CN115105576B

CN115105576B - Traditional Chinese medicine composition for treating ovarian cancer, traditional Chinese medicine preparation and application thereof

Info

Publication number: CN115105576B
Application number: CN202210667429.0A
Authority: CN
Inventors: 卢雯平; 崔永佳
Original assignee: Guanganmen Hospital of CACMS
Current assignee: Guanganmen Hospital of CACMS
Priority date: 2022-06-14
Filing date: 2022-06-14
Publication date: 2023-06-23
Anticipated expiration: 2042-06-14
Also published as: CN115105576A

Abstract

The invention discloses a traditional Chinese medicine composition for treating ovarian cancer, a traditional Chinese medicine preparation and application thereof. The Chinese medicinal composition comprises radix astragali, atractylodis rhizoma, radix Ranunculi Ternati, rhizoma arisaematis preparata, herba Duchesneae Indicae, herba Solani Nigri, herba Hedyotidis Diffusae, scolopendra, nidus Vespae, semen Citri Reticulatae, fructus Aurantii, radix et rhizoma Rhei preparata, ganoderma, radix Aconiti lateralis Preparata, semen Ziziphi Spinosae preparata, cortex Magnoliae officinalis, fructus Toosendan, and Curcumae rhizoma. The traditional Chinese medicine composition is suitable for patients after ovarian cancer operation or radiotherapy and chemotherapy, is also suitable for patients incapable of tolerating chemotherapy or incapable of tolerating operation due to poor physical condition, can play roles in inhibiting tumor cell proliferation, reducing toxicity and enhancing efficiency and relieving discomfort, and can strengthen the root and banking up vigor, prolong the survival period of the patients and improve the life quality of the patients in the maintenance treatment stage.

Description

Traditional Chinese medicine composition for treating ovarian cancer, traditional Chinese medicine preparation and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines. More particularly relates to a traditional Chinese medicine composition for treating ovarian cancer, a traditional Chinese medicine preparation and application thereof.

Background

The ovarian malignant tumor is a female high-frequency gynecological tumor, the incidence rate of the ovarian malignant tumor is third in the gynecological malignant tumor, the ovarian malignant tumor is next to cervical cancer and uterine body cancer, the death rate of the ovarian malignant tumor is first in the female gynecological malignant tumor, and the female life is seriously threatened. Ancient books did not explicitly address the disease name of ovarian cancer, but the symptoms of ovarian cancer were described separately in different diseases. Ovarian cancer is seen in ancient books in the description of "ovarian, mass, accumulation of mass". Current treatments for ovarian cancer are mainly surgery, but with minimal symptoms perceived in the early stages, most patients do not find until the disease progression exceeds the metastasis of the ovaries to the abdomen and pelvis. Summarizing the value of developing traditional Chinese medicine in the treatment of ovarian cancer is of great importance.

In recent years, a plurality of traditional Chinese medicine formulas for treating ovarian cancer are reported, the formulas can inhibit cancer cells and consolidate root, and improve the self resistance of a patient, but at present, few traditional Chinese medicine compositions which are suitable for auxiliary treatment of postoperative or radiotherapy and chemotherapy treatment and can be used for drug treatment which cannot be operated or chemotherapy are reported, and development of a novel traditional Chinese medicine composition is urgently needed to overcome the problems, and the traditional Chinese medicine composition has important significance in the aspects of improving the illness state of the patient, improving the immunity, generating the illness of the patient, prolonging the life of the patient and the like.

Disclosure of Invention

Based on the above drawbacks, a first object of the present invention is to provide a traditional Chinese medicine composition for treating ovarian cancer. The traditional Chinese medicine composition is suitable for patients after ovarian cancer operation or radiotherapy and chemotherapy, is also suitable for patients incapable of tolerating chemotherapy or incapable of tolerating operation due to poor physical condition, can play roles in inhibiting tumor cell proliferation, reducing toxicity and enhancing efficiency and relieving discomfort, and can strengthen the root and banking up vigor, prolong the survival period of the patients and improve the life quality of the patients in the maintenance treatment stage.

A second object of the present invention is to provide a Chinese medicinal preparation comprising the above-mentioned Chinese medicinal composition.

The third aim of the invention is to provide an application of the traditional Chinese medicine composition or the traditional Chinese medicine preparation in preparing traditional Chinese medicines for treating ovarian cancer.

In order to achieve the first aim, the invention discloses a traditional Chinese medicine composition for treating ovarian cancer, which comprises astragalus, bighead atractylodes rhizome, catclaw, prepared arisaema tuber, indian mock-strawberry, black nightshade, oldenlandia diffusa, centipede, honeycomb, orange core, fructus aurantii, cooked rheum officinale, tree tongue, prepared aconite root, fried spina date seed, magnolia officinalis, szechwan chinaberry fruit and rhizoma curcumae.

The traditional Chinese medicine composition provided by the invention is subjected to traditional Chinese medicine formula screening according to the traditional Chinese medicine theory and the theory of dialectical treatment, has strict formula, has the effects of inhibiting tumor cell proliferation, reducing toxicity, enhancing efficacy and relieving discomfort of patients aiming at ovarian cancer patients with qi deficiency and blood stasis syndrome according to the dialectical of traditional Chinese medicine, can fix the root cause and banking up primordial energy, prevent recurrence and metastasis, prolong the life time of the patients and improve the life quality of the patients in the maintenance treatment stage. The traditional Chinese medicine composition has the advantages of small side effect, simple preparation, convenient administration, simple material acquisition and low price, and is suitable for long-term administration of patients. Patients who are not resistant to chemotherapy or to surgery due to poor physical condition, whether in the maintenance stage following ovarian cancer surgery, can be treated with the formulations of the present invention.

The sources and the functions of the medicinal materials adopted by the formula of the invention are mainly as follows:

radix astragali: sweet and slightly warm. Enter spleen and lung meridians. Tonify qi, raise yang, benefit defensive qi, strengthen superficies, remove toxicity, promote tissue regeneration, induce diuresis and alleviate edema. For "Ben Cao Jing Jie": the deficiency of the human body is not clear at both qi and blood ends. Astragalus root has sweet and warm smell and warm nature, so the shape is not sufficient; to supplement the flavor, so it is also deficient in replenishing essence. "

White atractylodes rhizome: bitter and sweet, warm. Invigorating spleen, invigorating qi, eliminating dampness, promoting diuresis, relieving sweating, and preventing miscarriage. Can be used for treating spleen deficiency, anorexia, dyspepsia, diarrhea, edema, spontaneous perspiration, and fetal movement.

Radix Ranunculi Ternati: sweet and spicy; temperature is high; sex level; liver-tonifying; lung meridian; the main functions are as follows: detoxification; resolving phlegm and resolving masses. Mainly treats scrofula; tuberculosis; pharyngitis; furuncle is caused by external injury; snake bite; malaria; migraine; toothache.

Preparing rhizoma arisaematis: has effects of eliminating dampness and phlegm, dispelling pathogenic wind and relieving spasm, resolving hard mass and detumescence, and can detumescence and resolving hard mass, and can be used for improving carbuncle and swelling phlegm core, traumatic injury, snake bite etc., and can be used for removing toxic substance and detumescence and relieving pain.

Mock strawberry: is the whole herb of Indian mockstrawberry herb of Rosaceae, and has sweet and bitter taste; cold, enter meridians: a lung; liver; large intestine meridian, mainly: clearing heat, cooling blood, detumescence and detoxification. For heat diseases, convulsion, epilepsy, cough, hematemesis, swelling and pain in throat, dysentery, carbuncle, furuncle, snake and insect bite, and fire injury.

Solanum nigrum L: bitter and cold. It is slightly toxic. Clearing heat, detoxicating, activating blood and detumescence. Can be used for treating furuncle, carbuncle, erysipelas, traumatic injury, sprain, chronic cough, asthma, edema, and cancer. Root: bitter, slightly sweet and cold. Can be used for treating dysentery, stranguria with turbid urine, leukorrhagia, traumatic injury, blood stasis dispelling, repercussive, and heat and toxic materials clearing away.

Herba Hedyotidis Diffusae: bitter, light, cold-nature and mainly indicated for: it is good at treating various inflammations with the actions of clearing heat and detoxicating, relieving pain and resolving hard mass, promoting urination and removing dampness.

Centipede): warm nature, pungent taste and toxicity. Has effects in calming endogenous wind, relieving spasm, removing toxic substances, resolving hard mass, dredging collaterals, and relieving pain.

Honeycomb: sweet in taste, flat in nature, and capable of restoring stomach meridian, counteracting toxic substances, killing parasites, dispelling pathogenic wind, and relieving pain, and can be used for treating pyocutaneous disease, swelling and toxin, acute mastitis, scrofula, skin intractable tinea, tinea manuum, toothache, rheumatalgia.

Orange core: bitter taste, good property, and good effect in regulating qi, resolving hard mass, and relieving pain, and can be used for treating hernia pain, testis swelling and pain, and mammary abscess and hyperplasia of mammary glands.

Fructus Aurantii: has the effects of regulating qi-flowing, relieving middle-jiao, activating stagnancy and relieving distention, and can be used for treating chest and hypochondrium qi stagnation, distention and pain, dyspepsia, phlegm retention, gastroptosis, rectocele, uterine prolapse, etc.

Cooked rheum officinale: bitter and cold. The Chinese medicinal composition has the effects of invigorating spleen, stomach, large intestine, liver and pericardium meridian, purging heat, removing heat from the intestines, cooling blood, removing toxicity, removing blood stasis and dredging meridian. Can be used for treating constipation due to excessive heat, abdominal pain due to stagnation, diarrhea, jaundice due to damp-heat, hematemesis, conjunctival congestion, pharyngeal swelling, intestinal abscess, abdominal pain, carbuncle, furuncle, blood stasis, amenorrhea, traumatic injury, and external scald due to pathogenic fire and water; upper gastrointestinal hemorrhage.

Tree tongue: has slightly bitter taste, has effects of invigorating spleen and stomach meridian, and has antiinflammatory and anticancer effects, and can be used for treating pharyngolaryngitis, esophageal cancer, and nasopharyngeal cancer.

Radix Aconiti lateralis Preparata: pungent and sweet, heat entering heart, spleen and kidney meridians has the effects of restoring yang, rescuing collapse, tonifying fire, supporting yang, dispelling cold and removing dampness.

Semen Ziziphi Spinosae: sweet and sour in taste, neutral in nature, and good in liver, gallbladder and heart meridian, and has the effects of nourishing heart, tonifying liver, calming heart, tranquilizing mind, arresting sweating and promoting fluid production.

Cortex Magnoliae officinalis: has effects of eliminating dampness, removing food stagnation, promoting qi circulation, relieving asthma, resolving food stagnation, dispelling pathogenic wind, and relieving pain.

Fructus Toosendan: bitter in property and cold in flavor, enters liver, small intestine and bladder meridian, has the effects of soothing liver, relieving heat, promoting qi circulation, relieving pain and killing parasites, and is used for treating liver depression, fire, chest and hypochondrium, abdominal pain, hernia pain and insect accumulation abdominal pain.

Zedoary turmeric: is mainly used for treating stagnation of qi and blood, distending pain of heart and abdomen, abdominal mass, indigestion, amenorrhea due to blood stasis of women and traumatic injury.

Ovarian cancer is located in the triple energizer, if the triple energizer is abnormal, deficiency cold grows internally, qi and blood deficiency and abnormal operation lead to qi depression, blood stasis and phlegm dampness, and the generation of toxin is the main pathogenesis; the ovaries are in the lower energizer, which is the power of primordial qi, and if yang qi in the lower energizer is deficient and deficiency cold is generated internally, or external cold drives internal cold, cold coagulation and blood stasis can ultimately generate toxic pathogen. According to the theory of triple energizer membrane striae, in the treatment, firstly, the disease is necessarily solved in the root, in the formula, astragalus and bighead atractylodes rhizome are taken as monarch drugs, astragalus is taken as a principal drug for tonifying qi, bighead atractylodes rhizome is used for tonifying spleen and qi, and the acquired is cultivated and reinforced, so that the spleen is fundamentally strengthened, qi and blood are generated, and healthy qi is supported. The ovarian cancer patients have abnormal qi and blood circulation, phlegm, blood stasis and toxicity agglomeration, and often have long-term diseases entering blood and collaterals. In the formula, zedoary, centipede, radix ranunculi ternati, prepared rhizoma arisaematis, fructus aurantii, semen citri reticulatae, magnolia officinalis, szechwan chinaberry fruit and cooked rheum officinale are used as ministerial drugs. The curcuma zedoary has the effects of removing blood stasis and resolving food stagnation, the force of the curcuma zedoary is obtained in the whole formula to avoid the phenomenon of keeping the door closed, and the combination of the curcuma zedoary and qi-tonifying herbs also restricts the force of breaking blood and resolving food stagnation, so as to avoid injuring vital qi; cold, deficiency and blood stasis act on ovary for a long time, and are easy to coagulate with phlegm and blood stasis, and are converted into cancer toxin, and the cat claw grass and the prepared rhizoma arisaematis are used for dispelling stubborn phlegm, dredging collaterals and resolving masses; the centipede has warm nature, is good at moving, has the functions of removing blood stasis and resolving hard mass, and can remove the evil of long-time internal obstruction of collaterals, dredge collaterals and resolve hard mass, so that blood is free from stagnation, and qi can be dredged; the prepared large Huang Tongda triple coke and rhubarb are steamed, then the purgation strength is reduced, the triple coke is cleaned, the stasis is removed and the new generation is realized, and the triple coke and the zedoary are used together to remove the hard-to-break dried blood; fructus Aurantii, semen Citri Reticulatae, cortex Magnoliae officinalis, fructus Toosendan, and fructus Toosendan can regulate qi, remove stagnation, sooth liver-qi, restore liver's liver-qi, smooth qi movement, and avoid stagnation of qi and blood to cause endogenous toxin. The monarch and minister drugs are compatible, strengthen healthy energy, promote qi circulation, remove phlegm, stasis and detoxify. In the recipe, prepared aconite root, oldenlandia, black nightshade, dendra, indian mockstrawberry herb, honeycomb and stir-fried wild jujube seed are used as adjuvant and guiding drugs. The lower-jiao is deficient in yang qi, cold is congealed and stasis, the processed aconite root is used for warming, activating and dispelling cold, so that the disadvantage of aggravating cold evil in the body is avoided, the aconite root is left without being blocked, and Wen Zhenyang is used for tonifying spleen yang. Late stage ovarian cancer can resolve heat and fire to consume body fluid after long time of phlegm and toxin stasis, such as oldenlandia diffusa, black nightshade and the like, clear and detoxify, nourish yin and promote the production of body fluid, resist inflammation and cancer of the dendranthema pallidum and the mock strawberry, and attack toxin and resist cancer of the honeycomb. Patients with ovarian cancer are prone to insomnia, mental retardation, and the semen zizyphi spinosae calm and promote sleep. The medicines are combined to achieve the effects of strengthening healthy energy, detoxifying and resisting cancer, so as to prolong the disease-free survival time of patients.

Further, the traditional Chinese medicine composition comprises, by weight, 15-50 parts of astragalus membranaceus, 12-50 parts of bighead atractylodes rhizome, 9-15 parts of radix ranunculi ternati, 6-12 parts of prepared rhizoma arisaematis, 15-30 parts of Indian mockstrawberry herb, 10-20 parts of black nightshade herb, 15-45 parts of oldenlandia diffusa, 2 centipedes, 5-10 parts of honeycomb, 9-12 parts of orange pits, 9-15 parts of fructus aurantii, 6-12 parts of prepared rheum officinale, 15-20 parts of tongue, 9-15 parts of prepared aconite root, 9-12 parts of szechwan chinaberry fruit, 9-12 parts of rhizoma curcumae, 15-30 parts of fried spina date seed and 9-12 parts of magnolia officinalis.

Further, the traditional Chinese medicine composition comprises, by weight, 30 parts of astragalus membranaceus, 15 parts of bighead atractylodes rhizome, 12 parts of radix ranunculi ternati, 12 parts of prepared rhizoma arisaematis, 15 parts of Indian mockstrawberry herb, 15 parts of black nightshade herb, 30 parts of oldenlandia diffusa, 2 centipedes, 5 parts of nidus Vespae, 12 parts of tangerine seeds, 12 parts of fructus aurantii, 12 parts of prepared rheum officinale, 20 parts of tree tongue, 9 parts of prepared aconite, 30 parts of fried spina date seeds, 9 parts of mangnolia officinalis, 12 parts of szechwan chinaberry fruit and 12 parts of curcuma zedoary.

Further, the traditional Chinese medicine composition comprises, by weight, 30 parts of astragalus membranaceus, 20 parts of bighead atractylodes rhizome, 12 parts of radix ranunculi ternati, 12 parts of prepared rhizoma arisaematis, 15 parts of Indian mockstrawberry herb, 20 parts of black nightshade, 30 parts of oldenlandia diffusa, 2 centipedes, 6 parts of honeycomb, 12 parts of tangerine seeds, 15 parts of fructus aurantii, 12 parts of prepared rheum officinale, 15 parts of tree tongue, 9 parts of prepared aconite, 30 parts of fried spina date seeds, 12 parts of mangnolia officinalis, 9 parts of szechwan chinaberry fruit and 9 parts of curcuma zedoary.

In order to achieve the second purpose, the invention discloses a traditional Chinese medicine preparation for treating ovarian cancer.

When in use, the traditional Chinese medicine composition can be prepared by weighing the raw materials according to a prescription, adding water for soaking for 30-40 minutes, and decocting for two times; wherein, after the first decoction is boiled with strong fire, the first decoction is boiled with slow fire for 40 minutes; and (3) boiling the second decoction with strong fire, decocting with slow fire for 30 minutes, and removing residues to obtain decoction. Or refining the effective components of the preparation with water or other suitable solvents, adding pharmaceutically acceptable adjuvants, and making into various dosage forms such as granule, tablet, capsule, pill, powder, and oral liquid. Experiments prove that the preparation method and the using method can realize the therapeutic effect of the medicament.

In order to achieve the third purpose, the invention discloses an application of the traditional Chinese medicine composition or the traditional Chinese medicine preparation in preparing a traditional Chinese medicine for treating ovarian cancer.

The beneficial effects of the invention are as follows:

1. the traditional Chinese medicine composition disclosed by the invention can inhibit the proliferation of tumor cells aiming at ovarian cancer patients with qi deficiency and blood stasis syndrome according to the differentiation of traditional Chinese medicine; auxiliary chemotherapy, attenuation and synergy; in the maintenance treatment stage, the medicine can strengthen the root and strengthen the primordial qi, prevent recurrence and metastasis, prolong the life cycle of a patient and improve the life quality of the patient. The traditional Chinese medicine composition has the advantages of small side effect, simple preparation, convenient administration, simple material acquisition and low price, and is suitable for long-term administration of patients. For the stage of maintenance treatment after ovarian cancer operation, patients who cannot tolerate chemotherapy or who cannot tolerate operation due to poor physical condition can be treated by the medicine of the invention.

2. The traditional Chinese medicine composition for treating ovarian cancer is screened according to the traditional Chinese medicine theory and the dialectical treatment theory, the proportion of the traditional Chinese medicine composition for treating ovarian cancer is scientific and reasonable, and the traditional Chinese medicine composition provided by the invention can inhibit the growth of tumor cells; has the functions of reducing toxicity, enhancing efficacy and reducing pain of patients with ovarian cancer; the long-term clinical experiment research shows that the traditional Chinese medicine composition for treating ovarian cancer provided by the invention has high safety and low toxic and side effects.

3. The traditional Chinese medicine composition for treating ovarian cancer provided by the invention can be conveniently prepared into various dosage forms with pharmaceutical carriers, and is convenient to clinically take.

Drawings

FIG. 1 shows the function of Kaplan-Meier survival analysis for patients in the treatment and control groups.

FIG. 2 shows a CCL18 with M2% scatter plot.

Detailed Description

In order to more clearly illustrate the present invention, the present invention will be further described with reference to preferred embodiments and the accompanying drawings. It is to be understood by persons skilled in the art that the following detailed description is illustrative and not restrictive, and that this invention is not limited to the details given herein.

Example 1

The formula comprises the following components: 30 parts of astragalus membranaceus, 15 parts of bighead atractylodes rhizome, 12 parts of radix ranunculi ternati, 12 parts of prepared rhizoma arisaematis, 15 parts of Indian mockstrawberry herb, 15 parts of black nightshade herb, 30 parts of oldenlandia diffusa, 2 centipedes, 5 parts of honeycomb, 12 parts of semen citri reticulatae, 12 parts of fructus aurantii, 12 parts of prepared rheum officinale, 20 parts of Ganoderma applanatum, 9 parts of processed aconite, 30 parts of fried spina date seed, 9 parts of magnolia officinalis, 12 parts of szechwan chinaberry fruit and 12 parts of curcuma zedoary;

weighing the raw materials according to the prescription, adding water for soaking for 30-40 minutes, and decocting twice; wherein, after the first decoction is boiled with strong fire, the first decoction is boiled with slow fire for 40 minutes; and (3) boiling the second decoction with strong fire, decocting with slow fire for 30 minutes, and removing residues to obtain decoction.

Example 2

The formula comprises the following components: 30 parts of astragalus membranaceus, 20 parts of bighead atractylodes rhizome, 12 parts of radix ranunculi ternati, 12 parts of prepared rhizoma arisaematis, 15 parts of Indian mockstrawberry herb, 20 parts of black nightshade herb, 30 parts of oldenlandia diffusa, 2 centipedes, 6 parts of honeycomb, 12 parts of semen citri reticulatae, 15 parts of fructus aurantii, 12 parts of prepared rheum officinale, 15 parts of Ganoderma applanatum, 9 parts of processed aconite, 30 parts of fried spina date seed, 12 parts of mangnolia officinalis, 9 parts of szechwan chinaberry fruit and 9 parts of rhizoma curcumae;

Clinical trial

1 subject of study

1.1 case Source

The cases are from 9 months in 2020 to 3 months in 2022, and are diagnosed at the oncology department clinic in Guangan-Men's hospital, and the platinum-resistant ovarian cancer is confirmed according to Western diagnosis standards, and the ovarian cancer patients with qi deficiency and blood stasis syndrome are identified according to the Chinese medical differentiation. The total sample size of the study design is 60, wherein 30 cases of treatment groups and 30 cases of control groups are treated, a random number table method is adopted, random numbers and corresponding intervention schemes are put into sealed and opaque envelopes, the envelopes are externally attached with numbers, researchers open the envelopes according to the sequence of the numbers, and patients are randomly divided into the treatment groups and the control groups.

1.2 diagnostic criteria

1.2.1 Western diagnostic criteria:

diagnosis is carried out according to platinum drug-resistant recurrent ovarian cancer diagnosis standards formulated in national comprehensive cancer network National Comprehensive Cancer Network, NCCN (national editions of China 2020) and according to the medical history, physical symptoms, tumor markers and imaging examination (such as X-ray, ultrasound, abdominal basin CT, nuclear magnetic resonance and the like) and pathology report (such as ascites cytology, tumor histology and the like) of patients, the patients are determined to be patients with advanced platinum drug-resistant recurrent ovarian cancer.

Platinum drug resistance standard: at least 1 platinum-based chemotherapy, relapse within 6 months after withdrawal, or progression through the chemotherapy.

Clinical staging criteria: clinical staging is determined by combining FIGO staging criteria with staged surgery, peritoneal irrigation fluid or ascites cytology, biopsy, and puncture pathology.

1.2.2 diagnostic criteria for chinese medicine:

the diagnosis standard of ' abdominal mass ' in the main code of traditional Chinese medicine gynecology ' of Zhang Yuzhen is consulted by the traditional Chinese medicine differentiation, the past medical history of the patient such as the history of feeling exogenous evil after menstruation, abnormal birth of menstruation and leucorrhea, abnormal emotion and other medical histories, the clinical manifestations such as abdominal distension, abdominal pain, abdominal mass, abnormal menstruation and other symptoms are combined, and the same western medicine diagnosis standard is assisted in examination.

Based on diagnosis and treatment guidelines of tumor Chinese medicine and the relevant contents of Chinese medicine diagnosis and treatment guidelines of Chinese higher medical institutions, the diagnosis and treatment standards of qi deficiency and blood stasis in the relevant contents of Chinese medicine diagnosis and treatment guidelines of Chinese medicine new medicine are formulated, and based on the four diagnosis results of patients, under the guidance of doctors of Chinese medicine, the diagnosis and treatment standards of qi deficiency and blood stasis are formulated, and the clinical manifestations are as follows:

main symptoms are as follows: shortness of breath and weakness; spontaneous perspiration; the complexion is sallow; the face is provided with ecchymosis; the abdominal pain is fixed and not moving, and the abdominal pain is touched with a bag block; numbness of limbs; skin nail error; the complexion is dark.

Secondary symptoms: pale and fat tongue with teeth marks on the pale side; dark tongue, ecchymosis and dark purple tongue vein; weak or thready and astringent pulse.

Has at least 2 main symptoms or 1 main symptom and 2 secondary symptoms, and meets the diagnosis standard.

1.3 inclusion criteria

The age is between 20-80 years old; patients diagnosed with primary epithelial ovarian cancer via surgical pathology examination; at least 1 platinum-based chemotherapy, relapse within 6 months after withdrawal, or progression during chemotherapy (normalized to imaging relapse or progression), and is diagnosed with platinum resistance for no more than 1-2 months; the traditional Chinese medicine distinguishes the disease as 'abdominal mass', and the syndrome is qi deficiency and blood stasis; ECOG score: 0-2 minutes; the expected lifetime is more than or equal to 2 months; the medical record data is complete; and signing an informed consent form.

1.4 exclusion criteria

(1) Other tumor medical history exists in the past;

(2) those suffering from infectious diseases or immune system diseases which are not yet controlled;

(3) immunosuppressants are used recently;

(4) patients with severe heart, liver, kidney and hematopoietic diseases, and uncontrolled;

(5) patients with mental diseases, serious neurological impairment (such as aphasia and aphasia) or other reasons can not be matched with the examination;

(6) allergic to the recipe.

1.5ECOG scoring criteria

Scoring was performed according to Zubrod-ECOG-WHO (ZPS, 5 score method) physical condition ECOG scoring criteria.

1.6 termination or Exit criteria

(1) The patient actively applies for withdrawal from the trial at any time;

(2) the patient dies or the disease progresses. Disease progression is defined by reference to a solid tumor efficacy evaluation criterion (RECIST): for measurable lesions, disease progression is defined as a 20% increase in the sum of the primary target lesion length and its absolute value increased by 5mm, and the appearance of new lesions; disease progression may also be assessed for non-measurable lesions if any new lesions appear, or have an estimated increase in lesions of more than 25%, or a sustained rise in tumor markers combined with clinical manifestations.

1.7 drop criteria

(1) Violating the requirement of research scheme, and not according to the prescription, the dosage is less than 80% or more than 120%;

(2) poor data recording quality, incomplete data and inaccuracy;

(3) cases in the group due to adverse reactions were not evaluated for efficacy, but their adverse drug reactions should be included in statistics.

1.8 study termination criteria

(1) More than 25% of patients experience more serious adverse events, which are likely to be associated with the intervention drug tested;

(2) external information proves that the intervention scheme is invalid or effective, and the current clinical test is unnecessary to go on;

(3) differences in the expected efficacy are achieved by the planned phase analysis, as has been observed when the intervention regimen for the test group is significantly better than for the control group.

2 treatment regimen

2.1 dosing regimen

Both treatment and control groups were treated according to the national integrated cancer network (NCCN) guidelines class i recommendations: paclitaxel Zhou Liaolian treatment with bevacizumab, topotecan combined bevacizumab, liposomal doxorubicin combined bevacizumab, gemcitabine (paclitaxel, intravenous infusion 60 mg/m) ² Infusion for 1h, day 1, 8, 15; topotecan, intravenous infusion 1.25mg/m ² 30min/d, 5d continuously, 1 time every 4 weeks; liposome doxorubicin, intravenous infusion 40-50mg/m ² 1 every 4 weeks. Gemcitabine for intravenous infusion of 1000mg/m ² Used on days 1, 8 and 21, 21d is 1 cycle. Bevacizumab was infused intravenously at 10mg/kg, 1 dose every 2 weeks. )

The treatment group takes the decoction of the example 1 on the basis, 300ml of the decoction is decocted in water, each time is 1 time in the morning and at night, the warm taking is carried out after meal, 1 course of treatment is carried out for two months, at least 6 months of taking or stopping taking is carried out in progress, and the decoction pieces are provided by the Guangan hospital pharmacy of the Chinese medical college; the control group was not additionally administered with other drugs.

2.2 observations index

2.2.1 main study endpoint:

progression Free Survival (PFS): follow-up observations of the patient from the time of entry into the group to the time of disease progression or death.

2.2.2 secondary study endpoint:

2.2.2.1 quality of life score

The quality of life of the two groups of patients was assessed using Karonofsky (karsons, KPS, percent) functional status scoring criteria and the scores before and after treatment were compared. The percentage is increased by more than 10 minutes than the last time, which shows that the quality of life is improved; the living quality is reduced by more than 10 minutes compared with the previous reduction, and the living quality is stable between the two.

Using the ovarian cancer patient quality of life assay table FACT-O, the quality of life of two groups of patients was evaluated from the following five aspects: physiological conditions, social conditions, emotional conditions, functional conditions, and other items of interest, and comparing the scores of the two sets before and after treatment. Each entry uses 5 rank scoring: "neither" is level 0, "one" is level 1, "normal" is level 2, "quite" is level 3, and "quite" is level 4. Class 0 scores 0, class 1 scores 1, and so on, the higher the score, the worse the quality of life.

2.2.2.2 integration of the syndrome in TCM

The related content of the Chinese medicine new medicine clinical research guidelines is referred to the diagnosis standard of qi deficiency syndrome and blood stasis syndrome, and the classification quantitative evaluation standard of the ovarian cancer Chinese medicine symptoms formulated by specialists are respectively evaluated at the time of group entering and the time of follow-up. A total score was 4 criteria, each of which was: the treatment effect was evaluated using a treatment effect criterion formula without score 0, with a mild score of 1, a moderate score of 2, and a severe score of 3: syndrome accumulation ratio= [ (pre-treatment integral-post-treatment integral)/pre-treatment integral ] x100%, set: the method has the advantages that: more than or equal to 70 percent, and partially improves: the integral ratio of the syndrome is less than 70% and is not effective: the syndrome accumulation ratio is less than 30%.

2.3 exploratory analysis

Peripheral blood M2%, CCL18 expression level: peripheral blood 10ml was collected at the time of patient group entry and at the end of study or disease progression, respectively. Marking M2 type macrophages by using CD206, and detecting the proportion of the M2 type macrophages in peripheral blood macrophages by using a flow cytometry method; CCL18 expression levels were detected with ELISA kits.

2.4 follow-up plans

Subjects were followed monthly after group entry to study end or disease progression as follows: (1) inquiring about clinical symptoms; (2) collecting review laboratory inspection and image data; (3) inquiring the medication condition; (4) collecting and scoring quality of life information by using a quality of life KPS scoring scale and an ovarian cancer patient quality of life measuring scale FACT-O; (5) recording the existence, type, occurrence time, duration, degree and alleviation mode of the adverse event.

2.5 statistical methods

Clinical data of 60 patients taken in are analyzed and sorted by SPSS26.0 data statistics software, and all data are analyzed by descriptive statistics, including demographics, baselines, efficacy evaluation indexes and the like. For metering data, normal distribution inspection is carried out, data conforming to normal distribution is inspected by an independent sample t, the average value, standard deviation, median, maximum value and minimum value of the data are described, and a 95% credible interval of the average value is calculated; data that do not fit the normal distribution uses a non-parametric rank sum test. For the count data, the chi-square test was used to describe the frequency and percentage, and the 95% confidence interval for that percentage was calculated. Survival analysis PFS analysis was performed using the Kaplan-Meier method, and the two groups of PFS were compared using the log-rank test. The correlation of the percentage of M2 type macrophages and CCL18 expression levels was analyzed using Pearson correlation assay. Aiming at the basic clinical data of patients and the correlation study of curative effect indexes before and after group treatment and PFS, a Cox regression model is adopted to analyze single factor and multiple factors, and independent prognosis factors affecting PFS are calculated, wherein P <0.05 is statistically significant difference.

3. Results of the study

3.1 patient baseline data

3.1.1 two groups of patient general data

Collecting patients who are diagnosed with platinum-resistant ovarian cancer according to Western diagnosis standards and are diagnosed with qi deficiency and blood stasis syndrome ovarian cancer according to traditional Chinese medicine differentiation, and taking 60 patients according to nano-ranking standards, wherein the patients are treated at the oncology clinic of Guangdong Hospital and the oncology hospitalization department from 9 months 2020 to 3 months 2022. The basic data of the cases included in the study can be seen in Table 1.

Table 1 platinum-resistant recurrent ovarian cancer patient baseline

3.1.2. Comparison of general data for two groups of patients

3.1.2.1 age comparisons of two groups of patients

The patient ages of the treatment group and the control group were in accordance with normal distribution, and the two groups were tested for variability using independent sample t-test, and the results showed no statistical difference in the ages of the two groups (p=0.130 > 0.05), as shown in table 2.

Table 2 age comparison of two groups of patients (mean.+ -. Standard deviation)

3.1.2.2 clinical stage and typing comparison of two groups of patients

Clinical stage comparison of the treatment group and the control group patients were tested for variability using the chi-square test, and the results showed no statistical difference between the two clinical stages (p=0.584 > 0.05), as shown in table 3.

Table 3 comparison of clinical stage and type of two groups of patients

3.1.2.3 comparison of the number of past treatment regimens and the number of treatment lines for two groups of patients

The number of past treatment regimens for the treatment group and the control group of patients were tested for variability using the chi-square test, which showed no statistical differences in the number of past treatment regimens (p=0.739 > 0.05), as shown in table 4.

Table 4 comparison of the number of previous treatment regimens and the number of treatment lines for two groups of patients

3.1.2.4 clinical metastasis and ascites combining comparison of two groups of patients

The differences of the lymph node metastasis, organ metastasis, pelvic external metastasis and ascites combining conditions of the treatment group and the control group patients are tested by using a chi-square test, and the results show that the lymph node metastasis, organ metastasis, pelvic external metastasis and ascites combining conditions of the two groups of patients have no statistical difference (P is more than 0.05), and are shown in table 5.

TABLE 5 metastasis and ascites combining conditions for two groups of patients

3.1.2.5 comparison of quality of life for two groups of patients

The quality of life KPS scores and the FACT-O scale scores of the patients in the treatment group and the control group are in accordance with normal distribution, and the two groups of differences are tested by using independent sample t test, so that the results show that the two groups of quality of life KPS scores and the FACT-O scale scores have no statistical difference (P=0.304 > 0.05 and P=0.691 > 0.05), and the results are shown in table 6.

Table 6 quality of life scores for two groups of patients

3.1.2.6 Chinese medicine syndrome integral comparison of two groups of patients

The Chinese medicine syndrome integral of the treatment group and the control group of patients accords with normal distribution, the two groups of differences are checked by using independent sample t test, and the results show that the two groups of Chinese medicine syndrome integral have no statistical difference (P=0.615 > 0.05), and the results are shown in table 7.

TABLE 7 integration of TCM syndrome for two groups of patients when they were entered into group

3.1.2.7 comparison of the percentage of M2 macrophages to macrophages (M2%) in two groups of patients

The treatment group and control group of patients M2% met normal distribution, and the two groups were tested for variability using independent sample t-test, which showed no statistical difference in M2% for both groups (p=0.416 > 0.05), as shown in table 8.

TABLE 8 percentage of peripheral blood M2-type macrophages (M2%) for two groups of patients when they were enrolled

Comparison of CCL18 expression levels in two groups of 3.1.2.8 patients

The treatment and control group of patients CCL18 met normal distribution, and the two groups were tested for variability using the independent sample t-test, which showed no statistical difference (p=0.826 > 0.05) for the two groups of CCL18, as shown in table 9.

TABLE 9 peripheral blood CCL18 expression levels in two groups of patients when they were entered into the group

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3.2 observations of index results

3.2.1. Progression Free Survival (PFS) of both groups of diseases

In the study, 60 platinum-resistant recurrent ovarian cancer patients are included, wherein 2 patients in the treatment group do not develop disease progress when the treatment group is subjected to follow-up date, and 3 patients in the control group fall off due to incomplete clinical data and are assigned to deletion data. Wherein the progression-free survival of 13 patients of 28 patients of the treatment group is < 6 months, the progression-free survival of 14 patients is within 6 months-12 months, and the progression-free survival of 1 patient is > 12 months; the progression free survival of 22 of the 27 patients in the control group was < 6 months, and the progression free survival of 5 patients was within 6 months-12 months, as shown in table 10.

Table 10 Progression Free Survival (PFS) for two groups of patients

The two groups were subjected to survival analysis using Kaplan-Meier survival analysis in SPSS software, with the final results showing: treatment group mPFS was 6.930 months (standard error: 1.222, 95% confidence interval: 4.535-9.325) and control group mPFS was 4.970 months (standard error: 0.234, 95% confidence interval: 4.512-5.428), as shown in table 11; the Log Rank was used to check whether there was a statistical difference between the two PFS groups and the final results showed: x-shaped articles ² =13.019, p=0.000, and the two groups were statistically different, with treatment group mPFS prolonged compared to control group mPFS, as shown in fig. 1.

TABLE 11 mean and median PFS of two groups of patients

Note that: a. if the time to live analysis has been detected, the estimation will be limited to the maximum time to live analysis.

3.2.2. Quality of life evaluation

Quality of life KPS scores, FACT-O scale scores were assessed on two groups of patients enrolled at months 3, 6, 9, respectively, of the follow-up period. The results show that:

after 3 months of the group, 30 patients were treated and 30 patients were control.

The quality of life KPS score of the treatment group was better than that of the control group, with statistical differences (p=0.003 < 0.05); there was no statistical difference between treatment and control quality of life KPS score before and after intervention.

The quality of life of the treatment group is scored better than the control group by the FACT-O scale, and has statistical difference (P=0.000 < 0.05); the treatment group FACT-O scale scoring dry prognosis is better than before the intervention, and has statistical difference (P=0.019 < 0.050), and the control group FACT-O scale scoring dry prognosis has no statistical difference than before the intervention.

After 6 months of the group, 18 patients in the treatment group and 16 patients in the control group.

The quality of life KPS score of the treatment group was better than that of the control group, with statistical differences (p=0.034 < 0.05); the quality of life KPS scores of the patients in the treatment group were better than before the intervention, had statistical differences (p=0.001 < 0.05), and the quality of life KPS scores of the patients in the control group were not statistically different before and after the intervention.

The quality of life of the treatment group is scored better than the control group with statistical difference (P=0.001 < 0.05); the treatment group FACT-O scale scoring dry prognosis is better than before the intervention, and has statistical difference (P=0.001 < 0.050), and the control group FACT-O scale scoring dry prognosis has no statistical difference than before the intervention.

After 9 months into the group, 6 patients in the treatment group and 5 patients in the control group.

The quality of life KPS score of the treatment group was better than that of the control group, with statistical differences (p=0.033 < 0.05); the quality of life KPS scores of the treatment group were better dry than before the intervention and were statistically different (p=0.005 < 0.05), and the quality of life KPS scores of the control group were not statistically different.

The quality of life of the treatment group is scored better than the control group, and the treatment group has statistical difference (P=0.003 < 0.05); the treatment group FACT-O scale scoring dry prognosis is better than before the intervention, and has statistical difference (P=0.001 < 0.050), and the control group FACT-O scale scoring dry prognosis has no statistical difference than before the intervention.

The results of the quality of life KPS scores for two groups of patients are shown in table 12. The differences in the quality of life KPS scores and the FACT-O scale scores of the two groups of patients are shown in tables 13 and 14.

Table 12 results of quality of life KPS scores before and after two groups of patient interventions

Table 13 difference in quality of life (KPS) scores before and after intervention for two groups of patients

Compared to the baseline of the present group (case of group entry):

treatment group was compared to this group baseline 3 months after group entry: t= -1.440, p=0.155; 6 months after the group, compared to the baseline of the group: t= -3.589, p=0.001; comparison to this group baseline 9 months after the group: t= -3.023, p=0.005. The control group was compared to the baseline of the present group 3 months after the group: t=0.360, p=0.72; 6 months after the group, compared to the baseline of the group: t= -1.901, p=0.064; comparison to this group baseline 9 months after the group: t= -0.788, p=0.435.

The same time point is compared with two groups:

after 3 months, the treatment group was compared with the control group: t=3.120, p=0.003; after 6 months, the treatment group was compared with the control group: t=2.212, p=0.034; after 9 months, the treatment group was compared with the control group: t=2.513 and p=0.033.

TABLE 14 quality of life FACT-O scale scoring results before and after two groups of patient interventions

Both groups were compared to the baseline of the present group (case at the time of group entry) respectively, and the treatment group was compared to the baseline of the present group 3 months after group entry: t=2.419, p=0.019; 6 months after the group, compared to the baseline of the group: t=6.294, p=0.001; comparison to this group baseline 9 months after the group: t=4.820, p=0.001. The control group was compared to the baseline of the present group 3 months after the group: t= -1.756, p=0.084; 6 months after the group, compared to the baseline of the group: t=1.573, p=0.123; comparison to this group baseline 9 months after the group: t= -0.375, p=0.710.

Two groups at the same time point were compared, and after 3 months, the treatment group was compared with the control group: t= -4.853, p=0.000; after 6 months, the treatment group was compared with the control group: t= -5.822, p=0.001; after 9 months, the treatment group was compared with the control group: t= -4.143, p=0.003.

3.2.3. Integral evaluation of Chinese medicine syndrome

The evaluation of the efficacy of the traditional Chinese medicine syndrome treatment was carried out on two groups of patients who were in the group at 3, 6 and 9 months of the follow-up period, and the results are shown in Table 15:

after 3 months of the treatment, the improvement rate of the treatment group is superior to that of the control group, and the improvement rates of the two groups are statistically significant (P=0.001 < 0.05); the improvement rates of the two groups after 6 months into the group were statistically significant (p=0.036 < 0.05); the improvement rates of the two groups after 9 months into the group were statistically significant (p=0.036 < 0.05).

Table 15 scoring results of the symptoms of chinese medical science after two groups of patients intervene

Note that: a: x-shaped articles ² ＝9.075，P＝0.001；b：χ ² ＝4.636，P＝0.036；c：χ ² ＝4.412，P＝0.036。

3.2.4. Changes in M2% before and after treatment in both groups

The percentages of M2 macrophages before and after treatment of the two groups of patients are normally distributed, and whether M2% before and after treatment of the treatment group and the control group are different is checked by using an independent sample t test, and the results show that the M2% of peripheral blood after treatment of the patients in the treatment group is lower than before treatment and has statistical significance (P=0.000 < 0.05), and the M2% of peripheral blood after treatment of the patients in the control group is also lower than before treatment and has statistical significance (P=0.000 < 0.05); after treatment, the treatment group patients had a statistically significant (p=0.000 < 0.05) with a lower M2% peripheral blood than the control group. The M2% results before and after intervention for both groups of patients are shown in table 16.

Table 16 two groups of treatment pre-and post-treatment M2% changes

Note that: comparison of treatment groups before and after treatment, a: t=11.407, p=0.000; comparison of control group before and after treatment, b: t=9.199, p=0.000.

3.2.5. Changes in CCL18 levels before and after treatment of both groups

The expression levels of CCL18 before and after treatment were normalized, and the difference between the expression levels before and after treatment was examined using the independent sample t-test, and the results are shown in table 17, in which the expression level of serum CCL18 after treatment was lower than before treatment for the patients in the treatment group (p=0.000 < 0.05), and the expression level of serum CCL18 after treatment was lower than before treatment for the patients in the control group (p=0.000 < 0.05); after treatment, the serum CCL18 expression level was also statistically significant (p=0.000 < 0.05) in the treated group patients compared to the control group.

Table 17 changes in CCL18 levels before and after two treatment groups

Note that: comparison of treatment groups before and after treatment, a: t=17.368, p=0.000; comparison of control group before and after treatment, b: t=11.657, p=0.000.

3.2.6. Correlation analysis of peripheral blood CCL18 levels and M2 phenotypes

The pre-treatment and post-treatment percentages of M2 type macrophages and CCL18 expression levels for the treatment and control patients are shown in the form of a scatter plot with CCL18 expression levels on the abscissa and percentages of M2 type macrophages on the ordinate, as shown in fig. 2. The points together fit to a straight line, with a corresponding increase in CCL18 expression level when the percentage of M2 macrophages increases, and conversely, with a corresponding decrease in CCL18 expression level when the percentage of M2 macrophages decreases, suggesting that CCL18 expression level is positively correlated with M2 macrophages. The correlation of the percentage of M2 type macrophages and the level of CCL18 expression was analyzed using Pearson correlation test and the results are shown in table 18, the differences being statistically significant (p=0.000 < 0.05).

TABLE 18 analysis of correlation of CCL18 expression levels with M2%

Note that: * At 0.01 scale (double tail), correlation was significant.

3.2.7. PFS-related influence factor analysis

Cox regression analysis is respectively carried out on the group entering type, age, histopathological type, clinical stage, lymph node metastasis condition, visceral organ metastasis condition, pelvic outer metastasis condition, ascites, CCL18 expression level and M2% of two groups of patients to obtain influence factors possibly related to PFS, and then multi-factor Cox regression analysis is carried out on the age, histopathological type, clinical stage, lymph node metastasis condition, visceral organ metastasis condition, pelvic outer metastasis condition, ascites, CCL18 expression level, M2% and PFS of the two groups of patients to compare whether the difference of the factors has influence on PFS or not, so that the result shows that: the classification of the group, the stage, the extra-pelvic metastasis, the number of treatment regimens, the CCL18 expression level, M2% are related to the length of PFS, the stage, the extra-pelvic metastasis, the number of treatment regimens are risk factors for the progression-free survival of platinum-resistant recurrent ovarian cancer patients, the classification of the group is a protective factor for the progression-free survival of platinum-resistant recurrent ovarian cancer patients (P < 0.05), and the age, histopathological type, lymph node metastasis, organ metastasis, and progression-free survival of abdominal and water-platinum-resistant recurrent ovarian cancer patients are independent (P > 0.05), as shown in table 19.

TABLE 19 results of PFS multifactor COX analysis

It should be understood that the foregoing examples of the present invention are provided merely for clearly illustrating the present invention and are not intended to limit the embodiments of the present invention, and that various other changes and modifications may be made therein by one skilled in the art without departing from the spirit and scope of the present invention as defined by the appended claims.

Claims

1. The traditional Chinese medicine composition for treating the qi deficiency and blood stasis type ovarian cancer is characterized by comprising 15-50 parts of astragalus membranaceus, 12-50 parts of bighead atractylodes rhizome, 9-15 parts of radix ranunculi ternati, 6-12 parts of prepared rhizoma arisaematis, 15-30 parts of Indian mockstrawberry herb, 10-20 parts of black nightshade, 15-45 parts of oldenlandia diffusa, 2 centipedes, 5-10 parts of honeycomb, 9-12 parts of orange pits, 9-15 parts of fructus aurantii, 6-12 parts of rheum officinale, 15-20 parts of tongue, 9-15 parts of radix aconiti carmichaeli, 9-12 parts of szechwan chinaberry fruit, 9-12 parts of rhizoma curcumae, 15-30 parts of stir-fried spina date seed and 9-12 parts of magnolia officinalis, wherein the parts and the number of the traditional Chinese medicine composition are 1 day.

2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from 30 parts of astragalus membranaceus, 15 parts of bighead atractylodes rhizome, 12 parts of radix ranunculi ternati, 12 parts of prepared rhizoma arisaematis, 15 parts of Indian mockstrawberry herb, 15 parts of black nightshade herb, 30 parts of oldenlandia diffusa, 2 centipedes, 5 parts of nidus vespae, 12 parts of semen citri reticulatae, 12 parts of fructus aurantii, 12 parts of rheum officinale, 20 parts of Ganoderma applanatum, 9 parts of radix aconiti carmichaeli, 30 parts of fried semen zizyphi spinosae, 9 parts of magnolia officinalis, 12 parts of szechwan chinaberry fruit and 12 parts of rhizoma curcumae, and the traditional Chinese medicine composition is 1 day dosage.

3. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from 30 parts of astragalus membranaceus, 20 parts of bighead atractylodes rhizome, 12 parts of radix ranunculi ternati, 12 parts of prepared rhizoma arisaematis, 15 parts of Indian mockstrawberry herb, 20 parts of black nightshade herb, 30 parts of oldenlandia diffusa, 2 centipedes, 6 parts of nidus vespae, 12 parts of semen citri reticulatae, 15 parts of fructus aurantii, 12 parts of rheum officinale, 15 parts of Ganoderma applanatum, 9 parts of radix aconiti carmichaeli, 30 parts of fried semen zizyphi spinosae, 12 parts of mangnolia officinalis, 9 parts of fructus toosendan and 9 parts of rhizoma curcumae, and the traditional Chinese medicine composition is 1 day in use amount.

4. A traditional Chinese medicine preparation for treating ovarian cancer due to qi deficiency and blood stasis, which is characterized in that the traditional Chinese medicine composition according to any one of claims 1-3 is prepared into decoction, granules, capsules, tablets, powder, pills or oral liquid.

5. The Chinese medicinal preparation according to claim 4, wherein the raw materials are weighed according to parts by weight, soaked in water for 30-40 minutes and decocted twice;

wherein, after the first decoction is boiled with strong fire, the first decoction is boiled with slow fire for 40 minutes; and (3) boiling the second decoction with strong fire, decocting with slow fire for 30 minutes, and removing residues to obtain decoction.

6. Use of a Chinese medicinal composition according to any one of claims 1-3 or a Chinese medicinal preparation according to any one of claims 4-5 in the preparation of a medicament for treating ovarian cancer due to qi deficiency and blood stasis.