Traditional Chinese medicine decoction for treating polycystic ovarian syndrome and application

Abstract

The invention relates to the technical field of traditional Chinese medicine, and discloses a traditional Chinese medicine decoction for treating polycystic ovarian syndrome and application, the traditional Chinese medicine decoction for treating polycystic ovarian syndrome is prepared by decocting a traditional Chinese medicine composition; the traditional Chinese medicine composition is prepared from radix rehmanniae preparata, cortex cinnamomi, semen brassicae, baked ginger, rhizoma curcumae longae, deer-horn glue, raw licorice roots, fried hawthorn fruits, herba leonuri, Chinese rose flowers, rhizoma chuanxiong and radix angelicae sinensis. The traditional Chinese medicine decoction for treating the polycystic ovarian syndrome has a remarkable curative effect on the symptoms of PCOS or PCOS infertility patients, and can improve the thickness and form of endometrium, regulate the phase hormone level and improve the follicle quality and the periodic ovulation rate at the same time, so that the effects of improving the clinical pregnancy rate and the total effective rate and reducing the biochemical pregnancy and fetal parturition rate are achieved; the traditional Chinese medicine decoction for treating the polycystic ovarian syndrome can improve BBT and acne of PCOS infertility patients, has no toxic or side effect, is safe and reliable, and has good clinical application value.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine decoction for treating polycystic ovary syndrome and application thereof. BACKGROUND

[0002] Polycystic ovary syndrome (PCOS) is a kind of endocrine disorder syndrome of women of childbearing age, and is the most important disease type of ovulation disorder infertility. The etiology is not completely clear, the pathogenesis is complex, and the clinical manifestations are diverse and heterogeneous. Its characteristics are HA caused by benign proliferation of ovary-related cells, and anovulation, oligo-ovulation and delayed menstruation caused by blocked dominant follicle selection. It is mainly manifested as clinical syndromes such as oligo- / amenorrhea, infertility, acne, hirsutism, easy weight gain, PCO, ovulation disorder and IR. At present, the treatment of PCOS infertility in modern medicine mainly includes lifestyle intervention, reduction of clinical and biochemical HA, restoration of menstrual cycle and induction of ovulation cycle, improvement of insulin sensitivity and assisted reproduction. However, high promotion, low pregnancy, OHSS, dysfunctional uterine bleeding, mental health disorders and increased risk of endometrial cancer may occur after induction of ovulation.

[0003] According to traditional Chinese medicine, PCOS infertility belongs to the category of infertility, and its pathogenesis is considered to be a syndrome of "deficiency in origin and excess in superficiality" and "deficiency and excess intermingled". Kidney deficiency is the main one, and spleen deficiency is also common. Pathological products such as phlegm and blood stasis are accumulated, and liver depression is easily accompanied. It is mainly caused by congenital deficiency of kidney qi, damage to spleen yang due to improper diet, or accompanied by liver depression and qi stagnation, which hinders the spleen, and pathological products such as phlegm and blood stasis are produced and mutually harmful, so that the reproductive axis function of "kidney-utero-chongren-uterus" is disordered. Under the guidance of the treatment thought of National Medical Master Yu Jing'ao, on the basis of the theories of "yang transforming qi and yin forming shape" and "yin is always in excess and yang is always in deficiency", based on the treatment ideas of "treating phlegm and fluid with warm herbs" and "blood cannot be transported without qi" and "blood will move when it is warmed", the theoretical basis and treatment prescription of "warm yang method" for treating PCOS infertility have been gradually formed. The classic prescription "Yanghe Decoction" is a representative prescription of "warm yang method". The prescription is composed of 2 liang of prepared rehmannia root, 5 fen of ephedra, 3 chen of deer antler glue, 2 chen of white mustard seed, 1 chen of peeled cinnamon, 1 chen of raw licorice root, and 5 fen of fried ginger carbon. It has the effects of warming yang, tonifying blood, dispelling cold and unblocking stagnation.

[0004] However, at present, Yanghe Decoction is mainly used in the treatment of bone and joint diseases, cancer, breast diseases, diabetic peripheral diseases, etc. Therefore, it is necessary to explore the treatment of PCOS infertility by "warm yang method" to improve the treatment effect and promote the rehabilitation of patients. SUMMARY

[0005] In order to solve the above technical problems, the present application provides a traditional Chinese medicine decoction for treating polycystic ovary syndrome, which is prepared by decocting a traditional Chinese medicine composition; the traditional Chinese medicine composition comprises prepared rehmannia, cassia, white mustard seed, prepared ginger, turmeric, deer antler glue, raw licorice, fried hawthorn fruit, motherwort, Chinese rose flower, Szechuan lovage and angelica.

[0006] Preferably, in the traditional Chinese medicine composition, the content of each component is: prepared rehmannia 14-22 parts, cassia 2-8 parts, white mustard seed 2-8 parts, prepared ginger 6-14 parts, turmeric 6-14 parts, deer antler glue 2-10 parts, raw licorice 5-13 parts, fried hawthorn fruit 11-19 parts, motherwort 11-19 parts, Chinese rose flower 6-14 parts, Szechuan lovage 6-14 parts and angelica 8-16 parts by weight.

[0007] Preferably, in the traditional Chinese medicine composition, the content of each component is: prepared rehmannia 16-20 parts, cassia 4-6 parts, white mustard seed 4-6 parts, prepared ginger 8-12 parts, turmeric 8-12 parts, deer antler glue 4-8 parts, raw licorice 7-11 parts, fried hawthorn fruit 13-17 parts, motherwort 13-17 parts, Chinese rose flower 8-12 parts, Szechuan lovage 8-12 parts and angelica 10-14 parts by weight.

[0008] Preferably, in the traditional Chinese medicine composition, the content of each component is: prepared rehmannia 18 parts, cassia 5 parts, white mustard seed 5 parts, prepared ginger 10 parts, turmeric 10 parts, deer antler glue 6 parts, raw licorice 9 parts, fried hawthorn fruit 15 parts, motherwort 15 parts, Chinese rose flower 10 parts, Szechuan lovage 10 parts and angelica 12 parts by weight.

[0009] Preferably, the deer antler glue is subjected to melting treatment before use.

[0010] In the above traditional Chinese medicine decoction, Prepared rehmannia is sweet, slightly warm, and belongs to liver and kidney channels. It can tonify blood and yin, fill essence and benefit marrow. It is the main drug for tonifying blood and yin and strengthening water. It is the first choice for essence and marrow deficiency. Modern studies have found that high-dose prepared rehmannia can effectively reduce the hematocrit and RBC aggregation of rats with blood stasis syndrome, effectively improve the blood rheology of rats with blood stasis syndrome, accelerate the proliferation of RBC and hemoglobin, speed up the RBC neogenesis, and improve the hematopoietic capacity of the body. The main component of prepared rehmannia oligosaccharide can effectively reduce blood sugar and blood lipid levels. In addition, prepared rehmannia also has the pharmacological effects of anti-aging, anti-tumor, immune enhancement, anti-inflammatory, and anti-fatigue.

[0011] Antler glue is sweet and warm in nature, and belongs to the liver and kidney channels. It can warm and nourish the liver and kidney, and nourish the blood. Although it is not as strong as deer horn, it is stronger than antler and antler frost. It has moderate effect and is not prone to over-heating, over-supplementation, or insufficient absorption and utilization. Modern research has found that antler glue can significantly improve the endometrial type, quality, and blood flow state, help improve endometrial dysplasia and increase the expression of vascular endothelial growth factor, enhance ER, and promote pregnancy. It can improve low E2 levels that cause endometrial dysplasia, restore organ indexes of the uterus and spleen, and correct the internal environment of endometrial dysplasia and ovarian lesions. It can significantly regulate the content of P, FSH, LH, and E2 in female rat serum and improve blood rheology indexes.

[0012] Cinnamon is acrid and sweet, and is hot in nature. It belongs to the kidney and spleen channels. It can warm and supplement the kidney and spleen, warm the channels, dispel cold, and return the fire to its original place. It is a key medicine for treating kidney yang deficiency, lower yang deficiency, and cold and cold in the uterus. It can warm and supplement the kidney and spleen, benefit yang and eliminate yin, move blood and blood vessels, and is good at removing cold and cold. The main components of cinnamon detected in the blood are syringic acid and ferulic acid. Syringic acid can regulate the function of the hypothalamus and treat kidney yang deficiency. Ferulic acid has the pharmacological effects of improving platelet aggregation inhibition and increasing blood flow. In addition, cinnamaldehyde has anti-inflammatory analgesic, anti-apoptotic, anticoagulant, and anti-platelet aggregation effects, and is believed to have similar effects to yang qi warming and driving function, which is the active ingredient of cinnamon in treating kidney yang deficiency.

[0013] White mustard seed is pungent and warm in nature, and belongs to the lung and stomach channels. It can warm the lungs, resolve phlegm, benefit qi, and relieve pain. It can resolve cold phlegm, unblock meridians, benefit qi, and relieve pain. Experiments have shown that fried white mustard seed has obvious effects on relieving cough and reducing sputum, and has antioxidant stress effects. It can also have anti-inflammatory analgesic, anti-androgen, and anti-inflammatory activities, and its components, white mustard seed oil and mustard alkaloid, have the effects of promoting cell apoptosis, inhibiting tumors, and eliminating nodules.

[0014] Paojiang is warm in nature and belongs to the spleen and liver channels. It can warm the channels and stop bleeding, and warm the middle and relieve pain. It is a processed product of raw ginger, which is good at warming the spleen and stomach, and good at moving blood and relieving pain and diarrhea. It is good at warming the channels and stopping bleeding. Studies have shown that the main components of Paojiang are ginger polysaccharide, ginger ketone, and zingiberol, which have anti-coagulation, cell apoptosis induction, and anti-oxidative stress effects, respectively. Paojiang decoction can significantly shorten the bleeding time and coagulation time of mice, while ginger charcoal decoction can only significantly shorten the bleeding time of mice. It was also found that 6-gingerol had a significant protective effect on DNA damage in rat islet cells (INS-1).

[0015] Turmeric is pungent, bitter, and warm, and belongs to the liver and spleen channels; it promotes blood flow and qi, and unblocks channels and relieves pain. The product is pungent, bitter, and warm, and can enter both the blood and qi, and is good at relieving pain, and is good at treating pain caused by qi stagnation and blood stasis. Studies have found that curcumin can inhibit platelet aggregation, reduce plasma viscosity and whole blood viscosity; it can also have anti-inflammatory, antioxidant, and lipid-lowering effects, and can protect the gastric mucosa, protect liver cells, stimulate bile secretion, enhance gastrointestinal peristalsis, and relieve symptoms such as indigestion and abdominal distension; in addition, it can enhance immune system function, resist tumors, and have neuroprotective effects.

[0016] Roasted hawthorn is sour and sweet, and slightly warm; it belongs to the spleen, stomach, and liver channels; it digests and removes food accumulation, promotes qi and disperses blood stasis, and lowers lipid. It is good at digesting and removing food accumulation, and is the main drug for treating indigestion of greasy food accumulation; it is warm and enters the liver and blood, and can promote qi and disperse blood stasis, and can activate blood and remove blood stasis, and can treat lower abdominal pain caused by blood stasis, incomplete lochia or dysmenorrhea, and amenorrhea. Hawthorn acid can act on macrophages by inhibiting the NF-κB signaling pathway and the STAT3 signaling pathway to exert anti-inflammatory effects, and can also affect the expression of cyclooxygenase-2 (COX-2) and inhibit the activity of protein kinase C (PKC) to inhibit inflammatory reactions, and can control blood glucose and AKT, and inhibit glycogen phosphorylase activity, and promote INS synthesis; in addition, hawthorn also has the effects of anti-platelet aggregation, promoting digestion, and accelerating the frequency of uterine contraction.

[0017] Motherwort is bitter and pungent, and belongs to the heart, liver, and bladder channels; it promotes blood flow and regulates menstruation, and removes water and reduces swelling, and clears heat and resolves toxicity; it enters the blood and is good at promoting blood flow and regulating menstruation, and removing blood stasis and unblocking channels; its name indicates its effects; modern research shows that motherwort can act on the endometrium and uterine microcirculation, on the one hand, it can inhibit the expression of inflammatory factors and reduce inflammatory reactions, thereby reducing oxidative damage and endometrial cell apoptosis, on the other hand, it can increase the expression of thromboxane B2 and reduce the expression of 6-keto-prostaglandin F1α, thereby promoting the dynamic balance of blood activation and hemostasis, and overall promoting the receptivity of the endometrium; the total alkaloid fraction of motherwort has anti-coagulation and anti-platelet aggregation effects, and can inhibit platelet aggregation and thrombus formation, and is considered to be the main mechanism of motherwort's effect of promoting blood flow and regulating menstruation.

[0018] Rose flowers are light and ascending, sweet and slightly bitter, and neutral, and belong to the liver channel; they promote blood flow and regulate menstruation, soothe the liver and relieve depression, and reduce swelling and detoxify; modern pharmacological research shows that rose flower pigments can significantly enhance the activity of various antioxidant enzymes in mice, and the rose flower pigment group significantly prolongs the duration of skeletal muscle in mice, reduces the content of malondialdehyde and blood lactic acid, delays fatigue and improves overall exercise capacity. The experiment of rose flower extract on isolated mouse uterus showed that low-dose rose flower extract could significantly reduce the frequency of uterine contractions in a dose-dependent manner, indicating that rose flower extract has an excitatory effect on the uterus; in addition, studies have found that rose flower polysaccharide RCJ2-Ⅰb can improve the coagulation-related biochemical indicators of acute blood stasis model rats, and has a significant in vivo anticoagulant effect.

[0019] Chuanxiong is pungent, warm, and returns to the liver, gallbladder, and pericardium meridians. It promotes blood circulation and unblocks qi, dispels wind and stops pain. It can ascend to the top of the head, descend to the uterus, and side through the limbs. It can not only promote blood circulation and regulate menstruation to help pregnancy, but also unblock qi and relieve depression to stop pain. It is used for blood stasis and qi stagnation, such as delayed menstruation, blood stasis, amenorrhea, and dysmenorrhea. It is a "blood and qi medicine". Chuanxiong has the pharmacological effects of antioxidant, nerve protection, vascular homeostasis maintenance, anti-inflammatory, and antibacterial. The main components of ligustilide and senkyunolide in Chuanxiong inhibit the transmission of inflammatory signals and affect the expression of downstream proteins, thereby exerting anti-inflammatory effects. Ligustilide can relieve vascular spasm, improve blood circulation, promote vascular endothelial cell proliferation, and angiogenesis, and directly reduce the levels of inflammatory factors by affecting COX-2, ERK2, and TNF-α.

[0020] Angelica is sweet and pungent, warm, and tonifies blood and regulates menstruation, promotes blood circulation and relieves pain, moistens the intestines and promotes defecation. It is named "Angelica" because it can make blood return to its proper channels. It is a recognized "sacred blood tonic" that can be used regardless of cold, heat, deficiency, or excess. The main component of Angelica is Angelica polysaccharide. Studies have shown that it can increase the levels of serum FSH, LH, and E2 in recurrent miscarriage rats, reduce platelet aggregation, improve blood rheology and blood circulation, up-regulate PI3K and AKT protein expression, promote vascular remodeling, and increase blood perfusion, thereby improving pregnancy outcomes, and the overall performance shows a positive dose dependence.

[0021] Raw licorice is slightly cold and returns to the heart, lung, and stomach meridians. It tonifies the spleen and benefits qi, expels phlegm and stops cough, relieves pain, clears heat and detoxifies, and harmonizes various drugs. It is good at entering the middle jiao, can tonify the spleen and benefit qi, can relieve pain with a sweet taste, and can expel phlegm. Raw licorice can clear heat and detoxify. The main component of raw licorice, glycyrrhizin, can inhibit 3', 5'-cyclic adenosine monophosphate (cAMP) phosphodiesterase, play a role in anti-platelet aggregation, inhibit acetyl-CoA acetyltransferase activity, block the generation of platelet activation factors, and have anti-inflammatory, immune regulation, anti-inflammatory, anti-viral, anti-diuretic, and lipid-lowering effects.

[0022] The traditional Chinese medicine decoction for treating polycystic ovary syndrome is used for treating polycystic ovary syndrome.

[0023] Further, the traditional Chinese medicine decoction for treating polycystic ovary syndrome is taken as follows: the patient takes it orally 2 times a day, 200 ml each time.

[0024] Further, the traditional Chinese medicine decoction for treating polycystic ovary syndrome is taken as follows: it is taken from the first day of the menstrual cycle and taken until the day of cohabitation when the mature follicle is discharged. If there is no mature follicle or no ovulation, it is taken until the next menstruation.

[0025] Further, the traditional Chinese medicine decoction for treating polycystic ovary syndrome is taken for 3 menstrual cycles.

[0026] Compared with the prior art, the present application has the following beneficial effects: 1. The traditional Chinese medicine decoction for treating polycystic ovary syndrome of the present application is Yanghe Xiaogan Decoction formed by modifying the classical prescription Yanghe Decoction, and is the main method of treating polycystic ovary syndrome by warming the kidney and invigorating the spleen, resolving phlegm and removing blood stasis. The traditional Chinese medicine decoction for treating polycystic ovary syndrome of the present application has a significant effect on treating the symptoms of PCOS infertility patients, and can simultaneously improve the endometrial thickness and morphology, reduce the levels of T, LH, F-T, ASD, INH-B and AMH, reduce the PCO state, improve the follicle quality and cycle ovulation rate, so as to improve the clinical pregnancy rate, total effective rate and reduce the biochemical pregnancy rate and fetal stop growth rate. The traditional Chinese medicine decoction for treating polycystic ovary syndrome of the present application can also improve the BBT and acne of PCOS infertility patients, and has good clinical application value. 2. The traditional Chinese medicine decoction for treating polycystic ovary syndrome of the present application has no any toxic and side effects, and is safe and reliable. BRIEF DESCRIPTION OF DRAWINGS

[0027] Figure 1 is a test comparison chart of recovery rate, significant efficiency, effective rate and inefficiency of the Wenyang method group and the letrozole group (LE group) after treatment of the present application; Figure 2 is a test comparison chart of confirmed pregnancy rate, clinical pregnancy rate, biochemical pregnancy rate, fetal stop growth rate and ectopic pregnancy rate of the Wenyang method group and the letrozole group (LE group) after treatment of the present application; Figure 3 is an En test comparison chart of the Wenyang method group and the letrozole group (LE group) after treatment of the present application; Figure 4 is an endocrine index (T, ASD, P) test comparison chart of the Wenyang method group and the letrozole group (LE group) after treatment of the present application; Figure 5 is an endocrine index (E2, APRL, INH-B) test comparison chart of the Wenyang method group and the letrozole group (LE group) after treatment of the present application; Figure 6 is an endocrine index (AMH, LH, FSH, F-T) test comparison chart of the Wenyang method group and the letrozole group (LE group) after treatment of the present application. DETAILED DESCRIPTION

[0028] The technical solutions in the embodiments of the present application will be clearly and completely described below in combination with the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0029] EMBODIMENT A traditional Chinese medicine decoction for treating polycystic ovary syndrome is prepared by decocting a traditional Chinese medicine composition; in terms of weight parts, the content of each component in the traditional Chinese medicine composition is: 18 parts of prepared rehmannia, 5 parts of cassia, 5 parts of white radish seed, 10 parts of processed ginger, 10 parts of turmeric, 6 parts of cornu cervi (melted), 9 parts of raw licorice, 15 parts of fried hawthorn fruit, 15 parts of motherwort, 10 parts of Chinese rose flower, 10 parts of chuanxiong rhizome, and 12 parts of angelica.

[0030] Experimental example 1.1 Research data The observation objects were derived from outpatients of a certain TCM hospital from January 2021 to December 2023, and 120 outpatients who met the inclusion criteria and were willing to accept clinical observation were selected.

[0031] 1.1.1 Inclusion criteria 1) Age ≧ 22 years and ≦ 40 years; 2) Meet the diagnostic criteria for female infertility; 3) Meet the diagnostic criteria of ESHRE / ASRM (European Society of Human Reproduction and Embryology / Royal College of Obstetricians and Gynaecologists) for PCOS; 4) Meet the diagnostic criteria of TCM for spleen-kidney deficiency and blood stasis blocking the collaterals; 5) Voluntarily participate and sign the project informed consent form.

[0032] 1.1.2 Exclusion criteria 1) Uncooperative or without fertility requirements; 2) Amenorrhea (including primary and secondary) caused by congenital or acquired abnormalities or damage of the reproductive organs; 3) Abnormal liver and kidney function or having severe primary diseases of the cardiovascular system, mental and hematopoietic system, etc.; 4) Ovarian reserve decline, hyperprolactinemia, luteal insufficiency, and other ovulation disorder infertility; 5) Used hormone therapy within 3 months or participated in other clinical trials within 3 months; 6) Combined with antiphospholipid syndrome, increased platelet aggregation rate, and other immune infertility-related causes, or taking anti-immune infertility drugs; 7) Adrenal, thyroid, diabetes, and other endocrine gland function abnormalities; 8) ≧ 3 cm uterine adenomyoma, myoma, and ovarian cyst, and other diseases found by color Doppler ultrasound; 9) Presence of fallopian tube factors such as poor patency, obstruction, or hydrosalpinx; 10) Allergic to known research drug ingredients.

[0033] 1.1.3 Exclusion criteria 1) Diagnosed and included incorrectly; 2) One of the exclusion criteria is met; 3) Simultaneous use of drugs with similar efficacy (such as metformin, CC, HMG, Gn, or combined HCG, etc.), which makes it impossible to evaluate the efficacy; 4) In the assisted reproduction cycle; 5) Cannot be followed up or has incomplete data.

[0034] 1.1.4 Dropout criteria In the case of no clinical pregnancy, patients voluntarily choose to discontinue the trial due to subjective and objective reasons, or do not complete a course of treatment, or have poor compliance and fail to take medication on time, are considered as dropouts.

[0035] 1.1.5 Termination criteria In the treatment observation process, if serious adverse events, adverse reactions occur, or the research plan has a major design flaw, or the drug efficacy and safety evaluation cannot be carried out, treatment must be terminated immediately.

[0036] 1.2 Grouping 120 subjects who voluntarily participate in the observation are randomly allocated to the Wenyang method group (taking the Chinese medicine decoction for treating polycystic ovary syndrome in the embodiment) and the letrozole group (LE group) in a 1:1 ratio (Note: During the observation, 2 cases in the LE group were excluded due to misregistration and simultaneous use of similar efficacy drugs. In the Wenyang method group, 1 case was excluded during the auxiliary period, and 1 case was excluded due to incomplete data during the treatment process).

[0037] 1.3 Treatment method 1.3.1 Wenyang method group On the first day of the menstrual cycle (D1), take the Chinese medicine decoction for treating polycystic ovary syndrome in the embodiment, 200 mL / time, twice a day, until the day of ovulation with mature follicles. If there are no mature follicles or no ovulation, it can be taken until the next menstruation.

[0038] 1.3.2 LE group Take LE 2.5 mg / d, take for 5 consecutive days, and repeat every menstrual cycle.

[0039] 1.3.3 Supplementary scheme If the BBT curve is monophasic on D28, there is no >=1.5 cm follicle in the ovulation monitoring, and the endometrial thickness (En) is <=7 mm, give estrogen + progestin (the dosage and duration of estrogen are determined according to En and clinical conditions) or progestin alone for withdrawal bleeding. The drugs are estradiol valerate + dydrogesterone or dydrogesterone. After stopping the drug and bleeding, a new cycle of treatment is performed.

[0040] 1.3.4 Monitoring ovulation and guiding coitus During the treatment process, the development of follicles in both groups is monitored by transvaginal ultrasound every cycle, and subjects are advised to have coitus 1 day before and on the day of ovulation. For subjects who do not have menstruation 14 days after ovulation, serum β-HCG is detected in time, and a positive result is determined as confirmed pregnancy. Intrauterine pregnancy sac is seen by transvaginal ultrasound 30 days after ovulation, and subsequent monitoring shows that the embryo and primitive fetal heart beat are determined as clinical pregnancy.

[0041] 1.3.5 Course (treatment cycle) The treatment cycle of the Yang-warming method group and the LE group is 3 menstrual cycles, and 3 menstrual cycles (from the first day of the first menstrual cycle after treatment to the day before the next menstrual cycle) are considered as one course of treatment.

[0042] 1.4 Observation indicators 1.4.1 Outcome indicators 1.4.1.1 Primary outcome indicator - clinical pregnancy rate 1.4.1.2 Secondary outcome indicators (1) Pregnancy rate (2) Biochemical pregnancy, fetal growth arrest rate, and ectopic pregnancy rate (3) Endometrial thickness (En, mm), cycle ovulation rate (4) Endocrine indicators Changes in endocrine hormone levels before and after treatment were recorded. On the 2nd-4th day of the menstrual cycle or hormone withdrawal bleeding, the endocrine hormones [serum testosterone (T), prolactin (PRL), luteinizing hormone (LH), follicle-stimulating hormone (FSH), serum progesterone (P), estradiol (E2), free testosterone (F-T), androstenedione (ASD), inhibin B (INH-B), and anti-Mullerian hormone (AMH)] were measured in the morning on an empty stomach. Screening and end-of-trial examinations were conducted.

[0043] (5) TCM symptom score The clinical manifestations of each subject before and after treatment were recorded, including menstrual cycle and amount, color, and accompanying conditions. The symptom grading and quantification standard was developed based on the "Guidelines for Clinical Research on New Drugs of Traditional Chinese Medicine (Trial)", guided by the "Tongzhi Law" thought of National Medical Master Yu Jing'ao, and combined with the clinical summary of PCOS pathogenesis as "spleen and kidney deficiency and phlegm and blood stasis blocking the collaterals". The scores of symptoms such as postmenstrual period or amenorrhea, light menstrual flow, dark menstrual color, irregular menstrual flow, blood clots, soreness of the waist and knees, dizziness and tinnitus, pale complexion, fatigue, chest tightness and nausea, obesity, excessive and watery leukorrhea, clear and frequent urination, lack of sexual desire, irregular abdominal pain and pressing, irregular bleeding, breast discomfort before or during menstruation, thick and sticky leukorrhea, sticky stool, pale and slightly dark tongue with blood stasis spots and patches, and thin and slippery or slow and rough pulse were observed, as well as the total TCM symptom score.

[0044] (6) BBT determination Sleep for 6-8 hours, and measure the oral sublingual temperature in the morning in a resting state. The patient uses a mercury thermometer prepared in advance, measures the oral sublingual temperature, and records the value and corresponding symbol on the issued basal body temperature sheet. At the end of the month, connect the daily body temperature numbers into a curve. If the temperature is higher than 0.2℃ for 3 consecutive days compared to the previous 6 days, it is considered to be biphasic, and if the high temperature phase appears continuously for ≧2 times with a fluctuation of 0.2℃ or more, it is considered to be atypical biphasic body temperature.

[0045] (7) Acne According to the Pillsbury grading score standard, the degree, location, number of acne and the presence or absence of cystic inflammatory disease changes are observed; Pillsbury grading score standard: 0 points, no acne; 1 point, mild acne ≥2mm, <10 on the face or trunk (face and / or back); 2 points, mild acne 10-20 (face and / or back); 3 points, mild acne >20 or pustules <20 (face and / or back); 4 points, severe pustules ≥20 (face and / or back); 5 points, cystic inflammatory disease.

[0046] 1.4.2 Safety indicators 1.4.2.1 OHSS incidence OHSS is the most common disease caused by drug hypersensitivity or excessive use of ovulation drugs. OHSS is classified according to the Golan classification recommended by WHO: ① Mild, grade I: E2≧5500pmol / L, ovarian diameter ≤5cm, no symptoms or only abdominal distension; grade II: grade I + early luteal phase P>96pmol / L, nausea, vomiting, etc.; ② Moderate, grade III: grade II + 5cm<ovarian diameter ≦12cm, abdominal enlargement, weight gain, ultrasonic display of ascites signs; ③ Severe, grade IV: grade III + ascites and abdominal pain, respiratory distress, etc.; grade V: grade IV + ovarian diameter ≥12cm, unable to lie flat, blood concentration, coagulation dysfunction and decreased urine output, hypoproteinemia; Regardless of the mild, moderate, and severe manifestations of OHSS, it is considered as clinical OHSS.

[0047] 1.4.2.2 General physical examination / vital signs The respiratory rate, heart rate and blood pressure of each subject in a calm state were checked before entering the group and at the end of the test.

[0048] 1.4.2.3 Blood, urine routine and main liver and kidney function indicators The blood routine, urine routine and liver and kidney function [mainly including alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (γ-GT), creatinine (Cr), urea nitrogen (BUN)] of each subject were checked before entering the group and at the end of the test.

[0049] 1.4.2.4 Electrocardiogram The electrocardiogram was checked before entering the group and at the end of the test.

[0050] 1.4.2.5 Adverse events If a subject shows abnormalities in relevant physical and chemical examinations, the researcher should, after review, inform the subject to undergo the examination again as soon as possible to ensure that there is no error caused by human factors. If the results are still abnormal after the re-examination, the follow-up frequency should be increased and regular re-examinations should be carried out to dynamically observe the changes and outcomes of relevant physical and chemical examinations.

[0051] 1.4.3 Observation Time Point This study had 5 visit points and 5 visits in total: at enrollment, at the end of the first treatment cycle, at the end of the second treatment cycle, at the end of the third treatment cycle, and at follow-up. Note: Record all validity indicators and the incidence of 0HSS at each visit; other safety indicators (general physical examination, routine blood and urine tests, liver and kidney function tests are only observed on visits 1 and 5) are recorded.

[0052] 1.5 Statistical Methods All statistical analyses employed two-tailed hypothesis testing. The data included both quantitative and ordinal data, with professional statisticians selecting the most appropriate testing method based on the specific data. Descriptive and comparative tests between groups followed these guidelines: Quantitative indicators were expressed as mean ± standard deviation (mean ± standard deviation). Statistical descriptions were provided for data including the median (upper quartile, lower quartile) [Median(Q1,Q3)], minimum, and maximum (Min-Max). For normally distributed data, t-tests were used; for non-normally distributed data, Wilcoxon rank-sum tests were used for inter-group comparisons, along with confidence intervals for the mean differences. Ordinal data were analyzed using the number of cases and percentages, with chi-square tests used for inter-group comparisons. A p-value ≤ 0.05 was considered statistically significant. Analysis software: R4.3.1 statistical software and SPSS 26.0 were used to validate the statistical results; Note: Before conducting outcome statistics, patients underwent various pre-treatment examinations and data collection and analysis. Finally, the baseline variables from the first patient examination, the last examination, and outcome-related variables were integrated and analyzed.

[0053] 2. Results 2.1 Key Outcome Indicators and Overall Effectiveness 2.1.1 Clinical pregnancy rate ; As shown in Table 1, after treatment, the number of clinical pregnancies in the LE group was 13, with a clinical pregnancy rate of 22.4%, while the number of clinical pregnancies in the Wen Yang method group was 23, with a clinical pregnancy rate of 39.7%. There was a significant difference in the clinical pregnancy rate between the two groups after treatment (P<0.05), indicating that the Wen Yang method group was significantly better than the LE group in improving the clinical pregnancy rate.

[0054] 2.1.2 Total effective rate ; As can be seen from Table 2, Figure 1 After treatment, the LE group had 13 cases of recovery, 16 cases of marked effectiveness, 17 cases of effectiveness, and 12 cases of ineffectiveness, with a recovery rate of 22.4%, a marked effectiveness rate of 27.6%, an effectiveness rate of 29.3%, and an ineffectiveness rate of 20.7%; the Wenyang method group had 23 cases of recovery, 9 cases of marked effectiveness, 24 cases of effectiveness, and 2 cases of ineffectiveness, with a recovery rate of 39.7%, a marked effectiveness rate of 15.5%, an effectiveness rate of 41.4%, and an ineffectiveness rate of 3.4%. Comparing the total effective rates of the two groups of subjects after the experiment (total effective rate = number of cases of recovery + number of cases of marked effectiveness + number of cases of effectiveness / number of observed cases), the total effective rate of the LE group was 79.3%, and the total effective rate of the Wenyang method group was 96.6%. The total effective rates of the two groups were significantly different (P < 0.05), indicating that the Wenyang method group was significantly better than the LE group in terms of total effective rate.

[0055] 2.2 Secondary outcome indicators 2.2.1 Pregnancy rate, biochemical pregnancy rate, fetal loss rate, ectopic pregnancy rate (1) The pregnancy rate (pregnancy rate = number of cases of confirmed pregnancy / total number of cases) was compared between the two groups of subjects after the experiment, with confirmation of pregnancy as one of the efficacy indicators. ; As can be seen from Table 3, Figure 2 After treatment, the LE group had 23 cases of confirmed pregnancy and 35 cases of unconfirmed pregnancy, with a pregnancy rate of 39.7%; the Wenyang method group had 25 cases of confirmed pregnancy and 33 cases of unconfirmed pregnancy, with a pregnancy rate of 43.1%. There was no significant difference in the number of cases of confirmed pregnancy and the pregnancy rate between the two groups (P > 0.05), indicating that there was no significant difference between the Wenyang method group and the LE group in promoting pregnancy (confirmed pregnancy).

[0056] (2) Biochemical pregnancy and fetal loss reflect the outcomes of different time periods and different ways of pregnancy, and ectopic pregnancy is something that should be avoided in clinical practice. ; As can be seen from Table 4, Figure 2 After treatment, the LE group had 4 cases of biochemical pregnancy, 6 cases of fetal loss, and 0 cases of ectopic pregnancy, with a biochemical pregnancy rate of 17.4%, a fetal loss rate of 26.1%, and an ectopic pregnancy rate of 0%; the Wenyang method group had 1 case of biochemical pregnancy, 1 case of fetal loss, and 0 cases of ectopic pregnancy, with a biochemical pregnancy rate of 4.0%, a fetal loss rate of 4.0%, and an ectopic pregnancy rate of 0%. Overall, there was a significant difference in the biochemical pregnancy rate, fetal loss rate, and ectopic pregnancy rate between the two groups after treatment (P < 0.05), with an ectopic pregnancy rate of 0% in both groups, which was not significantly different between the two groups (P > 0.05). Combined with data analysis, it is shown that the Wenyang group has no significant difference with the LE group in promoting pregnancy (confirmed pregnancy) of PCOS patients with infertility, but it is significantly better than the LE group in reducing biochemical pregnancy rate and fetal stop growth rate. LE is the first-line drug for clinical ovulation promotion of PCOS infertility, which is a new generation of non-steroidal aromatase inhibitor. It can inhibit the conversion of ASD to estrone and the conversion of T to E2, block the negative regulation of E on the hypothalamic-pituitary axis by reducing E production, increase the secretion of Gn from the pituitary, or increase the sensitivity of granulosa cell FSH receptor due to the accumulation of E precursors ASD and T, thereby promoting follicular development and maturation. Moreover, LE has a short half-life and does not compete with estrogen receptors, without anti-estrogen effect. Many clinical reports show that the ovulation rate of LE is 70%-84%, the clinical pregnancy rate is 20%-27%, the abortion rate is 22%-41%, and the multiple pregnancy rate is about 3.4%, which still has the problem of "high ovulation and low pregnancy". The Chinese medicine decoction for treating polycystic ovary syndrome in the Wenyang group is composed of kidney-tonifying, yang-warming, blood-activating, and phlegm-dissolving, which can intervene in multiple pathways of PCOS infertility and can effectively reduce the "high ovulation and low pregnancy" phenomenon and the occurrence of biochemical pregnancy and fetal stop growth of LE in PCOS infertility.

[0057] 2.2.2 Color ultrasound monitoring indicators (1) Endometrial thickness (En, mm) ① Comparison of En between the two groups after treatment ; ② Comparison of En changes before and after treatment within the two groups ; (Note: En.1 indicates that the data of the second cycle is compared with the first cycle as the outcome, and En.2 indicates that the data of the third cycle is compared with the first cycle as the outcome) ③ Comparison of En outcome and baseline difference between the two groups ; (Note: En.1 indicates that the data of the second cycle is compared with the first cycle as the outcome, and En.2 indicates that the data of the third cycle is compared with the first cycle as the outcome) As shown in Tables 5-7, Figure 3 , it is known that the En of each cycle in the three cycles during the treatment period is statistically compared. The En of the first cycle (P=0.559) has no significant difference between the two groups (P>0.05), and the En of the second and third cycles (both P<0.001) has significant difference between the two groups (P<0.05), indicating that the Wenyang group is better than the LE group in improving En in the second and third cycles. The En of the two groups before and after treatment was compared. The En of the first cycle was used as the baseline. After treatment, the En of the second cycle of the Wenyang method group was significantly different from the first cycle (P<0.001), and the En of the third cycle was also significantly different from the first cycle (P<0.001) (P<0.05), indicating that the Wenyang method group was superior to the first cycle in improving En in the second and third cycles. The difference between the second cycle and the first cycle (P=0.14) and the difference between the third cycle and the first cycle (P=0.06) were not statistically significant (P>0.05) in the LE group. The En outcomes of the two groups were compared with the baseline. The En of the first cycle was used as the baseline, and the En outcomes of the second and third cycles were compared with the baseline. The En.1 difference (P<0.001) and En.2 difference (P<0.001) were significantly different (P<0.05), indicating that the Wenyang method group was significantly different from the LE group in improving the En difference between the second and first cycles and the En difference between the third and first cycles. The difference between the groups in the evaluation level of efficacy was better than the simple comparison of outcomes, and it could more accurately and objectively reflect the efficacy of the treatment method. In summary, the traditional Chinese medicine decoction for treating polycystic ovary syndrome has the effect of improving En month by month, and is superior to the LE group in improving En month by month.

[0058] (2) Cycle ovulation rate ; As shown in Table 8, the ovulation rate of each cycle in the three cycles during the treatment period was calculated (ovulation rate = number of ovulation cases / total number of cases). The first cycle ovulation rate (P=0.075) and the second cycle ovulation rate (P=0.448) were not statistically different between the two groups (P>0.05), and the third cycle ovulation rate (P=0.0008) was significantly different between the two groups (P<0.05). Based on the data analysis, the LE group had more ovulation cases than the Wenyang method group in the first and second cycles, but there was no significant difference, while the Wenyang method group was significantly better than the LE group in the third cycle ovulation rate. In summary, the traditional Chinese medicine decoction for treating polycystic ovary syndrome has the same effect as LE in continuously improving the cycle ovulation rate. The LE group had more ovulation cases than the Wenyang method group in the first and second cycles, but there was no significant difference, while the Wenyang method group was significantly better than the LE group in the third cycle ovulation rate.

[0059] 2.2.3 Endocrine index (1) Comparison of endocrine outcome indicators between groups ; (2) Comparison of endocrine outcome indicators within groups ; From Table 9-10 and Figures 4-6 It can be seen that the statistical comparison of endocrine hormone levels between the two groups after treatment, the F-T (P=0.035), INH-B (P=0.01), AMH (P<0.001) of the two groups have significant differences (P<0.05) in the outcome hormone level. Combined with data analysis, it shows that the WYF group is better than the LE group in improving F-T, INH-B and AMH. While there is no significant difference (P>0.05) in T (P=0.176), PRL (P=0.097), LH (P=0.135), FSH (P=0.833), P (P=0.41), E2 (P=0.091), ASD (P=0.677) between the two groups; The statistical comparison of each endocrine index between the two groups before and after treatment (baseline, outcome) shows that there is a significant difference (P<0.05) in T (P<0.001), LH (P<0.001), F-T (P<0.001), ASD (P=0.006), INH-B (P<0.001), AMH (P<0.001) between the WYF group and the baseline. Combined with data analysis, it shows that the WYF group has the effect of reducing T, LH, F-T, ASD, INH-B and AMH. While there is a significant difference (P<0.05) in LH (P=0.049), F-T (P=0.005), INH-B (P=0.015), AMH (P<0.001) between the LE group and the baseline. Combined with data analysis, it shows that the LE group has the effect of reducing LH, F-T, INH-B and AMH. In summary, the Chinese medicine decoction for treating polycystic ovary syndrome can well regulate the related hormone levels, thereby achieving the therapeutic effect on PCOS infertility.

[0060] 2.2.4 TCM symptom score (1) Outcome total score ① Comparison of outcome total score between groups ; ② Comparison of outcome total score within groups ; (2) TCM symptom score ① Comparison of outcome score of each symptom between groups , , ; ② Changes of TCM symptoms before and after treatment between groups ; From Tables 11-14, the total outcome scores of TCM symptoms in the two groups were compared. The total outcome scores of TCM symptoms in the two groups were significantly different (P<0.001). The total outcome scores of TCM symptoms in the WYF group were significantly better than those in the LE group (P<0.05). The total outcome scores of TCM symptoms in the WYF group (P<0.001) and the LE group (P<0.001) were significantly different from the baseline scores. The TCM symptoms in both groups were improved, but the improvement in the LE group was relatively limited. The outcome scores of each symptom in the two groups were compared. The outcome scores of TCM symptoms in the two groups were significantly different (P<0.001) in terms of postmenstrual period or amenorrhea (P<0.001), light menstrual flow (P<0.001), pale menstrual color (P<0.001), poor menstrual flow (P<0.001), menstrual blood clots (P<0.001), fatigue (P=0.001), excessive and watery leukorrhea (P=0.006), frequent clear urine (P=0.007), abdominal pain during menstruation and aggravated by pressing (P<0.001), irregular bleeding (P<0.001), breast discomfort before or during menstruation (P<0.001), sticky stool (P<0.001), pale and slightly dark tongue with ecchymoses (P=0.004), and thin and slippery or slow and rough pulse (P<0.001). The WYF group was better than the LE group in terms of postmenstrual period or amenorrhea, light menstrual flow, pale menstrual color, poor menstrual flow, menstrual blood clots, fatigue, excessive and watery leukorrhea, frequent clear urine, abdominal pain during menstruation and aggravated by pressing, irregular bleeding, breast discomfort before or during menstruation, sticky stool, pale and slightly dark tongue with ecchymoses, and thin and slippery or slow and rough pulse. There was no significant difference (P>0.05) in terms of waist and knee soreness (P=0.228), dizziness and tinnitus (P=0.304), pale face (P=0.469), chest tightness and nausea (P=0.339), obesity (P=0.632), indifferent sex drive (P=0.598), and thick leukorrhea (P=0.146). There were statistically significant differences in the baseline of less menstrual flow, pale complexion, and watery and clear leukorrhea, and premenstrual or menstrual breast pain and discomfort between the two groups. There were no statistically significant differences in the baseline of soreness of the waist and knees, dizziness and tinnitus, pale complexion, chest tightness and nausea, obesity, and sexual apathy, and thick and sticky leukorrhea. The comparison of the changes in symptoms before and after treatment (outcomes) between the two groups could more objectively and directly reflect the differences in the efficacy of various symptoms between the two groups. The outcome value of each TCM symptom was subtracted from the baseline value. If the value was negative, the symptom was alleviated. If the value was positive, the symptom was aggravated. If the value was 0, there was no change. There were statistically significant differences in the changes before and after treatment (outcomes) in less menstrual flow (P=0.009), soreness of the waist and knees (P<0.001), dizziness and tinnitus (P=0.03), pale complexion (P=0.001), and premenstrual or menstrual breast pain and discomfort (P<0.001) between the two groups. Combined with the data, it was indicated that the WYF group was significantly better than the LE group in improving the symptoms of less menstrual flow, pale complexion, premenstrual or menstrual breast pain and discomfort, soreness of the waist and knees, and dizziness and tinnitus. There were no statistically significant differences in the changes in chest tightness and nausea (P=0.923), obesity (P=0.26), watery and clear leukorrhea (P=0.377), sexual apathy (P=0.139), and thick and sticky leukorrhea (P=0.122) between the two groups. In addition, there were statistically significant differences in the baseline of watery and clear leukorrhea, and there were no statistically significant differences in the changes in symptoms before and after treatment (baseline and outcomes) between the two groups. Therefore, although there were statistically significant differences in the outcome scores between the WYF group and the LE group, it could not be determined that there were significant differences in the outcomes between the two groups. In summary, the Chinese medicine decoction for treating polycystic ovary syndrome can significantly improve most symptoms and tongue and pulse conditions of PCOS patients, thereby directly solving the patients' troubles and improving the patients' trust, and further promoting the efficacy of treatment.

[0061] 2.2.5 BBT (1) Comparison of BBT between the two groups at each visit ; (2) Comparison of changes in BBT before and after treatment within the group ; (Note: 1 represents the comparison of the data of the 2nd cycle as the outcome with the 1st cycle. 2 represents the comparison of the data of the 3rd cycle as the outcome with the 1st cycle. The bold underlined numbers are the number of aggravation cases) From Table 15-16, the statistical comparison of BBT curve patterns between the two groups after treatment showed that there was a significant difference (P<0.05) between the two groups in the first cycle (P=0.0007). According to the specific values, the LE group improved BBT better than the Wenyang method group in the first cycle. There was no significant difference (P>0.05) between the two groups in the second cycle (P=0.161) and the third cycle (P=0.455). Overall, although the Wenyang method improved BBT worse than the LE group in the first cycle, there was no difference between the two groups in the latter two cycles, which may be related to the sustained effect of the Chinese medicine decoction for treating polycystic ovary syndrome. The statistical comparison of BBT curve patterns between the two groups before and after treatment showed that there was no significant difference (P>0.05) between the two groups in the first cycle. After treatment, there was a significant difference (P<0.05) between the two groups in the second cycle (P<0.001) and the third cycle (P<0.001). According to the data analysis, the Wenyang method group improved BBT curve patterns significantly better in the second cycle than in the first cycle. The LE group and the Wenyang method group improved BBT curve patterns significantly better in the third cycle than in the first cycle. Overall, the Chinese medicine decoction for treating polycystic ovary syndrome improved BBT curve patterns worse than the LE group in the first cycle, but under the sustained effect of the Wenyang method group, it had a sustained effect on improving BBT curve patterns, and there was no difference between the two groups in the subsequent cycles.

[0062] 2.2.6 Acne (1) Comparison of acne grades between groups at each visit point ; (2) Changes in acne grades between groups before and after treatment ; From Table 17-18, the statistical comparison of acne grades between the two groups at 3 treatment cycles and after treatment showed that there were significant differences (P<0.05) between the two groups in the second cycle (P<0.001), the third cycle (P<0.001), and after treatment (P<0.001). According to the numerical analysis, the Wenyang method group improved acne grades better than the LE group in the second cycle, the third cycle, and after treatment. There was no significant difference (P>0.05) between the two groups in the first cycle (P=0.155). The comparison of acne grade changes at different visit points between groups can more objectively and directly reflect the differences in acne grade changes between the two groups. The changes in acne grade at different visit points between the two groups were compared, and the acne grade before treatment was used as the baseline. The changes in acne grade at different visit points and after treatment were compared with the baseline, and the difference in acne grade at different visit points was calculated. If the value was negative, the symptoms were alleviated; if the value was positive, the symptoms were aggravated; if the value was 0, there was no change. The first cycle (P<0.001), the second cycle (P=0.001), the third cycle (P<0.001), and after treatment (P<0.001) were significantly different from before treatment (P<0.05). According to the data, it is believed that the LE group is superior to the WYF group in improving acne grade in the first cycle. This may be related to the fact that the traditional Chinese medicine decoction for treating polycystic ovary syndrome can warm the yang and open the meridians, thereby causing the phlegm and blood to be transformed into fat and water, and the yang to be added to the yin, which is called sweating (Su Wen • Yin and Yang Differentiation). The early treatment of the disease can help to expel the evil from the sweat pores. After the evil is expelled, the WYF group is superior to the LE group in improving acne grade in the second cycle, the third cycle, and after treatment. However, there is no significant difference between the two groups in the difference between after treatment and the third cycle (P=0.242). In summary, the traditional Chinese medicine decoction for treating polycystic ovary syndrome is inferior to the LE group in improving acne grade in the first cycle, but it is superior to the LE group in improving acne grade in the second cycle, the third cycle, and after treatment. After treatment with the traditional Chinese medicine decoction for treating polycystic ovary syndrome, acne can be significantly alleviated.

[0063] 2.3 Safety evaluation All patients were monitored for general vital signs such as respiration, heart rate, and resting blood pressure before and after treatment, and blood and urine routine, ALT, AST, ALP, γ-GT, BUN, Cr, and electrocardiogram were examined. The results showed that there were no obvious abnormalities; during treatment, one case of grade I OHSS occurred in the LE group in the first cycle and the second cycle, respectively, and no other discomfort was observed during dynamic observation, and treatment was continued; no adverse reactions occurred in both groups during treatment.

[0064] Although embodiments of the present application have been shown and described, it will be understood by those having ordinary skill in the art that various changes, modifications, alternatives, and variations can be made thereto without departing from the principles and spirit of the application, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine decoction for treating polycystic ovary syndrome, characterized in that, The traditional Chinese medicine decoction for treating polycystic ovary syndrome is prepared by decocting a combination of traditional Chinese medicines, including Rehmannia glutinosa, cinnamon, white mustard seed, prepared ginger, turmeric, deer antler glue, raw licorice, stir-fried hawthorn, motherwort, rose, chuanxiong and angelica.

2. The traditional Chinese medicine decoction for treating polycystic ovary syndrome according to claim 1, characterized in that, The deer antler glue is melted before use.

3. The traditional Chinese medicine decoction for treating polycystic ovary syndrome according to claim 1, characterized in that, The components of the traditional Chinese medicine composition, by weight, are as follows: Rehmannia glutinosa 14-22 parts, Cinnamomum cassia 2-8 parts, Sinapis alba 2-8 parts, Zingiber officinale (processed) 6-14 parts, Curcuma longa 6-14 parts, Cervi cornu colla 2-10 parts, Glycyrrhiza uralensis (raw) 5-13 parts, Crataegus pinnatifida (fried) 11-19 parts, Leonurus japonicus 11-19 parts, Rosa chinensis 6-14 parts, Ligusticum chuanxiong 6-14 parts, and Angelica sinensis 8-16 parts.

4. The traditional Chinese medicine decoction for treating polycystic ovary syndrome according to claim 1, characterized in that, The components of the traditional Chinese medicine composition, by weight, are as follows: Rehmannia glutinosa 16-20 parts, Cinnamomum cassia 4-6 parts, Sinapis alba 4-6 parts, Zingiber officinale (processed) 8-12 parts, Curcuma longa 8-12 parts, Cervi cornu colla 4-8 parts, Glycyrrhiza uralensis (raw) 7-11 parts, Crataegus pinnatifida (fried) 13-17 parts, Leonurus japonicus 13-17 parts, Rosa chinensis 8-12 parts, Ligusticum chuanxiong 8-12 parts, and Angelica sinensis 10-14 parts.

5. The traditional Chinese medicine decoction for treating polycystic ovary syndrome according to claim 1, characterized in that, The components of the traditional Chinese medicine composition, by weight, are as follows: 18 parts Rehmannia glutinosa, 5 parts Cinnamomum cassia, 5 parts Sinapis alba, 10 parts Zingiber officinale (processed), 10 parts Curcuma longa, 6 parts Cervi cornu colla, 9 parts Glycyrrhiza uralensis (raw), 15 parts Crataegus pinnatifida (fried), 15 parts Leonurus japonicus, 10 parts Rosa chinensis, 10 parts Ligusticum chuanxiong, and 12 parts Angelica sinensis.

6. The application of the traditional Chinese medicine decoction for treating polycystic ovary syndrome according to claim 1 in the treatment of polycystic ovary syndrome.

7. The application as described in claim 6, characterized in that, The traditional Chinese medicine decoction for treating polycystic ovary syndrome is administered as follows: the patient takes 200 mL orally twice a day.

8. The application as described in claim 6, characterized in that, The traditional Chinese medicine decoction for treating polycystic ovary syndrome is taken as follows: start taking it on the first day of the menstrual cycle and continue until the day of intercourse when the follicle matures and is released. If there is no mature follicle or no ovulation, continue taking it until the next menstrual cycle.

9. The application as described in claim 6, characterized in that, The course of treatment for polycystic ovary syndrome (PCOS) with the traditional Chinese medicine decoction is 3 menstrual cycles.

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