Traditional Chinese medicine composition for treating condyloma acuminatum as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating condyloma acuminatum as well as a preparation method and application thereof, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from 10-40 parts of rhizoma smilacis glabrae, 10-40 parts of rhizoma paridis, 5-15 parts of silkworm larva, 10-30 parts of cortex dictamni, 5-15 parts of herba schizonepetae, 5-15 parts of radix angelicae pubescentis, 5-15 parts of notopterygium root, 5-15 parts of spina gleditsiae, 2-10 parts of radix aconiti kusnezoffii preparata, 2-10 parts of radix aconiti preparata, 5-15 parts of radix clematidis and 5-15 parts of radix saposhnikoviae. The preparation method of the traditional Chinese medicine composition comprises the following steps: weighing the medicinal materials according to a prescription; the medicinal materials are subjected to high-temperature drying, mixing and crushing, then soaked in glacial acetic acid and placed in a dark place for sealed storage; and collecting the soak solution obtained in the previous step, filtering to remove medicine residues, and taking the filtrate to obtain the traditional Chinese medicine composition. The traditional Chinese medicine composition for treating condyloma acuminatum provided by the invention is simple in formula and preparation process, low in production cost, remarkable in clinical curative effect, small in side effect and low in recurrence rate, and has a wide market application prospect.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating condyloma acuminata, and a preparation method and application thereof. Background Art

[0002] Genital warts are a sexually transmitted disease caused by human papillomavirus (HPV) infection, most commonly occurring on the genitals and perianal area. Clinically, they present as small, pale red papules that gradually enlarge into cauliflower-like or mushroom-like growths. Patients often experience a foreign body sensation, burning pain, or itching. In a few cases, the warts may become malignant, significantly impacting their quality of life.

[0003] At present, there are two main clinical treatment methods for condyloma acuminata: (1) Physical and surgical therapy: such as carbon dioxide laser, microwave therapy, photodynamic therapy, etc. Large warts can be surgically removed. The above treatments have the characteristics of rapid removal of warts, but the disadvantages are that they are easy to cause bleeding in the genital and perianal mucosa, the treatment process is painful, nerve anesthesia is required, the operation is relatively complicated, and the damage is large, which can easily cause damage to the reproductive organs and affect the patient's subsequent quality of life; at the same time, the wound surface is also prone to infection and the recurrence rate is high. (2) Topical chemical drug treatment. Commonly used topical drugs include solutions and creams or ointments of phthalamide, 5-fluorouracil, podophyllin, podophyllin, scar remedy, trichloroacetic acid, bleomycin, etc. The clinical use of the above drugs has certain efficacy, but after use, they may cause local edema, erosion, or even necrosis and other side effects of varying degrees, further causing damage to the mucosal tissue.

[0004] In the prior art, the invention patent application with application number CN202011248722.0, "A Chinese medicine composition for treating condyloma acuminata and its preparation method", discloses a Chinese medicine composition for treating condyloma acuminata, the formula of which includes the following components in parts by weight: 20-70 parts of olive leaves, 10-40 parts of black olive leaves, 40-50 parts of bupleurum, 70-80 parts of turmeric, 95-105 parts of angelica, 70-80 parts of red peony root, 40-50 parts of honeysuckle, 70-80 parts of forsythia, 40-50 parts of rhubarb, 50-60 parts of sodium sulfate, 95-105 parts of sophora flavescens, and 95-105 parts of smilax glabra. , 40-50 parts of Phellodendron chinense, 25-30 parts of Plantago seeds, 25-30 parts of Artemisia capillaris, 30-40 parts of Patrinia chinensis, 30-40 parts of Kochia scoparia, 30-40 parts of Cnidium monnieri, 30-40 parts of Snake skins, 30-40 parts of Cicada skins, 40-50 parts of Schizonepeta tenuifolia, 30-40 parts of Saposhnikovia divaricata, 25-30 parts of Angelica dahurica, 50-60 parts of Houttuynia cordata, 70-80 parts of Tamarix chinensis, 50-60 parts of Fritillaria cirrhosa, 70-80 parts of Fritillaria thunbergii, 110-140 parts of Sophora flavescens, 80-125 parts of Stemona japonica, 30-60 parts of Red Peony Root, 60-90 parts of Pittosporum tobira bark, 50-80 parts of Vitex chinensis, and 30-50 parts of Cistanche deserticola. The traditional Chinese medicine composition provided by this study can effectively treat genital warts, and has the advantages of high cure rate, low recurrence rate and few side effects on the human body. However, it still has the following disadvantages: the formula and preparation method of the traditional Chinese medicine composition are complex, the production cost is high, and the study did not evaluate and determine its clinical efficacy, so the specific effect is unknown.

[0005] Based on this, this study follows the principles of Chinese medicine compatibility, conducts syndrome differentiation and compatibility formulation, and provides a Chinese medicine composition for the treatment of condyloma acuminata, as well as its preparation method and application, aiming to provide a drug with significant effects, simple operation and few side effects for the treatment of condyloma acuminata. Summary of the Invention

[0006] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating condyloma acuminata and its preparation method and application.

[0007] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0008] The traditional Chinese medicine composition for treating condyloma acuminatum of the present invention comprises the following components in parts by weight: 10-40 parts of Smilax glabra, 10-40 parts of Paris polyphylla, 5-15 parts of Bombyx batryticatus, 10-30 parts of Dictamni cortex, 5-15 parts of Schizonepeta tenuifolia, 5-15 parts of Angelica dahurica, 5-15 parts of Notopterygium wilfordii, 5-15 parts of Gleditsia sinensis thorns, 2-10 parts of processed Aconitum kusnezoffii, 2-10 parts of processed Chuanwuji, 5-15 parts of Clematidis, and 5-15 parts of Saposhnikovia divaricata.

[0009] Preferably, the traditional Chinese medicine composition for treating condyloma acuminatum of the present invention comprises the following components in parts by mass: 10-30 parts of Smilax glabra, 10-30 parts of Paris polyphylla, 5-10 parts of Bombyx batryticatus, 10-20 parts of Dictamni cortex, 5-10 parts of Schizonepeta tenuifolia, 5-10 parts of Angelica dahurica, 5-10 parts of Notopterygium wilfordii, 5-10 parts of Gleditsia chinensis thorns, 2-5 parts of processed Aconitum kusnezoffii, 2-5 parts of processed Aconiti kusnezoffii, 5-10 parts of Clematidis, and 5-10 parts of Saposhnikovia divaricata.

[0010] Further preferably, the traditional Chinese medicine composition for treating condyloma acuminatum of the present invention comprises the following components in parts by mass: 15 parts of Smilax glabra, 15 parts of Paris polyphylla, 10 parts of Bombyx batryticatus, 15 parts of Dictamni cortex, 10 parts of Schizonepeta tenuifolia, 10 parts of Angelica dahurica, 10 parts of Notopterygium wilfordii, 10 parts of Spina gleditsiae, 5 parts of processed Aconitum kusnezoffii, 5 parts of processed Chuanwu, 10 parts of Clematidis, and 10 parts of Saposhnikovia divaricata.

[0011] The preparation method of the Chinese medicine composition for treating condyloma acuminata of the present invention comprises the following steps:

[0012] S1: Weigh out Smilax glabra, Paris polyphylla, Bombyx batryticatus, Dictamni cortex, Schizonepeta tenuifolia, Angelica dahurica, Notopterygium wilfordii, Gleditsia sinensis thorn, processed Aconitum kusnezoffii, processed Chuanwu, Clemati radix and Saposhnikovia divaricata according to the prescription;

[0013] S2: Weigh each medicinal material according to the prescription, dry it at high temperature, mix it, grind it, soak it in glacial acetic acid, and store it in a dark and sealed place;

[0014] S3: collecting the soaking liquid from step S2, filtering to remove the medicinal residue and then taking the filtrate to obtain the product.

[0015] Preferably, in the method for preparing the traditional Chinese medicine composition for treating condyloma acuminata of the present invention, the acidity of the glacial acetic acid in step S1 is 5-30°.

[0016] Further preferably, in the method for preparing the traditional Chinese medicine composition for treating condyloma acuminata of the present invention, the acidity of the glacial acetic acid in step S1 is 5°.

[0017] Preferably, in the method for preparing the traditional Chinese medicine composition for treating condyloma acuminata of the present invention, the amount of glacial acetic acid used in step S1 is 150-250 times the total mass of the medicinal materials.

[0018] Further preferably, in the method for preparing the traditional Chinese medicine composition for treating condyloma acuminata of the present invention, the amount of glacial acetic acid used in step S1 is 200 times the total mass of the medicinal materials.

[0019] Preferably, in the method for preparing the traditional Chinese medicine composition for treating condyloma acuminata of the present invention, the sealed storage time in step S1 is 2 months.

[0020] The invention relates to the use of the traditional Chinese medicine composition for treating condyloma acuminata in the preparation of medicines for treating condyloma acuminata.

[0021] Beneficial effects of the present invention:

[0022] The present invention follows the principles of Chinese medicine compatibility and conducts dialectical compatibility formulation to provide a Chinese medicine composition for treating condyloma acuminata. The Chinese medicine composition has a simple formula and preparation process, and a low production cost. Clinical efficacy verification experiments have confirmed that the Chinese medicine composition provided by the present invention has a significant therapeutic effect on condyloma acuminata, few side effects, and a low recurrence rate. The Chinese medicine composition provided by the present invention has great clinical application value and broad market application prospects. DETAILED DESCRIPTION

[0023] The following is a detailed description of the technical solution of the present invention in conjunction with specific embodiments. The following embodiments are only for explanation and illustration, and do not constitute a limitation of the technical solution of the present invention.

[0024] Example 1

[0025] The Chinese medicine composition for treating condyloma acuminata has the following formula:

[0026] 15g of Chinese yam, 15g of parsley, 10g of white silkworm, 15g of white mulberry bark.

[0027] Schizonepeta 10g, Angelica dahurica 10g, Notopterygium incisum 10g, Gleditsia sinensis 10g

[0028] Processed Radix Aconiti Kusnezoffii 5g, ... Clematidis 10g, Saposhnikovia Divaricata 10g

[0029] Example 2

[0030] The Chinese medicine composition for treating condyloma acuminata has the following formula:

[0031] 10g of Smilax glabra, 10g of Paris polyphylla, 5g of Bombyx batryticatus, 10g of Dictamni root bark

[0032] Schizonepeta 5g, Angelica dahurica 5g, Notopterygium incisum 5g, Gleditsia sinensis 5g

[0033] Processed Radix Aconiti Kusnezoffii 2g, Processed Radix Aconiti Chuanwu 2g, Clematidis 5g, Saposhnikovia Divaricata 5g

[0034] Example 3

[0035] The Chinese medicine composition for treating condyloma acuminata has the following formula:

[0036] 30g of Chinese yam, 30g of parsley, 10g of white silkworm, 20g of white mulberry bark

[0037] Schizonepeta 10g, Angelica dahurica 10g, Notopterygium incisum 10g, Gleditsia sinensis 10g

[0038] Processed Radix Aconiti Kusnezoffii 5g, ... Clematidis 10g, Saposhnikovia Divaricata 10g

[0039] Example 4 (Examples 1-3 are prepared according to any one of the preparation methods of Examples 4-8)

[0040] The preparation method of the traditional Chinese medicine composition for treating condyloma acuminata comprises the following steps:

[0041] S1: Weigh out Smilax glabra, Paris polyphylla, Bombyx batryticatus, Dictamni cortex, Schizonepeta tenuifolia, Angelica dahurica, Notopterygium wilfordii, Gleditsia sinensis thorn, processed Aconitum kusnezoffii, processed Chuanwu, Clemati radix and Saposhnikovia divaricata according to the prescription;

[0042] S2: Weigh each medicinal material according to the prescription, dry it at high temperature, mix it, grind it, soak it in glacial acetic acid with an acidity of 5° and a concentration of 200 times the total weight of the medicinal material, and store it in a dark, sealed container for 2 months;

[0043] S3: collecting the soaking liquid from step S1, filtering to remove the medicinal residue and then taking the filtrate to obtain the product.

[0044] Example 5

[0045] The preparation method of the traditional Chinese medicine composition for treating condyloma acuminata comprises the following steps:

[0046] S1: Weigh out Smilax glabra, Paris polyphylla, Bombyx batryticatus, Dictamni cortex, Schizonepeta tenuifolia, Angelica dahurica, Notopterygium wilfordii, Gleditsia sinensis thorn, processed Aconitum kusnezoffii, processed Chuanwu, Clemati radix and Saposhnikovia divaricata according to the prescription;

[0047] S2: Weigh each medicinal material according to the prescription, dry it at high temperature, mix it, grind it, soak it in 10° glacial acetic acid with a concentration of 150 times the total weight of the medicinal material, and store it in a dark, sealed place for 2 months;

[0048] S3: collecting the soaking liquid from step S1, filtering to remove the medicinal residue and then taking the filtrate to obtain the product.

[0049] Example 6

[0050] The preparation method of the traditional Chinese medicine composition for treating condyloma acuminata comprises the following steps:

[0051] S1: Weigh out Smilax glabra, Paris polyphylla, Bombyx batryticatus, Dictamni cortex, Schizonepeta tenuifolia, Angelica dahurica, Notopterygium wilfordii, Gleditsia sinensis thorn, processed Aconitum kusnezoffii, processed Chuanwu, Clemati radix and Saposhnikovia divaricata according to the prescription;

[0052] S2: Weigh each medicinal material according to the prescription, dry it at high temperature, mix it, grind it, soak it in glacial acetic acid with an acidity of 15° and a concentration of 200 times the total weight of the medicinal material, and store it in a dark, sealed container for 2 months;

[0053] S3: collecting the soaking liquid from step S1, filtering to remove the medicinal residue and then taking the filtrate to obtain the product.

[0054] Example 7

[0055] The preparation method of the traditional Chinese medicine composition for treating condyloma acuminata comprises the following steps:

[0056] S1: Weigh out Smilax glabra, Paris polyphylla, Bombyx batryticatus, Dictamni cortex, Schizonepeta tenuifolia, Angelica dahurica, Notopterygium wilfordii, Gleditsia sinensis thorn, processed Aconitum kusnezoffii, processed Chuanwu, Clemati radix and Saposhnikovia divaricata according to the prescription;

[0057] S2: Weigh each medicinal material according to the prescription, dry it at high temperature, mix it, grind it, soak it in glacial acetic acid with an acidity of 30° and a concentration of 250 times the total weight of the medicinal material, and store it in a dark, sealed place for 2 months;

[0058] S3: collecting the soaking liquid from step S1, filtering to remove the medicinal residue and then taking the filtrate to obtain the product.

[0059] Example 8

[0060] According to the above prescription and preparation method, a syrup for treating condyloma acuminata is prepared and used as follows:

[0061] First, disinfect the affected area with a sterile cotton swab dipped in iodine. Then, apply the solution to the wart using a sterile cotton swab, gently pressing repeatedly for 5-10 seconds (depending on the degree of keratinization). Monitor the wart for changes after application. If bleeding occurs, treat promptly and discontinue treatment once the bleeding stops. If the wart turns white or becomes unresponsive, observe for 30 seconds before reapplying. Repeat the application of the solution to each wart 1-3 times, which constitutes one treatment session. One treatment session should be completed daily for one week.

[0062] In order to further verify the reliability of the present invention and screen out the best solution, the inventors conducted a series of experiments, as follows:

[0063] 1. The origin of the traditional Chinese medicine prescription for treating condyloma acuminata

[0064] 1.1 Raw materials

[0065] The raw materials of the Chinese medicine composition are: rhizoma smilax, parietia, bombyx batryticatus, bark of licorice, schizonepeta, angelica dahurica, notopterygium wilfordii, thorn of soapberry, processed aconite, processed Chuanwu, clematis root and siler.

[0066] 1.2 Basis of formula

[0067] The medications used in this study adhere to the principles of Traditional Chinese Medicine (TCM) compatibility. The formula features Rhizoma Smilacis Glabrae, Rhizoma Paridis, and Cortex Dictamni as the main ingredients, which clear heat and detoxify, reduce swelling, and dispel dampness. Modern pharmacological research has shown that these herbs inhibit bacterial and viral replication, making them commonly used clinically for the treatment of skin diseases and sexually transmitted diseases. Bombyx Batryticatus, Saposhnikovia Divaricata, Schizonepeta Tenuifolia, Rhizoma Notopterygii, Rhizoma Duhuo, and Radix Clematis as auxiliary ingredients, which function to dispel wind and pathogenic factors, and resolve exterior symptoms and toxins. Chuanwu, Aconitum Kusnezoffii, and Spina Gleditsiae serve as adjuvants, providing detoxification and dampness removal, and also possessing a certain anesthetic effect, alleviating pain experienced during use. Modern Chinese Medicine considers genital warts to be exogenous diseases, primarily caused by wind and dampness, with some intervening cold and heat pathogens. Therefore, the formula focuses on the underlying etiology of this disease, with the therapeutic principles of clearing heat and detoxifying, dispelling wind and dampness. The addition of glacial acetic acid, which has a corrosive effect, breaks down the keratinous structure of genital warts, allowing the herbal ingredients to effectively penetrate the warts, destroying them and effectively reducing recurrence.

[0068] Smilax glabra (Tu Fu Ling): Neutral in nature, sweet and bland in flavor, it enters the liver, spleen, and stomach meridians. Benefits: Detoxifies, removes dampness, and promotes joint function. It is clinically used to treat itchy skin, scabies, exudative and erosive skin diseases, and sexually transmitted diseases such as syphilis and gonorrhea.

[0069] Paris polyphylla: Slightly cold in nature, bitter in flavor, enters the Liver Meridian. Efficacy: Clears heat and detoxifies, reduces swelling and relieves pain, and cools the liver and calms convulsions. Clinically used for boils, carbuncles, sore throat, snake bites, injuries from falls, and convulsions.

[0070] Bombyx batryticatus: Salty in nature, neutral in flavor, enters the liver, lung, and stomach meridians. Efficacy: dispels wind and stops spasms, resolves phlegm and disperses stagnation. Clinically used for stroke, epilepsy, headache, throat paralysis, scrofula, tuberculosis, eczema, and other conditions.

[0071] Dictamnus Cortex: Cold in nature, bitter in flavor, enters the spleen and lung meridians. Efficacy: Dispels wind and relieves itching, dries dampness and detoxifies. Clinically used for rubella, eczema, scabies, jaundice, and damp-heat arthritis caused by wind-heat and dampness.

[0072] Schizonepeta: Warm in nature, slightly bitter in flavor, enters the lung and liver meridians. Efficacy: Dispels wind and relieves exterior symptoms, promotes the passage of rashes and stops bleeding. Clinically used for colds, fever, headaches, itchy eyes, coughs, sore throats, measles, carbuncles, scabies, epistaxis, hematemesis, bloody stools, and metrorrhagia.

[0073] Saposhnikovia root: Slightly warm in nature, pungent and sweet in flavor, enters the bladder, liver, and spleen meridians. Efficacy: Dispels wind and relieves exterior symptoms, dispels dampness and relieves pain, and stops spasms. Clinically used for symptoms of exogenous infection, pruritus caused by rubella, rheumatic pain, tetanus, and spleen deficiency and dampness.

[0074] Qiang Huo: Warm in nature, pungent and bitter in flavor. Enters the bladder and kidney meridians. Efficacy: Dispels cold, dispels wind and dampness. Clinically used for exogenous wind-cold, rheumatic pain, and headaches.

[0075] Duhuo: Slightly warm in nature, pungent and bitter in flavor. Enters the bladder and kidney meridians. Efficacy: Dispels wind and dampness, relieves numbness and relieves pain. Clinically used to treat pain caused by wind, cold and dampness, pain in the waist and knees, and headaches due to wind-hidden wind in the Shaoyin meridians.

[0076] Gleditsia chinensis: Warm in nature, pungent in flavor, enters the lung and bladder meridians. Benefits: Reduces swelling, detoxifies, drains pus, and kills parasites. Clinically used for carbuncle, scrofula, rashes, and stubborn ringworms.

[0077] Prepared Radix Aconiti Kusnezoffii: Warm in nature, pungent and bitter in flavor, it enters the Heart, Liver, Kidney, and Spleen meridians. Efficacy: Dispels wind and dampness, warms the meridians and relieves pain. Clinically used for wind-cold-dampness arthralgia, joint pain, abdominal pain, and pain from cold hernia.

[0078] Processed Chuanwu: Pungent, hot, bitter, and toxic, it enters the Heart, Liver, Kidney, and Spleen meridians. Efficacy: Dispels wind and dampness, warms the meridians, and relieves pain. Clinically used for wind-cold-dampness arthralgia, breast pain, chest pain, joint pain, heart and abdominal pain caused by cold, hernia pain, and as anesthesia and analgesia.

[0079] Clematis chinensis: Warm in nature, pungent and salty in flavor, it enters the bladder meridian. Benefits: Relieves rheumatism and dredges the meridians. Clinically used to treat limb joint pain, numbness, difficulty flexing and extending, and joint swelling and deformation caused by wind, cold, and dampness.

[0080] 2. Prescription and preparation of syrup for treating condyloma acuminata

[0081] 2.1 Prescription

[0082] The prescription for the treatment of genital warts provided in this study is as follows:

[0083] Smilax glabra 10-40g, Paris polyphylla 10-40g, Bombyx batryticatus 5-15g, Dictamni cortex 10-30g

[0084] Schizonepeta 5-15g, Angelica dahurica 5-15g, Notopterygium incisum 5-15g, Gleditsia sinensis 5-15g

[0085] Processed Aconitum kusnezoffii 2-10g, processed Chuanwu 2-10g, Smilax glabra 5-15g, Saposhnikovia divaricata 5-15g.

[0086] 2.2 Preparation process

[0087] The preparation method of the syrup for treating condyloma acuminata provided in this study is as follows:

[0088] (1) Weigh 15g of Rhizoma Smilacis Glabrae, 15g of Paris Polygoni Multiflori, 10g of Bombyx Batryticatus, 15g of Dictamni Cortex, 10g of Schizonepeta Tenuifolia, 10g of Angelicae Pubescentis, 10g of Notopterygium Incisi, 10g of Gleditsiae Spinosae, 5g of processed Aconitum Kusnezoffii, 5g of processed Chuanwu Radix, 10g of Clematidis, and 10g of Saposhnikovia Divaricata.

[0089] (2) The medicinal materials weighed according to the prescription are dried at high temperature, mixed, and crushed, and then soaked in 200 times the weight of glacial acetic acid with an acidity of 5-30°, and stored in a dark place under a sealed container for 2 months.

[0090] (3) After 2 months, filter and remove the residue, collect the soaking liquid, and seal it for future use. 3. Clinical efficacy verification of the liquid for treating condyloma acuminata

[0091] 3.1 Enrollment criteria

[0092] The inclusion criteria were: age 18-65 years old; positive 5% acetic acid white test; positive low-risk HPV test; no history of liver and kidney dysfunction or other serious visceral diseases; non-immunodeficiency; and no recent use of immunomodulators.

[0093] A total of 120 patients who met the above inclusion criteria and were diagnosed with genital warts in the dermatology and venereology clinic from October 2021 to October 2023 were selected and enrolled in this study after the patients signed the informed consent form.

[0094] 3.2 Treatment methods

[0095] First, disinfect the affected area with a sterile cotton swab dipped in iodine. Then, apply the solution to the wart using a sterile cotton swab, gently pressing repeatedly for 5-10 seconds (depending on the degree of keratinization). Monitor the wart for changes after application. If bleeding occurs, treat promptly and discontinue treatment once the bleeding stops. If the wart turns white or becomes unresponsive, observe for 30 seconds before reapplying. Repeat the application of the solution to each wart 1-3 times, which constitutes one treatment session. One treatment session should be completed daily for one week.

[0096] 3.3 Notes

[0097] (1) When using a sterile cotton swab to apply the liquid medicine of the present invention, do not apply too much, and try to avoid the liquid medicine from overflowing onto normal skin and mucous membranes during application. If the liquid medicine overflows onto normal skin tissue during use, it should be promptly absorbed and wiped with sterile gauze or cotton swabs to avoid corrosion of normal skin or mucous membranes.

[0098] (2) If the wart is large or the wart epidermis is excessively keratinized, it is necessary to use a microwave therapeutic device or a fire needle to properly clean the keratinized part of the wart epidermis before applying the liquid medicine of the present invention.

[0099] (3) The liquid medicine of the present invention may cause pain during the treatment process. For example, patients with cardiovascular and cerebrovascular diseases, hypertension, coronary heart disease, or those who are older, weaker, or have intolerance to pain should apply 5% compound lidocaine cream to the affected area for 40-60 minutes before using the liquid medicine for treatment.

[0100] (4) If the wart ruptures and bleeds, apply pressure with a cotton swab to stop the bleeding immediately. Do not stop treatment after the bleeding stops. Bandage or pack the wart with sterile gauze. Observe for 30 minutes until no bleeding is observed before allowing the patient to leave.

[0101] (5) Advise patients not to get wet or take a bath within 24 hours after treatment, avoid strenuous exercise, and eat less spicy, greasy, and irritating foods.

[0102] (6) After a period of treatment, if the local wound does not heal properly, becomes infected or ulcerated, symptomatic treatment should be given promptly.

[0103] 3.4 Observation indicators

[0104] Observe and record in detail the number of warts, lesion area, recurrence, and degree of skin ulceration. Observe and record in detail any local pain, burning sensation, exudation, redness, swelling, and wound healing rate during the entire treatment and follow-up period.

[0105] 3.5 Efficacy assessment

[0106] With reference to the Diagnostic Criteria and Treatment Principles of Condyloma Acuminatum and literature, the efficacy evaluation criteria are formulated as follows:

[0107] ①Cure: Skin lesions completely disappear;

[0108] ② Markedly effective: the number of warts or the area of lesions decreased by ≥60%;

[0109] ③Effective: the number of warts or the area of lesions decreased by ≥20% but <60%;

[0110] ④ Ineffective: The number of warts or the area of lesions decreases by less than 20% or continues to worsen.

[0111] The effective rate was calculated according to the above efficacy evaluation criteria. The effective rate calculation formula is as follows:

[0112] Effective rate = (number of cured cases + number of markedly effective cases) / total number of cases × 100%

[0113] Clinical cure and recurrence assessment: complete removal of visible warts, no reappearance of new warts at the original lesion within 3 months after treatment, and a negative acetic acid white test result indicate clinical cure; recurrence is defined as the appearance of new warts in and around the original lesion within 3 months after treatment.

[0114] 3.6 Typical Case Examples

[0115] (1) Case 1

[0116] Dai, male, 21 years old, a college student with a history of unclean sexual life, came to the dermatology department for examination in February 2023 due to the appearance of unidentified vegetation around the anus. Physical examination revealed dense keratotic papules at 3 and 9 o'clock around the anus, with irregular surface and positive acetic acid white test. He was diagnosed with perianal condyloma acuminata. He reported that he was diagnosed with the disease at another hospital, and the hospital recommended laser surgery. Because he was worried about the sequelae of the surgery, he came to our hospital for treatment with the above method. He was given the topical solution of this study, which was used once a day for one week. After continuous medication, the perianal vegetation partially fell off. After another two weeks of treatment, all the lesions fell off. There was no recurrence after one year of follow-up.

[0117] (2) Case 2

[0118] Xu, a 73-year-old male, retired cadre, was diagnosed with genital warts in another hospital in June 2023 due to the appearance of unidentified growths on the glans penis and foreskin. He then underwent laser resection and oral immune-enhancing drugs. Two months later, the disease relapsed, so he came to our hospital for treatment. Physical examination revealed two cauliflower-like growths on the patient's coronal sulcus and urethral opening. The surface was brittle, and bleeding occurred when touched with a cotton swab. The acetic acid white test was positive. The topical solution of this study was given. After application, the warts began to ooze blood. After stopping the bleeding with a cotton swab, the patient was pressed with a cotton ball. The patient was asked to come to our hospital for dressing changes every day. After one week of continuous treatment, the warts were basically completely shed. One week after stopping the medication, the wound healed. The patient was asked to take the medicine home for treatment and apply it externally once every two days to prevent recurrence. The medication was discontinued after one month of continuous use. Follow-up by phone one year later showed no recurrence.

[0119] (3) Case 3

[0120] Han, female, 32 years old, company employee, unmarried, was diagnosed with vulvar condyloma acuminata in an external hospital in December 2022 and was given photodynamic therapy for 3 consecutive months. The lesions subsided and no new lesions were seen. Later, due to her busy work, she worked overtime for half a month. In April 2023, she found light red papules on the inside of the labia majora, accompanied by mild itching, and came to our hospital for treatment. Physical examination revealed that the patient had 3 light red growths on the inside of the left labia majora, near the clitoris. The growths were of different sizes. The larger one was cauliflower-shaped with an irregular surface. The acetic acid white test was positive, and the diagnosis of condyloma acuminata was made. The topical lotion of the present invention was given, and the medicine was applied with a cotton swab, once a day. After 1 week of continuous use, the warts on the labia majora fell off. The patient was asked to use it once every 2 days. After 2 weeks of continuous use, no new lesions were seen. Follow-up after 1 year showed no recurrence.

[0121] (4) Case 4

[0122] Ms. Yang, a 27-year-old unmarried woman, presented to our dermatology department on January 21, 2023, with multiple keratinized growths around the anus, more than 10 in number, varying in size, with the largest being pea-sized. Some lesions were flat, with hyperkeratotic surfaces and a positive acetowhite test. She was treated with the liquid medicine of the present invention once daily. After two weeks of treatment, the warts fell off. A follow-up visit three months later revealed no recurrence.

[0123] (5) Case 5

[0124] Ma, a 44-year-old married woman, presented to the hospital on June 10, 2023, with a brown, millet-sized growth on her left labia majora. The growth was soft and easily bled upon contact, and the acetic acid white test was positive. She was diagnosed with condyloma acuminata. She was given the liquid of the present invention for application and rubbing with appropriate force, which caused bleeding and subsequent shedding of the wart. After three days of continued treatment, the wart formed a scab. Upon return to the hospital two weeks later, the lesion had disappeared. A follow-up call three months later showed no recurrence.

[0125] 3.7 Results and Analysis

[0126] Clinical efficacy results are shown in Table 1. As shown in Table 1, among the 120 enrolled patients, the efficacy rate after one course of treatment was 77.4%, after two courses of treatment was 82.8%, and after three courses was 89.5%. One patient developed exudative symptoms after bathing, which resolved after one week of symptomatic treatment.

[0127] Table 1 Clinical efficacy observation results of the treatment of condyloma acuminata

[0128]

[0129]

[0130] Recurrence: Enrolled patients were followed up for three months. Some of the enrolled patients dropped out of the study for various reasons and no feedback was provided. A total of 106 patients were tracked, and their recurrence patterns are shown in Table 2. Table 2 shows that the recurrence rate among these 106 patients was only 9.4%.

[0131] Table 2 Statistics of recurrence after treatment

[0132]

[0133] The above results show that the medicated solution achieved a clinical efficacy of 77.4% after one course of treatment. The efficacy gradually increased with the extension of the course of treatment, reaching a high efficacy of 89.5% after three courses of treatment. Furthermore, the recurrence rate was only 9.4% among the 106 patients enrolled in this study for the treatment of condyloma acuminata. Thus, the medicated solution of the present invention can effectively remove condyloma acuminata from the genital area, is effective rapidly, has a low recurrence rate, is simple to operate, and has minimal side effects, thus having high clinical application value.

[0134] Although the present invention has been described in detail above using general explanations, specific embodiments, and experiments, it will be apparent to those skilled in the art that modifications and improvements may be made based on the present invention. Therefore, such modifications and improvements, which do not depart from the spirit of the present invention, are intended to be within the scope of protection claimed herein.

Claims

1. A Chinese medicine composition for treating condyloma acuminata, characterized in that: The invention comprises the following components in parts by mass: 10-40 parts of Smilax glabra, 10-40 parts of Paris polyphylla, 5-15 parts of Bombyx batryticatus, 10-30 parts of Dictamni cortex, 5-15 parts of Schizonepeta tenuifolia, 5-15 parts of Angelica dahurica, 5-15 parts of Notopterygium wilfordii, 5-15 parts of Gleditsia chinensis thorns, 2-10 parts of processed Aconitum kusnezoffii, 2-10 parts of processed Chuanwuji, 5-15 parts of Clematidis, and 5-15 parts of Saposhnikovia divaricata.

2. The Chinese medicine composition according to claim 1, characterized in that The invention comprises the following components in parts by mass: 10-30 parts of Smilax glabra, 10-30 parts of Paris polyphylla, 5-10 parts of Bombyx batryticatus, 10-20 parts of Dictamni cortex, 5-10 parts of Schizonepeta tenuifolia, 5-10 parts of Angelica dahurica, 5-10 parts of Notopterygium wilfordii, 5-10 parts of Gleditsia chinensis thorns, 2-5 parts of processed Aconitum kusnezoffii, 2-5 parts of processed Chuanwuji, 5-10 parts of Clematis chinensis, and 5-10 parts of Saposhnikovia divaricata.

3. The Chinese medicine composition according to claim 2, characterized in that The invention comprises the following components in parts by weight: 15 parts of rhizoma smilacis gracile, 15 parts of parsnip, 10 parts of bombyx batryticatus, 15 parts of cortex dichotoma, 10 parts of herba schizonepetae, 10 parts of angelica dahurica, 10 parts of notopterygium wilfordii, 10 parts of gleditsia spinulosae, 5 parts of processed aconite, 5 parts of processed radix aconiti kusnezoffii, 10 parts of radix clematis, and 10 parts of siler.

4. The method for preparing the Chinese medicine composition for treating condyloma acuminata according to claim 1, wherein Here are the steps: S1: Weigh out Smilax glabra, Paris polyphylla, Bombyx batryticatus, Dictamni cortex, Schizonepeta tenuifolia, Angelica dahurica, Notopterygium wilfordii, Gleditsia sinensis thorn, processed Aconitum kusnezoffii, processed Chuanwu, Clemati radix and Saposhnikovia divaricata according to the prescription; S2: Weigh each medicinal material according to the prescription, dry it at high temperature, mix it, grind it, soak it in glacial acetic acid, and store it in a dark and sealed place; S3: collecting the soaking liquid from step S2, filtering to remove the medicinal residue and then taking the filtrate to obtain the product.

5. The method for preparing the Chinese medicine composition for treating condyloma acuminata according to claim 4, wherein: The acidity of the glacial acetic acid in step S1 is 5-30°.

6. The method for preparing the Chinese medicine composition for treating condyloma acuminata according to claim 5, wherein: The acidity of the glacial acetic acid in step S1 is 5°.

7. The method for preparing the Chinese medicine composition for treating condyloma acuminata according to claim 4, wherein: The amount of glacial acetic acid added in step S1 is 150-250 times the total mass of the medicinal materials.

8. The method for preparing the Chinese medicine composition for treating condyloma acuminata according to claim 7, wherein: The amount of glacial acetic acid added in step S1 is 200 times the total mass of the medicinal materials.

9. The method for preparing the Chinese medicine composition for treating condyloma acuminata according to claim 4, wherein: The sealed storage time in step S1 is 2 months.

10. Use of the traditional Chinese medicine composition for treating condyloma acuminata as claimed in claim 1 in preparing a medicine for treating condyloma acuminata.

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