A Chinese medicine composition for treating knee osteoarthritis and its application

Abstract

The present invention relates to a Chinese medicine composition for treating knee osteoarthritis, which is prepared from the following raw materials in parts by weight: 6-14 parts of angelica sinensis, 6-14 parts of cyathula, 2-10 parts of polygonum cuspidatum, 6-14 parts of lycopodiella ciliata, 2-10 parts of safflower, 2-10 parts of perilla bark, 2-10 parts of sappan wood, 6-14 parts of millettia spatholobi, 6-14 parts of wormwood, and 2-10 parts of zanthoxylum bungeanum. The composition can significantly relieve joint pain in patients, and the treatment efficiency of clinical efficacy is as high as 93.33%, which can improve the quality of life of patients, and the Chinese medicine composition of the present invention has reasonable compatibility, no toxic side effects, and has good application prospects.

Description

Technical Field

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

[0002] Knee osteoarthritis is a chronic progressive joint disease based on degenerative pathological changes. It is common in middle-aged and elderly patients, with a higher incidence in women than in men. It is generally caused by degenerative lesions of the knee joint, trauma, overwork, obesity and other factors. Its pathological characteristics are degeneration, cracking, subchondral bone sclerosis and cystic changes of articular cartilage, as well as bone hyperplasia and osteophyte formation at the edge of the joint. Knee osteoarthritis can cause joint pain, especially during activities. In severe cases, joint dysfunction may occur, and even disability may occur, causing inconvenience to daily life and seriously reducing the quality of life.

[0003] At present, the cause of the disease is still unclear, but it is related to many factors, including age, obesity, climate, trauma and inflammation, joint structure and occupational factors. There are also many treatments for knee osteoarthritis. A stepped and individualized treatment plan is selected based on the patient's age, gender, weight, risk factors, lesion site and severity.

[0004] In traditional Chinese medicine, knee osteoarthritis belongs to the category of "arthritis", also known as "knee arthritis". "Zhang's Medical Encyclopedia" says: "The knee is the home of tendons. Knee pain is caused by liver and kidney deficiency. If the liver and kidney are deficient, wind, cold and dampness will attack them." The first reason is that the tendons are different from the meridians. The tendons start from the extremities and run in the chest and abdomen. They do not enter the internal organs, but they rely on the nourishment of the internal organs to the tendons. Moreover, the evil qi of the five internal organs stays in the part where the tendons gather. Therefore, if the kidney is deficient, it will not be able to control the bones, and if the liver is deficient, it will not be able to nourish the tendons. The second reason is that if the external evil is not eliminated, phlegm and blood stasis will be generated for a long time, causing knee tendons to contract and joint movement to be limited. In traditional Chinese medicine, this is a process caused by tendon injury, involving bones, and the final result is tendon and bone disease.

[0005] In Western medicine today, commonly used anti-inflammatory and analgesic drugs in clinical practice can cause significant side effects, and the therapeutic effect needs to be improved. At the same time, the disease is prone to recurrence, and the cost and discomfort of treatment are more prominent. In comparison, traditional Chinese medicine has the unique advantages of preventing and curing diseases and relieving pain in the treatment of rheumatic cold joint pain. There are currently many Chinese medicine prescriptions for knee osteoarthritis, such as the Chinese patent CN112274613A, published on January 29, 2021, which discloses a Chinese medicine composition for the treatment of knee osteoarthritis. The raw materials for the active ingredients of the Chinese medicine composition are composed of the following Chinese medicinal materials in parts by mass: 3-10 parts of cinnamon twigs, 3-10 parts of mugwort leaves, 3-10 parts of radix polygoni lobatae, and 3-10 parts of scutellaria baicalensis. , 2-6 parts of Notopterygium wilfordii, 3-10 parts of Angelica dahurica, 2-6 parts of Pittosporum tobira bark, 2-6 parts of Siegesbeckia scabra, 1.5-5 parts of processed Chuanwuji, 2-6 parts of Trillium, 2-6 parts of Curcuma zedoaria, 2-6 parts of Sappan wood, 2-10 parts of Lycopodiella cuneata, 2-6 parts of Eupatorium fortunei, 5-10 parts of Clematis chinensis, 1-5 parts of Asarum, 4-10 parts of Curcuma longa, and 1-5 parts of processed Aconitum carmichaelii. The prescription composition is unique. When used, grind each component into powder, decocted into medicinal juice for fumigation, which can treat osteoarthritis of the knee, relieve pain and edema, and has good therapeutic effect. Another Chinese patent CN115068576A, published on September 20, 2022, discloses an external Chinese medicine composition for preventing and treating osteoarthritis of the knee, wherein the Chinese medicine composition is composed of the following raw materials in parts by weight: 20-40 parts of Angelica sinensis, 15-30 parts of Cyathula capitata, 15-30 parts of Radix Angelicae Pubescentis, 10-20 parts of frankincense, 10-20 parts of myrrh, 3-6 parts of Asarum, 10-20 parts of Sichuan pepper, 10-20 parts of peach kernel, 10-20 parts of safflower, 10-20 parts of processed Aconite, 10-20 parts of processed Aconite, 15-30 parts of Saposhnikovia divaricata, 10-20 parts of papaya, 10-20 parts of Lycopodiella cuneata, 15-30 parts of Gentiana macrophylla, 15-30 parts of cinnamon twig, 10-20 parts of Curcuma zedoaria, 10-20 parts of Trillium, and 15-30 parts of Notopterygium wilfordii. The external Chinese medicine composition of the invention can effectively prevent and treat knee osteoarthritis, with a total effective rate of 82.14%. The above-disclosed prescription has a large number of medicinal ingredients, which increases the procedure for drug preparation and is relatively cumbersome. It also has the disadvantages of being difficult to obtain materials, expensive, and having no significant efficacy. It is necessary to develop a drug for preventing and treating knee osteoarthritis with a moderate number of medicinal ingredients, clear therapeutic effects, and easy preparation. However, there is no report on a Chinese medicine composition for treating knee osteoarthritis and its application as the present invention. Summary of the invention

[0006] The first object of the present invention is to provide a Chinese medicine composition for treating knee osteoarthritis in view of the deficiencies in the prior art.

[0007] The second object of the present invention is to provide an application of a Chinese medicine composition.

[0008] To achieve the above first purpose, the technical solution adopted by the present invention is:

[0009] A traditional Chinese medicine composition for treating knee osteoarthritis is prepared from the following raw materials in parts by weight: 6-14 parts of angelica sinensis, 6-14 parts of cyathula, 2-10 parts of polygonum cuspidatum, 6-14 parts of lycopodiella ciliata, 2-10 parts of safflower, 2-10 parts of perilla bark, 2-10 parts of sappan wood, 6-14 parts of millettia spatholobi, 6-14 parts of wormwood, and 2-10 parts of Zanthoxylum bungeanum.

[0010] As a preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 8-12 parts of Angelica sinensis, 8-12 parts of Cyathula capitata, 4-8 parts of Polygonum cuspidatum, 8-12 parts of Lycopodiella cuneata, 4-8 parts of Carthamus tinctorius, 4-8 parts of Perennial Perilla frutescens, 4-8 parts of Sappan wood, 8-12 parts of Millettia spatholobi, 8-12 parts of Artemisia argyi, and 4-8 parts of Zanthoxylum bungeanum.

[0011] More preferably, the Chinese medicine composition is made of the following raw materials in parts by weight: 10 parts of Angelica sinensis, 10 parts of Cyathula capitata, 6 parts of Polygonum cuspidatum, 10 parts of Lycopodiella cuneata, 6 parts of Carthamus tinctorius, 6 parts of Perennial Perilla frutescens, 6 parts of Sappan wood, 10 parts of Millettia spatholobi, 10 parts of Artemisia argyi, and 6 parts of Zanthoxylum bungeanum.

[0012] More preferably, the Chinese medicine composition is a Chinese medicine composition for external use.

[0013] More preferably, the external Chinese medicine composition is a foot bath Chinese medicine composition.

[0014] More preferably, the method of using the foot bath Chinese medicine composition is: weigh each raw material medicine according to the weight ratio, boil for half an hour, then add warm water, soak the feet once a day, each time for 20-30 minutes.

[0015] To achieve the above second purpose, the technical solution adopted by the present invention is:

[0016] Use of any of the above-mentioned Chinese medicine compositions in the preparation of a drug for treating knee osteoarthritis.

[0017] As a preferred example, the syndrome of knee osteoarthritis is cold-dampness arthralgia syndrome or liver-kidney deficiency syndrome.

[0018] The compatibility relationship of the Chinese medicine composition of the present invention is:

[0019] Main drugs: Chinese angelica and spatholobi. Chinese angelica is good at promoting blood circulation and replenishing blood, relieving pain and regulating menstruation. Spatholobi has the effects of reducing swelling and relieving pain, removing dampness and expelling wind, and unblocking meridians and relaxing muscles. Assistant drugs: Cyathula officinalis, safflower, Perilla frutescens and Millettia reticulata. Cyathula officinalis and Perilla frutescens can remove dampness and promote blood circulation, nourish the liver and kidney and strengthen tendons and bones. Safflower can promote blood circulation, remove blood stasis and relieve pain. Millettia reticulata can promote blood circulation and nourish blood, unblock meridians and relax muscles. Polygonum cuspidatum and Sappan wood are adjuvant drugs. Polygonum cuspidatum can remove dampness and unblock meridians, and Sappan wood can regulate qi and unblock meridians. Artemisia argyi and Zanthoxylum bungeanum are guiding drugs, which warm the meridians and promote blood circulation. The combination of these drugs has the effects of relaxing tendons and promoting blood circulation, reducing swelling and relieving pain, and unblocking joints. DETAILED DESCRIPTION

[0020] Below in conjunction with specific embodiment, further elaborate the present invention.It should be understood that these embodiments are only used to illustrate the present invention and are not used to limit the scope of the present invention.In addition, it should be understood that after reading the content of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope limited by the appended claims of the present application.If not specifically indicated, the technical means used in the embodiment are conventional means well known to those skilled in the art and commercially available common instruments and reagents, and references such as " Molecular Cloning Experiment Guide (3rd Edition) " (Science Press), " Microbiology Experiment (4th Edition) " (Higher Education Press) and the manufacturer's instructions of corresponding instruments and reagents can be found.

[0021] Example 1 Chinese medicine composition for treating knee osteoarthritis of the present invention (I)

[0022] 10 parts of Angelicae Sinensis, 10 parts of Cyathulae Bidentatae, 6 parts of Polygonum Cuspidati, 10 parts of Herba Lycopodii, 6 parts of Flos Carthami, 6 parts of Cortex Periplocae, 6 parts of Lignum Sappan, 10 parts of Caulis Spatholobi, 10 parts of Folium Artemisiae Argyi, 6 parts of Zanthoxylum bungeanum.

[0023] Example 2 Chinese medicine composition for treating knee osteoarthritis of the present invention (II)

[0024] 10 parts of Angelicae Sinensis, 8 parts of Cyathulae Bidentatae, 8 parts of Polygonum Cuspidati, 6 parts of Herba Lycopodii, 10 parts of Flos Carthami, 6 parts of Cortex Periplocae, 4 parts of Lignum Sappan, 12 parts of Caulis Spatholobi, 6 parts of Folium Artemisiae Argyi, and 10 parts of Zanthoxylum bungeanum.

[0025] Example 3 Chinese medicine composition for treating knee osteoarthritis of the present invention (III)

[0026] 8 parts of Angelicae Sinensis, 12 parts of Cyathulae Bidentatae, 2 parts of Polygonum Cuspidati, 14 parts of Herba Lycopodii, 6 parts of Flos Carthami, 4 parts of Cortex Periplocae, 8 parts of Lignum Sappan, 6 parts of Caulis Spatholobi, 14 parts of Folium Artemisiae Argyi, 6 parts of Zanthoxylum bungeanum.

[0027] Example 4 Chinese medicine composition for treating knee osteoarthritis of the present invention (IV)

[0028] 12 parts of Angelicae Sinensis, 6 parts of Cyathulae Bidentatae, 10 parts of Polygonum Cuspidati, 10 parts of Herba Lycopodii, 4 parts of Flos Carthami, 8 parts of Cortex Periplocae, 2 parts of Lignum Sappan, 14 parts of Caulis Spatholobi, 10 parts of Folium Artemisiae Argyi, 4 parts of Zanthoxylum bungeanum.

[0029] Example 5 Chinese medicine composition for treating knee osteoarthritis of the present invention (V)

[0030] 6 parts of Chinese Angelicae Sinensis, 14 parts of Cyathulae Bidentatae, 6 parts of Polygonum Cuspidati, 8 parts of Herba Lycopodii, 8 parts of Flos Carthami, 2 parts of Cortex Periplocae, 10 parts of Lignum Sappan, 10 parts of Caulis Spatholobi, 8 parts of Folium Artemisiae Argyi, 8 parts of Zanthoxylum bungeanum.

[0031] Example 6 Chinese medicine composition for treating knee osteoarthritis of the present invention (VI)

[0032] 14 parts of Angelicae Sinensis, 10 parts of Cyathulae Bidentatae, 4 parts of Polygonum Cuspidati, 12 parts of Herba Lycopodii, 2 parts of Flos Carthami, 10 parts of Cortex Periplocae, 6 parts of Lignum Sappan, 8 parts of Caulis Spatholobi, 12 parts of Folium Artemisiae Argyi, 2 parts of Zanthoxylum bungeanum.

[0033] Example 7 Chinese medicine composition for treating knee osteoarthritis of the present invention (VII)

[0034] 10 parts of Angelicae Sinensis, 12 parts of Cyathulae Bidentatae, 2 parts of Polygonum Cuspidati, 14 parts of Herba Lycopodii, 6 parts of Flos Carthami, 4 parts of Cortex Periplocae, 8 parts of Lignum Sappan, 6 parts of Caulis Spatholobi, 14 parts of Folium Artemisiae Argyi, 6 parts of Zanthoxylum bungeanum.

[0035] Example 8 Chinese medicine composition for treating knee osteoarthritis of the present invention (VIII)

[0036] 8 parts of Angelicae Sinensis, 6 parts of Cyathulae Bidentatae, 10 parts of Polygonum Cuspidati, 10 parts of Herba Lycopodii, 4 parts of Flos Carthami, 8 parts of Cortex Periplocae, 2 parts of Lignum Sappan, 14 parts of Caulis Spatholobi, 10 parts of Folium Artemisiae Argyi, 4 parts of Zanthoxylum bungeanum.

[0037] Example 9 Chinese medicine composition for treating knee osteoarthritis of the present invention (IX)

[0038] 12 parts of Angelicae Sinensis, 14 parts of Cyathulae Bidentatae, 6 parts of Polygonum Cuspidati, 8 parts of Herba Lycopodii, 8 parts of Flos Carthami, 2 parts of Cortex Periplocae, 10 parts of Lignum Sappan, 10 parts of Caulis Spatholobi, 8 parts of Folium Artemisiae Argyi, 8 parts of Zanthoxylum bungeanum.

[0039] Example 10 Chinese medicine composition for treating knee osteoarthritis of the present invention (ten)

[0040] 6 parts of Chinese Angelicae Sinensis, 10 parts of Cyathulae Bidentatae, 4 parts of Polygonum Cuspidati, 12 parts of Herba Lycopodii, 2 parts of Flos Carthami, 10 parts of Cortex Periplocae, 6 parts of Lignum Sappan, 8 parts of Caulis Spatholobi, 12 parts of Folium Artemisiae Argyi, 2 parts of Zanthoxylum bungeanum.

[0041] Example 11 Chinese medicine composition for treating knee osteoarthritis of the present invention (XI)

[0042] 14 parts of Angelicae Sinensis, 8 parts of Cyathulae Bidentatae, 8 parts of Polygonum Cuspidati, 6 parts of Herba Lycopodii, 10 parts of Flos Carthami, 6 parts of Cortex Periplocae, 4 parts of Lignum Sappan, 12 parts of Caulis Spatholobi, 6 parts of Folium Artemisiae Argyi, 10 parts of Zanthoxylum bungeanum.

[0043] Example 12 Preparation of a Chinese medicine composition for treating knee osteoarthritis of the present invention (XI)

[0044] Weigh the raw materials according to the weight ratio of any Chinese medicine composition in Examples 1-11, grind them and pass them through a 100-mesh sieve, pack them in seamless cloth bags, 1 bag per time, soak them in boiling water and use them for foot bath when the temperature is appropriate.

[0045] Example 13 Clinical efficacy experiment

[0046] 1 Clinical Data

[0047] 1.1 Case source

[0048] The cases observed in this study were all patients who visited the TCM Acupuncture and Traumatology Department and Acupuncture and Massage Department of Gonghe Xinlu Street Community Health Service Center.

[0049] 1.2 Diagnostic criteria

[0050] 1.2.1 Western medicine diagnostic criteria

[0051] According to the diagnostic criteria for knee osteoarthritis (KOA) in the Expert Consensus on Stepwise Treatment of Knee Osteoarthritis (2018 Edition): recurrent knee pain in the past month; X-rays (standing or weight-bearing position) showing narrowing of the joint space, subchondral bone sclerosis and (or) cystic changes, and osteophyte formation at the edge of the joint; slightly viscous joint fluid, clear color, and white blood cell count <2000 / mL; morning stiffness time ≤30 minutes; bone friction sound (feeling) during activity. Those who meet any 3 or more of the above items can be diagnosed with KOA.

[0052] 1.2.2 Standards for TCM Syndrome Differentiation

[0053] It complies with the diagnostic criteria for knee arthritis (cold-dampness arthritis or liver-kidney deficiency) in the "Expert Consensus on Diagnosis and Treatment of Knee Osteoarthritis in Traditional Chinese Medicine (2015 Edition)" and the "Clinical Diagnosis and Treatment Guidelines for Orthopedics in Traditional Chinese Medicine·Knee Arthritis (Knee Osteoarthritis)". Main symptoms: joint pain, weakness. Secondary symptoms: joint hypertrophy, limited movement, dizziness and tinnitus. Tongue and pulse: red tongue, little coating, deep, thin and weak pulse. Patients who meet the main symptoms and 2 or more secondary symptoms can be diagnosed by combining tongue and pulse.

[0054] 1.3 Inclusion criteria

[0055] Patients who meet the above-mentioned Chinese and Western medicine diagnostic criteria for knee osteoarthritis; aged 40-80 years old; have not taken non-steroidal anti-inflammatory drugs or Chinese herbal preparations with the same efficacy as therapeutic drugs within 7 days before treatment; patients and their families accept the treatment plan of this study and sign the informed consent form.

[0056] 1.4 Exclusion criteria

[0057] Patients with other bone and joint diseases; those with damaged or infected lower limbs who are not suitable for foot baths; those with contraindications to electroacupuncture therapy; those with severe organic diseases and mental and nervous system diseases; and those with hematopoietic dysfunction.

[0058] 1.5 Elimination criteria

[0059] Patients with poor compliance who stop treatment midway; patients with severe adverse reactions who are unable to continue the study;

[0060] Patients who voluntarily give up treatment due to personal reasons and cannot persist in treatment.

[0061] 1.6 Dropout Cases

[0062] (1) For subjects who withdraw from the trial due to adverse reactions, researchers should adopt appropriate response measures for the adverse reactions and record the adverse events in detail;

[0063] (2) For subjects who withdraw from the trial due to dissatisfaction with the treatment effect, the researchers will take appropriate compensatory treatment measures based on the actual situation;

[0064] (3) When a subject drops out, the researcher can contact the subject by phone, email, or home visit to ask for the reason, and complete the corresponding assessment items as much as possible;

[0065] (4) Fill in the “Summary of Treatment Completion” of the Case Report Form (CRF) and evaluate and analyze the patient’s compliance.

[0066] 2 Research Methods

[0067] 2.1 Grouping method

[0068] Thirty patients with knee osteoarthritis who met the inclusion criteria were randomly divided into an observation group and a control group. Simple randomization was used to generate random numbers using SPSS software, which were kept by a dedicated person. The random numbers were immediately obtained by phone, text message or E-mail according to the order of the patients' visits for treatment. The trial strictly included patients according to the random design sequence.

[0069] 2.2 Treatment methods

[0070] Control group: The 15 patients in this group took a sitting position, and the skin in the acupoint area was routinely disinfected and acupuncture was performed in sequence: Xuehai acupoint was pierced obliquely 1 inch, Liangqiu acupoint was pierced obliquely 1 inch, Neixiyan acupoint and Dubi acupoint were pierced inwardly obliquely 1 inch, Yinlingquan and Yanglingquan acupoints were pierced vertically 1-1.5 inches, and Zusanli acupoint was pierced vertically 1-1.5 inches; after acupuncture of all the acupoints, the method of equal tonification and equal drainage was used, and the modulated pulse continuous wave was selected using the G-6805 electroacupuncture instrument. The needles were removed after 30 minutes of needling, and the treatment was repeated once every other day.

[0071] Observation group: 15 patients in this group received Chinese medicine foot bath treatment on the basis of electroacupuncture treatment. Drug composition: 10g of Angelica sinensis, 10g of Cyathula officinalis, 6g of Polygonum cuspidatum, 10g of Lycopodiella ciliata, 6g of Carthamus tinctorius, 6g of Perennial Herb, 6g of Sappanwood, 10g of Millettia reticulata, 10g of Artemisia argyi, 6g of Zanthoxylum bungeanum, crushed and passed through a 100-mesh sieve, packed in a seamless bag, 1 bag / time, soaked in boiling water and then soaked in the foot bath when the temperature is appropriate, 20 minutes each time, once a day.

[0072] 2.3 Treatment options

[0073] Ten sessions constituted one course of treatment, and both groups received two courses of treatment in total.

[0074] 2.4 Evaluation Method

[0075] The control group was given single electroacupuncture treatment, and the observation group was given two courses of combined treatment with Chinese medicine foot bath on the basis of electroacupuncture treatment. The clinical efficacy, pain visual analogue score (VAS score), knee joint function score (HSS score) and other indicators were observed and evaluated before and 4 weeks after treatment between the two groups.

[0076] 2.5 Clinical observation indicators

[0077] 2.5.1 Basic Information

[0078] Thirty patients with knee osteoarthritis who were treated in our center from March 2023 to June 2023 were selected, including 12 male patients and 18 female patients, aged 36-80 years old, with an average age of (50.32±9.16) years; course of disease: 1.8-14.9 years, with an average course of disease of (8.82±1.73) years; lesion site: 13 patients were unilateral and 17 patients were bilateral. The above basic data were tested and there was no statistically significant difference between the control group and the observation group.

[0079] 2.5.2 Clinical efficacy evaluation

[0080] The efficacy standard refers to the evaluation standard of clinical efficacy of Chinese medicine for osteoarthritis in the "Guidelines for Clinical Research of New Chinese Medicines" and the "Guidelines for Diagnosis and Treatment of Osteoarthritis". Cured: pain and other symptoms disappear, joint movement is normal, and the score is reduced by ≥95%; markedly effective: pain and other symptoms disappear, joint movement is not restricted, and the score is reduced between 70% and 95%; effective: pain and other symptoms are basically eliminated, joint movement is partially restricted, and the score is reduced between 30% and 75%; ineffective: pain and other symptoms do not disappear, joint movement is restricted, and the score is reduced by less than 30%.

[0081] 2.5.3 Knee joint function score (HSS score)

[0082] The knee joint function of the two groups was evaluated before and 4 weeks after treatment, including six aspects: pain, function, joint mobility, muscle strength, knee flexion deformity, and knee instability. The higher the score, the better the recovery of knee joint function.

[0083] 2.5.4 Visual Analogue Scale (VAS) for Pain

[0084] Visual Analogue Scale (VAS) is the most commonly used method for detecting pain. In order to more intuitively and accurately record the knee pain of the subjects during the measurement, the subjects were asked to look at a scale marked with 0-10, where 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain, 7-9 represents severe pain, and 10 represents the most severe pain that is unbearable. The patients were asked to read the pain score at that time according to the intensity of their knee pain.

[0085] Improvement score = score before treatment - score after treatment

[0086] 2.6 Observation time and follow-up methods

[0087] The clinical efficacy, pain visual analogue score (VAS score), knee joint function score (HSS score) and other indicators were observed and evaluated by outpatient follow-up or telephone interview before and 4 weeks after treatment between the two groups.

[0088] 3 Statistical methods

[0089] SPSS23.0 statistical software was used for statistical analysis. The normality test was performed on the measurement data first. The data that met the normal distribution were expressed as mean ± standard deviation (x-±s), and those that did not meet the normal distribution were expressed as median (quartile) [Median (QL~QU)]. The two-sample t-test was used for inter-group comparison of those that met the normal distribution, and the paired t-test was used for intra-group comparison. Non-parametric tests were used for inter-group comparison of those that did not meet the normal distribution; count data were expressed as percentages, and count data were tested using the X2 test. P < 0.05 was considered statistically significant.

[0090] 4 Research results

[0091] 4.1 Clinical efficacy evaluation

[0092] The cure rate of the control group was 26.67% (4 / 15), the marked efficacy rate was 22.92% (5 / 15), the effective rate was 20.83% (3 / 15), the ineffective rate was 20.00% (3 / 15), and the total effective rate was 80%. The cure rate of the observation group was 53.33% (8 / 15), the marked efficacy rate was 33.33% (5 / 15), the effective rate was 6.67% (1 / 15), the ineffective rate was 6.67% (1 / 15), and the total effective rate was 93.33%. The differences between the groups were statistically significant by t test (P < 0.05).

[0093] 4.2 Knee function score

[0094] The knee joint function score of the control group was (66.68±12.95) points, and the knee joint function score of the observation group was (80.26±14.71) points. The difference between the two groups was statistically significant by t test (P<0.05).

[0095] 4.3 Visual analogue scale for pain

[0096] The VAS score of the control group was (2.37±1.26) points, and the VAS score of the observation group was (0.96±0.66) points. The difference between the two groups was statistically significant by t test (P<0.05).

[0097] The above is only a preferred embodiment of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention. These improvements and supplements should also be regarded as the scope of protection of the present invention.

Claims

1. Use of an external Chinese medicine composition in the preparation of a drug for treating knee osteoarthritis with cold-dampness arthralgia syndrome or liver-kidney deficiency syndrome, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 6-14 parts of angelica sinensis, 6-14 parts of cyathula, 2-10 parts of polygonum cuspidatum, 6-14 parts of lycopodiella ciliata, 2-10 parts of safflower, 2-10 parts of perilla bark, 2-10 parts of sappan wood, 6-14 parts of millettia reticulata, 6-14 parts of wormwood, and 2-10 parts of Zanthoxylum bungeanum.

2. The use according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 8-12 parts of angelica sinensis, 8-12 parts of cyathula, 4-8 parts of polygonum cuspidatum, 8-12 parts of lycopodiella ciliata, 4-8 parts of safflower, 4-8 parts of perilla bark, 4-8 parts of sappan wood, 8-12 parts of millettia reticulata, 8-12 parts of wormwood, and 4-8 parts of zanthoxylum bungeanum.

3. The use according to claim 2, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 parts of angelica sinensis, 10 parts of Cyathula capitata, 6 parts of Polygonum cuspidatum, 10 parts of Lycopodiella cuneata, 6 parts of Carthamus tinctorius, 6 parts of Perennial Perilla frutescens, 6 parts of Sappan wood, 10 parts of Millettia spatholobi, 10 parts of Artemisia argyi, and 6 parts of Zanthoxylum bungeanum.

4. The use according to any one of claims 1 to 3, characterized in that: The external Chinese medicine composition is a foot bath Chinese medicine composition.