Traditional Chinese medicine composition combined with needle-knife for treating cervical spondylotic radiculopathy and preparation method of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating cervical spondylotic radiculopathy in combination with a needle-knife and a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 18 to 22 parts of radix puerariae, 18 to 22 parts of radix astragali seu hedysari, 10 to 15 parts of cassia twig, 28 to 32 parts of radix paeoniae alba, 13 to 17 parts of radix angelicae sinensis, 10 to 15 parts of rhizoma chuanxiong, 13 to 17 parts of radix clematidis, 10 to 15 parts of vinegar-processed rhizoma corydalis, 10 to 15 parts of rhizoma seu radix notopterygii and 10 to 15 parts of radix saposhnikoviae. The traditional Chinese medicine composition gives full play to the advantage of syndrome differentiation and treatment of traditional Chinese medicine, the oral traditional Chinese medicine composition can regulate and smooth qi and blood, the external small needle knife can release adhesion, regulate tendons and relieve pain, the two components have a synergistic effect, the treatment targets of taking both symptoms and root causes and treating both inside and outside are achieved, and a safe, convenient, economical, continuous and effective treatment approach is provided for clinical treatment of cervical spondylotic radiculopathy. Good clinical application values are realized.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating cervical spondylotic radiculopathy in combination with needle knife and a preparation method thereof. BACKGROUND

[0002] Cervical spondylotic radiculopathy (CSR) is mainly characterized by limited cervical movement and pain and numbness in the neck, shoulder, back and arm. Although the modern disease name is not mentioned in ancient medical literature, similar diseases have been described. The Huangdi Neijing describes arthralgia as "strong neck and back", "neck muscle gathering" and "cervical spasm". The Jingluo of the Lingshuo describes the symptoms of the bladder foot-taiyang meridian as eye swelling and neck stiffness, which are highly similar to the symptoms of cervical spondylotic radiculopathy, providing a reference for the treatment of the disease in later generations. Combined with the etiology, pathogenesis and clinical symptoms, CSR belongs to the category of "arthralgia", "cervical pain" and "stiff neck" in traditional Chinese medicine. If it persists for a long time, muscle atrophy may occur, which can be classified as "flaccid syndrome".

[0003] Current clinical treatment methods include Western medicine, surgery and traditional Chinese medicine acupuncture, massage and traditional Chinese medicine. In Western medicine treatment, long-term use of non-steroidal anti-inflammatory drugs has greater side effects, surgical treatment has great trauma, high cost and long postoperative recovery period. Traditional Chinese medicine acupuncture and massage have limited efficacy, oral traditional Chinese medicine has a slow onset and is difficult to quickly relieve muscle spasm and nerve compression symptoms. SUMMARY

[0004] Therefore, the present application provides a traditional Chinese medicine composition for treating cervical spondylotic radiculopathy in combination with needle knife and a preparation method thereof. The present application focuses on cervical spondylotic radiculopathy, a common and frequently-occurring disease in clinical practice. In view of the complexity of the pathogenesis, the limited efficacy of single therapy and the difficulty of recurrence, the present application innovatively combines traditional Chinese medicine external treatment (needle knife release) with internal treatment (traditional Chinese medicine compound oral administration), forming a comprehensive treatment program of "treating muscles and bones together and repairing internally and externally". The present application not only provides a better treatment option for clinical practice, enriches the treatment of CSR in combination with traditional Chinese and Western medicine, but also makes an important contribution to the in-depth exploration of the scientific connotation of the synergistic effect of traditional Chinese medicine external treatment and internal treatment and the promotion of the mode of treating orthopedic diseases in combination with traditional Chinese and Western medicine.

[0005] To achieve the above-mentioned purpose, the present application provides the following technical solutions:

[0006] According to a first aspect of the present application, the present application provides a traditional Chinese medicine composition for treating cervical spondylotic radiculopathy in combination with needle knife, wherein the raw materials are as follows in terms of weight fraction: 18-22 parts of radix puerariae, 18-22 parts of radix astragali, 10-15 parts of ramulus cinnamomi, 28-32 parts of radix paeoniae alba, 13-17 parts of angelica sinensis, 10-15 parts of ligusticum wallichii, 13-17 parts of radix clematidis, 10-15 parts of rhizoma corydalis, 10-15 parts of nardostachys jatamansi, 10-15 parts of saposhnikovia divaricata and 10-15 parts of saposhnikovia divaricata.

[0007] Furthermore, by weight, the raw materials are: 20 parts kudzu root, 20 parts astragalus root, 12 parts cinnamon twig, 30 parts white peony root, 15 parts angelica root, 12 parts chuanxiong rhizome, 15 parts clematis root, 12 parts vinegar-processed corydalis rhizome, 12 parts notopterygium root, and 12 parts saposhnikovia root.

[0008] According to a second aspect of the present invention, the present invention provides a method for preparing the traditional Chinese medicine composition as described above, the method comprising: mixing kudzu root, astragalus root, cinnamon twig, white peony root, angelica root, chuanxiong rhizome, clematis root, vinegar-processed corydalis rhizome, notopterygium root, and saposhnikovia root, and then decocting them in water.

[0009] Further, soak in water for 0.5 hours, bring to a boil over high heat, then reduce to a simmer and maintain a gentle boil for 1 hour. Boil twice and combine the decoctions.

[0010] According to a third aspect of the present invention, the present invention provides the use of the traditional Chinese medicine composition as described above in the preparation of a medicament for treating cervical spondylosis of the nerve root type, combined with acupuncture and knife therapy.

[0011] The traditional Chinese medicine composition provided by this invention uses kudzu root, astragalus root, cinnamon twig, white peony root, angelica root, chuanxiong rhizome, clematis root, vinegar-processed corydalis rhizome, notopterygium root, and saposhnikovia root as raw materials. Kudzu root and astragalus root are the principal herbs, one promoting blood circulation and the other tonifying, directly targeting the affected area and establishing the overall formula's foundation. Cinnamon twig, white peony root, angelica root, chuanxiong rhizome, and vinegar-processed corydalis rhizome are the assistant herbs. Cinnamon twig and white peony root are combined to harmonize the body's vital energy and relieve pain; the angelica-chuanxiong rhizome pair works synergistically with vinegar-processed corydalis rhizome to invigorate blood circulation, remove blood stasis, and relieve pain. Notopterygium root, saposhnikovia root, and clematis root are used as adjuvant herbs to dispel wind and dampness, and relax muscles and tendons. The entire formula integrates the harmonizing effects of "Guizhi Tang" (cinnamon twig, white peony root, and prepared licorice root), the pain-relieving effects of "Shaoyao Gancao Tang," and the blood-invigorating and qi-regulating effects of "Fo Shou San" (angelica root and chuanxiong rhizome). At the same time, the "stillness" of Astragalus and Licorice is combined with the "movement" of Ligusticum chuanxiong, Notopterygium incisum, and Cinnamomum cassia, and the "tonification" of Angelica sinensis and Paeonia lactiflora is combined with the "unblocking" of Corydalis yanhusuo, so as to achieve "tonification without stagnation and unblocking without harm", and together play the original intention of "dispelling wind, cold and dampness to eliminate evil, promoting blood circulation and removing blood stasis to stop pain, and benefiting qi, nourishing blood and harmonizing the body to consolidate the foundation".

[0012] This invention systematically combines acupuncture and knife therapy with specific traditional Chinese medicine formulas for the treatment of CSR, establishing a standardized combined intervention program. This program is not a simple additive approach, but rather based on the core pathogenesis of "meridian and tendon obstruction, qi and blood stagnation, and liver and kidney deficiency," achieving a synergistic effect of "external treatment to loosen meridian and tendon adhesions and dredge local qi and blood; and internal administration to invigorate blood circulation, remove blood stasis, dispel wind and dampness, and tonify the liver and kidneys."

[0013] The embodiments of the present invention have the following advantages:

[0014] This invention fully leverages the advantages of traditional Chinese medicine's syndrome differentiation and treatment, employing a combined treatment approach of oral herbal composition and external acupuncture knife therapy for muscle relaxation and manipulation. The oral herbal composition regulates Qi and blood circulation, while the external acupuncture knife releases adhesions, relaxes muscles, and relieves pain. The synergistic effect of these two methods achieves a comprehensive treatment goal that addresses both the root cause and the symptoms. This combined acupuncture knife manipulation and oral herbal composition treatment method provides a safe, convenient, economical, and consistently effective treatment approach for cervical spondylosis of the nerve root type, demonstrating significant clinical application value. Detailed Implementation

[0015] The following specific embodiments illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0016] Example 1

[0017] This embodiment provides a traditional Chinese medicine composition for treating cervical spondylosis of nerve root type using acupuncture knife therapy. The raw materials are: 20g of kudzu root, 20g of astragalus root, 12g of cinnamon twig, 30g of white peony root, 15g of angelica root, 12g of chuanxiong rhizome, 15g of clematis root, 12g of vinegar-processed corydalis rhizome, 12g of notopterygium root, and 12g of saposhnikovia root.

[0018] The preparation method of the above-mentioned traditional Chinese medicine composition is as follows: Weigh the corresponding weights of kudzu root, astragalus root, cinnamon twig, white peony root, angelica root, chuanxiong rhizome, clematis root, vinegar-processed corydalis rhizome, notopterygium root, and saposhnikovia root, soak in water for 0.5 hours, bring to a boil over high heat, then simmer over low heat for 1 hour, decoct twice, combine the decoctions, and obtain about 300 ml of water decoction.

[0019] Example 2

[0020] This embodiment provides a traditional Chinese medicine composition for treating cervical spondylosis of nerve root type using acupuncture knife therapy. The raw materials are: 18g of kudzu root, 22g of astragalus root, 10g of cinnamon twig, 30g of white peony root, 17g of angelica root, 10g of chuanxiong rhizome, 13g of clematis root, 15g of vinegar-processed corydalis rhizome, 10g of notopterygium root, and 15g of saposhnikovia root.

[0021] The preparation method of the above-mentioned traditional Chinese medicine composition is the same as that in Example 1.

[0022] Example 3

[0023] This embodiment provides a traditional Chinese medicine composition for treating cervical spondylosis of nerve root type using acupuncture knife therapy. The raw materials are: 22g of kudzu root, 18g of astragalus root, 12g of cinnamon twig, 28g of white peony root, 13g of angelica root, 15g of chuanxiong rhizome, 17g of clematis root, 10g of vinegar-processed corydalis rhizome, 15g of notopterygium root, and 10g of saposhnikovia root.

[0024] The preparation method of the above-mentioned traditional Chinese medicine composition is the same as that in Example 1.

[0025] Experimental Example 1

[0026] This experimental case was used to verify the efficacy of a combination of acupuncture and traditional Chinese medicine in the treatment of cervical radiculopathy.

[0027] 1. Research Subjects

[0028] 1.1 Source of cases

[0029] The subjects of this study were patients with cervical spondylosis of the nerve root type who visited the Department of Orthopedics and Traumatology at Shanxi University of Traditional Chinese Medicine. A total of 70 patients who met the criteria were included.

[0030] 1.2 Diagnostic criteria

[0031] Referring to the diagnostic criteria for radicular cervical spondylosis in the "Expert Consensus on Classification, Diagnosis and Non-surgical Treatment of Cervical Spondylosis" published in the Chinese Journal of Surgery in 2018:

[0032] ① It has relatively typical nerve root symptoms (numbness and pain in the arm), the extent of which is consistent with the area innervated by the cervical spinal nerve, and the physical examination shows a positive cervical compression test or brachial plexus traction test.

[0033] ②The findings on imaging examinations are consistent with the clinical manifestations.

[0034] ③ Diseases that cause upper limb pain, excluding cervical spondylosis (such as thoracic outlet syndrome, tennis elbow, carpal tunnel syndrome, frozen shoulder, biceps tendinitis, and apical lung tumors).

[0035] 1.3 Inclusion Criteria

[0036] ① Patients who visit the orthopedic outpatient department of our hospital, aged between 18 and 79 years old, regardless of gender, and whose disease course is >3 months.

[0037] ② Meets the above clinical diagnostic criteria for cervical radiculopathy.

[0038] ③ The patient has a good history of good health and no serious heart disease, diabetes, hypertension, cerebrovascular disease, or blood disorders.

[0039] ④ The patient had not received any treatment related to cervical radiculopathy in the 3 weeks prior to the consultation.

[0040] ⑤ Agree to cooperate with the treatment and not to adopt any treatment methods other than experimental methods, including acupuncture, massage, and various oral Chinese and Western medicines.

[0041] 1.4 Exclusion Criteria

[0042] ①Those who have surgical indications or have already undergone cervical spine surgery.

[0043] ②Women who are pregnant, planning to become pregnant, or currently breastfeeding.

[0044] ③ Individuals suffering from severe liver or kidney dysfunction, severe cardiovascular disease, hematopoietic dysfunction, or other serious underlying diseases.

[0045] ④ Patients for whom it is difficult to evaluate the efficacy of treatment (including patients with mental illnesses).

[0046] ⑤ Those who have not completed the full course of treatment or who do not cooperate with the treatment.

[0047] ⑥ Those who are allergic to the medication used.

[0048] 1.5 Rejection Criteria

[0049] ① Patients who meet the exclusion criteria.

[0050] ② Patients who do not cooperate with data collection or treatment after the start of the experiment.

[0051] ③ Patients who develop life-threatening diseases such as cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, unrelated to oral medications after the start of the experiment.

[0052] ④ Patients who experience drug allergies during treatment.

[0053] 1.6 Shedding Criteria

[0054] ① Patients who started experimental treatment but changed or added other treatment methods without authorization during the treatment.

[0055] ② Patients for whom the treatment method was definite, but who did not follow the experimenter's medical advice.

[0056] ③ Patients who had other diseases during the experiment and who took drugs that affected the determination of the efficacy of the experiment.

[0057] 1.7 Termination of Test Criteria

[0058] ① Patients who experience adverse reactions after taking oral Chinese medicine.

[0059] ②Those who drop out of treatment midway.

[0060] ③ Patients who develop urgent complications or other illnesses that prevent them from continuing the experiment.

[0061] ④ Patients who, despite signing informed consent, are unable to strictly comply with the experimental methods.

[0062] ⑤ Sample data that is missing or erroneous for various reasons.

[0063] 2. Research Methods

[0064] 2.1 Random Grouping

[0065] Seventy eligible patients with cervical spondylosis of the nerve root type were collected and numbered from 1 to 70 according to their order of consultation. They were then randomly divided into a treatment group and a control group using a random number table, with 35 patients in each group.

[0066] 2.2 Treatment methods

[0067] The treatment group received acupuncture and knife release combined with oral Chinese medicine, while the control group received oral Chinese medicine.

[0068] 2.2.1 Treatment group:

[0069] ① Patients in the treatment group need to change their lifestyle and work habits during treatment, avoid prolonged periods of looking down, and pay attention to keeping their necks warm.

[0070] ② Take the herbal composition of Example 1 orally, one dose per day, divided into two packets, each packet containing approximately 150ml, taken warm half an hour after breakfast and dinner. Use continuously for one month.

[0071] ③ Needle knife release

[0072] (1) Position: The patient lies prone with a soft pillow under the upper chest to keep the neck in a forward flexed position, exposing the patient's head, neck and shoulders.

[0073] (2) Localization: Accurately locate the stage of cervical spine lesion based on physical examination and imaging examination. A total of 5 treatment points are selected: ①: Lower edge of the external occipital protuberance (release target: nuchal ligament insertion point) ②: Intersection of the external occipital protuberance on the affected side and the superior nuchal line 2.5cm lateral to the affected side (release target: semispinalis capitis muscle, nuchal ligament) ③: The spinous process points of the cervical vertebrae one and one below the lesion segment (release target: nuchal ligament, spinous process tip muscle) ④: Transverse process points of the lamina on the affected side (release target: posterior cervical fascia layers, facet joint capsule; longitudinal location: 4cm lateral to the posterior midline; transverse location: horizontal line of the spinous process of the lower cervical vertebrae, such as the C4-C5 facet joint located at the horizontal line of the C5 spinous process). Mark them with a marker.

[0074] (3) Routine disinfection, draping with sterile drapes, the surgeon washes and disinfects his hands according to the surgical handwashing method and wears sterile gloves, prepare 2-5ml of 1% lidocaine for local infiltration anesthesia at the surgical site, and it is best to anesthetize until the local tissue is no longer sensitive to pain, but still has sensation.

[0075] (4) Operating method:

[0076] ① Lower edge of the occipital protuberance: The surgeon presses the marked point with the tip of their left thumb, holds the needle knife in their right hand, and inserts the needle knife into the skin along the lower edge of the occipital protuberance, passing through the superficial fascia and nuchal ligament to reach the bone surface of the skull. The direction of the blade is then reversed to be perpendicular to the sagittal plane, and the needle knife is withdrawn subcutaneously before cutting back to the bone surface. After the procedure, the needle is removed, bleeding is stopped, the patient is reassured, and a sterile dressing is applied and secured with adhesive tape.

[0077] ②2.5cm lateral to the external occipital protuberance on the affected side: The needle insertion and release methods are the same as above.

[0078] ③ Cervical spinous process point: Insert the needle knife into the skin, fascia, and nuchal ligament at the marked point to reach the bone surface of the spinous process tip. Then turn the knife head to be parallel to the horizontal plane, lift the needle knife to the subcutaneous tissue, and then cut to the bone surface of the spinous process tip. Continue to cut the interspinous muscle along the upper or lower edge of the spinous process (amplitude 2-3 mm). Remove the needle, stop bleeding, comfort the patient, and cover with sterile dressing and fix with adhesive tape.

[0079] ④ Transverse process point of the affected vertebral lamina (affected side): The operator holds the needle knife with the blade line at a 45° angle to the sagittal plane (from the upper outer side to the lower inner side). The needle knife is inserted into the skin at the marked point, passing through the superficial fascia, various muscle layers, and nuchal ligament to the facet joint bone surface. The needle knife is then lifted subcutaneously and inserted into the bone surface to cut. The blade line is then turned to be parallel to the horizontal plane on the bone surface to explore the facet joint gap. The needle knife is gently lifted to the surface of the joint capsule and then cut to the bone surface to release the joint capsule. After the operation, the needle is removed, bleeding is stopped, the patient is comforted, and a sterile dressing is applied and the area is fixed with adhesive tape.

[0080] ⑤ Treatment course: One treatment every 7 days, with 3 treatments constituting one course of treatment.

[0081] ⑥ The following precautions should be taken:

[0082] (1) During local infiltration anesthesia, a syringe needle can be used to conduct a preliminary exploration of the affected area to confirm the general adhesion of local tissues.

[0083] (2) When inserting the knife, make sure the blade is parallel to the longitudinal axis of the spine to avoid excessive damage to subcutaneous tissue and muscle fascia. During the cutting process, keep the blade close to the bone surface. When you feel a sense of emptiness under the knife, stop inserting the needle immediately to avoid cutting important organs, nerves and blood vessels.

[0084] (3) After the acupuncture knife procedure, you can lie flat for 5-10 minutes to ease the tension caused by the acupuncture knife treatment.

[0085] 2.2.2 Control group:

[0086] ① Patients in the control group needed to change their lifestyle and work habits during treatment, avoid prolonged periods of looking down, and keep their necks warm.

[0087] ② The herbal composition of Example 1 was administered orally, in the same manner as the treatment group. It was used continuously for one month.

[0088] 2.3 Observation Indicators

[0089] Three time points were selected: before treatment (DAY1), 4 weeks after treatment (DAY28), and 3 months after treatment (DAY90). The simplified McGill Pain Questionnaire and the Tanaka Yasuhisa Cervical Spondylosis Symptom Scale were used to evaluate the two groups of patients. The overall efficacy of the two groups before treatment, 4 weeks after treatment, and 3 months after treatment was also analyzed.

[0090] 2.3.1 Simplified McGill Pain Questionnaire Assessment Method

[0091] During the assessment, the trial administrators first explained the purpose of the questionnaire to the 90 patients who met the trial criteria, and then carefully questioned each patient about each item. This scale consists of three parts (PRI, VAS, PPI).

[0092] 2.3.1.1 Assessment of the Pain Rating Index (PRI)

[0093] The assessment comprises 15 pain scales (11 sensory items and 4 emotional items) and is divided into four levels of pain intensity: no pain, mild, moderate, and severe, with each level of pain scored as 0, 1, 2, and 3 points respectively. During the assessment, medical staff ask the patient questions for each item, and score the pain intensity based on the patient's answers to the sensory and emotional items, which are then summed up.

[0094] 2.3.1.2 Visual Analogue Scale (VAS)

[0095] This assessment is a simple method for measuring pain intensity in clinical practice. During the clinical test, the examiner holds a ruler with the unmarked side facing the patient and explains the direction of the pain intensity distribution. The patient then marks the area on the ruler based on their subjective feeling. The test administrator then scores the patient based on the ruler's markings. The ruler is a 10cm ruler marked with mm graduations. The assessment consists of 11 pain intensity levels on a scale of 0 to 10, where 0 indicates no pain and 10 indicates severe pain; the higher the score, the more severe the pain.

[0096] 2.3.1.3 Assessment of Present Pain Intensity (PPI)

[0097] The assessment categorizes the severity of patient pain into six levels: no pain, mild discomfort, discomfort, unpleasant pain, terrible pain, and extreme suffering, corresponding to scores of 0, 1, 2, 3, 4, and 5 points, respectively. Medical personnel mark the corresponding scores based on the patient's subjective response to their pain.

[0098] When conducting an overall evaluation, the items of the simplified McGill Pain Questionnaire are added together, and the score is positively correlated with the pain symptoms; that is, a high score indicates severe pain, and vice versa. The simplified McGill Pain Questionnaire provides a relatively objective way to represent the subjective experience of pain.

[0099] 2.3.2 Assessment of Tanaka Yasuhisa's Cervical Spondylosis Symptom Scale

[0100] The scoring consists of four parts (out of a total of 20 points):

[0101] ①Symptoms (9 points): Pain and numbness in the shoulder and neck, the affected upper limb and fingers.

[0102] ② Whether their work and life abilities are normal (3 points).

[0103] ③ Physical signs (8 points): muscle strength, sensation, tendon reflexes, etc.

[0104] ④ Hand function: -2 points to 0 points. Each part is scored separately, and the four parts are added together. The score is negatively correlated with the severity of the condition. A higher score indicates a milder condition, and vice versa.

[0105] 2.3.3 Efficacy Evaluation Criteria

[0106] ① Cured: All original symptoms disappear, there is no pain, numbness, etc., the function and muscle strength of the neck, shoulder and affected limbs return to normal, and the patient can participate in daily work and labor normally.

[0107] ② Improvement: The original symptoms of each type are reduced compared to before, the pain and numbness of the affected limb are reduced, and the function of the neck, shoulder and affected limb is relieved.

[0108] ③ Not cured: The original symptoms have not been relieved.

[0109] Effective rate = (number of cured cases + number of cases improved) / total number of cases × 100%.

[0110] 2.4 Safety Standards

[0111] Safety testing includes: body temperature, pulse, respiration, blood pressure; liver function, kidney function; complete blood count; urinalysis; and stool analysis.

[0112] Strictly adhere to the drug dosage and administration method. If adverse reactions are observed, the clinician will determine whether to discontinue the trial based on the patient's condition.

[0113] Level 1: No adverse reactions, safe.

[0114] Level 2: Relatively safe, with slight discomfort, but it does not affect continued treatment.

[0115] Grade 3: Adverse reactions occur; symptomatic treatment followed by continued treatment.

[0116] Grade 4: Serious adverse reactions occur, and the trial is discontinued.

[0117] 2.5 Data Processing

[0118] The collected data were processed using SPSS 26.0 statistical analysis software. Quantitative data were expressed as mean ± standard deviation. Normality and homogeneity of variance tests were performed first. Data conforming to normality and homogeneity of variance were analyzed using t-tests, while non-parametric (rank-sum) tests were used for data not conforming to normality. For between-group statistical analysis, qualitative data were analyzed using the chi-square test (X-square). 2 For ordinal data, the rank-sum test and p-value test were used. A two-tailed test was consistently employed. A p-value > 0.05 indicated no statistical significance, while a p-value < 0.05 indicated statistical significance.

[0119] 3. Results

[0120] 3.1 General Information

[0121] 3.1.1 Gender

[0122] A chi-square test was performed on the gender data of the two groups of patients, and the result (P=0.632>0.05) showed no statistically significant difference, indicating that there was no significant difference in gender between the two groups. See Table 1 for details.

[0123] Table 1 Comparison of genders between the two groups of patients

[0124]

[0125] 3.1.2 Age

[0126] The ages of the two groups of patients ranged from 21 to 66 years, and their ages conformed to a normal distribution and homogeneity of squares. A t-test was performed on the age data of the two groups, and the result was P = 0.808 > 0.05, indicating no statistical significance. This suggests that there was no difference in the age of onset between the two groups, making them comparable. See Table 2 for details.

[0127] Table 2 Comparison of ages between the two groups of patients ( ±S)

[0128]

[0129] 3.1.3 Course of Disease

[0130] The shortest disease duration for both groups was 5 months, and the longest was 30 months. Based on the results of normality and homogeneity of variance tests, a t-test was performed on the patient disease duration data. The result was P = 0.630 > 0.05, indicating no statistical significance. This suggests that there was no difference in disease duration between the two groups, making a comparison meaningful. See Table 3 for details.

[0131] Table 3 Comparison of disease course between the two groups of patients ( ±S)

[0132]

[0133] 3.2 Comparison of cure rates between the two groups of patients

[0134] No significant adverse reactions occurred in either group of patients during the treatment period. The cure rate in the treatment group was 5.71% and the improvement rate was 94.29%, while the cure rate in the control group was 0% and the improvement rate was 100%. The difference between the two groups after treatment was statistically significant (P < 0.05). Detailed results are shown in Table 4.

[0135] Table 4 Comparison of cure rates between the two groups of patients

[0136]

[0137] Note: Compared with the control group, P < 0.05.

[0138] 3.3 Comparison of VAS scores between the two groups of patients

[0139] Both groups of patients' VAS scores before and after treatment did not conform to a normal distribution, so a nonparametric rank-sum test was used. Before treatment, the VAS scores of both groups were between 4 and 9 points (Z = -0.388, P = 0.698 > 0.05), indicating no statistically significant difference; therefore, the VAS scores of the two groups were comparable. (See Table 5 for details). At 4 weeks after treatment, Z = -2.743 (P = 0.006 < 0.05), showing a statistically significant difference; therefore, the treatment group showed more significant improvement in VAS scores than the control group. Within-group comparisons in the treatment group (Z = -5.237, P = 0.000) and the control group (Z = -5.351, P = 0.000) indicated that both groups improved patient pain. (See Table 6 for details). At 3 months after treatment, Z = -4.458 (P = 0.000 < 0.05), showing a statistically significant difference; therefore, the treatment group showed more significant improvement in VAS scores than the control group. Within-group comparison in the treatment group: Z = -5.330, P = 0.000; in the control group: Z = -5.283, P = 0.000, indicating that both groups could improve patients' pain. See Table 7 for details.

[0140] Table 5 Comparison of VAS scores before treatment in the two groups ( ±S)

[0141]

[0142] Table 6 Comparison of VAS scores between the two groups 4 weeks after treatment ( ±S)

[0143]

[0144] Table 7 Comparison of VAS scores between the two groups 3 months after treatment ( ±S)

[0145]

[0146] 3.4 Comparison of PRI scores between the two groups of patients

[0147] Both groups of patients showed normal distributions in their PRI scores before and after treatment, as analyzed by a t-test. Before treatment, the PRI scores of both groups ranged from 13 to 36 points (t = 0.186, P = 0.853 > 0.05), indicating no statistically significant difference; therefore, the PRI scores of the two groups were comparable. (See Table 8 for details). At 4 weeks post-treatment, the t-test was 3.172 (P = 0.002 < 0.05), showing a statistically significant difference, indicating that the treatment group showed more significant improvement in PRI scores than the control group. Within-group comparisons within the treatment group (t = 10.303, P = 0.000) and the control group (t = 7.870, P = 0.000) showed improvement in pain in both groups. (See Table 9 for details). At 3 months post-treatment, the t-test was 4.725 (P = 0.000 < 0.05), showing a statistically significant difference, indicating that the treatment group showed more significant improvement in PRI scores than the control group. Within-group comparison in the treatment group: t = 20.265, P = 0.000; in the control group: t = 17.629, P = 0.000, indicating that both groups could improve patients' pain. See Table 10 for details.

[0148] Table 8 Comparison of PRI scores before treatment in the two groups ( ±S)

[0149]

[0150] Table 9 Comparison of PRI scores between the two groups four weeks after treatment ( ±S)

[0151]

[0152] Table 10 Comparison of PRI scores between the two groups 3 months after treatment ( ±S)

[0153]

[0154] 3.5 Comparison of PPI scores between the two groups of patients

[0155] Both groups of patients' PPI scores before and after treatment did not conform to a normal distribution, so a nonparametric rank-sum test was used. Before treatment, the PPI scores of both groups were between 2 and 5 points (Z = -0.499, P = 0.618 > 0.05), indicating no statistically significant difference; therefore, the PPI scores of the two groups were comparable. (See Table 11 for details). At 4 weeks after treatment, Z = -2.396 (P = 0.017 > 0.05), indicating no statistically significant difference; therefore, the improvement in PPI scores between the treatment group and the control group was not significant in the first 4 weeks after treatment. Within-group comparisons in the treatment group (Z = -5.157, P = 0.000) and the control group (Z = -5.180, P = 0.000) showed that both groups improved patients' pain. (See Table 12 for details). At 3 months after treatment, Z = -5.280 (P = 0.000 < 0.05), indicating a statistically significant difference; therefore, the improvement in PPI scores in the treatment group was more significant than that in the control group after 3 months of treatment. Within-group comparison in the treatment group: Z = -5.215, P = 0.000; in the control group: Z = -5.231, P = 0.000, indicating that both groups could improve patients' pain. See Table 13 for details.

[0156] Table 11 Comparison of PPI scores before treatment in the two groups ( ±S)

[0157]

[0158] Table 12 Comparison of PPI scores between the two groups 4 weeks after treatment ( ±S)

[0159]

[0160] Table 13 Comparison of PPI scores between the two groups 3 months after treatment ( ±S)

[0161]

[0162] 3.6 Comparison of the two groups treated with Tanaka Yasuhisa's cervical spondylosis symptom scale assessment

[0163] The Tanaka Yasuhisa Cervical Spondylosis Symptom Scale (TSS) scores of both groups before and after treatment did not conform to a normal distribution, so a nonparametric rank-sum test was used. Before treatment, the TSS scores of both groups ranged from 3 to 16 points (Z = -0.488, P = 0.626 > 0.05), indicating no statistically significant difference; therefore, the TSS scores of the two groups were comparable. (See Table 14 for details). Four weeks after treatment, Z = -5.480 (P = 0.000 < 0.05), showing a statistically significant difference; therefore, the treatment group showed more significant improvement in TSS scores than the control group. Within-group comparisons in the treatment group (Z = -5.220, P = 0.000) and the control group (Z = -5.218, P = 0.000) indicate that both groups improved patients' pain and cervical spine mobility. (See Table 15 for details). Three months after treatment, Z = -4.135, P = 0.000 < 0.05, indicating a statistically significant difference. Therefore, the treatment group showed more significant improvement than the control group in terms of the Tanaka Yasuhisa Cervical Spondylosis Symptom Scale score. Within-group comparison in the treatment group, Z = -5.247, P = 0.000, while in the control group, Z = -5.201, P = 0.000, indicating that both groups improved patients' pain and cervical spine mobility. See Table 16 for details.

[0164] Table 14 Comparison of Tanaka Yasuhisa's Cervical Spondylosis Symptom Scale Assessment Before Treatment in Two Groups

[0165]

[0166] Table 15 Comparison of Tanaka Yasuhisa's Cervical Spondylosis Symptom Scale Assessment in Two Groups 4 Weeks After Treatment

[0167]

[0168] Table 16 Comparison of Tanaka Yasuhisa's Cervical Spondylosis Symptom Scale Assessment 3 Months After Treatment Between the Two Groups

[0169]

[0170] 3.7 Two sets of safety assessments

[0171] Safety tests were conducted on patients with cervical radiculopathy in both the treatment and control groups during the treatment period and for six months after the treatment. The results showed that no patients experienced any treatment-related adverse reactions.

[0172] In summary, the acupuncture-knife combined with traditional Chinese medicine provided by this invention has a more significant effect on the treatment of cervical spondylosis of nerve root type compared with traditional Chinese medicine. It can significantly reduce the patient's pain, improve the patient's cervical spine function and mobility, and has good safety, making it suitable for clinical promotion and application.

[0173] Although the present invention has been described in detail above with general descriptions and specific embodiments, modifications or improvements can be made to it, which will be obvious to those skilled in the art. Therefore, all such modifications or improvements made without departing from the spirit of the present invention fall within the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine composition for treating cervical spondylotic radiculopathy in combination with a needle knife, characterized in that, The raw materials are 18-22 parts of Pueraria, 18-22 parts of Astragalus, 10-15 parts of Ramulus Cinnamomi, 28-32 parts of Radix Paeoniae Alba, 13-17 parts of Angelica, 10-15 parts of Rhizoma Chuanxiong, 13-17 parts of Radix Trigonellae, 10-15 parts of Rhizoma Cynanchi, 10-15 parts of Rhizoma et Radix Notopterygii and 10-15 parts of Saposhnikovia.

2. The combination of the needle-knife and the traditional Chinese medicine composition for treating the nerve root type cervical spondylosis according to claim 1, characterized in that, The raw materials are 20 parts of Pueraria, 20 parts of Astragalus, 12 parts of Ramulus Cinnamomi, 30 parts of Radix Paeoniae Alba, 15 parts of Angelica, 12 parts of Rhizoma Chuanxiong, 15 parts of Radix Trigonellae, 12 parts of Rhizoma Cynanchi, 12 parts of Rhizoma et Radix Notopterygii and 12 parts of Saposhnikovia.

3. The preparation method of the traditional Chinese medicine composition according to claim 1, characterized in that, The method comprises the following steps: mixing Pueraria, Astragalus, Ramulus Cinnamomi, Radix Paeoniae Alba, Angelica, Rhizoma Chuanxiong, Radix Trigonellae, Rhizoma Cynanchi, Rhizoma et Radix Notopterygii and Saposhnikovia, and then water decocting.

4. The production method according to claim 3, characterized by, Soak in water for 0.5 h, boil with strong fire, then change to weak fire and keep boiling for 1 h, decoct twice, and combine the water decoction.

5. The Chinese medicine composition of claim 1 is used for preparing a medicine for treating nerve root type cervical spondylosis by combining needle knife.

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