Traditional Chinese medicine composition for treating or improving sjogren's syndrome

Abstract

The application provides a traditional Chinese medicine composition for treating or improving Sjogren's syndrome, and belongs to the technical field of traditional Chinese medicine pharmacy.The traditional Chinese medicine composition takes asparagus, lily and mulberry as monarch drugs, takes honeysuckle, semen astragali, rush and radix codonopsis as minister drugs, takes turmeric and atractylodes as auxiliary drugs, and takes licorice as a guide drug, and the drugs are combined to have the effects of nourishing yin and moistening dryness, clearing heat and dredging collaterals, tonifying qi and invigorating the spleen, and promoting blood circulation and improving eyesight.The traditional Chinese medicine composition can significantly reduce the water consumption of NOD mice, increase the saliva amount of NOD mice, significantly down-regulate the levels of inflammatory factors TNF-alpha, IL-17 and IL-1beta in the serum of NOD mice, improve the gland structure and lymphocyte infiltration in the submandibular gland tissue of NOD mice, and reduce the submandibular gland injury.In addition, the traditional Chinese medicine composition can significantly reduce the ESSDAI and ESSPRI scores of Sjogren's syndrome patients, improve the clinical symptoms such as dry mouth, dry eyes and salivary gland swelling of the patients, has a high total effective rate in clinical treatment, and can be further developed and researched as a drug for treating Sjogren's syndrome.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine pharmacy, and specifically relates to a traditional Chinese medicine composition for treating or improving Sjogren's syndrome. Background Art

[0002] Sjogren's syndrome (SS) is an autoimmune disease mainly caused by lymphocyte infiltration, with dry mouth and dry eyes as the main clinical manifestations, and there are also multi-system damage symptoms caused by the involvement of other exocrine glands and organs outside the glands. In severe cases, it can cause damage to other organs and even lead to death, seriously affecting the physical and mental health of patients. The prevalence rate of Sjogren's syndrome in China is 0.33% - 0.77%, and in recent years, the incidence rate and fatality rate of this disease have shown an increasing trend year by year, which has attracted great attention in the medical field. At present, the treatment of Sjogren's syndrome mainly follows the principles of relieving symptoms and protecting affected glands. Lubricants, artificial tears, and oral moisturizers can be used to relieve eye and mouth dryness; for patients with severe symptoms, immunosuppressants and other drugs may be needed to regulate the immune response, but the current treatment plan still has limitations, such as unstable efficacy, drug adverse reactions, and tolerance problems.

[0003] Modern traditional Chinese medicine names this disease as "dry arthralgia". Endowment deficiency, improper diet, or being affected by the pathogenic factor of dry heat, or internal retention of dampness and cold, which transforms into dryness after a long time, excessive dryness injures yin, and the body loses moistening, thus resulting in dry arthralgia. Traditional Chinese medicine has unique advantages in improving the condition of SS patients, reducing adverse reactions, and lowering the recurrence rate. A large number of studies have found that traditional Chinese medicine can improve the symptoms of SS patients and improve their quality of life by inhibiting inflammatory factors and maintaining immune balance. Summary of the Invention

[0004] (I) Technical Problem to be Solved

[0005] In view of the deficiencies of the prior art, the present invention provides a traditional Chinese medicine composition for treating or improving Sjogren's syndrome.

[0006] (II) Technical Solution

[0007] To achieve the above object, the present invention is realized through the following technical solutions:

[0008] A traditional Chinese medicine composition for treating or improving Sjogren's syndrome, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5 - 25 parts of asparagus, 5 - 25 parts of honeysuckle stem, 5 - 25 parts of turmeric, 5 - 25 parts of atractylodes rhizome, 5 - 25 parts of codonopsis pilosula, 5 - 25 parts of mulberry, 5 - 25 parts of Eriocaulon buergerianum, 5 - 25 parts of lily, 5 - 25 parts of juncus effusus, and 5 - 15 parts of licorice.

[0009] Preferably, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10-20 parts of Asparagus cochinchinensis, 10-20 parts of Lonicera japonica, 10-20 parts of Curcuma longa, 5-15 parts of Atractylodes lancea, 10-20 parts of Codonopsis pilosula, 10-20 parts of Morus alba, 10-20 parts of Eriocaulon buergerianum, 10-20 parts of Lilium brownii, 5-15 parts of Juncus effusus, and 5-10 parts of Glycyrrhiza uralensis.

[0010] Preferably, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts of Asparagus cochinchinensis, 12 parts of Lonicera japonica, 15 parts of Curcuma longa, 10 parts of Atractylodes lancea, 12 parts of Codonopsis pilosula, 12 parts of Morus alba, 12 parts of Eriocaulon buergerianum, 12 parts of Lilium brownii, 10 parts of Juncus effusus, and 6 parts of Glycyrrhiza uralensis.

[0011] The traditional Chinese medicine composition provided by this invention is used to prepare a drug for treating or improving Sjögren's syndrome. The drug is made from the above-mentioned parts by weight of traditional Chinese medicinal materials as raw materials, supplemented with medically acceptable excipients, and prepared into an oral dosage form, including granules, powders, decoctions, aqueous decoctions, oral liquids, pills, capsules, tablets, etc.

[0012] (III) Beneficial Effects

[0013] Sjögren's syndrome often originates from yin deficiency and fluid depletion, internal heat due to deficiency, and complex pathogenesis involving qi deficiency, blood stasis, and damp heat. Based on this, the herbal composition of this invention uses asparagus, lily, and mulberry as the principal herbs. Asparagus is sweet, bitter, and cold, and is good at nourishing yin, reducing fire, moistening dryness, and generating fluids, especially good at nourishing the yin of the lungs and kidneys. Lily is sweet and slightly cold, and is good at nourishing yin, moistening the lungs, clearing the heart, and calming the mind. It can help asparagus moisten the lungs and relieve restlessness caused by yin deficiency. Mulberry is sweet, sour, and cold, and has the effects of nourishing yin, replenishing blood, generating fluids, and moistening dryness. Its nature is mild, and it can nourish the yin of the liver and kidneys and replenish yin and blood. Asparagus moistens the lungs and kidneys from top to bottom, lily moistens the lungs and calms the mind, and mulberry nourishes the liver and kidneys from bottom to top. The three herbs work together as the principal herbs to replenish the body fluids of the whole body and directly address the root pathogenesis of yin deficiency and fluid depletion. Then, honeysuckle vine, cottonberry grass, rush pith, and codonopsis are used as assistant herbs. Honeysuckle vine is sweet and cold, and has the effects of clearing heat and detoxifying, dispelling wind and unblocking collaterals. Codonopsis grass is pungent, sweet and neutral, and has the effects of dispersing wind-heat and clearing away eye obstruction. Rush pith is sweet, bland and slightly cold, and has the effects of clearing the heart and reducing fire, and promoting urination. The three herbs work together to clear heat, targeting the symptoms of deficiency fire and dryness. Codonopsis is also added to strengthen the spleen and replenish qi, generate fluids and nourish blood, support the body's vital energy, assist the principal herbs in replenishing both qi and yin, ensure the source of fluid production, and prevent the yin-nourishing herbs from harming the stomach. Turmeric and Atractylodes lancea are used as adjuvant herbs. Turmeric is bitter, pungent, and warm in nature, and has the effects of breaking up blood stasis, promoting qi circulation, and relieving pain. It can invigorate blood circulation, remove blood stasis, and promote the flow of body fluids. As the saying goes, blood and body fluids share the same origin, and invigorating blood circulation helps to replenish and disperse body fluids. At the same time, its warm nature can counteract the bias of cold and cooling herbs. Atractylodes lancea is bitter, pungent, and warm in nature. Its effects of drying dampness and strengthening the spleen can invigorate the spleen and stomach, and counteract the cloying nature of yin-nourishing herbs, providing a foundation for the production of body fluids in the spleen and stomach, so as to achieve replenishment without stagnation. Finally, licorice is used as the guiding herb, which tonifies the spleen and replenishes qi, clears heat and detoxifies, and harmonizes the effects of the other herbs. The combined effects of these herbs are to nourish yin and moisten dryness, clear heat and unblock the meridians, replenish qi and strengthen the spleen, invigorate blood and improve eyesight.

[0014] Furthermore, animal experiments showed that the herbal composition of this invention can significantly reduce water intake and increase saliva production in NOD mice. Simultaneously, it can significantly downregulate the serum levels of inflammatory factors TNF-α, IL-17, and IL-1β in NOD mice, improve glandular structure and lymphocyte infiltration in the submandibular gland tissue, and alleviate submandibular gland damage. Clinical efficacy evaluation results showed that the herbal composition of this invention can significantly reduce ESSDAI and ESSPRI scores in patients with Sjögren's syndrome, improve clinical symptoms such as dry mouth, dry eyes, and salivary gland swelling, and has a high overall clinical efficacy rate. It can be further developed and researched as a drug for the treatment of Sjögren's syndrome. Attached Figure Description

[0015] Figure 1 The serum levels of IL-1β (A), TNF-α (B), and IL-17 (C) in each group of mice were measured. Note: ***P<0.001.

[0016] Figure 2 HE staining images of submandibular gland tissue from each group of mice.

[0017] Figure 3 The results of the histopathological scoring of the submandibular gland tissue of mice in each group are shown; Note: **P<0.01; ***P<0.001.

[0018] Figure 4 The results of TCM syndrome scores for the two groups of patients are shown. A represents the dry mouth score before and after treatment; B represents the dry eye score before and after treatment; and C represents the salivary gland swelling score before and after treatment. ***P<0.001. Detailed Implementation

[0019] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Example 1

[0020] A traditional Chinese medicine composition for treating or improving Sjögren's syndrome, the composition comprising the following raw materials in parts by weight: 8 parts Asparagus cochinchinensis, 6 parts Lonicera japonica, 6 parts Curcuma longa, 6 parts Atractylodes lancea, 6 parts Codonopsis pilosula, 8 parts Morus alba, 6 parts Eriocaulon buergerianum, 6 parts Lilium brownii, 6 parts Juncus effusus, and 5 parts Glycyrrhiza uralensis. Example 2

[0021] A traditional Chinese medicine composition for treating or improving Sjögren's syndrome, the composition comprising the following raw materials in parts by weight: 22 parts Asparagus cochinchinensis, 20 parts Lonicera japonica, 18 parts Curcuma longa, 18 parts Atractylodes lancea, 20 parts Codonopsis pilosula, 20 parts Morus alba, 18 parts Eriocaulon buergerianum, 20 parts Lilium brownii, 18 parts Juncus effusus, and 12 parts Glycyrrhiza uralensis. Example 3

[0022] A traditional Chinese medicine composition for treating or improving Sjögren's syndrome, the composition comprising the following raw materials in parts by weight: 18 parts Asparagus cochinchinensis, 16 parts Lonicera japonica, 16 parts Curcuma longa, 10 parts Atractylodes lancea, 16 parts Codonopsis pilosula, 16 parts Morus alba, 14 parts Eriocaulon buergerianum, 16 parts Lilium brownii, 12 parts Juncus effusus, and 10 parts Glycyrrhiza uralensis. Example 4

[0023] A traditional Chinese medicine composition for treating or improving Sjögren's syndrome, the composition comprising the following raw materials in parts by weight: 100 parts Asparagus cochinchinensis, 10 parts Lonicera japonica, 10 parts Curcuma longa, 5 parts Atractylodes lancea, 10 parts Codonopsis pilosula, 10 parts Morus alba, 10 parts Eriocaulon buergerianum, 10 parts Lilium brownii, 5 parts Juncus effusus, and 5 parts Glycyrrhiza uralensis. Example 5

[0024] A traditional Chinese medicine composition for treating or improving Sjögren's syndrome, the composition comprising the following raw materials in parts by weight: 20 parts Asparagus cochinchinensis, 20 parts Lonicera japonica, 20 parts Curcuma longa, 15 parts Atractylodes lancea, 20 parts Codonopsis pilosula, 20 parts Morus alba, 20 parts Eriocaulon buergerianum, 20 parts Lilium brownii, 15 parts Juncus effusus, and 10 parts Glycyrrhiza uralensis. Example 6

[0025] A traditional Chinese medicine composition for treating or improving Sjögren's syndrome, the composition comprising the following raw materials in parts by weight: 14 parts Asparagus cochinchinensis, 12 parts Lonicera japonica, 12 parts Curcuma longa, 8 parts Atractylodes lancea, 14 parts Codonopsis pilosula, 14 parts Morus alba, 12 parts Eriocaulon buergerianum, 12 parts Lilium brownii, 8 parts Juncus effusus, and 8 parts Glycyrrhiza uralensis. Example 7

[0026] A traditional Chinese medicine composition for treating or improving Sjögren's syndrome, the composition comprising the following raw materials in parts by weight: Asparagus 16 parts, Lonicera japonica vine 12 parts, Curcuma longa 16 parts, Atractylodes lancea 12 parts, Codonopsis pilosula 14 parts, Morus alba 14 parts, Eriocaulon buergerianum 12 parts, Lilium brownii 14 parts, Juncus effusus 12 parts, Glycyrrhiza uralensis 10 parts. Example 8

[0027] A traditional Chinese medicine composition for treating or improving Sjögren's syndrome, the composition comprising the following raw materials in parts by weight: 15 parts Asparagus cochinchinensis, 12 parts Lonicera japonica, 15 parts Curcuma longa, 10 parts Atractylodes lancea, 12 parts Codonopsis pilosula, 12 parts Morus alba, 12 parts Eriocaulon buergerianum, 12 parts Lilium brownii, 10 parts Juncus effusus, and 6 parts Glycyrrhiza uralensis.

[0028] Experimental Example 1

[0029] The therapeutic effect of the traditional Chinese medicine composition of the present invention on a mouse model of Sjögren's syndrome.

[0030] 1. Materials and Methods

[0031] 1.1 Laboratory Animals

[0032] Ten SPF-grade BALB / c mice and fifty NOD mice, females, 8 weeks old, weighing 16-25g. They were acclimatized for one week before the experiment.

[0033] 1.2 Experimental Drugs

[0034] The herbal composition of this invention is as follows: weigh out the raw materials according to the following weight proportions: 15g of Asparagus cochinchinensis, 12g of Lonicera japonica, 15g of Curcuma longa, 10g of Atractylodes lancea, 12g of Codonopsis pilosula, 12g of Morus alba, 12g of Eriocaulon buergerianum, 12g of Lilium brownii, 10g of Juncus effusus, and 6g of Glycyrrhiza uralensis. After washing, soak in 3 times the weight of water for 30 minutes, decoct twice, 30 minutes each time, combine the two filtrates, concentrate to a drug concentration of 1g / mL (each milliliter contains 1g of raw herb), and refrigerate for later use.

[0035] Positive control drug: Hydroxychloroquine sulfate tablets, 0.2g / tablet

[0036] 1.3 Methods

[0037] 1.3.1 Grouping and Administration

[0038] Fifty NOD mice were randomly divided into five groups of ten each: a model group, a hydroxychloroquine group, a high-dose traditional Chinese medicine (TCM) group, a medium-dose TCM group, and a low-dose TCM group. Ten age-matched BALB / c mice were used as a control group. After one week of acclimatization, mice in each group were administered the corresponding drug via gavage daily (0.2 mL / mouse / day). The hydroxychloroquine group received hydroxychloroquine sulfate tablets (4 mg / mL); the high-dose TCM group received the TCM liquid of this invention (1.5 g / mL); the medium-dose group received the TCM liquid of this invention (1.0 g / mL); and the low-dose group received the TCM liquid of this invention (0.5 g / mL). The control group and the model group received an equal volume of purified water via gavage. All groups were administered the drug once daily for four consecutive weeks.

[0039] 1.3.2 Detection Method

[0040] 1.3.2.1 Water Consumption Monitoring

[0041] Add water at a fixed time each day, and observe the remaining amount (mL) in the water bottle at the same time the next day. The difference between the two observations is the daily water intake of the mice. Observe and record the weekly water intake of the mice.

[0042] 1.3.2.2 Saliva volume detection

[0043] Saliva secretion in mice was measured on a fixed day each week. Mice were fasted for 1 hour before measurement, but water was allowed. Mice were sedated and hypnotized using 0.004 mL / g of 10% chloral hydrate. Immediately after sedation and hypnosis, 0.1 mL of pilocarpine (pilocarpine solution prepared with PBS buffer, freshly prepared and used, concentration 5 mg / kg) was injected intraperitoneally. Timing began immediately after pilocarpine injection. Saliva was collected from the mice's mouth using a 10 μL pipette and transferred to 1.5 mL EP tubes at appropriate times, for a total collection time of 15 min. The weight of the EP tubes was measured before and after saliva collection and recorded. The weight of mouse saliva secretion = weight of EP tube after collection - weight of EP tube before collection. Measurements were taken before administration and at 1, 2, 3, and 4 weeks after administration, for a total of 5 measurements.

[0044] 1.3.2.3 Serum inflammatory factor detection

[0045] Blood was collected from the abdominal aorta of mice in each group, allowed to stand, centrifuged, and the supernatant serum was collected. The serum levels of TNF-α, IL-17, and IL-1β were detected using an ELISA kit.

[0046] 1.3.2.4 Pathological observation of submandibular gland tissue

[0047] Mice were sacrificed after each group received drug treatment. One submandibular gland was removed, fixed in 4% paraformaldehyde solution, routinely embedded in paraffin, sectioned (4 μm thick), stained with hematoxylin and eosin (HE), and observed under a microscope. The submandibular gland pathology was scored. The scoring criteria are detailed in Table 1.

[0048] Table 1 Scoring criteria for submandibular gland involvement

[0049]

[0050] 1.4 Statistical Methods

[0051] Statistical software was used for analysis. Quantitative data were expressed as mean ± standard deviation, and paired t-tests were performed between groups. If the data did not conform to a normal distribution, nonparametric tests were used. After comparing the homogeneity of variances of the means, one-way ANOVA was used. If the variances were not homogeneous, Tamhane's T² (multiple comparisons based on t-tests) was used for analysis. A p-value < 0.05 was considered statistically significant.

[0052] 2 Results

[0053] 2.1 Comparison of water intake among mice in each group during drug administration

[0054] As shown in Table 2, before drug administration, NOD mice had significantly increased water intake compared to BALB / c mice (P<0.05). During the first week of drug administration, water intake in the hydroxychloroquine group was slightly lower than that in the model group, but the difference was not significant (P>0.05); water intake in the high, medium, and low dose groups of traditional Chinese medicine was significantly lower than that in the model group (P<0.05); water intake in the high dose group of traditional Chinese medicine was significantly lower than that in the hydroxychloroquine group (P<0.05); water intake in the medium and low dose groups of traditional Chinese medicine was slightly lower than that in the hydroxychloroquine group, but the difference was not significant (P>0.05).

[0055] In the second week of administration, the water intake of mice in the hydroxychloroquine group was slightly lower than that in the model group, but the difference was not significant (P>0.05); the water intake of mice in the high, medium and low dose groups of traditional Chinese medicine was significantly lower than that in the model group (P<0.05); the water intake of mice in the high and medium dose groups of traditional Chinese medicine was significantly lower than that in the hydroxychloroquine group (P<0.05).

[0056] During the third week of drug administration, the water intake of mice in each drug administration group was significantly lower than that in the model group (P<0.05); there was no significant difference between the hydroxychloroquine group and the low-dose traditional Chinese medicine group (P>0.05); the water intake of mice in the high- and medium-dose traditional Chinese medicine groups was significantly lower than that in the hydroxychloroquine group (P<0.05); there was no significant difference in water intake among the high-, medium-, and low-dose traditional Chinese medicine groups (P>0.05).

[0057] In the fourth week of drug administration, the water intake of mice in each drug administration group was significantly lower than that in the model group (P<0.05); there was no significant difference in water intake among the drug administration groups (P>0.05).

[0058] Table 2 Comparison of water intake in each group of mice

[0059]

[0060] Note: For data in the same column, the same lowercase letter or no letter indicates P>0.05, and different lowercase letters indicate P<0.05.

[0061] 2.2 Comparison of saliva volume among different groups of mice

[0062] The results are shown in Table 3. Before administration, NOD mice had significantly less saliva compared to BALB / c mice (P<0.05). During the first to third weeks of administration, the saliva volume in each treatment group was slightly increased compared to the model group, but the difference was not significant (P>0.05). During the fourth week of administration, the saliva volume in each treatment group was significantly increased compared to the model group (P<0.05); there was no significant difference in saliva volume among the treatment groups (P>0.05).

[0063] Table 3 Comparison of saliva volume in each group of mice

[0064]

[0065] Note: For data in the same column, the same lowercase letter or no letter indicates P>0.05, and different lowercase letters indicate P<0.05.

[0066] 2.3 Comparison of serum inflammatory factor levels in mice of different groups

[0067] The results are as follows Figure 1 As shown, compared with the normal group, the serum levels of inflammatory factors TNF-α, IL-17, and IL-1β in the model group mice were significantly increased (P<0.001). Compared with the model group, the serum levels of inflammatory factors TNF-α, IL-17, and IL-1β in each drug-treated group mice were significantly decreased (P<0.001).

[0068] 2.4 Comparison of pathological changes in submandibular gland tissue of mice in different groups

[0069] The results are as follows Figure 2-3 As shown, the submandibular glands of mice in the normal group had intact glandular structure, no edema in the glandular stroma, and no lymphocyte infiltration. In the model group, the submandibular gland structure was disrupted, with a large number of lymphocytes infiltrating and accumulating. Compared with the normal group, the pathological score of the submandibular gland tissue in the model group was significantly increased (P<0.001). Compared with the model group, the glandular structure in each treatment group was improved to varying degrees, lymphocyte infiltration was significantly improved, and the pathological scores of the submandibular gland tissue in each treatment group were significantly reduced (P<0.01, P<0.001).

[0070] 3. Conclusion

[0071] Based on the above experimental results, the herbal composition of this invention can significantly reduce water intake and increase saliva production in NOD mice. Simultaneously, it can significantly downregulate the serum levels of inflammatory factors TNF-α, IL-17, and IL-1β in NOD mice, improve glandular structure and lymphocyte infiltration in the submandibular gland tissue, and alleviate submandibular gland damage. This herbal composition holds promise for further development and research as a treatment for Sjögren's syndrome.

[0072] Experimental Example 2

[0073] Clinical observation of the efficacy of the traditional Chinese medicine composition of this invention in treating patients with Sjögren's syndrome

[0074] 1. General Information

[0075] Sixty patients with Sjögren's syndrome admitted between January and October 2025 were randomly divided into two groups using a random number table. The control group consisted of 30 patients (14 males and 18 females), aged 28–56 years (mean 38.26 ± 6.03 years), with a disease duration of 3–24 months (mean 12.09 ± 3.44 months). The treatment group consisted of 30 patients (13 males and 19 females), aged 30–60 years (mean 39.11 ± 7.23 years), with a disease duration of 3–24 months (mean 11.87 ± 4.02 months). There were no statistically significant differences in general characteristics between the two groups (P>0.05), indicating comparability.

[0076] Inclusion criteria: ① Meets the diagnostic criteria of Traditional Chinese Medicine: dry mouth, dry eyes, dry throat, dry skin, red tongue, etc.; ② Meets the diagnostic criteria of Western Medicine: namely, meeting 1 primary indicator (positive anti-Sjögren's syndrome A; >1 lymphocyte foci in labial gland biopsy) and 3 secondary indicators (dry mouth lasting more than 3 months, requiring drinking water to swallow dry food; dry eyes lasting more than 3 months, requiring artificial tears; positive Schirmer test); ③ Has not taken any Sjögren's syndrome-related medications in the past two months; ④ Has normal cognitive function, with clinical manifestations of joint pain and swelling; ⑤ Has given informed consent.

[0077] Exclusion criteria: ① Secondary Sjögren's syndrome; ② Coagulation disorders; ③ Failure of vital organs such as heart, liver, and brain; ④ Mental disorders that prevent completion of the examination; ⑤ Inability to complete drug research; ⑥ Taking glucocorticoids within the past month; ⑦ Pregnant or lactating women, or those who are uncooperative.

[0078] 2 Treatment methods

[0079] Control group: Oral administration of hydroxychloroquine sulfate tablets, 0.2g / tablet, once daily, 0.2g each time.

[0080] Treatment group: Orally administer the decoction of the Chinese herbal composition of this invention (15g of Asparagus cochinchinensis, 12g of Lonicera japonica, 15g of Curcuma longa, 10g of Atractylodes lancea, 12g of Codonopsis pilosula, 12g of Morus alba, 12g of Eriocaulon buergerianum, 12g of Lilium brownii, 10g of Juncus effusus, and 6g of Glycyrrhiza uralensis), one dose per day, decocted in 400mL of water and taken twice a day, morning and evening.

[0081] All groups were treated for 3 months.

[0082] 3 detection indicators

[0083] 3.1 Severity of symptoms

[0084] Symptom severity was assessed using the Sjögren's Syndrome Self-Report Index (ESSPRI) and the Sjögren's Syndrome Disease Activity Index (ESSDAI). The ESSDAI assesses symptoms across 12 items, including dry mouth, vertex and ptosis conjunctivitis, and oral ulcers, with each item scored out of 3. Lower scores indicate milder symptoms. The ESSPRI assesses symptoms across four areas: symptoms, fatigue, pain, etc., with each area scored out of 10. Lower scores indicate milder symptoms. The ESSPRI score is calculated as: (dry mouth symptom score + fatigue score + pain score + mental fatigue score) / 4.

[0085] 3.2 Traditional Chinese Medicine Symptom Scores

[0086] Based on relevant literature standards, patients with Sjögren's syndrome were scored on a scale of 0, 1, 2, and 3 for dry mouth, dry eyes, and salivary gland swelling, respectively, with higher scores indicating more severe symptoms.

[0087] 4. Efficacy criteria

[0088] This guideline was developed with reference to the relevant standards in the 2018 edition of the "Technical Guidelines for Clinical Research of New Traditional Chinese Medicines Based on Syndrome Differentiation" and the 2002 edition of the "Guiding Guidelines for Clinical Research of New Traditional Chinese Medicines".

[0089] Significant effect: The patient's score decreased by ≥70% before and after treatment;

[0090] Effective: The patient's score decreased by ≥50% and <70% before and after treatment;

[0091] Improvement: The patient's score decreased by ≥20% and <50% before and after treatment;

[0092] Ineffective: The patient's score decreased by <20% before and after treatment.

[0093] 5. Statistical Analysis

[0094] GEE was used to handle within-group correlations in repeated measures data, suitable for non-independent longitudinal data. The dependent variable was set as an ordinal multi-category efficacy level (e.g., ineffective to cured), and the independent variables included the treatment group (categorical variable), treatment duration (continuous variable), and their interaction terms. The model specified an exchangeable correlation matrix to characterize the correlation structure between individual measurements and controlled for confounding factors such as center variation using fixed effects. Parameter estimation used the maximum likelihood method, and the results were quantified as odds ratios (OR) and their 95% confidence intervals. The statistical significance of each variable was assessed using the Wald test to ensure robust inferences about the treatment effect and the impact of treatment duration.

[0095] 5 Results

[0096] 5.1 Comparison of ESSDAI and ESSPRI scores between the two groups of patients

[0097] Before treatment, there was no statistically significant difference in ESSDAI and ESSPRI scores between the two groups (P>0.05). After treatment, both groups showed significantly lower ESSDAI and ESSPRI scores than before treatment (P<0.05); after treatment, the observation group showed significantly lower ESSDAI and ESSPRI scores than the control group (P<0.05). The results are shown in Table 4.

[0098] Table 4 Comparison of ESSDAI and ESSPRI scores before and after treatment in the two groups of patients.

[0099]

[0100] Note: Intergroup comparison & P<0.05; within the group, compared with before treatment, # P<0.05.

[0101] 5.2 Comparison of TCM syndrome scores between the two groups of patients

[0102] The results are as follows Figure 4 As shown in the figure. Before treatment, there were no statistically significant differences in the scores of dry mouth, dry eyes, and salivary gland swelling between the two groups (P>0.05). After treatment, the scores of dry mouth, dry eyes, and salivary gland swelling in both groups were significantly lower than before treatment (P<0.05); after treatment, the scores of dry mouth, dry eyes, and salivary gland swelling in the observation group were significantly lower than those in the control group (P<0.05).

[0103] 5.3 Comparison of clinical efficacy between the two groups

[0104] The results are shown in Table 5. The total effective rate of treatment in the treatment group was 96.67%, while that in the control group was 90.00%. The difference between the two groups was statistically significant.

[0105] Table 5 Comparison of clinical efficacy between the two groups [n (%)]

[0106]

[0107] 6 Results

[0108] The herbal composition of this invention follows the principles of syndrome differentiation and treatment in traditional Chinese medicine and is scientifically formulated. It has the effects of nourishing yin and moistening dryness, clearing heat and unblocking collaterals, invigorating qi and strengthening the spleen, and promoting blood circulation and improving eyesight. It can significantly reduce the ESSDAI and ESSPRI scores of patients with Sjögren's syndrome and improve clinical symptoms such as dry mouth, dry eyes and salivary gland swelling. It has a high overall clinical efficacy rate and can be further developed and studied as a drug for the treatment of Sjögren's syndrome.

[0109] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for treating or improving Sjögren's syndrome, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Asparagus 5-25 parts, Honeysuckle vine 5-25 parts, Curcuma longa 5-25 parts, Atractylodes lancea 5-25 parts, Codonopsis pilosula 5-25 parts, Mulberry 5-25 parts, Eriocaulon buergerianum 5-25 parts, Lilium brownii 5-25 parts, Juncus effusus 5-25 parts, and Glycyrrhiza uralensis 5-15 parts.

2. The traditional Chinese medicine composition for treating or improving Sjögren's syndrome according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Asparagus 10-20 parts, Honeysuckle vine 10-20 parts, Curcuma longa 10-20 parts, Atractylodes lancea 5-15 parts, Codonopsis pilosula 10-20 parts, Morus alba 10-20 parts, Eriocaulon buergerianum 10-20 parts, Lilium brownii 10-20 parts, Juncus effusus 5-15 parts, and Glycyrrhiza uralensis 5-10 parts.

3. A traditional Chinese medicine composition for treating or improving Sjögren's syndrome according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15 parts Asparagus, 12 parts Honeysuckle Vine, 15 parts Curcuma, 10 parts Atractylodes, 12 parts Codonopsis, 12 parts Mulberry, 12 parts Eriocaulon, 12 parts Lilium, 10 parts Juncus effusus, and 6 parts Glycyrrhiza.

4. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating or improving Sjögren's syndrome, characterized in that, The drug is made from the above-mentioned proportions of Chinese medicinal herbs by weight, supplemented with pharmaceutically acceptable excipients, and prepared into oral dosage forms, including granules, powders, decoctions, oral liquids, pills, capsules, and tablets.

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