Traditional Chinese medicine composition for treating chronic central serous chorioretinopathy

Abstract

The application discloses a traditional Chinese medicine composition for treating chronic central serous chorioretinopathy. The traditional Chinese medicine composition is composed of Baizhu, Fuling, Zhuling, Zelan, Dangshen, Suanzaoren, Shanyao and Sharen, and has the effects of invigorating the spleen, removing dampness, dredging water passages and strengthening body resistance to eliminate pathogenic factors. Clinical test research shows that the traditional Chinese medicine composition can obviously improve the vision of patients with chronic central serous chorioretinopathy, promote the absorption of subretinal fluid, has a low recurrence rate and good safety.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine. Specifically, this invention relates to a traditional Chinese medicine composition and preparation for treating chronic central serous chorioretinopathy. Background Technology

[0002] Central serous chorioretinopathy (CSCR) is a common chorioretinal disease that primarily affects young and middle-aged men. Its clinical features include serous retinal neuroepithelial detachment, typically involving the macular region.

[0003] The etiology and pathogenesis of CSCR are not yet fully understood. It is currently believed that dysfunction of the retinal pigment epithelium (RPE) barrier and increased choroidal vascular permeability lead to the accumulation of subretinal fluid (SRF) and detachment of the retinal pigment epithelium.

[0004] CSCR is further divided into acute and chronic types. Most acute CSCR is self-limiting, with SRF resolving spontaneously within a few months and a good prognosis. About 15% of patients develop chronic CSCR after a disease course of 3-6 months or more. Chronic CSCR patients may experience RPE and secondary damage to photoreceptors, and even secondary choroidal neovascularization, leading to permanent visual impairment.

[0005] Currently, there are no established treatment guidelines or protocols for chronic CSCR. Although recent studies have shown that half-dose verteporfin photodynamic laser therapy (vPDT) can promote SRF absorption and improve vision in patients with chronic CSCR, most hospitals are unable to perform this treatment because it requires a specialized laser. Furthermore, verteporfin is not yet approved for the treatment of CSCR and is relatively expensive.

[0006] According to existing TCM theory, chronic cervical spondylosis (CSCR) falls under the category of visual impairment. The term first appeared in the *Zheng Zhi Zhun Sheng* (Standards of Diagnosis and Treatment), specifically in the section on miscellaneous diseases and the seven orifices. Its etiology and pathogenesis are often related to excessive thinking, internal damage to the spleen, spleen qi deficiency, impaired spleen function, and the upward flow of dampness to the eyes. TCM treatment for CSCR has shown good efficacy in clinical practice, offering advantages such as low cost, improvement of overall symptoms, and good patient compliance. However, current TCM therapies for chronic CSCR lack clinically proven safe and effective drugs. Summary of the Invention

[0007] Therefore, the purpose of this invention is to provide a traditional Chinese medicine composition and preparation for the effective treatment of chronic central serous chorioretinopathy.

[0008] In a first aspect, the invention provides a traditional Chinese medicine composition for effectively treating chronic central serous chorioretinopathy, the composition being made from the following raw materials in the indicated weight ratios: Atractylodes macrocephala 5-12g, Poria cocos 5-15g, Polyporus umbellatus 5-12g, Lycopus lucidus 10-15g, Codonopsis pilosula 5-30g, Ziziphus jujuba var. spinosa 5-15g, Dioscorea opposita 10-30g, and Amomum villosum 3-6g.

[0009] Preferably, the traditional Chinese medicine composition is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 10g, Poria cocos 10g, Polyporus umbellatus 6g, Lycopus lucidus 10g, Codonopsis pilosula 10g, Ziziphus jujuba var. spinosa 10g, Dioscorea opposita 10g, and Amomum villosum 5g.

[0010] Preferably, the traditional Chinese medicine composition is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 10g, Poria cocos 10g, Polyporus umbellatus 10g, Lycopus lucidus 10g, Codonopsis pilosula 15g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 15g, and Amomum villosum 5g.

[0011] Preferably, the traditional Chinese medicine composition is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 12g, Poria cocos 15g, Polyporus umbellatus 12g, Lycopus lucidus 15g, Codonopsis pilosula 30g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 30g, and Amomum villosum 6g.

[0012] Preferably, the traditional Chinese medicine composition is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 12g, Poria cocos 15g, Polyporus umbellatus 10g, Lycopus lucidus 10g, Codonopsis pilosula 20g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 20g, and Amomum villosum 6g.

[0013] Preferably, the traditional Chinese medicine composition is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 10g, Poria cocos 10g, Polyporus umbellatus 10g, Lycopus lucidus 10g, Codonopsis pilosula 10g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 10g, and Amomum villosum 5g.

[0014] Preferably, the traditional Chinese medicine composition is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 5g, Poria cocos 5g, Polyporus umbellatus 5g, Lycopus lucidus 10g, Codonopsis pilosula 5g, Ziziphus jujuba var. spinosa 5g, Dioscorea opposita 10g, and Amomum villosum 3g.

[0015] More preferably, the traditional Chinese medicine composition may further include licorice to harmonize the various medicines, and the weight ratio of licorice added is 1.5g-9g.

[0016] In a second aspect, the invention provides a traditional Chinese medicine preparation for effectively treating chronic central serous chorioretinopathy. The preparation is made as follows: Take the raw materials of the aforementioned traditional Chinese medicine composition by weight, add 500-800 ml of water, and soak for 30-60 minutes; First decoction: heat to a boil over high heat, then reduce to a simmer and cook for another 20-30 minutes, filtering while hot to obtain the liquid; Second decoction: add 400-600 ml of water to the dregs, bring to a boil over high heat, then reduce to a simmer and cook for another 15-20 minutes, filtering while hot to obtain the liquid; combine the two decoctions, approximately 400 ml, to obtain the traditional Chinese medicine preparation of the invention; If necessary, a third decoction can be performed: combine the first two decoctions, heat and concentrate to 400 ml to obtain the traditional Chinese medicine preparation of the invention.

[0017] In a third aspect, the invention provides a traditional Chinese medicine preparation for the effective treatment of chronic central serous chorioretinopathy, wherein the traditional Chinese medicine composition of the invention is prepared into any pharmaceutically acceptable dosage form, such as capsules, tablets, oral liquids, granules, powders, pills, drop pills, syrups, or mixtures.

[0018] To enable the above dosage forms to be realized, various pharmaceutically acceptable excipients, such as fillers, preservatives, flavoring agents, disintegrants, and matrices, need to be added during the preparation of these dosage forms.

[0019] In a fourth aspect of the invention, a method for preparing a traditional Chinese medicine preparation for effectively treating chronic central serous chorioretinopathy is provided. The method for preparing the traditional Chinese medicine preparation is as follows: Take the above-mentioned weight of the raw materials of the aforementioned traditional Chinese medicine composition, add 500-800 ml of water, and soak for 30-60 minutes; First decoction: Heat to a boil over high heat, then reduce to low heat and simmer for 20-30 minutes, filter while hot to retain the liquid; Second decoction: Add 400-600 ml of water to the dregs, bring to a boil over high heat, then reduce to low heat and simmer for 15-20 minutes, filter while hot to retain the liquid, combine the two liquids, approximately 400 ml; Third decoction if necessary: ​​Combine the first two liquids, heat and concentrate to 400 ml.

[0020] In a fifth aspect of the invention, the invention provides the use of a traditional Chinese medicine composition for preparing a traditional Chinese medicine preparation for treating chronic central serous chorioretinopathy, wherein the traditional Chinese medicine composition is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 10g, Poria cocos 10g, Polyporus umbellatus 6g, Lycopus lucidus 10g, Codonopsis pilosula 10g, Ziziphus jujuba var. spinosa 10g, Dioscorea opposita 10g, and Amomum villosum 5g.

[0021] Preferably, the traditional Chinese medicine composition is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 10g, Poria cocos 10g, Polyporus umbellatus 10g, Lycopus lucidus 10g, Codonopsis pilosula 15g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 15g, and Amomum villosum 5g.

[0022] Preferably, the traditional Chinese medicine composition is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 12g, Poria cocos 15g, Polyporus umbellatus 12g, Lycopus lucidus 15g, Codonopsis pilosula 30g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 30g, and Amomum villosum 6g.

[0023] Preferably, the traditional Chinese medicine composition is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 12g, Poria cocos 15g, Polyporus umbellatus 10g, Lycopus lucidus 10g, Codonopsis pilosula 20g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 20g, and Amomum villosum 6g.

[0024] Preferably, the traditional Chinese medicine composition is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 10g, Poria cocos 10g, Polyporus umbellatus 10g, Lycopus lucidus 10g, Codonopsis pilosula 10g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 10g, and Amomum villosum 5g.

[0025] Preferably, the traditional Chinese medicine composition is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 5g, Poria cocos 5g, Polyporus umbellatus 5g, Lycopus lucidus 10g, Codonopsis pilosula 5g, Ziziphus jujuba var. spinosa 5g, Dioscorea opposita 10g, and Amomum villosum 3g.

[0026] More preferably, the traditional Chinese medicine composition may further include licorice to harmonize the various medicines, and the weight ratio of licorice added is 1.5g-9g.

[0027] In a sixth aspect of the invention, the invention provides the use of a traditional Chinese medicine composition for preparing a traditional Chinese medicine preparation for treating chronic central serous chorioretinopathy, wherein the preparation is made by formulating the traditional Chinese medicine composition of the invention into any pharmaceutically acceptable dosage form, such as capsules, tablets, oral liquids, granules, powders, pellets, pills, drop pills, syrups, or mixtures.

[0028] In a seventh aspect of the invention, the invention provides the use of a traditional Chinese medicine composition and / or a traditional Chinese medicine preparation based on the traditional Chinese medicine composition in the preparation of a medicament for treating chronic central serous chorioretinopathy.

[0029] Preferably, when the traditional Chinese medicine composition and / or preparation of the present invention are used in the treatment of chronic central serous chorioretinopathy, one dose may be taken daily, 200 ml orally each time, divided into morning and evening doses. One month constitutes one course of treatment.

[0030] The medicinal properties and effects of each raw material in the traditional Chinese medicine composition of the present invention are as follows:

[0031] Atractylodes macrocephala: Sweet, bitter, and warm. It enters the spleen and stomach meridians. It invigorates qi and strengthens the spleen, dries dampness and promotes urination, stops sweating, and calms the fetus. It is hailed as "the foremost medicine for invigorating qi and strengthening the spleen." This herb excels at both invigorating qi to restore spleen function and drying dampness to eliminate dampness. The *Compendium of Materia Medica* states, "Among medicines for invigorating the spleen and stomach, none surpasses it."

[0032] Poria cocos: Sweet, bland, and neutral in nature. It enters the heart, spleen, and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. Poria cocos promotes diuresis without harming the body's vital energy, making it an essential herb for reducing swelling. It can be used to treat various types of edema, including those caused by cold, heat, deficiency, or excess.

[0033] Polyporus umbellatus: Sweet, bland, and neutral. It enters the kidney and bladder meridians. It promotes diuresis and eliminates dampness. Polyporus umbellatus has a descending nature and is good at clearing the water passages; it is used for various types of edema caused by water retention.

[0034] Eupatorium fortunei: Bitter, pungent, slightly warm. It enters the liver and spleen meridians. It promotes diuresis and reduces swelling, invigorates blood circulation and regulates menstruation. This herb can both invigorate blood circulation and remove blood stasis, and also promote diuresis and reduce swelling, making it particularly effective for edema caused by the mutual obstruction of water and blood stasis.

[0035] Codonopsis pilosula: Sweet, neutral. Enters the spleen and lung meridians. Tonifies spleen qi, lung qi, and blood and fluids. Used for spleen and lung qi deficiency syndrome. According to *Ben Cao Zheng Yi* (Correct Interpretation of Materia Medica): "It tonifies the spleen and stomach, moistens the lungs and generates fluids, and strengthens the middle qi."

[0036] Sour jujube seed: sweet, sour, and neutral in nature. It enters the heart, liver, and gallbladder meridians. It nourishes the heart and liver, calms the mind, reduces sweating, and promotes the production of body fluids. It is an essential medicine for nourishing the heart and calming the mind.

[0037] Yam: Sweet, neutral. It enters the spleen, lung, and kidney meridians. It benefits qi and nourishes yin, tonifying the spleen, lungs, and kidneys. Specifically, it tonifies spleen qi and nourishes spleen yin; it also tonifies lung qi and nourishes lung yin; and it tonifies kidney qi and nourishes kidney yin. The Compendium of Materia Medica states: "It benefits kidney qi and strengthens the spleen and stomach."

[0038] Amomum villosum: pungent, warm. It enters the spleen, stomach, and kidney meridians. It resolves dampness, promotes qi circulation, warms the middle jiao, and stops diarrhea. This herb is pungent, dispersing, and warming, with a fragrant aroma. It excels in resolving dampness, invigorating the spleen, promoting qi circulation, and warming the middle jiao, making it "an essential medicine for invigorating the spleen and regulating the stomach."

[0039] Licorice: Sweet, neutral. It enters the heart, lung, spleen, and stomach meridians. It tonifies the spleen and replenishes qi, eliminates phlegm and relieves cough, alleviates spasms and pain, clears heat and detoxifies, and harmonizes the effects of other herbs.

[0040] Therapeutic mechanism of this invention:

[0041] In this formula, Atractylodes macrocephala is the principal herb. It strengthens the spleen to promote the transformation and transportation of fluids. The *Ben Cao Tong Xuan* states that Atractylodes macrocephala is "the best herb for tonifying the spleen and stomach. When the earth element is strong, it can overcome dampness; therefore, those suffering from phlegm retention and edema rely on it." It is hailed as "the foremost herb for tonifying the spleen and strengthening its function," excelling not only in tonifying qi and strengthening the spleen to restore its function, but also in drying dampness and promoting urination to eliminate dampness. Codonopsis pilosula tonifies the spleen qi and strengthens the middle qi; Poria cocos promotes urination, eliminates dampness, strengthens the spleen, and calms the mind; Polyporus umbellatus has a descending nature and promotes urination; Lycopus lucidus promotes urination, reduces swelling, invigorates blood, and removes blood stasis; Amomum villosum transforms dampness and promotes qi circulation. Together, they form the assistant herbs. Dioscorea opposita benefits qi and nourishes yin, assisting Codonopsis pilosula and Atractylodes macrocephala in tonifying the spleen and qi, and also nourishing the yin of the spleen and kidneys; Ziziphus jujuba var. spinosa is sour and astringent, nourishing the heart yin and benefiting liver blood. The combination of these two herbs prevents the diuretic effect from damaging yin, thus serving as the adjuvant herb. Glycyrrhiza uralensis harmonizes all the herbs, serving as the guiding herb. The combined effects of these herbs strengthen the spleen, promote diuresis, facilitate urination, support the body's resistance to pathogens, and promote urination without harming the body's vital energy. The entire formula embodies the holistic diagnostic philosophy of traditional Chinese medicine, which seeks to treat the root cause of disease and addresses both the symptoms and the underlying cause.

[0042] The traditional Chinese medicine composition of this invention has the effects of strengthening the spleen and removing dampness, promoting water metabolism, and supporting the body's resistance to pathogens in the treatment of chronic central serous chorioretinopathy (CSCR). It can significantly improve the vision of CSCR patients, promote the absorption of subretinal fluid, and has good safety. Attached image description:

[0043] Figure 1 Comparison of mean LogMAR best corrected visual acuity (BCVA) of the affected eye before and after treatment

[0044] Figure 2 Comparison of mean foveal retinal thickness (CSRT) before and after treatment in the affected eye Detailed Implementation

[0045] The present invention will be further illustrated below with reference to embodiments, clinical trial data, and case studies:

[0046] Example 1:

[0047] A traditional Chinese medicine preparation for treating chronic central serous chorioretinopathy is composed of the following herbs: Atractylodes macrocephala 10g, Poria cocos 10g, Polyporus umbellatus 6g, Lycopus lucidus 10g, Codonopsis pilosula 10g, Ziziphus jujuba var. spinosa 10g, Dioscorea opposita 10g, and Amomum villosum 5g. Take the above-mentioned weights of raw herbs and add 500ml of water, soaking for 30 minutes. First decoction: Heat to a boil over high heat, then simmer over low heat for 20 minutes, filter while hot, and retain the liquid. Second decoction: Add 400ml of water to the dregs, bring to a boil over high heat, then simmer over low heat for 15 minutes, filter while hot, and retain the liquid. Combine the two decoctions, approximately 400ml. Third decoction: If necessary, combine the two decoctions and heat to concentrate to 400ml. One dose per day, 200ml orally each time, divided into morning and evening doses. One month constitutes one course of treatment.

[0048] Example 2:

[0049] A traditional Chinese medicine preparation for treating chronic central serous chorioretinopathy is composed of the following herbs: Atractylodes macrocephala 10g, Poria cocos 10g, Polyporus umbellatus 10g, Lycopus lucidus 10g, Codonopsis pilosula 15g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 15g, and Amomum villosum 5g. Take the above-mentioned weights of raw herbs and add 600ml of water, soaking for 30 minutes. First decoction: Heat to a boil over high heat, then reduce to a simmer and cook for another 20 minutes. Filter while hot and retain the liquid. Second decoction: Add 400ml of water to the dregs, bring to a boil over high heat, then reduce to a simmer and cook for another 15 minutes. Filter while hot and retain the liquid. Combine the two decoctions, approximately 400ml. Third decoction: If necessary, combine the two decoctions and heat to concentrate to 400ml. One dose per day, 200ml orally each time, divided into morning and evening doses. One month constitutes one course of treatment.

[0050] Example 3:

[0051] A traditional Chinese medicine preparation for treating chronic central serous chorioretinopathy is composed of the following herbs: Atractylodes macrocephala 12g, Poria cocos 15g, Polyporus umbellatus 12g, Lycopus lucidus 15g, Codonopsis pilosula 30g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 30g, and Amomum villosum 6g. Take the above-mentioned weights of raw herbs and add 800ml of water, soaking for 30 minutes. First decoction: Heat to a boil over high heat, then simmer over low heat for 20 minutes, filter while hot, and retain the liquid. Second decoction: Add 600ml of water to the dregs, bring to a boil over high heat, then simmer over low heat for 15 minutes, filter while hot, and retain the liquid. Combine the two decoctions, approximately 400ml. Third decoction: If necessary, combine the two decoctions and heat to concentrate to 400ml. One dose per day, 200ml orally each time, divided into morning and evening doses. One month constitutes one course of treatment.

[0052] Example 4:

[0053] A traditional Chinese medicine preparation for treating chronic central serous chorioretinopathy is composed of the following herbs: Atractylodes macrocephala 12g, Poria cocos 15g, Polyporus umbellatus 10g, Lycopus lucidus 10g, Codonopsis pilosula 20g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 20g, and Amomum villosum 6g. Take the above-mentioned weights of raw herbs and add 600ml of water, soaking for 30 minutes. First decoction: Heat to a boil over high heat, then simmer over low heat for 20 minutes, filter while hot, and retain the liquid. Second decoction: Add 500ml of water to the dregs, bring to a boil over high heat, then simmer over low heat for 15 minutes, filter while hot, and retain the liquid. Combine the two decoctions, approximately 400ml. Third decoction: If necessary, combine the two decoctions and heat to concentrate to 400ml. One dose per day, 200ml orally each time, divided into morning and evening doses. One month constitutes one course of treatment.

[0054] Example 5:

[0055] A traditional Chinese medicine preparation for treating chronic central serous chorioretinopathy is composed of the following herbs: Atractylodes macrocephala 10g, Poria cocos 10g, Polyporus umbellatus 10g, Lycopus lucidus 10g, Codonopsis pilosula 10g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 10g, and Amomum villosum 5g. Take the above-mentioned weights of raw herbs and add 500ml of water, soaking for 30 minutes. First decoction: Heat to a boil over high heat, then simmer over low heat for 20 minutes, filter while hot, and retain the liquid. Second decoction: Add 400ml of water to the dregs, bring to a boil over high heat, then simmer over low heat for 15 minutes, filter while hot, and retain the liquid. Combine the two decoctions, approximately 400ml. Third decoction: If necessary, combine the two decoctions and heat to concentrate to 400ml. One dose per day, 200ml orally each time, divided into morning and evening doses. One month constitutes one course of treatment.

[0056] Example 6:

[0057] A traditional Chinese medicine preparation for treating chronic central serous chorioretinopathy is composed of the following herbs: Atractylodes macrocephala 5g, Poria cocos 5g, Polyporus umbellatus 5g, Lycopus lucidus 10g, Codonopsis pilosula 5g, Ziziphus jujuba var. spinosa 5g, Dioscorea opposita 10g, and Amomum villosum 3g. Take the above-mentioned weights of raw herbs and add 400ml of water, soaking for 30 minutes. First decoction: Heat to a boil over high heat, then simmer over low heat for 20 minutes, filter while hot, and retain the liquid. Second decoction: Add 300ml of water to the dregs, bring to a boil over high heat, then simmer over low heat for 15 minutes, filter while hot, and retain the liquid. Combine the two decoctions, approximately 400ml. Third decoction: If necessary, combine the two decoctions and heat to concentrate to 400ml. One dose per day, 200ml orally each time, divided into morning and evening doses. One month constitutes one course of treatment.

[0058] Example 7:

[0059] To verify the therapeutic effect of this invention, a clinical trial was conducted on patients with chronic central serous chorioretinopathy who visited the hospital between 2017 and 2019.

[0060] 1. Materials and Methods

[0061] 1.1 Diagnostic criteria:

[0062] (1) Blurred vision, central shadow, mild color vision abnormality or distorted vision, and objects appear smaller;

[0063] (2) Fundus examination revealed a discoid serous retinal bulge in the macular region;

[0064] (3) Optical coherence tomography (OCT) examination shows serous retinal neuroepithelial detachment or combined retinal pigment epithelial detachment in the macular area; fundus fluorescein angiography (FFA) examination shows diffuse REP damage area and patchy hyperfluorescence; indocyanine green angiography (ICGA) examination shows choroidal vascular dilation and increased permeability.

[0065] (4) The course of the disease is ≥6 months.

[0066] 1.2 Inclusion criteria:

[0067] (1) Meets the diagnostic criteria for chronic CSCR;

[0068] (2) Age ≥ 18 years and ≤ 60 years;

[0069] (3) Best corrected visual acuity (BCVA) ≥ 0.1;

[0070] (4) Follow-up period ≥ 6 months.

[0071] 1.3 Exclusion criteria:

[0072] (1) Individuals with severe liver or kidney dysfunction;

[0073] (2) Pregnant and lactating women;

[0074] (3) Individuals allergic to sodium fluorescein and / or indocyanine green;

[0075] (4) To study choroidal neovascularization (CNV) in the eye;

[0076] (5) Investigate any other eye diseases that may cause SRF accumulation, such as diabetic retinopathy, polypoid choroidal angiopathy, optic disc fovea, etc.

[0077] (6) To study other eye diseases that affect or may affect vision, such as glaucoma and pathological myopia;

[0078] (7) History of laser photocoagulation, PDT or intraocular injection of anti-vascular endothelial growth factor drugs.

[0079] 1.4 General Information:

[0080] Based on the diagnostic criteria and inclusion and exclusion criteria, a total of 33 patients with chronic central serous chorioretinopathy were included. Among them, 24 were male (72.7%) and 9 were female (27.3%). The age ranged from 34 to 57 years, with a mean age of 43.6 (±5.9) years. The duration of disease ranged from 6 to 60 months, with a median of 6 months.

[0081] 1.5 Treatment methods:

[0082] The herbal decoction prepared according to Example 1 was administered by decocting in water. Each dose was decocted to 400 ml, and 200 ml was taken orally twice daily, once in the morning and once in the evening. The medication was continued until the SRF was completely absorbed or for 3 months.

[0083] 1.6 Observation Indicators

[0084] 1.6.1 Best corrected visual acuity (BCVA) was tested using the international standard logarithmic visual acuity chart, and the test results were converted into minimum resolution angle logarithmic (LogMAR) visual acuity for statistical analysis.

[0085] 1.6.2 Central subfield retinal thickness (CSRT) was measured using a Zeiss Cirrus HD-OCT4000 microscope from Germany. Linear scans were performed on the lesion in both horizontal and vertical directions.

[0086] 1.6.3 Subretinal fluid absorption

[0087] 1.6.4 Recurrence Study: New subretinal fluid appeared after complete absorption of the subretinal fluid in the eye.

[0088] 1.6.5 Systemic and ocular adverse events (AEs) are recorded at any time during the follow-up period.

[0089] 1.7 Efficacy Criteria

[0090] 1.7.1 Visual acuity efficacy criteria: Improvement: BCVA improves by 2 lines or more; Stable: Visual acuity improves or decreases by 1 line or remains unchanged; Decline: Visual acuity decreases by 2 lines or more.

[0091] 1.7.2 Criteria for the efficacy of subretinal fluid treatment: Cured: Subretinal fluid is completely absorbed; Effective: Subretinal fluid is partially absorbed (CSRT decreases by >25% compared to before treatment); Ineffective: Subretinal fluid is not absorbed (CSRT changes by ≤25% compared to before treatment).

[0092] 1.8 Statistical Methods

[0093] Statistical analysis was performed using SPSS 17.0 software. Quantitative data conforming to a normal distribution were expressed as mean ± standard deviation; non-normally distributed data were described using median and interquartile ranges. Paired t-tests were used to compare differences before and after treatment. P < 0.05 was considered statistically significant.

[0094] 2. Results

[0095] 2.1 Changes in visual acuity before and after treatment

[0096] Before treatment, the mean LogMAR best-corrected visual acuity of the affected eye was 0.34±0.22. At 1, 2, 3, and 6 months after treatment, the mean LogMAR best-corrected visual acuity of the affected eye was 0.20±0.15, 0.19±0.18, 0.18±0.22, and 0.15±0.20, respectively, all showing significant improvement compared to before treatment (all P<0.001) (Table 1). The line graph showing the changes in mean LogMAR best-corrected visual acuity before and after treatment is shown below. Figure 1 .

[0097] Table 1. Comparison of best corrected visual acuity (BCVA) of LogMAR in the affected eye before and after treatment.

[0098]

[0099] 2.2 Comparison of visual efficacy after treatment

[0100] Six months after treatment, visual acuity improved in 20 eyes (60.6%) and remained stable in 13 eyes (39.4%) (Table 2).

[0101] Table 2 Comparison of visual acuity after treatment

[0102]

[0103]

[0104] 2.3 Changes in foveal retinal thickness (CSRT) before and after treatment

[0105] Before treatment, the mean CSRT of the affected eyes was (343.1±98.4) μm. At 1, 2, 3, and 6 months after treatment, the mean CSRTs of the affected eyes were (261.8±72.4) μm, (236.7±67.1) μm, (230.2±73.9) μm, and (216.7±61.7) μm, respectively. The mean CSRT of the affected eyes at each observation time point after treatment was significantly lower than that before treatment (all P < 0.001) (Table 3). The bar chart showing the changes in mean CSRT of the affected eyes before and after treatment is shown below. Figure 2 .

[0106] 2.4 Comparison of treatment efficacy in terms of foveal retinal thickness (CSRT)

[0107] Six months after treatment, subretinal fluid was completely absorbed in 28 of the 33 affected eyes, resulting in a cure rate of 84.8%. Two eyes (6.1%) showed a CSRT reduction of >25% (effective), while three eyes (9.1%) showed a CSRT change of ≤25% (ineffective) (Table 4). The overall effective rate was 90.9%.

[0108] Table 3 Comparison of mean CSRT (um) of the affected eye before and after treatment

[0109]

[0110] Table 4 Comparison of CSRT efficacy after treatment

[0111]

[0112] Recurrence: No recurrence was observed in any of the affected eyes during a 6-month follow-up period.

[0113] Systemic and ocular adverse events: No treatment-related adverse reactions or systemic and ocular adverse events were observed in the patients.

[0114] The present invention also uses other embodiments to treat patients with chronic central serous chorioretinopathy, as detailed in the following cases.

[0115] Case 1: Mr. Liu, male, 50 years old, consulted in June 2017. He had experienced blurred vision and smaller-looking objects in his right eye for 8 months. His current symptoms included fatigue and loose stools. Ophthalmological examination revealed a BCVA of 0.6 in the right eye. Fundus examination showed a clear optic disc margin, normal color, and discoid edema in the macular region. OCT examination showed serous retinal neuroepithelial detachment in the macular region; FFA examination showed multiple punctate hyperfluorescence; and ICGA examination showed choroidal vascular dilation and increased permeability. His tongue was pale and swollen with a white coating, and his pulse was soft and slow. He was treated according to Example 5 of this invention, one dose daily, decocted in water, 200ml each time, divided into morning and evening doses. After 14 doses, the patient reported a reduction in blurred vision in his right eye. Ophthalmological examination showed a BCVA of 0.6 in the right eye, reduced macular edema, and a decreased CSRT on OCT examination. His fatigue and loose stools also improved. After continuing the medication for 14 more doses, the BCVA in the right eye was 0.8, and the macular edema in the fundus was completely resolved. OCT examination showed complete absorption of subretinal fluid. One month later, the BCVA in the right eye was 1.0. No recurrence was observed during a one-year follow-up.

[0116] Case 2: Ms. Huang, female, 42 years old, consulted in January 2018. She had a fixed central shadow in her right eye for 18 months. Current symptoms included fatigue, loss of appetite, and poor sleep. Ophthalmological examination revealed a BCVA of 0.4 in the right eye. Fundus examination showed a clear optic disc margin, normal color, discoid edema in the macular region, and yellowish-white punctate lesions. OCT examination revealed serous retinal neuroepithelial detachment in the macular region; FFA examination revealed diffuse RPE damage and patchy hyperfluorescence; ICGA examination revealed choroidal vascular dilation and increased permeability. Her tongue was pale with a white coating, and her pulse was slow. She was treated according to Example 2 of this invention, one dose daily, decocted in water, 200ml each time, divided into morning and evening doses. After 14 doses, the patient reported a reduction in the central shadow in her right eye. Ophthalmological examination revealed a BCVA of 0.6 in the right eye, absorption of macular edema, and absorption of subretinal fluid on OCT examination. Her fatigue, loss of appetite, and sleep improved. After continuing the medication for 28 doses, the BCVA of the right eye was 0.8, the macular edema in the fundus was completely absorbed, and OCT examination showed complete absorption of subretinal fluid. One and a half months later, the BCVA of the right eye was 1.0. No recurrence was observed during a one-year follow-up.

[0117] Case 3: Mr. Li, male, 36 years old, consulted in March 2018. He had experienced a fixed, pale central shadow in his left eye for 6 months. His current symptom was fatigue. Ophthalmological examination: left eye BCVA 0.8; fundus examination showed a clear optic disc margin and normal color, with discoid edema in the macular region. OCT examination revealed serous retinal neuroepithelial detachment in the macular region; FFA examination showed punctate hyperfluorescence; ICGA examination showed choroidal vascular dilation and increased permeability. His tongue was pale with a white coating, and his pulse was slow. He was treated according to Example 6 of this invention, one dose daily, decocted in water, 200ml each time, divided into morning and evening doses. After 14 doses, the patient reported a reduction in the pale central shadow in his left eye. Ophthalmological examination showed a left eye BCVA of 0.8, reduced macular edema, and OCT examination showed a decrease in subretinal fluid. His fatigue also lessened. After continuing the treatment for 21 more doses, the left eye BCVA reached 1.0, the macular edema completely resolved, and OCT examination showed complete absorption of the subretinal fluid. No recurrence was observed during the six-month follow-up period.

[0118] Case 4: Mr. Xu, male, 46 years old, consulted in July 2018. He had experienced blurred vision and distorted vision in his left eye for 10 months. Current symptoms included fatigue, lethargy, and loose stools. Ophthalmological examination revealed a BCVA of 0.5 in the left eye. Fundus examination showed a clear optic disc margin with normal color, discoid edema in the macular region, and yellowish-white punctate lesions. OCT examination revealed serous retinal neuroepithelial detachment in the macular region; FFA examination showed multiple punctate hyperfluorescence; and ICGA examination showed choroidal vascular dilation and increased permeability. His tongue was pale and swollen with a white, moist coating, and his pulse was soft and slow. He was treated according to Example 3 of this invention, one dose daily, decocted in water, 200ml each time, divided into morning and evening doses. After 14 doses, the patient reported a reduction in blurred vision and distorted vision in his left eye. Ophthalmological examination showed a BCVA of 0.6 in the left eye, reduced macular edema, and decreased subretinal fluid on OCT examination. His fatigue, lethargy, and loose stools also improved. After continuing the medication for 28 doses, the BCVA in the left eye reached 1.0, the macular edema in the fundus was completely absorbed, and OCT examination showed complete absorption of the subretinal fluid. No recurrence was observed during a 2-year follow-up.

[0119] Case 5: Mr. Cao, male, 45 years old, consulted in February 2019. He had experienced blurred vision and decreased visual size in his right eye for 12 months. His current symptoms included fatigue and loose stools. Ophthalmological examination revealed a BCVA of 0.5 in the right eye. Fundus examination showed a clear optic disc border and normal color in the left eye, but with macular pigmentary disturbances, discoid edema, and yellowish-white punctate lesions. OCT examination revealed serous retinal neuroepithelial detachment with small pigment epithelial detachment in the macular region; FFA examination revealed diffuse RPE damage and multiple punctate hyperfluorescence; ICGA examination revealed choroidal vascular dilation and increased permeability. His tongue was pale and swollen with a white coating, and his pulse was soft and slow. He was treated according to Example 4 of this invention, one dose daily, decocted in water, 200ml each time, divided into morning and evening doses. After 14 doses, the patient reported a reduction in blurred vision in his right eye. Ophthalmological examination showed a BCVA of 0.6 in the right eye, reduced macular edema, and decreased subretinal fluid on OCT examination. His fatigue and loose stools also improved. After continuing the medication for 42 doses, the BCVA in the right eye was 0.8, the macular edema in the fundus was completely absorbed, and the pigmentary disturbance was observed. OCT examination showed complete absorption of subretinal fluid. No recurrence was observed during a one-year follow-up.

Claims

1. A traditional Chinese medicine composition for treating chronic central serous chorioretinopathy, the composition being made from the following raw materials in the indicated weight ratios: Atractylodes macrocephala 5-12g, Poria cocos 5-15g, Polyporus umbellatus 5-12g, Lycopus lucidus 10-15g, Codonopsis pilosula 5-30g, Dioscorea opposita 10-30g, Ziziphus jujuba var. spinosa 5-15g, and Amomum villosum 3-6g.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, It is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 10g, Poria cocos 10g, Polyporus umbellatus 6g, Lycopus lucidus 10g, Codonopsis pilosula 10g, Ziziphus jujuba var. spinosa 10g, Dioscorea opposita 10g, Amomum villosum 5g.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 10g, Poria cocos 10g, Polyporus umbellatus 10g, Lycopus lucidus 10g, Codonopsis pilosula 15g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 15g, Amomum villosum 5g.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 12g, Poria cocos 15g, Polyporus umbellatus 12g, Lycopus lucidus 15g, Codonopsis pilosula 30g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 30g, Amomum villosum 6g.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 12g, Poria cocos 15g, Polyporus umbellatus 10g, Lycopus lucidus 10g, Codonopsis pilosula 20g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 20g, Amomum villosum 6g.

6. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 10g, Poria cocos 10g, Polyporus umbellatus 10g, Lycopus lucidus 10g, Codonopsis pilosula 10g, Ziziphus jujuba var. spinosa 15g, Dioscorea opposita 10g, Amomum villosum 5g.

7. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in the following weight ratios: Atractylodes macrocephala 5g, Poria cocos 5g, Polyporus umbellatus 5g, Lycopus lucidus 10g, Codonopsis pilosula 5g, Ziziphus jujuba var. spinosa 5g, Dioscorea opposita 10g, Amomum villosum 3g.

8. A method for preparing a traditional Chinese medicine composition as described in any one of claims 1-7, characterized in that, The method is as follows: Take the above-mentioned weight of the raw material of any one of the traditional Chinese medicine compositions according to claims 1-7, add 500-800ml of water, and soak for 30-60 minutes; First decoction: Heat to a boil over high heat, then reduce to low heat and decoct for 20-30 minutes, filter while hot and retain the liquid; Second decoction: Add 400-600ml of water to the dregs, bring to a boil over high heat, then reduce to low heat and decoct for 15-20 minutes, filter while hot and retain the liquid, combine the two liquids, 400ml, to obtain the traditional Chinese medicine composition.

9. A traditional Chinese medicine preparation for treating chronic central serous chorioretinopathy, characterized in that, Prepare pharmaceutically acceptable dosage forms from any of the traditional Chinese medicine compositions described in claims 1-7.

10. The traditional Chinese medicine preparation as described in claim 9, characterized in that, The traditional Chinese medicine preparations mentioned are capsules, tablets, oral liquids, powders, granules, pills, syrups, or mixtures.

11. The traditional Chinese medicine preparation as described in claim 9 or 10, characterized in that, Various pharmaceutically acceptable excipients need to be added during preparation.

12. The traditional Chinese medicine preparation as described in claim 11, characterized in that, The excipients are fillers, preservatives, flavoring agents, or disintegrants.

13. The use of the traditional Chinese medicine composition according to any one of claims 1-7 and / or the traditional Chinese medicine preparation according to any one of claims 9-12 in the preparation of a medicament for treating chronic central serous chorioretinopathy.

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