Traditional Chinese medicine composition for rehabilitation after hip and knee replacement

Abstract

The traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: 15-30 parts of codonopsis pilosula, 15-30 parts of astragalus membranaceus, 10-20 parts of prepared rehmannia root, 10-20 parts of angelica sinensis, 6-12 parts of ginger processed pinellia, 3-10 parts of fresh ginger, 6-15 parts of mangnolia officinalis, 6-15 parts of pericarpium citri reticulatae, 10-30 parts of poria cocos, 10-20 parts of rhizoma alismatis, 6-12 parts of peach kernel, 3-10 parts of safflower and 5-15 parts of liquorice. The whole prescription is combined with common clinical manifestations of qi-blood deficiency, blood stasis blocking collaterals, spleen-stomach weakness and the like, systematic syndrome differentiation is carried out, the formed prescription fully embodies the core thought of treatment based on syndrome differentiation of traditional Chinese medicine, and the traditional Chinese medicine composition has the effects of invigorating qi and blood, promoting blood circulation to remove blood stasis, regulating qi and harmonizing stomach and treating both symptoms and root causes, and is suitable for rehabilitation conditioning of different postoperative stages.

Description

TECHNICAL FIELD

[0001] The application belongs to the important technical field, and particularly relates to a traditional Chinese medicine composition for postoperative rehabilitation of hip and knee arthroplasty. BACKGROUND

[0002] After hip and knee arthroplasty, patients often have different degrees of TCM pathological states such as qi and blood deficiency, blood stasis blocking collaterals and dysfunction of spleen and stomach, which are manifested as postoperative problems such as slow wound healing, local swelling and pain, loss of appetite, nausea and vomiting. At the same time, due to postoperative activity limitation, the patient's blood circulation is not smooth, and conditions such as lower limb swelling, venous circulation disorder and blood stasis are prone to occur, and even complications such as deep vein thrombosis can be induced, which seriously affects the rehabilitation process and recovery of activity ability.

[0003] Although modern rehabilitation medicine emphasizes multi-dimensional rehabilitation programs such as postoperative functional exercise, physiotherapy intervention and psychological support, there are still certain limitations in regulating qi and blood, resolving blood stasis and promoting spleen and stomach transportation, especially for elderly patients with weak constitution or many underlying diseases, the rehabilitation process is often slow and the curative effect is not ideal. In addition, modern rehabilitation treatment relies on western medicine for anti-inflammatory and analgesic, anticoagulant and anti-platelet, and long-term use can easily have adverse effects on liver and kidney function, and may also interfere with the stability of the immune system.

[0004] Traditional Chinese medicine has unique advantages in regulating postoperative constitution, promoting tissue repair and improving dysfunction. Traditional Chinese medicine believes that postoperative hip and knee arthroplasty belongs to the category of “Bi syndrome” and “stagnation of blood stasis”, which is mainly caused by surgical damage to vital qi, blood stasis and poor blood circulation. The treatment principle should be to tonify qi and blood, promote blood circulation and regulate qi and stomach. In recent years, more and more studies have shown that traditional Chinese medicine compound treatment can effectively relieve postoperative pain, reduce swelling, promote bone healing and joint function recovery, and has little side effect and high compliance, which has become an important supplement to modern rehabilitation treatment.

[0005] Although some traditional Chinese medicine preparations have been used in postoperative rehabilitation in clinical practice, most of them lack compound preparations developed for typical pathological states after hip and knee arthroplasty, especially in terms of considering multiple treatment mechanisms such as tonifying deficiency, resolving blood stasis, regulating qi and harmonizing stomach. At present, there is still a lack of systematic prescriptions developed for the characteristics of “qi and blood deficiency with blood stasis blocking collaterals” after hip and knee arthroplasty. Therefore, it is of great clinical significance and market prospect to develop a traditional Chinese medicine composition for whole-process management during postoperative rehabilitation period, guided by the concept of TCM syndrome differentiation and treatment, and with multiple target action mechanisms. SUMMARY

[0006] In view of the problems existing in the prior art, the purpose of the embodiments of the present application is to provide a traditional Chinese medicine composition for postoperative rehabilitation of hip and knee arthroplasty.

[0007] According to a first aspect of the embodiments of the present application, a traditional Chinese medicine composition for rehabilitation after hip and knee arthroplasty is provided, which comprises the following traditional Chinese medicine raw materials in parts by weight: Radix Codonopsis 15-30 parts, Radix Astragali 15-30 parts, Radix Rehmanniae Preparata 10-20 parts, Radix Angelicae Sinensis 10-20 parts, Rhizoma Pinelliae Praeparatum 6-12 parts, Rhizoma Zingiberis Recens 3-10 parts, Cortex Magnoliae Officinalis 6-15 parts, Pericarpium Citri Reticulatae 6-15 parts, Poria 10-30 parts, Rhizoma Alismatis 10-20 parts, Semen Persicae 6-12 parts, Flos Carthami 3-10 parts, and Radix Glycyrrhizae 5-15 parts.

[0008] Further, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: Radix Codonopsis 20-30 parts, Radix Astragali 20-30 parts, Radix Rehmanniae Preparata 15-20 parts, Radix Angelicae Sinensis 15-20 parts, Rhizoma Pinelliae Praeparatum 6-12 parts, Rhizoma Zingiberis Recens 5-10 parts, Cortex Magnoliae Officinalis 6-12 parts, Pericarpium Citri Reticulatae 8-12 parts, Poria 15-25 parts, Rhizoma Alismatis 15-20 parts, Semen Persicae 6-10 parts, Flos Carthami 6-10 parts, and Radix Glycyrrhizae 6-12 parts.

[0009] Further, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: Radix Codonopsis 20 parts, Radix Astragali 30 parts, Radix Rehmanniae Preparata 15 parts, Radix Angelicae Sinensis 15 parts, Rhizoma Pinelliae Praeparatum 9 parts, Rhizoma Zingiberis Recens 6 parts, Cortex Magnoliae Officinalis 10 parts, Pericarpium Citri Reticulatae 10 parts, Poria 20 parts, Rhizoma Alismatis 9 parts, Semen Persicae 6 parts, Flos Carthami 6 parts, and Radix Glycyrrhizae 6 parts.

[0010] According to a second aspect of the embodiments of the present application, the use of the traditional Chinese medicine composition of any one of the first aspect in the preparation of a medicine for rehabilitation after hip and knee arthroplasty is provided.

[0011] According to a third aspect of the embodiments of the present application, a medicine for rehabilitation after hip and knee arthroplasty is provided, which is prepared from the traditional Chinese medicine composition of the first aspect.

[0012] Further, the medicine is a decoction, granules or oral liquid.

[0013] On the basis of fully analyzing the common constitution and syndrome of patients after hip and knee arthroplasty, combined with clinical common manifestations such as "deficiency of both qi and blood, blood stasis blocking collaterals, weakness of spleen and stomach", systematic differentiation is carried out, and the formed prescription fully embodies the core thought of TCM "treatment based on syndrome differentiation". The Chinese medicine composition tonifies qi and blood, promotes blood circulation to remove blood stasis, regulates qi and harmonizes stomach, and gives consideration to both principal and secondary, and is suitable for rehabilitation conditioning at different stages after operation. Dangshen and Huangqi are used as the main components, which tonify qi and blood, consolidate the exterior and generate muscle, and help the recovery of physical strength after operation; Shudihuang and Dangui are used as the auxiliary components, which nourish blood and assist in repairing wounds and improving deficiency of qi and blood; Jiangbanxia, Shengjiang, Houpu, Chenpi, Fuling and Zexie are used as the auxiliary components, which regulate qi and invigorate the spleen, dry dampness and descend adverse qi, improve postoperative gastrointestinal function and promote nutrient absorption; Taoren and Honghua are used as the auxiliary components, which activate blood and dredge collaterals, remove stasis and relieve pain, and assist in wound repair; Gancao is used as the auxiliary component, which harmonizes all the components, tonifies qi and supports the center, and enhances the synergistic effect. The overall prescription has the functions of tonifying qi and blood, regulating qi and harmonizing stomach, and promoting blood circulation to remove swelling, and is suitable for rehabilitation conditioning after hip and knee arthroplasty.

[0014] It should be understood that the foregoing general description and the following detailed description are only exemplary and explanatory and are not restrictive of the present application. DETAILED DESCRIPTION

[0015] The present application will be described below through specific examples, but the present application is not limited thereto.

[0016] The experimental methods used in the following examples are conventional methods unless otherwise specified; the reagents, materials, etc. used in the following examples can be obtained from commercial channels unless otherwise specified.

[0017] The Dangshen, Huangqi, Shudihuang, Dangui, Jiangbanxia, Shengjiang, Houpu, Chenpi, Fuling, Zexie, Taoren, Honghua and Gancao used in the present application are all Chinese medicinal materials (dry products), which all meet the relevant provisions of Chinese Pharmacopoeia (2020 edition) Part I under each medicinal material. Before feeding, each medicinal material is identified to be consistent with the name and the quality meets the standard.

[0018] The pathological state of patients after hip and knee arthroplasty is not single, and most of them have problems such as consumption of qi and blood during operation, postoperative deficiency of qi and blood, weakness of spleen and stomach, and residual blood stasis, etc. The main manifestations are: postoperative limb swelling, obvious pain, local activity limitation, redness and swelling or ecchymosis around the wound; patients often feel fatigue, shortness of breath, and poor appetite; night sweating, pale complexion, or palpitation, insomnia, anxiety and restlessness; some patients may have loose stools or difficult defecation, short and red urine; slow wound recovery, blood stasis, heavy limbs; pale or dark red tongue, thin yellow or white fur, thin or rough pulse, or slippery and rapid pulse.

[0019] Based on this, the application provides a traditional Chinese medicine composition for treating postoperative rehabilitation of hip and knee arthroplasty, which comprises the following traditional Chinese medicine raw materials in parts by weight: Radix Codonopsis 15-30 parts, Radix Astragali 15-30 parts, Radix Rehmanniae Preparata 10-20 parts, Angelica sinensis 10-20 parts, Rhizoma Pinelliae Preparatum 6-12 parts, Zingiber officinale 3-10 parts, Magnolia officinalis 6-15 parts, Citrus reticulata 6-15 parts, Poria cocos 10-30 parts, Alisma orientalis 10-20 parts, Semen Persicae 6-12 parts, Carthamus tinctorius 3-10 parts, and Glycyrrhiza uralensis 5-15 parts.

[0020] Preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: Radix Codonopsis 20-30 parts, Radix Astragali 20-30 parts, Radix Rehmanniae Preparata 15-20 parts, Angelica sinensis 15-20 parts, Rhizoma Pinelliae Preparatum 6-12 parts, Zingiber officinale 5-10 parts, Magnolia officinalis 6-12 parts, Citrus reticulata 8-12 parts, Poria cocos 15-25 parts, Alisma orientalis 15-20 parts, Semen Persicae 6-10 parts, Carthamus tinctorius 6-10 parts, and Glycyrrhiza uralensis 6-12 parts. The increased amount of Radix Codonopsis and Radix Astragali highlights the effects of tonifying qi and consolidating the exterior. The range of “qi-regulating, spleen-strengthening and dampness-removing drugs” such as Citrus reticulata, Magnolia officinalis and Poria cocos is narrowed, which is more conducive to regulating the function of the spleen and stomach; the amount of blood-activating drugs such as Carthamus tinctorius and Semen Persicae is kept between 6-10 parts to avoid excessive bleeding risk.

[0021] More preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: Radix Codonopsis 20 parts, Radix Astragali 30 parts, Radix Rehmanniae Preparata 15 parts, Angelica sinensis 15 parts, Rhizoma Pinelliae Preparatum 9 parts, Zingiber officinale 6 parts, Magnolia officinalis 10 parts, Citrus reticulata 10 parts, Poria cocos 20 parts, Alisma orientalis 9 parts, Semen Persicae 6 parts, Carthamus tinctorius 6 parts, and Glycyrrhiza uralensis 6 parts. It is found through clinical observation that the traditional Chinese medicine composition with the specific proportion has a better effect. The largest proportion of Radix Codonopsis and Radix Astragali tonifies qi, consolidates the exterior and promotes rehabilitation. The amount of Radix Rehmanniae Preparata and Angelica sinensis is kept at 15 parts, which not only tonifies blood but also avoids excessive greasiness. The moderate amount of spleen-strengthening and dampness-removing drugs such as Rhizoma Pinelliae Preparatum, Zingiber officinale, Magnolia officinalis, Citrus reticulata, Poria cocos and Alisma orientalis prevents postoperative anorexia and abdominal distension. The amount of blood-activating drugs such as Semen Persicae and Carthamus tinctorius is kept at 6 parts, which activates blood and prevents excessive bleeding. The amount of Glycyrrhiza uralensis is kept at 6 parts, which balances the effects of other drugs.

[0022] The following will be specifically described in combination with examples.

[0023] Example 1 Preparation of the traditional Chinese medicine composition of the application (I) Take Radix Codonopsis 15 parts, Radix Astragali 15 parts, Radix Rehmanniae Preparata 10 parts, Angelica sinensis 10 parts, Rhizoma Pinelliae Preparatum 6 parts, Zingiber officinale 3 parts, Magnolia officinalis 6 parts, Citrus reticulata 6 parts, Poria cocos 10 parts, Alisma orientalis 10 parts, Semen Persicae 6 parts, Carthamus tinctorius 3 parts, and Glycyrrhiza uralensis 5 parts in parts by weight.

[0024] Example 2 Preparation of the traditional Chinese medicine composition of the application (II) Take 30 parts of Dangshen, 30 parts of Huangqi, 20 parts of Shudihuang, 20 parts of Danggui, 12 parts of Jiangbanxia, 10 parts of Shengjiang, 15 parts of Huhoupu, 15 parts of Chenpi, 30 parts of Fuling, 20 parts of Zexie, 12 parts of Taoren, 10 parts of Honghua, and 15 parts of Gancao, in terms of maximum weight parts.

[0025] Example 3 Preparation of the traditional Chinese medicine composition in the present application (three) Take 25 parts of Dangshen, 25 parts of Huangqi, 15 parts of Shudihuang, 15 parts of Danggui, 9 parts of Jiangbanxia, 6 parts of Shengjiang, 10 parts of Huhoupu, 10 parts of Chenpi, 20 parts of Fuling, 15 parts of Zexie, 9 parts of Taoren, 6 parts of Honghua, and 10 parts of Gancao, in terms of intermediate weight parts.

[0026] Example 4 Preparation of the medicine for rehabilitation after hip and knee joint replacement surgery in the present application (one) Take each raw medicinal material in the weight parts as described in any one of Examples 1-3, remove impurities, and slice or break as necessary. Place the medicinal materials into a decocting container, add 8-10 times the amount of water, and soak at room temperature for 30 minutes. After heating to boiling, maintain a state of slight boiling for 30-40 minutes, and filter out the decoction. Add 6-8 times the amount of water to the residue, heat to boiling again, maintain a state of slight boiling for 20-30 minutes, and filter out the decoction. Combine the two decoctions, filter out the residue, and prepare into a decoction. The decoction can also be concentrated to the desired volume under normal pressure and stored in airtight containers.

[0027] Example 5 Preparation of the medicine for rehabilitation after hip and knee joint replacement surgery in the present application (two) Take each raw medicinal material in the weight parts as described in any one of Examples 1-3, remove impurities from each medicinal material, and pulverize into coarse powder (pass through a 20-mesh sieve, with a particle size of about 850 μm) using a pulverizer. Take the coarse powder, add 8 times the amount of water, and soak at room temperature for 30 minutes. Decoct twice, for 60 minutes the first time and 40 minutes the second time. Combine the decoctions and filter the residue. Reduce the combined decoction under pressure to a thick paste with a relative density of 1.20-1.25 (60°C). Spray dry the thick paste to obtain a dry extract powder. Mix the obtained extract powder with excipients (dextrin, sucrose powder, and an appropriate amount of honey) at a ratio of extract powder: excipients = 1:1. Add an appropriate amount of ethanol (60-70%) as a wetting agent, prepare into soft material, and pass through a shaking granulator to form granules. Dry at 60°C using hot air, pass through a 16-mesh sieve to sieve the granules, and obtain light brown granules. Store the granules in composite bags and seal to preserve.

[0028] Example 6 Preparation of the medicine for rehabilitation after hip and knee joint replacement surgery in the present application (three) The weight parts of each raw material are weighed according to any one of embodiments 1-3, and each raw material is cut into slices or ground into fine powder (passing through a 60-mesh sieve, particle size about 250 μm). Decoction extraction: the fine powder is placed in an extraction tank, 10 times the amount of water is added, and soaked for 30 minutes; decocted twice, each time for 60 minutes; the decoction is combined and the residue is filtered. The combined decoction is concentrated under reduced pressure to a relative density of 1.10-1.15 (60°C). After the concentrated solution is cooled, an appropriate amount of excipient (such as sucrose, sodium benzoate) is added for flavoring and as a preservative; stand or centrifuge to clarify and remove insoluble substances. The clarified liquid is divided into ampoule bottles or oral liquid bottles, each containing 10 ml; sterilized in a 100°C water bath for 30 minutes to obtain a dark brown clear oral liquid with a slightly bitter taste, which is stored in a light-proof container.

[0029] Example 7 Clinical trial of the present application for rehabilitation medicine after hip and knee arthroplasty 1. Method From June 2023 to January 2025, 50 patients who met the inclusion and exclusion criteria in the Department of Orthopedics of Zhejiang Provincial Hospital of Traditional Chinese Medicine underwent hip and knee arthroplasty were selected and divided into a control group and a treatment group by random number table method, with 25 cases in each group. The control group was 58.47 ± 15.58 years old, including 14 males and 11 females; the average weight was 69.20 ± 1.50 kg. The treatment group was 62.40 ± 14.86 years old on average; there were 15 males and 10 females; the average weight was 65.82 ± 1.38 kg. There was no statistically significant difference in age, gender, and disease duration between the two groups.

[0030] The control group was given routine accelerated rehabilitation perioperative management, and all patients were routinely given flurbiprofen axetil for pain relief, pantoprazole for stomach protection, cefuroxime sodium for anti-infection, low molecular weight heparin sodium for anticoagulation, and other routine treatments. All patients kept the incision clean, changed dressings regularly, elevated the affected limb after surgery, and performed active rehabilitation exercises under the guidance of the same rehabilitation therapist. If the patient had adverse reactions, timely measures were taken and recorded.

[0031] The treatment group took Yanggufang: Dangshen 15g, Huangqi 15g, Shudihuang 12g, Danggui 15g, Jiangbanxia 6g, Shengjiang 6g, Houpu 12g, Chenpi 9g, Fuling 12g, Zexie 12g, Taoren 6g, Honghua 6g, Gancao 9g. One set per day, decocted in water to 500ml, taken in the morning and evening. The rest of the treatment was the same as the control group.

[0032] 2. Diagnostic criteria Western medicine diagnostic criteria: (1) K-L classification Ⅲ or above or femoral head necrosis: ARCO stage IV (femoral head collapse, hip joint space narrowing), middle-aged and elderly people with obvious hip or knee joint dysfunction; (2) exclude other diseases that can cause knee pain, dysfunction, etc.; (3) patients whose knee joint symptoms did not improve after 6 months of systemic treatment.

[0033] TCM syndrome diagnostic criteria: The TCM syndrome was determined according to the Guiding Principle of Clinical Research for New Drugs of Traditional Chinese Medicine.

[0034] Deficiency of qi and blood syndrome, main symptoms: deficiency of qi: fatigue, shortness of breath, and lazy speech; deficiency of blood: pale or yellowish complexion, dizziness, palpitation, and insomnia. Secondary symptoms: fatigue of limbs, decreased appetite, less menstrual flow, and pale color; self-sweating. Tongue and pulse: pale tongue, thick tongue body or teeth marks, thin white fur; weak pulse.

[0035] Blood stasis syndrome, main symptoms: pain like needle or knife, aggravated at night, fixed and unmovable; local swelling, stiffness, and limited movement; rough and dry skin; dark complexion or ecchymosis; purple lips; dysmenorrhea, dark menstrual blood with blood clots. Secondary symptoms: tongue and pulse: purple tongue, ecchymosis, and tortuous purple sublingual veins; pulse is tight or intermittent.

[0036] Spleen and stomach deficiency syndrome, main symptoms: decreased appetite, abdominal distension after eating, and thin and loose stool. Secondary symptoms: fatigue, pale complexion, stomachache, nausea, vomiting, and edema. Tongue and pulse: pale tongue, thick tongue body or teeth marks, thin white fur or greasy white fur; weak or slow pulse.

[0037] Diagnostic criteria: All main symptoms and 2 or more secondary symptoms, combined with typical tongue and pulse, can be diagnosed.

[0038] 4. Inclusion and exclusion criteria Inclusion criteria: (1) patients who meet the above-mentioned western diagnostic criteria, meet one TCM syndrome, and undergo unilateral total knee arthroplasty for the first time; (2) the same surgical approach and anesthetic method are used; (3) patients aged 50-70 years; (4) patients who sign the informed consent form, voluntarily participate in this study, and can cooperate with follow-up; (5) patients with no displacement of the prosthesis position and no infection at the surgical site after reexamination; (6) the same type of prosthesis from the same manufacturer is used; Exclusion criteria: ① patients who do not meet the inclusion criteria; ② patients with severe liver, kidney, and heart dysfunction or critical illness; ③ patients who have used traditional Chinese medicine, western medicine, or Chinese patent medicine that may affect the experimental results within the past 3 months; ④ patients with deep vein thrombosis or coagulation dysfunction, bleeding, and infection after B-ultrasound examination of the lower extremity deep veins; ⑤ patients with severe mental illness; ⑥ patients who have participated in other clinical trials within the past 3 months; ⑦ pregnant or lactating women.

[0039] 4. Treatment The control group received standard accelerated rehabilitation perioperative management, including preoperative assessment, postoperative analgesia, anti-infection, anticoagulation, rehabilitation exercise, diet guidance and other comprehensive measures. The drugs used include flurbiprofen axetil, pantoprazole, cefuroxime sodium, low molecular weight heparin sodium, etc. The patient starts active activity training on the day after surgery.

[0040] The treatment group is combined with oral and Yangyufang on this basis: Dangshen 15g, Huangqi 15g, Shudihuang 12g, Danggui 15g, Jiangbanxia 6g, Shengjiang 6g, Houpu 12g, Chenpi 9g, Fuling 12g, Zexie 12g, Taoren 6g, Honghua 6g, Gancao 9g. One dose per day, decoct with water to get about 500ml of juice, take 2 times in the morning and evening, continuously take for 14 days.

[0041] 5. Effect observation The efficacy evaluation time points are set as the 3rd, 7th, 14th day after surgery and 1 month after surgery, and the following indicators are observed: 1) Improvement of subjective symptoms: changes in pain score (VAS), fatigue, poor appetite, sleep quality, etc. 2) Objective indicators: postoperative limb circumference, incision healing, wound redness and swelling; 3) Laboratory indicators: postoperative hemoglobin (hemoglobin, Hb) changes, C-reactive protein; 4) Adverse reaction monitoring: nausea, diarrhea, rash, infection, venous thrombosis, etc. 5) Comprehensive efficacy judgment criteria are divided into three levels of marked effect, effectiveness and invalidity, which are comprehensively judged according to the symptom improvement rate, laboratory indicators and functional recovery. In order to fully evaluate the application effect of the traditional Chinese medicine composition in the invention in the rehabilitation after hip and knee joint replacement, the invention adopts a three-level efficacy judgment system, namely marked effect, effectiveness and invalidity. The judgment basis is the comprehensive improvement degree of the patient's subjective symptoms, objective signs, laboratory indicators and functional recovery, which is as follows: Marked effect: the patient's postoperative pain is significantly reduced (VAS improvement rate ≥ 50%), the postoperative limb swelling is significantly subsided (circumference reduction ≥ 50% or 2 grades or more than baseline), the incision heals well, the redness and swelling are significantly reduced, the laboratory indicators (such as C-reactive protein decrease ≥ 50% or close to normal, hemoglobin rebound ≥ 10 g / L compared with the lowest point after surgery), and the symptoms such as fatigue, poor appetite and sleep quality are significantly improved. Comprehensive judgment is that the rehabilitation effect is remarkable.

[0042] Effective: the patient's postoperative pain is relieved (VAS improvement rate 30–<50%), the postoperative limb swelling is reduced (circumference reduction 30–<50% or 1 grade), the incision healing is improved, the laboratory indicators are improved compared with the baseline (such as CRP decrease 30–<50%, Hb rebound 5–<10 g / L), and the symptoms such as fatigue, poor appetite or sleep are improved. Comprehensive judgment is that the rehabilitation is effective.

[0043] Invalid: the main symptoms and signs of the patient after operation have no obvious improvement (VAS improvement rate <30%, swelling relief is less than 30%, incision healing has no obvious progress), or laboratory indicators and general condition have no improvement or even aggravation.

[0044] 6 Statistical methods SPSS 26.0 statistical software was used for data processing. Measurement data was expressed as x±s, and independent sample t test was used for comparison between groups; count data was expressed as frequency and percentage, and χ² test was used for comparison between groups; rank sum test was used for rank data. P<0.05 was considered statistically significant.

[0045] 7 Results The pain scores (VAS) of the two groups of patients are as follows in Table 1. It can be seen that the pain of the treatment group decreased faster and more.

[0046] Table 1 Pain score (points, 0=no pain, 10=most severe) The hemoglobin of the two groups of patients before and after operation is as follows in Table 2. It can be seen that the hemoglobin of the treatment group decreased less in the early postoperative period, recovered faster afterwards, and the recovery degree was closer to the preoperative level in the same time.

[0047] Table 2 Hemoglobin (Hb, g / L) The C-reactive protein of the two groups of patients before and after operation is as follows in Table 3. It can be seen that the C-reactive protein of the treatment group increased less in the early postoperative period, decreased faster afterwards, recovered faster from inflammation, and the recovery degree was closer to the preoperative level in the same time.

[0048] Table 3 C-reactive protein (CRP, mg / L) The swelling of the affected limb of the two groups of patients after operation is as follows in Table 4. It can be seen that the swelling of the treatment group was lighter after operation, relieved faster afterwards, and the recovery degree was closer to the preoperative level in the same time.

[0049] Table 4 Swelling of the affected limb (thigh circumference, cm, preoperative baseline=0) The indexes of the patients in the two groups were observed, and the rehabilitation degree of the patients was judged based on the three-level efficacy judgment system. As shown in Table 5, the observation results show that, on the basis of the standard accelerated rehabilitation management, the joint application of the traditional Chinese medicine composition can reduce postoperative pain, promote the recovery of hemoglobin, reduce the inflammation level, relieve limb swelling, and no serious adverse reactions are found. The traditional Chinese medicine composition has good application value in the rehabilitation after hip and knee joint replacement. No adverse reactions are detected.

[0050] Table 5 Comparison of comprehensive efficacy

Claims

1. A Chinese medicine composition for treating postoperative rehabilitation of hip and knee replacement, characterized in that: Calculated by weight, the composition includes the following Chinese medicinal raw materials: 15–30 parts of Codonopsis pilosula, 15–30 parts of Astragalus membranaceus, 10–20 parts of Rehmannia root, 10–20 parts of Angelica sinensis, 6–12 parts of Pinellia ternata, 3–10 parts of ginger, 6–15 parts of Magnolia officinalis, 6–15 parts of Tangerine peel, 10–30 parts of Poria cocos, 10–20 parts of Alisma orientalis, 6–12 parts of Peach kernel, 3–10 parts of Carthamus tinctorius, and 5–15 parts of Licorice root.

2. The Chinese medicine composition according to claim 1, characterized in that The invention comprises the following Chinese medicinal raw materials by weight: 20-30 parts of Codonopsis pilosula, 20-30 parts of Astragalus membranaceus, 15-20 parts of Rehmannia root prepared, 15-20 parts of Angelica sinensis, 6-12 parts of Pinellia ternata, 5-10 parts of ginger, 6-12 parts of Magnolia officinalis, 8-12 parts of dried tangerine peel, 15-25 parts of Poria cocos, 15-20 parts of Alisma orientalis, 6-10 parts of peach kernel, 6-10 parts of safflower, and 6-12 parts of liquorice.

3. The Chinese medicine composition according to claim 1, characterized in that The preparation comprises the following Chinese medicinal materials by weight: 20 parts of Codonopsis pilosula, 30 parts of Astragalus membranaceus, 15 parts of Rehmannia root, 15 parts of Angelica sinensis, 9 parts of Pinellia ternata, 6 parts of ginger, 10 parts of Magnolia officinalis, 10 parts of Tangerine peel, 20 parts of Poria cocos, 9 parts of Alisma orientalis, 6 parts of Peach kernel, 6 parts of Carthamus tinctorius, and 6 parts of Licorice.

4. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for rehabilitation after hip and knee replacement surgery.

5. A drug for rehabilitation after hip and knee replacement surgery, characterized in that: The medicine is prepared from the traditional Chinese medicine composition according to any one of claims 1 to 3.

6. The drug according to claim 5, characterized in that The medicine is in the form of decoction, granules or oral solution.

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