Traditional Chinese medicine composition for treating obstructive sleep apnea hypopnea syndrome

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating obstructive sleep apnea hypopnea syndrome, which is prepared from the following raw material medicines: raw ephedra, cassia twig, gentian, asarum, schisandra chinensis, processed pinellia ternate, bitter apricot kernel, astragalus membranaceus, raw liquorice, dried rehmannia root, scutellaria baicalensis, dried ginger, fried fructus aurantii, fried white paeony root, Chinese yam, gordon euryale seed, rhizoma acori graminei, medicated leaven and semen lepidii. Aiming at the symptoms and pathogenesis of the obstructive sleep apnea-hypopnea syndrome, the traditional Chinese medicine composition adopts the treatment principles of pungent-warm joint drinking, phlegm eliminating, blood stasis dispersing, spleen strengthening and snore removing, and is low in raw material cost, simple and convenient to prepare, convenient to use, small in side effect, capable of being taken for a long time and free of toxic and side effects. The traditional Chinese medicine composition has a good clinical curative effect on the obstructive sleep apnea hypopnea syndrome.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and specifically, to a traditional Chinese medicine composition for treating obstructive sleep apnea hypopnea syndrome and its application. Background Art

[0002] Obstructive sleep apnea hypopnea syndrome (OSAHS) refers to apnea and hypoventilation caused by upper airway obstruction due to various reasons during sleep, accompanied by symptoms such as snoring, sleep structure disorder, hypoxemia, daytime sleepiness, mood abnormalities, etc. In recent years, OSAHS has gradually attracted attention. The incidence of OSAHS shows an increasing trend year by year, and there is a lack of effective treatment methods. Therefore, the research on the effective treatment of this disease is of great significance.

[0003] During sleep, there is snoring with irregular snoring sounds, disordered breathing and sleep rhythms, repeated apnea and awakening, or the patient feels suffocated, increased nocturia, morning headache, dry mouth. Due to repeated awakening and awakening reactions in the cerebral cortex at night, the normal sleep structure rhythm is disrupted, the sleep efficiency is significantly reduced, and daytime sleepiness and memory decline occur. In severe cases, psychological, intellectual, and behavioral abnormalities may occur, and even multi-organ and multi-system damage throughout the body may be caused. And it may be combined with hypertension, coronary heart disease, arrhythmia, especially slow-fast arrhythmia, pulmonary heart disease, stroke, type 2 diabetes and insulin resistance, etc., and there may be progressive weight gain. It has become a potentially fatal chronic systemic sleep disease.

[0004] At present, the treatment of obstructive sleep apnea hypopnea syndrome in Western medicine mainly includes general treatment, non-invasive positive pressure ventilation treatment and surgical treatment. There are also drug treatment, oral appliance treatment, transcutaneous electrical stimulation treatment, etc. General treatment includes weight loss, diet and weight control, and appropriate exercise. However, most patients have poor mobility and the effect is poor. Continuous positive airway pressure (CPAP) is the preferred method for the treatment of OSAHS and is also the most effective treatment method recognized at present. However, clinical studies have found that most patients have poor compliance with this treatment method, which limits its clinical application. Surgical treatment is only applicable to patients with clear airway stenosis. The cause of upper airway stenosis is removed from the source. Different surgical methods are selected according to the location and degree of airway obstruction in patients. However, it has little effect on patients without obvious airway stenosis. There is no specific drug for the treatment of OSAHS. However, with the in-depth research, the clinical understanding of its pathogenesis has been improved. At present, some drugs have been applied in clinical treatment, but the number of cases is limited. There is still a lack of large-scale, multi-center clinical studies to further confirm its effectiveness and safety. Its mechanism of action still needs to be further studied and clarified, and the effect of controlling the number of apnea is not good. Transcutaneous electrical nerve stimulation treatment is applicable to OSAHS patients who cannot tolerate CPAP treatment, are not suitable for oral appliance treatment, and have no obvious upper airway anatomical obstruction. Oral appliance treatment is applicable to patients with simple snoring and mild to moderate or position-dependent OSAHS, especially those with mandibular retrusion. Therefore, the course of treatment or cost of the overall treatment measures is relatively high, the clinical compliance is difficult to maintain, the curative effect is not significant, and obstructive sleep apnea hypopnea syndrome is a major research topic in the field of respiration.

[0005] There is no record of the syndrome differentiation and typing of OSAHS in traditional Chinese medical classics. At present, there is still a lack of unified syndrome differentiation and typing, the diagnostic criteria are not standardized, and the treatment mainly relies on personal clinical experience, mostly adopting the treatment methods of removing dampness, resolving phlegm, promoting blood circulation, and tonifying deficiency. OSAHS is a syndrome of deficiency in origin and excess in superficiality. The deficiency in origin is mainly due to insufficient congenital endowment, deficiency and damage of the lungs, spleen and kidneys, or qi deficiency, yin deficiency, and yang deficiency. The excess in superficiality is mainly due to phlegm-dampness, blood stasis, and unfavorable qi transformation of the triple energizer. Among them, phlegm-dampness is the main pathological factor, running through the whole process of OSAHS. Therefore, in terms of treatment, it is necessary to take the principle of removing dampness and resolving phlegm, and at the same time, take into account the causes of blood stasis formation and the differences between deficiency and excess. Chinese patent medicines such as Erchen Granules, Tongqiao Biyan Tablets, and Xuefu Zhuyu Pills can be taken orally, or decoctions adjusted according to personal circumstances. Acupuncture treatment can also be used, selecting acupoints such as Zusanli, Fenglong, Feishu, Yanglingquan, and Xuehai for acupuncture treatment; acupoint catgut embedding can also be performed, selecting acupoints such as Zusanli, Fenglong, and Feishu for embedding; or auricular point pressing pills can be used, selecting auricular point areas such as Shenmen, Sympathetic, and Subcortex for treatment; acupoint application can be applied to acupoints such as the neck and Tanzhong. These drugs or methods have certain curative effects, but there are also some problems, such as slow onset of drugs, inconvenient preparation and use, troublesome operation, not very obvious effect, long taking time, unstable curative effect, and relatively high recurrence rate, etc.

[0006] However, there has been no report on a traditional Chinese medicine composition for the treatment of obstructive sleep apnea hypopnea syndrome with small side effects, low recurrence rate, and can be taken for a long time. Summary of the Invention

[0007] The purpose of the present invention is to provide a traditional Chinese medicine composition for the treatment of obstructive sleep apnea hypopnea syndrome with small side effects and can be taken for a long time in view of the deficiencies in the prior art.

[0008] In the first aspect of the present invention, there is provided a traditional Chinese medicine composition for the treatment of obstructive sleep apnea hypopnea syndrome, which is composed of the following raw materials in parts by weight: 6-12 parts of raw Ephedra, 6-12 parts of Cinnamon Twig, 6-9 parts of Gentiana, 3-6 parts of Asarum, 6-12 parts of Schisandra chinensis, 9-15 parts of processed Pinellia ternata, 6-12 parts of Bitter Apricot Kernel, 15-20 parts of Astragalus membranaceus, 6-9 parts of raw Licorice Root, 9-15 parts of Rehmannia glutinosa, 6-12 parts of Scutellaria baicalensis, 6-12 parts of Dried Ginger, 6-15 parts of stir-fried Fructus Aurantii, 10-20 parts of stir-fried White Peony Root, 10-20 parts of Chinese Yam, 10-20 parts of Gorgon Fruit, 10-20 parts of Acorus tatarinowii, 10-20 parts of Six-Flavored Divine Powder, 6-12 parts of Lepidium apetalum.

[0009] Further, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 9 parts of raw Ephedra, 12 parts of Cinnamon Twig, 6 parts of Gentiana, 3 parts of Asarum, 9 parts of Schisandra chinensis, 12 parts of processed Pinellia ternata, 9 parts of Bitter Apricot Kernel, 15 parts of Astragalus membranaceus, 6 parts of raw Licorice Root, 12 parts of Rehmannia glutinosa, 9 parts of Scutellaria baicalensis, 6 parts of Dried Ginger, 12 parts of stir-fried Fructus Aurantii, 12 parts of stir-fried White Peony Root, 15 parts of Chinese Yam, 15 parts of Gorgon Fruit, 15 parts of Acorus tatarinowii, 15 parts of Six-Flavored Divine Powder, 12 parts of Lepidium apetalum.

[0010] In a second aspect of the present invention, there is provided a traditional Chinese medicine compound preparation using the above-mentioned traditional Chinese medicine composition as an active ingredient, and the traditional Chinese medicine compound preparation is prepared into a commonly used pharmaceutical dosage form by a conventional preparation method in the art.

[0011] Furthermore, the dosage form of the traditional Chinese medicine compound preparation is decoction, tablet, capsule, granule, pill, oral liquid or syrup.

[0012] Furthermore, the traditional Chinese medicine compound preparation further includes pharmaceutically acceptable excipients.

[0013] In a third aspect of the present invention, there is provided an application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating obstructive sleep apnea hypopnea syndrome.

[0014] Furthermore, the traditional Chinese medicine syndrome type of the obstructive sleep apnea hypopnea syndrome is the syndrome type of internal obstruction of phlegm-dampness.

[0015] In a fourth aspect of the present invention, there is provided an application of the above-mentioned traditional Chinese medicine compound preparation in the preparation of a drug for treating obstructive sleep apnea hypopnea syndrome.

[0016] The traditional Chinese medicine compound preparation of the present invention is formulated on the basis of years of clinical practice, under the guidance of traditional Chinese medicine theory, by carefully selecting herbs and forming a prescription. This prescription is developed by Professor Wang Qingqi through studying the classics, referring to the medication characteristics of "Xiaoqinglong Decoction" in "Treatise on Febrile and Miscellaneous Diseases", extracting its essence, and combining clinical experience and modern pharmaceutical research results. It is modified by summarizing and inheriting the academic thought of "opposing and stimulating, reversing and following" of the master of traditional Chinese medicine, Mr. Qiu Peiran. In the moderate and severe phlegm-dampness obstruction syndrome of OSAHS, phlegm-dampness is the pathological basis of OSAHS, running through the whole process of the disease. The obstruction of phlegm-turbidity in the throat is its core pathogenesis. Over time, it stagnates and transforms into heat, resulting in the intermingling of phlegm, heat, and stasis. The pathogenesis is complex with cold, heat, deficiency, and excess. Therefore, the treatment method adopts the method of "opposing and stimulating, reversing and following", taking advantage of the opposite and stimulating properties of the herbs in this prescription to play a greater role, that is, the meaning of "complementary with the opposite". This prescription "eliminates fluid-retention with pungent-warm herbs, tonifies the lung and spleen to cut off the source of phlegm production", and "clears the lung with bitter-cold herbs, promotes the flow of lung qi" to clear the latent phlegm and stagnant heat, jointly achieving the effect of resolving phlegm and eliminating snoring. In the prescription, raw Ephedra and Cinnamon Twig are used as the monarch herbs, promoting the dispersing and descending of lung qi to dispel pathogenic factors and resolve phlegm. Raw Ephedra is the key herb for dispersing lung qi, relieving asthma and stopping snoring. Cinnamon Twig calms the adverse qi rushing upward to stop snoring, warms and dredges the channels to resolve phlegm and stasis, promotes qi movement and water circulation to facilitate the transformation of internal fluid-retention. Gentiana is bitter and cold, which can descend the qi of the lung and stomach, clear the stagnant heat of the triple energizer. When the lung qi descends, snoring stops. The nose is the gateway to the pharynx. Asarum promotes the opening of the nasal orifices, combined with Dry Ginger to warm the lung and resolve fluid-retention, facilitating the elimination of phlegm-saliva, and assisting raw Ephedra and Cinnamon Twig to dredge the orifices and soothe the throat to dispel pathogenic factors. Bitter Apricot Kernel descends the lung qi to resolve phlegm. Raw Astragalus membranaceus tonifies the lung and spleen to tonify the qi of the triple energizer. Rehmannia glutinosa nourishes blood and yin. Prolonged snoring consumes qi and injures yin. The combination of the two herbs supplements qi and nourishes yin. Prepared Schisandra chinensis tonifies the lung, spleen, and kidney, astringes the lung qi, stops prolonged snoring and adverse qi rushing upward. Stir-fried White Peony Root harmonizes and nourishes nutrient blood. The combination of the two herbs with Ephedra and Cinnamon Twig combines astringency and dispersion, complements each other, can not only enhance the effect of stopping snoring and relieving asthma, but also restrict the excessive pungent, dispersing, warm, and dry properties of various herbs. Pinellia ternata processed with ginger dries dampness and resolves phlegm, harmonizes the stomach and subdues adverse qi. Acorus tatarinowii opens orifices and resolves phlegm. The combination of the two herbs eliminates stubborn phlegm. Honey-fried Fructus Aurantii Amarae relaxes the chest and regulates qi, disperses binds and relieves distension, making qi smooth and phlegm disappear. Scutellaria baicalensis clears heat and dries dampness to dispel stasis-phlegm, playing an antagonistic role. Dioscorea opposita and Euryale ferox enhance the function of strengthening the spleen, tonifying the kidney, and promoting diuresis. Lepidium apetalum enters the lung, dredges obstruction and relieves fullness, can regulate the flow of lung qi. Six-Flavored Powder is sweet in taste, breaking accumulation and expelling phlegm. The combination of the two herbs clears the airway. Licorice root is a good herb for soothing the throat and resolving phlegm, and also can harmonize various herbs. The whole prescription combines astringency and dispersion, combines cold and heat, combines warming and clearing, regulates yin and yang, complements each other, combines dispersing the lung and purging the lung, regulates the lung, strengthens the spleen and tonifies the kidney together, fitting the pathogenesis of the deficiency-excess complexity with yin-yang imbalance, phlegm-dampness blocking the throat, and disorder of qi movement of dispersion and descent in OSAHS. The compatibility of various herbs achieves the effects of "eliminating fluid-retention with pungent-warm herbs, removing phlegm and stasis, strengthening the spleen and eliminating snoring".

[0017] The advantages of the present invention are as follows:

[0018] In view of the symptoms and pathogenesis of obstructive sleep apnea hypopnea syndrome, the present invention adopts the treatment principles of dispelling pathogenic fluid with pungent-warm herbs, resolving phlegm and stasis, and strengthening the spleen to eliminate snoring. The raw materials of the traditional Chinese medicine composition are inexpensive, easy to prepare, convenient to use, with few side effects and can be taken for a long time. After years of clinical application, observation and analysis, the traditional Chinese medicine composition of the present invention can significantly improve the apnea hypopnea index level of patients, increase the lowest oxygen saturation level, relieve snoring at night, and has good curative effects in aspects such as dull snoring, apnea and waking up due to suffocation. It is indicated that the traditional Chinese medicine composition has significant therapeutic effects on patients with obstructive sleep apnea hypopnea syndrome, improves the overall rehabilitation level and quality of life of patients, and has good clinical curative effects. Given the large number of people suffering from obstructive sleep apnea hypopnea syndrome, which brings great physical and mental pain to patients, and the current western medicine treatment has poor effects and is prone to recurrence after drug withdrawal, the traditional Chinese medicine compound preparation provided by the present invention has good application prospects. Detailed Embodiments

[0019] The following detailed description of the specific embodiments provided by the present invention will be given in conjunction with the examples.

[0020] Example 1: The traditional Chinese medicine composition of the present invention

[0021] 6 parts of raw Ephedra, 6 parts of Cinnamon Twig, 6 parts of Gentiana, 3 parts of Asarum, 6 parts of Schisandra Chinensis, 9 parts of Prepared Pinellia, 6 parts of Bitter Apricot Kernel, 15 parts of Astragalus Membranaceus, 6 parts of Licorice Root, 9 parts of Rehmannia Glutinosa, 6 parts of Scutellaria Baicalensis, 6 parts of Dried Ginger, 6 parts of Stir-fried Fructus Aurantii, 10 parts of Stir-fried White Peony Root, 10 parts of Chinese Yam, 10 parts of Gorgon Fruit, 10 parts of Acorus Tatarinowii, 10 parts of Six-Flavor Medicinal Leaven, 6 parts of Lepidium Seed.

[0022] Example 2: The traditional Chinese medicine composition of the present invention

[0023] 8 parts of raw Ephedra, 8 parts of Cinnamon Twig, 7 parts of Gentiana, 4 parts of Asarum, 8 parts of Schisandra Chinensis, 10 parts of Prepared Pinellia, 8 parts of Bitter Apricot Kernel, 16 parts of Astragalus Membranaceus, 7 parts of Licorice Root, 10 parts of Rehmannia Glutinosa, 8 parts of Scutellaria Baicalensis, 8 parts of Dried Ginger, 9 parts of Stir-fried Fructus Aurantii, 15 parts of Stir-fried White Peony Root, 12 parts of Chinese Yam, 12 parts of Gorgon Fruit, 12 parts of Acorus Tatarinowii, 12 parts of Six-Flavor Medicinal Leaven, 8 parts of Lepidium Seed.

[0024] Example 3: The traditional Chinese medicine composition of the present invention

[0025] 9 parts of raw Ephedra, 12 parts of Cinnamon Twig, 6 parts of Gentiana, 3 parts of Asarum, 9 parts of Schisandra Chinensis, 12 parts of Prepared Pinellia, 9 parts of Bitter Apricot Kernel, 15 parts of Astragalus Membranaceus, 6 parts of Licorice Root, 12 parts of Rehmannia Glutinosa, 9 parts of Scutellaria Baicalensis, 6 parts of Dried Ginger, 12 parts of Stir-fried Fructus Aurantii, 12 parts of Stir-fried White Peony Root, 15 parts of Chinese Yam, 15 parts of Gorgon Fruit, 15 parts of Acorus Tatarinowii, 15 parts of Six-Flavor Medicinal Leaven, 12 parts of Lepidium Seed.

[0026] Example 4: The traditional Chinese medicine composition of the present invention

[0027] 10 parts of raw ephedra, 10 parts of cinnamon twig, 8 parts of gentian, 5 parts of asarum, 10 parts of schisandra, 14 parts of processed pinellia, 10 parts of bitter almond, 18 parts of astragalus, 8 parts of raw liquorice, 14 parts of raw rehmannia, 10 parts of scutellaria, 10 parts of dried ginger, 10 parts of stir-fried fructus aurantii, 18 parts of stir-fried white peony root, 18 parts of yam, 18 parts of euryale ferox, 18 parts of calamus, 18 parts of liushenqu, and 9 parts of scutellaria baicalensis.

[0028] Embodiment 5: Chinese medicine composition of the present invention

[0029] 12 parts of raw ephedra, 9 parts of cinnamon twig, 9 parts of gentian, 6 parts of asarum, 12 parts of schisandra, 15 parts of processed pinellia, 12 parts of bitter almond, 20 parts of astragalus, 9 parts of raw liquorice, 15 parts of raw rehmannia, 12 parts of scutellaria, 12 parts of dried ginger, 15 parts of stir-fried fructus aurantii, 20 parts of stir-fried white peony root, 20 parts of yam, 20 parts of euryale ferox, 20 parts of calamus, 20 parts of liushenqu, and 10 parts of scutellaria baicalensis.

[0030] Example 6: Preparation of decoction

[0031] The conventional method for preparing Chinese herbal decoction is adopted, that is, the Chinese herbal composition described in any one of Examples 1-5 is weighed, and water is added to boil it into a decoction.

[0032] Example 7: Preparation of tablets / capsules

[0033] Weigh the Chinese medicine composition described in any one of Examples 1-5, grind it into powder, decoct it, and concentrate it under reduced pressure to obtain an extract. Dry and crush the extract into granules, add pharmaceutical excipients, and press it into tablets or fill it into capsules.

[0034] Example 8: Preparation of granules

[0035] Weigh the Chinese medicine composition described in any one of Examples 1-5, grind it into powder, decoct it, and concentrate it under reduced pressure to obtain an extract, which is then dried and crushed to prepare granules.

[0036] Example 9: Preparation of pills / oral liquid / syrup

[0037] Weigh the Chinese medicine composition described in any one of Examples 1-5, grind it into powder, decoct it, take the supernatant, and concentrate it into a thick extract; add appropriate pharmaceutical excipients (such as sugar, honey, benzopropionic acid or ethylparaben) to prepare pills, oral liquid or syrup.

[0038] Example 10: Pharmacodynamics Experiment (Clinical Trial)

[0039] (I) Case source: The research cases in this example were all patients who visited the Department of Respiratory Medicine of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from January 2024 to December 2024 and were diagnosed with moderate / severe phlegm-dampness obstruction syndrome of OSAHS. A total of 80 cases were randomly divided into a treatment group (40 cases) and a control group (40 cases) with informed consent.

[0040] (2) Inclusion criteria: Meeting the diagnostic criteria for moderate to severe OSAHS; being diagnosed as phlegm-dampness obstruction syndrome of snoring according to traditional Chinese medicine; patients aged ≥30 years and ≤70 years, regardless of gender; patients who voluntarily participate in this study and sign the informed consent form; patients meeting the criteria for non-invasive ventilator treatment.

[0041] (3) Exclusion criteria: Excluding patients with immune diseases, infections, heart and kidney insufficiency, severe adverse reactions, pregnancy and suspected pregnancy, severe trauma, and those suffering from other diseases that affect the treatment effect.

[0042] (4) Research methods:

[0043] 1. Baseline data: 80 patients were randomly divided into a control group and a treatment group according to the random number table method, with 40 patients in each group. The age of the control group was 35 - 64 (49.90 ± 13.33) years; the course of disease was 2 - 8 (4.75 ± 2.45) years; the age of the treatment group was 34 - 63 (48.28 ± 14.07) years; 2 - 8 (5.01 ± 2.11) years. There were no statistically significant differences in the data such as age and course of disease between the two groups of patients (P > 0.05), and they were comparable.

[0044] 2. Experimental design

[0045] Control group: General treatment + non-invasive ventilator treatment

[0046] General treatment: Referring to the OSAHS diagnosis and treatment guidelines formulated by the Sleep Respiratory Diseases Group of the Chinese Medical Association's Respiratory Medicine Branch, providing multi-faceted guidance to OSAHS patients, including (1) weight loss, diet and weight control, and appropriate exercise; (2) alcohol abstinence, smoking cessation, and cautious use of sedative hypnotics and other drugs that can cause or exacerbate OSAHS; (3) sleeping on the side; (4) appropriately raising the head of the bed; (5) avoiding excessive fatigue during the day; Non-invasive ventilator treatment: Referring to the OSAHS diagnosis and treatment guidelines formulated by the Sleep Respiratory Diseases Group of the Chinese Medical Association's Respiratory Medicine Branch, using a single-level non-invasive ventilator in the continuous positive airway pressure / CPAP mode, once a night, with the evening treatment time ≥6 h, for a course of 8 weeks, and the pressure is set according to the patient's tolerance.

[0047] Treatment group: General treatment + non-invasive ventilator treatment + traditional Chinese medicine composition treatment

[0048] The control group was given a Chinese medicine composition: oral administration of ephedra 9 g, cinnamon twig 12 g, gentian 6 g, asarum 3 g, schisandra 9 g, processed pinellia 12 g, raw astragalus 15 g, raw licorice 6 g, raw rehmannia glutinosa 12 g, scutellaria 9 g, dried ginger 6 g, stir-fried aurantium 12 g, bitter almond 9 g, stir-fried white peony root 12 g, yam 15 g, euryale ferox 15 g, calamus 15 g, liushenqu 15 g, scutellaria 12 g. The decoction was boiled and taken once a day, twice a day, in the morning and evening;

[0049] Both groups of patients took the medicine for 8 consecutive weeks and were followed up for 6 months.

[0050] (V) Observation indicators:

[0051] The clinical efficacy of the two groups was observed. The AHI (apnea-hypopnea index), TCM syndrome score, and LSpO of the two groups of patients before and after treatment were examined and recorded. 2 (minimum oxygen saturation) changes. Among them, the TCM syndrome score is assigned 0, 2, 4, and 6 points for the main symptoms of nighttime snoring, dull snoring, apnea, and suffocation according to the degree of absence, mild, moderate, and severe, respectively. The secondary symptoms of head and body heaviness, daytime drowsiness, obesity, dry mouth and no desire to drink, cough and wheezing, and coughing up white or yellow sticky sputum are assigned 0, 1, 2, and 3 points according to the degree of absence, mild, moderate, and severe, respectively. The TCM syndrome score levels of the two groups of patients before and after the intervention are compared, and the lower the score, the better.

[0052] 6. Criteria for determining efficacy:

[0053] Refer to the relevant standards for evaluating the efficacy of obstructive sleep apnea-hypopnea syndrome. Clinical efficacy: AHI reduction rate = (AHI before treatment - AHI after treatment) / AHI before treatment × 100%; Clinical control: Clinical manifestations are basically eliminated, <5 times / h; Significant effect: Clinical manifestations are significantly improved, <20 times\h and AHI is reduced by ≥50%; Effective: Clinical manifestations are relieved compared with before, AHI is reduced by ≥15%; Ineffective: Clinical manifestations are basically not significantly improved, AHI is reduced by <15%;

[0054] 7. Data analysis:

[0055] The data of this study were statistically analyzed using SPSS 27.0 (IBM Corp.). The normality of all continuous variables was verified by the Kolmogorov-Smirnov method: those conforming to the normal distribution were presented in the form of mean and standard deviation, and the independent samples t-test was used for inter-group differences (the homogeneity of variance was verified by the Levene method), and the paired t-test was performed for longitudinal comparisons within the group; non-normally distributed data were characterized by the median (M) and interquartile range (IQR), the Mann-Whitney U test was used for inter-group difference analysis, and the Wilcoxon signed-rank test was used for within-group changes. Categorical variables were described by frequency (constituent ratio), and the test or Fisher's exact probability method was selected for inter-group comparison. The Mann-Whitney U rank sum test was used for the difference analysis of ordinal variables. Missing value verification and outlier correction were completed before data analysis. The significance threshold was set at two-sided α = 0.05, and P < 0.05 was used to indicate that the difference was statistically significant.

[0056] (VIII) Results:

[0057] 1. Clinical effect: The total effective rate of the treatment group after treatment was 87.50%, higher than 72.50% of the control group, P < 0.05, and the difference was statistically significant. See Table 1.

[0058] Table 1 Comparison of clinical efficacy between two groups of patients with obstructive sleep apnea hypopnea syndrome

[0059]

[0060] 2. Comparison of AHI levels before and after treatment: After treatment, the AHI of both groups was less than that before treatment (P < 0.05), and the AHI of the treatment group was significantly lower than that of the control group (P < 0.05), indicating that the treatment group had a better effect on reducing AHI than the control group. See Table 2.

[0061] Table 2 Comparison of AHI between two groups before and after treatment

[0062]

[0063] 3. Comparison of the total scores of traditional Chinese medicine syndromes before and after treatment: After treatment, the total scores of traditional Chinese medicine syndromes of both groups were less than those before treatment (P < 0.05), and the total score of traditional Chinese medicine syndromes of the patients in the treatment group was significantly lower than that of the control group (P < 0.01). See Table 3.

[0064] Table 3 Comparison of the total scores of traditional Chinese medicine syndromes between two groups before and after treatment

[0065]

[0066] 4. Comparison of LSpO before and after treatment 2Horizontal comparison: After treatment, the LSpO of both groups 2 was higher than that before treatment (P < 0.05), and the LSpO of the treatment group 2 was significantly increased compared with the control group (P < 0.05), indicating that the treatment group had a better curative effect on increasing LSpO 2 than the control group. See Table 4.

[0067] Table 4 Comparison of LSpO of both groups before and after treatment 2

[0068]

[0069] Clinical efficacy observation shows that the traditional Chinese medicine composition of the present invention can significantly improve the apnea hypopnea index level of patients, increase the lowest oxygen saturation level, relieve snoring at night, and has a good curative effect in aspects such as dull snoring, apnea and waking up due to suffocation. It is suggested that the traditional Chinese medicine composition has a significant therapeutic effect on patients with obstructive sleep apnea hypopnea syndrome, and can improve the overall rehabilitation level and quality of life of patients.

[0070] The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the described embodiments. Those skilled in the art can also make various equivalent modifications or substitutions without departing from the spirit of the present invention, and these equivalent modifications or substitutions are all included in the scope defined by the claims of this application.​

Claims

1. A Chinese medicine composition for treating obstructive sleep apnea-hypopnea syndrome, characterized in that: The invention is composed of the following raw materials in parts by weight: 6-12 parts of raw ephedra, 6-12 parts of cassia twig, 6-9 parts of gentian, 3-6 parts of asarum, 6-12 parts of schisandra, 9-15 parts of processed pinellia, 6-12 parts of bitter almond, 15-20 parts of astragalus, 6-9 parts of raw licorice, 9-15 parts of raw rehmannia, 6-12 parts of scutellaria, 6-12 parts of dried ginger, 6-15 parts of stir-fried fructus aurantii, 10-20 parts of stir-fried white peony root, 10-20 parts of yam, 10-20 parts of euryale ferox, 10-20 parts of calamus, 10-20 parts of liushequ and 6-12 parts of scutellaria baicalensis.

2. The Chinese medicine composition for treating obstructive sleep apnea-hypopnea syndrome according to claim 1, characterized in that: The drug is composed of the following raw materials in parts by weight: 9 parts of raw ephedra, 12 parts of cinnamon twig, 6 parts of gentian, 3 parts of asarum, 9 parts of schisandra, 12 parts of processed pinellia, 9 parts of bitter almond, 15 parts of astragalus, 6 parts of raw licorice, 12 parts of raw rehmannia, 9 parts of scutellaria, 6 parts of dried ginger, 12 parts of stir-fried fructus aurantii, 12 parts of stir-fried white peony root, 15 parts of yam, 15 parts of euryale ferox, 15 parts of calamus, 15 parts of liushenqu, and 12 parts of scutellaria baicalensis.

3. A Chinese medicine compound preparation using the Chinese medicine composition as claimed in claim 1 or 2 as an active ingredient, characterized in that: The traditional Chinese medicine compound preparation is prepared into a common dosage form in pharmacy by conventional preparation methods in the art.

4. The Chinese medicinal compound preparation according to claim 3, characterized in that: The dosage form of the Chinese medicine compound preparation is decoction, tablet, capsule, granule, pill, oral liquid or syrup.

5. The Chinese medicinal compound preparation according to claim 3, characterized in that: The traditional Chinese medicine compound preparation also includes pharmaceutically acceptable auxiliary materials.

6. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating obstructive sleep apnea-hypopnea syndrome.

7. The use according to claim 6, characterized in that: The TCM syndrome type of the obstructive sleep apnea-hypopnea syndrome is the syndrome type of internal obstruction of phlegm and dampness.

8. Use of the Chinese medicinal compound preparation according to any one of claims 3 to 5 in the preparation of a medicament for treating obstructive sleep apnea-hypopnea syndrome.

Images