A traditional Chinese medicine composition for treating allogeneic hematopoietic stem cell transplantation period diarrhea and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating allogeneic hematopoietic stem cell transplantation period diarrhea, which is prepared from the following components in parts by weight: mature Fuzi tablet 6-12 parts, dried ginger 6-12 parts, Coptis chinensis 3-9 parts, Ramulus Cinnamomi 6-12 parts, dark plum 10-20 parts, gallnut 3-9 parts and ginger juice 57-123 parts. The traditional Chinese medicine composition can safely and conveniently relieve diarrhea caused by complex causes during the transplantation period, and reduce the risk of perianal infection during the transplantation period.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically, it relates to a traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells and its application. Background Technology

[0002] Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a key treatment for hematologic malignancies such as leukemia. However, this procedure involves high-dose chemoradiotherapy pretreatment and immunosuppressive therapy, often leading to various complications, among which diarrhea is particularly common and severely impacts patients' quality of life and prognosis. The incidence of diarrhea during transplantation is as high as 40%-90%, with complex and diverse etiologies, mainly including direct damage to the intestinal mucosa from pretreatment toxicity, graft-versus-host disease (GVHD) affecting the intestines, various infections (bacteria, viruses, fungi) under immunosuppression, side effects of multiple drugs (such as immunosuppressants and antibiotics), and intestinal flora imbalance. This diarrhea not only causes malabsorption, dehydration, and electrolyte disturbances in patients but also increases the risk of perianal infections and complicates treatment. In patients with leukopenia (especially neutrophils), perianal abscess formation is significantly associated with intestinal flora translocation. Microbiome dysbiosis is not only a result of infection but also a core factor driving the occurrence, progression, and treatment resistance of anorectal infections.

[0003] Currently, Western medicine treatment for peri-transplant diarrhea mainly involves etiological treatment and symptomatic supportive care. Commonly used antidiarrheal drugs include loperamide, montmorillonite powder, and octreotide. Although these drugs have some effect, their efficacy is often unsatisfactory for diarrhea caused by GVHD or severe mucositis; long-term or improper use may lead to side effects such as constipation and abdominal distension, and some drugs should be used with caution in cases of infectious diarrhea; in addition, transplant patients often experience nausea, vomiting, and mucositis, making oral administration difficult and resulting in poor absorption; symptomatic antidiarrheal treatment is also insufficient to repair damaged mucosa or regulate disordered immune function.

[0004] Against this backdrop, seeking safer, more effective, and convenient treatment methods is particularly important. Traditional Chinese medicine (TCM) external therapies, especially poultices, have shown unique potential. TCM poultices, through the dual effects of transdermal absorption and acupoint stimulation, can exert multiple effects such as local anti-inflammatory, mucosal repair, immune regulation, and diarrhea and pain relief. The strengthening and tonifying effects of TCM poultices, along with their ability to reduce toxicity and enhance efficacy, can effectively prevent diarrhea and are of great significance in regulating intestinal flora, reducing the risk of perianal infections, and improving prognosis. Compared to oral medications, they have advantages such as high safety, fewer side effects, ease of use (especially suitable for patients who have difficulty taking oral medications), and good patient compliance. Previous research on digestive system diseases, such as the treatment of diarrhea-predominant irritable bowel syndrome (IBS), has accumulated experience and shown good efficacy.

[0005] However, there are currently no systematic studies or reports on the design, safety, effectiveness, and ease of clinical application of a traditional Chinese medicine (TCM) poultice therapy specifically designed for the treatment of diarrhea with complex etiologies occurring during the peri-transplantation period of allogeneic hematopoietic stem cells in leukemia patients, as well as the high incidence of intestinal microbiota imbalance and perianal infection due to chemotherapy-induced diarrhea. Therefore, developing a targeted, effective, safe, and convenient TCM poultice specifically for treating peri-transplantation diarrhea in leukemia patients has significant clinical importance and application value. Summary of the Invention

[0006] The purpose of this invention is to provide a traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells.

[0007] Another object of the present invention is to provide the application of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells.

[0008] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0009] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells, which is made of the following components in parts by weight: 6-12 parts of prepared aconite root, 6-12 parts of dried ginger, 3-9 parts of coptis root, 6-12 parts of cinnamon twig, 10-20 parts of dried plum, 3-9 parts of gallnut, and 57-123 parts of fresh ginger juice.

[0010] Preferably, the traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells is made from the following components in parts by weight: 9 parts prepared aconite root, 9 parts dried ginger, 6 parts Coptis chinensis, 9 parts cinnamon twig, 15 parts dried plum, 6 parts gallnut, and 90 parts fresh ginger juice.

[0011] Preferably, the traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells is made from the following components in parts by weight: 6 parts prepared aconite root, 6 parts dried ginger, 3 parts coptis root, 6 parts cinnamon twig, 10 parts dried plum, 3 parts gallnut, and 57 parts fresh ginger juice.

[0012] Preferably, the traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells is made from the following components in parts by weight: 12 parts prepared aconite root, 12 parts dried ginger, 9 parts Coptis chinensis, 12 parts cinnamon twig, 20 parts dried plum, 9 parts gallnut, and 123 parts fresh ginger juice.

[0013] In a second aspect, the present invention provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells.

[0014] A third aspect of the present invention provides a pharmaceutical preparation made from the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0015] Preferably, the dosage form of the pharmaceutical preparation is a topical preparation, and more preferably a patch.

[0016] The preparation method of the patch includes the following steps:

[0017] According to the formula, the prepared aconite root, coptis root, dried ginger, cinnamon twig, dried plum, and gallnut are ground into a fine powder, sieved (100 mesh), and sterilized by electron beam irradiation (irradiation dose 4 kGy) to obtain the medicinal powder.

[0018] Mix the medicinal powder with ginger juice and stir until it becomes a paste. Make the paste into a patch.

[0019] The patch is a circular medicated cake measuring 2.0 cm × 2.0 cm and approximately 1.5 cm thick.

[0020] Instructions for use: After cleaning the patient's five acupoints (Shenque, bilateral Tianshu, and bilateral Zusanli), place one medicated patch on each acupoint and secure it with a patch cloth. Apply once a day for 12 hours each time.

[0021] The ginger juice is prepared by: taking fresh ginger, juicing it, filtering to remove residue, and obtaining pure ginger juice. The mass ratio of ginger juice to fresh ginger is 1:2.

[0022] In a fourth aspect, the present invention provides the use of the pharmaceutical preparation in the preparation of a medicament for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells.

[0023] This invention uses prepared aconite root (pungent, sweet, and very hot, entering the heart, kidney, and spleen meridians, restoring yang and rescuing from collapse) and dried ginger (pungent and hot, entering the spleen, stomach, heart, and lung meridians, warming the middle and dispelling cold) as the chief ingredients, cinnamon twig (pungent, sweet, and warm, entering the heart, lung, and bladder meridians, warming and assisting yang) as the assistant ingredients, and coptis root (bitter and cold, entering the heart, spleen, stomach, gallbladder, and large intestine meridians, clearing heat and drying dampness) as the counteracting ingredient. It is combined with dried plum (sour, astringent, and neutral, entering the liver, spleen, lung, and large intestine meridians, astringing the intestines and generating fluids) and gallnut (sour, astringent, and cold, entering the lung, large intestine, and kidney meridians, astringing sores and stopping bleeding) as the adjuvant ingredients. The whole formula takes into account the functions of warming yang, clearing heat, astringing, and repairing.

[0024] The properties, meridian tropism, and indications of the raw materials used in this invention are as follows:

[0025] Prepared aconite root: pungent, sweet, and very hot; toxic; enters the heart, kidney, and spleen meridians; has the effects of tonifying fire and assisting yang, dispelling cold and relieving pain; mainly treats diarrhea due to deficiency and cold, and cold pain in the epigastrium and abdomen.

[0026] Dried ginger: pungent and hot, it enters the spleen, stomach, kidney, heart, and lung meridians; it has the effect of warming the middle and dispelling cold, and is mainly used to treat diarrhea and cold pain in the stomach and abdomen.

[0027] Cinnamon twig: pungent, sweet, and warm in nature; enters the heart, lung, and bladder meridians; has the effects of warming and unblocking the meridians, assisting yang and transforming qi, and is mainly used to treat cold pain in the epigastrium and abdomen.

[0028] Coptis chinensis: bitter, cold, enters the heart, spleen, stomach, liver, gallbladder and large intestine meridians; has the effects of clearing heat and drying dampness, purging fire and detoxifying, and is mainly used to treat damp-heat fullness and diarrhea.

[0029] Ume plum: sour, astringent, neutral, enters the liver, spleen, lung and large intestine meridians; has the effect of astringing the intestines and stopping diarrhea, and is mainly used to treat chronic diarrhea and dysentery.

[0030] Gallnut: Sour, astringent, and cold in nature; enters the lung, large intestine, and kidney meridians; has the effect of astringing the intestines and stopping diarrhea, and is mainly used to treat chronic diarrhea and dysentery.

[0031] By adopting the above technical solution, the present invention has the following advantages and beneficial effects:

[0032] The traditional Chinese medicine composition provided by this invention has four functions: warming yang, clearing heat, astringing, and repairing mucosa. It has a significant relieving effect on complicated diarrhea in the peri-transplant period, significantly reduces the incidence of perianal infection, has outstanding safety, and is absorbed transdermally, avoiding the gastrointestinal irritation caused by oral administration. It is easy to use and is especially suitable for patients who have difficulty taking oral medication after transplantation (mucositis, vomiting). The nursing burden is light, requiring only skin cleaning and monitoring for skin allergic reactions.

[0033] The traditional Chinese medicine composition provided by this invention can safely and conveniently alleviate diarrhea caused by complex etiologies during the peri-transplant period and reduce the risk of perianal infection during the peri-transplant period. Detailed Implementation

[0034] To more clearly illustrate the present invention, the following description, in conjunction with preferred embodiments, further clarifies the invention. Those skilled in the art should understand that the specific descriptions below are illustrative rather than restrictive, and should not be construed as limiting the scope of protection of the present invention.

[0035] Example 1

[0036] A traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells is made from the following components by weight: 9g of prepared aconite root, 9g of dried ginger, 6g of coptis root, 9g of cinnamon twig, 15g of dried plum, 6g of gallnut, and 90g of fresh ginger juice.

[0037] The method for preparing the above-mentioned traditional Chinese medicine composition into a patch includes the following steps:

[0038] According to the formula, processed Aconitum carmichaelii, Coptis chinensis, dried ginger, cinnamon twig, dried plum, and gallnut are ground into fine powder, passed through a 100-mesh sieve, and sterilized by electron beam irradiation with an irradiation dose of 4 kGy to obtain the medicinal powder.

[0039] Ginger juice preparation: Take 180g of fresh ginger, extract the juice, filter to remove residue, and obtain 90g of pure ginger juice.

[0040] Mix the medicinal powder with 90g of ginger juice and stir until it becomes a paste. Make the paste into patches. This invention can make 45 patches, each patch being a circular medicated cake with a size of 2.0 cm × 2.0 cm and a thickness of about 1.5 cm.

[0041] Instructions for use: After cleaning the patient's five acupoints (Shenque, bilateral Tianshu, and bilateral Zusanli), place one medicated patch on each acupoint and secure it with a patch cloth. Apply once a day for 12 hours each time.

[0042] Example 2

[0043] A traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells is made from the following components by weight: 6g of prepared aconite root, 6g of dried ginger, 3g of Coptis chinensis, 6g of cinnamon twig, 10g of dried plum, 3g of gallnut, and 57g of fresh ginger juice.

[0044] The method for preparing the above-mentioned traditional Chinese medicine composition into a patch includes the following steps:

[0045] According to the formula, processed Aconitum carmichaelii, Coptis chinensis, dried ginger, cinnamon twig, dried plum, and gallnut are ground into fine powder, passed through a 100-mesh sieve, and sterilized by electron beam irradiation with an irradiation dose of 4 kGy to obtain the medicinal powder.

[0046] Preparation of ginger juice: Take 114g of fresh ginger, extract the juice, filter to remove the residue, and obtain 57g of pure ginger juice.

[0047] Mix the medicinal powder with 57g of ginger juice and stir until it becomes a paste. Make the paste into patches. This invention can make 28 patches, each patch being a circular medicated cake with a size of 2.0 cm × 2.0 cm and a thickness of about 1.5 cm.

[0048] Instructions for use: After cleaning the patient's five acupoints (Shenque, bilateral Tianshu, and bilateral Zusanli), place one medicated patch on each acupoint and secure it with a patch cloth. Apply once a day for 12 hours each time.

[0049] Example 3

[0050] A traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells is made from the following components by weight: 12g of prepared aconite root, 12g of dried ginger, 9g of Coptis chinensis, 12g of cinnamon twig, 20g of dried plum, 9g of gallnut, and 123g of fresh ginger juice.

[0051] The method for preparing the above-mentioned traditional Chinese medicine composition into a patch includes the following steps:

[0052] According to the formula, processed Aconitum carmichaelii, Coptis chinensis, dried ginger, cinnamon twig, dried plum, and gallnut are ground into fine powder, passed through a 100-mesh sieve, and sterilized by electron beam irradiation with an irradiation dose of 4 kGy to obtain the medicinal powder.

[0053] Preparation of ginger juice: Take 246g of fresh ginger, extract the juice, filter to remove the residue, and obtain 123g of pure ginger juice.

[0054] Mix the medicinal powder with 123g of ginger juice and stir until it becomes a paste. Make the paste into patches. This invention can make 62 patches, each patch being a circular medicated cake with a size of 2.0 cm × 2.0 cm and a thickness of about 1.5 cm.

[0055] Instructions for use: After cleaning the patient's five acupoints (Shenque, bilateral Tianshu, and bilateral Zusanli), place one medicated patch on each acupoint and secure it with a patch cloth. Apply once a day for 12 hours each time.

[0056] Example 4

[0057] Clinical trials

[0058] 1. Clinical Data

[0059] 1.1 General Information

[0060] This randomized controlled trial evaluated whether the traditional Chinese medicine composition of the present invention could reduce the duration of diarrhea, prevent perianal infection, and improve the quality of life in patients undergoing allogeneic hematopoietic stem cell transplantation. A total of 109 patients (57 males and 52 females) were assigned to the intervention group (54 patients) and the control group (55 patients). t-tests and chi-square tests showed no significant differences between the two groups in terms of age, sex, body mass index, disease type, and perianal infection grade (P>0.05).

[0061] 1.2 Diagnostic criteria:

[0062] Patients who receive allogeneic hematopoietic stem cell transplantation (allo-HSCT) have a primary disease diagnosis that meets the WHO / ICC classification criteria (AML, ALL, MDS, SAA, thalassemia, etc.).

[0063] 1.3 Inclusion criteria:

[0064] The research subjects should meet the following criteria:

[0065] 1.3.1 First-time allogeneic hematopoietic stem cell transplantation;

[0066] 1.3.2 Age 14 ≤ age ≤ 70, gender not limited;

[0067] 1.3.3 Primary disease type: hematologic malignancy or aplastic anemia, regardless of disease stage or degree of remission;

[0068] 1.3.4 Transplantation type: sibling fully matched, related haploidentical, unrelated donor;

[0069] 1.3.5 Types of transplant pretreatment: myeloablative / reduced dose / non-myeloablative;

[0070] 1.3.6 Informed consent and voluntary participation in this clinical study.

[0071] 1.4 Exclusion Criteria:

[0072] 1.4.1 Subjects meeting any of the following criteria will be excluded from this study;

[0073] 1.4.2 Intestinal infection was present within 2 weeks prior to enrollment;

[0074] 1.4.3 Previous diagnosis of inflammatory bowel disease / irritable bowel syndrome;

[0075] 1.4.4 Primary disease with intestinal involvement confirmed by pathology or imaging;

[0076] 1.4.5 ECOG ≥ 2 points, or organ failure, and cannot tolerate allogeneic hematopoietic stem cell transplantation;

[0077] 1.4.6 For those who have an allergic reaction to the investigational drug or whose physical condition is not suitable for sitz baths;

[0078] 1.4.7 Individuals with mental disorders / those for whom informed consent cannot be obtained;

[0079] 1.4.8 Those with poor compliance who have not implemented intervention measures for 3 consecutive days;

[0080] 1.4.9 HIV-infected individuals, patients who use drugs or have a history of alcohol abuse that affects the evaluation of test results;

[0081] 1.5 Rejection Criteria:

[0082] 1.5.1 Obvious non-compliance with research interventions;

[0083] 1.5.2 If a patient experiences a skin allergic reaction, including skin redness, rash, itching, or pain, continuing participation in the study may no longer be in the best interests of the study subject;

[0084] 1.5.3 Disease progression to the point where research intervention needs to be discontinued;

[0085] 1.5.4 The study subjects meet the exclusion criteria (newly emerging or confirmed);

[0086] 1.5.5 The research subjects are unable to accept the research intervention for a certain period of time.

[0087] 2. Research Methods:

[0088] 2.1 Treatment methods:

[0089] Intervention group: Starting 24 hours before the pretreatment, the patient's five acupoints (Shenque, bilateral Tianshu, and bilateral Zusanli) were cleaned. One medicated plaster was placed on each acupoint and fixed with a plaster patch. This was done once a day for 12 hours each time.

[0090] The preparation method of the dressing is the same as in Example 1.

[0091] Control group: Standard treatment with no special intervention.

[0092] 2.2 Efficacy observation indicators

[0093] 2.2.1 Within 30 days after transplantation, the onset and duration of diarrhea are as follows: more than 3 bowel movements per day, more than 200 grams of stool per day, loose stool texture, and water content >85%.

[0094] 2.2.2 Diarrhea grading: The ECOG version of the Common Toxicity Criteria (CTC) treatment toxicity assessment criteria were adopted: Grade 0: No diarrhea; Grade 1: Increased bowel movements 2-3 times / day; Grade 2: Increased bowel movements 4-6 times / day; Grade 3: Increased bowel movements 7-9 times / day; Grade 4: Increased bowel movements ≥10 times / day, dehydration, requiring parenteral nutrition, where severe diarrhea is defined as Grade ≥3.

[0095] 2.2.3 Perianal infection: Perianal infection was classified according to the WHO classification standard, namely: Grade 0 (i.e., no infection): the perianal skin is clean and dry, the mucosa is intact, and there are no subjective symptoms; Grade 1: the perianal skin is indurated or (and) the mucosa is red and swollen, and there is pain during defecation but no bleeding; Grade 2: the perianal skin is red, swollen, hot and painful, or the skin is dry and cracked with a diameter <0.5cm; Grade 3: the perianal skin is red, swollen, hot and painful and accompanied by abscess, or the skin is dry and cracked with a diameter ≥0.5cm.

[0096] 2.3 Safety Observation

[0097] Physical examination: local skin color and integrity. Patient self-report: presence of any abnormal discomfort such as itching, burning sensation, or pain.

[0098] 2.4 Statistical Methods

[0099] A database was established using IBM SPSS 26.0, and statistical tests were performed on the data. Frequency and percentage were used to describe the general data of the research subjects. Frequency, percentage (categorical data), mean, and standard deviation (normally distributed data), or median and quartiles (non-normally distributed data) were used to describe the general data of the research subjects. For continuous data, t-tests were used if the data conformed to a normal distribution; otherwise, rank-sum tests were used. Chi-square tests were used for categorical data.

[0100] 3. Results

[0101] The incidence of grade ≥2 diarrhea was significantly lower in the intervention group than in the control group (50.9% vs 72.2%, P=0.023). The duration of diarrhea [median (interquartile range): 9 (3, 13) days] was significantly shorter in the intervention group than in the control group [median (interquartile range): 13 (3, 22) days] (P=0.038). The incidence of new perianal infections within 30 days post-transplantation was significantly lower in the intervention group (3.6% vs 22.2%, p=0.004). No treatment-related adverse events were reported in the intervention group.

[0102] Conclusion: The patch of this invention has a good therapeutic effect on diarrhea during allogeneic hematopoietic stem cell transplantation, significantly reducing the incidence of severe diarrhea, shortening the duration of diarrhea, and reducing perianal infections in patients. The intervention is safe, well-tolerated, and can improve patients' quality of life and reduce the risk of infection. The patch prepared by this invention can serve as a supportive strategy to alleviate diarrhea-related complications and promote the recovery of transplant recipients.

[0103] Example 5

[0104] The patient, Ms. Lai, 18 years old, was admitted to the hospital due to "diagnosed with acute myeloid leukemia more than 6 months ago and diarrhea for 1 month".

[0105] The patient presented with petechiae on the lower extremities in October 2025. A blood test at another hospital showed a WBC count of 11.76 × 10⁻⁶. 9 / L, Hb 75g / L, Plt 23×10 9 / L, bone marrow aspiration morphology suggested AML-M2B, flow cytometry showed 6.98% abnormal primitive cells, chromosome t(8;21), positive ETO fusion gene, high WT1 expression, KIT D816H and D820Y mutations, and KDM6A variant. After multiple cycles of chemotherapy including Ida+AraC, HD-AraC+HHT+avatinib, the patient underwent the fourth cycle of HD-AraC+HHT+avatinib on March 20, 2026. During chemotherapy, the patient experienced mild diarrhea, with bowel movements increasing to 3-4 times / day, loose stools, approximately 200g / day, CTC grade 1, without specific treatment. Three days after the end of chemotherapy, the diarrhea worsened, with bowel movements increasing to 7-9 times / day, watery stools, approximately 400g / day, CTC grade 3 (severe diarrhea), accompanied by mild abdominal pain and hyperactive bowel sounds. The patient received symptomatic and supportive treatment including montmorillonite powder, loperamide, oral rehydration salts, probiotics, and anti-infectives, but the diarrhea symptoms did not improve significantly and persisted for more than a month. On April 30, 2026, the patch prepared in Example 1 of this invention was added for intervention. The skin of the patient's Shenque acupoint, bilateral Tianshu acupoints, and bilateral Zusanli acupoints was cleaned, and one patch was placed at each acupoint and fixed with a medical dressing. It was applied once a day for 12 hours each time. On the 7th day after use, the frequency of bowel movements decreased to 4-5 times / day, and the stool was still loose but the amount decreased to about 250g / day, with CTC grade 2; on the 10th day after use, it decreased to 2-3 times / day, and the stool gradually became formed, with CTC grade 1; on the 18th day after use, the bowel movements completely returned to normal (1-2 times / day, formed stool).

[0106] No adverse reactions such as redness, rash, itching, or burning were observed on the skin at the patch application site. Patient compliance was good, indicating that the patch was easy to use and did not increase the burden of nursing care.

[0107] Example 6

[0108] The patient, Mr. Zhang, male, 47 years old, was diagnosed with acute myeloid leukemia one month ago and experienced diarrhea for three days after chemotherapy.

[0109] One month ago, the patient presented with fatigue and fever. A complete blood count showed pancytopenia. Bone marrow aspiration morphology, flow cytometry, and gene testing indicated acute myeloid leukemia (AML-M2). Initial complete remission was achieved after induction chemotherapy with the IA regimen (daunorubicin + cytarabine). The patient underwent a second cycle of consolidation chemotherapy with the DAE regimen (daunorubicin + cytarabine + etoposide). During chemotherapy, the patient experienced mild nausea and decreased appetite, which were tolerable. On the third day, the patient developed diarrhea, with bowel movements increasing to 2-3 times per day, unformed stools, and a volume of approximately 250g per day, meeting the CTC grade 1 diarrhea criteria. The patient was treated with the patch prepared in Example 1 of this invention. The skin of the Shenque acupoint, bilateral Tianshu acupoints, and bilateral Zusanli acupoints was cleaned, and one patch was placed at each acupoint and secured with a medical dressing. This was done once daily for 12 hours each time. On the fifth day, bowel movements returned to normal, with the frequency decreasing to 1-2 times per day and the stool becoming formed. Throughout the chemotherapy process, no adverse reactions such as redness, rash, itching, or burning were observed on the skin at the patch application site, and patient compliance was good.

[0110] Example 7

[0111] Patient Zhang, male, 25 years old, was admitted to the hospital for allogeneic hematopoietic stem cell transplantation after being diagnosed with acute myeloid leukemia 3 months ago.

[0112] Three months prior, the patient presented with fatigue and fever. A complete blood count showed pancytopenia, and bone marrow aspiration morphology, flow cytometry, and gene testing indicated AML-M2 type. Initial complete remission was achieved after induction chemotherapy. This patient was admitted for allogeneic hematopoietic stem cell transplantation. Six days prior to transplantation, the patch prepared in Example 1 of this invention was administered. The skin of the patient's Shenque (CV8), bilateral Tianshu (ST25), and bilateral Zusanli (ST36) acupoints was cleaned, and one patch was placed at each acupoint and secured with a medical dressing. This was done once daily for 12 hours each time, for 5 weeks (until day 30 post-transplantation). Day 1 before transplantation (-1 day): The patient experienced mild diarrhea, with bowel movements increasing to 2-3 times / day. The stool was loose, meeting the CTC grade 1 diarrhea criteria. This was considered to be due to intestinal mucosal toxicity from the pretreatment drugs. The patch intervention prepared in Example 1 of this invention was continued, and no other antidiarrheal medications were added. Days 9-10 post-transplant: Diarrhea worsened, with bowel movements increasing to 4-6 times / day, loose stools, approximately 280g / day, meeting the CTC grade 2 diarrhea criteria. Mild borborygmus and abdominal pain were present, but no fever. The patch intervention prepared in Example 1 of this invention was continued. Day 11 post-transplant: Diarrhea subsided, bowel movements returned to 1-2 times / day, formed stools. Day 17 post-transplant: One episode of mild diarrhea occurred, with bowel movements 2-3 times / day, loose stools, CTC grade 1. Day 18 post-transplant: Diarrhea subsided, bowel movements returned to 1-2 times / day, formed stools. Day 24 post-transplant: Another episode of mild diarrhea occurred, with bowel movements 2-3 times / day, loose stools, CTC grade 1. Day 25 post-transplant: Diarrhea subsided, bowel movements returned to 1-2 times / day, formed stools. During the observation period, the patient's diarrhea exhibited a fluctuating pattern of "acute onset - rapid relief - occasional mild symptoms," and did not progress to severe diarrhea of ​​CTC grade 3 or above. Throughout the entire transplant observation period, the patient's perianal skin remained clean and dry, with intact mucosa, without redness, swelling, induration, heat, pain, or ulceration, and no perianal infection occurred. No adverse reactions such as redness, rash, itching, burning sensation, or damage were observed on the local skin at the patch sites (Shenque, Tianshu, and Zusanli acupoints).

[0113] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-described technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells, characterized in that, It is made from the following components in parts by weight: 6-12 parts prepared aconite root, 6-12 parts dried ginger, 3-9 parts Coptis chinensis, 6-12 parts cinnamon twig, 10-20 parts dried plum, 3-9 parts gallnut, and 57-123 parts fresh ginger juice.

2. The traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells according to claim 1, characterized in that, The traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells is made from the following components in parts by weight: 9 parts prepared aconite root, 9 parts dried ginger, 6 parts Coptis chinensis, 9 parts cinnamon twig, 15 parts dried plum, 6 parts gallnut, and 90 parts fresh ginger juice.

3. The traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells according to claim 1, characterized in that, The traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells is made from the following components in parts by weight: 6 parts prepared aconite root, 6 parts dried ginger, 3 parts coptis root, 6 parts cinnamon twig, 10 parts dried plum, 3 parts gallnut, and 57 parts fresh ginger juice.

4. The traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells according to claim 1, characterized in that, The traditional Chinese medicine composition for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells is made from the following components in parts by weight: 12 parts prepared aconite root, 12 parts dried ginger, 9 parts Coptis chinensis, 12 parts cinnamon twig, 20 parts dried plum, 9 parts gallnut, and 123 parts fresh ginger juice.

5. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells.

6. A pharmaceutical preparation, characterized in that, It is made from the traditional Chinese medicine composition as described in any one of claims 1 to 4 and pharmaceutically acceptable excipients.

7. The pharmaceutical preparation according to claim 6, characterized in that, The dosage form of the pharmaceutical preparation is a topical preparation.

8. The pharmaceutical preparation according to claim 7, characterized in that, The dosage form of the drug preparation is a patch.

9. The pharmaceutical preparation according to claim 8, characterized in that, The preparation method of the patch includes the following steps: According to the formula, the prepared aconite root, coptis root, dried ginger, cinnamon twig, dried plum, and gallnut are ground into fine powder, sieved, and sterilized by electron beam irradiation to obtain the medicinal powder. Mix the medicinal powder with ginger juice and stir until it becomes a paste. Make the paste into a patch.

10. The use of a pharmaceutical preparation according to any one of claims 6 to 9 in the preparation of a medicament for treating peri-transplantation diarrhea of ​​allogeneic hematopoietic stem cells.