A disease-distinguishing and treatment chronic prostatitis traditional Chinese medicine composition and application thereof

Abstract

The application discloses a kind of disease identification and treatment chronic prostatitis traditional Chinese medicine composition and application, the composition includes cinnamon, Herba Epimedii, Radix Rehmanniae Praeparatae, Chinese yam, dogwood, bletilla striata, Acorus gramineus Soland, Fructus Schisandrae, Lindera aggregata, gardenia, radix paeoniae alba, radix curcumae, lychee kernel.The composition of the application has the effects of tonifying kidney and assisting yang, removing dampness and turbidity, soothing liver and regulating qi, promoting blood circulation and relieving pain, etc., and can be used for disease identification and treatment of chronic prostatitis, effectively alleviating four clinical symptom groups of pain symptoms, lower urinary tract symptoms, mental and psychological disorders, sexual dysfunction, etc. involved in chronic prostatitis. According to clinical verification, the disease identification and treatment drug of the application can achieve outstanding clinical efficacy, and is more consistent with the actual scene of clinical use of Chinese patent medicine preparations.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically, it relates to a traditional Chinese medicine composition for the treatment of chronic prostatitis based on disease differentiation and its application. Background Technology

[0002] Chronic prostatitis refers to a disease characterized by pelvic pain or discomfort and urinary abnormalities, caused by pathogens and / or certain non-infectious factors affecting the prostate. Its clinical manifestations are complex, and the condition is protracted and difficult to cure. Patients often experience pain and lower urinary tract symptoms; some also experience psychological disorders such as anxiety, depression, and fear, as well as sexual dysfunctions such as erectile dysfunction and premature ejaculation. This seriously affects the patient's physical and mental health and quality of life, and increases the socioeconomic burden.

[0003] The current domestic statistics show that the incidence of chronic prostatitis ranges from 6.0% to 32.9%, with a particularly high prevalence among young and middle-aged men under 50 years old. This disease is a heterogeneous clinical syndrome with multiple etiologies, different progression pathways, diverse symptoms, and varying responses to treatment. Currently, there is no single therapy with significant clinical efficacy. Clinically, the main treatment model for chronic bacterial prostatitis (type II) in Western medicine is a combination of antibiotics and traditional Chinese medicine preparations; patients with asymptomatic prostatitis (type IV) rarely seek medical attention due to the lack of symptoms; the main treatment model for chronic prostatitis / chronic pelvic pain syndrome (type III) in Western medicine is symptomatic treatment (α-receptor blockers and / or nonsteroidal anti-inflammatory drugs and / or M-receptor blockers and / or β3-receptor agonists and / or antidepressants and anti-anxiety drugs) combined with traditional Chinese medicine preparations.

[0004] The advantage of Traditional Chinese Medicine (TCM) treatment lies in its combination of syndrome differentiation and disease-based treatment. However, according to incomplete statistics, the vast majority of patients with chronic prostatitis consult urologists or andrologists, employing the aforementioned treatment models and widely using prepared Chinese herbal medicines. Only a very small number of patients consult TCM departments, where a treatment method combining disease and syndrome differentiation is used, primarily employing decoctions or granules. Currently, urologists or andrologists generally lack the ability to differentiate syndromes using TCM, making disease-based treatment with prepared Chinese medicines more in line with clinical practice. Therefore, developing prepared Chinese medicines for treating chronic prostatitis that only require disease differentiation is more meaningful.

[0005] Research reveals that current traditional Chinese medicine (TCM) preparations for treating chronic prostatitis are primarily based on the TCM theory of syndrome differentiation and treatment, mainly targeting the damp-heat with blood stasis type, with a few targeting the kidney deficiency and blood stasis type. However, the TCM syndrome types differ among different patients with chronic prostatitis, and even among the same patient at different stages of the disease, the TCM syndrome type varies, leading to inconsistent efficacy of existing TCM preparations for treating chronic prostatitis. The development and improvement of TCM compositions for chronic prostatitis are ongoing. Therefore, based on clinical practice, we have developed an effective TCM composition formula for treating chronic prostatitis, grounded in TCM disease differentiation theory. Summary of the Invention

[0006] The technical problem to be solved by this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine composition for the treatment of chronic prostatitis and its application. To solve the above technical problem, the basic concept of the technical solution adopted by this invention is as follows:

[0007] This invention provides a traditional Chinese medicine composition for treating chronic prostatitis, comprising the following parts by weight of medicinal materials: 3-6 parts cinnamon, 10-15 parts epimedium, 20-30 parts prepared rehmannia root, 10-15 parts yam, 10-15 parts cornus officinalis, 10-15 parts dioscorea hypoglauca, 10-15 parts acorus tatarinowii, 10-15 parts alpinia oxyphylla, 10-15 parts lindera strychnifolia, 6-12 parts gardenia, 10-15 parts achyranthes bidentata, 6-12 parts turmeric, and 6-12 parts litchi seed.

[0008] Furthermore, the herbal ingredients include the following parts by weight: 6 parts cinnamon, 15 parts epimedium, 30 parts prepared rehmannia root, 15 parts yam, 15 parts cornus officinalis, 15 parts dioscorea hypoglauca, 15 parts acorus tatarinowii, 15 parts alpinia oxyphylla, 15 parts lindera root, 12 parts gardenia, 15 parts achyranthes bidentata, 12 parts turmeric, and 12 parts litchi seed.

[0009] Another aspect of the present invention provides a drug for treating chronic prostatitis, the raw materials of which include the above-mentioned traditional Chinese medicine composition.

[0010] Furthermore, the drug also includes pharmaceutically acceptable excipients.

[0011] Furthermore, the excipients include excipients.

[0012] Furthermore, the excipient is honey.

[0013] Furthermore, the dosage form of the drug is a decoction, tablet, pill, granule, or capsule.

[0014] While there is no specific disease called "chronic prostatitis" in ancient Chinese medical texts, based on its etiology, pathogenesis, and symptoms, it can be categorized under "seminal turbidity," "urinary tract infection," "leukorrhea," and "muscle weakness." The related symptoms of urinary tract infection and muscle weakness first appeared in the *Huangdi Neijing*, laying the foundation for its etiology and pathogenesis. The *Suwen* (Plain Questions) chapter on "Wei Lun" states: "When thoughts are endless and desires are not fulfilled, and one indulges in excessive sexual activity, the tendons become lax, leading to muscle weakness and leukorrhea." The *Suwen* chapter on "Wu Chang Zheng Da Lun" states: "When the Qi is greatly weakened, it cannot rise or be used," indicating that excessive sexual activity damaging the kidney Qi is the fundamental cause and pathogenesis. Regarding its symptoms, the *Jinkui Yaolue* (Essential Prescriptions of the Golden Chamber) mentions: "The disease of urinary tract infection is characterized by urine resembling millet grains, lower abdominal distension, and pain radiating to the navel." The *Treatise on the Causes and Symptoms of Various Diseases* states in its section on "Lymphoid Disease": "All types of dysuria are caused by kidney deficiency and bladder heat." The same text states in its section on "Consumptive Impotence": "Exhaustion injures the kidneys, leading to kidney deficiency and inability to nourish the genitals, resulting in weakness." The *Revised Formulas for Saving Lives* states in its section on "Treatise on Deficiency and Damage": "Five types of exhaustion and seven types of injury weaken the true yang, ... leading to impotence." The *Complete Works of Jingyue* states: "...there is also dysuria that persists for a long time, even after the pain and discomfort have subsided, but the discharge remains, resembling white turbidity; this is due to the sinking of the middle qi and the instability of the gate of life..." All these texts emphasize that exhaustion, kidney deficiency, and damp-heat accumulation in the bladder are the causes and mechanisms of dysuria and impotence, especially chronic dysuria. The *Clinical Guide to Medical Cases* points out in its section on "Various Pains": "Accumulated injury enters the collaterals, causing stagnation of qi and blood, resulting in impaired circulation; this is what is meant by 'pain due to obstruction.'" This indicates that blood stasis is one of the causes of pain due to obstruction. The concept of "the kidneys governing water" originates from the *Huangdi Neijing* (Yellow Emperor's Inner Classic). The *Suwen* (Plain Questions) section on "The Primordial Innocence of Antiquity" states, "The kidneys govern water." The *Suwen* section on "Reversal and Regulation" states, "The kidneys store water and govern body fluids." The textbook *Basic Theories of Traditional Chinese Medicine* (9th edition) elaborates on the meaning of "the kidneys governing water": Kidney Qi has the function of governing and regulating the metabolism of body fluids throughout the body, including the promoting effect of kidney Qi on the organs involved in body fluid metabolism, and the kidney Qi's role in urine production and excretion. Jiang Shi's *Hygiene Handbook* (Concise View of Health) states, "The bladder... can excrete fluids through Qi transformation; however, sufficient kidney Qi enables transformation, while insufficient kidney Qi prevents transformation." This further explains that the normal functioning of the bladder depends on kidney Qi; sufficient kidney Qi allows the bladder to transform fluids and excrete metabolic waste products.

[0015] Through in-depth study of traditional Chinese medicine classics and literature review, summarizing the views of physicians from the Han Dynasty to the present, and combining long-term clinical practice, the inventor innovated while inheriting tradition, believing that the main disease location of chronic prostatitis is in the kidneys, bladder, and seminal vesicles, the root cause of the pathogenesis is kidney deficiency, the manifestation of the pathogenesis is damp-heat, the key to the pathogenesis is blood stasis, and emotional factors affect the outcome of the disease, which is its characteristic pathogenesis. When the qi transformation and steaming of the kidneys and bladder are obstructed or damp-heat descends, symptoms such as difficulty urinating, frequent urination, urinary hesitancy, incomplete urination, or weak urination may occur. When damp-heat is combined with blood stasis, qi stagnation and blood stasis, or obstruction of the seminal vesicle vessels, pain occurs due to obstruction, resulting in local pain, or dull pain and discomfort in the perineum and lower abdomen, or soreness and distension in the lumbosacral region, suprapubic region, and groin area, and even painful urination and painful ejaculation may occur. Kidney deficiency leads to malnourishment of the genital tendons and weakness of the seminal gate, resulting in impotence, premature ejaculation, and seminal emission. This disease is chronic and difficult to cure, and it is prone to recurrence. It can easily lead to stagnation of liver qi, resulting in neuropsychiatric symptoms such as dizziness, fatigue, insomnia, low mood, anxiety, and depression.

[0016] Based on the etiology and pathogenesis of chronic prostatitis, and the characteristics of pathological transformation at different stages of the disease, and adhering to the principles of "treatment based on evidence" and "medication based on treatment principles," the inventors pioneered the following treatment principles for traditional Chinese medicine preparations for chronic prostatitis: 1. Differentiate the disease and treat accordingly; 2. Warming the kidneys and promoting diuresis are fundamental, while invigorating blood circulation, removing blood stasis, and eliminating dampness and turbidity are key. Given the chronic and difficult-to-cure nature of this disease, which easily leads to liver qi stagnation, the importance of soothing the liver, relieving depression, regulating qi, and alleviating pain is emphasized. Based on the principle of "medication based on treatment principles," and fully leveraging the advantages of traditional Chinese medicine's "multiple effects" and "synergistic effects," the invention uses the classic formula Shenqi Wan and Yang's Bixie Fenqing Yin as the base formulas. Through more than 10 years of clinical practice and continuous exploration and optimization, the traditional Chinese medicine composition scheme of this invention has been formed.

[0017] The self-developed traditional Chinese medicine formula of this invention consists of: cinnamon, epimedium, prepared rehmannia root, yam, cornus officinalis, dioscorea hypoglauca, acorus tatarinowii, alpinia oxyphylla, lindera strychnifolia, gardenia, achyranthes bidentata, turmeric, and litchi seed.

[0018] In this invention's formula, cinnamon, being pungent, sweet, and extremely hot, can both tonify fire and assist yang, benefit yang and eliminate yin, with a mild and lasting effect, making it a key medicine for treating deficiency of kidney yang. It can also promote blood circulation, dispel cold and relieve pain, and guide fire back to its source. Epimedium excels at tonifying the kidneys and strengthening yang; modern pharmacology shows it can enhance the secretory function of the hypothalamus-pituitary-gonadal axis. The combination of these two herbs tonifies kidney yang deficiency, assists in the restoration of qi transformation, and guides deficient fire back to its source, serving as the principal herbs. Traditional Chinese medicine believes that the kidneys are the organ of water and fire, containing primordial yin and primordial yang, with yin and yang mutually generating and rooting each other. Therefore, it is said that "those who are good at tonifying yang must seek yang within yin, so that yang receives the assistance of yin, and its generation and transformation are endless." Thus, the formula heavily uses Rehmannia glutinosa to nourish yin and tonify the kidneys, combined with Dioscorea opposita and Cornus officinalis to tonify the liver and spleen and nourish essence and blood, serving as the assistant herbs. This formula differs from the norm, with the principal herbs used in small, mild doses while the assistant herbs are used in larger, heavier doses, to invigorate kidney qi, truly embodying the principle that yang receives the assistance of yin, and its generation and transformation are endless. The formula contains Dioscorea hypoglauca, which promotes diuresis and separates clear from turbid fluids, making it a key herb for treating leukorrhea. Acorus tatarinowii, pungent, fragrant, bitter, and warm, transforms dampness and turbidity to enhance the effects of Dioscorea hypoglauca. Alpinia oxyphylla tonifies the kidneys and strengthens yang; its astringent nature is used to warm the kidneys and spleen, reduce urination, and stop seminal emission. Lindera strychnifolia warms the kidneys, dispels cold, removes cold qi from the bladder, and treats frequent urination. Gardenia jasminoides, bitter and cold, clears and descends, effectively clearing heat from the three jiaos, purging heart fire and relieving irritability, and also effectively clearing damp-heat from the lower jiao to promote urination. Achyranthes bidentata invigorates blood and removes blood stasis, tonifies the liver and kidneys, promotes urination, and further enhances... The combination of these eight herbs—cinnamon, turmeric, and lychee seed—is a powerful remedy for chronic prostatitis. Turmeric, with its pungent and dispersing properties, invigorates blood and qi, effectively treating pain caused by blood stasis. Its pungent, cold, and bitter nature enters the liver and heart meridians, relieving liver stagnation and opening the orifices, while also clearing the heart and relieving irritability. Lychee seed, with its pungent, warm, and bitter nature, enters the liver and stomach meridians, relieving liver stagnation, regulating qi, and alleviating pain, as well as dispelling cold and relieving pain. These eight herbs work together as adjuvants, assisting the principal and assistant herbs in tonifying the kidneys, strengthening yang, and promoting diuresis. They also promote diuresis, eliminate dampness and turbidity, invigorate blood, remove blood stasis, regulate qi, relieve pain, soothe the liver, relieve stagnation, and clear the heart and relieve irritability. The combined effects of these herbs fully leverage the advantages of traditional Chinese medicine, including "treatment based on evidence," "medication based on treatment principles," "multiple effects from one herb," ​​and "synergistic enhancement," comprehensively covering the fundamental causes and pathogenesis of chronic prostatitis at different stages of the disease. They also provide treatment and prevention for the four major symptom clusters, addressing their presence and preventing their absence.

[0019] By adopting the above technical solution, the present invention has the following beneficial effects compared with the prior art.

[0020] The traditional Chinese medicine composition provided by this invention has the effects of tonifying the kidney and strengthening yang, promoting diuresis and eliminating turbidity, soothing the liver and regulating qi, and promoting blood circulation and relieving pain. It can be used to treat chronic prostatitis and effectively relieve the four major clinical symptom groups of chronic prostatitis.

[0021] (1) Pain: Pain in the perineum, testicles, pubic area, penis, urethra, perianal area, groin, lumbosacral region, etc.;

[0022] (2) Lower urinary tract symptoms: urinary frequency, urgency, dysuria, incomplete emptying of the bladder, weak urine stream, urinary hesitancy, thin urine stream, urethral discharge, etc.

[0023] (3) Mental and psychological disorders: Anxiety, depression, insomnia, memory loss, etc. related to this disease;

[0024] (4) Sexual dysfunction: erectile dysfunction and premature ejaculation.

[0025] This invention is based on the theory of disease differentiation and treatment, and can be used without syndrome differentiation, and can achieve outstanding clinical efficacy, which is more in line with the actual clinical use of traditional Chinese medicine preparations.

[0026] The specific embodiments of the present invention will be described in further detail below. Detailed Implementation

[0027] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments will be clearly and completely described below. The following embodiments are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0028] Example 1

[0029] (1) According to the proportions shown in Example 1 in Table 1, mix and decoct the various Chinese herbal raw materials. Use a clay pot as a container, add an appropriate amount of water, and decoct twice, each time for 30 minutes. Mix the resulting Chinese herbal decoctions together. The weight ratio of the Chinese herbal mixture to water is 1:1, both times. (1:1-1.5 can achieve the same effect. The ratio of the Chinese herbal mixture to water has no effect on the efficacy, but the minimum amount of water is required to ensure that the Chinese herbal mixture can always be boiling during the 30-minute decoction process. The amount of water can be slightly more, but not less. It is necessary to take all the decoctions as required. For patients who also have other diseases that are not suitable for drinking too much water at one time, choose a 1:1 ratio if possible.)

[0030] (2) Divide all the Chinese herbal decoctions obtained in (1) into two equal portions and take them warm half an hour before breakfast and dinner. Example 1 is more suitable for patients with milder symptoms and shorter disease course.

[0031] Example 2

[0032] Similar to Example 1, the difference lies in the formulation of each Chinese herbal medicine ingredient, as shown in Example 2 in Table 1. Example 2 is more suitable for patients with more severe conditions and longer disease courses.

[0033] Example 3

[0034] Similar to Example 1, the difference lies in the formulation of each Chinese herbal medicine ingredient, as shown in Example 3 in Table 1. Example 3 is more suitable for patients with more severe conditions and longer disease courses.

[0035] Table 1. Ingredient Combinations for Each Example

[0036] King drug (2) Cinnamon 3 4 6 Epimedium 10 12 15 Ministerial drug (3) Prepared Rehmannia Root 20 24 30 Common Yam Rhizome 10 12 15 Asiatic Cornelian Cherry Fruit 10 12 15 Assistant and guiding drug (8) Dioscorea Hypoglauca Rhizome 10 12 15 Acorus Tatarinowii Rhizome 10 12 15 Alpinia Oxyphylla Fruit 10 12 15 Lindera Aggregata Root-bark 10 12 15 Gardenia Fruit 6 10 12 Achyranthes Bidentata Root 10 12 15 Curcuma Aromatica Salisb 6 10 12 Semen Litchi 6 10 12

[0037] The clinical effects of Examples 1-3 are not significantly different, and all can exert the following effects: tonifying the kidney and assisting yang, promoting diuresis and eliminating turbidity, soothing the liver and regulating qi, and promoting blood circulation and relieving pain.

[0038] Effect verification

[0039] This invention has been under development since 2011, undergoing annual clinical validation. Adhering to the principle of identifying and solving problems, it fully leverages the "one drug, multiple effects" and "reduced toxicity, increased efficacy" effects, minimizing the number of medicinal ingredients while ensuring the formula's rationale and efficacy. Incorporating new clinical experience and discoveries, the version has been continuously optimized, undergoing three iterations by 2020 to form the traditional Chinese medicine composition version of this invention. These three generations of versions have progressively reduced the number of medicinal ingredients, resulting in a more comprehensive coverage of the four major symptom groups of chronic prostatitis. Clinical observation data are as follows.

[0040] 1. First-generation version

[0041] 1.1 By weight, the traditional Chinese medicine composition includes the following components: 6 parts of prepared aconite root, 10 parts of cinnamon twig, 30 parts of prepared rehmannia root, 15 parts of yam, 15 parts of cornus officinalis, 15 parts of poria cocos, 15 parts of alisma plantago-aquatica, 10 parts of peony bark, 15 parts of achyranthes bidentata, 10 parts of plantain seed, 15 parts of alpinia oxyphylla, 15 parts of lindera root, 15 parts of dioscorea hypoglauca, 15 parts of acorus tatarinowii, 12 parts of gardenia fruit, 12 parts of turmeric, 12 parts of litchi seed, and 12 parts of salted tangerine seed.

[0042] 1.2 Statistical Period

[0043] October 2011 - September 2014

[0044] 1.3 Statistical objects (hereinafter the same):

[0045] Patients who visited the outpatient or inpatient department of the Department of Traditional Chinese Medicine at the Seventh Medical Center of the PLA General Hospital during the aforementioned period, whose diagnoses included chronic prostatitis, and who used this traditional Chinese medicine regimen.

[0046] 1.4 Criteria and methods for evaluating efficacy (hereinafter the same):

[0047] 1.4.1 Routine examination of prostatic fluid: Under high magnification, the average value of three randomly selected fields of view is calculated as follows: WBC count <10 / HP is (-), 10-19 / HP is (+), 20-29 / HP is (++), 30-49 / HP is (+++), and >50 / HP is (++++), scored as 0, 1, 2, 3, and 4 points respectively. SPL count >40 / HP is (++++), 30-39 / HP is (+++), 20-29 / HP is (++), 10-19 / HP is (+), and <10 / HP is "few," scored as 4, 3, 2, 1, and 0 points respectively.

[0048] 1.4.2 The TCM syndrome scoring system was based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs." Symptoms included pain, urinary symptoms, sexual dysfunction, mental symptoms, and general condition. Primary symptoms were graded into four levels based on severity: none, mild, moderate, and severe, scored as 0, 3, 6, and 9 points respectively. Secondary symptoms were also graded into four levels based on severity: none, mild, moderate, and severe, scored as 0, 2, 4, and 6 points respectively, for a total score of 0–42 points. The degree of decrease in syndrome score was calculated as (pre-treatment score - post-treatment score) / pre-treatment score × 100%.

[0049] 1.4.3 Efficacy Evaluation Criteria

[0050] (1) Cured: Pain or urination symptoms completely disappear, no tenderness in the prostate upon digital rectal examination, prostate fluid score of 0 or a decrease of ≥75%, and TCM syndrome score decrease of ≥90%. (2) Significant: Pain or urination symptoms significantly improve, prostate tenderness significantly improves upon digital rectal examination, 60% ≤ prostate fluid score decrease of <75%, 70% ≤ TCM syndrome score decrease of <90%. (3) Improved: Pain or urination symptoms are somewhat relieved, prostate tenderness is somewhat relieved upon digital rectal examination, 25% ≤ prostate fluid score decrease of <60%, 30% ≤ TCM syndrome score decrease of <70%. (4) Ineffective: Pain or urination symptoms are not significantly relieved, prostate tenderness is present upon digital rectal examination, prostate fluid score decrease of <25%, and TCM syndrome score decrease of <30%. Total effective rate = (number of cured cases + number of significantly improved cases + number of improved cases) / total number of cases × 100%.

[0051] 1.5. Usage Instructions (hereinafter the same)

[0052] Prepare the traditional Chinese medicine decoction according to the method required in Example 1, and administer it to the patient. One course of treatment lasts for 6 weeks.

[0053] 1.6. Precautions (the same applies below)

[0054] (1) This medicine is contraindicated for patients who are allergic to any of the ingredients in the oral Chinese medicine formula of this invention.

[0055] (2) During the use of this plan, avoid using other traditional Chinese medicine preparations, decoctions or granules at the same time. If you take other Western medicines at the same time, you need to take them at least 1 hour apart.

[0056] (3) Note that the present invention should be taken half an hour before meals.

[0057] 1.7. Statistical Analysis of Clinical Outcome Data

[0058] The treatment results for chronic prostatitis are shown in Table 2:

[0059] Table 2

[0060] 277 186 58 20 13 95.31% 0 0

[0061] Note: The results above show that the first-generation formula of this invention, based on disease differentiation, achieved a very satisfactory efficacy rate in treating chronic prostatitis, verifying the feasibility and effectiveness of using modified classical formulas to treat chronic prostatitis based on disease differentiation according to the evolution of etiology and pathogenesis. By adhering to the evolution of etiology and pathogenesis, rationally modifying the formula, and fully utilizing its "multi-effect" properties, the first-generation formula was optimized, resulting in a new version, and even a new generation of "disease-differentiated classical formulas." Based on this, the first-generation formula was further optimized to form the second-generation version.

[0062] 2. Second-generation version

[0063] 2.1 By weight, the traditional Chinese medicine composition comprises the following components: 6 parts of prepared aconite root, 10 parts of cinnamon twig, 30 parts of prepared rehmannia root, 15 parts of yam, 15 parts of cornus officinalis, 15 parts of achyranthes bidentata, 15 parts of alpinia oxyphylla, 15 parts of lindera root, 15 parts of dioscorea hypoglauca, 15 parts of acorus tatarinowii, 12 parts of gardenia fruit, 12 parts of turmeric, 12 parts of litchi seed, and 12 parts of salted tangerine seed.

[0064] 2.2 Statistical Period

[0065] October 2014 - September 2020

[0066] 2.3 Statistical subjects (same as above):

[0067] Patients who visited the outpatient or inpatient department of the Department of Traditional Chinese Medicine at the Seventh Medical Center of the PLA General Hospital during the aforementioned period, whose diagnoses included chronic prostatitis, and who used this traditional Chinese medicine regimen.

[0068] 2.4 Criteria and methods for evaluating efficacy (same as above):

[0069] 2.5. Usage method (same as above)

[0070] 2.6. Precautions (same as above)

[0071] 2.7. Statistical Analysis of Clinical Outcome Data

[0072] The treatment results for chronic prostatitis are shown in Table 3:

[0073] Table 3

[0074] 386 249 98 22 17 95.60% 0 0

[0075] Note: After rational modification of the first-generation Chinese medicine composition, its efficacy in treating chronic prostatitis was comparable to, and slightly improved from, that of the first-generation version, indicating that the optimization of the second-generation version was very successful. Prepared aconite is the primary medicine for tonifying Yang, but it is toxic. Modern pharmacology reveals it contains various aconitine compounds, exhibiting strong toxicity, especially cardiotoxicity. Although no adverse reactions occurred during the use of the first and second generations, "reducing toxicity and increasing efficacy" is a principle adhered to in this invention while ensuring efficacy. Through literature review and clinical practice, cinnamon and epimedium, with their milder and longer-lasting effects, were selected to replace prepared aconite and cinnamon twig. This still allows the traditional Chinese medicine advantage of "seeking Yang within Yin" to be utilized. When using this formula, the salted tangerine seed is removed, better leveraging the effects of turmeric combined with litchi seed to soothe the liver, relieve depression, regulate Qi, and alleviate pain; turmeric combined with achyranthes root to promote Qi circulation, invigorate blood, and remove blood stasis; and achyranthes root combined with cinnamon to guide fire back to its source. This further optimizes the third-generation version.

[0076] 3. Third-generation version

[0077] 3.1 The third-generation version is the combination ratio in Example 1.

[0078] 3.2 Statistical Period

[0079] October 2020 - March 2024

[0080] 3.3 Statistical Objects:

[0081] Patients who visited the outpatient or inpatient department of the Department of Traditional Chinese Medicine at the Seventh Medical Center of the PLA General Hospital during the aforementioned period, whose diagnoses included chronic prostatitis, and who used this traditional Chinese medicine regimen.

[0082] 3.4 Efficacy assessment criteria and methods (same as above):

[0083] 3.5. Usage method (same as above)

[0084] 3.6. Precautions (same as above)

[0085] 3.7. Statistical Analysis of Clinical Outcome Data

[0086] The treatment results for chronic prostatitis are shown in Table 4:

[0087] Table 4

[0088] 167 129 23 9 6 96.41% 0 0

[0089] Note: After nearly 10 years of continuous practice and optimization, the third-generation Chinese medicine composition (i.e. the composition of this invention) is superior to the classic prescriptions, forming a new prescription meaning and becoming a brand-new Chinese medicine composition scheme. More importantly, it is based on the theory of disease differentiation and treatment in traditional Chinese medicine, which is more in line with the actual clinical treatment of chronic prostatitis, and its clinical effect has reached a satisfactory level.

[0090] 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 chronic prostatitis based on disease differentiation, characterized in that, It is composed of the following Chinese medicinal materials in parts by weight: cinnamon 3-6 parts, epimedium 10-15 parts, prepared rehmannia root 20-30 parts, yam 10-15 parts, cornus officinalis 10-15 parts, dioscorea hypoglauca 10-15 parts, acorus tatarinowii 10-15 parts, alpinia oxyphylla 10-15 parts, lindera strychnifolia 10-15 parts, gardenia 6-12 parts, achyranthes bidentata 10-15 parts, turmeric 6-12 parts, and litchi seed 6-12 parts.

2. The traditional Chinese medicine composition for treating chronic prostatitis according to claim 1, characterized in that, It is composed of the following Chinese medicinal materials in the indicated weight proportions: 6 parts cinnamon, 15 parts epimedium, 30 parts prepared rehmannia root, 15 parts yam, 15 parts cornus officinalis, 15 parts dioscorea hypoglauca, 15 parts acorus tatarinowii, 15 parts alpinia oxyphylla, 15 parts lindera root, 12 parts gardenia, 15 parts achyranthes bidentata, 12 parts turmeric, and 12 parts litchi seed.

3. A drug for treating chronic prostatitis based on disease differentiation, characterized in that, The raw materials are made from the traditional Chinese medicine composition as described in claim 1 or 2.

4. The drug according to claim 3, characterized in that, The drug also includes pharmaceutically acceptable excipients.

5. The drug according to claim 4, characterized in that, The excipients include excipients.

6. The drug according to claim 5, characterized in that, The excipient is honey.

7. The drug according to claim 6, characterized in that, The dosage form of the drug is decoction, tablets, pills, granules, or capsules.