A traditional Chinese medicine composition with the functions of clearing heat and removing dampness, promoting blood circulation to remove blood stasis, dredging collaterals and relieving pain

Abstract

Inventive name: A traditional Chinese medicine composition with the functions of clearing heat and removing dampness, promoting blood circulation to remove blood stasis, and dredging collaterals to relieve pain Technical field: A traditional Chinese medicine composition for treating rheumatoid arthritis with damp-heat and obstruction of collaterals Technical problem: The composition can treat rheumatoid arthritis with damp-heat and obstruction of collaterals, and the symptoms include red and swollen joints, pain like burning, morning stiffness, limited activity, accompanied by aversion to wind and fever, sweat without relief, irritability, thirst, dry stool and red urine, red tongue, yellow or dry fur, and slippery and rapid pulse. Solution: The composition is prepared from honeysuckle, atractylodes, atractylodes rhizome, giant knotweed, cuscuta, angelica, white peony root, milkvetch root, sago palm seed, centipede, nitraria, and licorice in a specific weight ratio. Main use: The composition can treat rheumatoid arthritis with damp-heat and obstruction of collaterals.

Description

Technical fields:

[0001] This application pertains to a traditional Chinese medicine composition for treating rheumatoid arthritis, specifically addressing the problems of joint redness, swelling, burning pain, morning stiffness, and limited mobility in patients with rheumatoid arthritis suffering from damp-heat obstruction syndrome. Background technology:

[0002] Those skilled in the art will understand that rheumatoid arthritis patients often experience burning pain and swelling in the joints, morning stiffness, limited mobility, aversion to wind and fever, persistent sweating, irritability, thirst, dry stools, and dark urine, which are typically manifestations of damp-heat obstruction. To address these issues, traditional Chinese medicines that clear heat, promote diuresis, and invigorate blood circulation can be added to the formula. Those skilled in the art are confident that this herbal composition invention possesses the overall technical effect of treating damp-heat obstruction syndrome in rheumatoid arthritis, and can effectively solve the problem of limited clinical efficacy.

[0003] This formula contains detailed experimental data and formula analysis: Honeysuckle is the principal herb. Honeysuckle is sweet and cold in nature, and excels at clearing heat and detoxifying, dispersing wind-heat. It is an essential herb for relieving rheumatic toxins and can also relieve the internal heat caused by prolonged wind-cold-dampness. Atractylodes lancea and Atractylodes macrocephala are used together. Atractylodes lancea excels at drying dampness, while Atractylodes macrocephala excels at strengthening the spleen. Together, they enhance the effect of drying dampness and strengthening the spleen, so that dampness is removed and the spleen is strengthened, and the spleen is strengthened and dampness is resolved. Polygonum cuspidatum dispels wind and promotes diuresis, disperses blood stasis and relieves pain. The above three herbs are used as assistant herbs. Cuscuta chinensis tonifies the liver and kidneys; Angelica sinensis and Paeonia lactiflora strengthen the spleen, promote diuresis, invigorate blood circulation, and relieve pain; Astragalus membranaceus tonifies qi to promote blood circulation and relieves numbness. These four herbs simultaneously support the body's resistance and expel pathogenic factors, treating both wind and dampness. Coix lacryma-jobi uniquely enters the Yangming channel, dispelling damp-heat and benefiting the tendons and collaterals; Scolopendra subspinipes is pungent and warm in nature, adept at calming wind and relieving spasms, attacking toxins and dispersing nodules, and unblocking collaterals to relieve pain. In this formula, it can remove turbidity and open up stagnation, harmonizing qi and blood in the meridians. It serves as an adjuvant herb along with Cuscuta chinensis, Angelica sinensis, Paeonia lactiflora, and Astragalus membranaceus. Notopterygium incisum is pungent and ascending in nature, but its dispersing properties are reversed. It is used as a guide to the meridians, opening up the upper and lower parts of the body, thus dispelling wind and eliminating dampness. Glycyrrhiza uralensis is used to harmonize the other herbs. The combined effects of these herbs are to clear heat and promote diuresis, invigorate blood circulation, remove blood stasis, unblock collaterals, and relieve pain. The dosage ratios of the herbs also correspond to the structure of the above-mentioned formula. Summary of the Invention:

[0004] A traditional Chinese medicine composition with the functions of clearing heat and dampness, promoting blood circulation and removing blood stasis, and relieving pain by unblocking the meridians is characterized in that the raw materials, by weight, include: 15 parts honeysuckle, 9 parts atractylodes, 12 parts white atractylodes, 15 parts polygonum cuspidatum, 12 parts dodder seed, 10 parts angelica sinensis, 9 parts white peony root, 15 parts astragalus, 18 parts coix seed, 1 part centipede, 10 parts notopterygium root, and 6 parts licorice.

[0005] When formulated in a specific weight ratio, it can treat rheumatoid arthritis patients with damp-heat obstruction, characterized by symptoms such as red, swollen, and burning pain in the joints, morning stiffness, and limited mobility. Accompanying symptoms include aversion to wind, fever, persistent sweating, irritability, thirst, dry stools, and dark urine. The tongue is red with a yellow or dry coating, and the pulse is slippery and rapid.

[0006] This invention provides a traditional Chinese medicine composition primarily for improving joint pain, and for treating rheumatoid arthritis of the damp-heat obstruction type characterized by joint redness, swelling, pain, morning stiffness, and limited mobility. It is a traditional Chinese medicine composition for treating the common symptoms of joint redness, swelling, pain, morning stiffness, and limited mobility in patients with damp-heat obstruction type rheumatoid arthritis, and optimizes the treatment plan of clearing heat and dampness, removing blood stasis and relieving pain. Attached image description:

[0007] Figure 1 Line chart comparing the mean DAS28 scores of the two groups

[0008] Figure 2 Line graph comparing the mean scores of two groups of TCM syndromes

[0009] Figure 3 Line graph comparing the mean number of swollen joints in the two groups

[0010] Figure 4 Line graph comparing the mean number of joint tenderness in the two groups

[0011] Figure 5 Line chart comparing two sets of VAS scores

[0012] Figure 6 Line graph comparing the clinical disease activity indices of the two groups

[0013] Figure 7 Line chart comparing the two sets of HAQ-DI scores

[0014] Figure 8 Comparison of two sets of FACIT-F scores (line graph) Detailed implementation method:

[0015] A traditional Chinese medicine composition for treating rheumatoid arthritis with damp-heat obstruction syndrome, possessing the functions of clearing heat and dampness, promoting blood circulation and removing blood stasis, and relieving pain by unblocking the meridians, is characterized in that the traditional Chinese medicine composition is made from the following raw materials in parts by weight: honeysuckle 10-20 parts, Atractylodes lancea 6-12 parts, Atractylodes macrocephala 8-16 parts, Polygonum cuspidatum 10-20 parts, Cuscuta chinensis 8-16 parts, Angelica sinensis 8-12 parts, Paeonia lactiflora 6-12 parts, Astragalus membranaceus 10-20 parts, Coix lacryma-jobi 12-24 parts, Scolopendra subspinipes 1-3 parts, Notopterygium incisum 8-12 parts, and Glycyrrhiza uralensis 4-8 parts.

[0016] Example 1: Prepared from 12 parts honeysuckle, 6 parts atractylodes, 8 parts atractylodes macrocephala, 12 parts polygonum cuspidatum, 10 parts dodder seed, 9 parts angelica sinensis, 6 parts white peony root, 12 parts astragalus membranaceus, 15 parts coix seed, 1 part centipede, 9 parts notopterygium incisum, and 4 parts licorice.

[0017] Example 2: Prepared from 15 parts honeysuckle, 8 parts atractylodes, 12 parts white atractylodes, 15 parts Japanese knotweed, 12 parts dodder seed, 10 parts angelica, 9 parts white peony root, 15 parts astragalus, 18 parts coix seed, 2 parts centipede, 10 parts notopterygium root, and 6 parts licorice.

[0018] Example 3: Prepared from 18 parts honeysuckle, 9 parts atractylodes, 15 parts white atractylodes, 18 parts Japanese knotweed, 15 parts dodder seed, 12 parts angelica, 12 parts white peony root, 18 parts astragalus, 20 parts coix seed, 3 parts centipede, 12 parts notopterygium root, and 8 parts licorice.

[0019] The processed products of the Chinese medicinal materials are: raw honeysuckle, stir-fried Atractylodes lancea, stir-fried Atractylodes macrocephala, raw Polygonum cuspidatum, salt-processed Cuscuta chinensis, raw Angelica sinensis, stir-fried Paeonia lactiflora, raw Astragalus membranaceus, stir-fried Coix lacryma-jobi, raw centipede, raw Notopterygium incisum, and prepared licorice root.

[0020] The dosage form of this traditional Chinese medicine composition can be decoction, capsule, tablet, pill, granule, gavage, or enema.

[0021] Dosage: Oral administration.

[0022] Clinical trial data:

[0023] This formula has demonstrated its beneficial effects in treating rheumatoid arthritis with damp-heat obstruction syndrome through a prospective clinical cohort study, and detailed experimental data have been recorded:

[0024] 1. Inclusion criteria: ① Meets the 2010 ACR / EULAR RA classification criteria; ② 5.1 > DAS28 > 3.2; ③ RA patients with damp-heat obstruction syndrome; ④ 18 to 70 years old; ⑤ Patients gave informed consent to participate in this study.

[0025] 2. Exclusion criteria for cases: ① Patients with severe organ lesions or mental illnesses; ② Patients who are allergic to or have contraindications to the drugs involved in the study protocol.

[0026] 3. Criteria for evaluating efficacy: The following indicators were observed before treatment and at weeks 12 and 24 of treatment, including primary efficacy assessment indicators and secondary efficacy assessment indicators.

[0027] (1) Main efficacy assessment indicators

[0028] DAS28 score, DAS28 remission rate (DAS28 < 2.6), DAS28 low activity rate (DAS28 ≤ 3.2), and DAS28 difference before and after.

[0029] Note: 28 joint disease activity scores (DAS28).

[0030] (2) Secondary efficacy assessment indicators

[0031] Traditional Chinese Medicine syndrome score; number of distended joints (SJC); number of tender joints (TJC); visual pain score (VAS); clinical disease activity index (CDAI); health assessment questionnaire (HAQ-DI); functional assessment of chronic disease treatment - fatigue scale (FACIT-Fatigue).

[0032] Laboratory indicators: ESR, CRP, RF, anti-CCP antibody.

[0033] (3) Safety indicators

[0034] Complete blood count, blood biochemistry, and routine urine / stool tests.

[0035] 4. Statistical Analysis Methods

[0036] (1) Database creation and data entry

[0037] An electronic medical record system was established, and data was entered synchronously using a double entry method. The data was checked and reviewed regularly, and any inconsistent results were verified against the original CRF table and corrected promptly.

[0038] (2) Data Statistics and Analysis

[0039] ① All statistical tests were two-tailed, and a p-value less than or equal to 0.05 was considered statistically significant.

[0040] ② Descriptive analysis: Count data are described using proportions, measurement data are described using means, standard deviations, etc., and non-normally distributed data are described using medians, etc.

[0041] ③ The comparison of the two groups of general situations will be analyzed using appropriate methods according to the type of indicators. For quantitative data, the intergroup comparison will use the independent t-test or Wilcoxon rank-sum test. For categorical data, the chi-square test or exact probability method will be used. For ordinal data, the Wilcoxon rank-sum test or CMH test will be used.

[0042] ④ Statistical analysis was performed using SPSS 25.0 software.

[0043] 5. Statistical Analysis Results

[0044] Patients with rheumatoid arthritis and damp-heat syndrome who met the inclusion criteria and worked at the applicant's workplace from October 2019 to December 2022 were selected as the study subjects and randomly divided into a treatment group and a control group. The treatment group received the traditional Chinese medicine combination in addition to the treatment with methotrexate tablets, while the control group received only methotrexate tablets. A total of 153 effective cases were finally included, with 80 effective cases in the treatment group and 73 effective cases in the control group.

[0045] (1) Baseline general situation comparison

[0046] Regarding baseline general characteristics, there were 80 patients in the treatment group and 73 patients in the control group. The mean age of patients in the treatment group was 47.92 ± 9.8 years, with 6 males (7.5%) and 74 females (92.5%). The mean height was 159.91 ± 12.5 cm and the mean weight was 57.89 ± 9.53 kg. There were no statistically significant differences in baseline characteristics between the two groups (P > 0.05), indicating comparability. The distribution of past medical history indicators was balanced between the groups (P > 0.05), also indicating comparability.

[0047] Table 1 Baseline characteristics of the study population

[0048]

[0049] (2) Key efficacy assessment indicators

[0050] ①DAS28 score

[0051] At week 0, the mean DAS28 value for the traditional Chinese medicine and Western medicine group was 4.14 with a standard deviation of 0.49; the mean DAS28 value for the Western medicine group was 4.26 with a standard deviation of 0.38. At week 12, the mean DAS28 value for the traditional Chinese medicine and Western medicine group was 3.30 with a standard deviation of 0.58; the mean DAS28 value for the Western medicine group was 3.63 with a standard deviation of 0.55. At week 24, the mean DAS28 value for the traditional Chinese medicine and Western medicine group was 2.67 with a standard deviation of 0.64; the mean DAS28 value for the Western medicine group was 3.10 with a standard deviation of 0.54. See Table 2 for details.

[0052] The results showed that the DAS28 scores of both groups gradually decreased with the progress of drug intervention, with the Chinese medicine and Western medicine group showing the greatest rate and magnitude of decrease from 0 to 12 weeks. The average DAS28 scores of the Chinese medicine and Western medicine group were lower than those of the Western medicine group at 12 and 24 weeks, and the differences were statistically significant (P < 0.05).

[0053] Table 2 Comparison of DAS28 scores between the two groups (scores, X±s)

[0054]

[0055] Note: * indicates P < 0.05 compared to baseline; # indicates P < 0.05 compared to 12 weeks.

[0056] ②DAS28 remission rate

[0057] At week 12, 12 cases (15%) in the traditional Chinese medicine and Western medicine group achieved the DAS28 response rate standard; 1 case (1.37%) in the Western medicine group achieved the DAS28 response rate standard. At week 24, 37 cases (46.25%) in the traditional Chinese medicine and Western medicine group achieved the DAS28 response rate standard; 20 cases (27.40%) in the Western medicine group achieved the DAS28 response rate standard. See Table 3 for details.

[0058] The results showed that the DAS28 remission rate in both groups gradually increased with the duration of drug intervention. At weeks 12 and 24, the DAS28 remission rate in the traditional Chinese medicine group was higher than that in the Western medicine group, and the differences were statistically significant.

[0059] Table 3 Comparison of DAS28 remission rates between the two groups of subjects

[0060]

[0061] ③ DAS28 low activity rate

[0062] At week 12, 33 cases (41.25%) in the traditional Chinese medicine and Western medicine group met the DAS28 low activity rate criteria, while 24 cases (32.88%) in the Western medicine group did. At week 24, 62 cases (77.5%) in the traditional Chinese medicine and Western medicine group met the DAS28 low activity rate criteria, while 46 cases (63.01%) in the Western medicine group did. See Table 4 for details.

[0063] The results showed that the low DAS28 activity rate gradually increased in both groups as the drug intervention progressed. At week 24, the low DAS28 activity rate was significantly higher in the traditional Chinese medicine / Western medicine group than in the Western medicine group.

[0064] Table 4 Comparison of DAS28 low activity rates between the two groups of subjects

[0065]

[0066] ④Difference before and after DAS28

[0067] At 12 weeks, the mean difference in DAS28 values ​​before and after treatment in the traditional Chinese medicine and Western medicine group was 0.85, with a standard deviation of 0.53; while in the Western medicine group, the mean difference was 0.61, with a standard deviation of 0.50. At 24 weeks, the mean difference in DAS28 values ​​before and after treatment in the traditional Chinese medicine and Western medicine group was 1.51, with a standard deviation of 0.68; while in the Western medicine group, the mean difference was 1.20, with a standard deviation of 0.60. Compared with 12 weeks, at 24 weeks, the mean difference in DAS28 values ​​before and after treatment in the traditional Chinese medicine and Western medicine group was 0.66, with a standard deviation of 0.53; while in the Western medicine group, the mean difference was 0.60, with a standard deviation of 0.61. See Table 5 for details.

[0068] Regarding the difference before and after DAS28, at 12 weeks, the mean difference in the traditional Chinese medicine group (0.85±0.53) was higher than that in the Western medicine group (0.61±0.50), and the difference was statistically significant. At 24 weeks, the mean difference in the traditional Chinese medicine group (1.51±0.68) was higher than that in the Western medicine group (1.20±0.60), and the difference was statistically significant (P<0.05).

[0069] Table 5 Comparison of DAS28 score differences between the two groups (points, X±s)

[0070]

[0071] (3) Secondary efficacy assessment indicators

[0072] ① Traditional Chinese Medicine Syndrome Scoring

[0073] At week 0, the mean TCM syndrome score for the combined Chinese and Western medicine group was 21.08, with a standard deviation of 6.27; the mean TCM syndrome score for the Western medicine group was 19.53, with a standard deviation of 4.77. At week 12, the mean TCM syndrome score for the combined Chinese and Western medicine group was 13.23, with a standard deviation of 4.58; the mean TCM syndrome score for the Western medicine group was 15.2, with a standard deviation of 5.06. At week 24, the mean TCM syndrome score for the combined Chinese and Western medicine group was 8.75, with a standard deviation of 4.87; the mean TCM syndrome score for the Western medicine group was 10.96, with a standard deviation of 5.83. See Table 6 for details.

[0074] The results showed that the TCM syndrome scores of both groups gradually decreased with the progress of drug intervention. Compared with baseline, the TCM syndrome scores of both groups decreased at 12 and 24 weeks, with the TCM-Western medicine group showing the greatest rate and magnitude of decrease from 0 to 12 weeks. Intergroup comparisons showed that the average TCM syndrome scores of the TCM-Western medicine group were lower than those of the Western medicine group at both 12 and 24 weeks, and the differences were statistically significant (P < 0.05).

[0075] Table 6 Comparison of TCM syndrome scores between the two groups of subjects (scores, X±s)

[0076]

[0077] Note: * indicates P < 0.05 compared to baseline; # indicates P < 0.05 compared to 12 weeks.

[0078] After the follow-up period, the TCM syndrome efficacy index was compared between the two groups (see Table 7). The results showed that the TCM and Western medicine group had 3 cured cases, 31 with significant effects, 75 with effective cases, and 5 with no effect, while the Western medicine group had 0 cured cases, 12 with significant effects, 55 with effective cases, and 18 with no effect. The differences were statistically significant (P < 0.05).

[0079] Table 7 Comparison of TCM syndrome efficacy index between the two groups of subjects (scores, X±s)

[0080]

[0081] ② Number of joint swellings

[0082] At week 0, the mean number of swollen joints in the traditional Chinese medicine and Western medicine group was 4.69 (standard deviation 2), while the mean number of swollen joints in the Western medicine group was 4.52 (standard deviation 1.94). At week 12, the mean number of swollen joints in the traditional Chinese medicine and Western medicine group was 2.38 (standard deviation 1.48), while the mean number of swollen joints in the Western medicine group was 3.10 (standard deviation 1.29). At week 24, the mean number of swollen joints in the traditional Chinese medicine and Western medicine group was 0.97 (standard deviation 0.96), while the mean number of swollen joints in the Western medicine group was 2.41 (standard deviation 1.18). See Table 8 for details.

[0083] The results showed that the number of joint swellings in both groups gradually decreased as the drug intervention time progressed. The average number of joint swellings in the Chinese medicine group and the Western medicine group was lower than that in the Western medicine group at both 12 weeks and 24 weeks, and the differences were statistically significant.

[0084] Table 8 Comparison of the number of swollen joints between the two groups (minutes, X±s)

[0085]

[0086] Note: * indicates P < 0.05 compared to baseline; # indicates P < 0.05 compared to 12 weeks.

[0087] ③ Number of joint tenderness

[0088] At week 0, the mean number of tender joints in the traditional Chinese medicine (TCM) and Western medicine group was 5.49 (standard deviation 2.01), while the mean number of tender joints in the Western medicine group was 5.11 (standard deviation 2.02). At week 12, the mean number of tender joints in the TCM and Western medicine group was 2.82 (standard deviation 1.08), while the mean number of tender joints in the Western medicine group was 3.63 (standard deviation 1.48). At week 24, the mean number of tender joints in the TCM and Western medicine group was 1.90 (standard deviation 1.03), while the mean number of tender joints in the Western medicine group was 2.56 (standard deviation 0.96). See Table 9.

[0089] The results showed that the number of tender joints in both groups gradually decreased with the duration of drug intervention. The average number of tender joints in the Chinese medicine and Western medicine groups showed statistically significant differences at both 12 and 24 weeks.

[0090] Table 9 Comparison of the number of joint tenderness points between the two groups (min, X±s)

[0091]

[0092] Note: * indicates P < 0.05 compared to baseline; # indicates P < 0.05 compared to 12 weeks.

[0093] ④ Visual Analogue Scale (VAS) for Pain

[0094] At week 0, the mean VAS of the traditional Chinese medicine and Western medicine group was 3.95 with a standard deviation of 1.32, while the mean VAS of the Western medicine group was 4.11 with a standard deviation of 0.86. At week 12, the mean VAS of the traditional Chinese medicine and Western medicine group was 2.96 with a standard deviation of 0.82, while the mean VAS of the Western medicine group was 3.41 with a standard deviation of 0.71. At week 24, the mean VAS of the traditional Chinese medicine and Western medicine group was 2.14 with a standard deviation of 0.85, while the mean VAS of the Western medicine group was 2.55 with a standard deviation of 0.80. See Table 10 for details.

[0095] The results showed that the visual analog scale scores for pain gradually decreased in both groups as the duration of drug intervention progressed. Statistically significant differences were observed between the two groups at both 12 and 24 weeks.

[0096] Table 10 Comparison of visual analog scale scores for pain between the two groups of subjects (scores, X±s)

[0097]

[0098] Note: * indicates P < 0.05 compared to baseline; # indicates P < 0.05 compared to 12 weeks.

[0099] ⑤ Clinical Disease Activity Index (CDAI)

[0100] At week 0, the mean CDAI for the traditional Chinese medicine and Western medicine group was 19.54 with a standard deviation of 4.10, while the mean CDAI for the Western medicine group was 18.82 with a standard deviation of 4.37. At week 12, the mean CDAI for the traditional Chinese medicine and Western medicine group was 12.38 with a standard deviation of 2.88, while the mean CDAI for the Western medicine group was 14.05 with a standard deviation of 3.24. At week 24, the mean CDAI for the traditional Chinese medicine and Western medicine group was 8.05 with a standard deviation of 2.87, while the mean CDAI for the Western medicine group was 10.63 with a standard deviation of 3.43. See Table 11 for details.

[0101] The results showed that the CDAI scores of both groups gradually decreased with the progression of drug intervention, with the Chinese medicine and Western medicine group showing the greatest rate and magnitude of decrease from 0 to 12 weeks. At 12 and 24 weeks, the CDAI scores of the Chinese medicine and Western medicine group were lower than those of the Western medicine group, and the differences were statistically significant.

[0102] Table 11 Comparison of Clinical Disease Activity Index between the Two Groups (points, X±s)

[0103]

[0104]

[0105] Note: * indicates P < 0.05 compared to baseline; # indicates P < 0.05 compared to 12 weeks.

[0106] ⑥ Health Assessment Questionnaire (HAQ-DI)

[0107] At week 0, the mean HAQ-DI for the traditional Chinese medicine and Western medicine group was 12.81 with a standard deviation of 12.78, while the mean HAQ-DI for the Western medicine group was 11.05 with a standard deviation of 10.41. At week 12, the mean HAQ-DI for the traditional Chinese medicine and Western medicine group was 6.88 with a standard deviation of 8.67, while the mean HAQ-DI for the Western medicine group was 6.65 with a standard deviation of 8.35. At week 24, the mean HAQ-DI for the traditional Chinese medicine and Western medicine group was 4.61 with a standard deviation of 7.51, while the mean HAQ-DI for the Western medicine group was 4.51 with a standard deviation of 6.92. (See Table 12 for details.)

[0108] The results showed that the HAQ-DI scores of both groups gradually decreased as the drug intervention time progressed, but no statistically significant difference was observed between the two groups at 12 and 24 weeks.

[0109] Table 12 Comparison of HAQ-DI scores between the two groups of subjects (scores, X±s)

[0110]

[0111] Note: * indicates P < 0.05 compared to baseline; # indicates P < 0.05 compared to 12 weeks.

[0112] ⑦ Functional assessment for chronic disease treatment - fatigue (FACIT-F)

[0113] At week 0, the mean FACIT-F in the treatment group was 35.01 with a standard deviation of 9.90, while the mean FACIT-F in the control group was 36.44 with a standard deviation of 9.31. At week 12, the mean FACIT-F in the treatment group was 41.10 with a standard deviation of 7.71, while the mean FACIT-F in the control group was 38.61 with a standard deviation of 9.32. At week 24, the mean FACIT-F in the treatment group was 43.18 with a standard deviation of 7.39, while the mean FACIT-F in the control group was 41.57 with a standard deviation of 7.39. See Table 13 for details.

[0114] The results showed that the FACIT-F scores of both groups gradually increased with the duration of drug intervention. The average FACIT-F score of the treatment group was higher than that of the control group at both 12 and 24 weeks, and the differences were statistically significant.

[0115] Table 13 Comparison of FACIT-F scores between the two groups of subjects (scores, X±s)

[0116]

[0117] Note: * indicates P < 0.05 compared to baseline; # indicates P < 0.05 compared to 12 weeks.

[0118] (4) Evaluation of laboratory indicators

[0119] The Shapiro-Wilk test confirmed that the baseline, 12-week, and 24-week ESR, CRP, RF, and anti-CCP antibody levels in both groups did not conform to a normal distribution (P < 0.05), and a nonparametric rank-sum test was used. The Mann-Whitney U test showed no statistically significant differences in baseline levels of ESR, CRP, RF, and anti-CCP antibody between the two groups (P > 0.05), indicating comparability between the groups.

[0120] Compared with baseline, the levels of ESR, CRP, RF, and anti-CCP antibody in the Chinese medicine and Western medicine groups decreased significantly at 12 and 24 weeks, with statistically significant differences (P < 0.05); the levels of ESR and CRP in the Western medicine group decreased significantly at 12 and 24 weeks, with statistically significant differences (P < 0.05). For details, please refer to Tables 14, 15, and 16.

[0121] Intergroup comparisons showed that at 12 weeks, the ESR and CRP in the traditional Chinese medicine group were significantly lower than those in the Western medicine group (P < 0.05); at 24 weeks, the RF in the traditional Chinese medicine group was lower than that in the Western medicine group (P < 0.05); there were no statistically significant differences in anti-CCP antibody levels between the two groups at 12 and 24 weeks (P > 0.05).

[0122] Table 14 Comparison of ESR and CRP levels between the two groups of subjects (X±s)

[0123]

[0124] Note: * indicates that P < 0.05 compared to baseline.

[0125] Table 15 Comparison of RF between the two groups of subjects (X±s)

[0126]

[0127] Note: * indicates that P < 0.05 compared to baseline.

[0128] Table 16 Comparison of anti-CCP antibodies between the two groups of subjects (X±s)

[0129]

[0130] Note: * indicates that P < 0.05 compared to baseline.

[0131] (5) Security Analysis

[0132] There were no statistically significant differences in the distribution of routine blood, urine, and stool tests, as well as liver function (AST, ALT) and kidney function (Cr, BUN) indicators between the two groups (P > 0.05). No serious complications or adverse drug events occurred in either group. Subjects experiencing adverse reactions received only short-term symptomatic treatment, and these adverse reactions did not affect the final clinical efficacy assessment. All adverse events resolved during follow-up.

[0133] (6) Research Conclusions

[0134] This traditional Chinese medicine composition can effectively reduce DAS28, CDAI, and SDAI scores in RA patients, improve DAS28 remission rates and low activity rates, reduce the number of swollen and tender joints, and improve the overall condition of patients; it also reduces the levels of inflammatory markers such as RF, CRP, and ESR; lowers the TCM syndrome score of subjects, improves the FACIT-F score, and improves patients' clinical symptoms and quality of life; and reduces the occurrence of combined medications and adverse reactions at the same DAS28 score. The combined use of this traditional Chinese medicine composition with Western medicine is more effective than Western medicine alone and is worthy of clinical promotion and application.

Claims

1. A traditional Chinese medicine composition for treating rheumatoid arthritis with damp-heat obstruction syndrome, characterized in that... The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15 parts honeysuckle, 9 parts atractylodes, 12 parts white atractylodes, 15 parts cuscuta, 12 parts dodder seed, 10 parts angelica, 9 parts white peony root, 15 parts astragalus, 18 parts coix seed, 1 part centipede, 10 parts notopterygium root, and 6 parts licorice.

2. A traditional Chinese medicine composition according to claim 1, wherein the processed products of the raw materials are: raw honeysuckle, stir-fried Atractylodes lancea, stir-fried Atractylodes macrocephala, raw Polygonum cuspidatum, salt-processed Cuscuta chinensis, raw Angelica sinensis, stir-fried Paeonia lactiflora, raw Astragalus membranaceus, stir-fried Coix lacryma-jobi, raw Scolopendra subspinipes, raw Notopterygium incisum, and processed Glycyrrhiza uralensis, extracted and prepared according to conventional methods in the field of traditional Chinese medicine.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that: Dosage forms include decoctions, capsules, tablets, pills, granules, oral enemas, and enemas.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicine for treating rheumatoid arthritis with damp-heat obstruction syndrome.

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