Traditional Chinese medicine composition for treating or improving sicca syndrome

Abstract

The invention provides a traditional Chinese medicine composition for treating or improving sicca syndrome, and belongs to the technical field of traditional Chinese medicine pharmacy. According to the traditional Chinese medicine composition, radix asparagi, lilies and mulberries are used as monarch drugs, honeysuckle stems, pipewort, juncus roemerianus and codonopsis pilosula are used as ministerial drugs, turmeric and rhizoma atractylodis are used as adjuvant drugs, liquorice is used as conductant drugs, and all the drugs are combined to achieve the effects of nourishing yin, moistening dryness, clearing heat, dredging collaterals, replenishing qi, invigorating the spleen, activating blood and improving eyesight. The traditional Chinese medicine composition can significantly reduce the water intake of NOD mice, increase the saliva volume of the NOD mice, significantly reduce the levels of inflammatory factors TNF-alpha, IL-17 and IL-1beta in serum of the NOD mice, improve the gland structure and lymphocyte infiltration condition in submaxillary gland tissue of the NOD mice, and relieve submaxillary gland injury. Besides, the traditional Chinese medicine composition can remarkably reduce ESSDAI and ESSPRI scores of sicca syndrome patients and improve the clinical symptoms such as mouth dryness, eye dryness and salivary gland swelling of the patients, has high clinical treatment total effective rate and can be used as a medicine for treating the sicca syndrome to be further developed and researched.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating or improving Sjogren's syndrome. BACKGROUND

[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 other symptoms of multi-system damage such as other exocrine glands and other organs, which can cause damage to other organs and even death in severe cases, and seriously affect the physical and mental health of patients. The prevalence of Sjogren's syndrome in China is 0.33% to 0.77%, and in recent years the incidence and mortality of the disease have been increasing year by year, which has attracted great attention from the medical community. The current treatment of Sjogren's syndrome is mainly based on the principle of relieving symptoms and protecting affected glands, and lubricants, artificial tears and oral moisturizers can be used to relieve dry eyes and dry mouth; for patients with severe symptoms, immunosuppressive agents and other drugs may be used to regulate immune response, but the current treatment regimen still has limitations such as unstable efficacy, adverse drug reactions and tolerance.

[0003] Modern Chinese medicine names this disease as "dry arthralgia", and the disease is caused by deficiency, improper diet, or exposure to dry heat, or internal accumulation of dampness and cold, which can cause dryness and damage to yin, and the body loses moisture, resulting in dry arthralgia. Traditional Chinese medicine has unique advantages in improving the condition of SS patients, reducing adverse reactions and reducing the recurrence rate. A large number of studies have found that traditional Chinese medicine can inhibit inflammatory factors, maintain immune balance, improve the symptoms of SS patients, and improve their quality of life. SUMMARY

[0004] (I) Technical problems solved In view of the shortcomings of the prior art, the present application provides a traditional Chinese medicine composition for treating or improving Sjogren's syndrome.

[0005] (II) Technical solutions In order to achieve the above purpose, the present application is realized by the following technical solutions: A traditional Chinese medicine composition for treating or improving Sjogren's syndrome, the traditional Chinese medicine composition is composed of the following raw materials by weight: asparagus 5-25 parts, honeysuckle 5-25 parts, turmeric 5-25 parts, atractylodes 5-25 parts, radix codonopsis 5-25 parts, mulberry 5-25 parts, ginseng 5-25 parts, lily 5-25 parts, rush 5-25 parts, and licorice 5-15 parts.

[0006] Preferably, the traditional Chinese medicine composition is composed of the following raw materials by weight: asparagus 10-20 parts, honeysuckle 10-20 parts, turmeric 10-20 parts, atractylodes 5-15 parts, codonopsis 10-20 parts, mulberry 10-20 parts, valerian 10-20 parts, lily 10-20 parts, rush 5-15 parts, and licorice 5-10 parts.

[0007] Preferably, the traditional Chinese medicine composition is composed of the following raw materials by weight: asparagus 15 parts, honeysuckle 12 parts, turmeric 15 parts, atractylodes 10 parts, codonopsis 12 parts, mulberry 12 parts, valerian 12 parts, lily 12 parts, rush 10 parts, and licorice 6 parts.

[0008] The traditional Chinese medicine composition provided by the present application is used for preparing a medicine for treating or improving Sjogren's syndrome, and the medicine is prepared from the traditional Chinese medicinal materials in the above weight proportions, supplemented with a medically acceptable adjuvant, into an oral dosage form, which includes granules, powders, decoctions, water decoctions, oral liquids, pills, capsules, tablets, etc.

[0009] (Three) beneficial effects Sjogren's syndrome is caused by complex pathogenesis such as yin deficiency, fluid deficiency, internal dryness, blood stasis, dampness, and heat, and based on this, asparagus, lily, and mulberry are used as monarch drugs in the traditional Chinese medicine composition; asparagus is sweet and bitter and cold, is good at nourishing yin and reducing fire, moistening dryness and producing fluid, and is especially good at nourishing lung and kidney yin; lily is sweet and cold, is good at nourishing yin, moistening lung, and calming heart and spirit, can help asparagus to nourish lung, and can relieve restlessness of heart and spirit caused by yin deficiency; mulberry is sweet and sour and cold, can nourish yin and blood, produce fluid and moisten dryness, and is mild, can nourish liver and kidney yin, and fill yin blood; asparagus moistens lung and kidney from top to bottom, lily moistens lung and calms heart, and mulberry nourishes liver and kidney from bottom to top, and the three drugs are used as monarch drugs to nourish the whole body fluid, and directly aim at the root pathogenesis of yin deficiency and fluid deficiency; honeysuckle, valerian, rush, and codonopsis are used as ministerial drugs; honeysuckle is sweet and cold, has the effects of clearing heat and detoxifying, and dispersing wind and dredging collaterals; valerian is pungent and sweet and cold, has the effects of dispersing wind and heat, and clearing vision and removing nebula; rush is sweet and cold, has the effects of clearing heart and reducing fire, and diuresis and dredging collaterals, and the three drugs are used to clear heat, and aim at the symptoms of internal dryness and virtual fire; codonopsis is used to assist the monarch drugs to supplement qi and yin, and to support the healthy qi, and at the same time, to make the fluid production source, and prevent the yin drugs from affecting stomach; turmeric and atractylodes are used as auxiliary drugs; turmeric is pungent and bitter and warm, has the effects of breaking blood and dredging collaterals, and can activate blood and remove stasis, and flow the fluid, and the so-called fluid and blood are of the same origin, activating blood can help fluid supplement and disperse, and the warm nature of turmeric can regulate the cold and cool drugs; atractylodes is pungent and bitter and warm, has the effects of drying dampness and invigorating spleen, can regulate the nourishing yin drugs, and provide the spleen and stomach foundation for fluid production, and achieve supplementing without stagnation; finally, licorice is used as a guide drug to supplement spleen and qi, clear heat and detoxify, and harmonize the drugs, and the drugs are used together to achieve the effects of nourishing yin and moistening dryness, clearing heat and dredging collaterals, supplementing qi and invigorating spleen, and activating blood and clearing vision.

[0010] Further, the animal experiment results show that the traditional Chinese medicine composition can significantly reduce the water consumption of NOD mice, increase the saliva volume of NOD mice, and significantly down-regulate the levels of inflammatory factors TNF-α, IL-17 and IL-1β 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 damage. The clinical efficacy evaluation results show that the traditional Chinese medicine composition can significantly reduce the ESSDAI and ESSPRI scores of patients with Sjogren's syndrome, improve the clinical symptoms such as dry mouth, dry eyes and salivary gland swelling of the patients, has a high total clinical treatment effective rate, and can be further developed and researched as a drug for treating Sjogren's syndrome. BRIEF DESCRIPTION OF DRAWINGS

[0011] Figure 1 The IL-1β (A), TNF-α (B) and IL-17 (C) levels in the serum of mice in each group; note that P<0.001.

[0012] Figure 2 The HE staining diagram of the submandibular gland tissue of mice in each group.

[0013] Figure 3 The pathological score results of the submandibular gland tissue of mice in each group; note that P<0.01; ***P<0.001.

[0014] Figure 4 The TCM symptom score results of the two groups of patients, wherein A is the dry mouth score of the patients before and after treatment; B is the dry eye score of the patients before and after treatment; C is the salivary gland swelling score of the patients before and after treatment; ***P<0.001. DETAILED DESCRIPTION

[0015] To make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be described clearly and completely below in combination with the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application. Embodiment 1

[0016] A traditional Chinese medicine composition for treating or improving Sjogren's syndrome, the traditional Chinese medicine composition is composed of the following raw materials by weight: asparagus 8 parts, honeysuckle 6 parts, turmeric 6 parts, atractylodes 6 parts, radix codonopsis 6 parts, mulberry 8 parts, valerian 6 parts, lily 6 parts, rush 6 parts, and licorice 5 parts. Embodiment 2

[0017] A traditional Chinese medicine composition for treating or improving Sjogren's syndrome, which is composed of the following raw materials in parts by weight: asparagus 22 parts, honeysuckle 20 parts, turmeric 18 parts, atractylodes 18 parts, radix codonopsis 20 parts, mulberry 20 parts, valerian 18 parts, lily 20 parts, rush 18 parts, and licorice 12 parts. Example 3

[0018] A traditional Chinese medicine composition for treating or improving Sjogren's syndrome, which is composed of the following raw materials in parts by weight: asparagus 18 parts, honeysuckle 16 parts, turmeric 16 parts, atractylodes 10 parts, radix codonopsis 16 parts, mulberry 16 parts, valerian 14 parts, lily 16 parts, rush 12 parts, and licorice 10 parts. Example 4

[0019] A traditional Chinese medicine composition for treating or improving Sjogren's syndrome, which is composed of the following raw materials in parts by weight: asparagus 100 parts, honeysuckle 10 parts, turmeric 10 parts, atractylodes 5 parts, radix codonopsis 10 parts, mulberry 10 parts, valerian 10 parts, lily 10 parts, rush 5 parts, and licorice 5 parts. Example 5

[0020] A traditional Chinese medicine composition for treating or improving Sjogren's syndrome, which is composed of the following raw materials in parts by weight: asparagus 20 parts, honeysuckle 20 parts, turmeric 20 parts, atractylodes 15 parts, radix codonopsis 20 parts, mulberry 20 parts, valerian 20 parts, lily 20 parts, rush 15 parts, and licorice 10 parts. Example 6

[0021] A traditional Chinese medicine composition for treating or improving Sjogren's syndrome, which is composed of the following raw materials in parts by weight: asparagus 14 parts, honeysuckle 12 parts, turmeric 12 parts, atractylodes 8 parts, radix codonopsis 14 parts, mulberry 14 parts, valerian 12 parts, lily 12 parts, rush 8 parts, and licorice 8 parts. Example 7

[0022] A traditional Chinese medicine composition for treating or improving Sjogren's syndrome, which is composed of the following raw materials in parts by weight: asparagus 16 parts, honeysuckle 12 parts, turmeric 16 parts, atractylodes 12 parts, radix codonopsis 14 parts, mulberry 14 parts, valerian 12 parts, lily 14 parts, rush 12 parts, and licorice 10 parts. Example 8

[0023] A traditional Chinese medicine composition for treating or improving Sjogren's syndrome, which is composed of the following raw materials in parts by weight: asparagus 15 parts, honeysuckle 12 parts, turmeric 15 parts, atractylodes 10 parts, radix codonopsis 12 parts, mulberry 12 parts, valerian 12 parts, lily 12 parts, rush 10 parts, and licorice 6 parts. Test Example 1

[0024] Therapeutic effect of the traditional Chinese medicine composition of the present application on a Sjogren's syndrome model mouse 1 Materials and methods 1.1 Experimental animals SPF BALB / c mice 10, NOD mice 50, female 8 weeks old, body weight 16-25 g. Adapted to feed for 1 week before the experiment.

[0025] 1.2 Experimental drugs The traditional Chinese medicine composition of the present application: according to the following weight parts, the raw materials are weighed: asparagus 15 g, honeysuckle 12 g, turmeric 15 g, atractylodes 10 g, radix codonopsis 12 g, mulberry 12 g, valerian 12 g, lily 12 g, rush 10 g, licorice 6 g, wash and soak in 3 times the weight of water for 30 min, decoct twice, 30 min each time, combine the filtrates of the two times, concentrate to a drug concentration of 1 g / mL (1 g of raw material per milliliter), and store in the refrigerator.

[0026] Positive control drug: hydroxychloroquine sulfate tablets, 0.2 g / tablet 1.3 Methods 1.3.1 Grouping and administration The 50 NOD mice were randomly divided into 5 groups, 10 mice in each group, namely the model group, the hydroxychloroquine group, the traditional Chinese medicine high-dose group, the traditional Chinese medicine medium-dose group, and the traditional Chinese medicine low-dose group. 10 BALB / c mice of the same age were used as the normal group. After 1 week of adaptive feeding, the mice in each group were given the corresponding drugs by gavage (0.2 mL per mouse per day) every day. The hydroxychloroquine group of mice was given hydroxychloroquine sulfate tablets (4 mg / mL); the traditional Chinese medicine high-dose group was given the traditional Chinese medicine liquid of the present application (1.5 g / mL); the medium-dose group was given the traditional Chinese medicine liquid of the present application (1.0 g / mL); the low-dose group was given the traditional Chinese medicine liquid of the present application (0.5 g / mL); the blank group and the model group were given the same amount of purified water by gavage. Each group was given drugs once a day, and the administration was continued for 4 weeks.

[0027] 1.3.2 Detection method 1.3.2.1 Water consumption detection Water was added at a fixed time every day, and the remaining amount (mL) in the water bottle was observed at the same time the next day. The difference between the two times was the daily water consumption of the mice, and the weekly water consumption of the mice was observed and recorded.

[0028] 1.3.2.2 Saliva volume detection The saliva secretion of mice was measured every week on a fixed day. The mice were fasted for 1 h before measurement and not deprived of water. The mice were sedated using 10% chloral hydrate 0.004 mL / g. After the mice were sedated and stable, 0.1 mL of pilocarpine (pilocarpine solution was prepared using PBS buffer, and the concentration was 5 mg / kg) was injected intraperitoneally. After the injection of pilocarpine, the saliva was collected in the mouse mouth using a 10-μL pipette gun, and the saliva was moved into a 1.5-mL EP tube in a timely manner. The saliva was collected for 15 min. The weight of the EP tube was measured before and after the collection of saliva, and the results were recorded. The weight of the saliva secreted by the mouse was the weight of the EP tube after collection minus the weight of the EP tube before collection. The measurement was performed 5 times before administration, 1 week, 2 weeks, 3 weeks, and 4 weeks after administration, respectively.

[0029] 1.3.2.3 Detection of serum inflammatory factors The abdominal aorta of each mouse was bled, and the upper serum was obtained after centrifugation. The levels of TNF-α, IL-17, and IL-1β in the serum were detected using an ELISA kit.

[0030] 1.3.2.4 Histopathological observation of submandibular gland After the administration of each group was completed, the mice were sacrificed, and one side of the submandibular gland was removed and fixed in a 4% paraformaldehyde solution. The submandibular gland was routinely embedded in paraffin, sliced, and the thickness of the slice was 4 μm. The slice was stained with HE, and observed under a microscope. The pathology of the submandibular gland was scored. The scoring criteria are shown in Table 1. Table 1 Scoring criteria for submandibular gland involvement

[0031] 1.4 Statistical method Statistical software was used for analysis. The measurement data were represented by mean ± standard deviation, and paired t test was performed between groups. If the data did not meet the normal distribution, nonparametric test was used. After the homogeneity of variance was compared, one-way analysis of variance was used. If the variance was not homogeneous, Tamhane’s T2 (multiple comparison based on t test) was used for analysis. P<0.05 was considered to have statistical significance.

[0032] 2 Results 2.1 Comparison of water consumption of mice in each group during administration As shown in Table 2, before administration, the water consumption of NOD mice was significantly increased compared with that of BALB / c mice (P<0.05). In the first week of administration, the water consumption of mice in the hydroxychloroquine group was slightly decreased compared with that in the model group, but the difference was not significant (P>0.05); the water consumption of mice in the high-, medium-, and low-dose traditional Chinese medicine groups was significantly decreased compared with that in the model group (P<0.05); the water consumption of mice in the high-dose traditional Chinese medicine group was significantly lower than that in the hydroxychloroquine group (P<0.05); the water consumption of mice in the medium- and low-dose traditional Chinese medicine groups was slightly lower than that in the hydroxychloroquine group, but there was no significant difference (P>0.05).

[0033] The second week of administration, hydroxychloroquine group of mice drinking water than the model group slightly decreased, but the difference was not significant (P> 0.05); Chinese medicine high, medium and low dose group of mice drinking water than the model group decreased significantly, the difference was significant (P<0.05); Chinese medicine high, medium dose group of mice drinking water was significantly lower than the hydroxychloroquine group (P<0.05).

[0034] The third week of administration, each administration group of mice drinking water were significantly lower than the model group, the difference was significant (P<0.05); among which hydroxychloroquine group and Chinese medicine low dose group was not significantly different (P> 0.05); Chinese medicine high, medium dose group of mice drinking water was significantly lower than the hydroxychloroquine group (P<0.05); Chinese medicine high, medium and low dose group of mice drinking water was not significantly different (P>0.05).

[0035] The fourth week of administration, each administration group of mice drinking water were significantly lower than the model group, the difference was significant (P<0.05); each administration group of mice drinking water was not significantly different (P>0.05).

[0036] Table 2 Comparison of drinking water of mice in each group

[0037] Note: same column data, the same lowercase letter or no letter means P>0.05, different lowercase letters mean P<0.05.

[0038] 2.2 Comparison of saliva volume of mice in each group As shown in Table 3, before administration, NOD mice had significantly lower saliva volume than BALB / c mice (P<0.05). During the first to third weeks of administration, the saliva volume of each administration group of mice was slightly increased compared with the model group, but the difference was not significant (P>0.05). The fourth week of administration, the saliva volume of each administration group of mice was significantly increased compared with the model group (P<0.05); the saliva volume of each administration group of mice was not significantly different (P>0.05).

[0039] Table 3 Comparison of saliva volume of mice in each group

[0040] Note: same column data, the same lowercase letter or no letter means P>0.05, different lowercase letters mean P<0.05.

[0041] 2.3 Comparison of serum inflammatory factor levels of mice in each group As shown in Table 4, before administration, the serum inflammatory factor levels of NOD mice were significantly higher than those of BALB / c mice (P<0.05). During the first to third weeks of administration, the serum inflammatory factor levels of each administration group of mice were slightly decreased compared with the model group, but the difference was not significant (P>0.05). The fourth week of administration, the serum inflammatory factor levels of each administration group of mice were significantly decreased compared with the model group (P<0.05); the serum inflammatory factor levels of each administration group of mice were not significantly different (P>0.05). Figure 1As 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).

[0042] 2.4 Comparison of pathological changes in submandibular gland tissue of mice in different groups The results are as follows Figures 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).

[0043] 3. Conclusion 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. Experimental Example 2

[0044] Clinical observation of the efficacy of the traditional Chinese medicine composition of this invention in treating patients with Sjögren's syndrome 1. General Information 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.

[0045] Inclusion criteria: ① meet the diagnostic criteria of traditional Chinese medicine: dry mouth, dry eyes, dry throat, dry skin, red tongue, etc.; ② meet the diagnostic criteria of Western medicine: meet one major indicator (anti-dryness syndrome A positive; labial gland biopsy lymphocyte focus >1) and three secondary indicators (dry mouth for more than 3 months, swallowing dry food requires drinking water assistance; dry eyes for more than 3 months and requires artificial tears; Schirmer test positive); ③ no dryness syndrome related drugs in the past two months; ④ normal cognitive function, clinical manifestations of joint pain and swelling; ⑤ informed consent.

[0046] Exclusion criteria: ① secondary dryness syndrome; ② coagulation dysfunction; ③ concurrent heart, liver, brain and other important organ failure; ④ mental disorders, unable to complete the examination; ⑤ unable to complete the drug study; ⑥ taking glucocorticoids in the past 1 month; ⑦ pregnant, lactating women, or those who do not cooperate.

[0047] 2. Treatment method Control group: oral hydroxychloroquine sulfate tablets, 0.2g / tablet, once a day, 0.2g at a time.

[0048] Treatment group: oral traditional Chinese medicine composition decoction (Asparagus 15g, Honeysuckle 12g, Turmeric 15g, Atractylodes 10g, Codonopsis 12g, Mulberry 12g, Gypsum 12g, Lily 12g, Rush 10g, Licorice 6g), one dose per day, decoct 400mL of medicinal juice, take 2 times in the morning and evening.

[0049] Each group was treated for 3 months.

[0050] 3. Detection index 3.1 Severity of symptoms The severity of symptoms was evaluated by dryness syndrome self-report index (ESSPRI) and dryness syndrome disease activity index (ESSDAI) score, wherein ESSDAI mainly evaluates 12 items such as oral dryness inflammation, top and inferior conjunctivitis, and oral ulcer, each item is scored 3 points, and the lower the score, the lighter the symptoms. ESSPRI scale mainly evaluates 4 aspects such as symptoms, fatigue, pain, and mental fatigue, each aspect is scored 10 points, and the lower the score, the lighter the symptoms. (dryness symptom score + fatigue score + pain score + mental fatigue score) / 4 = ESSPRI score.

[0051] 3.2 TCM syndrome score According to the relevant literature standard, the dryness syndrome patients' dry mouth, dry eyes and salivary gland swelling were scored 0, 1, 2 and 3 points according to no, mild, moderate and severe degrees, and the higher the score, the more severe the symptoms.

[0052] 4. Efficacy standard Refer to the 2018 edition of "Technical Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine with Symptoms" and the 2002 edition of "Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine" to develop relevant standards: Marked effect: The patient's score decreased by ≥70% before and after treatment; Effective: The patient's score decreased by ≥50% before and after treatment, and <70%; Improvement: The patient's score decreased by ≥20% before and after treatment, and <50%; No effect: The patient's score decreased by <20% before and after treatment.

[0053] 5 Statistical analysis GEE was used to process the correlation of repeated measurement data within the group, which was suitable for non-independent longitudinal data. The dependent variable was set as the ordered multiple classification of therapeutic effect level (such as no effect to recovery), and the independent variables included treatment group (categorical variable), treatment time (continuous variable) and their interaction terms. The model specified the exchange correlation matrix to describe the correlation structure between intra-individual measurements, and controlled confounding factors such as central variation through fixed effects. The maximum likelihood method was used for parameter estimation, and the results were quantified with odds ratio (OR) and its 95% confidence interval to quantify the effect size, while the statistical significance of each variable was evaluated based on Wald test to ensure the robust inference of treatment effect and course of disease.

[0054] 5 Results 5.1 Comparison of ESSDAI and ESSPRI scores of patients in two groups There was no statistically significant difference in ESSDAI and ESSPRI scores between the two groups before treatment (P>0.05). The ESSDAI and ESSPRI scores of patients in the two groups after treatment were significantly lower than those before treatment (P<0.05); after treatment, the ESSDAI and ESSPRI scores of the observation group were significantly lower than those of the control group (P<0.05). The results are shown in Table 4.

[0055] Table 4 Comparison of ESSDAI and ESSPRI scores of patients in two groups before and after treatment

[0056] Note: Comparison between groups & P<0.05; comparison between treatment and before treatment within the group, # P<0.05.

[0057] 5.2 Comparison of TCM symptom scores of patients in two groups The results are shown in Figure 4 There was no statistically significant difference in dry mouth, dry eye and salivary gland swelling symptom scores between the two groups before treatment (P>0.05). The dry mouth, dry eye and salivary gland swelling symptom scores of patients in the two groups after treatment were significantly lower than those before treatment (P<0.05); after treatment, the dry mouth, dry eye and salivary gland swelling symptom scores of the observation group were significantly lower than those of the control group (P<0.05).

[0058] 5.3 Comparison of clinical efficacy of two groups The results are shown in Table 5, the total effective rate of the treatment group was 96.67%, and the total effective rate of the control group was 90.00%, and the difference between the two groups was significant.

[0059] Table 5 Comparison of clinical efficacy of two groups [n (%)]

[0060] 6 Results The traditional Chinese medicine composition in the application follows the principle of TCM syndrome differentiation and treatment, is scientifically matched, has 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, can significantly reduce the ESSDAI and ESSPRI scores of patients with Sjogren's syndrome, improve the clinical symptoms such as dry mouth, dry eyes and salivary gland swelling of 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.

[0061] The above examples are only used to illustrate the technical solutions of the application, but not to limit it; although the application has been described in detail with reference to the foregoing examples, those skilled in the art should understand that the technical solutions recorded in the foregoing examples can still be modified, or some technical features can be replaced by equivalents; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the application.

Claims

1. A traditional Chinese medicine composition for treating or improving Sjögren's syndrome, characterized in that, The traditional Chinese medicine composition is composed of 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 composed of 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 composed of the following raw materials in parts by weight: 15 parts Asparagus, 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.

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 medically acceptable excipients, and prepared into oral dosage forms, including granules, powders, decoctions, aqueous decoctions, oral liquids, pills, capsules, tablets, etc.

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