A traditional Chinese medicine composition for treating knee synovitis and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating knee synovitis and a preparation method thereof, and particularly relates to the field of traditional Chinese medicines. The composition comprises a blood-activating and swelling-eliminating plaster and a qi-tonifying and swelling-eliminating soup. The blood-activating and swelling-eliminating plaster comprises angelica sinensis, ligusticum chuanxiong, red peony root, persicae semen, safflower, phellodendri cortex, raw olibanum, raw myrrh, dragon's blood, radix angelicae pubescentis, taraxacum, radix sanguisorbae, curcuma, raw rhubarb and mirabilite; and the qi-tonifying and swelling-eliminating soup comprises smilax glabra, atractylodes, coix seed, phellodendri cortex, radix cyathulae, motherwort, raw astragalus, alisma orientale, anemarrhena asphodeloides, psoralea, persicae semen, safflower and licorice. The research result of the blood-activating and swelling-eliminating plaster and the qi-tonifying and swelling-eliminating soup used in combination for treating knee synovitis has not only help to understand the action mechanism of the external treatment technology of traditional Chinese medicine, but also helps to develop a new treatment method with definite curative effect and no toxic side effect, and has remarkable social and economic benefits.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, specifically to a traditional Chinese medicine composition for treating knee synovitis and its preparation method. Background Technology

[0002] Knee synovitis (KC) is a common knee joint disease in clinical practice, characterized by aseptic inflammatory reactions with symptoms such as pain, swelling, increased local skin temperature, and limited mobility around the joint. Damp-heat obstruction is a common syndrome type of KC. It is usually caused by falls, sprains, prolonged strain, surgery, or other factors affecting the knee joint, leading to synovial membrane damage and a series of aseptic inflammatory reactions with symptoms such as pain, swelling, increased local skin temperature, and limited mobility around the joint. Studies show that the incidence of knee osteoarthritis increases with age, reaching 37.4% in people aged 60 and above. Approximately 90% of the 250 million people with knee osteoarthritis worldwide also have synovial inflammation. It generally includes two types: Type I: mainly affecting the elderly, often accompanied by knee osteoarthritis, primarily caused by joint degeneration and bone hyperplasia irritating surrounding soft tissues, leading to pathological changes such as synovial edema, effusion, and joint effusion. Type II: This type mostly affects young adults and is primarily caused by acute or chronic injuries. It often involves meniscus tears, collateral ligament injuries, or cruciate ligament injuries, with significant joint effusion. If acute traumatic synovitis of the knee is not treated promptly and effectively, a large proportion of patients will develop chronic synovitis, which is prone to recurrence and difficult to cure, affecting joint function and causing joint movement disorders, resulting in a huge burden on patients' lives and finances.

[0003] Currently, Western medicine primarily treats knee synovitis through topical medications, oral medications (non-steroidal anti-inflammatory drugs, antibiotics, etc.), intra-articular injections (sodium hyaluronate injection), ozone oxidation therapy, and aspiration of effusion and lavage. Surgical treatment is only considered if conservative treatment is ineffective or joint function is significantly impaired. However, surgical treatment is often less effective, carries complications such as joint infection, and is prone to recurrence. Western oral medications often have significant side effects; for example, non-steroidal anti-inflammatory drugs increase the risk of adverse cardiovascular events and affect gastrointestinal coagulation function, while also causing liver and kidney toxicity. With the continuous exploration of Traditional Chinese Medicine (TCM), numerous and effective methods for treating this disease have been discovered. These methods avoid the side effects of Western medicine and fully embody the characteristics of "inexpensive, simple, and efficient" TCM, gradually developing new treatment goals for this disease and showing broad clinical application prospects. Summary of the Invention

[0004] Therefore, the present invention provides a traditional Chinese medicine composition for treating knee synovitis and its preparation method, in order to solve the problems of poor efficacy and large side effects of existing treatments for knee synovitis.

[0005] Traditional Chinese medicine considers this disease to mainly fall under the categories of "Bi syndrome" and "muscle injury," and it is mostly related to insufficient vital energy, invasion of external pathogens, or stagnation of meridians. Insufficient vital energy is often due to deficiency of the liver, kidneys, and spleen; external pathogens are most commonly wind, cold, and dampness, while heat often combines with dampness to attack the joints; when vital energy is deficient, the circulation of qi and blood is insufficient, and when pathogens enter the meridians, blood stasis and qi stagnation occur, often resulting in symptoms of meridian deficiency or stagnation.

[0006] The Blood-Activating and Swelling-Reducing Plaster is a self-developed formula by the Department of Orthopedics and Traumatology of the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine, based on extensive clinical experience from renowned veteran TCM doctors in our hospital. The plaster is composed of Angelica sinensis, Ligusticum chuanxiong, Paeonia lactiflora, Prunus persica, Carthamus tinctorius, and Phellodendron chinense, among other ingredients. The combined effects of these herbs promote blood circulation, remove blood stasis, reduce swelling and relieve pain, and clear heat and dampness. Previous clinical applications have confirmed its certain anti-inflammatory and analgesic effects. However, effective evidence-based medical research is still lacking. This invention, using a randomized controlled trial, aims to observe the clinical efficacy of the Blood-Activating and Swelling-Reducing Plaster in treating knee osteoarthritis, thereby providing a reliable basis for its clinical promotion and further research.

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] According to one aspect of the present invention, a traditional Chinese medicine composition for treating knee synovitis is provided, the composition comprising a blood-activating and swelling-reducing ointment and a qi-tonifying and swelling-reducing decoction.

[0009] Furthermore, the blood-activating and swelling-reducing ointment includes Angelica sinensis, Ligusticum chuanxiong, Paeonia lactiflora, Prunus persica, Carthamus tinctorius, Phellodendron chinense, Boswellia carterii, Commiphora myrrha, Daemonorops draco, Angelica dahurica, Taraxacum mongolicum, Dipsacus asper, Curcuma longa, Rheum palmatum, and

[0010] Furthermore, the blood-activating and swelling-reducing ointment comprises 20-30 parts of Angelica sinensis, 15-20 parts of Ligusticum chuanxiong, 20-30 parts of Paeonia lactiflora, 20-30 parts of Prunus persica, 20-30 parts of Carthamus tinctorius, 30-40 parts of Phellodendron chinense, 10-15 parts of Boswellia carterii, 10-15 parts of Commiphora myrrha, 10-15 parts of Daemonorops draco, 10-15 parts of Angelica dahurica, 10-15 parts of Taraxacum mongolicum, 10-20 parts of Dipsacus asper, 10-15 parts of Curcuma longa, 20-30 parts of Rheum palmatum, and 10-15 parts of Glauber's salt.

[0011] Furthermore, the blood-activating and swelling-reducing ointment comprises 20 parts of Angelica sinensis, 20 parts of Ligusticum chuanxiong, 20 parts of Paeonia lactiflora, 20 parts of Prunus persica, 20 parts of Carthamus tinctorius, 30 parts of Phellodendron chinense, 10 parts of raw Boswellia carterii, 10 parts of raw Commiphora myrrha, 10 parts of Dracaena cochinchinensis, 10 parts of Angelica dahurica, 10 parts of Taraxacum mongolicum, 10 parts of Dipsacus asper, 10 parts of Curcuma longa, 20 parts of raw Rheum palmatum, and 10 parts of Glauber's salt.

[0012] Furthermore, the Qi-boosting and swelling-reducing decoction includes Smilax glabra, Atractylodes lancea, Coix lacryma-jobi, Phellodendron chinense, Achyranthes bidentata, Leonurus japonicus, Astragalus membranaceus, Dioscorea hypoglauca, Anemarrhena asphodeloides, Lycium chinense root bark, Prunus persica, Carthamus tinctorius, and Glycyrrhiza uralensis.

[0013] Furthermore, the Qi-boosting and swelling-reducing decoction comprises 20-30 parts of Smilax glabra, 10-15 parts of Atractylodes lancea, 20-30 parts of Coix lacryma-jobi, 10-15 parts of Phellodendron chinense, 15-20 parts of Achyranthes bidentata, 20-30 parts of Leonurus japonicus, 20-50 parts of Astragalus membranaceus, 15-20 parts of Dioscorea hypoglauca, 10-15 parts of Anemarrhena asphodeloides, 10-15 parts of Lycium chinense root bark, 10-15 parts of Prunus persica, 10-15 parts of Carthamus tinctorius, and 6-9 parts of Glycyrrhiza uralensis.

[0014] Furthermore, the Qi-boosting and swelling-reducing decoction comprises 25 parts of Smilax glabra, 15 parts of Atractylodes lancea, 20 parts of Coix lacryma-jobi, 10 parts of Phellodendron chinense, 15 parts of Achyranthes bidentata, 20 parts of Leonurus japonicus, 20 parts of Astragalus membranaceus, 20 parts of Dioscorea hypoglauca, 10 parts of Anemarrhena asphodeloides, 10 parts of Lycium chinense root bark, 12 parts of Prunus persica, 12 parts of Carthamus tinctorius, and 9 parts of Glycyrrhiza uralensis.

[0015] According to another aspect of the present invention, a method for preparing a traditional Chinese medicine composition for treating knee synovitis includes:

[0016] Step 1: Preparation of the blood-activating and swelling-reducing ointment

[0017] Weigh the ingredients for the blood-activating and swelling-reducing ointment according to the proportion, grind them into powder, mix the medicine with honey until it becomes a viscous state, and take a blank medical dressing to make an ointment.

[0018] Step 2: Preparation of Qi-Boosting and Swelling-Reducing Decoction

[0019] Weigh out the ingredients for the Qi-Boosting and Swelling-Reducing Decoction according to the specified proportions, and decoct them in water to obtain the Qi-Boosting and Swelling-Reducing Decoction liquid.

[0020] The present invention has the following advantages:

[0021] The traditional Chinese medicine composition of the present invention is based on the external application of the blood-activating and swelling-reducing ointment and combined with the TCM syndrome differentiation and treatment. By using the blood-activating and swelling-reducing ointment externally in combination with the qi-tonifying and swelling-reducing decoction to treat the damp-heat obstruction type of knee synovitis, better clinical efficacy is achieved for patients with the most common damp-heat obstruction type of KC.

[0022] The research findings of this invention on the external application of the blood-activating and swelling-reducing ointment combined with the qi-tonifying and swelling-reducing decoction for the treatment of knee synovitis not only help to understand the mechanism of action of traditional Chinese medicine external treatment techniques, but also help to develop new treatment methods with definite efficacy and no toxic side effects, with significant social and economic benefits.

[0023] This invention utilizes a topical blood-activating and swelling-reducing ointment combined with a qi-tonifying and swelling-reducing decoction to treat knee synovitis of the damp-heat obstruction type. Internally, it clears heat and removes dampness; externally, it activates blood circulation, reduces swelling, and relieves pain, treating the lesions and congestion points around the knee joint, effectively alleviating clinical symptoms such as joint swelling, pain, and limited mobility. This combined treatment for knee synovitis is simple, safe, reliable, economical, and practical. It also contributes to the development of new treatment methods with definite efficacy and no toxic side effects, demonstrating significant social and economic benefits. This method possesses a certain degree of innovation and advancement, exhibiting unique technical characteristics specific to orthopedics. It is particularly suitable for treating patients with early to mid-stage knee synovitis, providing a safe, convenient, inexpensive, and consistently effective treatment approach for knee synovitis. Detailed Implementation

[0024] 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.

[0025] 1. Mechanism of application of plaster

[0026] Ointments are viscous, semi-solid or semi-fluid substances prepared through boiling, and are one of the five major dosage forms in traditional Chinese medicine (pills, powders, ointments, elixirs, and decoctions). Their mechanisms of action have been discussed by physicians throughout history. Xu Dachun stated that ointments can be used to treat external ailments, such as expelling pus and necrotic tissue, relieving pain, promoting tissue regeneration, and protecting the flesh from wind; these ointments should be thin and changed daily. Ointments can also be used to treat internal ailments, such as dispelling wind and cold, harmonizing qi and blood, eliminating phlegm, or strengthening muscles and bones; the dosage should be adjusted according to the disease, and these ointments should be thick and applied for a long time. Wu Shangxian summarized this as "drawing out the disease and cutting off the evil." Professor Zhang Qiwen, a renowned modern TCM expert, in his book *Chinese Ointment Therapy*, believes that ointments act in two ways: first, through skin application to the internal organs, possibly by inducing activity in the endocrine, enzyme, and immune systems through the nervous system, or by reaching the affected organs through the subcutaneous lymphatic cavity, capillaries, arteries, and veins; second, through skin application to the local area, directly acting on the diseased skin tissue. Based on previous research, it is generally believed that the effects of medicated plasters are mainly related to transdermal drug absorption, the theory of meridians and acupoints, and the balance of three micro-adjustments ("micro-effects," "micro-stimulation," and "micro-absorption"). By penetrating from the skin and flesh to the muscles and bones, from the inside out, it reduces edema and inflammation, relieves pain, and promotes the recovery of joint function and mobility. Drugs absorbed in this way avoid the first-pass effect, reducing the toxic side effects of the drugs. It has the advantages of long-lasting and stable efficacy, convenient use, and the ability to discontinue use at any time.

[0027] 2. Analysis of the prescription and medication of the blood-activating and swelling-reducing ointment

[0028] The efficacy of this prescription is to promote blood circulation, remove blood stasis, promote diuresis and unblock the meridians, and clear heat and dampness.

[0029] Fang Yi's analysis: This formula uses Phellodendron bark and Angelica sinensis as the principal herbs. Phellodendron bark is bitter and cold in nature, and has the effects of clearing heat and drying dampness, purging fire and detoxifying, and eliminating bone steaming. The *Zhenzhu Nang* states: "Phellodendron bark has six uses: first, to purge bladder fire; second, to relieve urinary retention; third, to eliminate lower abdominal swelling; fourth, to treat dysentery with initial bleeding; fifth, to treat umbilical pain; and sixth, to tonify kidney deficiency and strengthen bone marrow." Angelica sinensis is pungent, warm, and invigorating, and is good at promoting blood circulation and relieving pain. The *Yixue Qiyuan* states: "Angelica sinensis is warm in nature and sweet in taste, and can harmonize and nourish blood; its tail breaks up blood stasis, and its body harmonizes blood." The combination of Phellodendron bark and Angelica sinensis clears heat, removes dampness, invigorates blood, and reduces swelling, thus making them the principal herbs in this formula.

[0030] Peach kernel, safflower, and chuanxiong are the assistant herbs, all of which can invigorate blood and reduce swelling. Peach kernel and safflower are both blood-activating and stasis-removing herbs, and are often used together. Peach kernel combined with safflower: Peach kernel is heavy and descending, tending towards the interior of the body and the lower burner, excelling at breaking up blood stasis in the internal organs; safflower is light and ascending, reaching the exterior and upper parts of the body, clearing the meridians and collaterals, excelling at removing blood stasis in the meridians and upper parts of the body. The combined use of these two herbs enhances their effects of invigorating blood, clearing the meridians, removing stasis, promoting new blood production, reducing swelling, and relieving pain. The *Compendium of Materia Medica* states: "Chuanxiong is pungent and warm in nature; when used in blood-activating herbs, it can help blood circulation." Peach kernel, safflower, and chuanxiong, when used together, invigorate blood, relieve pain, clear the meridians, and reduce swelling, thus serving as the assistant herbs in this formula.

[0031] Red peony root, raw frankincense, raw myrrh, dragon's blood, angelica root, dandelion, Sichuan teasel root, turmeric, raw rhubarb, and mirabilite are used as adjuvants in this prescription. Rhubarb clears heat, promotes qi circulation, and regulates menstruation. The *Pharmacopoeia* states, "It treats chills and fever, aids digestion, nourishes the five internal organs, regulates menstruation in women, and relieves edema." Angelica root removes dampness and relieves pain, "It treats wind-related ailments throughout the body, and pain and numbness in the joints." Dandelion clears heat and detoxifies, and also reduces swelling. The *Correct Interpretation of Materia Medica* states, "Dandelion is cool in nature and treats all kinds of sores, carbuncles, redness, swelling, and heat toxicity; it can be taken orally or applied topically." Red peony root is bitter and slightly cold in nature, entering the liver meridian. It has the effects of clearing heat and cooling blood, promoting blood circulation, and removing blood stasis. The *Collection of Materia Medica* states, "Frankincense is an essential medicine for promoting blood circulation, dispelling wind, relaxing muscles, and relieving pain... It is also used for falls, fights, and injuries to muscles and bones." The Compendium of Materia Medica states: "It disperses blood stasis, reduces swelling, relieves pain, and promotes tissue regeneration." Frankincense invigorates blood, and myrrh disperses blood stasis; both can relieve pain, reduce swelling, and promote tissue regeneration, hence these two herbs are often used together. Therefore, frankincense and myrrh assist the formula in invigorating blood, relieving pain, and reducing swelling; Dipsacus asperoides promotes tendon regeneration, blood circulation, and tonifies the liver and kidneys; turmeric and Glauber's salt break up blood stasis and can also reduce swelling and heal sores; and dragon's blood is used externally to reduce carbuncles and boils.

[0032] 3. Modern pharmacological research

[0033] As an empirical prescription of the Orthopedics Department of the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine, Huoxue Xiaozhong Plaster has been clinically applied for more than ten years. Previous clinical studies have confirmed its good effects in detumescence and pain relief. There have also been many reports on the pharmacological studies of the single herbs in the composition of Huoxue Xiaozhong Plaster. Frankincense has the effect of eliminating tissue edema. Red peony root and rhubarb can inhibit platelet aggregation, and have anti-inflammatory and analgesic effects. Ferulic acid contained in Angelica sinensis can effectively inhibit thrombus formation and platelet aggregation. Frankincense and myrrh have certain anti-inflammatory, analgesic and detumescence effects. Angelica dahurica may exert analgesic effects through monoamine neurotransmitters in the brain, and at the same time has the effect of improving blood circulation. Prunin A and Prunin B in the extract of Prunus persica have obvious inhibitory effects on the hyperfunction of vascular permeability caused by inflammation, and have certain anti-inflammatory effects. The main component of safflower is safflower yellow pigment, and its good anti-inflammatory and analgesic effects may be related to its ability to reduce prostaglandin E2 in joint fluid.

[0034] Thus, whether in the selection and use of prescriptions in traditional Chinese medicine or in the modern pharmacological studies of Western medicine, it has been confirmed that Huoxue Xiaozhong Plaster has good effects in promoting blood circulation to remove stasis, promoting diuresis and dredging collaterals, clearing heat and removing dampness, so as to exert good effects in detumescence, anti-inflammation and analgesia. However, due to the complex composition of the plaster, direct contact with the skin, and poor air permeability caused by the fixation of external accessories, skin allergy is its most common adverse reaction. Some scholars have summarized the 50 most common traditional Chinese medicines that are likely to cause skin adverse reactions. Among them, Angelica dahurica, safflower, etc. are included. However, it cannot be considered unilaterally. What reactions occur between drugs during the co-use of many drugs should also be studied in depth and meticulously. If its adverse reactions can be reduced, it will greatly promote the clinical promotion of Huoxue Xiaozhong Plaster.

[0035] 4. The efficacy of Yiqi Xiaozhong Decoction: clearing heat and removing dampness, supplementing qi and promoting diuresis.

[0036] This prescription is composed of Rhizoma Atractylodis, Cortex Phellodendri, Radix Cyathulae, Semen Coicis, Smilax glabra, Leonurus japonicus, Astragalus membranaceus, Dioscorea septemloba, Anemarrhena asphodeloides, Cortex Lycii, Prunus persica, Carthamus tinctorius, and Glycyrrhiza uralensis on the basis of Sini Powder.

[0037] Fang Yi's analysis: In the Yi Qi Xiao Zhong Tang (Invigorating Qi and Reducing Swelling Decoction), Phellodendron bark has the effects of clearing heat and detoxifying, drying dampness and promoting urination, and is good at treating damp-heat in the lower burner; Atractylodes lancea dries dampness and strengthens the spleen, promoting the elimination of dampness and turbidity, so that when dampness is eliminated, heat has nowhere to attach; Coix seed strengthens the spleen, eliminates dampness, and reduces swelling; Achyranthes bidentata invigorates blood, removes blood stasis, and guides the medicine downwards. Targeting the swelling and pain characteristics of KS damp-heat obstruction type patients, Smilax glabra is added to clear heat and detoxify, remove dampness, and benefit the joints; Dioscorea hypoglauca promotes diuresis, removes turbidity, dispels wind, and eliminates obstruction, working together with Smilax glabra to benefit the joints and remove dampness from the knees; Astragalus membranaceus and Leonurus japonicus tonify the middle burner, replenish qi, promote diuresis, and reduce swelling; if heat is not eliminated, it can deplete yin fluids, leading to thick blood, so Anemarrhena asphodeloides and Lycium chinense root bark work together to nourish yin, moisten dryness, cool the blood, and eliminate steaming; Prunus persica and Carthamus tinctorius are good at draining blood stasis, have strong blood-stasis-dispersing power, and can promote metabolism; Glycyrrhiza uralensis is neutral in taste and harmonizes all the medicines. The formula contains Phellodendron bark, which is bitter and cold in nature, and can clear heat and dry dampness, purge fire and eliminate steaming. It is good at treating damp-heat in the lower burner. Modern research shows that Phellodendron bark contains a large number of alkaloid components (including fangchiine, berberine, baicalein, limonene, berberine, etc.), among which berberine and limonene have the most obvious antibacterial and anti-inflammatory effects. Zhang Li found that Phellodendron bark and its compound extracts have a significant inhibitory effect on Escherichia coli and optimize the balance of the intestinal microecology in mice. Achyranthes bidentata is sweet in nature and has the effects of promoting blood circulation, removing blood stasis, nourishing the liver and kidneys. It also guides the medicine downward, which can make the medicine accumulate in the knee joint to enhance the therapeutic effect. The main components of Achyranthes bidentata are sterones, polysaccharides, saponins, etc., which can enhance the body's immunity and improve microcirculation. Achyranthes bidentata can reduce the blood viscosity of rats and promote blood circulation, which is consistent with the blood-activating effect of Achyranthes bidentata. In addition, Achyranthes bidentata can change the activity of various enzymes in cartilage tissue, increase the expression of type II collagen and growth factor, and protect cartilage tissue. The main component of licorice, isoliquiritin, has a significant anti-inflammatory effect. It can inhibit NF-κBp65 and AP-1, and reduce inflammation of macrophages.

[0038] The pathogenesis of knee synovitis is complex and not fully understood. It is generally believed that acute injury or chronic strain is the main initiating factor. On the one hand, it can cause synovial damage and rupture, leading to knee joint effusion and hemarthrosis; on the other hand, it can damage articular cartilage, activating synovial cells through cartilage degradation products, prompting them to release a large number of inflammatory factors, further promoting articular cartilage damage, forming a "synovium-articular cartilage" inflammatory cascade, resulting in a persistent non-infectious synovial inflammatory response. After the synovial inflammatory response occurs, peripheral immune cells migrate and infiltrate the diseased synovial tissue, exacerbating the local inflammatory response.

[0039] The formula for Yiqi Xiaozhong Decoction was developed by the inventor based on more than ten years of clinical experience and was derived from Simiao Powder with added ingredients. Simiao Powder originated from Zhang Bingcheng's "Chengfangbian Du" in the Qing Dynasty and was derived from Cangzhu Powder in Wei Yilin's "Shiyi Dexiao Fang" in the Yuan Dynasty with added ingredients. Hu Hua et al. randomly divided 135 patients with knee synovitis of the damp-heat obstruction type into two groups after joint aspiration of effusion. The observation group was given a modified Simiao Powder orally (Atractylodes lancea 15g, Phellodendron chinense 15g, Achyranthes bidentata 15g, Coix lacryma-jobi 30g, Lycopus lucidus 15g, Plantago asiatica 15g, Dioscorea hypoglauca 15g, Smilax glabra 30g, Chaenomeles speciosa 30g, Clematis chinensis 15g, Sappanwood 15g, Boswellia carterii 10g, Commiphora myrrha 10g, Glycyrrhiza uralensis 5g). The control group was given aceclofenac sustained-release tablets. After four weeks of treatment, it was found that the observation group could effectively inhibit the levels of IL-1β, IL-6, TNF-α and hs-CRP in the joint fluid. The pain, swelling and joint function scores were better than those in the control group. This suggests that Simiao Powder can inhibit the expression of pro-inflammatory factors in KS joint fluid, reduce neuropeptide levels and alleviate the inflammatory response of the knee joint synovium. Liu Han's experiment showed that Simiao Powder had a significant inhibitory effect on the levels of various inflammatory factors (TNF-α, IL-1β, IL-6) in the joint fluid of the affected knee and various pain mediators (PGE2, NO, 5-HT) in the serum.

[0040] (1) The Qi-invigorating and swelling-reducing decoction selected in this invention is a commonly used clinical formula that has been used in clinical practice for more than ten years. It has a definite curative effect in eliminating the main symptoms of KC patients, improving joint function, and improving the quality of life of patients. It has been well received by patients and has laid a solid clinical foundation for this invention.

[0041] (2) Preliminary clinical studies have confirmed that the topical blood-activating and swelling-reducing ointment has good clinical efficacy for KC. The ointment treatment for KC based on the theory of syndrome differentiation in traditional Chinese medicine is in line with the basic principles of traditional Chinese medicine, and the selected experimental indicators are consistent with the understanding of KC in modern medicine.

[0042] (3) The project leader of this invention, Associate Chief Physician Kang Junfeng, and the members of the research group have long been engaged in the clinical treatment of knee synovitis and have a good foundation in traditional Chinese medicine. They have found research entry points from the theoretical thinking of traditional Chinese medicine and the external treatment methods of traditional Chinese medicine, and combined with modern advanced clinical efficacy evaluation methods, which have provided a certain theoretical basis and clinical support for this invention.

[0043] (4) This invention relies on the Department of Orthopedics and Traumatology of the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine and the Department of Orthopedics and Traumatology of Shanxi University of Traditional Chinese Medicine, which can provide the technology and diagnostic and treatment equipment required for the project experiments, providing hardware support for the smooth progress of the project. Our department has been using the blood-activating and swelling-reducing plaster to treat knee synovitis for many years. We are skilled in the production and use of the plaster, and treat about 2,000 patients with knee synovitis annually, with a total effective rate of over 90%. This can provide sufficient case sources and scientific and technical support for the implementation of this project.

[0044] (5) The Affiliated Hospital of Shanxi University of Traditional Chinese Medicine is a provincial-level medical institution that integrates medical treatment, teaching and research. It has good clinical and basic research capabilities and rich scientific research experience, and has strong scientific research strength.

[0045] Example 1

[0046] This embodiment provides a traditional Chinese medicine composition for treating knee synovitis:

[0047] The ingredients of this blood-activating and swelling-reducing plaster are: Angelica sinensis 20g, Ligusticum chuanxiong 20g, Paeonia lactiflora 20g, Prunus persica 20g, Carthamus tinctorius 20g, Phellodendron chinense 30g, Boswellia carterii 10g, Commiphora myrrha 10g, Dracaena cochinchinensis 10g, Angelica dahurica 10g, Taraxacum mongolicum 10g, Dipsacus asper 10g, Curcuma longa 10g, Rheum palmatum 20g, and Glauber's salt 10g. Usage: Grind the ingredients into powder, mix with honey to form a thick paste, take a blank medical dressing to make a plaster, and then apply it externally to the affected area twice a day, with a 4-hour interval, each time for 4 hours.

[0048] The formula for Yiqi Xiaozhong Decoction for knee synovitis consists of: Smilax glabra 25g, Atractylodes lancea 15g, Coix lacryma-jobi 20g, Phellodendron chinense 10g, Achyranthes bidentata 15g, Leonurus japonicus 20g, Astragalus membranaceus 20g, Dioscorea hypoglauca 20g, Anemarrhena asphodeloides 10g, Lycium chinense 10g, Prunus persica 12g, Carthamus tinctorius 12g, and Glycyrrhiza uralensis 9g. Usage: All herbs are sourced from the pharmacy of the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine and prepared and packaged according to standardized procedures. One dose is given daily, divided into two packets, each approximately 150ml, taken warm half an hour after breakfast and dinner.

[0049] Example 2

[0050] This embodiment provides a traditional Chinese medicine composition for treating knee synovitis:

[0051] Composition of the Blood-Activating and Swelling-Reducing Ointment: Angelica sinensis 20 parts, Ligusticum chuanxiong 15 parts, Paeonia lactiflora 20 parts, Prunus persica 20 parts, Carthamus tinctorius 20 parts, Phellodendron chinense 30 parts, Boswellia carterii 10 parts, Commiphora myrrha 10 parts, Daemonorops draco 10 parts, Angelica dahurica 10 parts, Taraxacum mongolicum 10 parts, Dipsacus asper 10 parts, Curcuma longa 10 parts, Rheum palmatum 20 parts, and Glauber's salt 10 parts. Usage: Grind into powder, mix with honey to form a viscous consistency, and use a blank medical dressing to make an ointment.

[0052] The formula for Yiqi Xiaozhong Decoction for knee synovitis consists of: 20 parts Smilax glabra, 10 parts Atractylodes lancea, 20 parts Coix lacryma-jobi, 10 parts Phellodendron chinense, 15 parts Achyranthes bidentata, 20 parts Leonurus japonicus, 20 parts Astragalus membranaceus, 15 parts Dioscorea hypoglauca, 10 parts Anemarrhena asphodeloides, 10 parts Lycium chinense root bark, 10 parts Prunus persica, 10 parts Carthamus tinctorius, and 6 parts Glycyrrhiza uralensis. Usage: All herbs are sourced from the pharmacy of the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine and are prepared and packaged according to standardized procedures by the decoction room.

[0053] Example 3

[0054] This embodiment provides a traditional Chinese medicine composition for treating knee synovitis:

[0055] Composition of the Blood-Activating and Swelling-Reducing Ointment: Angelica sinensis 30 parts, Ligusticum chuanxiong 20 parts, Paeonia lactiflora 30 parts, Prunus persica 30 parts, Carthamus tinctorius 30 parts, Phellodendron chinense 40 parts, Boswellia carterii 15 parts, Commiphora myrrha 15 parts, Daemonorops draco 15 parts, Angelica dahurica 15 parts, Taraxacum mongolicum 15 parts, Dipsacus asper 20 parts, Curcuma longa 15 parts, Rheum palmatum 30 parts, Glauber's salt 15 parts. Usage: Grind into powder, mix with honey to form a viscous consistency, and use a blank medical dressing to make an ointment.

[0056] The formula for Yiqi Xiaozhong Decoction for knee synovitis consists of: Smilax glabra 25 parts, Atractylodes lancea 15 parts, Coix lacryma-jobi 20 parts, Phellodendron chinense 10 parts, Achyranthes bidentata 15 parts, Leonurus japonicus 20 parts, Astragalus membranaceus 20 parts, Dioscorea hypoglauca 20 parts, Anemarrhena asphodeloides 10 parts, Lycium chinense 10 parts, Prunus persica 12 parts, Carthamus tinctorius 12 parts, and Glycyrrhiza uralensis 9 parts. Usage: All herbs are sourced from the pharmacy of the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine and are prepared and packaged according to standardized procedures by the decoction room.

[0057] Example 4

[0058] This embodiment provides a traditional Chinese medicine composition for treating knee synovitis:

[0059] Composition of the Blood-Activating and Swelling-Reducing Ointment: Angelica sinensis 25 parts, Ligusticum chuanxiong 18 parts, Paeonia lactiflora 25 parts, Prunus persica 25 parts, Carthamus tinctorius 25 parts, Phellodendron chinense 35 parts, Boswellia carterii 12 parts, Commiphora myrrha 12 parts, Dracaena cochinchinensis 12 parts, Angelica dahurica 12 parts, Taraxacum mongolicum 12 parts, Dipsacus asper 15 parts, Curcuma longa 12 parts, Rheum palmatum 25 parts, Glauber's salt 12 parts. Usage: Grind into powder, mix with honey to form a viscous consistency, and use a blank medical dressing to make an ointment.

[0060] The formula for Yiqi Xiaozhong Decoction for knee synovitis consists of: Smilax glabra 25 parts, Atractylodes lancea 12 parts, Coix lacryma-jobi 25 parts, Phellodendron chinense 12 parts, Achyranthes bidentata 12 parts, Leonurus japonicus 25 parts, Astragalus membranaceus 35 parts, Dioscorea hypoglauca 18 parts, Anemarrhena asphodeloides 12 parts, Lycium chinense 12 parts, Prunus persica 12 parts, Carthamus tinctorius 12 parts, and Glycyrrhiza uralensis 7 parts. Usage: All herbs are sourced from the pharmacy of the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine and are prepared and packaged according to standardized procedures by the decoction room.

[0061] Experimental Example 1

[0062] This experiment demonstrates the use of a blood-activating and swelling-reducing plaster and a qi-tonifying and swelling-reducing decoction to treat knee synovitis.

[0063] I. Research Content

[0064] 1.1 Source of Cases

[0065] The subjects of this study were selected from patients with KC damp-heat obstruction type who visited the Department of Orthopedics and Traumatology of Shanxi University of Traditional Chinese Medicine. A total of 80 patients who met the criteria were included.

[0066] 1.2 Diagnostic criteria

[0067] 1) Western Medicine Diagnostic Criteria

[0068] According to the diagnostic criteria for knee synovitis in "Orthopedics".

[0069] ① Local swelling of the knee joint;

[0070] ② Knee pain, discomfort, or swelling;

[0071] ③ Acute onset;

[0072] ④ Age ≥ 20 years old to ≤ 70 years old;

[0073] ⑤ Limited extension or flexion of the knee joint;

[0074] ⑥ The skin temperature in some areas is slightly elevated, and a fluctuating sensation can be felt when pressed;

[0075] ⑦ The tender point is not fixed;

[0076] ⑧ A positive patellar tap test or MRI showing effusion in the knee joint;

[0077] ⑨ Muscle atrophy around the knee joint, especially the quadriceps femoris muscle;

[0078] ⑩ Joint aspiration fluid is yellow or pale yellow.

[0079] A diagnosis of knee synovitis can be made if both criteria ①②③ and any three of criteria ④~⑩ are met.

[0080] 2) Traditional Chinese Medicine Diagnostic Criteria

[0081] The TCM diagnosis meets the criteria for damp-heat obstruction type synovitis of the knee joint in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine".

[0082] Main symptoms:

[0083] ① Joint pain;

[0084] ② Joint swelling;

[0085] ③ Feeling of heaviness;

[0086] ④ Difficulty in bending and stretching;

[0087] ⑤ Difficulty walking.

[0088] Secondary symptoms:

[0089] ① The joint area is red or hot;

[0090] ②Irritability, thirst, loose or dry stools, and dark yellow urine;

[0091] ③ Red tongue with yellow coating, and a soft, rapid pulse.

[0092] A diagnosis can be made if the patient meets both of the main symptoms ① and ②, as well as one other main symptom and two secondary symptoms.

[0093] 3) Grading criteria for swelling in knee synovitis:

[0094] ① Severe swelling: The swelling is very obvious, the skin is tight, and the texture and bony anatomical landmarks are gone. The patellar tap test is strongly positive (+++) on physical examination. The circumference of the affected limb is more than 8 cm longer than that of the healthy side.

[0095] ② Moderate swelling: Significant swelling, altered or even absent skin texture, indistinct bony anatomical landmarks, and patellar tap test (++) on physical examination. The circumference of the affected limb is 4–8 cm longer than that of the healthy limb.

[0096] ③ Mild swelling: Skin texture is shallower than normal, bony anatomical landmarks are still obvious, and the patellar tap test is positive during physical examination. The circumference of the affected limb is 2-4 cm longer than that of the healthy side.

[0097] ④ No swelling: No swelling, patellar tap test (-). The circumference of the affected limb is less than 2 cm longer than that of the healthy limb.

[0098] 1.3 Inclusion Criteria

[0099] ① Patients who register and visit the orthopedic outpatient department of our hospital, aged between 20 and 79, regardless of gender;

[0100] ② Meets the diagnostic criteria for knee synovitis.

[0101] ③ Meets the above clinical diagnostic criteria for knee synovitis of the damp-heat obstruction type in traditional Chinese medicine.

[0102] ④ The patient has a good history of good health and no serious heart disease, diabetes, hypertension, cerebrovascular disease, or blood disorders.

[0103] ⑤ The patient had not received any treatment related to knee synovitis in the 3 weeks prior to the visit.

[0104] ⑥ 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.

[0105] 1.4 Exclusion Criteria

[0106] ① Patients who do not meet the above inclusion criteria.

[0107] ② Individuals with poor compliance due to mental illness or other reasons, or those with communication difficulties who cannot understand the scoring criteria.

[0108] ③Women who are pregnant or breastfeeding;

[0109] ④ Patients who are unable to take traditional Chinese medicine orally for various reasons.

[0110] ⑤ Those who, for various reasons, do not cooperate with the treatment and have not signed the "Informed Consent Form".

[0111] 1.5 Rejection Criteria

[0112] ① Patients who meet the exclusion criteria.

[0113] ② Patients who do not cooperate with data collection or treatment after the start of the experiment.

[0114] 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.

[0115] ④ Patients who experience drug allergies during treatment.

[0116] 1.6 Shedding Criteria

[0117] ① Patients who started experimental treatment but changed or added other treatment methods without authorization during the treatment.

[0118] ② Patients for whom the treatment method was definite, but who did not follow the experimenter's medical advice.

[0119] ③ Patients who had other diseases during the experiment and who took drugs that affected the determination of the efficacy of the experiment.

[0120] 1.7 Termination of Test Criteria

[0121] ① Patients who experience adverse reactions after taking oral Chinese medicine.

[0122] ②Those who drop out of treatment midway.

[0123] ③ Patients who develop urgent complications or other illnesses that prevent them from continuing the experiment.

[0124] ④ Patients who, despite signing informed consent, are unable to strictly comply with the experimental methods.

[0125] ⑤ Sample data that is missing or erroneous for various reasons.

[0126] 2 Research Methods

[0127] 2.1 Random Grouping

[0128] Eighty eligible KC patients were collected and numbered from 1 to 80 according to their order of visit. They were then randomly divided into a treatment group and a control group, with 40 patients in each group.

[0129] 2.2 Treatment methods

[0130] Control group 1:

[0131] ①. Rest is necessary during treatment, and heavy lifting should be minimized.

[0132] ②. During treatment, patients should perform muscle strengthening exercises such as quadriceps exercises daily.

[0133] ③. Example 1: Prepared external application of a blood-activating and swelling-reducing ointment (a preparation from our hospital's orthopedics department, containing: Angelica sinensis 20g, Ligusticum chuanxiong 20g, Paeonia lactiflora 20g, Prunus persica 20g, Carthamus tinctorius 20g, Phellodendron chinense 30g, Boswellia carterii 10g, Commiphora myrrha 10g, Dracaena cochinchinensis 10g, Angelica dahurica 10g, Taraxacum mongolicum 10g, Dipsacus asper 10g, Curcuma longa 10g, Rheum palmatum 20g, and Glauber's salt 10g; grind into powder, mix with honey to form a viscous consistency, take a blank medical dressing to make an ointment, and then apply it externally to the affected area). Use once daily for 14 consecutive days.

[0134] Control group 2:

[0135] ①. Rest is necessary during treatment, and heavy lifting should be minimized.

[0136] ②. During treatment, patients should perform muscle strengthening exercises such as quadriceps exercises daily.

[0137] ③. The oral Qi-boosting and swelling-reducing decoction prepared in Example 1 (containing 25g of Smilax glabra, 15g of Achyranthes bidentata, 20g of Leonurus japonicus, 20g of Astragalus membranaceus, 20g of Dioscorea hypoglauca, 15g of Atractylodes lancea, 20g of Coix lacryma-jobi, 10g of Phellodendron chinense, 10g of Anemarrhena asphodeloides, 10g of Lycium chinense root bark, 12g of Prunus persica, and 12g of Carthamus tinctorius; all Chinese herbs were sourced from the pharmacy of the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine and were prepared and packaged according to standardized procedures by the decoction room) is taken once daily, divided into two packets, each approximately 150ml, taken warm half an hour after breakfast and dinner. One course of treatment is 7 days, with continuous use for 14 days.

[0138] Treatment group:

[0139] ①. Rest is necessary during treatment, and heavy lifting should be minimized.

[0140] ②. During treatment, patients should perform muscle strengthening exercises such as quadriceps exercises daily.

[0141] ③. Oral administration of Qi-boosting and swelling-reducing decoction combined with external application of blood-activating and swelling-reducing ointment:

[0142] The blood-activating and swelling-reducing ointment prepared in Example 1 was applied externally once a day for 14 consecutive days.

[0143] The oral Qi-boosting and swelling-reducing decoction prepared in Example 1 is taken once daily, divided into two packets, each approximately 150ml, and taken warm half an hour after breakfast and dinner. One course of treatment is 7 days, and the decoction is taken continuously for 14 days.

[0144] Functional training:

[0145] ① Quadriceps contraction method: The patient lies supine with the affected knee straight and contracts the quadriceps muscle. ② Hip and knee flexion and extension method: The patient lies supine and alternately flexes the hip and knee to 90°, then gradually straightens them, resembling cycling. ③ Straight leg raise: The patient lies supine on the bed, flexes the knee and hip of the healthy side, dorsiflexes the ankle of the affected side, fully straightens the knee, raises the lower limb about 10cm, holds for 15 seconds, then slowly lowers it to the bed, repeats the above movements after 5 seconds. ④ Seated leg swing method: The patient sits with both lower limbs hanging off the edge of the bed and swings both lower limbs alternately, straightening the knee joint when dorsiflexing the ankle. Functional exercises begin on the same day after the first treatment, performed 3 times a day, 30 repetitions for each movement.

[0146] 2.3 Observation Indicators

[0147] 2.3.1 Swelling degree: Before treatment, after the treatment course (2 weeks later), and 1 month after the end of treatment, the circumference of the knee joint was measured with the knee extended. A measuring tape was used to measure the circumference at the superior border of the patella, the midpoint between the superior and inferior borders of the patella, and the inferior border of the patella. The plane enclosed by the measuring tape should be perpendicular to the longitudinal axis of the lower limb. The average of the three circumferences was taken.

[0148] 2.3.2 Pain scoring: Use a scoring ruler approximately 10cm long. Mark the scales on each scale, score the pain according to the patient's own perception, and record the score.

[0149] Visual analog scores (VAS) for pain

[0150] This is a pain intensity test form: a ruler approximately 10cm long with 10 markings, marked with "0" and "10" at each end. 0 indicates no pain; 1-3 indicates mild pain, tolerable; 4-6 indicates moderate pain, still tolerable, but affecting sleep; 7-9 indicates severe pain, severely affecting sleep; 10 indicates excruciating pain, unbearable. The numerical value represents the corresponding pain intensity. Please fill in the corresponding score in the table according to your pain experience.

[0151]

[0152] 2.3.3 Lysholms Knee Score: The Lysholms score includes eight items: limping, support, locking, stability, pain, swelling, stair climbing, and squatting. It is used to assess knee joint function; a higher score indicates better joint function, and vice versa. See Table 1 for details. The tester asks the patient detailed questions based on the indicators recorded on the Lysholms score and marks the scores in each column of the score sheet, recording the total score.

[0153] Table 1 Lysholms rating table

[0154]

[0155]

[0156] 2.3.4 TCM syndrome scoring: Before treatment, after treatment (14 days), and 1 month after the end of treatment, a TCM syndrome grading and quantification table was developed with reference to the relevant content in the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes", as shown in Table 2. The TCM syndrome status of the subjects was evaluated using the scoring method.

[0157] Table 2 Traditional Chinese Medicine Syndrome Scoring Table

[0158]

[0159]

[0160] 2.4 Evaluation of therapeutic effect

[0161] Clinical treatment efficacy was determined according to the standards outlined in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines".

[0162] Recovery: No pain or swelling, negative patellar tap test, and normal joint function;

[0163] Significant effect: Pain and swelling are significantly reduced, the patellar tap test is negative, and joint function has basically returned to normal;

[0164] Effective: Pain relief, swelling reduction, negative patellar tap test, and joint range of motion limitation reduced to less than half of the normal value;

[0165] Ineffective: No improvement in pain and swelling symptoms compared to before treatment, positive patellar tap test, and significantly limited joint movement.

[0166] Effective rate = (number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases × 100%.

[0167] 2.5 Detection Indicators ① Joint fluid was collected from the affected knee of all patients before treatment (DAY 1) and 2 weeks after treatment (DAY 14) for testing. The levels of TNF-α, IL-1β, and IL-6 in the joint fluid were detected using enzyme-linked immunosorbent assay (ELISA). ② The tibial angle was measured on anteroposterior X-ray films of the knee joint of all patients before treatment (DAY 1) and 2 weeks after treatment (DAY 14).

[0168] 2.6 Safety Standards

[0169] Safety testing includes: body temperature, pulse, respiration, blood pressure; liver function, kidney function; complete blood count; urinalysis; and stool analysis.

[0170] 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.

[0171] Level 1: No adverse reactions, safe.

[0172] Level 2: Relatively safe, with slight discomfort, but it does not affect continued treatment.

[0173] Grade 3: Adverse reactions occur; symptomatic treatment followed by continued treatment.

[0174] Grade 4: Serious adverse reactions occur, and the trial is discontinued.

[0175] 2.7 Data Processing Methods

[0176] SPSS 26.0 was used for database establishment, data entry, and statistical analysis. All continuous data were described statistically using X±S. Normality and homogeneity of variance tests were performed first. For data meeting normality and homogeneity of variance requirements, a two-sample t-test was used for between-group comparisons with a completely randomized design, and a paired t-test was used for within-group comparisons. Otherwise, a rank-sum test was used. Count data were expressed as rates or proportions and analyzed using the chi-square test. Ordinal data were analyzed using the rank-sum test. A p-value < 0.05 was considered statistically significant, and a p-value > 0.05 was considered not statistically significant.

[0177] 3 Results

[0178] 3.1 General Data Comparison

[0179] 3.1.1 Gender

[0180] This study included 88 patients with damp-heat obstruction type knee synovitis. Using a random number table, these patients were randomly divided into a treatment group and a control group, with 44 patients in each group. Two patients dropped out during the study: one in the treatment group (treatment interruption due to non-adherence to medication instructions) and one in the control group (discontinuation due to unauthorized use of other medications leading to data collection bias). Ultimately, 86 patients were included, with 43 in the treatment group and 43 in the control group.

[0181] The study included 86 patients, of whom 19 were male and 24 were female in the treatment group, and 16 were male and 27 were female in the control group. The gender composition of the two groups was qualitative data, and the chi-square test showed no statistical significance (P = 0.510 > 0.05). Therefore, there was no significant difference in gender between the two groups, making comparison meaningful. See Table 3 for details.

[0182] Table 3: Gender composition ratio of the two patient groups

[0183]

[0184] 3.1.2 Age

[0185] The ages of the two groups of patients ranged from 38 to 73 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 = 0.196 > 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 4 for details.

[0186] Table 4: Comparison of ages between the two groups of patients (years, )

[0187]

[0188] 3.1.3 Course of Disease

[0189] The shortest course of disease in the two groups of patients was two weeks, and the longest was seven months. Based on the results of normality and homogeneity of variance tests, a t-test was performed on the patient course data. The result was P = 0.859 > 0.05, indicating no statistical significance. This suggests that there was no difference in the course of disease between the two groups, and the comparison was meaningful. See Table 5 for details.

[0190] Table 5: Comparison of disease duration between the two groups (months, )

[0191]

[0192] 3.2 Comparison of Clinical Data

[0193] 3.2.1 Comparison of pain scores

[0194] 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 ranged from 3 to 9 (Z = -0.922, P = 0.356 > 0.05), showing no statistically significant difference, thus the VAS scores of the two groups were comparable. After treatment, Z = -5.210 (P = 0.000 < 0.05), showing a statistically significant difference, indicating that the treatment group showed more significant improvement in VAS scores than the control group. Within-group comparisons in the treatment group (Z = -5.749, P = 0.000) and the control group (Z = -5.739, P = 0.000) indicate that both groups improved patients' pain. See Table 6 for details.

[0195] Table 6: Comparison of pain scores before and after treatment (M(P25, P75))

[0196]

[0197]

[0198] 3.2.2 Comparison of swelling scores

[0199] Before treatment, the swelling scores of both groups of patients conformed to a normal distribution and homogeneity of variance. Using a t-test, t = 2.671, P = 0.154 > 0.05, indicating no statistically significant difference. Therefore, the swelling degree between the two groups before treatment was comparable. After treatment, the difference in swelling degree between the two groups conformed to a normal distribution but not homogeneity of variance. Using a t-test, t = 14.162, P = 0.000 < 0.005, indicating a statistically significant difference, suggesting that the treatment group was more effective in reducing knee swelling after treatment. Paired-samples t-tests were used for within-group comparisons. Within-group comparisons in the treatment group showed t = 60.446, P = 0.000, while within-group comparisons in the control group showed t = 72.473, P = 0.000, indicating that both treatment methods could reduce knee swelling. See Table 7 for details.

[0200] Table 7: Comparison of swelling scores before and after treatment (cm, )

[0201]

[0202] 3.2.3 Lysholms Comparison

[0203] Before treatment, the Lysholms scores of both groups followed a normal distribution but did not exhibit homogeneity of variance. Using a t-test, t = -0.682, P = 0.497 > 0.05, indicating no statistically significant difference between the two groups, suggesting a comparative significance between their Lysholms scores. After treatment, the Lysholms scores of both groups followed a normal distribution and exhibited homogeneity of variance. Using a t-test, t = 5.257, P = 0.000 < 0.005, indicating that the treatment group showed a more significant improvement in Lysholms scores than the control group. Paired-samples t-tests were used for within-group comparisons. The within-group comparison t in the treatment group was [value missing], P = 0.000, while the within-group comparison t in the control group was 72.473, P = 0.000, indicating that both treatment methods improved knee joint function. See Table 8 for details.

[0204] Table 8: Comparison of Lysholms before and after treatment

[0205]

[0206] 3.2.4 Comparison of TCM syndrome scores

[0207] Intergroup comparison: The scores of various TCM symptoms before and after treatment did not follow a normal distribution. A nonparametric rank-sum test was used. Before treatment, the p-values ​​were all greater than 0.05, indicating no significant differences in the various TCM symptoms before treatment, making comparison meaningful. After treatment, the p-values ​​for joint swelling and pain, joint redness and heat, difficulty walking, limited flexion and extension, sticky stools, and restlessness were all less than 0.05 between the two groups, indicating that the treatment group was significantly better than the control group in treating various TCM symptoms.

[0208] Within-group comparison: Before and after treatment, the rank-sum test was used. The p-values ​​for joint swelling and pain, joint redness and heat, difficulty walking, limited flexion and extension, sticky stools, and irritability were all less than 0.05, indicating statistically significant differences between the two groups. This shows that the scores of all symptoms improved before and after treatment in both groups. See Table 9 for details.

[0209] Table 9: Comparison of TCM syndrome scores before and after treatment (M(P25, P75))

[0210]

[0211]

[0212]

[0213] Note: Since it does not conform to a normal distribution, a nonparametric rank-sum test is used.

[0214] 3.2.5 Comparison of Total Score of Traditional Chinese Medicine Syndromes

[0215] Intergroup comparison: The total TCM syndrome scores of both groups before and after treatment did not conform to a normal distribution. Using a nonparametric rank-sum test, before treatment, Z = -0.166, P = 0.868 > 0.05, indicating no significant difference in total scores before treatment, making comparison meaningful. After treatment, Z = -3.324, P = 0.001 < 0.05, which was statistically significant, indicating that the treatment group was superior to the control group in improving the total TCM syndrome score after treatment.

[0216] Within-group comparisons: Data from within-group comparisons in both the treatment and control groups did not conform to a normal distribution. A non-parametric rank-sum test was used for both. The within-group comparisons in the treatment group showed Z = -5.717, P = 0.000, and in the control group, Z = -5.719, P = 0.000, both showing significant differences. This indicates that the medications used in both the treatment and control groups were effective in improving the overall TCM syndrome score. See Table 10 for details.

[0217] Table 10: Comparison of total TCM syndrome scores before and after treatment (M(P25, P75))

[0218]

[0219] 3.2.6 Comparison of treatment effectiveness rates

[0220] After one course of treatment, 5 out of 43 patients in the treatment group were cured (11.63%), 26 showed significant improvement (60.47%), 12 showed improvement (27.91%), and 3 showed no improvement (6.98%). In the control group, 2 patients were cured (4.65%), 14 showed significant improvement (32.56%), 19 showed improvement (44.19%), and 8 showed no improvement (18.60%). The effective rate was calculated as the sum of the cure rate, the significant improvement rate, and the effective rate. The effective rate in the treatment group was 93.02%, while the effective rate in the control group was 81.04%. Z = -2.223, P = 0.026, indicating a significant difference in the effective rate between the two groups. See Table 11 for details.

[0221] Table 11: Comparison of effectiveness rates between the two groups (examples)

[0222]

[0223] 3.2.7 Comparison of TNF-α, IL-1β and IL-6 levels before and after treatment

[0224] The levels of TNF-α, IL-1β, and IL-6 in both groups before and after treatment were normally distributed and homogeneous in variance. Using a t-test, the differences were statistically significant (P < 0.05) compared to pre-treatment levels in both groups, and also statistically significant (P < 0.05) after 2 weeks of treatment. See Table 12 for details.

[0225] Table 12 Comparison of TNF-α, IL-1β, and IL-6 levels before and after treatment in the two groups of patients.

[0226] Group Time point TNF-α (ng / L) IL-1β (ng / L) IL-6 (ng / mL) Treatment group Before treatment 1.84±0.20 21.36±0.44 10.24±0.20 Two weeks after treatment <![CDATA[0.84±0.19* △ ]]> <![CDATA[16.32±0.24* △ ]]> <![CDATA[5.22±0.20* △ ]]> control group Before treatment 1.76±0.18 21.18±0.45 10.16±0.20 Two weeks after treatment 1.17±0.20* 18.99±0.21* 7.10±0.23*

[0227] Note: Compared with the group before treatment, *P<0.05; compared with the control group at the same time point, △P<0.05.

[0228] 3.2.8 Comparison of tibial angle on anteroposterior X-ray of the knee joint before and after treatment

[0229] The tibial angle measurements on the anteroposterior X-ray films of the knee joint before and after treatment in both groups of patients conformed to normal distribution and homogeneity of variance. Using a t-test, the differences between the two groups before and after treatment were statistically significant (P < 0.05). Two weeks after treatment, the differences between the two groups were also statistically significant (P < 0.05). See Table 13 for details.

[0230] Table 13 Comparison of tibial angles before and after treatment in the two groups of patients ( Spend)

[0231]

[0232] Note: Compared with the group before treatment, *P<0.05; compared with the control group at the same time point, △P<0.05.

[0233] (1) This invention analyzes the efficacy of external application of blood-activating and swelling-reducing plaster combined with qi-tonifying and swelling-reducing decoction in treating knee synovitis of damp-heat obstruction type. It helps to better understand the mechanism of action of traditional Chinese medicine plaster external treatment techniques, explore its clinical efficacy, and has significant social and economic benefits. It provides a safe, convenient, inexpensive and continuously effective treatment approach for the clinical treatment of knee synovitis.

[0234] (2) It is of great significance to better understand the therapeutic principle of external application of blood-activating and swelling-reducing ointment for knee synovitis and to further objectively explain the mechanism of action of external application of blood-activating and swelling-reducing ointment for knee synovitis.

[0235] (3) To supplement the deficiencies of traditional Chinese medicine external treatment methods, although external application of blood-activating and swelling-reducing plasters can achieve certain therapeutic effects in treating knee synovitis, its improvement on the TCM syndrome of clinical patients is limited. This invention, through the holistic TCM syndrome differentiation and treatment, combines TCM external treatment with syndrome differentiation and treatment to achieve better clinical efficacy for patients with the most common type of knee synovitis caused by damp-heat obstruction.

[0236] (4) Knee synovitis is a common chronic degenerative disease. This invention is based on the principles of traditional Chinese medicine (TCM) syndrome differentiation and treatment, using a combination of oral administration of a Qi-boosting and swelling-reducing decoction and a self-made blood-activating and swelling-reducing ointment to treat knee synovitis. This approach combines internal and external treatment, is safe, reliable, economical, and practical. Furthermore, it can help develop new comprehensive TCM treatment methods with definite efficacy and no toxic side effects, resulting in significant social and economic benefits. It also has positive social benefits for the inheritance and promotion of TCM and the innovation and development of TCM external treatment techniques.

[0237] 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 knee synovitis, characterized in that, The composition includes a blood-activating and swelling-reducing ointment and a qi-tonifying and swelling-reducing decoction; The blood-activating and swelling-reducing ointment is made from 20-30 parts of Angelica sinensis, 15-20 parts of Ligusticum chuanxiong, 20-30 parts of Paeonia lactiflora, 20-30 parts of Prunus persica, 20-30 parts of Carthamus tinctorius, 30-40 parts of Phellodendron chinense, 10-15 parts of Boswellia carterii, 10-15 parts of Commiphora myrrha, 10-15 parts of Daemonorops draco, 10-15 parts of Angelica dahurica, 10-15 parts of Taraxacum mongolicum, 10-20 parts of Dipsacus asper, 10-15 parts of Curcuma longa, 20-30 parts of Rheum palmatum, and 10-15 parts of Glauber's salt. The Qi-Boosting and Swelling-Reducing Decoction is made from 20-30 parts of Smilax glabra, 10-15 parts of Atractylodes lancea, 20-30 parts of Coix lacryma-jobi, 10-15 parts of Phellodendron chinense, 15-20 parts of Achyranthes bidentata, 20-30 parts of Leonurus japonicus, 20-50 parts of Astragalus membranaceus, 15-20 parts of Dioscorea hypoglauca, 10-15 parts of Anemarrhena asphodeloides, 10-15 parts of Lycium chinense root bark, 10-15 parts of Prunus persica, 10-15 parts of Carthamus tinctorius, and 6-9 parts of Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition for treating knee synovitis according to claim 1, characterized in that, The blood-activating and swelling-reducing ointment is made from 20 parts of Angelica sinensis, 20 parts of Ligusticum chuanxiong, 20 parts of Paeonia lactiflora, 20 parts of Prunus persica, 20 parts of Carthamus tinctorius, 30 parts of Phellodendron chinense, 10 parts of raw Boswellia carterii, 10 parts of raw Commiphora myrrha, 10 parts of Dracaena cochinchinensis, 10 parts of Angelica dahurica, 10 parts of Taraxacum mongolicum, 10 parts of Dipsacus asper, 10 parts of Curcuma longa, 20 parts of raw Rheum palmatum, and 10 parts of Glauber's salt.

3. The traditional Chinese medicine composition for treating knee synovitis according to claim 1, characterized in that, The Qi-Boosting and Swelling-Reducing Decoction is made from 25 parts of Smilax glabra, 15 parts of Atractylodes lancea, 20 parts of Coix lacryma-jobi, 10 parts of Phellodendron chinense, 15 parts of Achyranthes bidentata, 20 parts of Leonurus japonicus, 20 parts of Astragalus membranaceus, 20 parts of Dioscorea hypoglauca, 10 parts of Anemarrhena asphodeloides, 10 parts of Lycium chinense root bark, 12 parts of Prunus persica, 12 parts of Carthamus tinctorius, and 9 parts of Glycyrrhiza uralensis.

4. A method for preparing the traditional Chinese medicine composition for treating knee synovitis as described in claim 1, characterized in that, include: Step 1: Preparation of the blood-activating and swelling-reducing ointment Weigh the ingredients for the blood-activating and swelling-reducing ointment according to the proportion, grind them into powder, mix the medicine with honey until it becomes a viscous state, and take a blank medical dressing to make an ointment. Step 2: Preparation of Qi-Boosting and Swelling-Reducing Decoction Weigh out the ingredients for the Qi-Boosting and Swelling-Reducing Decoction according to the specified proportions, and decoct them in water to obtain the Qi-Boosting and Swelling-Reducing Decoction liquid.

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