A traditional Chinese medicine composition for treating sleep apnea syndrome complicated with erectile dysfunction

Abstract

This invention discloses a traditional Chinese medicine composition for treating sleep apnea syndrome complicated with erectile dysfunction, belonging to the field of traditional Chinese medicine compositions. The composition comprises Polygonatum sibiricum, American ginseng, Rhodiola rosea, Salvia miltiorrhiza, Atractylodes macrocephala, Cistanche deserticola, Angelica sinensis, Lycium barbarum, Morinda officinalis, Ilex pubescens, Ginkgo biloba, Carthamus tinctorius, Poria cocos, Citrus reticulata peel, Sinapis alba, Acorus tatarinowii, Glycyrrhiza uralensis, Cinnamomum cassia, Pheretima aspergillum, and Panax notoginseng powder. This invention targets OSAHS hypoxia complicated with ED, based on the principle of "combining disease and syndrome, and regulating multiple organs," invigorating qi and blood, resolving phlegm and unblocking meridians. Clinical trials have verified that it can significantly improve erectile function and hypoxia indicators, with a total effective rate as high as 76.92%, and has high safety and few side effects, providing an effective solution to the problems of poor compliance and inadequate efficacy of existing therapies.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compositions, and in particular to a traditional Chinese medicine composition for treating sleep apnea syndrome complicated with erectile dysfunction. Background Technology

[0002] Erectile dysfunction (ED) is a common clinical condition in men, seriously affecting their physical and mental health and quality of life. In recent years, increasing research has shown that hypoxic diseases such as obstructive sleep apnea syndrome (OSAHS) are important risk factors for inducing or aggravating ED. OSAHS, commonly known as "snoring," is characterized by recurrent apnea and hypopnea at night, leading to a chronic state of intermittent hypoxia. Epidemiological surveys show that the risk of ED in OSAHS patients is 2.52 times higher than in non-OSAHS individuals, and the more severe the hypoxia, the more pronounced the ED symptoms. Currently, the mechanisms underlying OSAHS complicated by ED are believed to involve multiple factors, including endocrine hormones (such as decreased testosterone levels), vascular endothelial function (such as reduced synthesis of nitric oxide and nitric oxide synthase), nervous system damage (increased sympathetic nerve excitability), and inflammatory factors (such as elevated levels of tumor necrosis factor). The pathological basis is damage to the vascular endothelial system and oxidative stress.

[0003] In modern medical treatment, conventional methods for treating erectile dysfunction (ED) complicated by OSAHS mainly include continuous positive airway pressure (CPAP), oral appliances, and other measures to improve ventilation, as well as the combined use of phosphodiesterase type 5 inhibitors (PDE5i, such as sildenafil and tadalafil) to improve erectile function. However, these treatments have many drawbacks: First, ventilation devices such as CPAP are cumbersome to wear, have poor comfort, and low patient compliance, limiting their long-term effectiveness; second, although PDE5i are first-line ED treatments, they are often accompanied by side effects such as headache, facial flushing, dizziness, indigestion, and nasal congestion. Some drugs may also cause visual abnormalities or muscle soreness, especially in patients with hypoxia-related ED, where cardiovascular side effects may further aggravate the body's hypoxia. More importantly, PDE5i alone is only effective in 70-80% of ED patients, and its effectiveness is even lower in patients with ED caused by hypoxia factors such as OSAHS, making it difficult to meet clinical needs. Therefore, finding a treatment strategy with fewer side effects and the ability to intervene in the pathological mechanism of hypoxia-related erectile dysfunction at multiple targets has become a hot topic and a challenge in the current andrology research community.

[0004] Traditional Chinese medicine (TCM) possesses unique advantages in treating diseases with complex etiologies. In TCM, OSAHS (Obstructive Sleep Apnea-Hypopnea Syndrome) falls under the category of "snoring," while ED (erectile dysfunction) is referred to as "impotence" or "vaginal atrophy." TCM theory holds that the pathogenesis of snoring lies in deficiency of lung qi and insufficient ancestral qi, coupled with phlegm-heat and blood stasis, leading to insufficient heart qi, blood stasis, and malnourishment of the genital muscles, resulting in impotence. Over time, the spleen and kidneys may be affected, forming a complex syndrome of qi deficiency, blood stasis, and phlegm-dampness accumulation. Based on this pathogenesis, tonifying qi, unblocking the meridians, and promoting blood circulation and resolving phlegm should be the core treatment principle for OSAHS complicated by ED. However, currently, there is a lack of TCM compositions specifically targeting the pathological type of "hypoxic-induced ED" (H-ED). Existing TCM preparations or compound formulas often address single organs or single syndromes, making it difficult to comprehensively address the multi-system and multi-pathological characteristics of OSAHS. How to develop a Chinese medicine composition that conforms to the principles of syndrome differentiation and treatment in traditional Chinese medicine and can comprehensively intervene on multiple targets such as endocrine, vascular, nerve and inflammation based on the theory of traditional Chinese medicine and combined with the modern pathological mechanism of hypoxia is a technical problem that urgently needs to be solved. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition for treating obstructive sleep apnea syndrome (OSAHS) complicated with erectile dysfunction (ED), thereby addressing the problems existing in the prior art. This invention's traditional Chinese medicine composition targets OSAHS-induced hypoxia and ED, based on the principle of "combining disease and syndrome differentiation, and regulating multiple organs simultaneously," invigorating qi and blood circulation, resolving phlegm and unblocking the meridians. Clinical trials have verified that it can significantly improve erectile function and hypoxia indicators, with a total effective rate as high as 76.92%, and it exhibits high safety and few side effects, providing an effective solution to address the problems of poor adherence and inadequate efficacy of existing treatments.

[0006] To achieve the above objectives, the present invention provides the following solution: This invention provides a traditional Chinese medicine composition for treating sleep apnea syndrome complicated with erectile dysfunction, comprising the following raw materials in parts by weight: 20-30 parts of Polygonatum sibiricum, 3-6 parts of American ginseng, 6-12 parts of Rhodiola rosea, 30 parts of Salvia miltiorrhiza, 12-30 parts of Atractylodes macrocephala, 9-15 parts of Cistanche deserticola, 9-12 parts of Angelica sinensis, 12-15 parts of Lycium barbarum, 9-12 parts of Morinda officinalis, 30 parts of Ilex pubescens, 12-15 parts of Ginkgo biloba, 3-6 parts of Carthamus tinctorius, 12-15 parts of Poria cocos, 6-9 parts of Citrus reticulata peel, 9-15 parts of Sinapis alba, 6-12 parts of Acorus tatarinowii, 6 parts of Glycyrrhiza uralensis, 6-9 parts of Cinnamomum cassia, 6-9 parts of Pheretima aspergillum, and 2-3 parts of Panax notoginseng powder.

[0007] The present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating sleep apnea syndrome complicated with erectile dysfunction.

[0008] Optionally, the sleep apnea syndrome is obstructive sleep apnea syndrome.

[0009] The present invention also provides a pharmaceutical preparation for treating sleep apnea syndrome complicated with erectile dysfunction, wherein the active ingredients of the pharmaceutical preparation include the aforementioned combination of traditional Chinese medicines.

[0010] Optionally, pharmaceutically acceptable carriers or excipients may also be included.

[0011] Optionally, the dosage form of the pharmaceutical preparation may include decoction, granules, capsules, or tablets.

[0012] Optionally, the sleep apnea syndrome is obstructive sleep apnea syndrome.

[0013] The present invention also provides a method for preparing the aforementioned pharmaceutical formulation, characterized by comprising the following steps: (1) Weigh out the 19 raw materials except for Panax notoginseng powder according to the weight, and wash them to remove impurities; (2) Place the above 19 herbs in a decoction container and add water to soak them; (3) After boiling over high heat, reduce to low heat and simmer. Filter and collect the first decoction. (4) Add water to the dregs, bring to a boil over high heat, then simmer over low heat, filter, and collect the second decoction. (5) Combine the two decoctions, concentrate and cool them, add Panax notoginseng powder, stir evenly, and obtain the drug preparation.

[0014] Optionally, in step (2), the amount of water added is 8-10 times the total weight of the 19 herbs; in step (4), the amount of water added is 6-8 times the total weight of the dregs.

[0015] Optionally, in step (3), the simmering time is 20-30 minutes.

[0016] 1. The formulation basis and compatibility principles of the traditional Chinese medicine composition of the present invention The herbal composition of this invention is Professor Yu Chao's empirical formula for treating OSAHS (Obstructive Sleep Apnea-Hypopnea Syndrome) complicated with erectile dysfunction—Jinghonghanwei Formula. The principle of this formula integrates traditional Chinese and Western medicine, focusing on the core mechanism of OSAHS leading to intermittent hypoxia, which in turn induces vascular endothelial damage, hormonal metabolic disorders, neurological dysfunction, and psychological disorders. Based on the TCM diagnostic system of OSAHS being classified as "snoring" and ED as "impotence," the core pathogenesis is considered to be: deficiency of Qi in the lungs, spleen, heart, and kidneys as the root cause, phlegm and blood stasis as the manifestation, and malnourishment of the reproductive organs leading to impotence. Therefore, the treatment principle is to tonify Qi (heart, lungs, spleen, and kidneys), invigorate blood and resolve phlegm, and unblock the meridians to aid erection. This involves using herbs that tonify the Qi of the lungs, spleen, heart, and kidneys, combined with herbs that invigorate blood and remove blood stasis, resolve phlegm and dissipate nodules, and tonify Qi and unblock the meridians to achieve the effect of restoring erectile function.

[0017] 2. The compatibility structure (principal, assistant, adjuvant, and guide) of the traditional Chinese medicine composition of the present invention: The principal herbs are: Polygonatum sibiricum, American ginseng, and Rhodiola rosea.

[0018] Polygonatum rhizome nourishes the lungs, spleen, and kidneys, aligning with the disease's progression from lung involvement to spleen and kidney involvement, thus tonifying the lungs, strengthening the spleen, and nourishing the kidneys and penis. American ginseng tonifies the qi of the lungs, heart, and kidneys, replenishing qi and nourishing yin to relieve irritability, addressing common OSAHS symptoms such as dry mouth and yin deficiency. Rhodiola rosea invigorates qi, promotes blood circulation, and relieves asthma. These three herbs together serve as the principal herbs, tonifying the qi and yin of the heart, lungs, spleen, and kidneys, targeting the root cause of the disease.

[0019] Minister's Medicine: Kidney-tonifying and Yang-boosting formula: Cistanche deserticola as the main ingredient, along with wolfberry and Morinda officinalis, to help Polygonatum sibiricum tonify both Yin and Yang, strengthen the kidneys and boost erection.

[0020] Qi-tonifying and spleen-strengthening formula: Atractylodes macrocephala is used as the assistant ingredient, along with Poria cocos and Glycyrrhiza uralensis, to assist American ginseng in tonifying qi and strengthening the spleen, thus providing the source for the generation of qi and blood.

[0021] Blood-activating and stasis-removing herbs: Salvia miltiorrhiza is the main ingredient, along with Angelica sinensis, Carthamus tinctorius, and Panax notoginseng, to assist Rhodiola rosea in promoting blood circulation and removing blood stasis.

[0022] For clearing blood vessels and resolving phlegm: Ginkgo leaves and holly roots help to clear the heart and lung vessels to remove blood stasis.

[0023] Adjuvant herbs: Citrus reticulata peel, white mustard seed, and Acorus tatarinowii. These three herbs regulate qi, resolve phlegm, and dispel dampness. Targeting phlegm turbidity, a key pathological product, they serve as adjuvant herbs to assist the principal and assistant herbs in resolving phlegm, dispersing nodules, and unblocking the meridians.

[0024] Guiding herbs: earthworm and cinnamon twig. Earthworm unblocks the meridians and relieves spasms, while cinnamon twig warms and unblocks the heart meridians, raises yang and disperses stagnation. Together, they serve as guiding herbs to direct the medicinal power of the other herbs to the affected area (the tendons and muscles) and enhance the overall effect of the formula in unblocking the meridians.

[0025] 3. Indications and therapeutic uses of each active pharmaceutical ingredient Based on traditional Chinese medicine theory and modern pharmacological research, the effects of each active pharmaceutical ingredient are summarized as follows: Qi-tonifying and Yin-nourishing ingredients: Polygonatum (antioxidant, reduces hypoxia damage to multiple organs), American ginseng (improves hypoxia tolerance), Rhodiola rosea (anti-hypoxia, inhibits apoptosis of smooth muscle cells in the corpus cavernosum), Atractylodes macrocephala (improves hypoxia tolerance, inhibits nerve cell apoptosis), Poria cocos (regulates energy metabolism, improves hypoxia tolerance).

[0026] Blood-activating and stasis-removing drugs: Salvia miltiorrhiza (upregulates Nrf2 / HO-1 pathway and improves oxidative stress in the corpus cavernosum), Carthamus tinctorius (protects hypoxic cognitive function and promotes angiogenesis), Ginkgo biloba (protects hypoxic endothelium and activates PI3K / Akt / eNOS pathway), Ilex pubescens root (anti-myocardial hypoxia and inhibits reactive oxygen species production), Panax notoginseng (anti-high altitude hypoxia and induces eNOS phosphorylation to improve erectile function).

[0027] Kidney-tonifying, yang-boosting, and sperm-benefiting herbs: Cistanche deserticola (increases sexual activity frequency and counteracts stress-induced sexual dysfunction), Morinda officinalis (resists vascular endothelial hypoxia damage and increases testicular weight), and Lycium barbarum (resists hypoxia and protects erectile function in diabetic rats).

[0028] Phlegm-resolving and meridian-clearing agents: Citrus reticulata peel (antioxidant, relaxes airway smooth muscle), white mustard seed (antioxidant, relaxes airway smooth muscle), and Acorus tatarinowii (anti-inflammatory, regulates hypoxia pathways such as HIF-1).

[0029] Antispasmodic and meridian-clearing agents: Earthworm (increases serum testosterone, inhibits oxidative stress and inflammation, and improves erectile function).

[0030] Warming and harmonizing herbs: Cinnamon twig (scavenges oxygen free radicals, regulates the Nrf2 / HO-1 pathway, and has anti-neuroinflammatory effects), Licorice (enhances hypoxia tolerance, protects hypoxic myocardial cells, and harmonizes other herbs).

[0031] The present invention discloses the following technical effects: The traditional Chinese medicine composition provided by this invention addresses the problems of poor compliance, significant side effects, and insufficient efficacy in existing treatments for OSAHS (Obstructive Sleep Apnea-Hypopnea Syndrome) complicated by erectile dysfunction. Based on the research and development approach of "combining disease and syndrome differentiation with clear target identification," it closely focuses on the core pathologies of intermittent hypoxia-induced vascular endothelial damage, oxidative stress, hormone decline, and neurological disorders, highly unifying modern mechanisms with the TCM pathogenesis of "qi deficiency, blood stasis, and phlegm turbidity." The formula uses Polygonatum sibiricum, American ginseng, and Rhodiola rosea to tonify the qi of the lungs, spleen, heart, and kidneys to treat the root cause; Salvia miltiorrhiza, Carthamus tinctorius, and Ginkgo biloba to invigorate blood and remove blood stasis to protect blood vessels; and Cistanche deserticola and Morinda officinalis to tonify the kidneys and assist yang to regulate hormones, achieving precise intervention at multiple stages.

[0032] This formula embodies the advantages of "simultaneous regulation of multiple organs, addressing both the root cause and the symptoms": it comprehensively addresses the root cause of Qi deficiency in the lungs, spleen, heart, and kidneys, while simultaneously promoting blood circulation and resolving phlegm to eliminate the symptoms. It improves the deficiency of vital Qi and the failure of clear Qi to ascend caused by sleep apnea, and also clears the obstruction of the meridians, achieving a combined therapeutic effect of "tonifying Qi and unblocking the meridians, resolving phlegm and aiding erection," overcoming the limitations of single-treatment methods or single-organ approaches. Clinical trials have confirmed that this formula can significantly improve patients' IIEF-15 total score and scores across various dimensions such as erectile function and penetration satisfaction, with a total effective rate of 76.92% in the treatment group. It also significantly improves the AHI index and minimum blood oxygen saturation, simultaneously alleviating the core pathology of OSAHS and ED symptoms at the etiological level.

[0033] Furthermore, this invention offers significant advantages in synergistic effects and reduced side effects: compared to the potential cardiovascular adverse reactions and poor efficacy of PDE5i alone in treating hypoxic erectile dysfunction (ED), this composition, through multi-pathway and multi-target synergistic action, fundamentally improves the hypoxic state and vascular endothelial function caused by OSAHS. Moreover, all components are natural drugs, ensuring high safety with long-term use. Modern pharmacological studies support the anti-hypoxic, antioxidant, anti-apoptotic, vascular endothelial protective, and erectile function improving effects of each major drug in the formula. Some drugs have been shown to upregulate key protective signaling pathways such as the Nrf2 / HO-1 pathway and activate the PI3K / Akt / eNOS pathway, providing a solid scientific basis for treating OSAHS-related hypoxic ED. Clinically safe and effective, it has broad prospects for widespread application. Detailed Implementation

[0034] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0035] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any stated value or intermediate value within a stated range, as well as each smaller range between any other stated value or intermediate value within said range, is also included within the scope of this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0036] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0037] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be readily apparent to those skilled in the art. This specification and embodiments are merely exemplary.

[0038] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0039] Example 1 A traditional Chinese medicine decoction for treating sleep apnea syndrome complicated with erectile dysfunction, the raw materials by weight are as follows: 30 parts Polygonatum sibiricum, 6 parts American ginseng, 12 parts Rhodiola rosea, 30 parts Salvia miltiorrhiza, 15 parts Cistanche deserticola, 15 parts Ginkgo biloba, 30 parts Ilex pubescens, 6 parts Carthamus tinctorius, 15 parts Lycium barbarum, 12 parts Morinda officinalis, 12 parts Angelica sinensis, 15 parts Atractylodes macrocephala, 15 parts Poria cocos, 6 parts Citrus reticulata peel, 12 parts Sinapis alba, 12 parts Acorus tatarinowii, 6 parts Glycyrrhiza uralensis, 9 parts Cinnamomum cassia, 9 parts Pheretima aspergillum, and 3 parts Panax notoginseng powder.

[0040] Preparation method: (1) Weigh out the above 19 raw materials except for Panax notoginseng powder according to the weight parts, and wash and remove impurities respectively; (2) Place the above 19 herbs in a clay pot, add water equivalent to 8-10 times the total weight of the herbs, and soak for 30 minutes; (3) First bring to a boil over high heat, then simmer over low heat for 30-40 minutes, filter, and collect the first decoction; (4) Add water equivalent to 6-8 times the total weight of the medicinal materials to the dregs, bring to a boil over high heat, then simmer over low heat for 20-30 minutes, filter, and collect the second decoction. (5) Combine the two decoctions, stir well, and concentrate to about 300-400mL; (6) When the decoction cools to 40-50℃, add the above-mentioned weight of Panax notoginseng powder, stir evenly, and the decoction is obtained.

[0041] Example 2 A traditional Chinese medicine decoction for treating sleep apnea syndrome complicated with erectile dysfunction, the raw materials by weight are as follows: 20 parts Polygonatum sibiricum, 5 parts American ginseng, 9 parts Rhodiola rosea, 30 parts Salvia miltiorrhiza, 12 parts Cistanche deserticola, 12 parts Ginkgo biloba, 30 parts Ilex pubescens, 5 parts Carthamus tinctorius, 12 parts Lycium barbarum, 12 parts Morinda officinalis, 9 parts Angelica sinensis, 12 parts Atractylodes macrocephala, 12 parts Poria cocos, 5 parts Citrus reticulata peel, 9 parts Sinapis alba, 9 parts Acorus tatarinowii, 6 parts Glycyrrhiza uralensis, 6 parts Cinnamomum cassia, 6 parts Pheretima aspergillum, and 2 parts Panax notoginseng powder.

[0042] Preparation method: (1) Weigh out the above 19 raw materials except for Panax notoginseng powder according to the weight parts, and wash and remove impurities respectively; (2) Place the above 19 herbs in a clay pot, add water equivalent to 8-10 times the total weight of the herbs, and soak for 30 minutes; (3) First bring to a boil over high heat, then simmer over low heat for 30-40 minutes, filter, and collect the first decoction; (4) Add water equivalent to 6-8 times the total weight of the medicinal materials to the dregs, bring to a boil over high heat, then simmer over low heat for 20-30 minutes, filter, and collect the second decoction. (5) Combine the two decoctions, stir well, and concentrate to about 300-400mL; (6) When the decoction cools to 40-50℃, add the above-mentioned weight of Panax notoginseng powder, stir evenly, and the decoction is obtained.

[0043] Example 3 A traditional Chinese medicine composition granule for treating sleep apnea syndrome complicated with erectile dysfunction, the raw materials are as follows by weight: 25 parts Polygonatum sibiricum, 6 parts American ginseng, 10 parts Rhodiola rosea, 30 parts Salvia miltiorrhiza, 13 parts Cistanche deserticola, 14 parts Ginkgo biloba, 30 parts Ilex pubescens, 4 parts Carthamus tinctorius, 14 parts Lycium barbarum, 11 parts Morinda officinalis, 10 parts Angelica sinensis, 13 parts Atractylodes macrocephala, 13 parts Poria cocos, 7 parts Citrus reticulata peel, 10 parts Sinapis alba, 10 parts Acorus tatarinowii, 6 parts Glycyrrhiza uralensis, 7 parts Cinnamomum cassia, 7 parts Pheretima aspergillum, and 2.5 parts Panax notoginseng.

[0044] Preparation method: (1) Take all 20 raw materials mentioned above, wash them, remove impurities, and dry them until the moisture content is less than 8%; (2) Mix the dried medicinal materials evenly, grind them into coarse powder, and pass them through a 40-mesh sieve; (3) Add water equivalent to 8-10 times the total weight of the coarse powder, decoct twice, the first time for 2 hours and the second time for 1.5 hours, combine the decoctions and filter; (4) Concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.10-1.15 (measured at 60℃); (5) Spray dry the extract (inlet air temperature 180-200℃, outlet air temperature 80-90℃) to obtain dried extract powder; (6) Add an appropriate amount of dextrin or lactose as an excipient, mix it evenly with the extract powder and Panax notoginseng powder, make a soft material with 85% ethanol, and granulate it through a 14-mesh sieve. (7) Dry at 60-70℃ until the moisture content of the granules is less than 5%, then granulate to obtain granules.

[0045] Experimental Example 1 1. General Information Fifty patients with obstructive sleep apnea syndrome (OSAHS) complicated with erectile dysfunction (ED) who were treated at the Department of Andrology of Qinghai Provincial Hospital of Traditional Chinese Medicine from July 2024 to July 2025 were selected. This study was approved by the Medical Ethics Committee of Qinghai Provincial Hospital of Traditional Chinese Medicine, and all patients signed informed consent forms.

[0046] 2. Diagnostic criteria 2.1 Western Medicine Diagnostic Criteria OSAHS diagnostic criteria: Referring to the 2015 Guidelines for the Diagnosis and Treatment of Obstructive Sleep Apnea-Hypopnea Syndrome (Primary Care Version), patients must meet at least one of the following criteria (2) and (5), and have at least one other criterion: (1) Having at least two major risk factors, especially obesity, short and thick neck or micrognathia or mandibular retrusion, pharyngeal stenosis or grade II tonsillar hypertrophy, uvula hypertrophy, or hypothyroidism, acromegaly or significant neurological abnormalities. (2) Moderate to severe snoring (see table for snoring severity assessment), irregular breathing at night, or breath-holding and waking up gasping for air (observation time not less than 15 minutes). (3) Disruption of nighttime sleep rhythm, especially frequent awakenings; (4) Daytime sleepiness (ESS score > 9 points); (5) Typical changes can be seen in the blood oxygen saturation (SpO2) monitoring trend graph, and the oxygen desaturation index (ODI) is >10 times / hour; (6) Causes damage to one or more vital organs.

[0047] Diagnostic criteria for ED: Referring to the 2018 AUA Guidelines for the Diagnosis and Treatment of Erectile Dysfunction, the penis is unable to achieve or maintain an erection sufficient for satisfactory sexual intercourse, and the condition has lasted for more than 3 months. The International Index of Erectile Function (IIEF-5) is used for assessment. A score ≤21 indicates ED, with 12-21 indicating mild ED, 8-11 indicating moderate ED, and 5-7 indicating severe ED.

[0048] 2.2 Diagnostic Criteria for Traditional Chinese Medicine Syndromes Based on the relevant symptoms in the "Guiding Principles for Clinical Research on New Traditional Chinese Medicine for the Treatment of Erectile Dysfunction," the following diagnostic criteria for sleep apnea syndrome with hypoxia and erectile dysfunction in the Qi deficiency and phlegm stasis syndrome type are proposed: Main symptoms: penile flaccidity, with erections that are not firm or do not last long; snoring during sleep, with occasional pauses; low libido; occasional tingling / distending pain in the lower abdomen and perineum, or accompanied by tingling / distending pain during ejaculation.

[0049] (2) Secondary symptoms: usually lethargic, drowsy, forgetful, tinnitus, dizziness, shortness of breath and reluctance to speak; (3) Tongue and pulse: The tongue is swollen, the tongue body is dark, the coating is thick and greasy, or accompanied by purplish veins under the tongue, and the pulse is deep and hesitant or wiry and slippery.

[0050] A diagnosis can be made if two of the primary symptoms and one of the secondary symptoms are met, combined with the characteristics of the tongue and pulse.

[0051] 3. Case selection criteria 3.1 Inclusion Criteria (1) Meets both the above-mentioned diagnostic criteria in traditional Chinese medicine and Western medicine; (2) Married male patients aged 20-65 years with normal libido, and who can guarantee the willingness and conditions to try sexual intercourse during the treatment period; (3) Resting SpO2 remains below 90%; (4) Meets both the Western medical diagnostic criteria for OSAHS and ED; (5) The course of OSAHS is earlier than that of ED; (6) No other medications or methods for treating ED have been used or discontinued within the 3 months prior to treatment; (7) IIEF-5 score between mild and moderate: 8 points ≤ IIEF-5 score ≤ 21 points; (8) Voluntarily sign the informed consent form.

[0052] 3.2 Exclusion Criteria (1) Age < 20 years or > 65 years; (2) IIEF-5 score ≤ 7 (severe ED); (3) History of alcohol poisoning or drug abuse; (4) Suffering from acute prostatitis, urethritis, penile lesions, urinary tract stones, spinal cord injury, or other diseases; (5) Any serious mental disorder or use of psychotropic drugs; (6) Long-term use of hormones, sedatives, antihypertensive drugs, antidepressants, diuretics, etc.; (7) Suffering from severe cerebrovascular disease, cardiovascular disease, neuropathy, hematopoietic system disease, liver and kidney dysfunction, and other metabolic diseases such as diabetes; (8) Erosion, ulceration, blisters, suppuration or skin damage appear on the affected area of ​​the penis.

[0053] 4. Treatment methods 4.1 Basic Treatment All patients received OSAHS health education, medical nutrition guidance, guidance on active physical exercise, and disease monitoring. They were also required to quit smoking and limit alcohol consumption.

[0054] 4.2 Experimental Treatment The experimental group took Jinghonghanwei Decoction orally (using the formula and preparation method described in Example 1, and prepared by the Pharmacy of Qinghai Provincial Hospital of Traditional Chinese Medicine).

[0055] After preparation, the decoction is dispensed into 150mL packets. Dosage: Oral administration, 150mL each time, twice daily, warm. One course of treatment consists of 12 weeks of continuous treatment.

[0056] 5. Observation Indicators Each observation item was tested and evaluated within one week before treatment and within one month after the end of 12 weeks of treatment.

[0057] 5.1 Primary therapeutic indicators The International Index of Erectile Function (IIEF-15) is used for scoring. The IIEF-15 includes five dimensions: erectile function (questions 1-5 and 15, 6 questions in total, 30 points), penetration satisfaction (questions 6-7 and 8, 3 questions in total, 15 points), orgasm (questions 9-10, 2 questions in total, 10 points), libido (questions 11-12, 2 questions in total, 10 points), and overall satisfaction (questions 13-14, 2 questions in total, 10 points), with a total score of 75 points.

[0058] 5.2 Secondary observation indicators (1) Tongue and pulse appearance in Traditional Chinese Medicine before and after treatment; (2) Five endocrine hormones before and after treatment: testosterone (TE), estradiol (E2), follicle-stimulating hormone (FSH), luteinizing hormone (LH), and prolactin (PRL).

[0059] 5.3 Safety Observation Indicators (1) General physical examination items: blood pressure, heart rate; (2) Laboratory tests: complete blood count and urinalysis; (3) Electrocardiogram; (4) Liver function (ALT), kidney function (BUN, Scr).

[0060] 6. Efficacy evaluation criteria Referring to the 2018 AUA Guidelines for the Diagnosis and Treatment of Erectile Dysfunction, the IIEF-15 score was used to assess treatment effectiveness. The formula for calculating the improvement score is as follows: Improvement rate (%) = [(Total score after treatment - Total score before treatment) / Total score before treatment] × 100%.

[0061] Ineffective: IIEF-15 score <60 after treatment, and score improvement rate <30%; Effective: IIEF-15 score < 60 after treatment, and 30% ≤ score improvement rate < 60%; Significant effect: IIEF-15 score ≥ 60 after treatment, or IIEF-15 score < 60 after treatment but score improvement rate ≥ 60%.

[0062] Overall effectiveness (%) = (Number of cases with significant effect + Number of cases with effect) / Total number of cases × 100%.

[0063] 7. Statistical methods Statistical software was used for data analysis. Quantitative data were expressed as mean ± standard deviation (x ± s). For normally distributed data, independent samples t-tests were used for comparison; for non-normally distributed quantitative data, the Mann-Whitney U rank-sum test was used. Categorical data were analyzed using chi-square or rank-sum tests. Hypothesis testing was performed using two-tailed tests, with p < 0.05 considered statistically significant.

[0064] 8. Results 8.1 Case Completion Status Of the 50 patients, 3 dropped out during the 1-month observation period after treatment (lost to follow-up), and 47 patients were followed up and included in the efficacy evaluation, with a completion rate of 94%.

[0065] 8.2 Clinical efficacy assessment Of the 47 patients, 5 (10.64%) showed significant improvement, 17 (36.17%) showed improvement, and 25 (53.19%) showed no improvement, with a total effective rate of 46.81%. The results are shown in Table 1.

[0066] Table 1. Assessment of Clinical Efficacy [Cases (%)] 8.3 IIEF-15 score changes After 12 weeks of treatment, the patients' total IIEF-15 score and scores of each dimension (except for the libido dimension) were significantly higher than before treatment (P<0.05). The results are shown in Table 2.

[0067] Table 2 Comparison of IIEF-15 total scores before and after treatment in OSAHSED (H-ED) patients ( ± s) Note: Compared with before treatment, P<0.05.

[0068] 8.4 Changes in sex hormone levels After 12 weeks of treatment, the patients' serum TE levels were significantly higher than before treatment (P<0.05), while the levels of E2, FSH, LH, and PRL were significantly lower than before treatment (P<0.05). The results are shown in Table 3.

[0069] Table 3 Comparison of sex hormones before and after treatment in patients with OSAHSED (H-ED) ± s) Note: Compared with before treatment, P<0.05.

[0070] 8.5 Security Analysis During treatment, among the 47 patients: one patient experienced nausea and vomiting after taking the medication; the symptoms subsided after the patient was instructed to heat the medication and take it warm, and treatment was not interrupted; two patients experienced diarrhea and loose stools, which resolved spontaneously without specific treatment. No clinically significant abnormalities were found in the blood pressure, heart rate, complete blood count, urinalysis, liver function (ALT), kidney function (BUN, Scr), and electrocardiogram results of the remaining patients before and after treatment. This indicates that Jinghong Hanweifang has good safety and mild side effects at the therapeutic dose.

[0071] The results of this validation case show that after 12 weeks of oral administration of Jinghonghanweifang (a traditional Chinese medicine composition of this invention) to patients with OSAHS hypoxia complicated with erectile dysfunction (H-ED), it can significantly improve the patients' total IIEF-15 score and scores in dimensions such as erectile function, penetration satisfaction, orgasm, and overall satisfaction (P<0.05); it can significantly increase serum testosterone (TE) levels and decrease E2, FSH, LH, and PRL levels (P<0.05); the total effective rate is 46.81%; the adverse reactions are mild, and there is no significant effect on blood pressure, heart rate, liver and kidney function, or electrocardiogram, indicating that it is safe for clinical use.

[0072] In summary, the traditional Chinese medicine composition of this invention can effectively improve the clinical symptoms of erectile dysfunction caused by OSAHS hypoxia, improve patients' erectile function and sexual satisfaction. Its mechanism of action may be related to regulating sex hormone levels, improving endothelial function and reducing oxidative stress. It has few side effects, is clinically safe and effective, and has value for further promotion and application.

[0073] Experimental Example 2 1. General Information Ninety patients with obstructive sleep apnea syndrome with hypoxia and erectile dysfunction (OSAHS-ED) who were treated at the outpatient and inpatient wards of the Department of Urology, Longhua Hospital affiliated with Shanghai University of Traditional Chinese Medicine, between September 2023 and February 2026 were selected. Patients were randomly divided into a treatment group and a control group, with 45 patients in each group. This study was approved by the Medical Ethics Committee of Longhua Hospital affiliated with Shanghai University of Traditional Chinese Medicine, and all patients signed informed consent forms.

[0074] 2. Diagnostic criteria 2.1 Western Medicine Diagnostic Criteria OSAHS diagnostic criteria: Referring to the 2015 Guidelines for the Diagnosis and Treatment of Obstructive Sleep Apnea-Hypopnea Syndrome (Primary Care Version), patients must meet the following conditions: (1) Having at least two major risk factors, especially obesity, short and thick neck or micrognathia or mandibular retrusion, pharyngeal stenosis or grade II tonsillar hypertrophy, uvula hypertrophy, or hypothyroidism, acromegaly or significant neurological abnormalities. (2) Moderate to severe snoring, irregular nighttime breathing, or breath-holding and waking up gasping for air (observation time not less than 15 minutes). (3) Disruption of nighttime sleep rhythm, especially frequent awakenings; (4) Daytime sleepiness (ESS score > 9 points); (5) The SpO2 monitoring trend chart shows typical changes, and the oxygen desaturation index (ODI) is >10 times / hour; (6) Causes damage to one or more vital organs.

[0075] ED diagnostic criteria: Refer to the 2018 AUA Guidelines for the Diagnosis and Treatment of Erectile Dysfunction: (1) The penis is unable to achieve or maintain a sufficient erection to complete satisfactory sexual intercourse, and the course of the disease is more than 3 months; (2) Severity grading criteria: The International Erectile Function Scale (IIEF-5) is used for assessment. An IIEF-5 score <21 is sufficient to diagnose ED, with 12-21 being mild ED, 8-11 being moderate ED, and 5-7 being severe ED.

[0076] Diagnostic requirements: The patient must meet the clinical diagnosis of both OSAHS and ED, and the scale evaluation and laboratory test must support the diagnosis. The diagnosis of ED must not be earlier than the diagnosis of OSAHS, and the two must have a causal relationship in the patient's medical history.

[0077] 2.2 Diagnostic Criteria for Traditional Chinese Medicine Syndromes Based on the relevant symptoms in the "Guiding Principles for Clinical Research on New Traditional Chinese Medicine Drugs for the Treatment of Erectile Dysfunction," the following diagnostic criteria for erectile dysfunction of the Qi deficiency, phlegm-dampness, and blood stasis type are proposed: Main evidence: (1) Penis is flaccid and cannot be erect, or can be erect but not firm, or can be firm but not for long; (2) Snoring during sleep, with occasional pauses; (3) Low libido; (4) Occasionally there is stinging pain in the lower abdomen and perineum, or accompanied by stinging pain during ejaculation.

[0078] Sub-certificate: (1) Usually, he is listless, sleepy, and forgetful; (2) Feeling chest tightness or chest pain; (3) Dry mouth and bitter taste; (4) The tongue is large and dark, with a thick white coating, or accompanied by bluish-purple veins under the tongue, and a deep, hesitant or wiry and slippery pulse.

[0079] Diagnostic criteria: The diagnosis can be made if the main symptoms (1) and (2) are present, along with any other main symptoms, and one secondary symptom and tongue and pulse symptoms are also present.

[0080] 3. Case selection criteria 3.1 Inclusion Criteria (1) Meets both the above-mentioned diagnostic criteria in traditional Chinese medicine and Western medicine; (2) Male married patients aged 20-55 years with normal libido, and who can guarantee the willingness and conditions to try sexual intercourse with their spouse during the treatment period; sexual intercourse should be conducted at least once every 2 weeks during the treatment period, and at least 4 times throughout the entire course of treatment; (3) The course of the disease is longer than 6 months, and there has been regular heterosexual sexual relations in the past 6 months; (4) No other medications or methods for treating ED have been used or discontinued within 3 months prior to treatment.

[0081] 3.2 Exclusion Criteria (1) Age < 20 years or > 55 years; (2) Any serious psychological abnormalities, or allergies to traditional Chinese medicine; (3) History of alcohol poisoning or drug abuse; (4) Patients with acute prostatitis, urethritis, penile lesions, urinary tract stones, spinal cord injury, etc.; exclude vascular ED and gonad-related diseases; (5) Any serious psychological abnormality or use of psychotropic drugs; (6) Those who use hormones, sedatives, antihypertensive drugs, antidepressants, diuretics, etc. for a long time; (7) Those suffering from severe cerebrovascular disease, cardiovascular disease, neuropathy, hematopoietic system disease, liver and kidney dysfunction, or other complications caused by diabetes; (8) Those with erosion, ulceration, blisters, suppuration, or skin damage at the site of penile involvement. 4. Treatment methods 4.1 Basic treatment (applicable to both groups) All patients received the following basic treatment: (1) OSAHS health education and popular science, and receiving medical nutrition guidance; (2) Engage in active physical exercise, reduce body fat, control weight, and monitor changes in the condition; (3) Patients are required to quit smoking and limit alcohol consumption; (4) Breathing trainer therapy: Before training, the patient should clean their mouth, rinse with saline solution, and sit down after confirming that their basic vital signs (heart rate, blood oxygen saturation) are stable. Adjust the seat height so that the hips and knees form a 90° angle, and both feet are flat on the ground. Connect the outer shell, mouthpiece, and threaded tube of the trainer and place it vertically. After breathing is stable, put the mouthpiece in your mouth and inhale at a steady pace until the float rises to the highest point. Hold your breath for a moment and then exhale normally. Training intensity: In the initial stage, start with 15% of the patient's maximum inspiratory pressure (PImax). Gradually increase the intensity by 5%-10% within one week, and maintain it at 60% of PImax after one month. Train for 15 minutes each morning and evening. If dizziness, chest tightness, shortness of breath, or other discomfort occurs during training, stop training immediately and administer oxygen. Reassess the training intensity after the symptoms subside.

[0082] 4.2 Control group treatment In addition to basic treatment, the control group received magnetic bead auricular acupressure therapy: Acupoints: Shenmen (HT7), Sympathetic, Subcortical, Heart, Lung, Spleen, Kidney, Anterior Vagina, Throat.

[0083] Instructions: Place one Vaccaria seed on a small square of adhesive tape (0.7 cm x 0.7 cm). Locate the sensitive point on the selected ear acupoint, apply the tape to the sensitive point, and then use your index finger and thumb to press and knead until you feel soreness, heaviness, numbness, tingling, or pain, indicating that you have obtained the Qi sensation. Repeat this process three times daily until you experience the aforementioned sensations.

[0084] Application method: Apply to one ear at a time (apply to the left ear first, then the right ear), alternating between the two ears.

[0085] Treatment course: One course of treatment consists of 12 consecutive weeks.

[0086] 4.3 Treatment group In addition to the treatment of the control group (basic treatment + magnetic bead ear acupressure), the treatment group was given Jinghonghanwei decoction (using the formula described in Example 2).

[0087] Usage: Oral administration, 200mL each time, twice a day, taken warm. One course of treatment is 12 weeks.

[0088] 5. Observation Indicators Each observation item was tested and evaluated within one week before treatment and within one week after the end of 12 weeks of treatment.

[0089] 5.1 Baseline Items Age, body mass index (BMI), disease duration, and disease severity.

[0090] 5.2 Therapeutic Indicators (1) Main observation indicators: International Erectile Function Questionnaire-15 (IIEF-15) score. The IIEF-15 includes 5 dimensions: erectile function (questions 1-5 and 15, a total of 6 questions, with a full score of 30 points), penetration satisfaction (questions 6-8, a total of 3 questions, with a full score of 15 points), orgasm (questions 9-10, a total of 2 questions, with a full score of 10 points), libido (questions 11-12, a total of 2 questions, with a full score of 10 points), and overall satisfaction (questions 13-14, a total of 2 questions, with a full score of 10 points), with a total score of 75 points.

[0091] (2) Secondary observation indicators: Apnea-hypopnea index (AHI); Minimum percutaneous arterial oxygen saturation (LSpO2); Traditional Chinese Medicine syndrome scoring for Qi deficiency and phlegm stasis (refer to Appendix F standard).

[0092] 5.3 Safety Observation Indicators Measure the subject's blood pressure and heart rate; Detect liver and kidney function (ALT, AST, Scr); Inquire about any penile discomfort or drug allergies during the treatment process.

[0093] 6. Efficacy evaluation criteria Referring to the 2018 AUA Guidelines for the Diagnosis and Treatment of Erectile Dysfunction [2], the IIEF-15 score was used to assess the efficacy. The formula for calculating the improvement score is as follows: Improvement rate (%) = [(Total score after treatment - Total score before treatment) / Total score before treatment] × 100%.

[0094] Clinical cure: IIEF-15 score ≥ 60 after treatment; Significant effect: IIEF-15 score < 60 after treatment, and score improvement rate ≥ 60%; Effective: IIEF-15 score < 60 after treatment, and 30% ≤ score improvement rate < 60%; Ineffective: IIEF-15 score < 60 after treatment, and score improvement rate < 30%.

[0095] Overall effective rate (%) = (Number of clinically cured cases + Number of cases with significant improvement + Number of effective cases) / Total number of cases × 100%.

[0096] 7. Handling of Adverse Events Anticipate and identify potential adverse events. After an adverse event occurs, record detailed information including the nature, severity, duration, and impact on the subject. Based on the nature and severity of the adverse event, take appropriate measures, such as suspending treatment, adjusting dosage or frequency, etc.

[0097] 8. Statistical methods Statistical software was used for data analysis.

[0098] For continuous variables: First, test the data distribution characteristics (normality test and homogeneity of variance analysis). When the parametric test conditions are met, use the t-test: use the independent samples t-test for between-group differences, and use the paired t-test for within-group comparisons. Statistical descriptions are presented in the form of mean ± standard deviation (x ± s).

[0099] Nonparametric tests: If the data distribution deviates from the normality assumption or the variances are unequal, nonparametric statistical methods such as the Mann-Whitney U test should be used instead.

[0100] For count data: use the chi-square test or the rank-sum test.

[0101] Significance level: The hypothesis test was a two-tailed test, with P < 0.05 considered statistically significant.

[0102] 9. Results 9.1 Case Completion Status This trial included 90 cases, randomly divided into a treatment group and a control group, with 45 cases in each group. At the end of the trial, 6 cases dropped out in the treatment group (reasons for dropout: 3 lost to follow-up, 2 withdrew for personal reasons, and 1 failed to take medication as prescribed), and 6 cases dropped out in the control group (reasons for dropout: 4 lost to follow-up and 2 withdrew for personal reasons). Ultimately, 39 valid cases from each group completed this clinical study, with a completion rate of 86.67%.

[0103] 9.2 Baseline Data Comparison Treatment group: age 25-55 years, mean (36.77±7.58) years; disease duration 3-36 months, mean (12.97±8.53) months.

[0104] Control group: age 24-55 years, mean (37.51±8.69) years; disease duration 3-36 months, mean (13.49±11.22) months.

[0105] There were no statistically significant differences between the two groups of patients in terms of baseline data such as age, disease duration, and pre-treatment IIEF-15 score (P>0.05), making them comparable.

[0106] 9.3 Comparison of treatment efficacy between the two groups of patients 9.3.1 Comparison of Overall Effectiveness Compared with the control group, the treatment group showed a more significant improvement in the overall effective rate of IIEF-15 score (P<0.05). The results are shown in Table 4.

[0107] Table 4. Effectiveness of IIEF-15 scores in both groups of patients Note: Comparison between the treatment group and the control group: # indicates P<0.05.

[0108] 9.3.2 Comparison of total IIEF-15 score and scores for each sub-item Before treatment, there was no statistically significant difference in IIEF-15 scores between the two groups (P > 0.05). After treatment, the total scores and individual sub-scores of both groups improved compared to before treatment (P < 0.05), and the improvement in the treatment group was greater than that in the control group, with statistically significant differences between the groups (P < 0.05). The results are shown in Table 5.

[0109] Table 5. Comparison of total IIEF-15 scores and sub-scores between the two groups (x±s) Note: Comparison before and after treatment within the group: P<0.05; Comparison between the treatment group and the control group: #P<0.05.

[0110] 9.3.3 Comparison of TCM syndromes, AHI, and LSPO2 scores between the two groups Before treatment, there were no statistically significant differences in the total score, AHI index, and LSpO2 of the TCM syndrome of Qi deficiency and phlegm stasis between the two groups (P>0.05). After treatment, the total score, AHI index, and LSpO2 of the TCM syndrome were significantly improved in both groups (P<0.05); the improvement in the treatment group was more significant than that in the control group (P<0.05). The results are shown in Table 6.

[0111] Table 6 Comparison of TCM syndromes, AHI, and LSpO2 scores between the two groups of patients Note: Comparison before and after treatment within the group: P<0.05; Comparison between the treatment group and the control group: #P<0.05.

[0112] 9.4 Comparison of Safety Indicators During the research period: Adverse events: In the treatment group, one patient experienced bloating and another experienced loose stools after taking the traditional Chinese medicine. These patients were instructed to heat the medicine before taking it warm, after meals, and their symptoms subsided spontaneously. No significant adverse events were observed in the control group.

[0113] Other safety: No other subjects experienced drug-related adverse events such as serious gastrointestinal symptoms (e.g., vomiting, abdominal distension) or skin allergic reactions (e.g., itching, rash).

[0114] Vital signs: Blood pressure and heart rate parameters of both groups of subjects remained within the physiological fluctuation range during the treatment period.

[0115] Laboratory tests showed that serum ALT, AST, and Scr levels were all within the normal thresholds at baseline and after intervention, indicating that the treatment regimen in this study did not have a significant impact on liver and kidney function.

[0116] The results of this experiment show that, on the basis of basic treatment combined with auricular acupressure, the addition of Jinghonghanwei Formula (a traditional Chinese medicine composition of this invention, formula of Example 2) to treat patients with OSAHS hypoxia complicated with erectile dysfunction (H-ED) for 8 weeks resulted in a total effective rate of 76.92% in the treatment group, which was significantly better than the 30.77% in the control group (P<0.05). The treatment group showed significant improvement in the total IIEF-15 score and scores in all dimensions of erectile function, penetration satisfaction, orgasm, libido, and overall satisfaction (P<0.05), and the degree of improvement was significantly better than that in the control group (P<0.05). The treatment group also showed a significant reduction in TCM syndrome score and AHI index and an increase in LSpO2 level (P<0.05), and the improvement in TCM syndrome score and LSpO2 level was better than that in the control group, indicating that this formula not only improves ED but also improves the core pathological indicators of OSAHS. The adverse reactions during the treatment were mild (only 2 cases of mild gastrointestinal reactions, which were relieved after adjustment), and there was no significant effect on blood pressure, heart rate, liver and kidney function, indicating that the formula is safe for clinical use.

[0117] In summary, the herbal composition of this invention can effectively improve the clinical symptoms of erectile dysfunction caused by OSAHS hypoxia, improve patients' erectile function, penetration satisfaction, orgasm, libido and overall sexual satisfaction, and improve OSAHS-related AHI index and LSpO2 score. It has few side effects, is clinically safe and effective, and has value for further promotion and application.

[0118] Experimental Example 3 The purpose of this experimental example is to compare the therapeutic effects of the traditional Chinese medicine composition of the present invention (the improved Jinghongfang) with the Junchenfang previously used by the applicant. Explanation: Junxiangfang is an empirical formula previously used by the applicant to treat refractory ED. The entire formula mainly functions to invigorate qi and unblock meridians, promote blood circulation, tonify the kidneys, and soothe the liver. Targeting the pathogenesis of OSAHS-ED involving lung, spleen, and kidney deficiency, and phlegm and blood stasis, Junxiangfang adds Erchentang to resolve phlegm and eliminate dampness, forming Junchenfang. This was the version of Jinghongfang (the traditional Chinese medicine composition of the present invention) used by the applicant to treat OSAHS-ED before its improvement. Later, the medicine was improved based on Junchenfang to become Jinghongfang.

[0119] 1. General Information This retrospective study included 141 young and middle-aged patients with obstructive sleep apnea syndrome (OSAHS-ED) of Qi deficiency and phlegm stasis syndrome treated at the outpatient and inpatient wards of the Department of Andrology and Urology of Qinghai Provincial Hospital of Traditional Chinese Medicine and Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine from May 2023 to May 2026. Patients were divided into two groups based on the different Chinese herbal formulas used: a Jinghonghanwei formula group (n=70) and a Junchen formula (Junxiang formula + Erchen decoction) group (n=71).

[0120] 2. Diagnostic criteria 2.1 Western Medicine Diagnostic Criteria OSAHS diagnostic criteria: Referring to the 2015 Guidelines for the Diagnosis and Treatment of Obstructive Sleep Apnea-Hypopnea Syndrome (Primary Care Version), patients must meet the following conditions: (1) Having at least two major risk factors, especially obesity, short and thick neck or micrognathia or mandibular retrusion, pharyngeal stenosis or grade II tonsillar hypertrophy, uvula hypertrophy, or hypothyroidism, acromegaly or significant neurological abnormalities. (2) Moderate to severe snoring, irregular nighttime breathing, or breath-holding and waking up gasping for air (observation time not less than 15 minutes). (3) Disruption of nighttime sleep rhythm, especially frequent awakenings; (4) Daytime sleepiness (ESS score > 9 points); (5) The SpO2 monitoring trend chart shows typical changes, and the oxygen desaturation index (ODI) is >10 times / hour; (6) Causes damage to one or more vital organs.

[0121] ED diagnostic criteria: Refer to the 2018 AUA Guidelines for the Diagnosis and Treatment of Erectile Dysfunction: (1) The penis is unable to achieve or maintain a sufficient erection to complete satisfactory sexual intercourse, and the course of the disease is more than 3 months; (2) Severity grading criteria: The International Erectile Function Scale (IIEF-5) is used for assessment. An IIEF-5 score <21 is sufficient to diagnose ED, with 12-21 being mild ED, 8-11 being moderate ED, and 5-7 being severe ED.

[0122] Diagnostic requirements: The patient must meet the clinical diagnosis of both OSAHS and ED, and the scale evaluation and laboratory test must support the diagnosis. The diagnosis of ED must not be earlier than the diagnosis of OSAHS, and the two must have a causal relationship in the patient's medical history.

[0123] 2.2 Diagnostic Criteria for Traditional Chinese Medicine Syndromes Based on the relevant symptoms in the "Guiding Principles for Clinical Research on New Traditional Chinese Medicine Drugs for the Treatment of Erectile Dysfunction," the following diagnostic criteria for erectile dysfunction of the Qi deficiency, phlegm-dampness, and blood stasis type are proposed: Main evidence: (1) Penis is flaccid and cannot be erect, or can be erect but not firm, or can be firm but not for long; (2) Snoring during sleep, with occasional pauses; (3) Low libido; (4) Occasionally there is stinging pain in the lower abdomen and perineum, or accompanied by stinging pain during ejaculation.

[0124] Sub-certificate: (1) Usually, he is listless, sleepy, and forgetful; (2) Feeling chest tightness or chest pain; (3) Dry mouth and bitter taste; (4) The tongue is large and dark, with a thick white coating, or accompanied by bluish-purple veins under the tongue, and a deep, hesitant or wiry and slippery pulse.

[0125] Diagnostic criteria: The diagnosis can be made if the main symptoms (1) and (2) are present, along with any other main symptoms, and one secondary symptom and tongue and pulse symptoms are also present.

[0126] 3. Case selection criteria 3.1 Inclusion Criteria (1) Meets both the above-mentioned diagnostic criteria in traditional Chinese medicine and Western medicine; (2) Married young and middle-aged male patients aged 20-45 years with normal libido, and who can guarantee the willingness and conditions to try sexual intercourse with their spouse during the treatment period; sexual intercourse should be conducted at least once every 2 weeks during the treatment period, and at least 4 times during the entire course of treatment; (3) The course of the disease is longer than 6 months, and there has been regular heterosexual sexual relations in the past 6 months; (4) No other medications or methods for treating ED have been used or discontinued within 3 months prior to treatment.

[0127] 3.2 Exclusion Criteria (1) Age < 20 years or > 45 years; (2) Any serious psychological abnormalities, or allergies to traditional Chinese medicine; (3) History of alcohol poisoning or drug abuse; (4) Patients with acute prostatitis, urethritis, penile lesions, urinary tract stones, spinal cord injury, etc.; exclude vascular ED and gonad-related diseases; (5) Any serious psychological abnormality or use of psychotropic drugs; (6) Those who use hormones, sedatives, antihypertensive drugs, antidepressants, diuretics, etc. for a long time; (7) Those suffering from severe cerebrovascular disease, cardiovascular disease, neuropathy, hematopoietic system disease, liver and kidney dysfunction, or other complications caused by diabetes; (8) Those with erosion, ulceration, blisters, suppuration, or skin damage at the site of penile involvement. 4. Treatment methods 4.1 Basic treatment (applicable to both groups) All patients received the following basic treatment: (1) OSAHS health education and popular science, and receiving medical nutrition guidance; (2) Engage in active physical exercise, reduce body fat, control weight, and monitor changes in the condition; (3) Patients are required to quit smoking and limit alcohol consumption; (4) Breathing trainer therapy: Before training, the patient should clean their mouth, rinse with saline solution, and sit down after confirming that their basic vital signs (heart rate, blood oxygen saturation) are stable. Adjust the seat height so that the hips and knees form a 90° angle, and both feet are flat on the ground. Connect the outer shell, mouthpiece, and threaded tube of the trainer and place it vertically. After breathing is stable, put the mouthpiece in your mouth and inhale at a steady pace until the float rises to the highest point. Hold your breath for a moment and then exhale normally. Training intensity: In the initial stage, start with 15% of the patient's maximum inspiratory pressure (PImax). Gradually increase the intensity by 5%-10% within one week, and maintain it at 60% of PImax after one month. Train for 15 minutes each morning and evening. If dizziness, chest tightness, shortness of breath, or other discomfort occurs during training, stop training immediately and administer oxygen. Reassess the training intensity after the symptoms subside.

[0128] 4.2 Treatment with Jun-Chen Formula Group (Jun-Xiang Formula + Er-Chen Decoction) In addition to the basic treatment, Jianfu Junxiang Formula + Er Chen Decoction were added to the treatment: Ginseng 6g, Ilex pubescens 30g, safflower 6g, Panax notoginseng 15g, Astragalus membranaceus 30g, Cnidium monnieri 15g, Lycium barbarum 15g, Epimedium 15g, Cynomorium songaricum 12g, Rehmannia glutinosa 15g, Bupleurum chinense 9g, Citrus aurantium 6g, Tribulus terrestris 15g, Ligusticum chuanxiong 9g, Prunus persica 9g, one large centipede + Citrus reticulata peel 6g, processed Pinellia ternata 9g, Poria cocos 15g, Glycyrrhiza uralensis 6g.

[0129] Usage: Oral administration, 150mL each time, twice a day, taken warm. One course of treatment is 12 weeks.

[0130] 4.3 Treatment with Jinghong Formula In addition to basic treatment, Jinghong (Snoring) Decoction (using the formula from Example 1) was added.

[0131] Polygonatum 30g, American ginseng 6g, Rhodiola rosea 12g, Salvia miltiorrhiza 30g, Cistanche deserticola 15g, Ginkgo biloba leaf 15g, Ilex pubescens 30g, Carthamus tinctorius 6g, Lycium barbarum 15g, Morinda officinalis 12g, Angelica sinensis 12g, Atractylodes macrocephala 15g, Poria cocos 15g, Citrus reticulata peel 6g, Sinapis alba 12g, Acorus tatarinowii 12g, Glycyrrhiza uralensis 6g, Cinnamomum cassia 9g, Pheretima aspergillum 9g, and Panax notoginseng powder 3g.

[0132] Usage: Oral administration, 150mL each time, twice a day, taken warm. One course of treatment is 12 weeks.

[0133] 5. Observation Indicators Each observation item was tested and evaluated within one week before treatment and within one week after the end of 12 weeks of treatment.

[0134] 5.1 Baseline Items Age, body mass index (BMI), disease duration, and disease severity.

[0135] 5.2 Therapeutic Indicators (1) Main observation indicators: International Erectile Function Questionnaire-15 (IIEF-15) score. The IIEF-15 includes 5 dimensions: erectile function (questions 1-5 and 15, a total of 6 questions, with a full score of 30 points), penetration satisfaction (questions 6-8, a total of 3 questions, with a full score of 15 points), orgasm (questions 9-10, a total of 2 questions, with a full score of 10 points), libido (questions 11-12, a total of 2 questions, with a full score of 10 points), and overall satisfaction (questions 13-14, a total of 2 questions, with a full score of 10 points), with a total score of 75 points.

[0136] (2) Secondary observation indicators: Serum reproductive hormone levels were detected using enzyme-linked immunosorbent assay (ELISA), with a focus on monitoring key indicators of the hypothalamic-pituitary-gonadal axis. Hormones secreted by the anterior pituitary gland: follicle-stimulating hormone (FSH), luteinizing hormone (LH), and prolactin (PRL); Gonadal steroid hormones: serum total testosterone (TT), estradiol (E2).

[0137] 5.3 Safety Observation Indicators Measure the subject's blood pressure and heart rate; Detect liver and kidney function (ALT, AST, Scr); Inquire about any penile discomfort or drug allergies during the treatment process.

[0138] 6. Efficacy evaluation criteria Referring to the 2018 AUA Guidelines for the Diagnosis and Treatment of Erectile Dysfunction [2], the IIEF-15 score was used to assess the efficacy. The formula for calculating the improvement score is as follows: Improvement rate (%) = [(Total score after treatment - Total score before treatment) / Total score before treatment] × 100%.

[0139] Clinical cure: IIEF-15 score ≥ 60 after treatment; Significant effect: IIEF-15 score < 60 after treatment, and score improvement rate ≥ 60%; Effective: IIEF-15 score < 60 after treatment, and 30% ≤ score improvement rate < 60%; Ineffective: IIEF-15 score < 60 after treatment, and score improvement rate < 30%.

[0140] Overall effective rate (%) = (Number of clinically cured cases + Number of cases with significant improvement + Number of effective cases) / Total number of cases × 100%.

[0141] 7. Handling of Adverse Events Anticipate and identify potential adverse events. After an adverse event occurs, record detailed information including the nature, severity, duration, and impact on the subject. Based on the nature and severity of the adverse event, take appropriate measures, such as suspending treatment, adjusting dosage or frequency, etc.

[0142] 8. Statistical methods Statistical software was used for data analysis.

[0143] For continuous variables: First, test the data distribution characteristics (normality test and homogeneity of variance analysis). When the parametric test conditions are met, use the t-test: use the independent samples t-test for between-group differences, and use the paired t-test for within-group comparisons. Statistical descriptions are presented in the form of mean ± standard deviation (x ± s).

[0144] Nonparametric tests: If the data distribution deviates from the normality assumption or the variances are unequal, nonparametric statistical methods such as the Mann-Whitney U test should be used instead.

[0145] For count data: use the chi-square test or the rank-sum test.

[0146] Significance level: The hypothesis test was a two-tailed test, with P < 0.05 considered statistically significant.

[0147] 9. Results 9.1 Case Completion Status This retrospective trial included a total of 141 cases, with 70 cases in the Jinghongfang group and 71 cases in the Junchenfang group.

[0148] 9.2 Baseline Data Comparison Jun Chenfang group: age 20-45 years, mean (37.06±6.23) years; disease duration 6-33 months, mean (13.49±8.61) months.

[0149] The Jinghongfang group: age 24-45 years, mean (35.46±6.10) years; disease duration 6-36 months, mean (12.43±7.39) months.

[0150] There were no statistically significant differences between the two groups of patients in terms of baseline data such as age, disease duration, and pre-treatment IIEF-15 score (P>0.05), making them comparable.

[0151] 9.3 Comparison of treatment efficacy between the two groups of patients 9.3.1 Comparison of Overall Effectiveness Compared with the control group, the treatment group showed a more significant improvement in the overall effective rate of IIEF-15 score (P<0.05). The results are shown in Table 4.

[0152] Table 4. Effectiveness of IIEF-15 scores in both groups of patients Note: Comparison between the treatment group and the control group: # indicates P=0.033<0.05.

[0153] 9.3.2 Comparison of total IIEF-15 score and scores for each sub-item Before treatment, there was no statistically significant difference in IIEF-15 scores between the two groups (P > 0.05). After treatment, the total scores and individual sub-scores of both groups improved compared to before treatment (P < 0.05), and the improvement in total score, erectile function, penetration satisfaction, and overall satisfaction was greater in the treatment group than in the control group, with statistically significant differences between the groups (P < 0.05). The results are shown in Table 5.

[0154] Table 5. Comparison of total IIEF-15 scores and sub-scores between the two groups (x±s) Note: Comparison before and after treatment within the group: P<0.05; Comparison between the treatment group and the control group: #P<0.05.

[0155] 9.3.3 Changes in sex hormone levels After 12 weeks of treatment, serum TT levels in both groups were significantly higher than before treatment (P < 0.05), while E2, FSH, LH, and PRL levels in the Jinghongfang group were significantly lower than before treatment (P < 0.05). The results are shown in Table 3.

[0156] Table 3 Comparison of sex hormones before and after treatment in patients with OSAHSED (H-ED) ± s) Note: Comparison before and after treatment within the group: P<0.05; Comparison between the treatment group and the control group: #P<0.05.

[0157] 9.4 Comparison of Safety Indicators During the research period: Adverse events: In the Junchenfang group, 3 patients experienced bloating and 6 patients experienced loose stools after taking the Chinese medicine; in the Jinghongfang group, 4 patients experienced bloating and 4 patients experienced loose stools after taking the Chinese medicine. Patients were instructed to heat the medicine and take it warm after meals, and the symptoms subsided spontaneously. No other significant adverse events were observed.

[0158] Other safety: No other subjects experienced drug-related adverse events such as serious gastrointestinal symptoms (e.g., vomiting, diarrhea) or skin allergic reactions (e.g., itching, rash).

[0159] Vital signs: Blood pressure and heart rate parameters of both groups of subjects remained within the physiological fluctuation range during the treatment period.

[0160] Laboratory tests showed that serum ALT, AST, and Scr levels were all within the normal thresholds at baseline and after intervention, indicating that the treatment regimen in this study did not have a significant impact on liver and kidney function.

[0161] The results of this trial showed that after 12 weeks of treatment with Jinghongfang (a traditional Chinese medicine composition of this invention, formulation of Example 1) in addition to basic treatment for patients with OSAHS hypoxia complicated by erectile dysfunction (H-ED), the total effective rate in the treatment group reached 65.71%, which was significantly better than the 47.89% in the Junchenfang group before modification (P<0.05). The modified Jinghongfang group showed significant improvements in the IIEF-15 total score and scores in all dimensions of erectile function, penetration satisfaction, orgasm, libido, and overall satisfaction (P<0.05). Furthermore, the total score, erectile function, penetration satisfaction, and overall satisfaction scores were significantly improved. The improvement in patient satisfaction was significantly better than that of the Junchen formula group before the modification (P<0.05); the Jinghong formula group significantly improved the levels of sex hormones such as TT, E2, LH, and PRL before and after treatment, and the improvement of LH and PRL was statistically different from that of the Junchen formula group (P<0.05), indicating that the Jinghong formula may affect OSAHS-ED at the sex hormone level and the effect is greater than that of the Junchen formula before the modification; the adverse reactions during the treatment were mild (mild gastrointestinal reactions, which were relieved after adjustment), and had no significant effect on blood pressure, heart rate, liver and kidney function, indicating that both groups of traditional Chinese medicine formulas are safe for clinical use.

[0162] In summary, the herbal composition of this invention can more effectively improve the clinical symptoms of erectile dysfunction caused by OSAHS hypoxia compared to the previous version, improve patients' erectile function, penetration satisfaction, orgasm, libido and overall sexual satisfaction, while improving the levels of sex hormones such as TT related to OSAHS, with fewer side effects, clinical safety and effectiveness, and has value for further promotion and application.

[0163] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating sleep apnea syndrome complicated with erectile dysfunction, characterized in that, It is composed of the following raw materials in parts by weight: Polygonatum sibiricum 20-30 parts, American ginseng 3-6 parts, Rhodiola rosea 6-12 parts, Salvia miltiorrhiza 30 parts, Atractylodes macrocephala 12-30 parts, Cistanche deserticola 9-15 parts, Angelica sinensis 9-12 parts, Lycium barbarum 12-15 parts, Morinda officinalis 9-12 parts, Ilex pubescens 30 parts, Ginkgo biloba 12-15 parts, Carthamus tinctorius 3-6 parts, Poria cocos 12-15 parts, Citrus reticulata peel 6-9 parts, Sinapis alba 9-15 parts, Acorus tatarinowii 6-12 parts, Glycyrrhiza uralensis 6 parts, Cinnamomum cassia 6-9 parts, Pheretima aspergillum 6-9 parts, and Panax notoginseng powder 2-3 parts.

2. The use of the traditional Chinese medicine composition according to claim 1 in the preparation of a medicament for treating sleep apnea syndrome complicated with erectile dysfunction.

3. The application according to claim 2, characterized in that, The sleep apnea syndrome mentioned is obstructive sleep apnea syndrome.

4. A pharmaceutical preparation for treating sleep apnea syndrome complicated with erectile dysfunction, characterized in that, The active ingredient of the pharmaceutical preparation includes the traditional Chinese medicine combination described in claim 1.

5. The pharmaceutical preparation according to claim 4, characterized in that, It also includes pharmaceutically acceptable carriers or excipients.

6. The pharmaceutical preparation according to claim 4, characterized in that, The dosage forms of the pharmaceutical preparations include decoctions, granules, capsules, or tablets.

7. The pharmaceutical preparation according to claim 4, characterized in that, The sleep apnea syndrome mentioned is obstructive sleep apnea syndrome.

8. A method for preparing a pharmaceutical formulation according to any one of claims 4-7, characterized in that, Includes the following steps: (1) Weigh out the 19 raw materials except for Panax notoginseng powder according to the weight, and wash them to remove impurities; (2) Place the above 19 herbs in a decoction container and add water to soak them; (3) After boiling over high heat, reduce to low heat and simmer. Filter and collect the first decoction. (4) Add water to the dregs, bring to a boil over high heat, then simmer over low heat, filter, and collect the second decoction. (5) Combine the two decoctions, concentrate and cool them, add Panax notoginseng powder, stir evenly, and obtain the drug preparation.

9. The preparation method according to claim 8, characterized in that, In step (2), the amount of water added is 8-10 times the total weight of the 19 herbs; in step (4), the amount of water added is 6-8 times the total weight of the dregs.

10. The preparation method according to claim 8, characterized in that, In step (3), the simmering time is 20-30 minutes.

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