A traditional Chinese medicine composition for treating cancer-related fatigue, preparation and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating cancer-induced fatigue and a preparation and application thereof, and belongs to the technical field of traditional Chinese medicine and network pharmacology. The traditional Chinese medicine composition comprises the following raw medicinal materials: radix pseudostellariae, fructus schisandrae, radix astragali, radix codonopsis, radix atractylodis macrocephalae, poria cocos, angelica sinensis, prepared rehmannia, radix bupleuri, radix cimicifugae, silkworm chrysalis, curcuma zedoary, mountain yam, fritillaria thunbergii miq., and soap plant thorns. Main effective components of the traditional Chinese medicine composition are beta-sitosterol, luteolin, taraxerol, stigmasterol, kaempferol and quercetin, which can participate in PI3K-Akt, MAPK, Ras, FoxO and other signal pathway conduction through target points such as TP53, AKT1, EGFR, STAT3, ESR1, BCL2, IL6, HSP90AA1 and TN, and then play the roles of anti-inflammation and anti-tumor in biological processes such as inflammatory reaction, tumor growth, proliferation, invasion, angiogenesis and metastasis, and cell metabolism.

Description

Technical Field

[0001] This invention relates to the fields of traditional Chinese medicine and network pharmacology, specifically to a traditional Chinese medicine composition for treating cancer-related fatigue, its preparation, and its application. Background Technology

[0002] Cancer-related fatigue (CRF) is the most common and longest-lasting accompanying symptom in cancer patients, persisting throughout the entire course of tumor development, progression, treatment, and prognosis. The incidence of CRF at cancer diagnosis is approximately 40%, during radiotherapy and chemotherapy it is approximately 70%–95%, and moderate to severe CRF accounts for approximately 30%–60%. As a common symptom of cancer caused by the interaction of multiple factors, CRF is related to tumor nature, tumor cytokines, decreased hemoglobin, surgery, radiotherapy and chemotherapy, pain, decreased sleep quality, and negative psychological reactions. CRF differs significantly from fatigue after exertion in healthy individuals, characterized by its longer duration, greater severity, higher energy expenditure, and disproportionate and uncorrelated relief with the patient's activity level.

[0003] In recent years, the incidence of malignant tumors has been increasing. While advancements in treatment have improved cancer patient survival rates, cancer-related fatigue significantly impacts patients' quality of life, necessitating effective interventions. Currently, interventions for CRF patients include non-pharmacological and pharmacological interventions. Non-pharmacological interventions include physical activity, massage therapy, psychosocial interventions, nutritional counseling, cognitive behavioral therapy for sleep, and bright white light therapy. Pharmacological interventions may utilize central nervous system stimulants (methylphenidate), and corticosteroids (prednisone or dexamethasone) may be considered for end-stage patients. Traditional Chinese medicine classifies cancer-related fatigue as "asthenia," its pathogenesis often involving imbalances in qi, blood, yin, and yang, and deficiency of the five internal organs, closely related to the spleen, lungs, and kidneys. Its syndrome types include spleen qi deficiency, lung qi deficiency, liver qi stagnation, cold-dampness trapping the spleen, kidney yang deficiency, and spleen and stomach yin deficiency. Traditional Chinese medicine treatment primarily focuses on strengthening the body's resistance and consolidating its foundation, while also nourishing qi and blood, and warming and tonifying the spleen and kidneys. Although there has been some research on cancer-related fatigue in traditional Chinese medicine, the existing related Chinese patent medicines have unclear mechanisms of action and lack effective evidence to demonstrate their efficacy. There are no reports of related Chinese herbal combinations with anti-inflammatory and anti-tumor effects and clear mechanisms of action that can meet the treatment needs of patients.

[0004] Network pharmacology integrates systems pharmacology, biology, and computer science. It can explore the mechanism of action of traditional Chinese medicine through multi-level interaction diagrams of effective components, targets, genes, and signaling pathways. It has a significant advantage in studying the molecular level of traditional Chinese medicine in treating diseases. Summary of the Invention

[0005] Therefore, it is necessary to address the issues of unclear mechanisms of action and lack of effective evidence for the efficacy of current traditional Chinese medicine formulations used to treat cancer-related fatigue, and to provide a traditional Chinese medicine composition, its preparation, and its application for treating cancer-related fatigue.

[0006] This invention provides a traditional Chinese medicine composition for treating cancer-related fatigue, the composition comprising the following raw materials: Codonopsis pilosula, Schisandra chinensis, Astragalus membranaceus, Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Angelica sinensis, Rehmannia glutinosa, Bupleurum chinense, Cimicifuga foetida, Bombyx batryticatus, Curcuma zedoaria, Cremastra appendiculata, Fritillaria thunbergii, and Gleditsia sinensis thorns.

[0007] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-25 parts of Codonopsis pilosula, 5-15 parts of Schisandra chinensis, 10-30 parts of Astragalus membranaceus, 10-15 parts of Codonopsis pilosula, 10-15 parts of Atractylodes macrocephala, 10-15 parts of Poria cocos, 10-25 parts of Angelica sinensis, 10-25 parts of Rehmannia glutinosa, 10-15 parts of Bupleurum chinense, 5-10 parts of Cimicifuga foetida, 10-20 parts of Bombyx mori, 10-20 parts of Curcuma zedoaria, 10-25 parts of Cremastra appendiculata, 10-15 parts of Fritillaria thunbergii, and 10-25 parts of Gleditsia sinensis thorns.

[0008] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 15 parts of Codonopsis pilosula, 10 parts of Schisandra chinensis, 20 parts of Astragalus membranaceus, 15 parts of Codonopsis pilosula, 10 parts of Atractylodes macrocephala, 12 parts of Poria cocos, 10 parts of Angelica sinensis, 15 parts of Rehmannia glutinosa, 12 parts of Bupleurum chinense, 9 parts of Cimicifuga foetida, 12 parts of Bombyx mori, 12 parts of Curcuma zedoaria, 12 parts of Cremastra appendiculata, 10 parts of Fritillaria thunbergii, and 20 parts of Gleditsia sinensis thorns.

[0009] The present invention also provides a traditional Chinese medicine preparation for treating cancer-related fatigue, wherein the traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition for treating cancer-related fatigue described in any of the preceding technical solutions.

[0010] Preferably, the traditional Chinese medicine preparation is a decoction, which is prepared according to the following steps:

[0011] (1) Weigh the raw materials according to the weight parts, add 5-10 times the weight parts of water and soak for 30-120 minutes;

[0012] (2) Heat and boil the soaked raw materials together with water, filter, and collect the filtrate;

[0013] (3) Add 5-10 times the weight of water to the filter residue, boil, filter, and collect the filtrate;

[0014] (4) Combine the filtrates obtained after two decoctions and heat them to concentrate, and the decoction is obtained.

[0015] Preferably, the decocting time for both times is 30-60 minutes.

[0016] Preferably, the filtrates are combined and then concentrated by heating to 10%-20% of their original volume.

[0017] Furthermore, the present invention also provides the use of the traditional Chinese medicine composition for treating cancer-related fatigue as described in any of the preceding technical solutions in the preparation of a medicament for treating cancer-related fatigue.

[0018] The formula for the traditional Chinese medicine composition of this invention for treating cancer-related fatigue is explained below:

[0019] In this invention, a traditional Chinese medicine composition for treating cancer-related fatigue comprises: *Codonopsis pilosula*, *Codonopsis pilosula*, and *Astragalus membranaceus*, which invigorate qi and strengthen the spleen, nourish blood and promote body fluid production; and *Schisandra chinensis*, which tonifies the kidneys and calms the mind, serving as the principal herbs. *Atractylodes macrocephala*, *Poria cocos*, *Angelica sinensis*, and *Rehmannia glutinosa* are added to enhance the spleen-strengthening, diuretic, blood-nourishing, and yin-tonifying effects, serving as the assistant herbs. *Bupleurum chinense* and *Cimicifuga foetida* work together to raise yang qi; *Bombyx mori* resolves phlegm and dissipates nodules; *Curcuma zedoaria* breaks up blood stasis; and *Cremastra appendiculata* and *Fritillaria thunbergii* detoxify, reduce swelling, and dissipate nodules, serving as the adjuvant herbs. *Gleditsia sinensis* thorns guide the herbs to the carbuncles and ulcers, acting as a guide herb to ensure the herbs directly reach the affected area. The combined effects of these herbs in this composition harmonize qi and blood, addressing both the root cause and the symptoms, with a focus on tonifying deficiency, thus achieving the effects of invigorating the spleen and qi, promoting blood circulation and nourishing blood, and resolving phlegm and dissipating nodules. It is characterized by attacking pathogens without harming the body's vital energy, exhibiting remarkable efficacy, and being safe to use.

[0020] Specifically, each of the raw materials for traditional Chinese medicine has the following pharmacological characteristics:

[0021] Prince Ginseng: This product is the dried tuberous root of *Pseudostellaria heterophylla* (Miq.) Pax exPax et Hoffm., a plant in the Caryophyllaceae family. It has a sweet and slightly bitter taste, and is neutral in nature. It enters the spleen and lung meridians, and has the effects of invigorating qi and strengthening the spleen, promoting body fluid production and moistening the lungs.

[0022] Codonopsis pilosula: This product is the dried root of Codonopsis pilosula (Franch.) Nannf., Codonopsis pilosula Nannf. var. modesta (Nannf.) L. Shen, or Codonopsis tangshen Oliv., all belonging to the Campanulaceae family. It has a sweet taste and neutral properties. It enters the spleen and lung meridians, and has the effects of strengthening the spleen and replenishing qi, nourishing blood and promoting body fluid production.

[0023] Astragalus: This product is the dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge., belonging to the Fabaceae family. It is sweet in taste and slightly warm in nature. It enters the Lung and Spleen meridians and has the effects of tonifying Qi and raising Yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, generating fluids and nourishing blood, promoting circulation and relieving pain, promoting pus drainage and detoxification, and promoting wound healing and tissue regeneration.

[0024] Schisandra chinensis: This product is the dried, ripe fruit of Schisandra chinensis (Turcz.) Baill., a plant of the Magnoliaceae family. It has a sour and sweet taste and is warm in nature. It enters the lung, heart, and kidney meridians and has the effects of astringing and consolidating, replenishing qi and promoting body fluids, tonifying the kidneys and calming the mind.

[0025] Atractylodes macrocephala: This product is the dried rhizome of Atractylodes macrocephala Koidz., a plant of the Asteraceae family. It tastes sweet and bitter, is warm in nature, and enters the spleen and stomach meridians. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus.

[0026] Poria: This product is the dried sclerotium of the fungus Poria cocos (Schw.) Wolf (family Polyporaceae). It has a sweet and bland taste and is neutral in nature. It enters the heart, lung, spleen, and kidney meridians, and has the effects of promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind.

[0027] Angelica sinensis: This product is the dried root of Angelica sinensis (Oliv.) Diels, a plant of the Apiaceae family. It has a sweet and pungent taste, and is warm in nature. It enters the liver, heart, and spleen meridians, and has the effects of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements.

[0028] Rehmannia glutinosa (Shu Di): This product is a processed product of the tuberous root of Rehmannia glutinosa Libosch., a plant of the Scrophulariaceae family. It has a sweet taste and slightly warm properties. It enters the liver and kidney meridians and has the effects of nourishing blood and yin, replenishing marrow and essence.

[0029] Bupleurum: This product is the dried root of Bupleurum chinense DC. or Bupleurum corzonerifolium Willd., both belonging to the Apiaceae family. Based on their different characteristics, they are commonly known as "Northern Bupleurum" and "Southern Bupleurum." It has a pungent and bitter taste, and is slightly cold in nature. It enters the liver, gallbladder, and lung meridians, and has the effects of dispersing and reducing fever, soothing the liver and relieving depression, and raising yang qi.

[0030] Cimicifuga: This product is the dried rhizome of Cimicifuga heracleifolia Kom., Cimicifuga dahurica (Turcz.) Maxim., or Cimicifuga foetida L., all belonging to the Ranunculaceae family. It has a pungent and slightly sweet taste, and is slightly cold in nature. It enters the lung, spleen, stomach, and large intestine meridians, and has the effects of releasing exterior pathogens and promoting rash eruption, clearing heat and detoxifying, and raising yang qi.

[0031] Silkworm larvae (Bombyx mori Linnaeus) are the dried bodies of 4th-5th instar larvae that have died after being infected (or artificially inoculated) with Beauveria bassiana (Bals.) Vuillant. They are salty and pungent in taste, and neutral in nature. They enter the liver, lung, and stomach meridians, and have the effects of calming wind and stopping spasms, dispelling wind and relieving pain, and resolving phlegm and dissipating nodules.

[0032] Curcuma zedoaria: This product is the dried rhizome of Curcuma phaeocaulis Val., Curcuma wangsiensis SGLee et CFLiang, or Curcuma wenyujin YHChen et C.Ling, all belonging to the ginger family. The latter is commonly known as "Wen'e Curcuma". It has a pungent and bitter taste and is warm in nature. It enters the liver and spleen meridians and has the effects of promoting qi circulation, breaking up blood stasis, eliminating stagnation, and relieving pain.

[0033] Mountain Pseudobulb: The dried pseudobulb of *Cremastra appendiculata* (D.Don) Makino, *Pleione bulbocodioides* (Franch.) Rolfe, or *Pleione yunnanensis* Rolfe (orchid family). It has a sweet and slightly pungent taste, and is cool in nature. It enters the liver and spleen meridians, and has the effects of clearing heat and detoxifying, resolving phlegm and dissipating nodules.

[0034] Fritillaria thunbergii Miq., a plant in the Liliaceae family, is a dried bulb with a bitter and cold nature. It enters the lung and heart meridians and has the effects of clearing heat, resolving phlegm, relieving cough, detoxifying, dispersing nodules, and reducing swelling.

[0035] Gleditsia sinensis thorns: This product consists of the dried thorns of the legume Gleditsia sinensis Lam. It has a pungent taste and warm properties. It enters the liver and stomach meridians and has the effects of reducing swelling and promoting detoxification, draining pus, and killing parasites.

[0036] The mechanism of action, targets, and pathways of the traditional Chinese medicine composition for treating cancer-related fatigue of the present invention, as determined by network pharmacology studies, are as follows:

[0037] By screening the main components of the traditional Chinese medicine composition of this invention and constructing a schematic diagram of the multi-level interaction network between components and targets, it was found that β-sitosterol, luteolin, taraxasterol, stigmasterol, kaempferol, quercetin, isorhamnetin, fisetin, pelargonidin, schisandrin C, piperazine, dideoxycurcumin, and methylicosa-11,14-dienoic acid are the core compounds, most of which mainly play anti-inflammatory and anti-tumor roles. β-sitosterol can inhibit tumor growth, and its mechanism may be related to the regulation of the expression of IL-6, IFN-γ, and VEGF. β-sitosterol also has anti-inflammatory effects, inhibiting the production of CAS1 and the activation of the MAPK signaling pathway by inhibiting the activation of the inflammasome NLRP3 in epidermal cells and macrophages, thereby significantly reducing the production of TNF-α, IL-1β, IL-6, and IL-8 in cells. In addition, it can promote granulosa cell proliferation by activating the PI3K-Akt signaling pathway, increasing the expression levels of P-AKT and PI3K3CA proteins, and reducing the expression level of Caspase-S protein, thereby inhibiting granulosa cell apoptosis. Luteolin can inhibit tumor cell proliferation by inhibiting the activity of certain intracellular kinases and arresting the cell cycle. It can also induce tumor cell apoptosis through mitochondrial apoptosis pathway, endoplasmic reticulum stress, and death receptor apoptosis pathway. Dandelion terpenes have the effect of inhibiting tumor cell proliferation by arresting the cell cycle in the G2 / M phase and promoting cell apoptosis to inhibit AGS cell growth. Stigmasterol has been studied to have good antioxidant effects and can play a variety of anti-tumor roles, such as inhibiting tumor growth, destroying tumor angiogenesis in vivo, and inhibiting cancer cell migration. Stigmasterol has also been reported to have good anti-inflammatory effects. Quercetin can reduce cellular inflammatory damage by regulating the TLR4 / NF-κB signaling pathway, inhibiting LPS, and inducing mouse RAW264.7 cells to secrete inflammatory factors such as TNF-α and IL-6.

[0038] Based on Degree values, the top-ranked targets are primarily TP53 (tumor protein P53), AKT1 (serine / threonine protein kinase AKT), EGFR (epidermal growth factor receptor erbB1), STAT3 (signal transducer and activator of transcription 3), ESR1 (estrogen receptor α), BCL2 (BCL2, a regulator of apoptosis), IL6 (interleukin-6), HSP90AA1 (heat shock protein 90α family class A member 1), and TNF (tumor necrosis factor). These genes are mainly involved in multiple processes, including inflammation, angiogenesis, and tumor-related processes. TP53 is a crucial tumor suppressor gene, often referred to as the "genomic guardian." Under normal circumstances, TP53 is expressed at low levels. When cells are stimulated by various factors, TP53 is activated, playing different roles depending on the degree of cell damage. In cases of low-level damage, it regulates energy metabolism, repairs damage, and maintains genomic stability; while when cellular DNA damage is severe and cannot be fully repaired, TP53 initiates cellular senescence and apoptosis, thereby preventing tumor development and progression. AKT plays a crucial role in the transformation of malignant tumors, participating in multiple processes from tumor initiation to migration and invasion. AKT primarily targets downstream targets such as mTOR, GSK3α, and GSK3β, promoting cancer cell proliferation and enhancing their metabolism and cell cycle. It can also inhibit apoptosis, induce pro-tumor cytokines, and facilitate inflammatory cell infiltration and tumor angiogenesis, further supporting cancer cell survival and tumor growth. IL-6 is a pleiotropic cytokine that plays a vital role in the human immune system. When infection or tissue damage occurs, monocytes and macrophages immediately produce IL-6 to help clear infectious agents and repair damaged tissue. Once the host's infection or tissue damage is eliminated, IL-6 synthesis ceases. However, excessive or persistent production of IL-6 plays a pathological role in the development of various inflammatory diseases and cancers, indicating that IL-6 is a double-edged sword for the host. BCl2 protein molecules are key molecules regulating the MOMP process. MOMP is a channel for cytochrome C on the mitochondrial membrane. Cytochrome C is released from the mitochondrial interior into the cytoplasm and is crucial for apoptosis via the mitochondrial pathway.

[0039] Based on KEGG pathway analysis, the relevant pathways mainly include the PI3K-Akt signaling pathway, MAPK signaling pathway, AGE-RAGE signaling pathway, Ras signaling pathway, FoxO signaling pathway, PD-1 / PD-L1 signaling pathway, ErbB signaling pathway, VEGF signaling pathway, and Rap1 signaling pathway. The PI3K-AKT signaling pathway participates in regulating the cell cycle process and promotes tumorigenesis and development. Activated AKT can activate mTOR, which promotes the binding of cyclin D1 to cyclin-dependent kinases (CDKs), thereby initiating the cell cycle. AKT can also negatively regulate p27kip1, a CDK inhibitor that can inhibit CDK activity, leading to cell cycle arrest and blocking cell proliferation. AKT inhibits its cell cycle arrest effect, promotes G1 phase development, and accelerates cell proliferation and differentiation. The PI3K / AKT signaling pathway plays a crucial role in tumor invasion and metastasis. It promotes tumor cell transport and invasion by stimulating actin polarization, activating matrix metalloproteinases, and increasing the transcriptional activity of nuclear transcription factors. Furthermore, PI3K / AKT participates in regulating apoptosis through multiple pathways, promoting tumor cell survival. It is also closely related to angiogenesis, promoting both normal angiogenesis and tumor angiogenesis. Regarding energy metabolism in tumor cells, the PI3K signaling pathway regulates glycolysis, and AKT is known as Warburg kinase. The "Warburg effect" refers to the phenomenon that malignant tumor cells primarily undergo glycolysis to produce ATP for energy, even in aerobic environments. MAPK is a large family, with five parallel signaling pathways identified in mammalian cells: extracellular signal-regulated kinases (ERK1 and ERK2), c-Jun N-terminal kinases (JNK / SAPK), p38 kinase isoenzymes (p38α, p38β, p38γ, and p38δ), ERK3 / ERK4, and ERK5. They play crucial roles in cell proliferation, growth, apoptosis, and intercellular functional synchronization. The MAPK pathway is a complex system, and each pathway can produce diametrically opposed results when stimulated differently. For example, the ERK1 / 2, JNK, and p38 signaling pathways accelerate tumor cell division and proliferation by increasing the expression of cyclin D1, promoting the transition from G1 to S phase of the cell cycle (EKR plays the most significant role); however, when stimulated by the anti-tumor polysaccharide-1, they inhibit tumor cell proliferation. As for tumor cell apoptosis, p38 is the most significant contributor, and its mediated mechanism of tumor cell apoptosis is extremely complex.Some ROS induce apoptosis through direct or indirect activation of caspase family members via caspase-dependent pathways; others induce it through non-caspase-dependent pathways; some can phosphorylate specific sites on p53, activating them to induce apoptosis; others participate in regulating FAS-FasL-mediated apoptosis; and still others can directly act on anti-apoptotic protein Bcl-2 family members, inducing tumor cell apoptosis. The ROS signaling pathway is also complex. Lipid reactive oxygen species (ROS) can cause DNA damage and genomic instability, leading to the accumulation of carcinogenic alterations and promoting tumorigenesis. They further induce multiple signaling pathways, especially NF-kappaB, JNK / SAPK / p38, ERK / MAPK, and PI3K / Akt, which also promote tumor cell proliferation and metastasis. However, on the other hand, ROS also inhibits tumors, playing a key role in ferroptosis, an iron-dependent, non-apoptotic cell death pattern characterized by ROS accumulation. Accumulated ROS can cause senescent or other forms of cell death, but cancer cells also initiate antioxidant defenses. Therefore, it is not certain whether increased ROS will enhance or inhibit tumor development at different stages; it is not a black-and-white issue.

[0040] Compared with the prior art, the present invention has the following advantages:

[0041] The main effective components of the traditional Chinese medicine composition of this invention for treating cancer-related fatigue are β-sitosterol, luteolin, taraxasterol, stigmasterol, kaempferol, quercetin, etc. These compounds can participate in the transduction of signaling pathways such as PI3K-Akt, MAPK, Ras, and FoxO through targets such as TP53, AKT1, EGFR, STAT3, ESR1, BCL2, IL6, HSP90AA1, and TN. In this way, they exert anti-inflammatory and anti-tumor effects in biological processes such as inflammatory response, tumor growth, proliferation, invasion, angiogenesis and metastasis, and cell metabolism, thereby improving the clinical symptoms and discomfort of patients. The main clinical symptoms include improving cancer-related mental fatigue, weakness, shortness of breath and reluctance to speak and / or excessive sweating and / or spleen and stomach weakness, poor appetite, poor sleep, pale or dark tongue, weak or thready pulse, etc., which are mainly manifested as cancer-related fatigue symptoms, improving the quality of life of cancer patients, and synergistically promoting further anti-cancer treatment. The relevant mechanism of action is clear. Meanwhile, network pharmacology research provides more options and a basis for clinical prescription and medication. Attached Figure Description

[0042] Figure 1 Venn diagram showing the drug targets and gene targets of cancer-related fatigue in the traditional Chinese medicine composition for treating cancer-related fatigue in the embodiments of the present invention.

[0043] Figure 2 This is a protein-protein interaction network diagram of potential therapeutic targets in embodiments of the present invention;

[0044] Figure 3 This is a diagram of potential core gene targets of the traditional Chinese medicine composition in the embodiments of the present invention;

[0045] Figure 4 This is a drug-component-target diagram of the traditional Chinese medicine composition in the embodiments of the present invention;

[0046] Figure 5 This is a functional enrichment analysis diagram of GO, a potential therapeutic target, in the traditional Chinese medicine composition of the embodiments of the present invention.

[0047] Figure 6 This is a graph showing the enrichment analysis of the KEGG pathway, a potential therapeutic target, in the traditional Chinese medicine composition of this invention. Detailed Implementation

[0048] A traditional Chinese medicine composition for treating cancer-related fatigue, the composition comprising the following raw materials: Codonopsis pilosula, Schisandra chinensis, Astragalus membranaceus, Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Angelica sinensis, Rehmannia glutinosa, Bupleurum chinense, Cimicifuga foetida, Bombyx batryticatus, Curcuma zedoaria, Cremastra appendiculata, Fritillaria thunbergii, and Gleditsia sinensis thorns.

[0049] In one preferred embodiment, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-25 parts of Codonopsis pilosula, 5-15 parts of Schisandra chinensis, 10-30 parts of Astragalus membranaceus, 10-15 parts of Codonopsis pilosula, 10-15 parts of Atractylodes macrocephala, 10-15 parts of Poria cocos, 10-25 parts of Angelica sinensis, 10-25 parts of Rehmannia glutinosa, 10-15 parts of Bupleurum chinense, 5-10 parts of Cimicifuga foetida, 10-20 parts of Bombyx mori, 10-20 parts of Curcuma zedoaria, 10-25 parts of Cremastra appendiculata, 10-15 parts of Fritillaria thunbergii, and 10-25 parts of Gleditsia sinensis thorns.

[0050] In one preferred embodiment, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 15 parts of Codonopsis pilosula, 10 parts of Schisandra chinensis, 20 parts of Astragalus membranaceus, 15 parts of Codonopsis pilosula, 10 parts of Atractylodes macrocephala, 12 parts of Poria cocos, 10 parts of Angelica sinensis, 15 parts of Rehmannia glutinosa, 12 parts of Bupleurum chinense, 9 parts of Cimicifuga foetida, 12 parts of Bombyx mori, 12 parts of Curcuma zedoaria, 12 parts of Cremastra appendiculata, 10 parts of Fritillaria thunbergii, and 20 parts of Gleditsia sinensis thorns.

[0051] A traditional Chinese medicine preparation for treating cancer-related fatigue, wherein the preparation is prepared from the traditional Chinese medicine composition for treating cancer-related fatigue as described in any of the preceding technical solutions.

[0052] In one preferred embodiment, the traditional Chinese medicine preparation is a decoction, which is prepared according to the following steps:

[0053] (1) Weigh the raw materials according to the weight parts, add 5-10 times the weight parts of water and soak for 30-120 minutes;

[0054] (2) Heat and boil the soaked raw materials together with water, filter, and collect the filtrate;

[0055] (3) Add 5-10 times the weight of water to the filter residue, boil, filter, and collect the filtrate;

[0056] (4) Combine the filtrates obtained after two decoctions and heat them to concentrate, and the decoction is obtained.

[0057] In one preferred embodiment, the two simmering times are both 30-60 minutes.

[0058] In one preferred embodiment, the filtrates are combined and then heated to concentrate to 10%-20% of their original volume.

[0059] The traditional Chinese medicine composition for treating cancer-related fatigue can be used to prepare drugs for treating cancer-related fatigue.

[0060] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0061] Example 1

[0062] Screening of effective components in traditional Chinese medicine compositions for treating cancer-related fatigue

[0063] Using the Traditional Chinese Medicine Systems Pharmacology Database (TCMSP, http: / / lsp.Nwsuaf.edu.cn / tcmsp.php), as well as TCMID (http: / / www.megabionet.org / tcmid / ), the Taiwan Traditional Chinese Medicine Resource Database (TCM Database@Taiwan, http: / / tcm.cmu.edu.tw / ), and the Herb database as supplementary databases, the effective compound components contained in the TCM composition of this invention were searched and screened based on oral bioavailability (OB) ≥ 30% and drug-like index (DL) ≥ 0.18. Finally, 124 effective components of the TCM composition of this invention were obtained (some effective components were repeated), as shown in Table 1 (for each herb with more than 5 effective components, only the first 5 are listed).

[0064] Table 1 Main active ingredients of traditional Chinese medicine compositions

[0065]

[0066]

[0067] Example 2

[0068] Prediction of major potential therapeutic targets of traditional Chinese medicine compositions for treating cancer-related fatigue

[0069] The SMILES structures corresponding to the effective compounds contained in the herbal composition of this invention were retrieved from PubChem. The SMILES structures were then entered into the Swiss Target Prediction database, with "Homo sapiens" as the filtering condition, to select high-matching targets. Additionally, targets related to the effective components were searched in the TCMSP database as a supplement, and their corresponding Gene Symbols were retrieved from the SymMap database. Duplicate targets obtained from the two databases were removed to obtain drug-related targets. Using "Gene" and "Homo sapiens" as search conditions, targets related to cancer-related fatigue were searched in the Genecards database to obtain potential disease targets. The drug-related targets and potential disease targets were mapped in Venny2.1 to screen the intersection targets for treating cancer-related fatigue with the herbal composition of this invention.

[0070] Using "cancer-related fatigue" as the search term, 7427 target genes were retrieved from the Gnencard disease gene database. Using a score ≥ 26 as the screening criterion, 856 target genes were ultimately obtained. These were then mapped to the 769 target sites of the traditional Chinese medicine composition of this invention, ultimately yielding 144 intersection targets for the treatment of cancer-related fatigue using the traditional Chinese medicine composition of this invention. (See [link to relevant documentation]). Figure 1 ; Construct a PPI network of potential targets in the STRING11.5 database, see Figure 2 The Network Analyzer plugin in Cytoscape was used to calculate node connectivity degrees and filter the results, identifying the top 15 key targets by degree. (See attached image.) Figure 3 .

[0071] Example 3

[0072] Construction and Analysis of the Drug-Active Ingredient-Target Network for Traditional Chinese Medicine Compositions in the Treatment of Cancer-Related Fatigue

[0073] In the STRING11.5 database, intersection targets were input, and "Homo sapiens" was used as the species selection criterion to obtain a protein-protein interaction network diagram. Using Cytoscape 3.9.1 software, a "Traditional Chinese Medicine-Active Component-Potential Target" network was constructed, with traditional Chinese medicine, active components, and potential targets displayed as "nodes," and interactions between nodes displayed as "edges." The Degree value was calculated using the Network Analyzer plugin in Cytoscape software to screen the core targets of the traditional Chinese medicine composition of this invention. A total of 252 nodes (including 15 traditional Chinese medicine components, 93 active components, and 144 targets) and 1745 relationships were obtained. Figure 4 The more edges connect a node, the more important the node is.

[0074] Example 4

[0075] Functional enrichment analysis of potential related targets for treating cancer-related fatigue using traditional Chinese medicine compositions.

[0076] In the DAVID database, GO functional enrichment analysis and KEGG pathway enrichment analysis were performed on the intersection targets of the traditional Chinese medicine composition of the present invention for treating cancer-related fatigue. The results were saved and visualized using ImageGP.

[0077] GO functional enrichment analysis was performed on 144 potential therapeutic targets. Based on the criterion of "FDR < 0.05", 184 eligible targets were obtained, including 117 BP, 13 CC, and 54 MF. The top ten targets for BP, CC, and MF were visualized. Figure 5 In terms of BP, this includes protein phosphorylation, protein autophosphorylation, positive regulation of protein kinase B signaling, positive regulation of MAPK cascades, peptidyl tyrosine phosphorylation, positive regulation of kinase activity, transmembrane receptor protein tyrosine kinase signaling pathway, multicellular biological development, peptidyl serine phosphorylation, positive regulation of RNA polymerase II promoter transcription, positive regulation of phosphatidylinositol 3-kinase signaling, peptidyl threonine phosphorylation, and positive regulation of phosphorylation. In terms of CC, this includes cyclin-dependent protein kinase holoenzyme complex, transforming growth factor β1 type II receptor type I receptor complex, phosphatidylinositol 3-kinase complex, and RNA polymerase II transcription factor complex. In terms of MF, this includes protein serine / threonine / tyrosine kinase activity, protein kinase activity, transmembrane receptor protein tyrosine kinase activity, protein serine / threonine kinase activity, growth factor binding, estrogen response element binding, RNA polymerase II C-terminal domain kinase activity, and endopeptidase activity.

[0078] KEGG pathway analysis was performed on 144 potential therapeutic targets, using FDR < 0.05 as the screening criterion. A total of 133 pathways were identified that are related to the mechanism of action of the Fuzheng Gubenkangai formula in treating cancer-related fatigue. The top 25 pathways were selected and visualized using ImageGP. Figure 6 The relevant pathways mainly include the PI3K-Akt signal pathway, MAPK signal pathway, AGE-RAGE signal pathway, Ras signal pathway, FoxO signal pathway, PD-1 / PD-L1 signal pathway, ErbB signal pathway, VEGF signal pathway, and Rap1 signal pathway.

[0079] Example 5

[0080] Clinical Application of Traditional Chinese Medicine Compositions for Treating Cancer-Related Fatigue

[0081] Case 1: Ms. Zhao, female, 51 years old, first visit on September 15, 2023. She reported lung cancer (partial resection of the left upper lobectomy at a local hospital on July 18, 2023; postoperative pathology: mucinous adenocarcinoma; stage: T1N0M0). More than two months post-surgery, recovery was satisfactory; no radiotherapy or chemotherapy was performed; regular follow-up examinations were conducted. Main clinical manifestations included severe general weakness and fatigue, occasional hot flashes and sweating, difficulty falling asleep, poor sleep with vivid dreams, dry mouth, occasional dull pain or discomfort at the surgical site, occasional chest tightness and shortness of breath, occasional dry cough, epigastric fullness and indigestion, loose stools with incomplete bowel movements, and normal urination. Her tongue was dark with a greasy, slightly yellow coating; her right pulse was thin, and her left pulse was deep and wiry. Traditional Chinese Medicine diagnosis: deficiency of both Qi and Blood, with phlegm and blood stasis. Specialist examination: KPS score 70, NRS score 3. Examination: Postoperative pathology (2023-7-18): Routine examination and remaining tissue analysis [left upper lobe nodule] mucinous adenocarcinoma, apical growth pattern; maximum tumor diameter approximately 0.6cm; no vascular, nerve, or pleural invasion observed; no intra-aerospace dissemination observed; no abnormalities observed in the remaining lung tissue; no cancerous tissue seen at the suture margins. Immunohistochemical results: A.1: CK5 / 6 (-), P40 (-), TTF-1 (+). [Group 5 lymph nodes] No cancer metastasis observed (0 / 1); [Group 12 lymph nodes] No cancer metastasis observed (0 / 1). (2023-8-23) Chest CT: Based on the medical history, after partial resection of the left upper lobe, part of the left upper lobe is missing. A linear high-density shadow and suture line shadow are seen adjacent to the mediastinum, indicating postoperative changes. Multiple linear high-density shadows are visible in both lungs, and calcifications are seen in the right lower lobe. Diagnostic opinion: 1. Based on the medical history, changes were observed after partial resection of the left upper lobectomy; please further evaluate clinically. 2. Old lesions in both lungs. Liver and kidney function (2023-9-12): Total protein 61.3g / L, albumin 38.4g / L; Tumor markers (2023-9-22): CA-724 59.23U / mL. Traditional Chinese medicine prescribed this compound preparation for oral administration, with modifications: Codonopsis pilosula 10g, Schisandra chinensis 10g, Astragalus membranaceus 20g, Codonopsis pilosula 15g, Atractylodes macrocephala 10g, Poria cocos 15g, Angelica sinensis 10g, Rehmannia glutinosa 15g, Bupleurum chinense 12g, Cimicifuga foetida 9g, Bombyx batryticatus 12g, Curcuma zedoaria 12g, Glycyrrhiza uralensis 9g, Uncaria rhynchophylla 10g, Salvia miltiorrhiza 10g, Hedyotis diffusa 30g, one dose daily, divided into morning and evening doses. After two weeks of taking this medicine, the patient's fatigue, drowsiness, poor sleep, and excessive dreaming symptoms significantly improved. Regular follow-up visits were conducted to adjust the Chinese medicine prescription based on the patient's condition, with follow-up visits lasting two months. Examination: Blood routine (2023-12-18): White blood cell count 4.55×10⁻⁶. 9 / L, red blood cell count 4.64×10 9 / L, hemoglobin 134g / L, neutrophils 1.64×10 9 / L; Liver and kidney function: Total protein 72g / L, albumin 46.5g / L; Tumor markers (2023-12-18): CA-724 29.5U / mL, other abnormalities were not found. The patient's fatigue improved significantly, and symptoms such as chest tightness, shortness of breath, sweating, dry mouth, dull pain and discomfort at the surgical site, and dry cough disappeared. Bowel movements and urination were normal. KPS score was 90, NRS score was 0, total protein and albumin levels increased, and tumor marker CA-724 decreased. Regular follow-up visits were conducted with modifications to the original formula.

[0082] Case 2: Mr. Wang, male, 53 years old, was admitted to our department on September 23, 2023. He reported undergoing gastric cancer surgery (laparoscopic radical distal gastrectomy performed on June 9, 2017 at Jingxi Hospital of the Fourth Military Medical University; postoperative pathology: poorly differentiated adenocarcinoma of the gastric angle ulcer type; stage: pT2N3Mx), followed by 6 cycles of F0LFOX chemotherapy. Regular follow-up examinations showed stable condition with no obvious signs of recurrence or metastasis. In May 2023, after a "cold," he developed progressively worsening fatigue accompanied by dull pain and discomfort in his right lower limb after activity. Upon admission, his main clinical manifestations were severe fatigue, right lower limb pain aggravated by activity, abdominal pain worsening after meals, especially at night, normal urination, loose stools, poor sleep, and a weight loss of approximately 10 kg over the past 4 months. Specialist examinations: Karnofsky Performance Status (KPS) score 50, NRS score 3. Examination: Postoperative pathology (June 2017, Fourth Military Medical University, Jingxi Hospital): Ulcerative poorly differentiated adenocarcinoma, clean surgical margins, lesser curvature lymph nodes (8 / 22), greater curvature lymph nodes (0 / 2), pathological stage pT2N3a; immunohistochemistry HER-2(+), Ki-67 70%, Lauren diffuse type. PET-CT (June 2023, Xi'an High-tech Hospital): No signs of abdominal recurrence, bone metastasis in the right hip joint cannot be ruled out. Multiple solid nodules in the chest. Gastroscopy (August 2023, Affiliated Hospital of Qinghai University): Multiple ulcers A2 at the anastomosis, reflux esophagitis LA-B. Upper abdominal CT (October 27, 2023, follow-up at local hospital): No abnormal mass in the surgical area, low-density shadow seen in the liver, contrast enhancement recommended. Tumor markers (re-examination at local hospital on September 23, 2023): Cytokeratin 19 fragment CYFRA21-1 4.33 ng / ml, gastrin-releasing peptide precursor ProGRP 26.94 ng / ml; Thyroid function (re-examination at local hospital on September 23, 2023): TT 31.19 nmol / L; Liver function (re-examination at local hospital on September 23, 2023): Total protein quantification TP 53.00 g / L, Albumin quantification ALB 35.35 g / L, Globulin GLO 17.65 g / L. The patient was prescribed a modified traditional Chinese medicine formula for oral administration: Codonopsis pilosula 10g, Schisandra chinensis 10g, Astragalus membranaceus 20g, Codonopsis pilosula 15g, Atractylodes macrocephala 10g, Poria cocos 15g, Angelica sinensis 10g, Rehmannia glutinosa 15g, Bupleurum chinense 12g, Cimicifuga foetida 9g, Bombyx batryticatus 12g, Curcuma zedoaria 12g, Cremastra appendiculata 12g, Fritillaria thunbergii 10g, Gleditsia sinensis 20g, and Eupolyphaga sinensis 10g. One dose was taken daily, divided into morning and evening doses. After three weeks of treatment, the patient's symptoms of fatigue and pain significantly improved. After discharge, intermittent follow-up visits were conducted to adjust the herbal formula according to the patient's condition. After two months of follow-up, all symptoms had improved. Blood routine (December 9, 2023, Wangjing Hospital): White blood cell count 4.33 × 10⁻⁶. 9 / L, red blood cell count 3.85×10 9Hemoglobin 119 g / L; Thyroid function (December 9, 2023, Wangjing Hospital): TT3 1.4 nmol / L; Liver function (December 9, 2023, Wangjing Hospital): Total protein TP 56.96 g / L, Albumin ALB 37.4 g / L, Globulin GLO 19.56 g / L. Chest CT (December 9, 2023, Wangjing Hospital): Multiple solid nodules in the chest. Follow-up MRI of the right lower extremity: Suggested bone marrow edema, ruling out bone metastasis. Gastroscopy (December 9, 2023, Wangjing Hospital): Suggested reflux esophagitis; post-Bill's II gastrectomy; Anastomotic inflammation, no ulceration. The patient's fatigue improved, abdominal pain lessened, KPS score 80, NRS score 1. Hemoglobin, total protein, albumin, TT3 and other indicators increased, and subsequent regular follow-up visits were conducted with adjustments based on this prescription.

[0083] Case 3: Mr. Lu, male, 63 years old, was admitted to our department on September 21, 2023. He reported being diagnosed with lung cancer more than 3 years ago (stage: extensive-stage small cell lung cancer in the upper lobe of the right lung). On August 1, 2020, the patient was diagnosed with advanced small cell lung cancer at Peking University Cancer Hospital. He initially received 4 cycles of carboplatin or cisplatin plus etoposide treatment, followed by 30 sessions of radiotherapy to the right lung tumor. He then underwent 10 sessions of whole-brain prophylactic radiotherapy. Follow-up examination showed that the in situ tumor had shrunk. The patient then enrolled in a clinical trial and received 12 sessions of durvalumab immunotherapy for maintenance. Due to tumor progression, the patient withdrew from the clinical research group. From the end of 2021 to February 2022, he received 4 cycles of cisplatin plus etoposide chemotherapy (specific dosage unknown) for the in situ recurrence of the lesion. In March 2022, he underwent 8 sessions of SBRT radiotherapy to the in situ recurrence of the tumor. In April 2022, a follow-up chest CT scan revealed a recurrence of the lung tumor in situ, achieving complete remission (CR). In May 2022, brain metastases appeared, and the patient underwent five cycles of SBRT radiotherapy to treat the brain metastases, which continued to shrink. In July 2022, a chest CT scan revealed a new tumor in the right lung, and the patient began taking anlotinib capsules to treat the new tumor until progression occurred. At the end of October 2022, a brain MRI showed the brain tumor had shrunk to 4mm × 2mm. On January 18, 2023, a follow-up brain MRI showed the tumor had increased tenfold in size, and the patient began two cycles of albumin-bound paclitaxel chemotherapy. A follow-up head MRI in 2023 showed a left temporal lobe metastasis, which had increased in size compared to the previous scan. Anlotinib was discontinued after tumor progression. A follow-up chest CT scan showed that the right upper lobe lung cancer had increased in size compared to the previous scan, and the right lower hilar metastatic lesion had also increased in size, indicating progressive disease (PD). On March 2nd, 23rd, 5th, and 15th, 2023, the patient underwent six cycles of CPT-11 100mg day 1, 8 + Avastin 300g day 1 regimen. The treatment was successful. Follow-up tumor markers showed a significant decrease compared to previous tests. Follow-up head MRI showed a reduction in the size of intracranial metastatic lesions and primary and metastatic lung lesions, indicating a partial response (PR). On August 18th, 2023, radiotherapy for secondary lung lesions was completed smoothly. On August 24th, 31st, 9th, 10th, 5th, 12th, and 26th, 2023, the patient underwent CPT-11 100mg day 1, 8 + Avastin 300g day 1 regimen again. The main clinical manifestations were: severe fatigue, nocturnal chest tightness and pain, occasional headache, dyspnea, improvement during the day, poor appetite, poor sleep, normal bowel movements, and itchy skin with white patches. Specialist examinations: Karnofsky Performance Status (KPS) score 60, NRS score 3. Examination: Chest CT (February 24, 2023, Peking University Cancer Hospital): The right upper lobe lung cancer has increased in size compared to the previous scan; the area of ​​consolidation in the right upper lobe and posterior segment of the lower lobe has increased. The metastatic lesion in the right lower hilum has increased in size compared to the previous scan; the remaining mediastinal lymph nodes are the same as before. Head MRI (February 23, 2023, Peking University Cancer Hospital): Metastasis in the left temporal lobe, which has increased in size compared to the previous scan; the enhancement of the small enhancing nodule in the left temporal lobe has decreased compared to the previous scan, and its nature is yet to be determined and further investigation is needed. Multiple sinus inflammations are the same as before.Liver and kidney function (September 20, 2023, Wangjing Hospital): Total protein quantification 60.29 g / L, albumin quantification 39.4 g / L; Blood routine + C-reactive protein (September 20, 2023, Wangjing Hospital): White blood cell count 5.8 × 10. 9 / L, hemoglobin 116g / L, red blood cell count 3.67×10 12 / L, hematocrit 35.6%, mean corpuscular volume 97 fl, mean corpuscular hemoglobin 31.6 pg; tumor markers (Wangjing Hospital, 2023-9-20): NSE 12.78 ng / ml, gastrin-releasing peptide precursor 325.7 pg / ml. Western medicine treatment included irinotecan hydrochloride 100mg day 1 and bevacizumab 300g day 1 chemotherapy for maintenance therapy. Traditional Chinese medicine prescribed a modified compound preparation for oral administration: Codonopsis pilosula 20g, Schisandra chinensis 10g, Astragalus membranaceus 20g, Codonopsis pilosula 15g, Atractylodes macrocephala 10g, Poria cocos 10g, Angelica sinensis 10g, Rehmannia glutinosa 15g, Bupleurum chinense 12g, Bombyx batryticatus 12g, Curcuma zedoaria 12g, Cremastra appendiculata 12g, Citrus aurantium 15g, Allium macrostemon 15g, Salvia miltiorrhiza 20g, and Tussilago farfara 10g. One dose daily, divided into morning and evening administrations. After two weeks of treatment, the patient's symptoms of chest tightness, chest pain, fatigue, and poor sleep improved. Regular follow-up visits were conducted to adjust the Chinese medicine prescription according to the patient's condition. After one month of follow-up, all symptoms had improved. Liver and kidney function tests (Wangjing Hospital, December 13, 2023): Total protein quantification 70.36 g / L, albumin quantification 45.66 g / L; Blood routine + C-reactive protein (Wangjing Hospital, December 13, 2023): White blood cell count 5.47 × 10⁻⁶. 9 / L, hemoglobin 130g / L, red blood cell count 3.91×10 12 / L, hematocrit 39.1%, mean corpuscular volume 100 fl, mean corpuscular hemoglobin 33.2 pg; tumor markers (Wangjing Hospital, December 13, 2023): NSE 11.04 ng / ml, gastrin-releasing peptide precursor 349.5 pg / ml. The patient's fatigue significantly improved, and discomfort such as chest tightness and chest pain was significantly reduced. The KPS score was 80 points, and the NRS score was 1 point. Red blood cell count, hemoglobin, total protein, albumin and other indicators increased, while the tumor marker NSE value decreased. Regular follow-up visits were scheduled, with adjustments made to the basic formula.

[0084] Although the present invention has been described in detail in the embodiments through general description, specific implementation and experiment, any modifications or improvements that can be made without departing from the core of the present invention shall fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating cancer-related fatigue, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: Codonopsis pilosula 10-25 parts, Schisandra chinensis 5-15 parts, Astragalus membranaceus 10-30 parts, Codonopsis pilosula 10-15 parts, Atractylodes macrocephala 10-15 parts, Poria cocos 10-15 parts, Angelica sinensis 10-25 parts, Rehmannia glutinosa 10-25 parts, Bupleurum chinense 10-15 parts, Cimicifuga foetida 5-10 parts, Bombyx batryticatus 10-20 parts, Curcuma zedoaria 10-20 parts, Cremastra appendiculata 10-25 parts, Fritillaria thunbergii 10-15 parts, and Gleditsia sinensis thorns 10-25 parts.

2. The traditional Chinese medicine composition for treating cancer-related fatigue according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 15 parts of Codonopsis pilosula, 10 parts of Schisandra chinensis, 20 parts of Astragalus membranaceus, 15 parts of Codonopsis pilosula, 10 parts of Atractylodes macrocephala, 12 parts of Poria cocos, 10 parts of Angelica sinensis, 15 parts of Rehmannia glutinosa, 12 parts of Bupleurum chinense, 9 parts of Cimicifuga foetida, 12 parts of Bombyx mori, 12 parts of Curcuma zedoaria, 12 parts of Cremastra appendiculata, 10 parts of Fritillaria thunbergii, and 20 parts of Gleditsia sinensis thorns.

3. A traditional Chinese medicine preparation for treating cancer-related fatigue, characterized in that, The traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition for treating cancer-related fatigue as described in any one of claims 1-2.

4. The traditional Chinese medicine preparation for treating cancer-related fatigue according to claim 3, characterized in that, The traditional Chinese medicine preparation is a decoction, which is prepared according to the following steps: (1) Weigh the raw materials according to the weight parts, add 5-10 times the weight parts of water and soak for 30-120 minutes; (2) Heat and boil the soaked raw materials together with water, filter, and collect the filtrate; (3) Add 5-10 times the weight of water to the filter residue, boil, filter, and collect the filtrate; (4) Combine the filtrates obtained after two decoctions and heat them to concentrate, and the decoction is obtained.

5. The traditional Chinese medicine preparation for treating cancer-related fatigue according to claim 4, characterized in that, The cooking time for both simmering sessions is 30-60 minutes.

6. The traditional Chinese medicine preparation for treating cancer-related fatigue according to claim 4, characterized in that, The filtrates are combined and then concentrated by heating to 10%-20% of their original volume.

7. The use of the traditional Chinese medicine composition for treating cancer-related fatigue according to any one of claims 1-2 in the preparation of a medicament for treating cancer-related fatigue.

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