A traditional Chinese medicine composition and foot bath pack for perioperative rehabilitation of uterine lumps and other diseases.

Abstract

This invention provides a traditional Chinese medicine composition and foot bath pack for perioperative rehabilitation of uterine masses, belonging to the technical field of traditional Chinese medicine foot bath packs. The traditional Chinese medicine composition of this invention comprises the following raw materials by weight: 24-36 parts of Salvia miltiorrhiza, 24-36 parts of Spatholobus suberectus, 16-24 parts of Paeonia lactiflora, 16-24 parts of Caesalpinia sappan, 16-24 parts of Carthamus tinctorius, 12-18 parts of Prunus persica, 12-18 parts of Aconitum carmichaelii (processed), 16-24 parts of Artemisia argyi, and 16-24 parts of Achyranthes bidentata. The traditional Chinese medicine composition can be further processed into a foot bath pack. The traditional Chinese medicine composition and foot bath pack of this invention synergistically exert the effects of promoting blood circulation, removing blood stasis, warming the meridians, dispelling cold, and relieving pain. Applied to patients with uterine masses before and after surgery, it can significantly improve the preoperative blood circulation, relieve lower abdominal pain and distension, specifically regulate the preoperative pathological state of blood stasis, cold coagulation, and qi stagnation, improve surgical tolerance, and reduce the risk of postoperative complications.

Description

Technical Field

[0001] This invention belongs to the technical field of traditional Chinese medicine foot bath packs, and particularly relates to a traditional Chinese medicine composition and foot bath pack for perioperative rehabilitation of uterine lumps and similar diseases. Background Technology

[0002] Uterine fibroids, chocolate cysts, endometrial polyps, and endometriosis fall under the category of "abdominal masses" in Traditional Chinese Medicine (TCM), and their pathogenesis is often related to blood stasis, cold coagulation, and qi stagnation. Clinically, these diseases are often treated with surgery to remove the lesions and alleviate symptoms. However, surgery only removes the local lesions and cannot completely eliminate the underlying pathological basis of blood stasis in the patient's body. Furthermore, surgical trauma can damage the body's vital energy (Qi). Deficiency of vital energy weakens the body's defensive qi, making it easier for cold and dampness to invade, further aggravating blood stasis. This often leads to postoperative complications such as abdominal pain, prolonged lochia, cold and painful limbs, and slow recovery, severely impacting the patient's postoperative recovery process and quality of life.

[0003] In addition, these patients often have obvious blood stasis, cold coagulation, and qi stagnation before surgery. If this pathological state can be specifically regulated before surgery to enhance the circulation of qi and blood, the preoperative physical condition can be effectively optimized, providing a guarantee for the smooth progress of the surgery. At the same time, it can further reduce postoperative discomfort and lay a good foundation for postoperative recovery.

[0004] Currently, most existing external foot bath products are general-purpose conditioning products, lacking a design specifically for the core pathogenesis characteristics of gynecological masses, which involve the intertwining of "blood stasis, cold coagulation, and qi stagnation." Furthermore, they do not take into account the dual needs of preoperative conditioning and postoperative rehabilitation, and cannot accurately address the core issues of conditioning the preoperative pathological state of such patients and improving postoperative complications and promoting rehabilitation. Consequently, they are unable to meet the needs of targeted clinical rehabilitation care.

[0005] Therefore, there is a need for a traditional Chinese medicine foot bath pack that targets the above-mentioned pathogenesis and has the effects of promoting blood circulation, removing blood stasis, warming the meridians and dispelling cold, and relieving pain by unblocking the collaterals, so as to promote the rapid recovery of patients after surgery. Summary of the Invention

[0006] In view of this, the purpose of this invention is to provide a traditional Chinese medicine composition and foot bath pack for perioperative rehabilitation of uterine masses, which synergistically exert the effects of promoting blood circulation and removing blood stasis, warming the meridians and dispelling cold, and unblocking the collaterals and relieving pain. When applied to patients with uterine masses before and after surgery, it can significantly improve the circulation of qi and blood before surgery, relieve lower abdominal cold pain and distension, specifically regulate the pathological state of blood stasis, cold coagulation and qi stagnation before surgery, improve surgical tolerance, and reduce the risk of postoperative complications.

[0007] To achieve the above-mentioned objectives, the present invention provides the following technical solution: A traditional Chinese medicine composition for perioperative rehabilitation of uterine masses, comprising the following raw materials by weight: 24-36 parts of Salvia miltiorrhiza, 24-36 parts of Spatholobus suberectus, 16-24 parts of Paeonia lactiflora, 16-24 parts of Caesalpinia sappan, 16-24 parts of Carthamus tinctorius, 12-18 parts of Prunus persica, 12-18 parts of Aconitum carmichaelii (processed), 16-24 parts of Artemisia argyi, and 16-24 parts of Achyranthes bidentata.

[0008] Preferably, the raw materials include the following ingredients by weight: 30 parts of Salvia miltiorrhiza, 30 parts of Spatholobus suberectus, 20 parts of Paeonia lactiflora, 20 parts of Caesalpinia sappan, 20 parts of Carthamus tinctorius, 15 parts of Prunus persica, 15 parts of Aconitum carmichaelii (processed), 20 parts of Artemisia argyi, and 20 parts of Achyranthes bidentata.

[0009] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: mixing the raw materials, pulverizing, sterilizing, and drying.

[0010] Preferably, the particle size of the pulverized material is 20-60 mesh.

[0011] Preferably, the sterilization is performed using moist heat sterilization; the temperature of the moist heat sterilization is 121°C and the time is 15~20 minutes.

[0012] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a topical medicine for perioperative rehabilitation of uterine masses.

[0013] Preferably, the uterine lesions include uterine fibroids, endometriosis, chocolate cysts, and endometrial polyps.

[0014] Preferably, the perioperative period includes 3 days before surgery and after the patient has recovered from anesthesia and their vital signs are stable.

[0015] The present invention also provides a traditional Chinese medicine foot bath pack for perioperative rehabilitation of uterine lumps and other diseases, wherein the above-mentioned traditional Chinese medicine composition is packed into a non-woven fabric inner bag.

[0016] Preferably, the weight of a single herbal foot bath pack is 150-250g.

[0017] Compared with the prior art, the present invention has the following beneficial effects: The traditional Chinese medicine composition and foot bath pack of this invention are scientifically formulated to target the core pathogenesis of uterine masses, including blood stasis, cold coagulation, and qi stagnation. The nine medicinal materials work synergistically to promote blood circulation, remove blood stasis, warm the meridians, dispel cold, and relieve pain. When applied to patients with this type of disease before and after surgery, it can significantly improve the circulation of qi and blood before surgery, relieve lower abdominal cold pain and distension, specifically regulate the pathological state of blood stasis, cold coagulation, and qi stagnation before surgery, improve surgical tolerance, and reduce the risk of postoperative complications.

[0018] Postoperative use of the herbal composition and foot bath pack of this invention can effectively remove residual blood stasis in the body, improve postoperative problems such as residual blood stasis, cold and dampness invasion, and qi stagnation, and significantly reduce postoperative complications such as abdominal pain, lochia retention, and cold pain in the limbs; at the same time, it can replenish the body's vital energy, enhance the body's resistance, resist external pathogens, promote wound healing and recovery of bodily functions, shorten the postoperative recovery period, and fundamentally improve the patient's pathological state of blood stasis, cold coagulation, and qi stagnation, reducing the risk of recurrence of abdominal masses after surgery.

[0019] The herbal composition and foot bath pack of this invention can significantly improve the overall comfort of patients after surgery and improve the blood stasis and cold coagulation constitution. The satisfaction rate, continued use rate, and recommendation rate of patients with the overall recovery effect all reached 100%, and no adverse reactions such as skin allergies or redness occurred during the intervention, demonstrating good safety. Compared with conventional nursing and treatment programs, the improvement rate of various efficacy indicators of patients using the foot bath pack before and after surgery was significantly higher than that of conventional nursing and treatment, which fully proves that the herbal composition and foot bath pack of this invention can effectively promote the perioperative recovery of patients with uterine masses, taking into account both preoperative care and postoperative recovery needs. It solves the problem of poor targeting of existing general foot bath products, has clear clinical efficacy advantages, good safety, and clinical promotion value, and provides a practical and effective technical solution for perioperative TCM rehabilitation nursing of uterine masses. Detailed Implementation

[0020] This invention provides a traditional Chinese medicine composition for perioperative rehabilitation of uterine masses, comprising the following raw materials by weight: 24-36 parts of Salvia miltiorrhiza, 24-36 parts of Spatholobus suberectus, 16-24 parts of Paeonia lactiflora, 16-24 parts of Caesalpinia sappan, 16-24 parts of Carthamus tinctorius, 12-18 parts of Prunus persica, 12-18 parts of Aconitum carmichaelii (processed), 16-24 parts of Artemisia argyi, and 16-24 parts of Achyranthes bidentata.

[0021] Danshen: The dried root and rhizome of *Salvia miltiorrhiza*, a plant in the Lamiaceae family. It enters the Heart and Liver meridians. It invigorates blood circulation, removes blood stasis, regulates menstruation, relieves pain, cools the blood, reduces swelling, and clears the heart and relieves irritability. It is an important gynecological medicine for invigorating blood circulation without harming the body's vital energy. In this invention, the preferred amount of Danshen is 28-32 parts, and more preferably 30 parts.

[0022] Chicken Blood Vine: The dried vine stem of *Dendrobium nobile*, a legume. It enters the liver and kidney meridians. It invigorates blood circulation, nourishes blood, regulates menstruation, relieves pain, and relaxes muscles and tendons. It invigorates blood and nourishes blood, making it suitable for blood stasis and blood deficiency syndromes. In this invention, the preferred amount of Chicken Blood Vine is 28-32 parts, more preferably 30 parts. Red peony root: The dried root of Paeonia lactiflora, a plant in the Ranunculaceae family. It enters the liver meridian. It clears heat and cools the blood, disperses blood stasis and relieves pain. It clears stagnant heat in the blood, breaks up blood stasis, and dissipates masses. In this invention, the preferred amount of red peony root is 18-22 parts, and more preferably 20 parts.

[0023] Sappanwood: The dried heartwood of the legume Sappanwood. It enters the heart, liver, and spleen meridians. It invigorates blood circulation, removes blood stasis, regulates menstruation, reduces swelling, heals wounds, and relieves pain. It is commonly used in gynecological conditions for amenorrhea due to blood stasis and abdominal masses. In this invention, the preferred amount of sappanwood is 18-22 parts, more preferably 20 parts.

[0024] Safflower: The dried flower of *Carthamus tinctorius*, a plant in the Asteraceae family. It enters the Heart and Liver meridians. It invigorates blood circulation, regulates menstruation, disperses blood stasis, and relieves pain. It has a strong effect in invigorating blood and removing blood stasis, and is effective in treating blood stasis obstruction and masses. In this invention, the preferred safflower content is 18-22 parts, and more preferably 20 parts.

[0025] Peach kernel: The dried, mature seed of the peach, a plant in the Rosaceae family. It enters the Heart, Liver, and Large Intestine meridians. It invigorates blood circulation, removes blood stasis, moistens the intestines, and has a potent effect in breaking up blood clots and removing blood stasis. In this invention, the preferred amount of peach kernel is 14-16 parts, and more preferably 15 parts.

[0026] Prepared aconite root: A processed product of the root of Aconitum carmichaelii, a plant in the Ranunculaceae family. It enters the Heart, Kidney, and Spleen meridians. It tonifies Yang, dispels cold and relieves pain, and restores Yang to its original state. It warms and invigorates Yang Qi throughout the body, dispels cold pathogens, and warms and transforms cold-induced blood stasis. In this invention, the preferred amount of prepared aconite root is 14-16 parts, and more preferably 15 parts.

[0027] Artemisia argyi: Dried leaves of Artemisia argyi, a plant in the Asteraceae family. It enters the Liver, Spleen, and Kidney meridians. It warms the meridians and dispels cold, regulates menstruation and stops bleeding, warms the uterus and calms the fetus. It is an essential gynecological medicine for warming the uterus and dispersing cold and blood stasis in the uterus. The preferred amount of Artemisia argyi in this invention is 18-22 parts, more preferably 20 parts.

[0028] Achyranthes bidentata: The dried root of Achyranthes bidentata, a plant in the Amaranthaceae family. It enters the Liver and Kidney meridians. It dispels blood stasis, promotes blood circulation, and facilitates joint movement. It invigorates blood and removes blood stasis, specifically targeting the lower abdomen, guiding other herbs directly to the uterus. In this invention, the preferred amount of Achyranthes bidentata is 18-22 parts, more preferably 20 parts.

[0029] Analysis of the functions of each component in this invention and their compatibility: Nourishing and activating blood: Danshen (Salvia miltiorrhiza), bitter and slightly cold, excels at activating blood, removing blood stasis, regulating menstruation, and relieving pain, and it removes blood stasis without harming the body's vital energy, making it an essential medicine for activating blood and removing blood stasis; Jixueteng (Spatholobus suberectus) is effective in activating and nourishing blood, regulating menstruation, relieving pain, and relaxing muscles and tendons; Chishao (Paeonia lactiflora) clears heat, cools blood, disperses blood stasis, and relieves pain; Sumu (Caesalpinia sappan) activates blood, heals wounds, removes blood stasis, and regulates menstruation. The four herbs used together can synergistically achieve the goal of activating and nourishing blood, while avoiding harming the body's vital energy during the activation of blood.

[0030] Breaking up blood stasis and promoting blood circulation: Safflower is pungent and warm, promoting blood circulation, regulating menstruation, dispersing blood stasis and relieving pain, and powerfully breaking up blood stasis; Peach kernel promotes blood circulation and removes blood stasis. The two herbs have a strong effect of promoting blood circulation and breaking up blood stasis, and when combined with blood-nourishing and blood-activating ingredients, they can break up blood stasis without harming the body's vital energy.

[0031] Warming Yang and Activating Blood Circulation: Prepared aconite is very hot, tonifying fire and assisting Yang, dispelling cold and dampness, targeting the pathological state of cold coagulation and blood stasis; Artemisia argyi warms the meridians and stops bleeding, dispels cold and relieves pain, especially good at warming the lower abdomen. The combination of the two warms the meridians and dispels cold, assisting blood-activating drugs to better exert their effects of removing blood stasis and unblocking the meridians, and preventing the recurrence of blood stasis after surgery.

[0032] Guiding herbs: Achyranthes bidentata removes blood stasis and unblocks the meridians, and can guide the medicine downwards, directing the power of the medicines directly to the lesions in the lower abdomen.

[0033] The traditional Chinese medicine composition of this invention can improve the quality of perioperative recovery for patients with gynecological uterine masses, that is, it has both preoperative care and postoperative rehabilitation effects.

[0034] Preoperative care effects: Preoperative use can effectively enhance the patient's blood circulation, specifically regulate the pathological state of blood stasis, cold coagulation, and qi stagnation, dissipate mild preoperative stagnation, optimize the preoperative physical condition, provide a guarantee for the smooth operation of the surgery, reduce the risk of postoperative complications, and lay a good foundation for postoperative recovery.

[0035] Postoperative recovery effects: Postoperative use can effectively clear residual blood stasis in the body, improve problems such as residual blood stasis, cold and dampness invasion, and qi stagnation, significantly reduce postoperative complications such as abdominal pain, lochia retention, and cold pain in the limbs; at the same time, it can replenish the body's vital energy, enhance the body's resistance, resist external pathogens, promote wound healing and recovery of bodily functions, shorten the postoperative recovery period, and improve the patient's postoperative quality of life.

[0036] Overall conditioning effect: Improves the patient's blood and qi circulation, regulates the pathological state of blood stasis and masses, fundamentally improves the pathological state of "blood stasis, cold coagulation, and qi stagnation", reduces the risk of recurrence after surgery for uterine masses, and achieves the goal of combining "treatment and conditioning".

[0037] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: mixing the raw materials, pulverizing, sterilizing, and drying.

[0038] In this invention, the preferred particle size of the pulverized material is 20-60 mesh, more preferably 30-50 mesh, and even more preferably 40 mesh. A suitable particle size facilitates the dissolution of the active ingredients in the medicinal ingredients.

[0039] In this invention, it is preferred to use moist heat sterilization; more preferably, the temperature of moist heat sterilization is 121°C and the time is 15~20 min.

[0040] In this invention, it is preferred to dry to a moisture content of <13%; more preferably, the drying method is air drying or low-temperature hot air drying.

[0041] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a topical medicine for perioperative rehabilitation of uterine masses.

[0042] In this invention, preferred uterine lesions include uterine fibroids, endometriosis, chocolate cysts, and endometrial polyps; the preferred perioperative period includes 3 days before surgery and after the patient has recovered from anesthesia and their vital signs are stable.

[0043] The present invention also provides a traditional Chinese medicine foot bath pack for perioperative rehabilitation of uterine lumps and other diseases, wherein the above-mentioned traditional Chinese medicine composition is packed into a non-woven fabric inner bag.

[0044] In this invention, the preferred weight of a single herbal foot bath pack is 150-250g, and more preferably 188g.

[0045] As one possible implementation method, the foot bath pack of the present invention is used once a day before or after surgery. Specifically, place the foot bath pack in a foot bath tub, add an appropriate amount of boiling water, and when the water temperature drops to 38~42℃, soak both feet in the medicinal solution for 15~30 minutes, once a day.

[0046] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0047] Example 1 A traditional Chinese medicine foot bath pack for perioperative rehabilitation of uterine masses and related diseases, with the following formula and preparation method: The proportions of the Chinese herbal composition (parts by weight) are as follows: 30 parts of Salvia miltiorrhiza, 30 parts of Spatholobus suberectus, 20 parts of Paeonia lactiflora, 20 parts of Caesalpinia sappan, 20 parts of Carthamus tinctorius, 15 parts of Prunus persica, 15 parts of Aconitum carmichaelii (processed), 20 parts of Artemisia argyi, and 20 parts of Achyranthes bidentata.

[0048] Preparation method: Mix all raw materials, pulverize to 40 mesh, sterilize by moist heat (121℃, 15~20min), dry to a moisture content of <13%, and pack into a non-woven fabric inner bag to obtain a traditional Chinese medicine foot bath pack with a single bag weight of 188g.

[0049] Example 2 A traditional Chinese medicine foot bath pack for perioperative rehabilitation of uterine masses and related diseases, with the following formula and preparation method: The proportions of the Chinese herbal composition (parts by weight) are as follows: 24 parts of Salvia miltiorrhiza, 24 parts of Spatholobus suberectus, 16 parts of Paeonia lactiflora, 16 parts of Caesalpinia sappan, 16 parts of Carthamus tinctorius, 12 parts of Prunus persica, 12 parts of Aconitum carmichaelii (processed), 16 parts of Artemisia argyi, and 16 parts of Achyranthes bidentata.

[0050] Preparation method: Mix all raw materials, pulverize to 20 mesh, sterilize by moist heat (121℃, 15~20min), dry to a moisture content of <13%, and pack into a non-woven fabric inner bag to obtain a traditional Chinese medicine foot bath pack with a single bag weight of 150g.

[0051] Example 3 A traditional Chinese medicine foot bath pack for perioperative rehabilitation of uterine masses and related diseases, with the following formula and preparation method: The proportions of the Chinese herbal composition (parts by weight) are as follows: 36 parts of Salvia miltiorrhiza, 36 parts of Spatholobus suberectus, 24 parts of Paeonia lactiflora, 24 parts of Caesalpinia sappan, 24 parts of Carthamus tinctorius, 18 parts of Prunus persica, 18 parts of Aconitum carmichaelii (processed), 24 parts of Artemisia argyi, and 24 parts of Achyranthes bidentata.

[0052] Preparation method: Mix all raw materials, pulverize to 60 mesh, sterilize by moist heat (121℃, 15~20min), dry to a moisture content of <13%, and pack into a non-woven fabric inner bag to obtain a traditional Chinese medicine foot bath pack with a single bag weight of 250g.

[0053] Example 4 A traditional Chinese medicine foot bath pack for perioperative rehabilitation of uterine masses and related diseases, with the following formula and preparation method: The proportions of the Chinese herbal composition (parts by weight) are as follows: 27 parts of Salvia miltiorrhiza, 27 parts of Spatholobus suberectus, 18 parts of Paeonia lactiflora, 18 parts of Caesalpinia sappan, 18 parts of Carthamus tinctorius, 13 parts of Prunus persica, 13 parts of Aconitum carmichaelii (processed), 18 parts of Artemisia argyi, and 18 parts of Achyranthes bidentata.

[0054] Preparation method: Mix all raw materials, pulverize to 30 mesh, sterilize by moist heat (121℃, 15~20min), dry to a moisture content of <13%, and pack into a non-woven fabric inner bag to obtain a traditional Chinese medicine foot bath pack with a single bag weight of 226g.

[0055] Example 5 A traditional Chinese medicine foot bath pack for perioperative rehabilitation of uterine masses and related diseases, with the following formula and preparation method: The proportions of the Chinese herbal composition (parts by weight) are as follows: 33 parts of Salvia miltiorrhiza, 33 parts of Spatholobus suberectus, 22 parts of Paeonia lactiflora, 22 parts of Caesalpinia sappan, 22 parts of Carthamus tinctorius, 17 parts of Prunus persica, 17 parts of Aconitum carmichaelii (processed), 22 parts of Artemisia argyi, and 22 parts of Achyranthes bidentata.

[0056] Preparation method: Mix all raw materials, pulverize to 50 mesh, sterilize by moist heat (121℃, 15~20min), dry to a moisture content of <13%, and pack into a non-woven fabric inner bag to obtain a traditional Chinese medicine foot bath pack with a single bag weight of 168g.

[0057] Test case 1. Research subjects and grouping Eighty patients with uterine fibroids or other uterine lesions during the perioperative period were selected. All cases were admitted to the Department of Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences from February to July 2025. Inclusion criteria: ① Meeting the diagnostic criteria for uterine fibroids, endometriosis, chocolate cysts, endometrial polyps, or other uterine fibroids and scheduled for surgical treatment; ② Stable vital signs during the perioperative period and no serious organic lesions of the heart, liver, kidneys, or hematology system; ③ No history of foot skin damage or allergies, no contraindications to foot baths, and good compliance.

[0058] Patients were randomly divided into an observation group and a control group, with 40 patients in each group. The age of the patients in both groups ranged from 28 to 56 years, with a mean age of 41.5 ± 7.2 years.

[0059] Disease types: 32 cases of uterine fibroids, 18 cases of endometriosis, 15 cases of chocolate cysts, and 15 cases of endometrial polyps.

[0060] Surgical procedures included: myomectomy (25 cases), cystectomy (20 cases), polyp removal (20 cases), and hysterectomy (15 cases).

[0061] The duration of the disease ranged from 1 to 8 years, with an average of 3.6 ± 1.5 years. There was no statistically significant difference in baseline data. P (>0.05), making them comparable.

[0062] 2. Intervention methods 2.1 Control Group Routine perioperative nursing care and treatment for uterine malformations were implemented, including: ① preoperative examination, health education, psychological counseling, and guidance on preoperative preparation; ② postoperative symptomatic treatment such as fluid replacement, anti-infection, hemostasis, and analgesia, and monitoring of vital signs, wound and lochia; ③ guidance on postoperative diet, activity, personal care, and routine rehabilitation; no traditional Chinese medicine foot bath packs or other external rehabilitation aids were used.

[0063] 2.2 Observation Group Based on the routine nursing and treatment of the control group, the patient was given the traditional Chinese medicine foot bath pack for perioperative rehabilitation of uterine masses in Example 1. This foot bath pack is formulated to address the core pathogenesis of uterine masses, namely blood stasis, cold coagulation, and qi stagnation.

[0064] Timing of use: Start using 3 days before surgery and resume use on the first day after surgery (after anesthesia has worn off and vital signs have stabilized). Continuous intervention before and after surgery.

[0065] Instructions for use: Place one foot bath pack into a foot bath tub, add an appropriate amount of boiling water, and when the water temperature drops to 38~42℃, soak both feet in the solution for 15~30 minutes, once a day.

[0066] Precautions: Monitor the patient's physical sensations during the foot bath. If redness, itching, dizziness, or other discomfort occurs on the feet, discontinue use immediately. Avoid wetting the surgical wound during the foot bath after surgery.

[0067] 3. Observation Indicators and Evaluation Methods The observation indicators were set according to the core dimensions of the "Questionnaire on the Effect of Traditional Chinese Medicine Foot Bath Packs in the Perioperative Period for Uterine Abdominal Masses". Combined with the pathogenesis characteristics of blood stasis, cold coagulation and qi stagnation in uterine abdominal masses, the evaluation was carried out 3 days before the intervention and 7 days after the intervention. All data were collected and verified by two professional nurses to ensure accuracy.

[0068] 3.1 Preoperative efficacy indicators A four-level scoring method was used to evaluate the treatment effect on the pathogenesis of blood stasis, cold coagulation, and qi stagnation: ① Improvement in qi and blood circulation (significant improvement, some improvement, no significant change, aggravation); ② Relief of lower abdominal cold pain and distension (significant reduction, some reduction, no change, aggravation); ③ Improvement in surgical tolerance (significant improvement, some improvement, no change, decline).

[0069] 3.2 Postoperative efficacy indicators The four-level scoring method was used to evaluate the improvement of postoperative complications related to residual blood stasis and cold-dampness invasion: ① relief of abdominal pain and distension; ② improvement of lochia (amount and duration); ③ improvement of cold pain and aversion to cold in the limbs; ④ improvement of general weakness and lethargy; ⑤ improvement of soreness and numbness in the lower limbs; ⑥ wound healing speed (significantly faster, somewhat faster, no change, delayed).

[0070] 3.3 Overall Effectiveness and Satisfaction Indicators ① Overall rehabilitation-promoting effect (very helpful, somewhat helpful, not very helpful, no help); ② Improvement in postoperative comfort (significantly improved, somewhat improved, no change, decreased); ③ Improvement in physical condition (significant improvement, some improvement, no change, worsening), with a focus on evaluating the effects of conditioning for blood stasis and cold coagulation constitutions; ④ Willingness evaluation (willing to continue using / recommend, uncertain, unwilling), overall satisfaction rate = (very helpful + somewhat helpful) / total number of cases × 100%, recommendation rate = willing to continue using / number of recommended cases / total number of cases × 100%.

[0071] 3.4 Safety Indicators Observe and record whether adverse reactions such as foot skin allergy, itching, redness and swelling, and dizziness occur in the two groups of patients during the intervention period, and calculate the incidence of adverse reactions.

[0072] 3.5 Statistical Methods Data analysis was performed using SPSS 26.0 software. Count data were expressed as percentages (%), and comparisons between groups were performed using the chi-square test (x̄). 2 For ordinal data, the rank-sum test is used. P <0.05 indicates a statistically significant difference.

[0073] 4. Test Results 4.1 Comparison of preoperative efficacy indicators As shown in Table 1, the preoperative blood circulation improvement rate, lower abdominal pain and distension relief rate, and surgical tolerance improvement rate in the observation group were 95.0%, 92.5%, and 90.0%, respectively, all significantly higher than those in the control group (22.5%, 20.0%, and 17.5%). All differences between the groups were statistically significant. P<0.001), indicating that the herbal foot bath pack of the present invention can effectively regulate the pathological state of blood stasis, cold coagulation and qi stagnation in patients with uterine masses before surgery, significantly improve blood circulation, relieve lower abdominal cold pain and distension, and greatly improve the patient's surgical tolerance.

[0074] Table 1 Comparison of preoperative efficacy indicators between the two groups of patients (n=40, %)

[0075] Note: Improvement rate = (Number of cases with significant improvement / significant relief / significant improvement + number of cases with some improvement / some relief / some improvement) / total number of cases × 100%. This indicator directly reflects the preoperative conditioning effect of foot bath packs on the pathogenesis of blood stasis, cold coagulation, and qi stagnation.

[0076] 4.2 Comparison of postoperative efficacy indicators As shown in Table 2, the observation group showed significantly higher rates of relief from postoperative abdominal pain and distension, improvement in lochia, improvement in cold and aches in the limbs, improvement in general weakness and mental state, improvement in lower limb soreness and numbness, and faster wound healing compared to the control group. All these indicators showed highly statistically significant differences between the groups. P <0.001), indicating that the herbal foot bath pack of the present invention can effectively remove residual blood stasis after surgery, warm the meridians and dispel cold, unblock the collaterals and relieve pain, significantly reduce postoperative complications, accelerate wound healing, and promote rapid postoperative recovery of patients.

[0077] Table 2 Comparison of postoperative efficacy indicators between the two groups of patients (n=40, %)

[0078] Note: The improvement rate / acceleration rate is calculated in the same way as the preoperative indicators. The wound healing acceleration rate = (significantly accelerated + somewhat accelerated) number of cases / total number of cases × 100%. This indicator reflects the rehabilitation effect of the foot bath pack in removing residual blood stasis and dispelling cold and dampness after surgery.

[0079] 4.3 Comparison of overall effect and satisfaction As shown in Table 3, the overall rehabilitation satisfaction rate, postoperative comfort improvement rate, physical condition improvement rate, and continued use / recommendation rate in the observation group were 100.0%, 97.5%, 95.0%, and 100.0%, respectively, all significantly higher than those in the control group. The differences between the groups for each indicator were all statistically significant. P <0.001), which fully demonstrates that the herbal foot bath pack of the present invention can significantly improve the perioperative recovery effect and comfort of patients, effectively improve blood stasis and cold coagulation constitution, and the patient acceptance, satisfaction and willingness to recommend it are extremely high.

[0080] Table 3 Comparison of overall outcomes and satisfaction between the two groups of patients (n=40, %)

[0081] 4.4 Comparison of Safety Indicators Observation group: No adverse reactions occurred during the intervention period, and the incidence of adverse reactions was 0%.

[0082] Control group: No adverse reactions related to rehabilitation occurred during the intervention period, and the incidence of adverse reactions was 0%.

[0083] There was no statistically significant difference between the groups. P >0.05), indicating that the herbal foot bath pack of the present invention has a scientific formulation and good safety.

[0084] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for perioperative rehabilitation of uterine masses, characterized in that, The raw materials include the following ingredients by weight: 24-36 parts of Salvia miltiorrhiza, 24-36 parts of Spatholobus suberectus, 16-24 parts of Paeonia lactiflora, 16-24 parts of Sappanwood, 16-24 parts of Carthamus tinctorius, 12-18 parts of Prunus persica, 12-18 parts of processed Aconitum carmichaelii, 16-24 parts of Artemisia argyi, and 16-24 parts of Achyranthes bidentata.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw materials include the following ingredients by weight: 30 parts of Salvia miltiorrhiza, 30 parts of Spatholobus suberectus, 20 parts of Paeonia lactiflora, 20 parts of Caesalpinia sappan, 20 parts of Carthamus tinctorius, 15 parts of Prunus persica, 15 parts of Aconitum carmichaelii (processed), 20 parts of Artemisia argyi, and 20 parts of Achyranthes bidentata.

3. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: Mix all raw materials, pulverize, sterilize, and dry.

4. The preparation method according to claim 3, characterized in that, The particle size of the pulverized material is 20-60 mesh.

5. The preparation method according to claim 3, characterized in that, The sterilization is performed using moist heat sterilization; the temperature of the moist heat sterilization is 121℃, and the time is 15~20min.

6. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a topical medicine for perioperative rehabilitation of uterine masses.

7. The application according to claim 6, characterized in that, The uterine lesions mentioned include uterine fibroids, endometriosis, chocolate cysts, and endometrial polyps.

8. The application according to claim 6, characterized in that, The perioperative period includes the three days before surgery and after the patient has recovered from anesthesia and their vital signs are stable.

9. A traditional Chinese medicine foot bath pack for perioperative rehabilitation of uterine masses, characterized in that, The traditional Chinese medicine composition according to claim 1 or 2 is placed into a non-woven fabric inner bag.

10. The herbal foot bath pack according to claim 9, characterized in that, Each bag weighs 150~250g.

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