Traditional Chinese medicine composition for treating pressure sores as well as oil yarn product and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating pressure sores and an oil yarn product and application thereof, and the traditional Chinese medicine composition is characterized by being prepared from the following raw material medicines in parts by weight: 80-120 parts of lithospermum, 40-60 parts of golden cypress, 40-60 parts of scutellaria baicalensis, 40-60 parts of astragalus membranaceus, 30-50 parts of prepared frankincense, 30-50 parts of prepared myrrh and 15-25 parts of pseudo-ginseng powder. The preparation method comprises the following steps: adding sesame oil into a pot, boiling with big fire, turning off the fire, cooling for 1-2 minutes, sequentially adding radix arnebiae seu lithospermi, cortex phellodendri, radix scutellariae, radix astragali, prepared frankincense and prepared myrrh, after all the medicines are completely immersed into the sesame oil, boiling with slow fire for 4-5 minutes, turning off the fire, removing residues, filtering, finally adding pseudo-ginseng powder, and fully stirring and uniformly mixing to obtain the oil preparation for treating the skin ulcers. Use is convenient, and clinical popularization significance is high.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating bedsores and an oil gauze product and application thereof. Background Art

[0002] Pressure ulcers, also known as pressure injuries, refer to local injuries to the skin and / or subcutaneous tissue caused by pressure or pressure combined with shear force, usually located on bony prominences. Traditional Chinese medicine calls pressure ulcers "bed sores" or "bed sores." According to the latest international guidelines, the treatment of pressure sores should follow a combination of local and systemic treatments, especially local treatment of wounds. It is recommended to clean and / or debride the wound surface, use wound dressings, and follow the principle of moist healing. However, once pressure sores occur, they are usually difficult to heal, seriously affecting the patient's quality of life. In addition, the cost of treatment is high, which increases the patient's economic burden to a certain extent.

[0003] At present, there are many methods for treating pressure sores in clinical practice, which follow the local combined with systemic treatment methods. On the basis of actively treating the primary disease, it emphasizes the redistribution of pressure and nutritional support. Strengthening wound management is the key, cleaning the skin around the wound, debridement of necrotic tissue in the wound, controlling inflammation, covering with dressings, improving the wound microenvironment, and promoting wound growth. The etiology and pathogenesis of pressure sores in traditional Chinese medicine are mainly due to long-term bed rest, loss of qi and blood, poor circulation of qi deficiency and blood stasis, blocked meridians, lack of warmth and nourishment of local muscles and bones, skin decay, and infection, resulting in pressure sores. In external treatment with traditional Chinese medicine, the drug is directly applied to the affected area, and the drug effect is directly absorbed through the skin or subcutaneous tissue, and the effect is more obvious. Therefore, how to improve the cost-effectiveness of clinical treatment of pressure sores is extremely important. Summary of the invention

[0004] The technical problem to be solved by the present invention is to provide a Chinese medicine composition for treating pressure sores which has significant curative effect and low cost, and an oil gauze product and application thereof.

[0005] The technical solution adopted by the present invention to solve the above technical problems is: a traditional Chinese medicine composition for treating pressure sores, which is prepared from the following raw materials in parts by weight: 80-120 parts of lithospermum officinale, 40-60 parts of phellodendron chinense, 40-60 parts of scutellaria baicalensis, 40-60 parts of astragalus, 30-50 parts of processed frankincense, 30-50 parts of processed myrrh, and 15-25 parts of Panax notoginseng powder.

[0006] Preferably, the above-mentioned traditional Chinese medicine composition for treating pressure sores is made of the following raw materials in parts by weight: 100 parts of Lithospermum officinale, 50 parts of Phellodendron chinense, 50 parts of Scutellaria baicalensis, 50 parts of Astragalus membranaceus, 40 parts of processed frankincense, 40 parts of processed Myrrha, and 20 parts of Panax notoginseng powder.

[0007] The present invention also provides application of the above-mentioned traditional Chinese medicine composition for treating bedsores in preparing oil gauze products.

[0008] Furthermore, the preparation method of the oil yarn product has the following steps: take 800 ml of pure sesame oil, boil it over high heat, turn off the heat and cool it for 1-2 minutes, add lithospermum officinale, phellodendron amurense, scutellaria baicalensis, astragalus, processed frankincense and processed myrrh in sequence, and after all the medicines are completely immersed in the sesame oil, boil it again over low heat for 4-5 minutes and then turn off the heat, remove the residue and filter it, finally add Panax notoginseng powder, stir and mix thoroughly to obtain the mat sore oil preparation.

[0009] Another object of the invention is to disclose the use of the above-mentioned Chinese medicine composition in the preparation of a medicine for treating pressure sores.

[0010] Compared with the prior art, the advantages of the present invention are: the Chinese medicine composition of the present invention can be used to prepare drugs for pressure sores, and while ensuring the efficacy, it has long-lasting efficacy, stable efficacy, convenient treatment, portable drugs, strong economy, etc. The clinical application of bed sore oil has enriched the treatment methods of pressure sores to a certain extent. Clinical application has proved that it has outstanding efficacy, relatively low treatment costs, simple preparation, convenient use, and high clinical promotion significance. DETAILED DESCRIPTION

[0011] The technical solution of the present invention will be clearly and completely described below in conjunction with the embodiments. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0012] The Chinese medicine composition for treating bedsores used in the present invention uses lithospermum officinale as the main ingredient in the bedsore oil. Modern medical clinical studies have shown that lithospermum officinale contains rich acetylshikonin, lithospermum officinale extract, alkalized shikonin, etc., which have antibacterial, anti-inflammatory, antioxidant, antiviral and other effects. Traditional Chinese medicine believes that Lithospermum officinale is sweet, salty, and cold, and it belongs to the liver meridian and enters the blood. The sweet and cold can clear away heat and detoxify, and the salty and cold can clear away heat and cool blood, and can activate blood circulation, reduce swelling and promote tissue regeneration, and is good at treating carbuncle, swelling, and ulcers; it is combined with Scutellaria baicalensis and Phellodendron chinense to strengthen the function of drying dampness and detoxification; adding Astragalus membranaceus can strengthen the spleen and replenish the middle, raise yang and lift the sunken, support toxins and promote tissue regeneration, and is good at treating ulcers that are difficult to ulcerate, decay, and heal. According to the "Shennong's Herbal Classic", it is recorded that "it is mainly used to treat carbuncle, long-term decayed ulcer, discharge pus and relieve pain... tonify deficiency." Therefore, in the middle and late stages of pressure sores, when the wound surface is flat and difficult to heal, the effect of Astragalus membranaceus to replenish qi is cleverly used to support the effect of detoxification and tissue regeneration; frankincense can activate blood circulation, myrrh can disperse blood, and Panax notoginseng can stop bleeding, remove blood stasis and promote new tissue regeneration without hurting the body. The combined use of these medicines can clear away heat and detoxify, remove decay and reduce swelling, and can also strengthen the body and remove evil, remove blood stasis and promote tissue regeneration, and treat both the symptoms and the root causes.

[0013] The technical solution of the present invention will be further described below in conjunction with specific embodiments. 1. Specific embodiments

[0015] Embodiment 1, the weight of raw materials in Chinese medicine composition is as follows: 100g of Radix Lithospermi, 50g of Cortex Phellodendri, 50g of Radix Scutellariae, 50g of Radix Astragali, 40g of processed frankincense, 40g of processed Myrrha and 20g of Radix Notoginseng powder. Its oil yarn product preparation method step is as follows: take pure sesame oil 800ml, boil over high heat, turn off the heat and cool for 1-2 minutes, put into the above-mentioned Chinese medicine (except Radix Notoginseng powder) successively, after all medicines are completely immersed in sesame oil, turn off the heat after boiling for 4-5 minutes again with slow fire, remove the residue and filter, finally put into Radix Notoginseng powder, fully stir and mix, can with sealed sterile glass bottle, and store refrigerated. When using, take sterile yarn strips and soak the liquid to make mat sore oil yarn strips and apply them to the affected part after high temperature and high pressure sterilization.

[0016] Example 2 is the same as Example 1, except that the weights of the raw materials in the Chinese medicine composition are as follows: 80 g of Lithospermum officinale, 40 g of Phellodendron chinense, 40 g of Scutellaria baicalensis, 40 g of Astragalus membranaceus, 30 g of processed frankincense, 30 g of processed Myrrha and 15 g of Panax notoginseng powder.

[0017] Example 3 is the same as Example 1, except that the weights of the raw materials in the Chinese medicine composition are as follows: 120 g of Lithospermum officinale, 60 g of Phellodendron chinense, 60 g of Scutellaria baicalensis, 60 g of Astragalus membranaceus, 50 g of processed frankincense, 50 g of processed Myrrha and 15-25 g of Panax notoginseng powder.

[0018] 2. Clinical Trials

[0019] 1. Research subjects

[0020] This study was approved by the Medical Ethics Committee of Daishan County Hospital of Traditional Chinese Medicine (approval number: Daishan Traditional Chinese Medicine 2023

[002] ). A total of 76 patients with pressure ulcers admitted to our hospital from January 2023 to December 2023 were collected. They were randomly divided into a treatment group of 38 cases and a control group of 38 cases. The basic data of the two groups of patients, such as age, gender, disease, nutritional score (refer to the simple nutritional evaluation method), pressure ulcer stage (refer to the international guideline staging system standard), pressure ulcer site, and number of pressure ulcers, were compared. There was no significant difference (P>0.05), as shown in Table 1.

[0021] Table 1 Comparison of general information of the two groups of patients (n=76)

[0022]

[0023]

[0024] Note: (1) t value; (2) x 2 Value; ⑶Z value

[0025] 2. Diagnostic criteria

[0026] TCM diagnosis: refer to the TCM industry standard of the People's Republic of China "TCM Disease Diagnosis and Efficacy Standards - Bedsores" (ZY / T001.1-94).

[0027] Western medicine diagnosis: Refer to the latest 2019 version of "Pressure Ulcers / Pressure Injuries Prevention and Treatment: Clinical Practice Guidelines" jointly developed by NPIAP, EPUAP and PPPIA. Error! Reference source not found.

[0028] 3. Inclusion and Exclusion Criteria

[0029] Inclusion criteria: Meet the diagnosis and treatment standards of traditional Chinese medicine and western medicine and sign the informed consent.

[0030] Exclusion criteria: those who changed the treatment plan on their own; those with unstageable pressure ulcers or suspected deep tissue damage; those who could not actively cooperate with pressure ulcer care and treatment of the primary disease; patients in the terminal stage of the disease; those with allergic constitution; those who refused to sign the informed consent form.

[0031] 4. Treatment Methods

[0032] Both groups were first given conventional treatment: treatment of the primary disease, strengthening of bedsore care, improvement of nutritional status, prevention or treatment of infection; wound debridement treatment, repeated washing of the wound with hydrogen peroxide and normal saline, disinfection with povidone-iodine cotton balls, and multiple removal of necrotic tissue from the wound using the nibbling method.

[0033] Control group: After completing the above conventional treatment, the affected area was evenly smeared with moist burn ointment (Shantou Mebao Pharmaceutical Co., Ltd., National Medicine Standard Z20000004) combined with silver ion dressing (Smith & Nephew Medical Products International Trading Co., Ltd., National Food and Drug Administration (Enterprise) No. 3642808, 2010) and covered with sterile gauze. The treatment was performed once a day, and the PUSH score was recorded weekly.

[0034] Treatment group: After completing the above conventional treatment, apply the appropriate size of the puffer gauze prepared in the specific example to the affected area evenly, and cover and bandage with sterile gauze once a day, and record the PUSH score every week.

[0035] 5. Observation indicators

[0036] Clinical efficacy judgment: Refer to the Chinese Medicine Industry Standard of the People's Republic of China "Standards for Diagnosis and Efficacy of TCM Diseases and Symptoms·Decubitus Ulcers" (ZY / T001.1-94) to determine the clinical treatment effect: cured means the brown erythema disappears, or the ulcer heals; improved means the erythema does not disappear completely, or the ulcer surface sloughs, new flesh grows, and the ulcer surface gradually shrinks; unhealed means the ulcer surface enlarges, and the ulceration continues. Total effective rate = (cured + improved) / total number of treatments.

[0037] Clinical cost-effectiveness: Compare the treatment costs of the two groups of patients at the end of the observation period. The costs only include dressing fees, material fees, and debridement fees. The charging standards are based on the 2021 version of the "Zhejiang Basic Medical Insurance Medical Service Item Catalog" formulated by the Zhejiang Provincial Price Bureau and the Zhejiang Provincial Health Department.

[0038] The pressure ulcer healing score table (PUSH) was used to comprehensively evaluate the pressure ulcer situation before and after treatment by adding the total score of tissue morphology, pressure ulcer area and exudate. The standard of pressure ulcer exudate was that the wound surface was dry as no exudate, the first layer of dressing was completely soaked as a small amount of exudate, the second layer of dressing was completely soaked as a moderate amount of exudate, and the exudate completely leaked out of the dressing as a large amount of exudate, as shown in Table 2. The PUSH scores were recorded at 0d (before treatment), 7d (7 days after treatment), 14d, 21d, and 28d. When the patient had multiple pressure ulcers before treatment, the highest PUSH score was used as the basis for fixed comparison.

[0039] Table 2 Pressure ulcer healing assessment form

[0040] score <![CDATA[Pressure ulcer area [length × width (cm 2 ﹚]]]> Exudate Organizational form 0 0 No exudate Complete skin 1 ＜0.3 Small amount of exudate Epithelial tissue 2 0.3-0.6 Moderate exudate Granulation tissue 3 0.7-1.0 Large amount of exudate Slough tissue 4 1.1-2.0 - Necrotic tissue 5 2.1-3.0 - - 6 3.1-4.0 - - 7 4.1-8.0 - - 8 8.1-12.0 - - 9 12.1-24.0 - - 10 ＞24.0 - -

[0041] Organize relevant personnel to conduct standardized training and assessment on the PUSH scoring method, and arrange specialist nurses to track the entire process, dynamically monitor and record changes in scores.

[0042] 6. Statistical methods

[0043] Statistical analysis was performed using SPSS 26.0. Count data were described by case number and percentage (%), and inter-group comparison was performed using χ 2 Test; rank data were analyzed by rank sum test (Mann-Whitney U test); measurement data were analyzed by mean ± standard deviation The data were described and were in accordance with normal distribution. The t-test and two-factor repeated measures analysis of variance were used. P < 0.05 was considered statistically significant.

[0044] 7. Treatment results

[0045] (1) Comparison of clinical efficacy and cost-effectiveness

[0046] After 4 weeks of treatment, the clinical efficacy was observed. The total effective rate of the treatment group was 97.37%, and the total effective rate of the control group was 89.47%. The rank sum test showed that Z = 0.939, P = 0.348 > 0.05 for the two groups of data, indicating that both the topical application of Xichuang oil to treat bedsores and the topical application of moist burn ointment combined with silver ion dressings to treat bedsores had significant clinical efficacy. The treatment costs of the two groups of patients at the end of the observation period were compared, t = 2.946, P = 0.004, indicating that the topical application of Xichuang oil to treat bedsores was more cost-effective than the topical application of moist burn ointment combined with silver ion dressings to treat bedsores, as shown in Table 3.

[0047] Table 3 Comparison of total clinical efficacy and cost between the two groups of patients [n (%)]

[0048]

[0049] Note: ⑴Z value; ⑵t value;

[0050] (2) Comparison of PUSH scores between the two groups before and after treatment

[0051] The data were in accordance with normal distribution, and two-factor repeated measures variance analysis was used to determine the effects of different interventions on the PUSH scores of the subjects over time. Table 4 shows that the PUSH scores of both groups showed a progressive downward trend after medication.

[0052] Table 4 Comparison of PUSH scores before and after treatment within and between the two groups

[0053]

[0054] Note: The interaction term group*time does not satisfy the ball-shaped hypothesis. After correction using the Greenhouse-Geisser method, F=5.455, P<0.05, the interaction between group and time has a statistically significant effect on the PUSH score. Therefore, the separate effects of the two in-subject factors group and time were tested.

[0055] According to the test of group single effect: the PUSH scores before treatment, 1 week, 2 weeks and 3 weeks after treatment were compared between the two groups, and the difference was not statistically significant (P>0.05). The PUSH scores between the two groups were compared after 4 weeks of treatment, P=0.048<0.05, and the difference was statistically significant, indicating that the clinical efficacy of the topical application of mat oil for the treatment of pressure sores was better than that of the topical application of moist burn ointment combined with silver ion dressing after 4 weeks of treatment. Test the single effect of time in the two groups: According to the comparison of the PUSH scores at two time points before and after treatment in each group every week, the differences were statistically significant (P<0.001). It shows that the PUSH scores of patients with pressure sores at different measurement times in the same group are significantly different. With the extension of time after treatment, the clinical efficacy of the two groups is obvious, and the efficacy of the treatment group is better than that of the control group.

[0056] (3) Observation of adverse reactions

[0057] No obvious adverse reactions were observed in both groups of patients during the treatment.

[0058] In summary, the present invention compares the total clinical efficacy, cost-effectiveness and PUSH scores of the two groups of patients after 4 weeks of treatment between the groups and within the groups at 5 different time points before and after treatment. It is found that both the topical application of blister oil for the treatment of bedsores and the topical application of moist burn ointment combined with silver ion dressings for the treatment of bedsores have significant clinical efficacy, but the cost-effectiveness of blister oil is higher. After 4 weeks of treatment, the clinical efficacy of blister oil is better than that of the topical application of moist burn ointment combined with silver ion dressings. The clinical application of blister oil has enriched the treatment methods of bedsores to a certain extent. Clinical applications have proved that it has outstanding efficacy, relatively low treatment costs, simple preparation, convenient use, and high clinical promotion significance.

[0059] The above description is not intended to limit the present invention, and the present invention is not limited to the above examples. Any changes, modifications, additions or substitutions made by a person skilled in the art within the spirit and scope of the present invention shall also fall within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating bedsores, characterized in that The invention is prepared from the following raw materials in parts by weight: 80-120 parts of lithospermum officinale, 40-60 parts of phellodendron, 40-60 parts of scutellaria baicalensis, 40-60 parts of astragalus, 30-50 parts of processed frankincense, 30-50 parts of processed myrrh and 15-25 parts of notoginseng powder.

2. A Chinese medicine composition for treating pressure sores according to claim 1, characterized in that The medicine is prepared from the following raw materials in parts by weight: 100 parts of lithospermum officinale, 50 parts of phellodendron amurense, 50 parts of scutellaria baicalensis, 50 parts of astragalus, 40 parts of processed frankincense, 40 parts of processed myrrh, and 20 parts of notoginseng powder.

3. Use of the Chinese medicinal composition for treating pressure sores according to claim 1 in the preparation of oil gauze products.

4. The use of the Chinese medicine composition for treating pressure sores according to claim 3 in the preparation of oil gauze products, characterized in that The preparation method of the oil yarn product comprises the following steps: taking 800 ml of pure sesame oil, boiling it over high heat, turning off the heat and cooling it for 1-2 minutes, sequentially adding lithospermum officinale, phellodendron amurense, scutellaria baicalensis, astragalus, processed frankincense and processed myrrh, and after all the medicines are completely immersed in the sesame oil, boiling it again over low heat for 4-5 minutes, turning off the heat, removing the residue and filtering it, and finally adding Panax notoginseng powder, stirring and mixing it thoroughly to obtain the mat sore oil preparation.

5. Use of the Chinese medicinal composition for treating pressure sores according to claim 1 in preparing a medicament for treating pressure sores.

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