Traditional Chinese medicine composition for improving chronic kidney disease related pruritus and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for improving chronic kidney disease related pruritus and application thereof. The traditional Chinese medicine composition is prepared from 15 g of radix paeoniae alba, 15 g of angelica sinensis, 24 g of tribulus terrestris, 9 g of radix saposhnikoviae, 24 g of radix rehmanniae recen, 12 g of herba schizonepetae, 15 g of moutan bark, 9 g of liquorice and 12 g of folium artemisiae argyi, the traditional Chinese medicines which are accurately weighed in the formula are ground into fine powder without particles through a traditional Chinese medicine grinding machine, then the fine powder is soaked in hot water or boiled in boiled water, and the mixture is placed at the proper water temperature for foot bath. The traditional Chinese medicine composition is effective in relieving chronic kidney disease related pruritus, the anxiety degree, depression degree and pruritus degree are obviously relieved, the sleep quality is obviously improved, and the traditional Chinese medicine composition has the advantages of good safety, convenience in operation and the like.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for improving chronic kidney disease-related itching and an application thereof. Background Art

[0002] Chronic kidney disease-related pruritus is a common symptom in patients with chronic kidney disease. It can persist in a fixed pattern for more than six weeks, and persistent itching has a negative impact on both the patient's physical and mental health. For most patients, the itching worsens at night, disrupting their sleep. This not only interferes with their normal life and social function, severely reduces their quality of life, and leads to depression, but also increases the risk of cardiovascular disease and can even lead to increased hospitalization rates and long-term mortality, affecting the patient's quality of life. Furthermore, persistent itching causes patients to scratch their skin, damaging the skin barrier and leading to infection.

[0003] Western medicine has limited options for treating pruritus associated with chronic kidney disease, primarily including optimizing dialysis modalities, systemic medications, and topical therapies. While Western medicine treatments may alleviate pruritus associated with chronic kidney disease to some extent, their effectiveness is uncertain, they can be associated with adverse reactions, and are expensive, increasing the medical burden on patients.

[0004] Traditional Chinese Medicine (TCM) believes that pruritus in patients with end-stage chronic kidney disease (CKD) is caused by kidney blood deficiency in the late stage of renal failure and the influence of wind pathogens. Primary treatments include internal and external Chinese medicine (TCM) therapies, as well as meridian and acupoint stimulation. Patients often require strict water control and avoid excessive medication intake. Internal use of TCM may not only burden the kidneys, have certain nephrotoxic effects, and accelerate the loss of renal function, but may also be limited by patients' difficulty with the taste of the medicine. Furthermore, the use of internal TCM formulas conflicts with the need for fluid restriction in CKD. These factors all constitute disadvantages of internal TCM formulas. External TCM therapies offer unique advantages, including definite efficacy, low cost, ease of use, few side effects, and no additional water intake. These methods may represent a new approach to treating CKD-associated pruritus. External TCM therapies include enema, external washes, baths, and soaks. However, these methods are often inconvenient, require difficult temperature control, require frequent manual manipulation, and require large and costly volumes of liquid medicine, hindering their widespread clinical application. The Qufeng Kushe ointment, developed by the Second Affiliated Hospital of Zhejiang Chinese Medical University for the treatment of uremic pruritus, requires repeated, frequent local massage, making it less suitable for frail elderly patients. Chronic kidney disease patients with pruritus are often physically weak and may not have the stamina to complete the frequent local massages required after applying the ointment. Studies have shown that foot baths using traditional Chinese medicine formulas with blood-nourishing and wind-removing properties can effectively alleviate itching symptoms in patients with chronic kidney disease. This approach avoids the drawbacks of external treatments with traditional Chinese medicine. By infusing fine powdered herbs with boiling water or boiling them until they reach a suitable temperature, foot baths are readily available.

[0005] How to develop a Chinese medicine formula that can relieve the itchy skin symptoms of patients with chronic kidney disease and is suitable for foot bathing is a technical problem that needs to be solved urgently. Summary of the Invention

[0006] To overcome the shortcomings of the prior art, the present invention provides a traditional Chinese medicine composition and its use for alleviating chronic kidney disease-related pruritus. The composition is prepared by infusing the finely ground traditional Chinese medicine powder with boiling water or boiling the mixture, bringing it to a suitable temperature, and then using it for foot bathing. This composition is easily disseminated and can treat kidney blood deficiency and dispel wind pathogens, thereby addressing the root cause of chronic kidney disease-related pruritus.

[0007] In order to achieve the above object, the technical solution adopted by the present invention is:

[0008] The first aspect of the present invention provides a traditional Chinese medicine composition for improving itching associated with chronic kidney disease, wherein the traditional Chinese medicine composition is composed of white peony root, angelica root, tribulus terrestris, siler, raw rehmannia root, schizonepeta tenuifolia, moutan bark, liquorice and mugwort.

[0009] White peony root, angelica root, and raw rehmannia root nourish the blood; white tribulus, saposhnikovia root, and schizonepeta dispel wind; peony bark cools the blood; licorice root detoxifies; and mugwort leaf detoxifies and regulates qi and blood. A foot bath using these nine traditional Chinese medicinal ingredients nourishes the blood and dispels wind, addressing kidney blood deficiency and dispelling wind pathogens, thereby addressing the root cause of itching associated with chronic kidney disease.

[0010] Furthermore, the Chinese medicine composition consists of 15 grams of white peony root, 15 grams of angelica root, 24 grams of tribulus terrestris, 9 grams of siler, 24 grams of rehmannia root, 12 grams of schizonepeta tenuifolia, 15 grams of moutan bark, 9 grams of licorice and 12 grams of mugwort.

[0011] The second aspect of the present invention provides a method for preparing a traditional Chinese medicine composition for improving itching associated with chronic kidney disease. The preparation method comprises the following steps: using a traditional Chinese medicine powder grinder to grind accurately weighed white peony root, angelica root, white tribulus terrestris, siler, raw rehmannia root, schizonepeta tenuifolia, peony bark, licorice and mugwort into fine powder without particles.

[0012] A third aspect of the present invention provides an application of a traditional Chinese medicine composition for improving itching associated with chronic kidney disease, wherein the application method is foot bathing.

[0013] Furthermore, the specific method of foot bathing is: soaking the Chinese medicine composition in hot water or boiling water, and then bathing the feet after the water reaches a suitable temperature.

[0014] Furthermore, the dosage ratio of the traditional Chinese medicine composition to water is 135g / 6000ml.

[0015] Furthermore, the temperature of the hot water soaking is 90-100° C., and the soaking time is 60 minutes.

[0016] Furthermore, the suitable water temperature is 41-45°C.

[0017] Furthermore, during foot bathing, the level of the medicinal liquid is controlled to be >10 cm above the ankle, the duration of foot bathing is 20 to 30 minutes, and the frequency of foot bathing is once a day.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] The present application provides a Chinese medicine composition for improving chronic kidney disease-related pruritus, which is composed of 15 grams of white peony root, 15 grams of angelica root, 24 grams of white tribulus terrestris, 9 grams of windproof, 24 grams of raw rehmannia root, 12 grams of schizonepeta tenuifolia, 15 grams of moutan bark, 9 grams of liquorice and 12 grams of mugwort. The Chinese medicine powder machine is used to grind the accurately weighed Chinese medicine into a fine powder without particles, and then soak it in hot water or boil it in boiling water. After it is put to a suitable water temperature, it is used for foot bathing. It is effective for alleviating chronic kidney disease-related pruritus, and its anxiety, depression and pruritus are significantly reduced, and sleep quality is significantly improved. It has the advantages of good safety and easy operation. Specifically, this Chinese medicine combination is applied to patients with chronic kidney disease pruritus by foot bathing. After the medicine is prepared by others according to the liquid preparation method, the patient can soak directly for half an hour without self-massage or continuous massage by others. It is simple and easy to do, and the promotion of this prescription foot bathing helps to expand the application field of traditional Chinese medicine theory and traditional Chinese medicine, and assists in promoting the development of traditional Chinese medicine theory. DETAILED DESCRIPTION

[0020] The following is a further description of specific embodiments of the present invention. It should be noted that the description of these embodiments is intended to facilitate understanding of the present invention and does not constitute a limitation of the present invention. In addition, the technical features involved in the various embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.

[0021] The experimental methods in the following examples are conventional methods unless otherwise specified, and the experimental materials used in the following examples are commercially available unless otherwise specified.

[0022] Example 1: A Chinese medicine composition for improving chronic kidney disease-related itching and its preparation method

[0023] A traditional Chinese medicine composition for improving itching associated with chronic kidney disease, comprising 15 grams of white peony root, 15 grams of angelica root, 24 grams of tribulus terrestris, 9 grams of siler, 24 grams of rehmannia root, 12 grams of schizonepeta tenuifolia, 15 grams of moutan bark, 9 grams of liquorice and 12 grams of mugwort.

[0024] A traditional Chinese medicine powdering machine is used to grind the accurately weighed white peony root, angelica root, white tribulus terrestris, siler, raw rehmannia root, schizonepeta tenuifolia, moutan bark, liquorice and mugwort into fine powder without particles, and the powder is packaged in sealed bags.

[0025] Experimental Example 1: Efficacy test of Chinese medicine composition

[0026] 1. Research subjects

[0027] A. Inclusion criteria

[0028] (1) ≥18 years old;

[0029] (2) Meet the Western medical diagnostic criteria and be diagnosed with chronic kidney disease stage 1 to 5;

[0030] (3) 5-D pruritus scale score ≥6 points;

[0031] (4) activated partial thromboplastin time and prothrombin time were within normal range;

[0032] (5) Ability to communicate fluently with researchers and answer their questions;

[0033] (6) Those who volunteer and sign the informed consent form.

[0034] B. Exclusion criteria

[0035] (1) A diagnosis of mental illness such as delusional disorder, anxiety disorder or depression;

[0036] (2) patients diagnosed with skin diseases such as eczema, atopic dermatitis, psoriasis, chronic urticaria, dermatophytosis, scabies infection, and pemphigoid;

[0037] (3) Chronic skin itching symptoms had occurred before the diagnosis of chronic kidney disease;

[0038] (4) Those with severe skin trauma, ulceration, infection, etc. who are not suitable for foot bathing;

[0039] (5) Those with skin itching caused by biliary cirrhosis, allergies, hyperthyroidism or hypothyroidism, diabetes, malignant tumors, blood diseases, parasites, etc.;

[0040] (6) confirmed neurogenic chronic pruritus caused by central nervous system space-occupying lesions or neurodegenerative diseases such as multiple sclerosis;

[0041] (7) Those who have used any medications for treating skin itching, such as corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressants, or other Chinese herbal preparations in the past month;

[0042] (8) Those who are known to be allergic to any of the Chinese medicines in the Yangxue Shufeng formula;

[0043] (9) After renal transplantation;

[0044] (10) Pregnant women, women preparing to become pregnant, and women who are breastfeeding;

[0045] (11) Participated in other drug trials within 3 months before enrollment;

[0046] (12) Participate in other interventional studies.

[0047] C. Diagnostic criteria for chronic kidney disease

[0048] Chronic kidney disease can be diagnosed if any of the following indicators appear for more than 3 months:

[0049] (1) Renal damage markers: ① proteinuria (albumin-creatinine ratio ≥ 30 mg / d; albumin excretion rate ≥ 30 mg / g); ② abnormal urine sediment; ③ renal tubular lesions; ④ histological abnormalities; ⑤ structural abnormalities seen on imaging; ⑥ history of renal transplantation.

[0050] (2) Decreased glomerular filtration rate: estimated glomerular filtration rate <60 ml / min / 1.73 m 2 .

[0051] D. Termination criteria

[0052] If any of the following conditions occurs, the trial of the subject shall be terminated:

[0053] (1) The subject is unable to continue the trial due to an allergic reaction during the intervention (including allergic reactions to be excluded);

[0054] (2) If a subject experiences a serious adverse reaction during the trial, or the condition worsens due to the primary disease or complications, or other special circumstances, and a dangerous event may occur, the treatment plan needs to be adjusted and the subject should not continue the trial. The main research medical staff will determine that the clinical trial of the subject should be stopped, and to protect the subject, the subject may receive other treatments. The adverse reaction assessment refers to the "Regulations on the Reporting and Monitoring of Adverse Drug Reactions" issued by the Ministry of Health in 2011.

[0055] (3) Those who arbitrarily change the experimental drugs or use drugs that are prohibited by the experimental regulations;

[0056] (4) The subject voluntarily requests to withdraw from the trial or refuses to cooperate with data collection.

[0057] E. Shedding Standard

[0058] (1) Lost to follow-up during the trial, failed to return for follow-up on time, or failed to cooperate with follow-up;

[0059] (2) The subjects had poor compliance and did not complete the entire course of treatment on time during the clinical observation period.

[0060] F. Elimination criteria

[0061] (1) The subjects were not strictly screened according to the inclusion and exclusion criteria;

[0062] (2) the control group received intervention measures from the experimental group for any reason;

[0063] (3) Those who did not receive intervention according to the study protocol for any reason;

[0064] (4) Missing data affects data analysts;

[0065] (5) Those who develop severe skin ulceration or infection during the test.

[0066] G. Handling of Dropout and Termination Cases

[0067] (1) During the follow-up, the subjects who dropped out should be contacted as much as possible, the reasons for withdrawal should be asked and recorded, and the assessment items that can be completed should be completed. If the subject drops out within 1 week of the start of the trial, it will be considered an invalid case. If the subject drops out after completing the treatment course as required, the pre- and post-treatment efficacy evaluation will still be calculated and participate in the data analysis;

[0068] (2) If the subject experiences an allergic reaction, damaged skin integrity, or other conditions that lead to unstable vital signs during or after the Yangxue Shufeng foot bath, the subject should report the situation to the physician, who will evaluate the subject and promptly administer anti-allergic or other symptomatic treatment, and terminate the intervention to ensure the patient's safety. If the condition is severe and a critical illness such as anaphylactic shock occurs, emergency medical treatment measures such as oxygen administration, infusion, respiratory stimulation, and cardiopulmonary resuscitation should be taken immediately. After the emergency is resolved, the subject should be followed up until the above symptoms disappear.

[0069] H. Sampling and grouping methods

[0070] Subjects were randomly assigned to groups using a concealed randomization method. The specific method was as follows: a sequence of 70 integer random numbers was generated using Microsoft Excel software in Office 2017. These numbers were printed out, cut out individually, and placed in opaque envelopes in the order in which the random numbers were generated and sealed. The envelopes were labeled 1 to 70 in the order in which the random numbers were generated and arranged in this order from front to back. This study specified that number 1 was the control group and number 2 was the control group. A researcher not involved in the intervention was assigned envelopes containing random numbers according to the order in which the subjects were enrolled. These envelopes were then given to the clinical implementer, who read the random numbers in the envelopes to determine the patient's group and kept a record. Concealed allocation was completed after the subject was enrolled and before the intervention began. This study was not blinded to the subjects or the clinical implementer; only the subject recruiters, data collectors, and data analysts were blinded.

[0071] 2. Preparation before treatment

[0072] The intervention was implemented in the patient's ward, and the indoor air-conditioning temperature was adjusted to 22-26°C (based on the subject's self-reported comfort). The indoor lighting was kept appropriate, quiet, and well-ventilated. A call bell was installed in the room, and the subjects were instructed to press the call bell to call medical staff if they felt unwell to ensure their safety. The subjects emptied their bowels and bladder before receiving the intervention.

[0073] 3. Treatment

[0074] Remove the sealed outer bag from a traditional Chinese medicine formula and soak in 6000ml of hot water at 90-100°C for 60 minutes, or boil the water until the water reaches a desired temperature (41-45°C). The container should be large enough to hold both feet, with the liquid level reaching >10cm above the ankles. The foot bath should last 20-30 minutes, and should be performed once daily. Closely monitor the patient's condition during the foot bath. If any discomfort, such as dizziness, nausea, fatigue, or palpitations, occurs, discontinue the foot bath immediately, report it to the physician, and cooperate with treatment.

[0075] 4. Treatment timing and course

[0076] Treatment was performed during the Youshi (5:00 PM to 7:00 PM) period, when the kidney meridian is in season and patients require minimal treatment. Furthermore, studies have found that pruritus is more severe at night, so this time period was chosen for intervention. Intervention was administered once daily during hospitalization, for a total of one week.

[0077] 5. Grouping

[0078] The control group received routine nephrology treatment and nursing services. Routine treatment services included diagnosis, examination, medication, and treatment (including dialysis). Routine nursing services included medication care, nutritional intervention, dietary guidance, lifestyle guidance, training and guidance for dialysis patients, and psychological care.

[0079] Treatment group: In addition to receiving routine diagnosis and treatment and nursing services from the Department of Nephrology, they also received a foot bath intervention with a combination of traditional Chinese medicine.

[0080] 6. Measurement Metrics and Tools

[0081] Pruritus severity was assessed using the 5-D Pruritus Scale, which is used to measure neurological function in patients with diabetic polyneuropathy and has subsequently been shown to be useful for assessing pruritus symptoms in dialysis patients. The 5-D Pruritus Scale includes five dimensions: duration of itch, intensity of itch, direction of itch, impact of itch on daily life, and location of itch. Duration of itch, intensity of itch, direction of itch, and location of itch were scored on a 5-point Likert scale. The impact of itch on daily life was scored using the mean score of the items in that dimension. The sum of the five dimensions yielded a total score ranging from 5 to 25, divided into five levels. Patients with a score of 5 or less were defined as having no itch, while those with a score of 6 to 25 were considered to have itch. Scores of 6 to 10 indicate mild itch, 11 to 20 indicate moderate itch, and 21 to 25 indicate severe itch.

[0082] Anxiety Level: Anxiety was measured using the Self-Rating Anxiety Scale (SAS), which measures anxiety levels over the past week. The SAS consists of 20 items, including four reverse-indicator items. The scores for all 20 items are summed to obtain a crude score, which is then converted to a standard score. The standard score is calculated as follows: standard score = in(1.25 × crude score), which is calculated by multiplying the crude score by 1.25 and rounding to the nearest integer. A standard score > 50 indicates anxiety.

[0083] Depression severity: Depression was measured using the Self-Rating Depression Scale (SDS), which measures the subject's depression level over the past week. The SDS consists of 20 items, including 10 reverse-sentence items. The sum of the 20 item scores yields a crude score, which is then converted to a standard score. This conversion is as follows: standard score = in(1.25 × crude score), which is calculated by multiplying the crude score by 1.25 and rounding to the nearest integer. A standard score > 53 indicates depression.

[0084] Sleep quality: The Pittsburgh Sleep Quality Index (PSQI) was used to measure the subjects' sleep quality over the past month. The PSQI consists of 19 self-assessment items and 5 peer-assessed items. The 18 self-assessment items are divided into 7 components, each scored from 0 to 3 points. The total score of all components is accumulated to obtain the total score, which ranges from 0 to 21 points. A score greater than 7 indicates sleep disorders, and a higher score indicates worse sleep quality.

[0085] 7. Data Collection

[0086] All data collection was completed by researchers not involved in the intervention. Patient-reported outcomes were completed by patients. For patients unable to write, data collectors read the results verbatim, and patients made their choices, which were then recorded by the data collectors. Laboratory parameters were obtained from the department's electronic medical record system. Data were collected before group assignment, 2 weeks after the intervention, and 1 month after the intervention.

[0087] Before grouping, junior nurses collected data face-to-face on the patients' itching severity, anxiety and depression levels, and sleep quality.

[0088] Two weeks after the intervention, junior nurses used the project's dedicated WeChat to send the 5-D Itch Rating Scale, SAS, and SDS to patients to collect information on their pruritus, anxiety, and depression levels.

[0089] One month after the intervention, junior nurses used the project's dedicated WeChat to send PSQI to patients to collect their sleep quality information.

[0090] 8. Statistical analysis

[0091] EPIDATA 3.0 software was used for double data entry to ensure data entry accuracy, and SPSS 22.0 software was used for statistical analysis. Normally distributed measurement data were calculated using the mean plus or minus the standard deviation. If the data does not obey the normal distribution, the median (interquartile range) [M(Q 25 ,Q 75 )], and enumeration data are expressed as frequency (n) and percentage (%). Comparisons between the two groups were performed using the Mann-Whitney U test. Comparisons within the groups were performed using the paired t-test if the distribution followed a normal distribution, and using the Wilcoxon signed-rank test if the distribution did not follow a normal distribution. The test level was α = 0.05. The comparison of the post-intervention efficacy indicators is shown in Table 1.

[0092] Table 1 Comparison of efficacy indicators before and after intervention

[0093]

[0094] Note: * indicates that the Wilcoxon signed-rank test was used for comparison within the group, P < 0.05; # indicates that the paired T test was used for comparison within the group, P < 0.05.

[0095] From the above experimental results, it can be seen that although all efficacy indicators of the control group were better than those of the experimental group before and after the intervention, there were no significant changes in all efficacy indicators of the control group after the intervention. However, the anxiety level (T=3.579, P=0.001), depression level (Z=84.50, P=0.007) and itching level (Z=87.00, P=0.003) of the experimental group were significantly reduced, and the sleep quality (Z=29.50, P=0.025) was significantly improved.

[0096] The embodiments of the present invention are described in detail above, but the present invention is not limited to the described embodiments. It is apparent to those skilled in the art that various changes, modifications, substitutions, and variations of these embodiments may be made without departing from the principles and spirit of the present invention, and the changes still fall within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for improving pruritus associated with chronic kidney disease, characterized in that: The traditional Chinese medicine composition consists of white peony root, angelica root, tribulus terrestris, siler, raw rehmannia root, schizonepeta tenuifolia, peony bark, liquorice and wormwood leaf.

2. A Chinese medicine composition for improving pruritus associated with chronic kidney disease according to claim 1, characterized in that: The traditional Chinese medicine composition consists of 15 grams of white peony root, 15 grams of angelica root, 24 grams of tribulus terrestris, 9 grams of siler, 24 grams of raw rehmannia root, 12 grams of schizonepeta tenuifolia, 15 grams of moutan bark, 9 grams of liquorice and 12 grams of artemisia argyi.

3. A method for preparing the Chinese medicine composition according to any one of claims 1 to 2, characterized in that: The preparation method comprises the following steps: using a traditional Chinese medicine powdering machine to grind accurately weighed white peony root, angelica root, white tribulus terrestris, siler, raw rehmannia root, schizonepeta tenuifolia, peony bark, liquorice and mugwort into fine powder without particles.

4. A use of the Chinese medicine composition according to any one of claims 1 to 2, characterized in that: The application method is foot bathing.

5. The use of the Chinese medicine composition according to claim 4, characterized in that, The specific method of the foot bath is: soaking the Chinese medicine composition in hot water or boiling the water, and then bathing the feet after the water reaches a suitable temperature.

6. The use of the Chinese medicine composition according to claim 5, characterized in that: The dosage ratio of the traditional Chinese medicine composition to water is 135g / 6000ml.

7. The use of the Chinese medicine composition according to claim 5, characterized in that: The temperature of the hot water soaking is 90-100° C., and the soaking time is 60 minutes.

8. The use of the Chinese medicine composition according to claim 5, characterized in that: The suitable water temperature is 41-45°C.

9. The use of the Chinese medicine composition according to claim 5, characterized in that: When bathing your feet, control the level of the medicine liquid to be >10 cm above the ankle. The duration of the foot bath should be 20 to 30 minutes, and the frequency of foot bath should be once a day.

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