A traditional Chinese medicine preparation for treating muscle spasticity and pain of stroke phlegm and blood stasis blockage syndrome and a preparation method thereof

Abstract

A kind of traditional Chinese medicine preparation for treating muscle tension disorder and pain of stroke phlegm and blood stasis syndrome and its preparation method belong to the field of traditional Chinese medicine preparation.Cortex radicis aconiti, cortex radicis aconiti, honeycomb, rhabdophis nigrocinctus, wenyujin, kaempferia, trillium, cassia, asarum, musk, and mentha haplocalyx are pulverized and mixed with appropriate amount of ginger juice to form a paste, which is then spread in the middle of a medical dressing to prepare a traditional Chinese medicine paste.The sEMG data of relevant muscle groups of patients are collected, combined with MTS scale, FMA score, modified Barthel index (MBI) score and other related target achievement scales, and the changes of serum inflammatory factor level and TCM syndrome score are observed to evaluate the objective and standardized treatment of stroke muscle tension disorder and pain and provide clinical basis for predicting the rehabilitation effect.The results show that the targeted treatment based on the traditional Chinese medicine combination of the prescription and the selection of characteristic paste therapy can effectively treat muscle tension disorder and pain of stroke phlegm and blood stasis syndrome, and the effect is significant.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparations, specifically relating to a traditional Chinese medicine preparation for treating muscle dystonia and pain caused by phlegm and blood stasis in stroke, and its preparation method. Background Technology

[0002] Cerebral stroke (CS), also known as cerebrovascular accident or simply "apoplexy," is a group of organic cerebrovascular diseases caused by various factors that damage cerebral blood vessels, resulting in focal (or systemic) brain tissue damage and causing localized brain dysfunction. It is characterized by high incidence, high mortality, high disability rate, and high recurrence rate. Globally, CS is the leading cause of disability in adults and the second leading cause of death. Therefore, conducting relevant clinical research on CS is of great practical significance.

[0003] Following a stroke, approximately 65% ​​of patients develop dystonia, primarily due to chronic motor dysfunction caused by upper motor neuron damage. This manifests as increased muscle tone accompanied by hyperactive tendon reflexes. This increased muscle tone leads to pain, impaired motor function, and even affects daily living activities, thus hindering the rehabilitation process. Currently, clinical treatments primarily utilize oral central muscle relaxants or antispasmodics and surgery to improve dystonia. However, conventional basic rehabilitation therapies are often ineffective in improving muscle tone, necessitating further exploration of other effective treatment methods.

[0004] Traditional Chinese medicine poultices, as a form of external therapy, involve directly applying Chinese herbs to the affected skin. The active ingredients in the herbs come into contact with the skin, causing local irritation, and are absorbed into the body through the skin, mucous membranes, and sweat glands. This improves local blood circulation and lymphatic function, restoring tissue nutrition. Furthermore, the medicinal components in the poultice can relieve pain and inflammation through various mechanisms, thereby achieving the goal of treating the disease. Summary of the Invention

[0005] The technical problem to be solved by this invention is to provide a traditional Chinese medicine preparation for treating dystonia and pain caused by phlegm and blood stasis in stroke. Combined with traditional Chinese medicine plaster therapy, the active ingredients in the preparation are promoted to penetrate the skin and reach the affected area through drug penetration and warm stimulation. It has the effects of dispelling wind and resolving phlegm, dispersing blood stasis and relieving pain, and clearing the meridians and relieving spasms. It has good therapeutic effects on stroke hemiplegia, shoulder and hand syndrome, spastic paralysis, post-stroke sequelae, neck, shoulder, waist and leg pain, facial nerve inflammation, Hunter syndrome, facial muscle spasm, trigeminal neuralgia, migraine and other conditions caused by phlegm and blood stasis.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0007] A traditional Chinese medicine preparation for treating dystonia and pain caused by phlegm and blood stasis in stroke is made from the following raw materials by weight:

[0008] Aconitum carmichaelii 30-50g, Aconitum kusnezoffii 30-45g;

[0009] 20-40g of honeycomb and 20-40g of black-striped snake;

[0010] Artemisia argyi 25-35g, Kaempferia galanga 25-35g, Pyrola rotundifolia 30-50g, Cinnamomum cassia 20-40g, Asarum heterotropoides 25-40g, Musk 10-30g, Artemisia capillaris 20-40g, Borneol 10-30g.

[0011] Applying herbal plasters is a treatment method guided by the basic theories of traditional Chinese medicine. It involves applying herbal preparations to the skin, orifices, acupoints, and affected areas. It belongs to the external treatment method of traditional Chinese medicine. Through drug penetration and heat stimulation, the relevant active ingredients in the medicine are encouraged to penetrate the skin and reach the affected area. It has the effects of dispelling wind and phlegm, dispersing blood stasis and relieving pain, and clearing the meridians and relieving spasms.

[0012] Post-stroke dystonia and pain, characterized by limb stiffness, immobility, and difficulty walking, are all signs of "rigidity." The 19th article of the *Suwen* (Plain Questions) chapter on the pathogenesis states, "All sudden rigidity belongs to wind, which is the primary 'thief,' the root of all harm." Combined with the symptoms of phlegm and blood stasis, Dr. Li Fei, Chief Physician of the Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine (Anhui Provincial Acupuncture Hospital), advocates treatment that dispels wind, unblocks the meridians, relaxes muscles and stops spasms, while also resolving phlegm, eliminating stagnation, dispersing blood stasis, and relieving pain. Based on years of clinical experience, he has formulated a traditional Chinese medicine poultice formula, with *Aconitum carmichaelii* (Chuanwu) and *Aconitum kusnezoffii* (Caowu) as the principal ingredients. While both *Aconitum carmichaelii* and *Aconitum kusnezoffii* share similar properties—pungent and hot in nature—they both dispel wind and dampness, relax muscles and relieve pain. However, upon closer examination, they differ in their emphasis. *Aconitum carmichaelii* is slightly more toxic and has a stronger effect, focusing on dispelling wind and dampness, and restoring yang to rescue from collapse. Aconitum carmichaelii, primarily used for its ability to dredge meridians, relieve pain, and reduce fever, serves as the principal ingredient in both herbs, targeting stubborn conditions like spasms and numbness. Modern pharmacological studies have confirmed that Aconitum carmichaelii and Aconitum kusnezoffii contain alkaloids that have nerve-blocking effects, inhibiting pain responses and raising the pain threshold. Beehive and Zaocys dhumnades are used as assistant ingredients; beehive dispels wind, relieves pain, breaks up accumulations, and eliminates blood stasis; Zaocys dhumnades dispels wind, stops spasms, unblocks meridians, and calms the nerves. Both are sweet and neutral in nature, mitigating the toxicity of the principal ingredients and enhancing their effects. Artemisia argyi, Kaempferia galanga, and musk promote qi circulation, relieve pain, eliminate stagnation, and resolve blood stasis; cinnamon warms and unblocks the meridians; Asarum clears the orifices and resolves phlegm; Pyrola rotundifolia and Artemisia capillaris strengthen muscles and bones—all are adjuvant ingredients. Borneol clears heat, promotes tissue regeneration, relieves pain, prevents decay, and has antibacterial and anti-inflammatory properties. Its excellent permeability allows it to directly reach the affected area, making it an adjuvant ingredient. The combined use of these herbs achieves excellent clinical therapeutic effects.

[0013] As a preferred embodiment of the present invention, the traditional Chinese medicine preparation is made from the following traditional Chinese medicine raw materials by weight:

[0014] Aconitum carmichaelii 40g, Aconitum kusnezoffii 40g;

[0015] 30g of honeycomb and 30g of black-striped snake;

[0016] Artemisia argyi 30g, Kaempferia galanga 30g, Pyrola rotundifolia 40g, Cinnamomum cassia 30g, Asarum heterotropoides 30g, Musk 20g, Artemisia capillaris 30g, Borneol 20g.

[0017] Surface electromyography (sEMG) is a one-dimensional time-series electrical signal obtained by guiding and recording bioelectrical changes in the neuromuscular system during muscle activity using an electromyography (EMG) instrument. This signal is then processed by a computer into time- and frequency-dependent values ​​that are specific to and sensitive to muscle functional states. These bioelectrical signals are correlated to varying degrees with muscle activity and functional states, thus reflecting neuromuscular activity to some extent and revealing specific muscle function and neuromuscular activity in normal individuals or stroke patients. Commonly used analytical indicators for sEMG include integrated electromyography (iEMG), root mean square (RMS), mean power frequency (MPF), and median frequency (MF). The first three are time-domain indicators, while the latter is a frequency-domain indicator. By collecting sEMG data from the biceps brachii (BB), triceps brachii (TB), extensor carpi ulnaris (ECU), flexor carpi radialis (FCR), rectus femoris (RA), and gastrocnemius (GM) muscles of stroke patients, the analysis of muscle activity provides a basis for assessing balance dysfunction and developing rehabilitation programs.

[0018] This invention utilizes a surface electromyography (EMG) assessment system to quantitatively detect surface EMG signals in relevant muscle groups of stroke patients with phlegm-stasis obstruction syndrome exhibiting dystonia and pain. It analyzes and records integrated EMG values ​​(iEMG), root mean square (RMS) values, mean power frequency (MPF), and median frequency (MF), and combines these with goal achievement scales such as the MTS scale, FMA score, modified Barthel Index (MBI) score, and modified Ashworth Spasticity Scale to observe changes in relevant inflammatory factors and TCM syndrome scores for evaluation. This study explores the impact of a traditional Chinese medicine (TCM) herbal poultice on the biomechanical properties of muscles in stroke patients with phlegm-stasis obstruction syndrome exhibiting dystonia and pain, thereby verifying the clinical efficacy of the herbal preparations in this invention.

[0019] Experiments have confirmed that:

[0020] 1. After four courses of treatment, a comparison between the control group and the treatment group revealed varying degrees of differences in surface electromyography (EMG) signals in patients with cerebral stroke due to phlegm-blood stasis and obstruction syndrome exhibiting dystonia and pain. RMS, MPF, and MF indices all increased (P<0.05), while iEMG indices decreased (P<0.05). Compared to the control group, the treatment group showed more significant improvements in iEMG, RMS, MPF, and MF in the biceps brachii, triceps brachii, biceps femoris, and quadriceps femoris muscles (P<0.01).

[0021] 2. Before treatment, there were no statistically significant differences in MTS scores, FMA scores, modified Barthel Index (MBI) scores, modified Ashworth Spasticity Scale scores, related serum inflammatory factors, and TCM syndrome scores between the control group and the treatment group (P > 0.05). After treatment, both groups showed improvement compared to before treatment (P < 0.01). Compared to the control group, the treatment group showed significant improvement (P < 0.01). Therefore, TCM patch application can significantly improve surface electromyography signals, MTS scores, FMA scores, modified Barthel Index (MBI) scores, modified Ashworth Spasticity Scale scores, related serum inflammatory factors, and TCM syndrome scores in patients with phlegm-blood stasis syndrome and dystonia after stroke, demonstrating significant therapeutic efficacy.

[0022] Therefore, the traditional Chinese medicine preparation proposed in this invention involves pulverizing the various herbal ingredients in the prescribed amount and mixing them with an appropriate amount of ginger juice to form a paste-like medicinal cake weighing approximately 5g. This paste is then spread evenly in the center of a medical patch (6cm × 6cm) to prepare a traditional Chinese medicine patch. This patch effectively treats dystonia and pain associated with phlegm-blood stasis syndrome in stroke patients, with significant results. Furthermore, this invention utilizes surface electromyography (SEMG) to detect the surface electromyographic signals of relevant muscle groups before and after treatment for dystonia and pain associated with phlegm-blood stasis syndrome in stroke patients. This assesses the SEMG signal output of relevant muscle groups before and after treatment, thereby providing evidence for the therapeutic effect of the traditional Chinese medicine patch. This provides clinical evidence for the objective and standardized treatment and prediction of rehabilitation efficacy for dystonia and pain in stroke patients, and has significant clinical and social value in reducing muscle tone, alleviating pain, and improving the quality of life in stroke patients. Detailed Implementation

[0023] This study investigates the effects of traditional Chinese medicine (TCM) herbal plaster application on changes in surface electromyographic (EMG) signals in patients with dystonia and pain due to phlegm-blood stasis syndrome following stroke, thereby comparing and evaluating the clinical efficacy of this TCM preparation. Details are as follows:

[0024] 1 data

[0025] 1.1 General Information

[0026] A prospective study was conducted on 70 patients with dystonia and pain due to phlegm-blood stasis syndrome who were admitted to the Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine (Anhui Provincial Acupuncture Hospital) from March 2022 to March 2023. The patients were randomly divided into two groups: a treatment group and a control group, with 35 patients in each group.

[0027] 1.2 Diagnostic criteria

[0028] (1) Western medicine diagnostic criteria for CS: Confirmed by CT or MRI to meet the Western medicine diagnostic criteria of the 2021 "Guidelines for Prevention and Treatment of Stroke in China" and the TCM diagnostic criteria for stroke in the "Standards for Diagnosis and Efficacy Evaluation of Stroke";

[0029] (2) Diagnostic criteria for phlegm-blood stasis syndrome: The diagnostic criteria for phlegm-blood stasis syndrome are formulated with reference to the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine": facial paralysis, stiff tongue and speech impediment or aphasia, hemiplegia, fixed hands, constipation and urinary retention, limb spasm, muscle pain, rough and dry skin, dizziness and headache, dark complexion and dark lips, excessive phlegm, dark purple tongue or ecchymosis, white and greasy tongue coating, and wiry and hesitant pulse.

[0030] 1.3 Case inclusion criteria:

[0031] (1) Meets the diagnostic criteria for CS using both traditional Chinese and Western medicine;

[0032] (2) Meets the diagnostic criteria for the TCM syndrome of phlegm and blood stasis obstruction;

[0033] (3) Patients diagnosed for the first time who have a history of stroke but no sequelae, as confirmed by CT or MRI.

[0034] (4) Age 40-75 (inclusive);

[0035] (5) Patients diagnosed with dystonia and pain by a detailed specialist physical examination conducted by two or more (including two) senior physicians;

[0036] (6) The patient had not taken muscle relaxants or antispasmodics within 3 months prior to enrollment;

[0037] (7) No serious heart, lung, or kidney dysfunction or severe diabetes mellitus, and the patient or their family members have signed an informed consent form.

[0038] 1.4 Case exclusion criteria:

[0039] (1) Those who do not meet the diagnostic criteria of CS in both Chinese and Western medicine and the diagnostic criteria of phlegm-blood stasis syndrome in traditional Chinese medicine;

[0040] (2) Age exceeding the range specified in this study (<40 years or >75 years);

[0041] (3) Those who have taken medications that affect the assessment of efficacy within the past 3 months;

[0042] (4) Those with abnormal limb muscle tone caused by brain tumors, craniocerebral trauma, or other lesions;

[0043] (5) Those with severe loss of consciousness;

[0044] (6) Patients with serious primary diseases of the heart, liver, kidney, endocrine system, etc., or those whose diseases are confirmed to be unrelated to CS but whose etiology may affect muscles and bones;

[0045] (7) Patients with skin scars or severe skin diseases at the site of application of traditional Chinese medicine;

[0046] (8) Patients who cannot tolerate traditional Chinese medicine plasters.

[0047] 1.5 Criteria for Case Termination or Exclusion:

[0048] (1) Poor compliance;

[0049] (2) Patients who request to withdraw from the clinical study due to poor treatment or adverse events;

[0050] (3) Those who experience severe adverse drug reactions during treatment;

[0051] (4) Patients who did not strictly follow the prescribed treatment protocol or who used other methods to interfere with the trial results during the study period.

[0052] 2 methods

[0053] 2.1 Treatment methods

[0054] Control group: The control group was given baclofen tablets [10mg / tablet, Ningbo Tianheng Pharmaceutical Co., Ltd., Fu'an Pharmaceutical Group; National Drug Approval Number H19980103] orally. The initial dose was 1 / 2 tablet (5mg) three times a day. The dose could be increased by 5mg every three days until the optimal effect was achieved, but the maximum daily dose should not exceed 80mg (20mg, four times a day). One course of treatment was 7 days, and a total of four courses of treatment were administered.

[0055] Treatment group: Traditional Chinese medicine (TCM) patch therapy was used. The TCM prescription was as follows: Aconitum carmichaelii 40g, Aconitum kusnezoffii 40g, Vespa nidus 30g, Zaocys dhumnades 30g, Artemisia argyi 30g, Kaempferia galanga 30g, Pyrola rotundifolia 40g, Cinnamomum cassia 30g, Asarum heterotropoides 30g, Musk 20g, Artemisia capillaris 30g, Borneol 20g. The specific procedure was as follows: ① After pulverizing the above-mentioned herbs, sift them into a fine powder, add an appropriate amount of ginger juice, and mix to form a paste weighing approximately 5g. Spread this paste evenly in the center of a medical patch (6cm × 6cm); ② The patient lay supine, fully exposing the affected area (i.e., the muscle corresponding to dystonia and pain). After cleaning the skin surface, apply the medicated patch to the affected area. Each application lasted 3 hours, once daily. During the application period, closely observe the patient's local skin for redness, swelling, or damage, and address any abnormalities immediately. ③ When applying the medication, use an infrared therapy device to irradiate the affected area for 30 minutes at a distance of 20cm. The temperature should be adjusted to the patient's comfort level. One course of treatment lasts 7 days, and a total of 4 courses of treatment are required.

[0056] 2.2 Procedure for Surface Electromyography

[0057] Before and after treatment, surface electromyography (EMG) analysis was performed using a system (Flex Comp Infiniti, Canada). Patients were placed in a supine position, and surface electrodes were applied to the most prominent points of the biceps brachii, triceps brachii, wrist extensors, and wrist flexors in the upper arm, and the rectus femoris, gastrocnemius, and tibialis anterior muscles in the lower limbs, with tertiary electrode pads applied along the direction of muscle fiber growth. Each muscle was measured three times, with a 5-second interval between each measurement. After the measurements, the surface EMG software system analyzed the data to obtain relevant information for each muscle.

[0058] 2.3 Observation Indicators

[0059] 2.3.1 Relevant electromyographic signal indices on muscle surface

[0060] The surface electromyography parameters (iEMG, RMS, MPF, and MF) of the biceps brachii (BB), triceps brachii (TB), extensor carpi ulnaris (ECU), flexor carpi radialis (FCR), rectus femoris (RA), and gastrocnemius (GM) were measured in the treatment group and the control group before treatment.

[0061] The surface electromyography (EMG), iEMG, RMS, MPF, and MF of the biceps brachii (BB), triceps brachii (TB), extensor carpi ulnaris (ECU), flexor carpi radialis (FCR), rectus femoris (RA), and gastrocnemius (GM) muscles were measured in both the treatment and control groups after treatment.

[0062] 2.3.2 Scale Indicators

[0063] The changes in the modified Tardieu Scale (MTS) scores before and after treatment were observed in the treatment and control groups; the changes in the upper and lower limb Fugl-Meyer Assessment (FMA) scores before and after treatment were observed in the treatment and control groups; the changes in the modified Barthel Index (MBI) scores before and after treatment were observed in the treatment and control groups; and the changes in the modified Ashworth Scale scores before and after treatment were observed in the treatment and control groups.

[0064] 2.3.3 Inflammatory Factor Indicators

[0065] Observe the changes in C-reactive protein (CRP), interleukin-6 (IL-6), and interleukin-10 (IL-10) levels in the treatment group and the control group before and after treatment;

[0066] 2.3.4 Traditional Chinese Medicine Syndrome Scoring Indicators

[0067] The changes in TCM syndrome scores before and after treatment were observed in the treatment group and the control group.

[0068] 2.4 Statistical Methods

[0069] Data analysis was performed using SPSS 26.0 statistical software. Quantitative data were expressed as mean ± standard deviation. Count data are expressed as cases or percentages. Within-group comparisons were performed using one-way ANOVA, and between-group comparisons were performed using t-tests. For non-normally distributed data, the rank-sum test was used. Spearman correlation analysis was performed on the iEMG, RMS, MPF, and MF values ​​of relevant muscle groups, and the significance of differences was analyzed. Statistical results showed P>0.05 as no statistical significance, P<0.05 as a significant difference, and P<0.01 as a significant difference.

[0070] 3 Results

[0071] 3.1 Comparison of iEMG, RMS, MPF, and MF values ​​of different muscle groups (BB, TB, ECU, FCR, RA, GM) before and after treatment in the control and treatment groups:

[0072] Table 1 Comparison of iEMG values ​​for BB, TB, ECU, FCR, RA, and GM

[0073]

[0074] Note: Compared with before treatment, * P<0.05; compared with the control group, △ P<0.05

[0075] Table 2 Comparison of RMS values ​​for BB, TB, ECU, FCR, RA, and GM

[0076]

[0077]

[0078] Note: Compared with before treatment, * P<0.05; compared with the control group, △ P<0.05

[0079] Table 3 Comparison of MPF values ​​for BB, TB, ECU, FCR, RA, and GM

[0080]

[0081] Note: Compared with before treatment, * P<0.05; compared with the control group, △ P<0.05

[0082] Table 4 Comparison of MF values ​​for BB, TB, ECU, FCR, RA, and GM

[0083]

[0084] Note: Compared with before treatment, * P<0.05; compared with the control group, △P<0.05

[0085] As can be seen from Table 1-4:

[0086] After four courses of treatment, the RMS, MPF, and MF indices of the biceps brachii (BB), triceps brachii (TB), extensor carpi ulnaris (ECU), flexor carpi radialis (FCR), rectus femoris (RA), and gastrocnemius (GM) muscles increased in both the treatment and control groups (P<0.05); the iEMG index decreased (P<0.05); and the improvement was more significant in the treatment group compared with the control group (P<0.05). Therefore, oral baclofen tablets and traditional Chinese medicine patch therapy have different degrees of improvement effects on the neuromuscular bioelectrical changes in stroke patients with phlegm-blood stasis obstruction, muscle dystonia, and pain. The improvement effect of traditional Chinese medicine patch therapy on the biceps brachii (BB), triceps brachii (TB), extensor carpi ulnaris (ECU), flexor carpi radialis (FCR), rectus femoris (RA), and gastrocnemius (GM) muscles is significantly better than that of oral baclofen tablets.

[0087] 3.2MTS Score:

[0088] Table 5. Changes in MTS scores in the two groups of patients.

[0089]

[0090] Note: Compared with before treatment, * P<0.05; compared with the control group, △ P<0.05

[0091] As shown in Table 5, compared with before treatment, the MTS scores of both the treatment group and the control group decreased significantly (P<0.05); after treatment, the MTS score of the treatment group decreased more significantly than that of the control group (P<0.05). This indicates that traditional Chinese medicine plaster therapy can effectively relieve limb spasticity symptoms and improve muscle tone and soft tissue compliance in patients with phlegm-blood stasis syndrome of stroke.

[0092] 3.3 FMA score:

[0093] Table 6. Changes in FMA scores in the two groups of patients.

[0094]

[0095] Note: Compared with before treatment, * P<0.05; compared with the control group, △ P<0.05

[0096] As shown in Table 6, compared with before treatment, the FMA scores of both the treatment group and the control group increased (P<0.05); after treatment, the FMA score of the treatment group increased more significantly than that of the control group (P<0.05). This indicates that traditional Chinese medicine plaster therapy can effectively relieve the limb motor function status of patients with phlegm-blood stasis syndrome and muscle dystonia and pain.

[0097] 3.4 MBI score

[0098] Table 7 Modified Barthel Index (MBI) scores for the two groups of patients

[0099]

[0100] Note: Compared with before treatment, * P<0.05; compared with the control group, △ P<0.05

[0101] As shown in Table 7, compared with before treatment, the MBI scores of both the treatment group and the control group were significantly increased (P<0.05); after treatment, the MBI score of the treatment group increased more significantly than that of the control group (P<0.05). This indicates that traditional Chinese medicine plaster therapy can improve the daily living abilities of patients with dystonia and pain due to phlegm and blood stasis syndrome in stroke.

[0102] 3.5 Modified Ashworth Scale Scoring:

[0103] Table 8. Changes in the modified Ashworth scale scores of the two groups.

[0104]

[0105] Note: Compared with before treatment, * P<0.05; compared with the control group, △ P<0.05

[0106] As shown in Table 8, compared with before treatment, the modified Ashworth scale scores of both the treatment group and the control group decreased significantly (P<0.05); after treatment, the modified Ashworth scale score of the treatment group decreased more significantly than that of the control group (P<0.01). This indicates that traditional Chinese medicine plaster therapy can effectively reduce muscle tone in stroke patients with phlegm-blood stasis syndrome and muscle dystonia and pain.

[0107] 3.6C-reactive protein (CRP), interleukin-6 (IL-6), and interleukin-10 (IL-10) scores:

[0108] Table 9. Changes in CRP, IL-6, and IL-10 scores in the two groups.

[0109]

[0110] Note: Compared with before treatment, * P<0.05; compared with the control group, △ P<0.05

[0111] As shown in Table 9, compared with before treatment, the levels of modified CRP, IL-6, and IL-10-related inflammatory factors decreased in both the treatment and control groups (P<0.05). After treatment, the levels of CRP, IL-6, and IL-10-related inflammatory factors decreased more significantly in the treatment group than in the control group (P<0.01). This indicates that traditional Chinese medicine plaster therapy can effectively reduce the serum inflammatory factor levels in patients with dystonia and pain due to phlegm-blood stasis syndrome after stroke, and alleviate pain.

[0112] 3.7 Traditional Chinese Medicine Syndrome Scoring:

[0113] Table 10 Changes in TCM syndrome scores between the two groups

[0114]

[0115] Note: Compared with before treatment, * P<0.05; compared with the control group, △ P<0.05

[0116] As shown in Table 10, compared with before treatment, the TCM syndrome scores of both the control group and the treatment group decreased (P<0.05), with a more significant decrease in the treatment group (P<0.05). After treatment, the TCM syndrome score of the treatment group was significantly lower than that of the control group (P<0.05). This indicates that TCM patch therapy can improve the TCM symptoms and signs of patients with phlegm-blood stasis syndrome and muscle dystonia and pain in stroke patients.

[0117] In summary, the traditional Chinese medicine preparation proposed in this invention, combined with the characteristic TCM therapy of herbal patch application, can be used to treat dystonia and pain caused by phlegm-blood stasis syndrome in stroke patients, demonstrating good therapeutic effects. Furthermore, this invention uses surface myoelectric imaging to assess the bioelectrical changes of the neuromuscular system in patients with dystonia and pain caused by phlegm-blood stasis syndrome in stroke patients, studies the therapeutic effect of herbal patch application, and combines relevant target achievement scales, serum inflammatory factor levels, and changes in TCM syndrome scores, thereby providing clinical evidence for the objective and standardized treatment and prediction of rehabilitation efficacy for dystonia and pain in stroke patients.

[0118] The above description is merely an example and illustration of the concept of the present invention. Those skilled in the art can make various modifications or additions to the specific embodiments described or use similar methods to replace them, as long as they do not deviate from the concept of the invention or exceed the scope defined in the claims, they should all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine preparation for treating muscle spasticity and pain of stroke phlegm and blood stasis blockage syndrome, characterized in that, Prepared from the following weight of traditional Chinese medicine raw materials: Radix et Rhizoma Aconiti 30-50g, Radix Aconiti 30-45g; Folium et Ramus Euonymi 20-40g, Amoeba 20-40g; Wupi 25-35g, Shannai 25-35g, Lujiancao 30-50g, Rougui 20-40g, Xixin 25-40g, Mosha 10-30g, Liujinuo 20-40g, Bingpian 10-30g; The prescription amount of each traditional Chinese medicine is crushed and mixed with an appropriate amount of ginger juice to form a paste, which is then spread in the middle of a medical dressing to prepare a traditional Chinese medicine paste.

2. The traditional Chinese medicine preparation of claim 1, characterized in that, Prepared from the following weight of traditional Chinese medicine raw materials: Radix et Rhizoma Aconiti 40g, Radix Aconiti 40g; Folium et Ramus Euonymi 30g, Amoeba 30g; Wupi 30g, Shannai 30g, Lujiancao 40g, Rougui 30g, Xixin 30g, Mosha 20g, Liujinuo 30g, Bingpian 20g.

3. Use of the traditional Chinese medicine preparation of claim 1 or 2 in the preparation of a drug for treating muscle tension disorder and pain of stroke phlegm and blood stasis syndrome.

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