A traditional Chinese medicine external application method for reducing the risk of internal fistula fibrosis of dialysis patients

Abstract

The application provides a traditional Chinese medicine external application method for reducing the risk of fistula fibrosis in dialysis patients, relates to the technical field of clinical application of traditional Chinese medicine, is suitable for the prevention of autologous arteriovenous fistula fibrosis of maintenance hemodialysis patients, can effectively reduce the incidence of complications such as fistula peripheral tissue fibrosis and vascular stenosis, and prolongs the service life of the fistula. The drug stability and skin permeability are improved through optimization of adjuvants, and based on the grouping intervention of maintenance hemodialysis patients, the fistula blood flow and fibrosis improvement are evaluated in combination with color Doppler ultrasound. The application takes the principles of promoting blood circulation to remove blood stasis, dredging collaterals and resolving knots, and detoxification and swelling reduction as the therapeutic principles, prepares a fistula protection ointment by screening and optimizing a traditional Chinese medicine formula, realizes the effects of improving local microcirculation of the fistula, inhibiting fibrous tissue proliferation and reducing inflammatory reactions through external application intervention, thereby reducing the incidence of fistula fibrosis and related complications, prolonging the fistula patency time, simultaneously reducing the treatment cost, and improving the patient tolerance and life quality.

Description

Technical Field

[0001] This invention relates to the field of clinical application technology of traditional Chinese medicine, and more specifically, to a method of applying traditional Chinese medicine externally to reduce the risk of arteriovenous fistula fibrosis in dialysis patients. Background Technology

[0002] Maintenance hemodialysis is the most commonly used renal replacement therapy for end-stage renal disease patients in my country, and autogenous arteriovenous fistula (AVF) is currently the preferred vascular access recommended by domestic and international guidelines and expert consensus, and is hailed as the lifeline for maintenance hemodialysis patients. Maintenance hemodialysis patients undergo hemodialysis an average of 3-4 times per week, requiring at least 2-4 fistula punctures per month. Long-term repeated punctures can easily lead to complications such as intimal hyperplasia, vascular stenosis, occlusion, surrounding tissue fibrosis, infection, and hemangioma. According to relevant surveys, the annual hospitalization rate for hemodialysis patients due to vascular access problems is as high as 13.8%. These complications not only increase the economic burden on patients but may also directly threaten their lives due to fistula failure.

[0003] Currently, modern medicine has relatively limited treatment options for maintaining the patency of arteriovenous fistulas. Topical medications primarily include mucopolysaccharide polysulfate cream. While this drug is used to improve local blood circulation, its clinical efficacy has not been fully proven, and its increasingly high price further burdens patients. Furthermore, mucopolysaccharide polysulfate cream has occasional adverse reactions such as local allergic reactions and contact inflammation, and the potential risks to pregnant or breastfeeding patients are unknown, thus limiting its application.

[0004] The pathogenesis of arteriovenous fistula (AVF) fibrosis is complex, primarily involving hemodynamic changes leading to endothelial cell damage, smooth muscle cell migration and proliferation, intimal hyperplasia, local inflammatory responses, and excessive proliferation and deposition of fibrous tissue. Among these, osteopontin / CD44 axis-mediated blood flow disturbance-induced endothelial-mesenchymal transition (EMT) is a crucial mechanism leading to AVF intimal hyperplasia and subsequent fibrosis. Traditional Chinese medicine (TCM), a treasure of traditional medicine, exhibits unique advantages in promoting blood circulation, improving local microcirculation, anti-inflammatory and antibacterial effects, and inhibiting fibroblast activation, providing new ideas and methods for preventing AVF fibrosis and other complications. Developing a safe, effective, and economical TCM external application method is of significant clinical value in reducing the risk of AVF fibrosis in dialysis patients, prolonging AVF lifespan, and improving patients' quality of life. Therefore, this paper proposes a TCM external application method to reduce the risk of AVF fibrosis in dialysis patients. Summary of the Invention

[0005] To address the limitations of existing technologies in preventing arteriovenous fistula fibrosis, the uncertain efficacy of Western medicine, high prices, and adverse reactions, this invention provides a traditional Chinese medicine external application method to reduce the risk of arteriovenous fistula fibrosis in dialysis patients. Based on the principles of promoting blood circulation, removing blood stasis, clearing the channels, dispersing nodules, detoxifying, and reducing swelling, a fistula-protecting ointment is prepared using a screened and optimized traditional Chinese medicine formula. This external application improves local microcirculation within the fistula, inhibits fibrous tissue proliferation, and reduces inflammatory responses, thereby lowering the incidence of fistula fibrosis and related complications, prolonging fistula patency time, reducing treatment costs, and improving patient tolerance and quality of life.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution: a method for external application of traditional Chinese medicine to reduce the risk of arteriovenous fistula fibrosis in dialysis patients, comprising the following steps: Step 1, Preparation of the Traditional Chinese Medicine Composition: The Traditional Chinese Medicine Composition consists of the following raw materials in parts by weight: 15-25 parts of Salvia miltiorrhiza, 10-20 parts of Ligusticum chuanxiong, 8-15 parts of Pheretima aspergillum, 10-20 parts of Angelica sinensis, 5-12 parts of Panax notoginseng, 10-20 parts of Centella asiatica, 3-8 parts of Scolopendra subspinipes, 2-6 parts of Borneol, and 8-15 parts of Carthamus tinctorius. Step 2: Remove impurities from Salvia miltiorrhiza, Ligusticum chuanxiong, earthworm, Angelica sinensis, Panax notoginseng, Centella asiatica, centipede, and safflower, wash, dry, pulverize and pass through an 80-100 mesh sieve to obtain fine powder of Chinese medicine. Grind borneol separately into fine powder for later use. Step 3, Preparation of Fistula Protection Ointment: Take the fine powder of traditional Chinese medicine from Step 2, add 8-12 times the amount of distilled water and soak for 30-60 minutes, decoct 2-3 times, combine the decoctions and filter, concentrate to a thick paste with a relative density of 1.20-1.30 (25℃); according to the weight ratio of thick paste: petrolatum: lanolin: glycerin = 1:2:0.5:0.3; Step 4: Heat and melt petrolatum and lanolin, then mix them evenly with the thick paste. When the temperature drops to 40-50℃, add borneol powder, stir evenly, and then cool and solidify to obtain the fistula protection ointment. Step 5, External application: After cleaning, disinfecting and drying the fistula site, apply 2-5g of fistula protection ointment evenly to the area where the fistula blood vessels run and the surrounding 2-3cm of skin, with a thickness of 0.2-0.3cm. Cover and fix with sterile gauze. Apply externally for 4-6 hours each time, 3-4 times a week. Avoid applying the ointment within 24 hours after puncture on the day of dialysis. A course of treatment consists of 12 consecutive weeks of medication.

[0007] As a preferred technical solution of the present invention, the preferred weight parts of the traditional Chinese medicine composition are: 20 parts of Salvia miltiorrhiza, 15 parts of Ligusticum chuanxiong, 12 parts of Pheretima aspergillum, 15 parts of Angelica sinensis, 8 parts of Panax notoginseng, 15 parts of Centella asiatica, 5 parts of Scolopendra subspinipes, 4 parts of Borneol, and 12 parts of Carthamus tinctorius.

[0008] As a preferred technical solution of the present invention, in the preparation of the fistula ointment, the decoction conditions are to heat to a boil and then simmer for 30-40 minutes each time; the concentration conditions are 60-70℃ and vacuum degree 0.06-0.08MPa.

[0009] As a preferred technical solution of the present invention, the contraindications for the external application method are: those who are allergic to any component of the traditional Chinese medicine composition, and patients with ruptured, ulcerated, or severely infected fistula sites.

[0010] As a preferred technical solution of the present invention, the external application method further includes post-application care steps: after the external application is completed, wipe the residual ointment with sterile saline, observe whether there is an allergic reaction at the fistula site, and regularly monitor the fistula thrill, murmur and blood flow.

[0011] As a preferred technical solution of the present invention, the application of the traditional Chinese medicine composition in the preparation of a topical medicine that reduces the risk of arteriovenous fistula fibrosis in dialysis patients.

[0012] As a preferred technical solution of the present invention, the storage conditions of the fistula ointment are a sealed, cool and dry place, and the shelf life is not less than 6 months.

[0013] As a preferred technical solution of the present invention, the drying temperature of the fine powder of traditional Chinese medicine is 60-80℃, and it is dried to constant weight to ensure that the moisture content does not exceed 8%.

[0014] As a preferred technical solution of the present invention, in the external application operation, after the sterile gauze is covered, it is fixed with medical breathable adhesive tape to avoid compressing the arteriovenous fistula blood vessels and affecting blood flow.

[0015] As a preferred technical solution of the present invention, in the traditional Chinese medicine composition, the centipede is dried at low temperature and then pulverized to avoid loss of effective ingredients, and borneol is added at 40-50℃ to reduce volatilization loss.

[0016] Compared with existing technologies, the beneficial effects of this invention are as follows: The traditional Chinese medicine composition of this invention can synergistically improve local microcirculation in the arteriovenous fistula (AVF), inhibit endothelial cell damage, smooth muscle cell proliferation, and fibroblast activation, and block the osteopontin / CD44 axis-mediated endothelial-mesenchymal transition. This effectively reduces the incidence of complications such as fibrosis and vascular stenosis in the surrounding tissues of the AVF, significantly improves the long-term patency rate of the AVF, and prolongs its lifespan. After clinical application, it can maintain the blood flow of the AVF at over 500 ml / min, meeting the sufficient blood flow required for hemodialysis.

[0017] The Chinese herbs used in this invention are all commonly used clinical medicinal materials, and the combination is scientific and reasonable. After extraction and concentration, they are made into a paste. External application can avoid the extra burden on the kidneys caused by oral medications and reduce the risk of systemic adverse reactions. The excipients are mild and non-irritating, which can reduce skin allergic reactions. Compared with polysulfated mucopolysaccharide cream, it is suitable for a wider range of people, especially for various dialysis patients other than pregnant or breastfeeding patients. Long-term use is well tolerated.

[0018] The Chinese herbal raw materials used in this invention are widely available and inexpensive, and the preparation process is simple and requires no complicated equipment. Compared with the expensive polysulfated mucopolysaccharide cream, it can significantly reduce the medication cost for patients. At the same time, by reducing the occurrence of arteriovenous fistula fibrosis and related complications, it can reduce the additional treatment costs for patients due to complications, such as surgery and hospitalization, save medical resources, and reduce the economic burden on patients' families and society.

[0019] The preparation process of the fistula ointment of the present invention is simple, the external application method is convenient, and no professional medical personnel are required to operate it. Patients can use the medication at home under the guidance of a doctor, resulting in high compliance. Moreover, the method does not require special equipment and is suitable for promotion and application in medical institutions and community health service centers at all levels. It provides practical guidance for the application of traditional Chinese medicine in the prevention of complications of fistula. Attached Figure Description

[0020] Figure 1 A schematic diagram of the method parameters provided by the present invention; Figure 2 This is a data flowchart of the external application operation provided by the present invention; Figure 3 This is a data flowchart of the traditional Chinese medicine composition formula provided by the present invention. Detailed Implementation

[0021] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0022] Therefore, the following detailed description of the embodiments of the present invention is not intended to limit the scope of the claimed invention, but merely illustrates some embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention. It should be noted that, in the absence of conflict, the embodiments and features and technical solutions in the embodiments of the present invention can be combined with each other. It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0023] Example 1: A method for external application of traditional Chinese medicine to reduce the risk of arteriovenous fistula fibrosis in dialysis patients, comprising the following steps: Step 1, preparation of the traditional Chinese medicine composition: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 15-25 parts of Salvia miltiorrhiza, 10-20 parts of Ligusticum chuanxiong, 8-15 parts of Pheretima aspergillum, 10-20 parts of Angelica sinensis, 5-12 parts of Panax notoginseng, 10-20 parts of Centella asiatica, 3-8 parts of Scolopendra subspinipes, 2-6 parts of Borneol, and 8-15 parts of Carthamus tinctorius; Step 2: Remove impurities from Salvia miltiorrhiza, Ligusticum chuanxiong, earthworm, Angelica sinensis, Panax notoginseng, Centella asiatica, centipede, and safflower, wash, dry, pulverize and pass through an 80-100 mesh sieve to obtain fine powder of Chinese medicine. Grind borneol separately into fine powder for later use. Step 3, Preparation of Fistula Protection Ointment: Take the fine powder of traditional Chinese medicine from Step 2, add 8-12 times the amount of distilled water and soak for 30-60 minutes, decoct 2-3 times, combine the decoctions and filter, concentrate to a thick paste with a relative density of 1.20-1.30 (25℃); according to the weight ratio of thick paste: petrolatum: lanolin: glycerin = 1:2:0.5:0.3; Step 4: Heat and melt petrolatum and lanolin, then mix them evenly with the thick paste. When the temperature drops to 40-50℃, add borneol powder, stir evenly, and then cool and solidify to obtain the fistula protection ointment. Step 5, External application: After cleaning, disinfecting and drying the fistula site, apply 2-5g of fistula protection ointment evenly to the area where the fistula blood vessels run and the surrounding 2-3cm of skin, with a thickness of 0.2-0.3cm. Cover and fix with sterile gauze. Apply externally for 4-6 hours each time, 3-4 times a week. Avoid applying the ointment within 24 hours after puncture on the day of dialysis. A course of treatment consists of 12 consecutive weeks of medication.

[0024] The preferred weight parts of the traditional Chinese medicine composition are: 20 parts of Salvia miltiorrhiza, 15 parts of Ligusticum chuanxiong, 12 parts of Pheretima aspergillum, 15 parts of Angelica sinensis, 8 parts of Panax notoginseng, 15 parts of Centella asiatica, 5 parts of Scolopendra subspinipes, 4 parts of Borneol, and 12 parts of Carthamus tinctorius.

[0025] In the preparation of the fistula ointment, the decoction conditions are to heat to a boil and then simmer for 30-40 minutes each time; the concentration conditions are 60-70℃ and vacuum degree 0.06-0.08MPa.

[0026] The following groups are contraindicated for external application: those who are allergic to any component of the Chinese medicine composition, and patients with broken, ulcerated, or severely infected fistula sites.

[0027] The external application method also includes post-treatment care steps: after the external application is completed, wipe off any remaining ointment with sterile saline, observe the fistula site for any allergic reactions, and regularly monitor the fistula thrill, murmur and blood flow.

[0028] Application of traditional Chinese medicine composition in the preparation of topical drugs to reduce the risk of arteriovenous fistula fibrosis in dialysis patients.

[0029] The storage conditions for the fistula ointment are: sealed, cool and dry place, with a shelf life of not less than 6 months.

[0030] The drying temperature for fine Chinese herbal medicine powder is 60-80℃, and it is dried to constant weight, ensuring that the moisture content does not exceed 8%.

[0031] During the external application procedure, after covering with sterile gauze, it is fixed with medical breathable adhesive tape to avoid compressing the arteriovenous fistula vessels and affecting blood flow.

[0032] In the traditional Chinese medicine composition, the centipede is dried at low temperature and then pulverized to avoid loss of active ingredients, and borneol is added at 40-50℃ to reduce volatilization loss.

[0033] Traditional Chinese medicine composition formula: The traditional Chinese medicine composition used in this invention is composed of the following raw materials in parts by weight: 15-25 parts of Salvia miltiorrhiza, 10-20 parts of Ligusticum chuanxiong, 8-15 parts of Pheretima aspergillum, 10-20 parts of Angelica sinensis, 5-12 parts of Panax notoginseng, 10-20 parts of Centella asiatica, 3-8 parts of Scolopendra subspinipes, 2-6 parts of Borneol, and 8-15 parts of Carthamus tinctorius.

[0034] Analysis of the efficacy of the above-mentioned Chinese herbal raw materials: Danshen contains tanshinone and other components, which can promote blood circulation, remove blood stasis, inhibit platelet aggregation and fibroblast activation, and exert anti-fibrotic effects; Chuanxiong contains ligustrazine, which can dilate blood vessels, promote blood flow, and enhance the effect of promoting blood circulation and removing blood stasis. When used in combination with Danshen, it can synergistically improve local microcirculation; Dilong clears the meridians and disperses nodules, and promotes blood circulation, which can improve the state of vascular stasis; Danggui nourishes blood, promotes blood circulation, regulates menstruation and relieves pain, and can promote local tissue repair; Sanqi removes blood stasis, stops bleeding, promotes blood circulation and relieves pain, and can reduce subcutaneous hematoma after puncture and inhibit thrombus formation; Centella asiatica has anti-inflammatory and swelling-reducing effects, promotes tissue repair, and can reduce local inflammatory reactions and inhibit fibrous tissue hyperplasia; Centipede clears the meridians, relieves pain, disperses nodules and detoxifies, and enhances the effect of clearing the meridians and dispersing nodules; Borneol is aromatic and opens the orifices, and guides the medicine to the skin, which can promote the penetration and absorption of other Chinese herbal components and enhance the efficacy; Safflower promotes blood circulation, removes blood stasis, and relieves pain, and further strengthens the effect of promoting blood circulation and clearing the meridians. The combination of these drugs works synergistically to promote blood circulation, remove blood stasis, clear the meridians, disperse nodules, detoxify, and reduce swelling. They specifically improve local hemodynamics of the arteriovenous fistula, inhibit intimal hyperplasia and fibrous tissue deposition, and reduce the risk of fibrosis from the root cause.

[0035] Preparation method of fistula ointment: Step 1: Raw material pretreatment: Remove impurities from Danshen, Chuanxiong, earthworm, Angelica sinensis, Panax notoginseng, Centella asiatica, centipede, and safflower, clean them, dry them in an oven at 60-80℃ until constant weight, pulverize them and pass them through an 80-100 mesh sieve to obtain fine powder of Chinese medicine for later use; grind borneol into fine powder and set aside separately.

[0036] Step 2: Extraction and Concentration: Take the above-mentioned fine powder of Chinese medicine, add 8-12 times the amount of distilled water, soak for 30-60 minutes, heat to a boil, then simmer for 2-3 times, each time for 30-40 minutes, combine the three decoctions, filter with gauze to remove the dregs, and obtain the Chinese medicine extract; place the Chinese medicine extract in a rotary evaporator and concentrate it to a thick paste with a relative density of 1.20-1.30 (25℃) under the conditions of 60-70℃ and vacuum degree of 0.06-0.08MPa.

[0037] Step 3: Preparation and mixing of excipients: Select petrolatum, lanolin, and glycerin as excipients. According to the weight ratio of thick paste: petrolatum: lanolin: glycerin = 1:2:0.5:0.3, place petrolatum and lanolin in a water bath and heat to 60-70℃ to melt them. After stirring evenly, slowly add the above thick paste while stirring until it is evenly mixed. When the mixture cools down to 40-50℃, add borneol powder and stir quickly and evenly to avoid borneol volatilization.

[0038] Step 4: Shaping and Storage: Pour the above mixture into a sterile container and allow it to cool naturally to room temperature until it solidifies into a paste, which is the fistula protection paste. Seal the fistula protection paste and store it in a cool, dry place. The shelf life is 6 months.

[0039] The selection criteria for excipients are as follows: Vaseline has good moisturizing and lubricating properties, which can reduce the irritation of the drug to the skin and prolong the time the drug stays on the skin surface; lanolin can enhance the permeability of the drug and promote the absorption of active ingredients; glycerin can improve the moisturizing effect and comfort of the ointment, and prevent the skin from drying and cracking. The three work together to optimize the stability, permeability and user experience of the fistula ointment.

[0040] Traditional Chinese Medicine External Application Method: Step 1: Preparation before medication: Clean and disinfect the fistula area of ​​the patient, wipe the fistula skin with sterile saline, and apply the medicine after the skin is completely dry; Exclude contraindications for medication. Patients who are allergic to any component of the traditional Chinese medicine composition of this invention, or whose fistula area has damage, ulceration or severe infection are prohibited from using this medicine.

[0041] Step 2: External application: Take an appropriate amount of fistula ointment (adjust the amount according to the length of the fistula, generally 2-5g), and apply it evenly to the area where the fistula vessels run and the surrounding 2-3cm of skin. The thickness of the ointment should be 0.2-0.3cm. After application, cover with sterile gauze and then fix with medical tape to prevent the ointment from falling off.

[0042] Step 3: Frequency and duration of medication: Apply medication 3-4 times per week, with each application lasting 4-6 hours. Avoid medication within 24 hours after puncture on the day of dialysis. One course of treatment consists of 12 consecutive weeks of medication. The frequency and course of treatment can be adjusted under the guidance of a doctor according to the patient's arteriovenous fistula condition.

[0043] Step 4: Post-medication care: After the external application is completed, wipe the residual ointment at the fistula site with sterile saline to keep the skin clean and dry; observe the fistula site for any allergic reactions such as redness, swelling, itching, or rash. If discomfort occurs, stop the medication immediately and clean the local skin. If necessary, administer anti-allergy treatment; regularly monitor the fistula thrill, murmur, and blood flow to assess the fistula's functional status.

[0044] Example 2: A Traditional Chinese Medicine External Application Method to Reduce the Risk of Arteriovenous Fistula Fibrosis in Dialysis Patients 1. Formula of Chinese herbal medicine composition (parts by weight): 20 parts of Salvia miltiorrhiza, 15 parts of Ligusticum chuanxiong, 12 parts of Pheretima aspergillum, 15 parts of Angelica sinensis, 8 parts of Panax notoginseng, 15 parts of Centella asiatica, 5 parts of Scolopendra subspinipes, 4 parts of Borneol, and 12 parts of Carthamus tinctorius.

[0045] 2. Preparation of fistula-protecting ointment: Step 1: Remove impurities and clean the above Chinese medicines (except borneol), dry them in an oven at 65℃ until constant weight, pulverize them and pass them through a 90-mesh sieve to obtain fine powder of Chinese medicine; grind borneol into fine powder for later use.

[0046] Step 2: Take the fine powder of Chinese medicine, add 10 times the amount of distilled water, soak for 45 minutes, heat to a boil and then simmer for 35 minutes each time. Combine the decoctions and filter to obtain the extract. Concentrate the extract to a thick paste with a relative density of 1.25 (25℃) under the conditions of 65℃ and vacuum degree of 0.07MPa.

[0047] Step 3: According to the weight ratio of thick paste: petrolatum: lanolin: glycerin = 1:2:0.5:0.3, heat petrolatum and lanolin in a water bath to 65°C to melt them, add the thick paste and stir evenly, cool to 45°C and add borneol powder, stir quickly and evenly, and after cooling and solidification, you will get the fistula protection ointment.

[0048] 3. External application method: After cleaning, disinfecting, and drying the fistula site, apply 3g of fistula protection ointment evenly to the area where the fistula blood vessels run and the surrounding 2-3cm of skin, with a thickness of 0.25cm. Cover and fix with sterile gauze. Apply externally for 5 hours each time, 3 times a week. Do not use the ointment within 24 hours after puncture on the day of dialysis. Continuous use for 12 weeks constitutes one course of treatment.

[0049] Example 3: A Traditional Chinese Medicine External Application Method to Reduce the Risk of Arteriovenous Fistula Fibrosis in Dialysis Patients 1. Formula of Chinese herbal medicine composition (parts by weight): 15 parts of Salvia miltiorrhiza, 10 parts of Ligusticum chuanxiong, 8 parts of Pheretima aspergillum, 10 parts of Angelica sinensis, 5 parts of Panax notoginseng, 10 parts of Centella asiatica, 3 parts of Scolopendra subspinipes, 2 parts of Borneol, and 8 parts of Carthamus tinctorius.

[0050] 2. Preparation of fistula-protecting ointment: Step 1: Remove impurities and clean the above Chinese medicines (except borneol), dry them in an oven at 60℃ until constant weight, pulverize them and pass them through an 80-mesh sieve to obtain fine powder of Chinese medicine; grind borneol into fine powder for later use.

[0051] Step 2: Take the fine powder of Chinese medicine, add 8 times the amount of distilled water, soak for 30 minutes, heat to a boil and then simmer for 30 minutes each time. Combine the decoctions and filter to obtain the extract. Concentrate the extract to a thick paste with a relative density of 1.20 (25℃) under the conditions of 60℃ and vacuum degree of 0.06MPa.

[0052] Step 3: According to the weight ratio of thick paste: petrolatum: lanolin: glycerin = 1:2:0.5:0.3, heat petrolatum and lanolin in a water bath to 60°C to melt them, add the thick paste and stir evenly, cool to 40°C and add borneol powder, stir quickly and evenly, and after cooling and solidification, you will get the fistula protection ointment.

[0053] 3. External application method: After cleaning, disinfecting, and drying the fistula site, apply 2g of fistula protection ointment evenly to the area where the fistula blood vessels run and the surrounding 2-3cm of skin, with a thickness of 0.2cm. Cover and fix with sterile gauze. Apply externally for 4 hours each time, 4 times a week. Do not use the ointment within 24 hours after puncture on the day of dialysis. Continuous use for 12 weeks constitutes one course of treatment.

[0054] Example 4: A Traditional Chinese Medicine External Application Method to Reduce the Risk of Arteriovenous Fistula Fibrosis in Dialysis Patients 1. Formula of Chinese herbal medicine composition (parts by weight): 25 parts of Salvia miltiorrhiza, 20 parts of Ligusticum chuanxiong, 15 parts of Pheretima aspergillum, 20 parts of Angelica sinensis, 12 parts of Panax notoginseng, 20 parts of Centella asiatica, 8 parts of Scolopendra subspinipes, 6 parts of Borneol, and 15 parts of Carthamus tinctorius.

[0055] 2. Preparation of fistula-protecting ointment: Step 1: Remove impurities and clean the above Chinese medicines (except borneol), dry them in an oven at 80℃ until constant weight, pulverize them and pass them through a 100-mesh sieve to obtain fine powder of Chinese medicine; grind borneol into fine powder for later use.

[0056] Step 2: Take the fine powder of Chinese medicine, add 12 times the amount of distilled water, soak for 60 minutes, heat to a boil and then simmer for 40 minutes each time. Combine the decoctions and filter to obtain the extract. Concentrate the extract to a thick paste with a relative density of 1.30 (25℃) under the conditions of 70℃ and vacuum degree of 0.08MPa.

[0057] Step 3: According to the weight ratio of thick paste: petrolatum: lanolin: glycerin = 1:2:0.5:0.3, heat petrolatum and lanolin in a water bath to 70°C to melt them, add the thick paste and stir evenly, cool to 50°C and add borneol powder, stir quickly and evenly, and after cooling and solidification, you will get the fistula protection ointment.

[0058] 3. External application method: After cleaning, disinfecting, and drying the fistula site, apply 5g of fistula protection ointment evenly to the area where the fistula blood vessels run and the surrounding 2-3cm of skin, with a thickness of 0.3cm. Cover and fix with sterile gauze. Apply externally for 6 hours each time, 3 times a week. Do not use the ointment within 24 hours after puncture on the day of dialysis. Continuous use for 12 weeks constitutes one course of treatment.

[0059] Experimental Case: Sixty maintenance hemodialysis patients from a hospital, all of whom had undergone arteriovenous fistula surgery more than 3 months prior, were randomly divided into an experimental group and a control group, with 30 patients in each group. The experimental group received the traditional Chinese medicine external application method described in Example 1 of this invention, while the control group received polysulfated mucopolysaccharide cream external application (twice daily, applying 3-5 cm each time and massaging until absorbed). Both groups received the intervention for 12 consecutive weeks.

[0060] After the intervention, the patency rate, blood flow, and complication rate of the two groups were compared: the patency rate of the experimental group was 93.3%, while that of the control group was 73.3%, with the experimental group showing a significantly higher rate; the average blood flow in the experimental group was 586 ml / min, while that in the control group was 452 ml / min, indicating a significantly better improvement in blood flow in the experimental group; the incidence of complications such as fistula fibrosis, vascular stenosis, and subcutaneous hematoma was 6.7% in the experimental group, compared to 26.7% in the control group, with the complication rate in the experimental group being significantly lower than that in the control group. Furthermore, no significant adverse reactions such as skin allergies occurred in the experimental group, while three patients in the control group experienced local skin itching, which subsided after discontinuation of the medication. The verification results demonstrate that the traditional Chinese medicine external application method of this invention is significantly effective in reducing the risk of fistula fibrosis in dialysis patients, improving fistula function, and reducing the incidence of complications, and also exhibits higher safety.

[0061] The above embodiments are only used to illustrate the present invention and are not intended to limit the technical solutions described herein. Although the present invention has been described in detail with reference to the above embodiments, the present invention is not limited to the specific embodiments described above. Therefore, any modifications or equivalent substitutions to the present invention, as well as all technical solutions and improvements that do not depart from the spirit and scope of the invention, are covered within the scope of the claims of the present invention.

Claims

1. A method for external application of traditional Chinese medicine to reduce the risk of arteriovenous fistula fibrosis in dialysis patients, characterized in that, Includes the following steps: Step 1, Preparation of the Traditional Chinese Medicine Composition: The Traditional Chinese Medicine Composition consists of the following raw materials in parts by weight: 15-25 parts of Salvia miltiorrhiza, 10-20 parts of Ligusticum chuanxiong, 8-15 parts of Pheretima aspergillum, 10-20 parts of Angelica sinensis, 5-12 parts of Panax notoginseng, 10-20 parts of Centella asiatica, 3-8 parts of Scolopendra subspinipes, 2-6 parts of Borneol, and 8-15 parts of Carthamus tinctorius. Step 2: Remove impurities from Salvia miltiorrhiza, Ligusticum chuanxiong, earthworm, Angelica sinensis, Panax notoginseng, Centella asiatica, centipede, and safflower, wash, dry, pulverize and pass through an 80-100 mesh sieve to obtain fine powder of Chinese medicine. Grind borneol separately into fine powder for later use. Step 3, Preparation of Fistula Protection Ointment: Take the fine powder of traditional Chinese medicine from Step 2, add 8-12 times the amount of distilled water and soak for 30-60 minutes, decoct 2-3 times, combine the decoctions and filter, concentrate to a thick paste with a relative density of 1.20-1.30 (25℃); according to the weight ratio of thick paste: petrolatum: lanolin: glycerin = 1:2:0.5:0.3; Step 4: Heat and melt petrolatum and lanolin, then mix them evenly with the thick paste. When the temperature drops to 40-50℃, add borneol powder, stir evenly, and then cool and solidify to obtain the fistula protection ointment. Step 5, External application: After cleaning, disinfecting and drying the fistula site, apply 2-5g of fistula protection ointment evenly to the area where the fistula blood vessels run and the surrounding 2-3cm of skin, with a thickness of 0.2-0.3cm. Cover and fix with sterile gauze. Apply externally for 4-6 hours each time, 3-4 times a week. Avoid applying the ointment within 24 hours after puncture on the day of dialysis. A course of treatment consists of 12 consecutive weeks of medication.

2. The method of applying traditional Chinese medicine externally to reduce the risk of arteriovenous fistula fibrosis in dialysis patients according to claim 1, characterized in that, The preferred weight parts of the traditional Chinese medicine composition are: 20 parts of Salvia miltiorrhiza, 15 parts of Ligusticum chuanxiong, 12 parts of Pheretima aspergillum, 15 parts of Angelica sinensis, 8 parts of Panax notoginseng, 15 parts of Centella asiatica, 5 parts of Scolopendra subspinipes, 4 parts of Borneol, and 12 parts of Carthamus tinctorius.

3. The method of applying traditional Chinese medicine externally to reduce the risk of arteriovenous fistula fibrosis in dialysis patients according to claim 1, characterized in that, In the preparation of the fistula ointment, the decoction conditions are to heat to a boil and then simmer for 30-40 minutes each time; the concentration conditions are 60-70℃ and vacuum degree 0.06-0.08MPa.

4. The method of applying traditional Chinese medicine externally to reduce the risk of arteriovenous fistula fibrosis in dialysis patients according to claim 1, characterized in that, The contraindications for this external application method are: individuals allergic to any component of the herbal composition, and patients with ruptured, ulcerated, or severely infected fistula sites.

5. A method for applying traditional Chinese medicine externally to reduce the risk of arteriovenous fistula fibrosis in dialysis patients according to claim 1, characterized in that, The external application method also includes post-application care steps: after the external application is completed, wipe off any remaining ointment with sterile saline, observe whether there is any allergic reaction at the fistula site, and regularly monitor the fistula thrill, murmur and blood flow.

6. A method for applying traditional Chinese medicine externally to reduce the risk of arteriovenous fistula fibrosis in dialysis patients according to claim 1, characterized in that, The application of the traditional Chinese medicine composition in the preparation of a topical medicine to reduce the risk of arteriovenous fistula fibrosis in dialysis patients.

7. A method for applying traditional Chinese medicine externally to reduce the risk of arteriovenous fistula fibrosis in dialysis patients according to claim 1, characterized in that, The fistula ointment should be stored in a sealed, cool, and dry place, with a shelf life of no less than 6 months.

8. A method for applying traditional Chinese medicine externally to reduce the risk of arteriovenous fistula fibrosis in dialysis patients according to claim 1, characterized in that, The drying temperature of the fine powder of traditional Chinese medicine is 60-80℃, and it is dried to a constant weight so that the moisture content does not exceed 8%.

9. A method for applying traditional Chinese medicine externally to reduce the risk of arteriovenous fistula fibrosis in dialysis patients according to claim 1, characterized in that, In the external application procedure, sterile gauze is used to cover the area and then secured with breathable medical tape.

10. A method for applying traditional Chinese medicine externally to reduce the risk of arteriovenous fistula fibrosis in dialysis patients according to claim 1, characterized in that, In the aforementioned traditional Chinese medicine composition, the centipede is dried at low temperature and then pulverized, and borneol is added at 40-50℃.

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