A traditional Chinese medicine composition for the prevention and treatment of peritoneal dialysis-related peritonitis with heat-toxin and blood stasis syndrome.

Abstract

This invention relates to a traditional Chinese medicine composition for the prevention and treatment of peritoneal dialysis-related peritonitis with heat-toxin and blood stasis syndrome. It is made from rhubarb, peony bark, peach kernel, winter melon seed, angelica, and euonymus alatus. It has the functions of clearing heat and detoxifying, resolving blood stasis and promoting bowel movement. It can effectively treat peritoneal dialysis-related peritonitis, improve the patient's heat-toxin and blood stasis syndrome including TCM syndrome, and reduce the recurrence rate of peritonitis.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for the prevention and treatment of peritoneal dialysis-related peritonitis with heat-toxin and blood stasis syndrome. Background Technology

[0002] Chronic kidney disease (CKD) is becoming a global epidemic, caused by kidney damage from various factors. Once diagnosed, it eventually progresses to end-stage renal disease (ESRD), imposing a severe burden on individuals and society. Peritoneal dialysis (PD) is an important renal replacement therapy for ESRD patients. Compared to hemodialysis, PD patients have a lower economic burden and a higher quality of life. Due to long-term PD treatment, the peritoneal cavity is always in a high-pressure and high-glucose environment. These factors, along with the uremic microinflammatory state of ESRD, easily lead to PD-related peritonitis. PD-related peritonitis is one of the common and serious complications of peritoneal dialysis, and a major cause of patient withdrawal and even death.

[0003] The root cause of peritoneal dialysis-associated peritonitis (PD-A) is the uremic microinflammation and the high-glucose environment of the peritoneal dialysis fluid, leading to peritoneal immune dysfunction. The microinflammatory state is a mild but persistent immune inflammatory response triggered by the activation of the mononuclear-macrophage system, induced by factors such as endotoxins, microorganisms, and immune complexes. This is mainly manifested by a mild increase in systemic circulating inflammatory response proteins such as IL-6 and TNF-α. Recent studies have shown a correlation between peritoneal resident macrophages and the occurrence of PD-A associated peritonitis. In the uremic microinflammatory state, the number of peritoneal resident macrophages with anti-inflammatory functions decreases, affecting normal peritoneal immune function and thus promoting the development of PD-A associated peritonitis.

[0004] Rhubarb and Peony Decoction, a classic traditional Chinese medicine formula for treating appendicitis, is widely used in clinical practice. However, its application in peritonitis is less frequently reported. Su Yumeng et al. reported the application of a modified Rhubarb and Peony Decoction in the treatment of acute peritonitis. All patients in the control group (Western medicine treatment group) received routine symptomatic treatment, such as anti-infection therapy. All patients in the observation group (integrated traditional Chinese and Western medicine treatment group) received integrated traditional Chinese and Western medicine therapy, supplementing the control group's treatment with a modified Rhubarb and Peony Decoction. The formula's ingredients are: rhubarb 12g, peony bark 3g, winter melon seed 30g, peach kernel 9g, mirabilite 9g, patrinia scabiosaefolia 15g, dandelion 15g. Gong Xunbin reported on the integrated traditional Chinese and Western medicine treatment of acute appendicitis peritonitis. Western medicine employed anti-infection measures, while the traditional Chinese medicine primarily used a modified Da Huang Mu Dan Tang formula: 15g raw rhubarb, 15g peony bark, 30g winter melon seed, 15g peach kernel, 15g red peony root, 30g patrinia root, 15g raw gardenia fruit, 15g magnolia bark, 15g citron, and 30g dandelion. Although Da Huang Mu Dan Tang can be used for peritonitis, there are currently no reports of its use for peritoneal dialysis (PD)-related peritonitis. Furthermore, for uremia patients, the underlying cause of PD-related peritonitis differs from that of general peritonitis, and treatment must consider the specific conditions of uremia patients, especially the limitations imposed by impaired renal function on drug application.

[0005] Therefore, existing medications are still insufficient for the clinical treatment of peritoneal dialysis (PD)-related peritonitis in patients with kidney disease, especially those with uremia. Summary of the Invention

[0006] The purpose of this invention is to provide a traditional Chinese medicine composition for the prevention and treatment of heat-toxin and blood stasis syndrome in peritoneal dialysis-related peritonitis. This composition has the functions of clearing heat and detoxifying, resolving blood stasis and promoting bowel movement. It can effectively treat heat-toxin and blood stasis syndrome in peritoneal dialysis-related peritonitis. At the same time, this composition can improve the function of peritoneal macrophages, reduce the levels of IL-6 and TNF-α in peritoneal dialysis fluid, accelerate the repair of peritoneal function, thereby improving the prognosis of peritoneal dialysis peritonitis patients and reducing the recurrence rate of peritonitis.

[0007] This invention provides a traditional Chinese medicine composition for the prevention and treatment of peritoneal dialysis-related peritonitis with heat-toxin and blood stasis syndrome, which is made from the following traditional Chinese medicine raw materials in parts by weight: rhubarb 5-25 parts, peony bark 2-10 parts, peach kernel 9-25 parts, winter melon seed 20-40 parts, angelica 10-25 parts, and euonymus alatus 10-40 parts.

[0008] The preferred ingredients are the following Chinese medicinal materials in parts by weight: 10-25 parts rhubarb, 2-10 parts peony bark, 9-25 parts peach kernel, 20-40 parts winter melon seed, 10-25 parts angelica, and 15-40 parts Euonymus alatus.

[0009] The preferred ingredients are the following Chinese medicinal materials in parts by weight: 10-20 parts rhubarb, 2-6 parts peony bark, 15-20 parts peach kernel, 22-30 parts winter melon seed, 12-20 parts angelica, and 18-30 parts Euonymus alatus.

[0010] The preferred ingredients are the following Chinese medicinal materials in parts by weight: 15-25 parts rhubarb, 2-8 parts peony bark, 10-20 parts peach kernel, 20-35 parts winter melon seed, 10-20 parts angelica, and 15-35 parts Euonymus alatus.

[0011] Further, it is made from the following Chinese medicinal materials in parts by weight: 20 parts rhubarb, 5 parts peony bark, 15 parts peach kernel, 30 parts winter melon seed, 15 parts angelica, and 25 parts Euonymus alatus.

[0012] Alternatively, it can be made from the following Chinese medicinal materials in parts by weight: 15 parts rhubarb, 5 parts peony bark, 12 parts peach kernel, 30 parts winter melon seed, 15 parts angelica, and 25 parts Euonymus alatus.

[0013] The heat-toxin and blood stasis syndrome includes one or more TCM syndromes selected from the frequency of abdominal pain attacks, duration of abdominal pain, fever, diarrhea, nausea and vomiting, abdominal distension, constipation, and tongue appearance.

[0014] The pathogenesis of peritoneal dialysis-related peritonitis with heat-toxin and blood stasis syndrome, as described in this invention, is based on spleen and kidney deficiency, with damp-heat and turbid toxins as the superficial manifestations. It is an invasion of turbid toxins on the basis of renal failure, often affecting the spleen, stomach, intestines, and gallbladder. In the early stage of this disease, the superficial manifestations are mainly excessive, with pathogenic factors accumulating in the intestines. The treatment principle is to clear heat and detoxify, and to promote bowel movement and eliminate turbidity, so as to quickly remove the tangible pathogenic factors, reduce intestinal distension, and improve the high-toxicity environment of the abdominal cavity to alleviate peritonitis symptoms. Rhubarb in this formula clears heat and detoxifies, and promotes bowel movement to eliminate turbidity. It can improve the inflammatory state in the patient's body and expel pathogenic factors, reducing the accumulation of toxins. Peony bark clears heat and cools the blood, invigorates blood and removes blood stasis. Its cold nature can resolve heat and toxins in the blood, while invigorating blood without leaving stasis. Peach kernel moistens the intestines, invigorates blood and removes blood stasis, promoting the excretion of toxins with feces. Winter melon seed is sweet, cold and slippery, moistening the intestines and promoting bowel movement, facilitating the excretion of turbid toxins from the intestines, and also drawing out damp heat through urination. Angelica sinensis nourishes the blood, moistens the intestines and promotes bowel movement, ensuring that the entire formula purges without harming the body's vital energy. Euonymus alatus breaks up blood stasis, disperses nodules and reduces swelling, preventing the formation of local thrombosis, and at the same time, dispersing nodules and reducing swelling can improve intestinal distension. The entire formula works together to clear heat and detoxify, resolve blood stasis and promote bowel movement.

[0015] The present invention also provides the above-mentioned traditional Chinese medicine composition for improving the efficacy of sensitive antibiotics in the treatment of peritoneal dialysis-related peritonitis. The sensitive antibiotic is selected from cephalosporins, preferably cefazolin sodium and / or cefoperazone sodium / sulbactam sodium.

[0016] The traditional Chinese medicine composition preparation can be selected from one of the following: decoction, pill, ointment, granule, tablet, capsule, or oral liquid.

[0017] The present invention also provides a method for preparing the traditional Chinese medicine composition, wherein each traditional Chinese medicine is extracted with water or a C1-C4 alcohol aqueous solution; preferably, peony bark, peach kernel, winter melon seed, angelica and euonymus are first extracted with water or a C1-C4 alcohol aqueous solution, and then rhubarb is added to continue extraction, and the extract is collected.

[0018] The alcohol is one of methanol, ethanol, propanol, or butanol. The aqueous solution of alcohol is preferably 10-95% ethanol, more preferably 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% ethanol solution.

[0019] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for the prevention and treatment of peritoneal dialysis-related peritonitis with heat-toxin and blood stasis syndrome.

[0020] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for the prevention and treatment of heat-toxin and blood stasis syndrome in peritoneal dialysis-related peritonitis in patients with kidney disease.

[0021] The kidney diseases mentioned are diabetic nephropathy, uremia, and chronic renal failure.

[0022] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in a medicament for reducing the recurrence of peritoneal dialysis-related peritonitis.

[0023] The traditional Chinese medicine composition of this invention has the functions of clearing heat and detoxifying, resolving blood stasis and promoting bowel movement. It can effectively treat heat-toxin and blood stasis syndrome, including traditional Chinese medicine syndrome, in patients with peritoneal dialysis-related peritonitis and reduce the recurrence rate of peritonitis.

[0024] Example 1

[0025] Preparation of decoction:

[0026] Formula: Rhubarb 20g, Moutan bark 5g, Peach kernel 15g, Winter melon seed 30g, Angelica sinensis 15g, Euonymus alatus 25g.

[0027] Preparation method: Add peony bark, peach kernel, winter melon seed, angelica and euonymus to 800ml of water and decoct for 40 minutes. Then add rhubarb and decoct for another 20 minutes. Filter and collect the filtrate. Add water to the dregs and decoct for another 20 minutes. Take the filtrate and combine the two filtrates to obtain the decoction.

[0028] Example 2

[0029] Preparation of decoction:

[0030] Formula: Rhubarb 15g, Moutan bark 5g, Peach kernel 25g, Winter melon seed 25g, Angelica sinensis 25g, Euonymus alatus 35g.

[0031] Preparation method: Add peony bark, peach kernel, winter melon seed, angelica and euonymus to 1000ml of water and decoct for 40 minutes. Then add rhubarb and decoct for another 20 minutes. Filter and collect the filtrate. Add water to the dregs and decoct for another 20 minutes. Take the filtrate and combine the two filtrates to obtain the decoction.

[0032] Example 3

[0033] Preparation of oral liquid:

[0034] Formula: Rhubarb 25g, Moutan bark 5g, Peach kernel 8g, Winter melon seed 25g, Angelica sinensis 10g, Euonymus alatus 15g.

[0035] Preparation method: Peony bark, peach kernel, winter melon seed, angelica and Euonymus alatus are added to 60% ethanol and heated and refluxed for extraction. Then rhubarb is added and refluxed for another 20 minutes. After filtration, the filtrate is collected. The residue is added to 70% ethanol and refluxed for another 20 minutes. The filtrate is collected, the two filtrates are combined, the ethanol is recovered, the mixture is concentrated, aspartame is added as a sweetener, the mixture is bottled, sterilized, and an oral liquid is obtained.

[0036] Example 4

[0037] Preparation of granules:

[0038] Formula: Rhubarb 20g, Moutan bark 10g, Peach kernel 10g, Winter melon seed 10g, Angelica sinensis 25g, Euonymus alatus 10g.

[0039] Preparation method: Rhubarb, peony bark, peach kernel, winter melon seed, and angelica are crushed separately. Then, peony bark, peach kernel, winter melon seed, angelica, and Euonymus alatus are added to 1000ml of water and decocted for 40 minutes. Then, rhubarb is added and decocted for another 20 minutes. After filtration, the filtrate is collected. The dregs are added to water and decocted for another 30 minutes. The filtrate is collected, and the two filtrates are combined, concentrated, dried, and crushed. Dextrin and magnesium stearate are added to make granules.

[0040] Experimental Example 1: Clinical study of the prevention and treatment of PD-related peritonitis with heat-toxin and blood stasis syndrome according to the present invention.

[0041] 1.1 The cases in this study were 90 patients with PD-related peritonitis admitted to the Department of Nephrology, First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from June 2021 to June 2022.

[0042] 1.2 Inclusion criteria:

[0043] 1.2.1. Subjects signed informed consent forms and cooperated with the study;

[0044] 1.2.2. Subjects aged 18-80 years;

[0045] 1.2.3. Patients diagnosed with end-stage renal disease according to the 2012 KDIGO Clinical Practice Guidelines for the Assessment and Management of CKD;

[0046] 1.2.4. Subjects who underwent membrane dialysis catheter placement at our hospital and were regularly followed up at our peritoneal dialysis center to maintain stable peritoneal dialysis.

[0047] 1.2.5. Subjects with complete clinical data who are able to complete the relevant statistical analyses for this study;

[0048] 1.2.6.2 No traditional Chinese medicine or prepared Chinese medicine was taken within the past week;

[0049] 1.2.7. Meets the diagnostic criteria for peritoneal dialysis-related peritonitis;

[0050] 1.3. Exclusion Criteria

[0051] 1.3.1. Those who do not meet the inclusion criteria;

[0052] 1.3.2. Patients with unstable conditions, complicated by serious chronic diseases of the heart, brain, liver, gastrointestinal tract, tumors, hematological diseases, and serious infectious diseases;

[0053] 1.3.3. Patients who are undergoing hemodialysis concurrently or who have undergone hemodialysis, plasma exchange, or hemofiltration within the past 3 months;

[0054] 1.3.4. Patients whose mental state is unable to cooperate with observation;

[0055] 1.3.5. Patients with acute renal failure;

[0056] 1.3.6. The researchers determined that the patient had other reasons that made them unsuitable for enrollment.

[0057] 1.3.7. Refractory peritonitis, fungal / tuberculous peritonitis, etc.;

[0058] 1.3.8. Pregnant or lactating women;

[0059] 1.3.9. Patients who have taken probiotics or other probiotic regulators, antibiotics, or immunosuppressants in the past two weeks;

[0060] 1.3.10. Patients with a history of abdominal trauma, gastrointestinal endoscopy, or surgery within the past 3 months.

[0061] 1.4 Treatment Method: The herbal formula of this invention is prepared as a decoction, taken twice daily, morning and evening, 200ml each time. Patients were randomly divided into three groups of 30 each. The herbal formula group received a sufficient dose of sensitive antibiotics (intraperitoneal injection of cefazolin sodium and cefoperazone sodium / sulbactam sodium) plus the herbal formula treatment; the rhubarb and peony decoction group received a sufficient dose of sensitive antibiotics (intraperitoneal injection of cefazolin sodium and cefoperazone sodium / sulbactam sodium) plus the rhubarb and peony decoction treatment; the control group received a sufficient dose of sensitive antibiotics (intraperitoneal injection of cefazolin sodium and cefoperazone sodium / sulbactam sodium). The treatment duration was 14 days.

[0062] One of the ingredients is Rhubarb and Peony Decoction: 12g rhubarb, 3g peony bark, 9g peach kernel, 30g winter melon seed, and 9g Glauber's salt. The rhubarb, peony bark, peach kernel, and winter melon seed are decocted in water, and Glauber's salt is added to the decoction to dissolve before taking.

[0063] Traditional Chinese medicine formula: rhubarb 15g, peony bark 5g, peach kernel 12g, winter melon seed 30g, angelica 15g, and euonymus alatus 25g.

[0064] 1.5 Observation indicators: cure rate, effective rate of TCM symptom score, time for peritonitis to turn negative, recurrence rate of peritonitis within 1 year, proportion of peritoneal macrophages before and after treatment, and changes in IL-6 and TNF-α levels in peritoneal dialysis fluid before and after treatment.

[0065] 1.5.1 Efficacy assessment of PD-related peritonitis with heat-toxin and blood stasis syndrome

[0066] (1) Significant effect: TCM clinical symptoms and signs are significantly improved, and the syndrome score is reduced by ≥70%. (2) Effective: TCM clinical symptoms and signs are improved, and the syndrome score is reduced by ≥30%. (3) Ineffective: TCM clinical symptoms and signs are not significantly improved, or even aggravated, and the syndrome score is reduced by less than 30%.

[0067] Referring to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", the formula for calculating the percentage reduction in syndrome score is: [(Total score before treatment - Total score after treatment) / Total score before treatment] × 100%.

[0068] The syndrome score was formulated with reference to the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases and Syndromes" (2012) and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" (2002). The assessment used TCM syndromes to evaluate the frequency of abdominal pain attacks, duration of abdominal pain, fever, diarrhea, nausea and vomiting, abdominal distension, constipation, and tongue appearance. Each item was scored out of 3 points; the lower the score, the better the effect. 1.6 Clinical Efficacy: Peritonitis in all groups showed significant improvement after treatment, and the inflammation was effectively treated. However, there were certain differences in the efficacy of TCM syndromes among the groups. Based on the TCM syndrome score efficacy and comparison of clinical symptoms and signs, it was found that the total effective rate of the TCM formula group of this invention was significantly higher than that of the control group. Therefore, the TCM composition of this invention has better efficacy and prognosis in alleviating various TCM syndromes of peritoneal dialysis-related peritonitis, demonstrating a significant overall therapeutic advantage (results are shown in Table 1).

[0069] Table 1 Comparison of the therapeutic effects of different groups on PD-related peritonitis with heat-toxin and blood stasis syndrome

[0070]

[0071] According to the results in Table 2, there was no significant difference in the time to clear peritonitis among the groups. However, the recurrence rate within one year was significantly different between the traditional Chinese medicine composition of the present invention and the control group and the rhubarb and peony decoction group. The traditional Chinese medicine composition of the present invention can significantly reduce the recurrence rate within one year (see Table 2).

[0072] Table 2 Comparison of peritonitis clearance time and recurrence rate among different groups

[0073]

[0074] Based on the above results, this invention further compared the number of macrophages residing in the peritoneal cavity and the levels of IL-6 and TNF-α in the peritoneal dialysis fluid before and after treatment between the herbal composition of this invention and the control group. The results are as follows:

[0075] Table 3 Comparison of peritoneal macrophages before and after treatment in the control group

[0076]

[0077] Table 4 Comparison of peritoneal macrophages before and after treatment with the traditional Chinese medicine composition of the present invention.

[0078]

[0079] The results in Tables 3 and 4 show that, compared with the number of peritoneal macrophages before and after treatment, the number of peritoneal macrophages in the traditional Chinese medicine group increased.

[0080] Table 5. IL-6 and TNF-α levels in peritoneal dialysis fluid of each group before treatment.

[0081]

[0082] Table 6. IL-6 and TNF-α levels in peritoneal dialysis fluid after treatment in each group.

[0083]

[0084] The results in Tables 5 and 6 show that the traditional Chinese medicine composition of the present invention can significantly reduce the levels of IL-6 and TNF-α in peritoneal dialysis fluid.

[0085] In summary, clinical trials have shown that traditional Chinese medicine formulas can effectively cure PD-related peritonitis, improve patients' TCM syndromes, improve the function of peritoneal macrophages, and reduce the recurrence rate.

[0086] Experiment Example 2

[0087] Case 1

[0088] Patient Chen, female, 67 years old, was admitted on November 7th due to "abdominal pain accompanied by turbid peritoneal dialysis fluid for 3 days". She has a 24-year history of hypertension, a 17-year history of diabetes, and a 10-year history of diabetic nephropathy. Four years ago, she underwent peritoneal dialysis catheter placement due to progression to end-stage renal disease. Post-operatively, she regularly underwent home dialysis, currently on a regimen of 1.5% PDS 2000ml x 3; 2.5% PDS 2000ml x 2, with 4 hours of catheterization. Three days prior, she experienced abdominal pain due to contaminated food, with turbid peritoneal dialysis fluid, fever (maximum temperature 38℃), which subsided after taking ibuprofen. Upon admission, she experienced abdominal pain accompanied by nausea, vomiting, stomach discomfort, loss of appetite, constipation, and turbid peritoneal dialysis fluid. She had no chills or fever, urinated 400ml, and underwent 24-hour peritoneal dialysis ultrafiltration of 400ml. Her tongue was pale red with a yellow coating, and her pulse was deep, slippery, and thready. Physical examination: Temperature 37.3℃, abdomen distended, mild tenderness around the umbilicus, no rebound tenderness, peritoneal dialysis catheter visible in the abdomen, no redness, swelling, bleeding or effusion at the tunnel opening, bilateral lower extremity edema. Visual analogue score (VAS): 5 points, Gastrointestinal Symptom Rating Scale (GSRS): 28 points. Admission peritoneal dialysis fluid routine examination: White blood cell count 10154.00x10⁻¹². 6 The patient's blood glucose level was 62.4% (6 / L), indicating peritoneal dialysis-associated peritonitis. Cefazolin sodium and cefoperazone sodium / sulbactam sodium were administered intraperitoneally. The patient experienced constipation, abdominal pain, nausea, and vomiting. Traditional Chinese medicine diagnosis indicated damp-heat and turbid toxins accumulating in the middle jiao (stomach and intestines), causing qi stagnation and abdominal pain, and impaired stomach function leading to constipation and vomiting. Treatment focused on clearing heat and detoxifying, and purging turbidity. A traditional Chinese medicine formula was prescribed (rhubarb 15g, peony bark 5g, peach kernel 12g, winter melon seed 30g, angelica 15g, and euonymus alatus 25g). On November 10th, ascites culture showed Escherichia coli. The patient's ascites routine showed a decrease in white blood cells, and the dialysis fluid was clear. Antibiotics were continued intraperitoneally, combined with oral traditional Chinese medicine decoction, until the full course of treatment was completed. On November 11th, the dialysis fluid routine test turned negative, the abdominal pain disappeared, and the ascites culture was negative. Ascites fluid cultures were performed on November 14th and November 21st. Ascites fluid cultures on November 17th and 24th were both negative. Visual Analogue Scale (VAS) score: 0; Gastrointestinal Symptom Rating Scale (GSRS) score: 19. On November 25th, the patient's peritoneal dialysis fluid flow was unobstructed, clear in color, with no significant edema in the lower extremities, and ultrafiltration was successful. Breath sounds were clear in both lungs, with no obvious dry or wet rales. The abdomen was soft and non-tender, with no edema in the lower extremities. The peritoneal dialysis-related peritonitis had improved, and the patient was discharged.

[0089] Case 2

[0090] Patient Zhang, female, 72 years old, was admitted on November 9th due to "turbid peritoneal dialysis fluid accompanied by fever and vomiting for 2 days". She has a history of chronic glomerulonephritis for over 30 years, hypertension for over 20 years, and coronary atherosclerotic heart disease for over 15 years. Six months ago, she underwent peritoneal dialysis catheter placement due to progression to end-stage renal disease. Post-operatively, she has been regularly performing home dialysis, currently on a regimen of 1.5% PDS 2000ml x 2; 2.5% PDS 2000ml x 1, with the catheter remaining in the peritoneum for 4 hours. Two days ago, without any obvious cause, the patient developed turbid peritoneal dialysis fluid accompanied by fever and vomiting, with a maximum temperature of 37.7℃, but no significant abdominal pain. Upon admission, the patient was alert and in good spirits. The peritoneal dialysis fluid was cloudy. The patient presented with general weakness, chills, constipation, bilateral lower extremity edema, eyelid edema, and poor appetite. There was no abdominal pain or fever. Urine output was 700-800 ml. 24-hour peritoneal dialysis ultrafiltration was 200-400 ml. The tongue was dark red with a white, greasy coating, and the pulse was deep and thready. Physical examination revealed a temperature of 36.5℃, abdominal distension, mild tenderness in the left abdomen without rebound tenderness, and a visible peritoneal dialysis catheter with no redness, swelling, bleeding, or oozing at the tunnel opening. Bilateral lower extremity edema and eyelid edema were also present. Visual analogue score (VAS): 5; Gastrointestinal Symptom Rating Scale (GSRS): 24. Routine peritoneal dialysis fluid analysis showed a white blood cell count of 11976.00 x 10⁻⁶. 6 / L, polymorphonuclear cell percentage 73.6%. Diagnosed as peritoneal dialysis-associated peritonitis. After 3 days of intraperitoneal injection of cefazolin sodium and cefoperazone sodium / sulbactam sodium, the patient experienced abdominal pain, constipation, and chills. Traditional Chinese medicine diagnosed this as the accumulation of turbid toxins in the intestines, causing qi stagnation and abdominal pain, and impaired intestinal function leading to constipation, with the toxins accumulating internally over time. Treatment focused on purging and detoxifying, using a traditional Chinese medicine formula (rhubarb 20g, peony bark 5g, peach kernel 15g, winter melon seed 30g, angelica 15g, and euonymus alatus 25g). On November 12th, ascites culture showed Staphylococcus aureus growth, and the patient's ascites routine white blood cell count decreased. The peritoneal dialysis fluid was clear, and treatment continued for 14 days. On November 14th, the peritoneal dialysis fluid routine white blood cell count was 60.00 x 10⁻⁶. 6 The patient's peritoneal dialysis fluid routine test was negative, abdominal pain disappeared, and ascites culture was negative. Ascites cultures were performed on November 16th and 23rd, and on November 19th and 27th, the results were also negative. Visual Analogue Scale (VAS) score: 0; Gastrointestinal Symptom Rating Scale (GSRS) score: 19. On November 28th, the patient's peritoneal dialysis fluid flow was unobstructed and clear. There was no significant edema in the lower extremities, ultrafiltration was successful, breath sounds were clear in both lungs without obvious dry or wet rales, and the abdomen was soft and non-tender. The patient was discharged.

[0091] Case 3

[0092] Patient Wang, female, 63 years old, was admitted on October 29th due to "abdominal pain accompanied by turbid peritoneal dialysis fluid for 3 days". She has a 15-year history of chronic glomerulonephritis, a 15-year history of hypertension, and a 10-year history of coronary heart disease. Four years ago, she underwent peritoneal dialysis catheter placement due to progression to end-stage renal disease. Post-operatively, she regularly performed home dialysis, currently on a regimen of 1.5% PDS 2000ml x 3; 2.5% PDS 2000ml x 1, with 4 hours of abdominal dialysis. Three days prior, after catching a cold, she developed abdominal pain accompanied by fever, nausea, and vomiting, with a maximum temperature of 38.5℃. The fever subsided after self-administering antipyretics and analgesics, and turbid peritoneal dialysis fluid was observed. Upon admission, she was alert, experiencing abdominal pain with turbid peritoneal dialysis fluid, nausea, vomiting, and bilateral lower extremity edema. She had one formed bowel movement per day, 800ml of urine, and 600-800ml of ultrafiltration per 24 hours of peritoneal dialysis. Her tongue was red with a yellow coating, and her pulse was wiry and thready. Physical examination: Temperature 36.5℃, abdomen distended, mild tenderness around the umbilicus, no rebound tenderness, peritoneal dialysis catheter visible in the abdomen, no redness, swelling, bleeding or effusion at the tunnel opening, bilateral lower extremity edema. Visual analogue score (VAS): 5 points, Gastrointestinal Symptom Rating Scale (GSRS): 27 points. Routine examination of peritoneal dialysis fluid showed a white blood cell count of 14385.00 x 10⁻⁶. 6 The patient's blood volume was 8 / L, with a polymorphonuclear cell percentage of 88.4%, leading to a diagnosis of peritoneal dialysis-associated peritonitis. The patient was treated with intraperitoneal injections of cefazolin sodium and cefoperazone sodium / sulbactam sodium for 3 days. The patient experienced abdominal pain, fever, nausea, and vomiting. Traditional Chinese medicine (TCM) diagnosis indicated damp-heat and toxin accumulation in the middle jiao (stomach and intestines), causing qi stagnation and abdominal pain. The treatment focused on clearing heat and detoxifying, and promoting bowel movement. A TCM formula was prescribed (rhubarb 20g, peony bark 5g, peach kernel 15g, winter melon seed 30g, angelica 15g, and euonymus alatus 25g). On November 1st, the ascites culture results showed Escherichia coli. The patient's ascites routine white blood cell count decreased, and the dialysis fluid was clear. The patient continued intraperitoneal antibiotics combined with oral TCM decoction until the full course of treatment was completed. On November 2nd, the dialysis fluid routine test turned negative, the abdominal pain disappeared, and the ascites culture was negative. Ascites fluid cultures were performed on November 4th and November 11th, and negative results were obtained on November 17th and 24th. The Visual Analogue Scale (VAS) score was 0, and the General Symptom Rating Scale (GSRS) score was 19. On November 12th, the patient's peritoneal dialysis fluid flow was unobstructed, clear in color, with no significant edema in the lower extremities, and ultrafiltration was successful. Breath sounds were clear in both lungs, with no obvious dry or wet rales. The abdomen was soft and non-tender, with no edema in the lower extremities. The peritoneal dialysis-related peritonitis had improved, and the patient was discharged.

[0093] The Visual Analogue Scale (VAS) is a commonly used pain rating system. 0 represents no pain, 10 represents severe pain, and the range from 0 to 10 represents different degrees of pain. The higher the score, the greater the pain.

[0094] The Gastrointestinal Symptom Rating Scale (GSRS) is a commonly used clinical assessment tool for gastrointestinal symptoms. It mainly evaluates symptoms such as abdominal pain, loss of appetite, vomiting, nausea, stomach discomfort, intestinal discomfort, constipation, diarrhea, flatulence, intestinal fullness, heartburn, indigestion, belching, bloating, and anal discomfort. The higher the score, the more pronounced the gastrointestinal symptoms.

Claims

1. A traditional Chinese medicine composition for improving the effect of sensitive antibiotic treatment of peritoneal dialysis related peritonitis with heat toxin blood stasis syndrome, characterized in that, The traditional Chinese medicine composition is made of the following traditional Chinese medicine raw materials in parts by weight: 15-25 parts of rhubarb, 2-8 parts of cortex moutan, 10-20 parts of persicae semen, 20-35 parts of winter melon kernel, 10-20 parts of angelica sinensis, and 15-35 parts of equus asinus.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made of the following traditional Chinese medicine raw materials in parts by weight: 20 parts of rhubarb, 5 parts of cortex moutan, 15 parts of persicae semen, 30 parts of winter melon kernel, 15 parts of angelica sinensis, and 25 parts of equus asinus.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made of the following traditional Chinese medicine raw materials in parts by weight: 15 parts of rhubarb, 5 parts of cortex moutan, 12 parts of persicae semen, 30 parts of winter melon kernel, 15 parts of angelica sinensis, and 25 parts of equus asinus.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that: The dosage form of the traditional Chinese medicine composition is selected from one of the following: decoction, pill, ointment, granule, tablet, capsule, and oral liquid.

5. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that: The preparation method of the traditional Chinese medicine composition comprises extracting each traditional Chinese medicine with water or C1-C4 alcohol aqueous solution.

6. The traditional Chinese medicine composition according to claim 5, characterized in that: The C1-C4 alcohol is one of the following: methanol, ethanol, propanol, and butanol.

7. The traditional Chinese medicine composition according to claim 1, characterized in that, The sensitive antibiotic is selected from cephalosporin antibiotics.

8. The traditional Chinese medicine composition according to claim 7, characterized in that, The cephalosporin antibiotic is selected from cefozolin sodium and / or cefoperazone sodium sulbactam sodium.

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