return to normal morphology, and improve the life quality of the patient. DETAILED DESCRIPTION

[0039] In order for those skilled in the art to better understand the present application, the technical solutions in the embodiments of the present application are described clearly and completely below. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work should belong to the scope of protection of the present application.

[0040] It should be noted that the terms "first", "second" and the like in the specification and claims of the present application are used to distinguish similar objects, and do not necessarily indicate a specific order or a chronological sequence. It should be understood that the data thus used can be interchanged under appropriate circumstances, so that the embodiments of the present application described herein can be implemented in an order other than that described herein. In addition, the terms "include" and "have" and any variations thereof are intended to cover non-exclusive inclusion, for example, a process, method, system, product or device including a series of steps or units does not have to be limited to those steps or units clearly listed, but can include other steps or units not clearly listed or inherent to these processes, methods, products or devices.

[0041] Example 1 Take 15g of Angelica, 10g of Chuanxiong, 15g of Red Peony Root, 15g of Prepared Rehmannia, 10g of Ramulus Cinnamomi, 10g of Peach Kernel, 15g of Danpi, 15g of Poria, 15g of Chinese Yam, 20g of Fructus Corni, 10g of Safflower, 10g of Bupleurum, 10g of Herba Epimedii, 10g of Herba Cynomorii, 10g of Aconiti Lateralis Radix Praeparata, 10g of Radix Pseudostellariae, and 10g of Xu Changqing. The above medicinal materials are washed and put into a pot, and cold water is added to immerse the medicinal materials. The mixture is soaked for 0.5h, and then decocted. The decocted liquid is collected to obtain the oral medicine.

[0042] Take 15g of Angelica, 10g of Chuanxiong, 15g of Red Peony Root, 15g of Prepared Rehmannia, 10g of Ramulus Cinnamomi, 10g of Peach Kernel, 15g of Danpi, 15g of Poria, 15g of Chinese Yam, 20g of Fructus Corni, 10g of Safflower, 10g of Bupleurum, 10g of Herba Epimedii, 10g of Herba Cynomorii, 10g of Aconiti Lateralis Radix Praeparata, 10g of Radix Pseudostellariae, 15g of Cnidium, 15g of Phellodendri, 15g of Sophora, 15g of Fructus Kochiae, and 10g of Herba Menthae. The above medicinal materials are washed, dried, and ground into fine powder to obtain the medicinal powder. The medicinal powder obtained above is mixed with honey and sesame oil at a ratio of 4:1.5:1.5, and stirred uniformly to obtain the external medicine.

[0043] Example 2 Take 24g of Angelica, 15g of Chuanxiong, 24g of Red Peony Root, 24g of Prepared Rehmannia, 15g of Ramulus Cinnamomi, 15g of Peach Kernel, 24g of Danpi, 24g of Poria, 24g of Chinese Yam, 30g of Fructus Corni, 15g of Safflower, 15g of Bupleurum, 15g of Herba Epimedii, 15g of Herba Cynomorii, 15g of Aconiti Lateralis Radix Praeparata, 15g of Radix Pseudostellariae, and 15g of Xu Changqing. The above medicinal materials are washed and put into a pot, and cold water is added to immerse the medicinal materials. The mixture is soaked for 2h, and then decocted. The decocted liquid is collected to obtain the oral medicine.

[0044] Take 24g of Angelica, 15g of Chuanxiong, 24g of Red Peony Root, 24g of Prepared Rehmannia, 15g of Ramulus Cinnamomi, 15g of Peach Kernel, 24g of Danpi, 24g of Poria, 24g of Chinese Yam, 20-40g of Fructus Corni, 15g of Safflower, 15g of Bupleurum, 15g of Herba Epimedii, 15g of Herba Cynomorii, 15g of Aconiti Lateralis Radix Praeparata, 15g of Radix Pseudostellariae, 15g of Xu Changqing, 24g of Cnidium, 24g of Phellodendri, 24g of Sophora, 24g of Fructus Kochiae, 24g of Herba Menthae, and 15g of Herba Menthae. The above medicinal materials are washed, dried, and ground into fine powder to obtain the medicinal powder. The medicinal powder obtained above is mixed with honey and sesame oil at a ratio of 4:1.5:1.5, and stirred uniformly to obtain the external medicine.

[0045] Example 3 Angelica 30g, Chuanxiong 20g, Red 30g, Rehmannia 30g, Cinnamon 20g, Peach 20g, Danpi 30g, Poria 30g, Yam 30g, Cornus 40g, Safflower 20g, Bupleurum 20g, Herba Epimedii 20g, Herba Cynomorii 20g, Aconite 20g, Xu Changqing 20g. The above medicinal materials are washed and put into a pot, and cold water is added to cover the medicinal materials. The mixture is soaked for 1 hour, and then decocted. The decocted liquid is collected to obtain the oral medicine.

[0046] Angelica 30g, Chuanxiong 20g, Red 30g, Rehmannia 30g, Cinnamon 20g, Peach 20g, Danpi 30g, Poria 30g, Yam 30g, Cornus 40g, Safflower 20g, Bupleurum 20g, Herba Epimedii 20g, Herba Cynomorii 20g, Aconite 20g, Xu Changqing 20g, Shechuangzi 30g, Huangbai 30g, Kuh 30g, Digupi 30g, Herba Menthol 20g. The above medicinal materials are washed and dried, then mixed, crushed and ground into fine powder to obtain the medicinal powder for use. The above obtained medicinal powder is added with honey and sesame oil, and the ratio of medicinal powder, honey and sesame oil is 4:1.5:1.5. After sufficient stirring, the external application medicine is obtained.

[0047] Case source: Select patients with vulvar leukoplakia who are treated in Hubei Provincial Maternal and Child Health Hospital from June 2023 to June 2024. 80 patients treated are observed, and all cases are randomly divided into treatment group and control group, 40 cases in each group. The general data of the two groups of patients are comparable (P≥0.05).

[0048] Diagnosis standard: Western medicine diagnosis refers to "Clinical Diagnosis and Treatment Expert Consensus on Female Vulvar Sclerosing Lichen (2021 Edition)" and "Obstetrics and Gynecology".

[0049] Chinese medicine diagnosis conforms to the standards of "Chinese Gynecology" and "Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine"; Inclusion criteria: ① Western medicine diagnosis of vulvar leukoplakia: pruritus of the vulva, or accompanied by edema and chapped phenomenon, severe sexual life difficulty or urination disorder; early skin is mainly dark red, pink, and skin with hyperkeratosis may be white, and severe skin texture is rough. Chinese medicine diagnosis: in addition to clinical symptoms, accompanied by five heat or sometimes hot sweating, dizziness, dry eyes, soreness of the waist and knees, tinnitus, red tongue, little or thin yellow, pulse is slow or fast. ② Women over 18 years old. ③ Patients voluntarily participate in the research of this topic, agree to the treatment plan of this topic, can strictly follow the doctor's advice, accept regular follow-up, and complete the clinical observation.

[0050] Exclusion criteria: (1) not in line with the inclusion criteria; (2) acute genital tract infection (genital herpes, vaginitis, cervicitis, pelvic inflammatory disease, etc.); (3) patients with mental illness seriously affect the evaluation, serious internal and external surgical diseases or recent other treatments, etc.; (4) allergic to the treatment drug; (5) recently used the same drug treatment.

[0051] Treatment method: Control group: give patients triamcinolone acetonide ointment treatment. One day smears the affected area twice, 10 times for a course of treatment, a total of 6 courses of treatment, before smearing on the affected area routine disinfection treatment and then smearing.

[0052] Treatment group: the use of oral drug and external application drug combination in example 1, oral drug, 1 dose 1d, two times a day, then give the external application drug treatment, treatment using the exposed vulva, daily morning and evening warm water clean vulva and perianal skin, smearing in the vulvar lesions local, and massage 1-2 min, 30 min after the external application drug with warm water wash away, 2 times a day.

[0053] In the above treatment process, patients are advised to pay attention to the hygiene of the vulva, clean every day, prohibit the use of irritating cleaning fluid for cleaning, and keep the vulva dry; Underwear should be made of pure cotton material, with enough tightness, and need to be sun dried after cleaning.

[0054] Efficacy evaluation: Observation index and method Referring to the symptom score standard in "Guiding principles for clinical research of new drugs of traditional Chinese medicine", the degree of vulvar itching, vaginal pain, pigment loss, skin elasticity and lesion range of patients before and after treatment were scored. The degree of vulvar itching and vaginal pain was scored as 0, 1, 2 and 3 respectively according to no, mild, moderate and severe. The degree of pigment loss was scored as 1, 2, 3 and 4 respectively according to light brown, light red, white and white. Lesion range: 1 point for clitoris; 1 point for each side of the labia minora; 1 point for each side of the labial sulcus; 1 point for each side of the labia majora; 1 point for anus and perineum; skin elasticity according to: normal skin, rich in elasticity, slightly reduced skin elasticity, slightly reduced fullness, significantly reduced skin elasticity, fullness disappeared, visible skin mild relaxation; significantly reduced elasticity, skin moderate relaxation, mild prolapse, thinning were scored as 0, 1, 2 and 3 respectively. The score is between 1 and 4, mild, between 5 and 8, moderate, and more than 9, severe.

[0055] Efficacy criteria: Follow-up was conducted 3 months after treatment, and efficacy was evaluated. Cure: All clinical symptoms disappeared, efficacy index ≥ 90%; Significantly effective: Significant improvement in vulvar itching, skin elasticity, lesion extent, and skin color after treatment, 60% ≤ efficacy index < 90%; Effective: Improvement in vulvar itching, skin elasticity, lesion extent, and skin color after treatment, 20% ≤ efficacy index < 60%; Ineffective: No improvement in vulvar itching, skin elasticity, lesion extent, or skin color after treatment, efficacy index < 20%. Efficacy index = (Pre-treatment score - Post-treatment score) / Pre-treatment score × 100%. Total effective rate = (Number of cured cases + Number of significantly effective cases + Number of effective cases) / Total number of cases × 100%.

[0056] Statistical methods: SPSS 22.0 software was used for statistical processing and analysis. Quantitative data were expressed as mean and standard deviation. x (ˉ±s) indicates that paired t-tests were used for within-group comparisons and independent samples t-tests were used for between-group comparisons; P<0.05 was considered statistically significant.

[0057] Methods for recording and reporting adverse events: Adverse clinical events may occur during treatment. In the event of any adverse events or other emergencies, the time of occurrence, clinical manifestations, treatment process, and duration of the adverse event should be recorded in detail on the case report form, including any medications used during transport. If abnormal test results are found, the patient must be followed up until the test results return to normal, or to pre-treatment levels, or until it is confirmed that the abnormality is unrelated to the investigational drug. In the event of a serious adverse event, a serious adverse reaction indication form should be completed and reported to superiors and health authorities within 24 hours.

[0058] Treatment results: Table 1 Comparison of age and disease duration between the two groups of patients Table 2 Comparison of therapeutic effects between the two groups.

[0059] Of the 40 cases in the treatment group, 6 were cured, 16 showed significant improvement, 14 showed improvement, and 4 showed no improvement, with a total effective rate of 90.00%.

[0060] In the control group of 40 cases, 1 case was cured, 10 cases showed significant improvement, 16 cases showed improvement, and 13 cases showed no improvement, with a total effective rate of 72.50%.

[0061] Table 3 Comparison of TCM syndrome scores before and after treatment.

[0062] After treatment, the scores for vulvar itching, vulvar pain, depigmentation, vulvar skin elasticity, and lesion extent in both groups were significantly different from those before treatment (P < 0.05). The scores for vulvar itching, vulvar pain, depigmentation, vulvar skin elasticity, and lesion extent in the treatment group were significantly lower than those in the control group after treatment (P < 0.05), indicating that the clinical efficacy of the treatment group was significantly better than that of the control group.

[0063] The above table demonstrates that the herbal composition of this invention has significant therapeutic effects, superior to the use of triamcinolone acetonide ointment alone. Conclusion: This invention, through the combination of oral and topical medications, has a good therapeutic effect on patients with vulvar leukoplakia, effectively relieving discomfort, improving local skin condition, and enhancing patients' quality of life. It is worthy of clinical promotion and application.

[0064] Typical case: Case 1: Patient 1, female, 41 years old, married, presented with vulvar itching and pain without any obvious cause, along with scanty, yellow, sticky vaginal discharge without odor. She initially ignored the symptoms, which occurred intermittently and worsened at night. She was diagnosed with vulvar leukoplakia. Two weeks prior, her condition worsened due to excessive stress. Gynecological examination revealed well-developed vulva, normal pubic hair, slight scratches and minor damage. The skin of the labia majora, interlabial sulcus, posterior commissure, and labia minora showed atrophy, hypopigmentation, and a grayish-white color; the skin was wrinkled and lacked elasticity. Internal genitalia were not examined. Western medical diagnosis: Vulvar leukoplakia.

[0065] Medication: The traditional Chinese medicine composition prepared in Example 1 was used, along with the oral and topical medications from Example 1. The oral medication was taken orally, one dose per day, divided into two doses, taken warm half an hour after breakfast and dinner. The topical medication was then applied. During treatment, the vulva was exposed. After cleaning the vulva and perianal skin with warm water morning and evening, the medication was applied to the affected area and massaged for 1 minute. After 30 minutes, the medication was washed off with warm water. This was done twice daily. Follow-up was conducted for any adverse reactions. One month later, at the second visit, the patient reported significant relief from vulvar itching and pain. Gynecological examination revealed well-developed vulva, normal pubic hair, no obvious scratches or damage, and slightly darkened pigmentation, wrinkling, and reduced elasticity of the skin on the labia majora, interlabial sulcus, posterior commissure, and labia minora. Internal genitalia were not examined. The herbal composition prepared in Example 1 was continued. One month later, at the third visit, the patient reported significant improvement in vulvar itching and pain. The herbal composition prepared in Example 1 was continued for consolidation treatment. After completing the medication, the patient reported that vulvar itching was relieved for a short period, with no further nighttime episodes, and no recurrence of vulvar itching.

[0066] Case 2: Patient 2, female, 50 years old, married, patient found vulva leukoplakia 5 years ago, occasionally itching discomfort, has used a variety of drugs for treatment, poor curative effect, the course of the disease pigment reduction gradually increased. In the past 2 months, the vulva hyperplasia, skin thickening, itching, unbearable, self-medication without obvious relief, western medicine diagnosis: vulvar leukoplakia. TCM diagnosis: yin itching. Drug: the oral medicine prepared by example 2 and the external medicine are used in combination, the oral medicine is washed, 1 dose 1d, twice a day, half an hour after breakfast and dinner, then the external medicine is given for treatment, when the treatment is used, the vulva is exposed, after the vulva and perianal skin are cleaned with warm water in the morning and evening, the external medicine is applied on the local lesion of the vulva, and is massaged for 2 min, then the external medicine is washed off with warm water after 30 min, 2 times a day.

[0067] Two months later, the patient complained that the itching was significantly reduced, and was susceptible to cold, and the skin of the affected area was smoother than before, so the patient continued to use the traditional Chinese medicine composition prepared by example 2, and kept the vulva dry and clean. Three months later, the patient complained that there was no obvious discomfort after using the traditional Chinese medicine composition, and the itching was significantly relieved, and there was basically no night attack.

[0068] Case 3: Patient 3, female, 37 years old, married, the patient complained of vulva itching for about 10 months, and the itching has been aggravated for about a month, and the patient complained of increased vaginal discharge, and the self-medication did not see obvious relief, and the patient complained of restlessness and insomnia. Gynecological examination: the married and produced type of vulva, the skin color of the inner side of the small labia and the large labia is white and rough; the amount of vaginal discharge is large, the color is white, and there is an odor; the cervix is normal, and the uterus body and the double adnexa have no obvious abnormalities. Diagnosis: vulvar leukoplakia. The oral medicine and the external medicine prepared by example 3 are used in combination, the oral medicine is washed, 1 dose 1d, twice a day, half an hour after breakfast and dinner, then the external medicine is given for treatment, when the treatment is used, the vulva is exposed, after the vulva and perianal skin are cleaned with warm water in the morning and evening, the external medicine is applied on the local lesion of the vulva, and is massaged for 2 min, then the external medicine is washed off with warm water after 30 min, 2 times a day.

[0069] Two months later, the patient complained that the itching was significantly reduced, and was susceptible to cold, and the skin of the affected area was smoother than before, so the patient continued to use the traditional Chinese medicine composition prepared by example 2, and kept the vulva dry and clean. Three months later, the patient complained that there was no obvious discomfort after using the traditional Chinese medicine composition, and the itching was significantly relieved, and there was basically no night attack.

[0070] It can be seen that the traditional Chinese medicine composition of the application is scientific and reasonable in combination, and the combination of the two can significantly improve the itching symptoms and atrophy degree of the patient, effectively relieve the clinical symptoms of the patient, effectively repair the vulva skin lesion, promote skin regeneration, restore the normal morphology of the vulva skin, and improve the life quality of the patient.

[0071] The above merely describes preferred specific embodiments of the present application, and the protection scope of the present application is not limited thereto, and any simple change or equivalent replacement of the technical solutions that can be obviously obtained by those skilled in the art within the technical range disclosed by the present application shall fall within the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for treating vulvar leukoplakia, characterized in that, The traditional Chinese medicine composition is combined by oral medicine and external medicine, the oral medicine is made of the following traditional Chinese medicinal materials: Angelica 15-30g, Chuanxiong 10-20g, Red peony root 15-30g, Prepared rehmannia 15-30g, Ramulus cinnamomi 10-20g, Peach kernel 10-20g, Danpi 15-30g, Poria 15-30g, Shanyao 15-30g, Cornus 20-40g, Safflower 10-20g, Bupleurum 10-20g, Herba Epimedii 10-20g, Herba Cynomorii 10-20g, Radix Morindae Officinalis 10-20g, Aconiti Praeparata 10-20g, Xuchangqing 10-20g; The external medicine is made of the following traditional Chinese medicinal materials: Angelica 15-30g, Chuanxiong 10-20g, Red peony root 15-30g, Prepared rehmannia 15-30g, Ramulus cinnamomi 10-20g, Peach kernel 10-20g, Danpi 15-30g, Poria 15-30g, Shanyao 15-30g, Cornus 20-40g, Safflower 10-20g, Bupleurum 10-20g, Herba Epimedii 10-20g, Herba Cynomorii 10-20g, Aconiti Praeparata 10-20g, Xuchangqing 10-20g, Shechuangzi 15-30g, Amur cork tree 15-30g, Kuh-seng 15-30g, Fructus Kochiae 15-30g, Herba Menthae 10-20g.

2. The traditional Chinese medicine composition for treating vulvar leukoplakia according to claim 1, characterized in that, The oral medicine is made of the following traditional Chinese medicinal materials: Angelica 15g, Chuanxiong 10g, Red peony root 15g, Prepared rehmannia 15g, Ramulus cinnamomi 10g, Peach kernel 10g, Danpi 15g, Poria 15g, Shanyao 15g, Cornus 20g, Safflower 10g, Bupleurum 10g, Herba Epimedii 10g, Herba Cynomorii 10g, Radix Morindae Officinalis 10g, Aconiti Praeparata 10g, Xuchangqing 10g.

3. The traditional Chinese medicine composition for treating vulvar leukoplakia according to claim 1, characterized in that, The external medicine is made of the following traditional Chinese medicinal materials: Angelica 15g, Chuanxiong 10g, Red peony root 15g, Prepared rehmannia 15g, Ramulus cinnamomi 10g, Peach kernel 10g, Danpi 15g, Poria 15g, Shanyao 15g, Cornus 20g, Safflower 10g, Bupleurum 10g, Herba Epimedii 10g, Herba Cynomorii 10g, Radix Morindae Officinalis 10g, Xuchangqing 10g, Shechuangzi 15g, Amur cork tree 15g, Kuh-seng 15g, Fructus Kochiae 15g, Herba Menthae 10g.

4. The traditional Chinese medicine composition for treating vulvar leukoplakia according to claim 3, characterized in that, The specific steps of the preparation method of the external medicine are: S1: washing and drying Angelica, Chuanxiong, Red peony root, Prepared rehmannia, Ramulus cinnamomi, Peach kernel, Danpi, Poria, Shanyao, Cornus, Safflower, Bupleurum, Herba Epimedii, Herba Cynomorii, Radix Morindae Officinalis, Xuchangqing, Shechuangzi, Amur cork tree, Kuh-seng, Fructus Kochiae, Herba Menthae, mixing, grinding into fine powder, and obtaining the medicine powder for use; adding honey and sesame oil into the medicine powder obtained in S1, fully stirring and uniformly obtaining the external medicine.

5. The preparation method according to claim 4, characterized in that, The ratio of the medicine powder, honey and sesame oil is 4:1.5:1.

5.

6. The traditional Chinese medicine composition for treating vulvar leukoplakia according to claim 2, characterized in that, The specific steps of the preparation method of the oral medicine are: washing Angelica, Chuanxiong, Red peony root, Prepared rehmannia, Ramulus cinnamomi, Peach kernel, Danpi, Poria, Shanyao, Cornus, Safflower, Bupleurum, Herba Epimedii, Herba Cynomorii, Radix Morindae Officinalis, Xuchangqing, putting into a pottery jar, adding cold water to immerse the medicine, then performing decocting, collecting the decocting liquid, and obtaining the oral medicine.

7. The process for preparing an oral medicament according to claim 6, characterized in that, Soaking the mixture of medicinal materials for 0.5-2h before adding water for decocting.

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