A traditional Chinese medicine composition for treating qi deficiency and blood stasis type adenomyosis and application thereof

Abstract

This invention discloses a traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type, which is made from the following components in parts by weight: ginseng 10-15 parts, astragalus 12-20 parts, stir-fried atractylodes macrocephala 6-12 parts, poria cocos 10-15 parts, hedyotis diffusa 10-20 parts, red peony root 6-12 parts, peony bark 10-15 parts, oldenlandia diffusa 20-40 parts, salvia miltiorrhiza 10-15 parts, scutellaria barbata 10-20 parts, costus root 3-9 parts, and corydalis yanhusuo 6-12 parts. The traditional Chinese medicine composition of this invention can significantly improve core clinical symptoms: A randomized, double-blind, placebo-controlled clinical trial confirmed that the effective rate of dysmenorrhea treatment in the treatment group reached 77.14%, significantly better than the control group. Simultaneously, it can significantly reduce patients' dysmenorrhea symptom scores, VAS scores, and number of days of pain, and improve TCM syndrome scores.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically, it relates to a traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type and its application. Background Technology

[0002] Adenomyosis (ADE) is a common gynecological disease characterized by the ectopic invasion of functional endometrial glands and stroma into the myometrium. Its core clinical manifestation is secondary, progressively worsening dysmenorrhea, often accompanied by menstrual irregularities (such as menorrhagia, prolonged menstrual periods, etc.). In addition, patients may experience uniform enlargement of the uterus or localized nodular protrusions, potentially leading to decreased fertility or even infertility. These clinical manifestations have a serious negative impact on the reproductive health, psychological state, and overall quality of life of women of reproductive age. Epidemiological data shows that ADE is most common in multiparous women aged 30-50, with a current incidence rate of 7-23%, and often coexists with endometriosis (EM) or uterine fibroids. Damage to the basal layer of the endometrium caused by repeated pregnancies, childbirth trauma, and multiple intrauterine procedures is considered closely related to the occurrence and development of this disease. Similar to emphysema, adenomatous uterine bleeding (ADE) also exhibits significant diagnostic delay, with an average delay of several years. This can lead to disease progression and missed opportunities for early intervention, especially for young women who wish to preserve their fertility. Early diagnosis and standardized management are therefore crucial in these cases. In terms of treatment, the goals of ADE management primarily focus on relieving pain, reducing abnormal uterine bleeding, improving fertility outcomes, and enhancing patients' quality of life. However, current Western medical interventions still face treatment bottlenecks: the effects of nonsteroidal anti-inflammatory drugs (NSAIDs) are limited to relieving pain; oral contraceptives, progestins, and gonadotropin-releasing hormone agonists can control the condition in the short term by suppressing ovarian function, inducing pseudopregnancy, or artificial menopause, but the relapse rate is high after discontinuation, and long-term use may lead to side effects such as bone loss, menopausal symptoms, liver function effects, and thrombosis risk, thus limiting their application in long-term management; among surgical treatments, hysterectomy, although curative, completely deprives the patient of fertility and is not suitable for women who wish to have children or retain their uterus; while conservative surgeries such as lesion resection, high-intensity focused ultrasound ablation, and uterine artery embolization, although aiming to preserve the uterus, still face problems such as postoperative recurrence risk, potential impact on ovarian function and endometrium, and increased risk of uterine rupture after pregnancy. How to strike a balance between effectively eliminating lesions and maximizing the protection of fertility potential remains a clinical challenge. Although Traditional Chinese Medicine (TCM) does not have a specific disease name, "adenomyosis," considering its accompanying symptoms such as dysmenorrhea, menstrual irregularities, and infertility, as well as physical signs like an enlarged and hardened uterus, it can be categorized under "dysmenorrhea" or "abdominal masses." TCM believes that the occurrence of this disease is often related to internal factors such as emotional distress, individual constitution, improper diet, and excessive sexual activity and childbirth, as well as external factors such as exposure to external pathogens and surgical trauma. These factors lead to dysfunction of the internal organs, damage to the Chong and Ren meridians, abnormal circulation of Qi and blood, and impaired function of the uterus. Throughout history, physicians have emphasized "blood stasis" as the key factor in its pathogenesis.Blood stasis obstructs the Chong and Ren meridians, damaging the uterus and hindering the flow of Qi and blood, which can lead to dysmenorrhea, the so-called "pain due to obstruction." If blood stasis obstructs the meridians, preventing the flow of new blood, it can cause excessive menstruation and prolonged periods. Over time, blood stasis can accumulate and form masses, clinically manifested as an enlarged and hardened uterus. Therefore, developing a traditional Chinese medicine composition with definite efficacy, good safety, and a relatively clear mechanism of action is of great significance for meeting clinical treatment needs.

[0003] For the treatment of ADE of Qi deficiency and blood stasis type, the existing technology has the following shortcomings: First, the treatment method is too simplistic and does not address both the symptoms and the root cause: Although simply promoting blood circulation and removing blood stasis can temporarily expel stagnation, it easily depletes Qi and damages the body's vital energy, making the already deficient vital energy even more vulnerable, resulting in blood stasis that is difficult to remove or recurs frequently. This is also the fundamental reason why the pain of this disease recurs repeatedly and is difficult to cure. Second, there is a lack of precise prescriptions that combine the disease and syndrome: There is a lack of specific prescriptions for the specific complex syndrome of "Qi deficiency and blood stasis", and the combination of tonifying vital energy and clearing away blood stasis has not been achieved. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type.

[0005] Another object of the present invention is to provide the application of the traditional Chinese medicine composition in the preparation of a medicament for treating adenomyosis of the qi deficiency and blood stasis type.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type, which is made of the following components in parts by weight: 10-15 parts ginseng, 12-20 parts astragalus, 6-12 parts stir-fried atractylodes macrocephala, 10-15 parts poria cocos, 10-20 parts hedyotis diffusa, 6-12 parts red peony root, 10-15 parts moutan bark, 20-40 parts oldenlandia diffusa, 10-15 parts salvia miltiorrhiza, 10-20 parts scutellaria barbata, 3-9 parts costus root, and 6-12 parts corydalis yanhusuo.

[0008] Preferably, the traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type is made from the following components in parts by weight: 12 parts ginseng, 15 parts astragalus, 9 parts stir-fried atractylodes macrocephala, 12 parts poria cocos, 15 parts hedyotis diffusa, 9 parts red peony root, 12 parts peony bark, 30 parts oldenlandia diffusa, 12 parts salvia miltiorrhiza, 15 parts scutellaria barbata, 6 parts costus root, and 9 parts corydalis rhizome.

[0009] Preferably, the traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type is made from the following components in parts by weight: 10 parts ginseng, 12 parts astragalus, 6 parts stir-fried atractylodes macrocephala, 10 parts poria cocos, 10 parts hedyotis diffusa, 6 parts red peony root, 10 parts peony bark, 20 parts oldenlandia diffusa, 10 parts salvia miltiorrhiza, 10 parts scutellaria barbata, 3 parts costus root, and 6 parts corydalis rhizome.

[0010] Preferably, the traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type is made from the following components in parts by weight: 15 parts ginseng, 20 parts astragalus, 12 parts stir-fried atractylodes macrocephala, 15 parts poria cocos, 20 parts hedyotis diffusa, 12 parts red peony root, 15 parts peony bark, 40 parts oldenlandia diffusa, 15 parts salvia miltiorrhiza, 20 parts scutellaria barbata, 9 parts costus root, and 12 parts corydalis yanhusuo.

[0011] In a second aspect, the present invention provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating adenomyosis of the qi deficiency and blood stasis type.

[0012] A third aspect of the present invention provides a pharmaceutical preparation made from the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0013] The dosage form of the pharmaceutical preparation is decoction, granules, decocted medicine, pills, tablets, capsules, oral liquid, mixture or syrup.

[0014] In a fourth aspect, the present invention provides the use of the pharmaceutical preparation in the preparation of a medicament for treating adenomyosis of the qi deficiency and blood stasis type.

[0015] The herbal composition of this invention is based on the core pathogenesis of "Qi deficiency as the root cause and blood stasis as the manifestation," and establishes the treatment principle of "tonifying Qi and supporting the body's resistance, clearing stasis and relieving pain," combining tonification and purgation to address both the root cause and the symptoms. The principal herbs are ginseng and astragalus. These two herbs work synergistically to greatly tonify the spleen and lung Qi. Ginseng is sweet and warm, tonifying Qi to generate blood and control blood; astragalus is sweet and warm, raising Yang and tonifying Qi, excelling at tonifying Qi and promoting blood circulation. Together, they are the principal herbs, strongly tonifying the original Qi, ensuring that the Qi is strong enough to guide the blood and that the meridians are unobstructed—this is "supporting the body's resistance" to treat the root cause. The assistant herbs are stir-fried atractylodes macrocephala and poria cocos, taking the meaning of half of the Four Gentlemen Decoction, to strengthen the spleen and eliminate dampness, assisting the source of Qi and blood production, and ensuring the body's resistance is replenished. Salvia miltiorrhiza, red peony root, and peony bark enter the blood level. Salvia miltiorrhiza is good at activating blood circulation, removing stasis, cooling blood, and eliminating carbuncles; red peony root clears heat, cools blood, disperses stasis, and relieves pain; peony bark clears heat, cools blood, activates blood circulation, and disperses nodules. Together, they clear away stagnant heat and resolve blood stasis, thus addressing the symptoms through "clearing stasis." The adjuvant herbs are: *Hedyotis diffusa*, *Hedyotis diffusa*, and *Scutellaria barbata*. These three herbs clear heat and detoxify, invigorate blood and promote diuresis, and disperse nodules and reduce swelling. Targeting the long-term pathogenesis of ADE (Acute Depression with Hyperactivity of Blood Stasis), where stagnant blood transforms into heat and phlegm and blood stasis intertwine, they assist the adjuvant herbs in clearing stagnant toxins and enhance the softening and dispersing effects of nodules. The guiding herbs are: *Saussurea costus* and *Corydalis yanhusuo*. *Saussurea costus* is a Qi-regulating herb of the Triple Burner, effectively regulating Qi and preventing stagnation; *Corydalis yanhusuo* is a "Qi-regulating herb in the blood," a holy medicine for pain relief, specifically designed to alleviate dysmenorrhea. The entire formula combines warming and clearing herbs, as well as tonifying and purging herbs, to achieve the effects of invigorating Qi and blood, clearing stasis, and relieving pain.

[0016] The properties, meridian tropism, efficacy, and indications of the traditional Chinese medicine raw materials of this invention are as follows:

[0017] Ginseng: Sweet and slightly bitter in taste, slightly warm in nature; enters the lung, spleen, heart, and kidney meridians. It greatly replenishes vital energy, restores the pulse and consolidates the body, tonifies the spleen and lungs, generates fluids and nourishes blood, calms the mind and improves intelligence. It is used for weakness and impending collapse, cold limbs and weak pulse, spleen deficiency and poor appetite, lung deficiency and cough, thirst due to fluid depletion, internal heat and thirst, deficiency of qi and blood, chronic illness and emaciation, palpitations and insomnia, impotence and cold uterus, etc.

[0018] Astragalus: Sweet in taste, slightly warm in nature; enters the spleen and lung meridians. It tonifies qi and raises yang, strengthens the exterior and stops sweating, promotes diuresis and reduces swelling, generates fluids and nourishes blood, promotes circulation and relieves numbness, promotes pus drainage and detoxification, and promotes tissue regeneration and wound healing. It is used for qi deficiency and fatigue, poor appetite and loose stools, sinking of middle qi, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, internal heat and thirst, anemia and chlorosis, hemiplegia, numbness and pain, carbuncles and boils that are difficult to heal, and chronic ulcers that do not heal.

[0019] Stir-fried Atractylodes macrocephala with wheat bran: Bitter and sweet in taste, warm in nature; enters the spleen and stomach meridians. It strengthens the spleen and replenishes qi, dries dampness and promotes diuresis, stops sweating, and calms the fetus. Stir-frying with wheat bran reduces its drying properties and enhances its spleen-strengthening effect. It is used for spleen deficiency with poor appetite, abdominal distension, fatigue, diarrhea, phlegm retention, dizziness, palpitations, edema, spontaneous sweating, and threatened abortion.

[0020] Poria cocos: Sweet and bland in taste, neutral in nature; enters the heart, lung, spleen, and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. It is used for edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0021] *Scutellaria baicalensis*: Bitter and pungent in taste, slightly cold in nature; enters the liver and spleen meridians. It invigorates blood circulation, removes blood stasis, clears heat and promotes diuresis, disperses nodules and reduces swelling. Used for irregular menstruation, dysmenorrhea, amenorrhea, metrorrhagia, hematochezia, damp-heat jaundice, dysentery due to heat toxin, dysuria, leukorrhea, rheumatic bone pain, scrofula, carbuncles, mastitis, herpes zoster, leprosy, traumatic injuries and swelling, etc.

[0022] Red peony root: Bitter in taste, slightly cold in nature; enters the liver meridian. Clears heat and cools the blood, disperses blood stasis and relieves pain. Used for heat entering the blood level, febrile rashes, hematemesis and epistaxis, red and swollen eyes, liver stagnation and hypochondriac pain, amenorrhea and dysmenorrhea, abdominal masses and pain, traumatic injuries, carbuncles and sores, etc.

[0023] Moutan bark: Bitter and pungent in taste, slightly cold in nature; enters the heart, liver, and kidney meridians. Clears heat and cools the blood, invigorates blood and removes blood stasis. Used for heat entering the blood level, febrile rashes, hematemesis, epistaxis, night fever and morning coolness, steaming bone without sweating, amenorrhea and dysmenorrhea, traumatic injuries, carbuncles and boils, etc.

[0024] Hedyotis diffusa: Bitter and sweet in taste, cold in nature; enters the heart, liver, and spleen meridians. It clears heat and detoxifies, disperses nodules and reduces swelling, promotes diuresis and relieves strangury. Used for carbuncles and boils, intestinal abscesses and abdominal pain, abdominal masses, painful urination due to heat, damp-heat jaundice, snake and insect bites, etc.

[0025] Salvia miltiorrhiza: Bitter in taste, slightly cold in nature; enters the heart and liver meridians. It invigorates blood circulation and removes blood stasis, regulates menstruation and relieves pain, clears the heart and eliminates irritability, cools the blood and reduces swelling. It is used for chest pain, abdominal and hypochondriac pain, abdominal masses, painful arthralgia due to heat, insomnia due to irritability, irregular menstruation, dysmenorrhea, amenorrhea, sores and swelling, etc.

[0026] Scutellaria barbata: pungent and bitter in taste, cold in nature; enters the lung, liver, and kidney meridians. Clears heat and detoxifies, resolves blood stasis and promotes diuresis. Used for boils and carbuncles, sore throat, traumatic injuries, edema, jaundice, snake and insect bites, etc.

[0027] Costus root: pungent and bitter in taste, warm in nature; enters the spleen, stomach, large intestine, triple burner, and gallbladder meridians. It promotes qi circulation and relieves pain, strengthens the spleen and aids digestion. Used for chest and rib pain, abdominal distension and pain, tenesmus after diarrhea, indigestion, and loss of appetite.

[0028] Corydalis Rhizome: pungent and bitter in taste, warm in nature; enters the liver and spleen meridians. It invigorates blood circulation, promotes qi circulation, and relieves pain. Used for chest and rib pain, abdominal pain, angina pectoris, amenorrhea, dysmenorrhea, postpartum blood stasis, and swelling and pain from falls and injuries.

[0029] By adopting the above technical solution, the present invention has the following advantages and beneficial effects:

[0030] This invention employs the "strengthening the body's resistance and clearing stasis" method, and for the first time proposes and applies this treatment approach to precisely treat ADE (Acute Depression and Blood Stasis) of Qi deficiency and blood stasis type. Compared with existing technologies that focus solely on promoting blood circulation and removing stasis or emphasize cold stagnation of Qi, this invention creatively combines "greatly tonifying the vital energy" with "clearing away blood stasis and toxins," achieving a "combination of tonification and purgation, addressing both the root cause and the symptoms," which is more in line with the complex pathological nature of this disease, involving both deficiency and excess.

[0031] This invention boldly employs ginseng and astragalus as the principal herbs in a relatively heavy dosage to strongly replenish vital energy and address the root cause, rather than simply substituting with milder tonics like codonopsis. Simultaneously, in selecting blood-activating herbs, it chooses cooling and blood-activating herbs such as salvia miltiorrhiza, red peony root, and peony bark, rather than simply warming and dispersing them, to address the common "blood stasis transforming into heat" phenomenon in the course of ADE (Acute Deficiency of Energy) disease. Furthermore, it combines herbs such as *Hedyotis diffusa*, *Hedyotis diffusa*, and *Scutellaria barbata* to clear heat, dissipate nodules, and detoxify, ensuring that the entire formula both supports the body's vital energy and clears away blood stasis and toxins, preventing the tonifying effect from generating heat or the warming effect from damaging yin.

[0032] The traditional Chinese medicine composition of the present invention is precisely targeted at specific syndrome types, and it is clear that the best applicable population of the present invention is patients with "qi deficiency and blood stasis type" adenomyosis, which makes the clinical application of the traditional Chinese medicine compound more precise and in line with the development direction of precision treatment in modern traditional Chinese medicine.

[0033] The traditional Chinese medicine composition of this invention can significantly improve core clinical symptoms: A randomized, double-blind, placebo-controlled clinical trial confirmed that the effective rate of dysmenorrhea treatment in the treatment group reached 77.14%, significantly better than the control group (35.29%, P<0.001). Simultaneously, it can significantly reduce patients' dysmenorrhea symptom scores, VAS scores, and number of days of pain (P<0.05), and improve TCM syndrome scores (P<0.001).

[0034] The traditional Chinese medicine composition of this invention can improve quality of life and psychological state, and can significantly reduce the EHP-5 (Endometriosis Patient Quality of Life Scale) score and the Self-Rating Depression Scale (SDS) score of patients (P<0.05), demonstrating the advantage of treating both body and mind.

[0035] The traditional Chinese medicine composition of the present invention can regulate coagulation function: it can significantly shorten activated partial thromboplastin time (APTT) and prolong thrombin time (TT) (P<0.05), showing a benign regulatory effect on the abnormal coagulation state of patients with ADE.

[0036] The traditional Chinese medicine composition of the present invention can reduce the hardness of lesion tissue: according to SWE test, the elastic modulus (E value) of the lesion in the patient after treatment decreased significantly from 1.56±0.62 kPa to 1.04±0.48 kPa (P<0.001), which objectively proves that the traditional Chinese medicine composition of the present invention can effectively reduce uterine myometrial fibrosis and reduce tissue hardness.

[0037] The traditional Chinese medicine composition of the present invention can reduce tumor markers: it can significantly reduce the serum CA125 level in patients (P<0.05), suggesting that it may inhibit the biological activity of lesions.

[0038] The traditional Chinese medicine composition of the present invention has good safety: no serious adverse events occurred during the entire clinical trial, and no abnormal changes were observed in the patients' blood routine and liver and kidney function indicators, which confirms that the traditional Chinese medicine composition of the present invention has high clinical drug safety. Attached Figure Description

[0039] Figure 1 This is a schematic diagram showing the comparison results of dysmenorrhea-related indicators before and after treatment in two groups.

[0040] Figure 2 This is a schematic diagram showing the comparison results of TCM syndrome scores before and after treatment in two groups.

[0041] Figure 3 This is a schematic diagram showing the comparison of EHP-5 scores before and after treatment in the two groups.

[0042] Figure 4 This is a diagram showing the comparison results of psychological state-related indicators before and after treatment in two groups.

[0043] Figure 5 This is a schematic diagram showing the comparison of PBAC scores before and after treatment in the two groups.

[0044] Figure 6 This is a schematic diagram showing the comparison results of coagulation function-related indicators before and after treatment in two groups.

[0045] Figure 7 This is a schematic diagram showing the comparison results of tumor markers before and after treatment in two groups.

[0046] Figure 8 This is a schematic diagram showing the comparison of AMH levels before and after treatment in the two groups.

[0047] Figure 9 This is a schematic diagram showing the comparison of sex hormone levels before and after treatment in two groups.

[0048] Figure 10 This is a schematic diagram showing the comparison of blood routine indicators before and after treatment in two groups.

[0049] Figure 11 This is a schematic diagram showing the comparison results of elasticity ultrasound indices before and after treatment in two groups. Detailed Implementation

[0050] To more clearly illustrate the present invention, the following description, in conjunction with preferred embodiments, further clarifies the invention. Those skilled in the art should understand that the specific descriptions below are illustrative rather than restrictive, and should not be construed as limiting the scope of protection of the present invention.

[0051] There is currently no scale for assessing the quality of life of patients with adenomyosis in the existing technology. Considering that both endometriosis and adenomyosis originate from the ectopic growth of endometrial tissue and can cause progressively worsening dysmenorrhea, chronic pelvic pain, and dyspareunia, this invention uses EHP-5 in clinical research.

[0052] Example 1

[0053] A traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type is made from the following components by weight: ginseng 12g, astragalus 15g, stir-fried atractylodes macrocephala 9g, poria cocos 12g, hedyotis diffusa 15g, red peony root 9g, peony bark 12g, oldenlandia diffusa 30g, salvia miltiorrhiza 12g, scutellaria barbata 15g, costus root 6g, and corydalis yanhusuo 9g.

[0054] Example 2

[0055] A traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type is made from the following components by weight: ginseng 10g, astragalus 12g, stir-fried atractylodes macrocephala 6g, poria cocos 10g, hedyotis diffusa 10g, red peony root 6g, peony bark 10g, oldenlandia diffusa 20g, salvia miltiorrhiza 10g, scutellaria barbata 10g, costus root 3g, and corydalis yanhusuo 6g.

[0056] Example 3

[0057] A traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type is made from the following components by weight: ginseng 15g, astragalus 20g, stir-fried atractylodes macrocephala 12g, poria cocos 15g, hedyotis diffusa 20g, red peony root 12g, peony bark 15g, oldenlandia diffusa 40g, salvia miltiorrhiza 15g, scutellaria barbata 20g, costus root 9g, and corydalis yanhusuo 12g.

[0058] The traditional Chinese medicine compositions provided in Examples 1-3 can all be decocted into a soup using conventional methods.

[0059] Example 4

[0060] Tablet preparation:

[0061] Take any of the traditional Chinese medicine compositions given in Examples 1-3, decoct twice with water. For the first decoction, add 10 times the amount of water and decoct for 2 hours. For the second decoction, add 8 times the amount of water and decoct for 1.5 hours. Combine the decoctions, filter, and concentrate the filtrate to a clear extract with a relative density of 1.10-1.15 (60°C). Spray dry to obtain a dry extract powder. Add starch and microcrystalline cellulose, mix well, granulate with 85% ethanol, dry, granulate, add magnesium stearate, mix well, and compress into tablets to obtain tablets.

[0062] Example 5

[0063] Preparation of capsules:

[0064] Take any of the traditional Chinese medicine compositions given in Examples 1-3, decoct twice with water. For the first decoction, add 10 times the amount of water and decoct for 2 hours. For the second decoction, add 8 times the amount of water and decoct for 1.5 hours. Combine the decoctions, filter, and concentrate the filtrate to a clear extract with a relative density of 1.10-1.15 (60°C). Spray dry to obtain a dry extract powder. Add starch and microcrystalline cellulose, mix well, granulate with 85% ethanol, dry, granulate, add magnesium stearate, mix well, and fill into capsules to obtain capsules.

[0065] Example 6

[0066] Preparation of granules:

[0067] Take any of the traditional Chinese medicine compositions given in Examples 1-3, decoct twice with water. For the first decoction, add 12 times the amount of water and decoct for 2 hours. For the second decoction, add 10 times the amount of water and decoct for 1.5 hours. Combine the decoctions, filter, and concentrate the filtrate to a clear extract with a relative density of 1.10-1.15 (60°C). Add dextrin, spray dry, and obtain a dry extract powder. Add sucrose powder, mix well, granulate with 85% ethanol, dry, and granulate to obtain granules.

[0068] Example 7

[0069] Preparation of the mixture:

[0070] Take any of the traditional Chinese medicine compositions given in Examples 1 to 3, add water and decoct twice. Add 10 times the amount of water for the first decoction and decoct for 2 hours. Add 8 times the amount of water for the second decoction and decoct for 1.5 hours. Combine the decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.05 to 1.10 (60°C). Add pharmaceutical excipients, mix well, and package to obtain the compound.

[0071] Example 8

[0072] Preparation of oral liquid:

[0073] Take any of the traditional Chinese medicine compositions given in Examples 1 to 3, prepare a paste according to the method of Example 12, add flavoring agents (such as sucrose and honey) and preservatives, mix well, filter, dispense into oral liquid bottles, sterilize, and obtain oral liquid.

[0074] Example 9

[0075] Preparation of syrup:

[0076] Take any of the traditional Chinese medicine compositions given in Examples 1 to 3, prepare a clear extract according to the method of Example 12, add sucrose, heat to dissolve, filter, add preservative, mix well, and package to obtain a syrup.

[0077] Example 10

[0078] Clinical efficacy verification

[0079] The efficacy of the traditional Chinese medicine composition (granules) of the present invention was verified using a randomized, double-blind, placebo-controlled clinical trial method.

[0080] 1. Study subjects: 72 patients who met the diagnostic criteria for Qi deficiency and blood stasis type adenomyosis were randomly divided into a treatment group and a control group, with 36 patients in each group.

[0081] 2. Selection Criteria

[0082] 2.1 Diagnostic criteria

[0083] The diagnostic criteria were based on the "Guidelines for the Diagnosis and Treatment of Adenomyosis with Integrated Traditional Chinese and Western Medicine" jointly issued by the China Association of Integrative Medicine, the China Association of Traditional Chinese Medicine, and the Chinese Medical Association in 2026.

[0084] 2.1.1 Western Medicine Diagnostic Criteria

[0085] 1) Clinical manifestations: ① progressive dysmenorrhea that gradually worsens; ② excessive menstrual flow and / or prolonged menstrual period; ③ infertility; ④ gynecological examination may reveal a uniformly enlarged uterus or localized nodular protrusions, which are hard and tender, with the tenderness being more severe during menstruation.

[0086] 2) Auxiliary examinations: ① Diffuse type: The uterus is spherically enlarged, with generally increased myometrial echoes and a coarse, granular, and uneven appearance; Anterior / posterior wall type: The uterus is asymmetrically enlarged, with thickened posterior myometrium accompanied by palisade-like echo attenuation, and the endometrium is displaced anteriorly; Focal type: The uterus is irregularly bulging, with lesions that are heterogeneous, hyperechoic, and have indistinct borders. Color Doppler shows that the blood flow signals within the lesions are scattered in a star-like or cord-like pattern, without abundant blood flow signals; ② MRI findings: The uterus is diffusely enlarged with a smooth outline. On T2-weighted images, low-signal lesions with indistinct borders adjacent to the endometrium are visible. The endometrial-myolipin junction (JZ) is indistinct, thickened, or distorted in shape.

[0087] The above clinical manifestation ① plus ultrasound or MRI findings are essential conditions, and clinical manifestations ②, ③, and ④ can be used as the basis for clinical diagnosis.

[0088] 2.1.2 Traditional Chinese Medicine Diagnosis – Differentiation Criteria for Qi Deficiency and Blood Stasis Syndrome

[0089] 1) Main symptoms: ① Menstrual cramps, relieved by pressure and warmth; ② Menstrual flow is either heavy or light, relieved by pressure and warmth; ③ Pelvic nodules or masses.

[0090] 2) Secondary symptoms: ① Dark menstrual blood, thin consistency or with blood clots; ② Fatigue, weakness, shortness of breath and reluctance to speak; ③ Poor appetite and loose stools; ④ Infertility after prolonged marriage and pale complexion.

[0091] 3) Tongue and pulse: The tongue is pale and swollen with ecchymosis on the edges and the coating is thin and white; the pulse is deep and hesitant.

[0092] The above-mentioned primary symptom plus two secondary symptoms are essential conditions, and can be used as a basis for clinical diagnosis in combination with tongue and pulse examination.

[0093] 2.2 Inclusion criteria:

[0094] ①Those who simultaneously meet the Western medical diagnostic criteria for adenomyosis and the traditional Chinese medicine diagnostic criteria for Qi deficiency and blood stasis syndrome.

[0095] ②Female, aged ≥20 years and ≤50 years;

[0096] ③ Fully understand the content of this study, voluntarily participate, and sign a written informed consent form.

[0097] 2.3 Exclusion criteria:

[0098] (1) Those who have severe liver or kidney dysfunction, primary hematologic disorders, or a history of mental illness;

[0099] (2) Those who are currently taking estrogen-progestin medications or have stopped taking estrogen-progestin medications for no more than 3 months;

[0100] (3) Allergy to the drugs used in this study;

[0101] (4) Pregnant or lactating women;

[0102] (2) Other circumstances will be determined by the researcher as unsuitable for participation in this study.

[0103] 2.4 Rejection Criteria:

[0104] If any of the following conditions are found after enrollment, the participant should be removed from the group:

[0105] ① Those who do not cooperate with the randomization protocol after inclusion, or those who have no trial records or data after randomization;

[0106] ② Cases that do not meet the inclusion or exclusion criteria after the study has begun;

[0107] ③ Poor treatment adherence, with actual medication dosage less than 80% or more than 120% of the prescribed dosage;

[0108] ④ During the observation period, the patient used combination drugs that were explicitly prohibited in the research protocol without authorization.

[0109] 2.5 Termination Criteria:

[0110] The study should be considered for termination if any of the following conditions are met:

[0111] ① The investigational drug experienced serious safety issues or adverse events;

[0112] ②During the research process, it was found that the drug's efficacy was poor and lacked clinical value for further research;

[0113] ③ Significant deviations occurred during the design or implementation of the research protocol, making it difficult to objectively evaluate the drug effect.

[0114] 2.6 Shedding Criteria:

[0115] A case is considered a dropout if it meets any of the following criteria:

[0116] ① The subjects withdrew voluntarily due to reasons such as feeling that the treatment was not effective or experiencing adverse reactions;

[0117] ②Loss of contact due to changes in contact information, relocation, or other reasons;

[0118] ③ Researchers may advise participants to withdraw from the study due to safety concerns (e.g., poor compliance, serious comorbidities or complications, or serious adverse events).

[0119] ④ Although the entire trial procedure was completed, the total amount of medication or treatment dose exceeded the expected range (less than 80% or more than 120%).

[0120] 3. Dosing regimen:

[0121] Treatment group: Orally administered granules prepared according to the formulation of Example 1 of this invention, specification: 8g per bag, twice daily, three bags each time, dissolved in boiling water. Starting from the first day of the menstrual cycle, the medication is used continuously for 14 days as one cycle, for a total of 3 menstrual cycles.

[0122] Control group: One-tenth the concentration of the treatment group was added to excipients to prepare placebo granules, aiming to maintain consistency with the study drug in appearance and smell as much as possible. Specifications: 8g per sachet, three sachets twice daily, dissolved in boiling water. Treatment lasts 14 days starting from the first day of the menstrual cycle, constituting one cycle, for a total of three menstrual cycles.

[0123] 4. Indicators for monitoring therapeutic effects

[0124] 4.1 Key Observation Indicators

[0125] Dysmenorrhea Symptom Score: Based on lower abdominal pain during and around menstruation, the score is 5 points. Regarding specific symptoms, pain intensity is divided into two levels: obvious (add 0.5 points) and unbearable (add 1 point). Accompanying symptoms include restlessness, cold extremities, and profuse sweating, each worth 1 point; shock is worth 1 point; and paleness is worth 0.5 points. Regarding impact on daily life, 1 point is added for requiring bed rest or affecting work or study. Regarding the effectiveness of pain relief measures, 0.5 points are added for relief with conventional pain relief measures, and 1 point is added for no relief. For local symptoms, 0.5 points are added for lower back pain, and 1 point is added for a feeling of rectal pressure. Regarding the duration of pain, 0.5 points are added for relief within one day, and 0.5 points are added for each additional day of duration. All symptoms are summed to obtain the total score.

[0126] The efficacy evaluation criteria were mainly formulated with reference to the relevant content of the "Technical Guidelines for Clinical Research of New Traditional Chinese Medicines Based on Syndrome Differentiation" published in 2018, and the specific judgments are as follows:

[0127] ① Cured: After intervention, the patient's lower abdominal pain and related clinical symptoms basically disappeared, and the dysmenorrhea symptom score decreased by ≥90%;

[0128] ②Significant effect: After intervention, patients experienced significant relief from lower abdominal pain and improvement in related clinical symptoms. They were able to maintain normal work and study without the need for painkillers, with 70% ≤ dysmenorrhea symptom scores decreasing by < 90%;

[0129] ③ Effective: After intervention, patients experienced some relief from lower abdominal pain and improvement in related clinical symptoms. They were able to maintain normal work and study after taking pain medication, with 30% ≤ dysmenorrhea symptom scores decreasing by < 70%.

[0130] ④ Ineffective: After intervention, the patient's lower abdominal pain and related clinical symptoms did not improve or worsened, and the dysmenorrhea symptom score decreased by <30%.

[0131] Reduction in dysmenorrhea symptom score = (Dysmenorrhea symptom score before intervention - Dysmenorrhea symptom score after intervention) / (Dysmenorrhea symptom score before intervention) × 100%

[0132] Effective rate of treatment for dysmenorrhea = (Number of cured cases + Number of cases with significant improvement + Number of cases with improvement) / Total number of cases × 100%

[0133] 4.2 Secondary observation indicators

[0134] (1) General information: age, marital status, medical history, allergy history, personal history, etc.

[0135] (2) Visual Analogue Scale (VAS) for Dysmenorrhea: A 10-centimeter scale was used as the assessment tool. Researchers guided subjects to mark their menstrual pain levels at corresponding locations. The scoring criteria were as follows: 0 points indicated no pain; 1 to 3 points corresponded to mild pain, which was tolerable and did not affect normal activities; 4 to 6 points represented moderate pain that interfered with sleep quality; and 7 to 10 points represented severe pain, which was intense and difficult to tolerate, requiring intervention with pain medication. After marking, the researchers read the scale values. By comparing the changes in the subjects' VAS scores before and after the intervention, the severity of dysmenorrhea could be objectively quantified.

[0136] (3) Cox Menstrual Symptom Scale (CMSS): This scale includes two assessment dimensions: symptom severity and symptom duration. It covers 18 typical dysmenorrhea-related symptom items, including lower abdominal pain, nausea, vomiting, loss of appetite, headache, back pain, leg pain, dizziness, fatigue, diarrhea, and changes in facial color. The scale uses a Likert 5-point scoring method. The severity dimension is graded from "asymptomatic" to "severely affecting daily activities," while the duration dimension is assessed based on the duration of symptom onset. A higher score indicates more severe dysmenorrhea symptoms.

[0137] (4) Endometriosis Health Profile-5 (EHP-5): The EHP-5 consists of a core questionnaire and a modular questionnaire. The core questionnaire contains 5 dimensions (pain, sense of control and helplessness, emotional health, social support, and self-image), with a total of 11 items, used to assess the main impact of the disease on life; the modular questionnaire contains 6 dimensions (work, sex life, impact on children, feelings towards healthcare professionals, treatment, and feelings related to infertility), with a total of 6 items, used to assess the additional impact in specific areas. Each item uses a Likert scale, and the degree of impairment in quality of life is quantified by calculating the total score of the dimensions or constructing a summary index; a higher score indicates a worse quality of life. This scale aims to assess changes in patients' quality of life before and after intervention.

[0138] (5) Pictorial Blood Loss Assessment Chart (PBAC): This method aims to assess menstrual blood loss in women using objective scoring criteria, and is used to assist in the screening and efficacy evaluation of diseases related to abnormal uterine bleeding. The core assessment dimensions of this chart typically include the number of sanitary pads or tampons used, the degree of blood staining on each sanitary item (divided into mild, moderate, and severe levels based on the area of ​​staining, corresponding to different scoring standards), and the presence and size of blood clots. Users need to record all sanitary items changed throughout the menstrual period and accumulate points according to the established scoring rules. This study used this method to assess menstrual flow in patients with ADE, quantifying menstrual flow through a point system to obtain more accurate results.

[0139] (6) Self-rating Depression Scale (SDS): The SDS was developed in 1965 by Professor William WK Zung of Duke University School of Medicine to assess the severity of an individual's depressive state and its changes during treatment. The scale contains 20 items, mainly covering typical symptoms in four areas: emotional state, physical sensations, psychomotor performance, and mental disorders. All items use a four-point rating scale (1 - no or very little time, 2 - a small amount of time, 3 - a considerable amount of time, 4 - most or all of the time), with 10 items using reverse scoring. To score, the scores for each item are first added together to obtain a raw total score, then multiplied by 1.25 and rounded to the nearest integer to obtain a standard score. The degree of depression can be determined based on the standard score. The specific assessment criteria are: below 53 points is within the normal range, 53 to 62 points indicates mild depression, 63 to 72 points indicates moderate depression, and above 72 points indicates severe depression.

[0140] (7) Self-rating Anxiety Scale (SAS): Developed by Professor Zung in 1971, this scale is a commonly used tool for measuring an individual's subjective experience of anxiety and its related physiological manifestations. The questionnaire covers 20 items and uses a four-point rating scale (1 - no or very little time, 2 - a small amount of time, 3 - a considerable amount of time, 4 - most or all of the time), including 5 items that require reverse rating. Its scoring method is the same as that of the SDS, which is to calculate the raw total score and convert it into a standard score for evaluation. The score directly reflects the degree of anxiety: a score below 50 is within the normal range, 50 to 59 indicates mild anxiety, 60 to 69 indicates moderate anxiety, and 70 and above indicates severe anxiety.

[0141] (8) Perceived Stress Scale (PSS): This tool was designed by Cohen et al. in 1983 to assess an individual's level of psychological stress experienced in the past month, i.e., the degree to which life events are unpredictable, uncontrollable, or overwhelming. The 14-item version used in this study includes 7 positive descriptive items reflecting a sense of control and 7 negative descriptive items reflecting a sense of tension and loss of control. All items were rated on a five-point scale from 0 (never) to 4 (always), with positive items being scored in reverse. The total score was obtained by summing the scores of each item, ranging from 0 to 56 points. A higher score indicates that the respondent has experienced more significant psychological stress recently.

[0142] (9) Traditional Chinese Medicine Syndrome Scoring Table: The evaluation criteria in this study were mainly based on the 2018 edition of the "Technical Guidelines for Clinical Research of Syndrome-Based Traditional Chinese Medicine New Drugs," with appropriate adjustments made to suit the characteristics of this project. Each TCM symptom was categorized according to severity: 0 points for no symptoms, 1 point for mild symptoms, 2 points for moderate symptoms, and 3 points for severe symptoms. The total syndrome score was calculated by accumulating these scores. The efficacy evaluation criteria are as follows:

[0143] ① Cured: Dysmenorrhea and TCM symptoms basically disappeared after intervention, N≥95%;

[0144] ②Significant effect: Dysmenorrhea and TCM symptoms were significantly improved after intervention, with 70% ≤ N < 95%;

[0145] ③ Effective: After intervention, dysmenorrhea and TCM symptoms improved, with 30% ≤ N < 70%;

[0146] ④ Ineffective: No change or worsening of dysmenorrhea or TCM symptoms after intervention, N<30%.

[0147] Therapeutic effect index (N) = (Total score before treatment - Total score after treatment) / Total score before treatment × 100%

[0148] The effective rate of TCM syndrome treatment = (number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases × 100%

[0149] (10) Coagulation function related indicators: Detect the levels of thrombin time (TT), prothrombin time (PT), activated partial thromboplastin time (APTT) and D-dimer (DDi).

[0150] (11) Tumor markers: Detect the levels of CA125 and Carbohydrate Antigen 19-9 (CA199).

[0151] (12) Sex hormones and ovarian function related indicators: Detect the levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2) and anti-Müllerian hormone (AMH), and calculate the LH / FSH ratio.

[0152] (13) Ultrasound elastography: All subjects underwent examinations performed by the same physician with over five years of ultrasound diagnostic experience, using an ultrasound diagnostic instrument equipped with SWE function (ultrasound model: Logic-E20-2) and a high-frequency linear array probe (frequency: 7.0MHz). First, a routine two-dimensional grayscale ultrasound examination was performed to comprehensively observe the uterine morphology, myometrial echo, endometrial line position, and lesion boundaries. After clearly displaying the largest longitudinal and transverse sections of the uterus, the images were frozen, and the diameters of the uterus were measured. The uterine volume (uterine volume = length × width × thickness) was observed and recorded. Then, the SWE mode was switched, and the sampling frame was placed in the target area, focusing on the most prominent lesion (i.e., areas of thickened myometrium and heterogeneous echoes) and the unaffected normal myometrial area as a control. The shear wave speed (V) and young's modulus (E) of the anterior and posterior uterine walls were measured. To ensure data representativeness, each area was measured at least three times, and the average value was used as the final statistical value.

[0153] (14) Safety indicators: blood routine, liver and kidney function.

[0154] 4.3 Observation Time Point

[0155] The relevant scoring scales were completed by the participants before the intervention and again three menstrual cycles after the intervention, based on their own circumstances. Blood parameters were measured by collecting venous blood samples on the morning of days 2-5 of the menstrual cycle before the intervention and again three menstrual cycles after the intervention, in an empty stomach. Ultrasound elastography was performed on days 3-7 after the menstrual period ended, both before the intervention and again three menstrual cycles after the intervention.

[0156] 4.4 Statistical Methods

[0157] This study used SPSS 29.0 statistical software to analyze and process the obtained data. For normally distributed continuous data, the mean ± standard deviation (x ± s) was used for description; for non-normally distributed data, the median and interquartile range [M(Q)] were used. In intra-group comparisons, if the data were normally distributed and homogeneous in variance, a paired t-test was used; if these conditions were not met, the Wilcoxon signed-rank test was used. In inter-group comparisons, if the data were normally distributed and homogeneous in variance, a two-sample t-test was used; if not, the Mann-Whitney U test was used. For categorical data, statistical description was performed by calculating rates and proportions; inter-group comparisons used the chi-square test, or Fisher's exact test if the theoretical frequencies did not meet the condition. For ordinal data, the Mann-Whitney U test was used for inter-group comparisons. The significance level for all statistical tests in this study was set at P < 0.05.

[0158] 4.5 Adverse Reactions:

[0159] All patients underwent complete blood count and liver and kidney function tests before and after treatment, and the results were all within the normal range. During treatment, only one patient complained of stomach discomfort, which was found to be related to a concurrent cold; as the cold improved, the stomach discomfort also subsided. No significant adverse reactions were observed in the remaining subjects throughout the treatment.

[0160] 5. Results

[0161] Figure 1 This is a schematic diagram showing the comparison results of dysmenorrhea-related indicators before and after treatment in two groups. For intra-group comparisons after treatment, P < 0.05; For intra-group comparisons after treatment, P < 0.001; For intergroup comparisons after treatment, P < 0.05. (a) shows the results of dysmenorrhea symptom scores; (b) shows the results of VAS scores; (c) shows the results of pain days; and (d) shows the results of CMSS scores. Comparison of dysmenorrhea-related indicators showed no statistically significant differences in dysmenorrhea symptom scores, VAS scores, pain days, and CMSS scores between the two groups before treatment (P > 0.05), indicating comparability. Intragroup comparisons showed that the dysmenorrhea symptom scores, VAS scores, pain days, and CMSS scores in the treatment group were significantly lower than before treatment (P < 0.05). Assessment of patients' psychological status revealed no statistically significant differences in depression, anxiety, and stress scores between the two groups before and after treatment (P > 0.05). After 3 menstrual cycles of treatment, the depression score in the treatment group significantly decreased (P < 0.05), while the anxiety and stress scores showed a decreasing trend, but did not reach statistical significance (P > 0.05); the scores in the control group did not show significant changes before and after treatment (P > 0.05). The control group showed improvement only in dysmenorrhea symptom scores (P<0.05). Figure 1 As shown in Figure a), there were no differences in VAS scores, number of days of pain, and CMSS scores before and after treatment (P > 0.05). Figure 1 (As shown in b and d). In the inter-group comparison after treatment, the treatment group had a significant advantage over the control group in reducing the number of days of pain (P<0.05). Figure 1 (as shown in c).

[0162] Figure 2 This is a schematic diagram showing the comparison results of TCM syndrome scores before and after treatment in two groups. For comparisons within the group after treatment, P < 0.001. Intergroup comparisons of TCM syndrome scores showed no statistically significant differences in scores before and after treatment between the two groups (p > 0.05). Intragroup comparisons showed that after 3 menstrual cycles of treatment, the TCM syndrome scores decreased in the treatment group (p < 0.001), while there was no significant statistical difference in the control group.

[0163] Figure 3 This is a schematic diagram showing the comparison of EHP-5 scores before and after treatment in the two groups. For intra-group comparisons after treatment, P < 0.05. Inter-group comparisons of EHP-5 scores showed no difference in scores before and after treatment between the two groups (P > 0.05). Within-group comparisons, the EHP-5 score decreased in the treatment group after treatment (P < 0.05), while there was no difference in the control group (P > 0.05).

[0164] Figure 4 This study compares the psychological state-related indicators before and after treatment in the two groups. For intra-group comparisons after treatment, P < 0.05. (a) shows the results of depression scores; (b) shows the results of anxiety scores; and (c) shows the results of stress scores. Assessment of patients' psychological states revealed no statistically significant differences in depression, anxiety, and stress scores between the two groups before and after treatment (P > 0.05). After 3 months of menstrual cycle treatment, the depression score in the treatment group significantly decreased (P < 0.05). Figure 4 As shown in Figure a), while anxiety and stress scores showed a decreasing trend, they did not reach statistical significance (P>0.05). Figure 4 (As shown in b and c); the scores of the control group did not change significantly before and after treatment (P>0.05).

[0165] Figure 5 This diagram illustrates the comparison of PBAC scores before and after treatment in the two groups. The intergroup comparison of PBAC scores showed no significant difference between the two groups before and after treatment (P>0.05). Within-group comparisons showed that although the treatment group's score decreased after treatment, the difference was not statistically significant (P>0.05); the control group showed no significant difference before and after treatment (P>0.05).

[0166] Figure 6 This is a schematic diagram showing the comparison results of coagulation function-related indicators before and after treatment in two groups. For intra-group comparisons after treatment, P < 0.05. (a) shows the results of PT; (b) shows the results of APTT; (c) shows the results of TT; and (d) shows the results of DDi. Comparison of coagulation-related indicators showed no difference in the levels of any indicator between the two groups before treatment (P > 0.05), indicating comparability. After 3 months of treatment, the APTT value in the treatment group was significantly shorter and the TT value was significantly longer than before treatment (P < 0.05). Figure 6 (As shown in b and c), while PT and DDi levels did not show significant changes ( Figure 6 (As shown in a and d). There were no significant differences in any indicators before and after treatment in the control group (P>0.05). Intergroup comparisons showed no statistically significant differences in coagulation function-related indicators between the two groups after treatment (P>0.05).

[0167] Figure 7 This is a schematic diagram showing the comparison results of tumor markers before and after treatment in two groups. For intragroup comparisons after treatment, P < 0.05. (a) shows the CA125 results; (b) shows the CA199 results. Before treatment, there were no differences in CA125 and CA199 levels between the two groups (P > 0.05), making them comparable. After 3 months of menstrual cycle treatment, the CA125 level in the treatment group decreased significantly (P < 0.05). Figure 7As shown in Figure a), while no significant changes were observed in the control group (as shown in Figure a). Figure 7 (As shown in a) Although the CA199 levels in the treatment group showed a decreasing trend, the difference was not statistically significant (P > 0.05). Figure 7 (As shown in b). Intergroup comparisons after treatment showed no difference in CA125 and CA199 levels between the two groups (P > 0.05).

[0168] Figure 8 This diagram illustrates the comparison of AMH levels before and after treatment in the two groups. Before treatment, there was no difference in AMH levels between the two groups (P>0.05), making them comparable. After 3 months of menstrual cycle treatment, the AMH level in the treatment group showed an upward trend, but the difference was not statistically significant (P>0.05), while no significant change was observed in the control group. Post-treatment intergroup comparisons showed no difference in AMH levels between the two groups (P>0.05).

[0169] Figure 9 This is a schematic diagram showing the comparison of sex hormone levels before and after treatment in two groups. For comparisons between groups after treatment, P < 0.05. (a) shows the FSH results; (b) shows the LH results; (c) shows the FSH / LH ratio results; and (d) shows the E2 results. Before treatment, there were no differences in FSH, LH, FSH / LH, and E2 between the two groups (P > 0.05), making them comparable. After 3 months of treatment, although FSH, LH, and FSH / LH in the treatment group showed an increasing trend compared to before treatment, and E2 showed a certain decreasing trend, the differences were not statistically significant (P > 0.05); the sex hormone indicators in the control group did not show significant changes. Post-treatment intergroup analysis showed that the treatment group had a more significant effect on regulating FSH and LH levels than the control group, with statistically significant differences between groups (P < 0.05). Figure 9 (As shown in a and b), but there were no statistically significant differences between the two groups in the degree of improvement of FSH / LH and E2 indicators (P > 0.05). Figure 9 (As shown in c and d).

[0170] Figure 10 This diagram illustrates the comparison of blood routine indicators before and after treatment in the two groups. (a) shows the C-reactive protein (CRP) result; (b) shows the hemoglobin result; and (c) shows the platelet count result. Before treatment, there were no significant differences in CRP, hemoglobin, and platelet count levels between the two groups (P>0.05), indicating comparability. After 3 months of menstrual cycle treatment, although hemoglobin in the treatment group showed an increasing trend compared to before treatment, and platelet count (PLT) showed a decreasing trend, the differences were not statistically significant (P>0.05). Figure 10 As shown in Figures b and c), there was no difference between the groups after treatment (P>0.05).

[0171] Figure 11 This is a schematic diagram showing the comparison results of elasticity ultrasound indices before and after treatment in two groups. For intragroup comparisons after treatment, P < 0.001. (a) shows the uterine volume results; (b) shows the V value results; and (c) shows the E value results. Before treatment, there were no differences in uterine volume, V value, and E value between the two groups (P > 0.05), making them comparable. After 3 menstrual cycles of treatment, although the uterine volume and V value in the treatment group showed a decreasing trend compared to before treatment, the differences did not reach a statistically significant level (P > 0.05). Figure 11 (As shown in a and b); the E value in the treatment group decreased significantly compared with that before treatment, and the difference was statistically significant (P < 0.001). Figure 11 (As shown in c); in the control group, there were no significant changes in uterine volume, V value, and E value. There were no differences between the two groups after treatment (P>0.05).

[0172] The treatment group showed significantly better improvement than the control group or before treatment in terms of dysmenorrhea efficacy rate, dysmenorrhea symptom score, VAS score, TCM syndrome score, EHP-5 score, SDS score, APTT, TT, serum CA125, and lesion elastic modulus E value.

[0173] Example 11

[0174] Exploration of the pharmacodynamic material basis and mechanism of action

[0175] 1. Experimental Drugs: The experimental animals were SPF-grade female SD rats, 7 weeks old, purchased from Shanghai Bikai Keyi Biotechnology Co., Ltd. The rats were housed in an SPF-grade animal facility at a temperature of 22–25°C, humidity of 50%–60%, with a 12-hour light-dark cycle (light 8:00–20:00), ventilation of 15–20 times / hour, and noise levels ≤60 dB, avoiding strong light and noise stimulation. After one week of acclimatization, they were used in the experiments.

[0176] 2. Medication and grouping: After acclimatization, female SD rats were randomly divided into two groups.

[0177] Drug administration group (1~3) The following administration was performed: The lyophilized powder of the traditional Chinese medicine composition of Example 1 of the present invention was administered at a dosage of 2.39 g of raw herb / day / animal, with an oral gavage volume of 2.5 mL / time, twice a day, for 2 consecutive days. Subsequently, the traditional Chinese medicine composition granules of Example 1 of the present invention were administered at a dosage of 3.58 g of raw herb / day / animal (plus 0.05 g of Poria cocos), with an oral gavage volume of 4.0 mL / time, twice a day, for 4 consecutive days.

[0178] Blank control group (4~6) ): Administer an equal volume of normal saline via gavage, following the same administration regimen as the control group.

[0179] The dosage was calculated based on the clinically equivalent adult dose and converted to the rat equivalent dose according to body surface area.

[0180] Preparation of the freeze-dried powder of the traditional Chinese medicine composition: Take the traditional Chinese medicine composition of Example 1, add water and decoct twice. For the first decoction, add 10 times the amount of water and decoct for 2 hours. For the second decoction, add 8 times the amount of water and decoct for 1.5 hours. Combine the decoctions, filter, and concentrate the filtrate to a clear extract with a relative density of 1.10~1.15 (60℃). Place the clear extract in a -80℃ freezer overnight (pre-freezing). The next day, transfer the frozen sample to a freeze dryer and freeze-dry under vacuum conditions. After drying, collect the freeze-dried powder to obtain the freeze-dried powder of the traditional Chinese medicine composition.

[0181] 3. Test metrics:

[0182] 3.1 Serum Collection

[0183] Blank serum: 1-3 days before drug administration. and 4~6 Approximately 1 mL of blood was drawn from the jugular vein of each rat and placed in a blood collection tube containing a coagulant. The tube was left at room temperature for 2 hours, centrifuged at 3500 rpm for 10 min, and approximately 400 μL of the supernatant was collected in an EP tube and stored at -80°C.

[0184] Post-administration serum: After the continuous administration was completed (day 6), blood was collected at 0.5h, 1h and 2h after administration in the afternoon. Approximately 1mL of blood was drawn from the jugular vein and the serum was processed according to the above method and stored at -80℃.

[0185] 3.2 UPLC-Q-TOF-MS Serum Drug Chemical Composition Analysis

[0186] Take 1 mL of blank serum and 3 mL of post-drug serum, respectively, add 3 times the volume of methanol (mass spectrometry grade) to precipitate the protein, vortex for 5 minutes, let stand for 20 minutes (4℃), centrifuge for 15 minutes (12000 rpm), collect the supernatant, centrifuge to concentrate and dry, and store at -80℃. Before analysis, reconstitute the residue with 100 μL of 50% methanol, vortex for 3 minutes, centrifuge for 15 minutes (12000 rpm), and collect the supernatant to obtain the test solution.

[0187] Data were acquired using a Waters H-Class ultra-high performance liquid chromatograph coupled with an AB Sciex Triple TOF® 4600 high-resolution mass spectrometer in ESI positive and negative ion modes. Chromatographic conditions: Agilent InfinityLab Poroshell Aq-C18 column (2.1×100 mm, 2.7 μm), column temperature 30℃, flow rate 0.3 mL / min, injection volume 5 μL, mobile phase acetonitrile-0.1% formic acid aqueous solution gradient elution.

[0188] 4. Results

[0189] 4.1 DEGs analysis between ADE patients and healthy controls

[0190] Differential expression analysis of GSE185392 yielded 123 DEGs, including 46 upregulated genes and 77 downregulated genes. Functional enrichment analysis showed that DEGs are mainly involved in biological processes (BP) such as system development, chemical responses, and negative regulation of cellular processes; they are enriched in cellular components (CC) such as extracellular regions / extracellular region parts, integral components of membranes, intrinsic components of membranes, vesicles, and endomembrane systems; and they are related to molecular functions (MF) such as catalytic activity; their KEGG pathways mainly involve metabolic pathways, retinol metabolism, and steroid hormone biosynthesis.

[0191] 4.2 HMGs Analysis of ADE Co-expression Network

[0192] Co-expression network analysis was performed on GSE185392, and β=24 (R2=0.85) was selected as the optimal soft threshold for constructing a scale-free network. Hierarchical clustering of gene modules was performed using a topological overlap matrix, and modules with similar expression patterns in the clustering tree were integrated. Ten co-expression modules were finally identified, among which the darkseagreen4 module showed the strongest correlation with ADE (r=0.55, p=0.01), containing a total of 177 HMGs. The functions and potential pathways of HMGs mainly involve biological processes such as system development, cellular developmental process, and cell differentiation; cellular components such as cytosol, endomembrane system, and vesicles; molecular functions such as cation binding; and KEGG pathways such as human papillomavirus infection, PI3K-Akt signaling pathway, and focal adhesion.

[0193] 4.3 Identification of ADE central genes and interaction network analysis

[0194] Intersection analysis of 123 DEGs and 177 HMGs revealed two genes that were upregulated in ADE: SCUBE1 (signal peptide, CUB domain, EGF (Epithelial growth factor)-like protein 1) and HPGD (15-hydroxyprostaglandin dehydrogenase), which were identified as ADE central genes and included in subsequent analysis.

[0195] 4.4 Relevant chromatograms and mass spectrometry results for the identification of blood-entering components of traditional Chinese medicine

[0196] Rat serum samples after administration of the traditional Chinese medicine composition of the present invention were analyzed by UPLC-Q-TOF / MS. Based on the multi-stage mass spectrometry information of the samples and the component characterization results of the traditional Chinese medicine composition of the present invention, a total of 127 components were identified from the drug-containing serum samples, including 20 prototype components. The results are shown in Table 1.

[0197] Table 1. Prototype components in serum samples after administration of the traditional Chinese medicine composition of the present invention.

[0198]

[0199] 4.5 Central Gene-Functional Pathway-Blood Component-Traditional Chinese Medicine Network Analysis

[0200] Functional pathways related to SCUBE1 and HPGD were retrieved from the CTD database, yielding 13 GO pathway pathways and 6 KEGG pathway pathways from the human species. Functional pathways associated with 20 prototype components in serum samples after administration of the herbal composition of this invention were retrieved. Intersection analysis was then performed on functional pathways related to central nervous system genes and prototype components, retaining pathways linked to both central nervous system genes and prototype components. Finally, combining the herbal composition from which the prototype components are derived, a network of central nervous system genes-functional pathways-blood-entered components-herbal composition was constructed, generating 34 potential connections that may represent the mechanism of action of the herbal composition of this invention in treating ADE.

[0201] 5. Conclusion:

[0202] 1. Serum Pharmacochemistry Study: UPLC-Q-TOF-MS was used to analyze the drug-containing serum of rats after gavage administration of the herbal composition of this invention. A total of 20 proto-plasmic components were identified, mainly including paeoniflorin, corydaline, astragaloside A, ginsenoside Rb1, ginsenoside Rd, protopine, palmatine, etc., clarifying their direct material basis in vivo.

[0203] 2. Network Pharmacology Study: Combining bioinformatics methods, SCUBE1 and HPGD were screened and validated as potential central targets for the treatment of adenomyosis using the composition of this invention. By constructing a "target-pathway-component-traditional Chinese medicine" network, it was revealed that the 20 blood-entering components of the composition of this invention may exert pharmacological effects such as improving coagulation, anti-inflammation, and anti-fibrosis by regulating signaling pathways such as inflammatory responses, arachidonic acid metabolism, and transcriptional dysregulation in cancer.

[0204] Example 12

[0205] Case Examples

[0206] Ms. Zhang, female, 28 years old. Initial consultation date: March 9, 2024.

[0207] Chief complaint: Progressive worsening of dysmenorrhea for more than 4 years.

[0208] Present Illness: The patient developed menstrual cramps 4 years ago without any obvious cause. Initially, the pain was tolerable, but it has progressively worsened over the past 2 years. She experiences lower abdominal distension and pain one day before each menstrual period, with severe, unbearable pain on the first two days of menstruation, requiring ibuprofen sustained-release capsules (2-3 capsules per dose) for relief. Her menstrual cycle is relatively regular, 7 / 28-30 days, with heavy menstrual flow, dark red color, and large blood clots, lasting 9-10 days. She usually experiences fatigue, lethargy, poor appetite, and loose stools, with 1-2 menstrual periods per day. In December 2023, a gynecological ultrasound at another hospital showed an enlarged uterus measuring approximately 7.8cm × 6.5cm × 6.2cm, with heterogeneous myometrial echoes, thickening of the posterior wall myometrium, and a palisade-like attenuation of echoes, suggestive of adenomyosis. Current symptoms: On the second day of menstruation, the patient experiences severe lower abdominal pain radiating to the lumbosacral region, relieved by pressure and warmth, accompanied by pale complexion, cold sweats, nausea, vomiting, fatigue, and weakness. The tongue is pale and swollen with ecchymosis on the edges, and the coating is thin and white. The pulse is deep and hesitant.

[0209] Past medical history: Denies history of surgery or trauma, denies history of drug allergies. 0 pregnancies, 0 deliveries, desires to have more children.

[0210] Auxiliary examinations: A follow-up gynecological ultrasound performed at another hospital on January 15, 2024, showed a uterus measuring 7.5cm × 6.3cm × 6.0cm, with a posterior myometrial thickness of approximately 3.8cm, heterogeneous echogenicity, and anterior displacement of the endometrium. Color Doppler flow imaging (CDFI) showed punctate blood flow signals within the lesion. Serum CA125: 78.6 U / mL.

[0211] Traditional Chinese Medicine diagnosis: Dysmenorrhea; Syndrome type: Qi deficiency and blood stasis syndrome.

[0212] Western medical diagnosis: Adenomyosis.

[0213] Treatment principle: Tonify Qi and strengthen the body's resistance, clear away blood stasis and relieve pain.

[0214] Prescription: Administer the traditional Chinese medicine composition of Example 1 of this invention, one dose daily, decocted in water and taken in two divided doses, morning and evening. Start taking the medicine continuously for 14 days from the first day of the menstrual cycle, and instruct the patient to continue treatment for 3 menstrual cycles.

[0215] Follow-up visit (April 13, 2024): The patient reported significant relief from dysmenorrhea in the first menstrual cycle after taking the medication. Pain was tolerable on days 1-2 of menstruation, and no pain medication was needed. Menstrual flow decreased by about one-third, and the menstrual period shortened to 7 days. Symptoms such as fatigue, poor appetite, and loose stools also improved. The tongue was pale and swollen, with reduced ecchymosis, a thin white coating, and a deep, thready pulse. The prescription was continued for another 14 doses, with the same administration method as before.

[0216] Follow-up visit (May 11, 2024): The patient reported further relief from dysmenorrhea in the second menstrual cycle. Her VAS score decreased from 8 to 3, menstrual flow returned to near normal, and her period lasted 6 days. She felt better, had a better appetite, and her stools were formed. Her tongue was pale red with a few petechiae on the edges, a thin white coating, and a thready pulse. A follow-up gynecological ultrasound showed that the uterus had shrunk to 6.8cm × 5.9cm × 5.5cm, with the posterior wall myometrium approximately 3.2cm thick, and the echogenicity was more uniform than before. Serum CA125 decreased to 45.2 U / mL. The previous prescription was continued for another 14 doses.

[0217] Follow-up visit (June 8, 2024): After the third menstrual cycle, the patient's dysmenorrhea had basically disappeared, menstrual flow was normal, and menstruation lasted 5-6 days. Symptoms of Qi deficiency, such as fatigue, weakness, and lethargy, had significantly improved. The tongue was pale red with a thin white coating, and the pulse was thready. A follow-up gynecological ultrasound showed the uterus to be 6.5cm × 5.6cm × 5.2cm, with a posterior wall myometrium thickness of approximately 2.9cm and relatively uniform echogenicity. Serum CA125 decreased to 32.8 U / mL. The dysmenorrhea symptom score decreased from 18 points before treatment to 3 points, indicating significant efficacy. The patient was satisfied with the treatment and was instructed to continue medication for two more courses to consolidate the treatment, with regular follow-up examinations.

[0218] Example 13

[0219] Case Examples

[0220] Ms. Li, female, 39 years old. Initial consultation date: June 22, 2024.

[0221] Chief complaint: progressively worsening dysmenorrhea for 8 years and increased menstrual flow for 5 years.

[0222] Present Illness: The patient first experienced menstrual cramps 8 years ago, which progressively worsened. In the past 5 years, her menstrual flow has significantly increased, requiring more than 30 sanitary napkins per period. Menstrual periods have lasted 10-12 days, with dark red menstrual blood containing large clots. Menstrual cramps are severe, requiring bed rest, and painkillers are ineffective. She also experiences fatigue, pale complexion, dizziness, palpitations, poor appetite, and insomnia. In September 2023, a gynecological ultrasound at another hospital showed a spherically enlarged uterus, approximately 9.2cm × 8.5cm × 7.8cm, with generally increased, coarsely granular, and uneven myometrial echoes, suggestive of diffuse adenomyosis. She received GnRH-a treatment at another hospital for 3 months, but symptoms recurred after discontinuation. Concerned about the side effects of long-term hormone therapy, she refused to continue and sought treatment from Traditional Chinese Medicine. Current symptoms: It is the 3rd day of menstruation, with still heavy menstrual flow, dark red in color with blood clots, lower abdominal pain relieved by pressure and warmth, accompanied by lower back pain, fatigue, dizziness, and palpitations. The patient's complexion is sallow, and the patient appears listless. The tongue is pale and swollen with ecchymosis on the edges and tip, and the coating is thin and white. The pulse is deep, thready, and hesitant.

[0223] Past medical history: 2 pregnancies, 1 para, 8 years post-cesarean section. No history of drug allergies.

[0224] Auxiliary examinations: On May 20, 2024, a gynecological ultrasound at another hospital showed a uterus measuring 8.8cm × 8.2cm × 7.5cm, with generally increased echogenicity in the myometrium, appearing coarse and uneven, and significant thickening of the myometrium in both the posterior and anterior walls. Hemoglobin was 98g / L. Serum CA125 was 95.4 U / mL.

[0225] Traditional Chinese Medicine diagnosis: dysmenorrhea, abdominal masses; syndrome type: Qi deficiency and blood stasis syndrome.

[0226] Western medicine diagnosis: 1. Diffuse adenomyosis; 2. Secondary anemia (mild).

[0227] Treatment principle: Tonify Qi and strengthen the body's resistance, clear away blood stasis and relieve pain.

[0228] Prescription: Administer the traditional Chinese medicine composition of Example 3 of this invention, a total of 14 doses, one dose daily, decocted in water and taken in two divided doses, morning and evening. Start taking the medicine continuously for 14 days from the first day of the menstrual cycle, and instruct the patient to continue treatment for 3 menstrual cycles.

[0229] Follow-up visit (July 20, 2024): After one menstrual cycle of medication, the patient reported a reduction in menstrual flow of approximately one-third, a shortened menstrual period of 8-9 days, and significant relief from dysmenorrhea. Her VAS score decreased from 9 to 5, her mental state improved, and her dizziness and palpitations lessened. Her tongue was pale and swollen, with reduced ecchymosis, a thin white coating, and a deep, thready pulse. The prescription was continued for another 14 doses.

[0230] Follow-up visit (August 17, 2024): After the second menstrual cycle of treatment, menstrual flow further decreased, menstruation lasted 7 days, and dysmenorrhea was mild and tolerable; no painkillers were taken. Complexion was rosier than before, and symptoms such as fatigue and dizziness significantly improved. Appetite increased, and sleep improved. Tongue was pale red with a few petechiae on the edges, thin white coating, and thready pulse. A repeat blood test showed hemoglobin at 112 g / L. Gynecological ultrasound showed the uterus had shrunk to 7.8 cm × 7.3 cm × 6.8 cm, with more uniform myometrial echoes. Serum CA125 decreased to 56.7 U / mL. The original prescription was continued for 14 doses.

[0231] Follow-up visit (September 14, 2024): After the third menstrual cycle, the patient's menstrual flow had basically returned to normal, with menstruation lasting 6-7 days, and dysmenorrhea had largely disappeared. Her complexion was rosy, her energy was high, and her dizziness and palpitations had disappeared. Her tongue was pale red with a thin white coating, and her pulse was thready. A follow-up gynecological ultrasound showed that the uterus measured 7.2cm × 6.8cm × 6.3cm, with significant improvement in myometrial echogenicity. Hemoglobin was 120g / L. Serum CA125 decreased to 38.2U / mL. The dysmenorrhea symptom score decreased from 22 points before treatment to 4 points, and the TCM syndrome score decreased from 32 points to 8 points, indicating significant efficacy. The patient was instructed to continue medication to consolidate the treatment and to have regular follow-up visits.

[0232] Example 14

[0233] Ms. Wang, female, 45 years old. Initial consultation date: August 3, 2024.

[0234] Chief complaint: Dysmenorrhea for 10 years, worsening with heavy menstrual bleeding for 3 years.

[0235] Present Illness: The patient experienced menstrual cramps 10 years ago, which gradually worsened over the years. In the past 3 years, her menstrual flow has significantly increased, with periods lasting 10-14 days. Her menstrual blood is dark red with numerous clots. During menstruation, she experiences severe abdominal pain, accompanied by nausea, vomiting, and profuse sweating, requiring pain medication and bed rest. She also experiences lower abdominal distension and discomfort outside of menstruation. She is generally fatigued, lethargic, has a sallow complexion, lower back pain, weak legs, poor appetite, loose stools, and frequent dreams. In June 2023, she underwent gynecological ultrasound and MRI at another hospital, which diagnosed diffuse adenomyosis complicated by adenomyoma (posterior wall). A hysterectomy was recommended, but the patient refused. Current Symptoms: On the 5th day after menstruation, she experiences lower abdominal pain, fatigue, sallow complexion, lower back pain, and poor appetite. Her tongue is pale and swollen with ecchymosis on the edges, a thin white coating with a slightly greasy root, and a deep, thready, and hesitant pulse.

[0236] Past medical history: 3 pregnancies, 1 para; 2 induced abortions. History of chronic pelvic inflammatory disease. Denies any history of drug allergies.

[0237] Auxiliary examinations: On July 10, 2024, a gynecological ultrasound at another hospital showed a uterus measuring 9.5cm × 8.8cm × 8.0cm, with a posterior wall myometrium thickness of approximately 4.2cm and significantly heterogeneous echogenicity. A hypoechoic nodule measuring approximately 3.5cm × 3.0cm with indistinct borders was observed, suggestive of adenomyosis. SWE testing showed an elastic modulus E value of 1.68±0.58 kPa for the lesion. Serum CA125: 112.5 U / mL. Hemoglobin: 92g / L.

[0238] Traditional Chinese Medicine diagnosis: abdominal masses, dysmenorrhea, menorrhagia; syndrome type: Qi deficiency and blood stasis syndrome.

[0239] Western medicine diagnosis: 1. Diffuse adenomyosis complicated with adenomyoma; 2. Secondary anemia (moderate).

[0240] Treatment principle: Tonify Qi and strengthen the body's resistance, clear away blood stasis and relieve pain, soften hardness and dissipate nodules.

[0241] Prescription: Administer the traditional Chinese medicine composition of Example 2 of this invention, a total of 14 doses, one dose daily, decocted in water and taken in two divided doses, morning and evening. Start taking the medicine continuously for 14 days from the first day of the menstrual cycle, and instruct the patient to continue treatment for 3 menstrual cycles.

[0242] Follow-up visit (September 7, 2024): After one menstrual cycle of medication, the patient reported that her menstrual flow had decreased by about one-third, her menstrual period had shortened to 9 days, and her dysmenorrhea had lessened. Her VAS score had decreased from 8 points before treatment to 5 points, and symptoms such as nausea, vomiting, and cold sweats had not recurred. Symptoms such as fatigue and poor appetite had improved. Her tongue was pale and swollen, with slightly reduced ecchymosis, a thin white coating, and a deep and thready pulse. The prescription was continued for another 14 doses.

[0243] Follow-up visit (October 5, 2024): After the second menstrual cycle of treatment, menstrual flow was significantly reduced by about half, menstruation lasted 7-8 days, dysmenorrhea was mild, and normal work and life were possible. Complexion improved, spirits improved, lower back pain lessened, and appetite increased. Tongue was pale red with a few petechiae on the edges, thin white coating, and pulse was thready. Repeat blood routine test showed hemoglobin 105g / L. Gynecological ultrasound showed that the uterus volume had shrunk to 8.5cm×7.8cm×7.2cm, and the adenomyoma on the posterior wall had shrunk to 2.8cm×2.5cm, with clearer borders than before. SWE test showed that the elastic modulus E value of the lesion was 1.32±0.45 kPa. Serum CA125 decreased to 68.3 U / mL. Continued with the original prescription for 14 doses.

[0244] Follow-up visit (November 2, 2024): After the third menstrual cycle, the patient's menstrual flow had basically returned to normal, with menstruation lasting 6-7 days, and dysmenorrhea had largely disappeared. Her complexion was rosy, she was energetic, and symptoms such as lower back pain and fatigue had significantly improved. Her appetite was normal, and bowel movements were regular. Her tongue was pale red with a thin white coating, and her pulse was thready. A follow-up gynecological ultrasound showed that the uterus measured 7.8cm × 7.2cm × 6.8cm, and the adenomyoma on the posterior wall had shrunk to 2.2cm × 2.0cm, with more uniform myometrial echoes. SWE testing showed an elastic modulus E value of 1.02±0.42 kPa for the lesion. Serum CA125 decreased to 41.6 U / mL, and hemoglobin was 118g / L. The dysmenorrhea symptom score decreased from 20 points to 3 points, and the TCM syndrome score decreased from 34 points to 7 points, indicating significant efficacy. The patient was very satisfied with the treatment and avoided hysterectomy. She was instructed to continue medication to consolidate the treatment and to have regular follow-up examinations.

[0245] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-described technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type, characterized in that, It is made from the following components in parts by weight: ginseng 10-15 parts, astragalus 12-20 parts, stir-fried atractylodes macrocephala 6-12 parts, poria cocos 10-15 parts, hedyotis diffusa 10-20 parts, red peony root 6-12 parts, peony bark 10-15 parts, oldenlandia diffusa 20-40 parts, salvia miltiorrhiza 10-15 parts, scutellaria barbata 10-20 parts, costus root 3-9 parts, and corydalis yanhusuo 6-12 parts.

2. The traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type according to claim 1, characterized in that, The traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type is made from the following components in parts by weight: 12 parts ginseng, 15 parts astragalus, 9 parts stir-fried atractylodes macrocephala, 12 parts poria cocos, 15 parts hedyotis diffusa, 9 parts red peony root, 12 parts peony bark, 30 parts oldenlandia diffusa, 12 parts salvia miltiorrhiza, 15 parts scutellaria barbata, 6 parts costus root, and 9 parts corydalis yanhusuo.

3. The traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type according to claim 1, characterized in that, The traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type is made from the following components in parts by weight: 10 parts ginseng, 12 parts astragalus, 6 parts stir-fried atractylodes macrocephala, 10 parts poria cocos, 10 parts hedyotis diffusa, 6 parts red peony root, 10 parts peony bark, 20 parts oldenlandia diffusa, 10 parts salvia miltiorrhiza, 10 parts scutellaria barbata, 3 parts costus root, and 6 parts corydalis yanhusuo.

4. The traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type according to claim 1, characterized in that, The traditional Chinese medicine composition for treating adenomyosis of the Qi deficiency and blood stasis type is made from the following components in parts by weight: 15 parts ginseng, 20 parts astragalus, 12 parts stir-fried atractylodes macrocephala, 15 parts poria cocos, 20 parts hedyotis diffusa, 12 parts red peony root, 15 parts peony bark, 40 parts oldenlandia diffusa, 15 parts salvia miltiorrhiza, 20 parts scutellaria barbata, 9 parts costus root, and 12 parts corydalis yanhusuo.

5. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for treating adenomyosis of the qi deficiency and blood stasis type.

6. A pharmaceutical preparation made from the traditional Chinese medicine composition according to any one of claims 1 to 4 and pharmaceutically acceptable excipients.

7. The pharmaceutical preparation according to claim 6, characterized in that, The dosage form of the pharmaceutical preparation is decoction, granules, decocted medicine, pills, tablets, capsules, oral liquid, mixture or syrup.

8. The use of the pharmaceutical preparation of claim 6 or 7 in the preparation of a medicament for treating adenomyosis of the Qi deficiency and blood stasis type.

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