A traditional Chinese medicine composition for treating chronic cervicitis combined with HPV infection and application thereof

Abstract

This invention relates to a traditional Chinese medicine composition for treating chronic cervicitis complicated with HPV infection. The composition is made from the following raw materials in parts by weight: 26-34 parts raw Astragalus membranaceus, 26-34 parts Smilax glabra, 11-19 parts Toona sinensis root bark, and 26-34 parts raw Coix lacryma-jobi. This invention also provides the uses of the traditional Chinese medicine composition. In this invention, raw Astragalus membranaceus is the principal ingredient, tonifying Qi and strengthening the body's resistance; Smilax glabra and Toona sinensis root bark clear heat and dry dampness; and raw Coix lacryma-jobi dispels dampness and promotes tissue regeneration, serving as assistant ingredients; the entire formula works synergistically to strengthen the body's resistance, eliminate pathogenic factors, and promote tissue regeneration.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical biotechnology, specifically to a traditional Chinese medicine composition for treating chronic cervicitis complicated with HPV infection and its application. Background Technology

[0002] Chronic cervicitis complicated by HPV infection refers to inflammation of the cervix coupled with infection by human papillomavirus (HPV). Chronic cervicitis is a chronic inflammatory response of the cervical tissue caused by long-term irritation or minor injury, while HPV infection further damages cervical cells. This combined infection may cause discomfort such as increased vaginal discharge, abnormal bleeding (in severe cases, contact bleeding), lower abdominal pain, and lower back pain.

[0003] Chinese patent document CN104784489A discloses a traditional Chinese medicine preparation for treating chronic cervicitis complicated with HPV infection and its preparation method. This preparation is made from the following medicinal ingredients: Dryopteris crassirhizoma, Taxillus chinensis, Astragalus membranaceus, Atractylodes macrocephala, Spatholobus suberectus, Cremastra appendiculata, Cyperus rotundus, Clematis armandii, Pteris vittata, Sophora flavescens, and Aucklandia lappa. Targeting the pathogenesis of this condition—damp-heat accumulation and qi stagnation with blood stasis—it effectively treats chronic cervicitis and also effectively clears HPV, addressing both the symptoms and the root cause, resulting in significant therapeutic effects.

[0004] Chinese patent document CN104740218A discloses a traditional Chinese medicine for treating chronic cervicitis of the damp-heat type, which is composed of the following components in parts by weight: 2-6 parts of Polyporus umbellatus, 4-8 parts of Eucommia ulmoides, 4-10 parts of Dolichos lablab flower, 2-4 parts of Gardenia jasminoides, 6-8 parts of Ramulus nummularia root, 6-8 parts of Althaea rosea flower, 8-12 parts of Patrinia scabiosaefolia, 6-10 parts of Achyranthes bidentata, 4-8 parts of Viola yedoensis, 6-10 parts of Ginkgo biloba, 8-12 parts of Allium tuberosum root, 6-8 parts of Cinnamomum cassia, 8-12 parts of Bupleurum chinense, 10-12 parts of Anemarrhena asphodeloides, 6-8 parts of Euryale ferox, 4-10 parts of Ligusticum chuanxiong, 4-6 parts of Chrysanthemum indicum, 6-8 parts of Cuscuta chinensis, 2-4 parts of Cyperus rotundus, 6-8 parts of Os draconis, 4-6 parts of Rehmannia glutinosa, 6-10 parts of Plantago asiatica, and 4-10 parts of Phellodendron chinense. This formula clears heat and dampness, strengthens the body's resistance, and eliminates pathogenic factors. The combined effects of these herbs are effective in treating damp-heat type chronic cervicitis, consistently yielding excellent clinical results. A four-year study involving 80 patients demonstrated that this medicine is effective in treating damp-heat type chronic cervicitis, with an efficacy rate of 90%.

[0005] Traditional Chinese medicine compositions for treating chronic cervicitis complicated with HPV infection have the following drawbacks: too many ingredients, difficult to source, and expensive; their efficacy is not obvious, and the treatment effect is poor. Therefore, there is an urgent need for a traditional Chinese medicine composition that is effective in treating chronic cervicitis complicated with HPV infection, has fewer ingredients, is practical to use, has high compliance, and is safe and effective. Summary of the Invention

[0006] The purpose of this invention is to address the shortcomings of existing technologies by providing a traditional Chinese medicine composition for treating chronic cervicitis complicated with HPV infection and its application.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating chronic cervicitis complicated with HPV infection, the traditional Chinese medicine composition being made from the following raw materials in parts by weight: 26-34 parts of raw Astragalus membranaceus, 26-34 parts of Smilax glabra, 11-19 parts of Toona sinensis root bark, and 26-34 parts of raw Coix lacryma-jobi.

[0008] As a preferred example, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 28-32 parts of raw Astragalus membranaceus, 28-32 parts of Smilax glabra, 13-17 parts of Toona sinensis root bark, and 28-32 parts of raw Coix lacryma-jobi.

[0009] As a preferred example, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 30 parts of raw Astragalus membranaceus, 30 parts of Smilax glabra, 15 parts of Toona sinensis root bark, and 30 parts of raw Coix lacryma-jobi.

[0010] As a preferred example, the traditional Chinese medicine composition further includes pharmaceutically acceptable excipients.

[0011] Secondly, this invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for treating chronic cervicitis complicated with HPV infection.

[0012] Thirdly, the present invention provides a pharmaceutical composition for treating chronic cervicitis complicated with HPV infection, wherein the pharmaceutical composition is composed of a traditional Chinese medicine composition and recombinant human interferon α2b.

[0013] Fourthly, the present invention provides the use of the pharmaceutical composition in the preparation of a drug for treating chronic cervicitis complicated with HPV infection.

[0014] Method of use: In accordance with the "Management Standards for Traditional Chinese Medicine Decoction Rooms in Medical Institutions," the hospital's traditional Chinese medicine pharmacy will uniformly decoct the herbs. Each dose will be concentrated and filtered using Ankun drinking water to make two bags of liquid, each bag containing 180 ml. Take one bag twice daily, half an hour after meals. The treatment will last for three months, with 20 days of treatment per month, starting three days after the end of menstruation and continuing until the start of the next menstruation.

[0015] The advantages of this invention are:

[0016] This invention uses raw Astragalus membranaceus as the principal ingredient to invigorate Qi and support the body's resistance; Smilax glabra and Toona sinensis root bark clear heat and dry dampness, while raw Coix lacryma-jobi removes dampness and promotes tissue regeneration, serving as assistant ingredients; the entire formula works together to support the body's resistance, eliminate pathogens, promote tissue regeneration, and eliminate toxins.

[0017] The combined treatment group of this invention consistently outperformed the rhIFN α2b group and the Ankun Yin single treatment group in improving all observed symptoms, achieving the most significant and lasting improvement in leukorrhea symptoms, local and systemic discomfort, and gastrointestinal, oral and urinary symptoms. Attached Figure Description

[0018] Figure 1 This invention provides a Traditional Chinese Medicine Syndrome (TCM) improvement scoring chart. Detailed Implementation

[0019] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent forms also fall within the scope defined by the appended claims.

[0020] Example 1: A Traditional Chinese Medicine Composition for Treating Chronic Cervicitis Complicated with HPV Infection (Part 1)

[0021] 30 parts raw Astragalus membranaceus, 30 parts Smilax glabra, 15 parts Toona sinensis root bark, and 30 parts raw Coix lacryma-jobi.

[0022] Example 2: A Traditional Chinese Medicine Composition for Treating Chronic Cervicitis Complicated with HPV Infection (Part Two)

[0023] 30 parts raw Astragalus membranaceus, 26 parts Smilax glabra, 19 parts Toona sinensis root bark, and 28 parts raw Coix lacryma-jobi.

[0024] Example 3: Traditional Chinese Medicine Composition for Treating Chronic Cervicitis Complicated with HPV Infection (Part Three)

[0025] Raw Astragalus membranaceus 26 parts, Smilax glabra 34 parts, Toona sinensis root bark 13 parts, raw Coix lacryma-jobi 32 parts.

[0026] Example 4: Traditional Chinese Medicine Composition for Treating Chronic Cervicitis Complicated with HPV Infection (Part Four)

[0027] Raw Astragalus membranaceus 34 parts, Smilax glabra 28 parts, Toona sinensis root bark 17 parts, raw Coix lacryma-jobi 30 parts.

[0028] Example 5: A Traditional Chinese Medicine Composition for Treating Chronic Cervicitis Complicated with HPV Infection (Part 5)

[0029] 28 parts raw Astragalus membranaceus, 32 parts Smilax glabra, 15 parts Toona sinensis root bark, and 26 parts raw Coix lacryma-jobi.

[0030] Example 6: A Traditional Chinese Medicine Composition for Treating Chronic Cervicitis Complicated with HPV Infection (VI)

[0031] 32 parts raw Astragalus membranaceus, 30 parts Smilax glabra, 11 parts Toona sinensis root bark, and 34 parts raw Coix lacryma-jobi.

[0032] Example 7: A Traditional Chinese Medicine Composition for Treating Chronic Cervicitis Complicated with HPV Infection (VII)

[0033] 30 parts raw Astragalus membranaceus, 34 parts Smilax glabra, 13 parts Toona sinensis root bark, and 32 parts raw Coix lacryma-jobi.

[0034] Example 8: A Traditional Chinese Medicine Composition for Treating Chronic Cervicitis Complicated with HPV Infection (Part 8)

[0035] 26 parts raw Astragalus membranaceus, 28 parts Smilax glabra, 17 parts Toona sinensis root bark, and 30 parts raw Coix lacryma-jobi.

[0036] Example 9: A Traditional Chinese Medicine Composition for Treating Chronic Cervicitis Complicated with HPV Infection (IX)

[0037] 34 parts raw Astragalus membranaceus, 32 parts Smilax glabra, 15 parts Toona sinensis root bark, and 26 parts raw Coix lacryma-jobi.

[0038] Example 10: A Traditional Chinese Medicine Composition for Treating Chronic Cervicitis Complicated with HPV Infection (X)

[0039] 28 parts raw Astragalus membranaceus, 30 parts Smilax glabra, 11 parts Toona sinensis root bark, and 34 parts raw Coix lacryma-jobi.

[0040] Example 11: A Traditional Chinese Medicine Composition for Treating Chronic Cervicitis Complicated with HPV Infection (XI)

[0041] 32 parts of raw Astragalus membranaceus, 26 parts of Smilax glabra, 19 parts of Toona sinensis root bark, and 28 parts of raw Coix lacryma-jobi.

[0042] Example 12 Clinical Trial

[0043] Test method:

[0044] (1) Patient randomization method

[0045] This study used a prospective randomization method to group patients. The enrolled patients were randomly and evenly assigned to the control group (recombinant human interferon α2b treatment group) according to the sample size. In the Ankun Decoction group and the Ankun Decoction combined with recombinant human interferon α2b treatment group of this invention: the RAND() function was used to generate a corresponding random number for each enrolled patient, and the random numbers were sorted in ascending order. According to the set sample size of each group, the corresponding sample number was selected according to the random number order and assigned to each group.

[0046] (2) Calculation of patient sample size

[0047] This study used recombinant human interferon α2b, a standard treatment for chronic cervicitis, as a control. The Ankun Yin group and the group receiving Ankun Yin combined with recombinant human interferon α2b were the study groups. The clinical efficacy of the three groups after treatment was observed, and therefore, a superiority test was used to calculate the sample size. The formula for estimating the sample size is as follows:

[0048]

[0049] Since the expected efficacy rates were 75% in the control group (recombinant human interferon α2b treatment group), 30% in the Ankun Yin group, and 80% in the Ankun Yin and recombinant human interferon α2b combination therapy group, and a 1:1:1 intergroup ratio design was adopted, the sample size was calculated using PASS 15.0 software, the w-value was 0.4625, the degrees of freedom were 2, the significance level α was set at 0.05, and the power (1-β) was set at 0.9. The calculation results are as follows (see Table 1):

[0050] Table 1. Calculation results of minimum sample size

[0051]

[0052] N=60, meaning a total sample size of 60 cases is needed across the three groups, with 20 cases needed in each group. Considering the possibility of loss to follow-up, the sample size is increased by 20%, resulting in a total sample size of 75 cases needed for the three groups. The calculation results are as follows (see Table 2):

[0053] Table 2. Final Sample Size Calculation Results

[0054]

[0055] (3) Treatment methods

[0056] Recombinant human interferon α2b treatment group

[0057] The recombinant human interferon α2b treatment group received treatment for a total of 3 months, with 20 days of treatment per month, starting 3 days after the end of menstruation and continuing until the start of the next menstruation. The medication was administered vaginally; before bedtime, the applicator was gently inserted deep into the vagina, and the pusher was used to push the recombinant human interferon α2b vaginal effervescent tablet to the vaginal fornix. One tablet (500,000 IU) was administered every two days. The recombinant human interferon α2b vaginal effervescent tablets were manufactured by Beijing Kaiyin Technology Co., Ltd., with approval number S20120019.

[0058] Ankun Drink Treatment Group

[0059] The Ankun Decoction treatment group received treatment for a total of 3 months, with 20 days of treatment per month, starting 3 days after the end of menstruation and continuing until the start of the next menstruation. The Ankun Decoction formula is as follows: 30g of raw Astragalus membranaceus, 30g of Smilax glabra, 15g of Toona sinensis root bark, and 30g of raw Coix lacryma-jobi. In accordance with the "Management Standards for Traditional Chinese Medicine Decoction Rooms in Medical Institutions," the hospital's pharmacy uniformly decocted the herbs. Each dose of Ankun Decoction was concentrated and filtered into two bags of liquid, each bag containing 180 ml. One bag was taken twice daily, half an hour after meals.

[0060] Ankun Decoction combined with recombinant human interferon α2b treatment group

[0061] The group treated with a combination of Ankun Decoction and recombinant human interferon α2b vaginal effervescent tablets underwent a total of 3 months of treatment, with 20 days of treatment per month, starting 3 days after the end of menstruation and continuing until the start of the next menstruation. The treatment involved taking 180 ml of Ankun Decoction twice daily, half an hour after meals. Simultaneously, one recombinant human interferon α2b vaginal effervescent tablet was inserted vaginally every two days.

[0062] (4) Treatment course and follow-up plan

[0063] Treatment Course: In this study, the control group, the Ankun Yin group, and the group receiving Ankun Yin combined with recombinant human interferon α2b vaginal effervescent tablets were all treated continuously for 3 months, with 20 days of treatment per month. Patients in all three groups were instructed to strictly avoid raw, cold, spicy, and greasy foods during treatment, maintain a light diet, abstain from alcohol and carbonated beverages, refrain from smoking, cultivate good habits of going to bed early and waking up early, maintain an optimistic attitude during treatment, and avoid sexual intercourse to prevent infection. If any discomfort occurs, patients should promptly notify medical staff for effective treatment. Patients should strictly follow the doctor's instructions during treatment and are strictly prohibited from changing the dosage or discontinuing medication without authorization. To minimize research error, patients did not use other medications during treatment.

[0064] Follow-up plan: Follow-up visits will be conducted at 3, 6, 9, and 12 months after the first treatment to more accurately monitor the timeliness and effectiveness of the treatment. Each follow-up visit will include: evaluation of the cure rate of chronic cervicitis, assessment of the HPV clearance rate, patient quality of life score, and adverse reactions.

[0065] result:

[0066] I. Baseline characteristics of the study population

[0067] This study included 75 patients with HPV infection, who were randomly divided into a control group, an Ankun Yin group, and a combined group in a 1:1:1 ratio, with 25 patients in each group. The three groups showed good balance in baseline characteristics, with no statistically significant differences (P>0.05), ensuring the reliability of the efficacy comparison between the groups.

[0068] Regarding age distribution, the mean age of patients in the control group was 33.0±3.9 years (range 25-40 years), with 12 patients (48.0%) aged 25-32 years and 13 patients (52.0%) aged 33-40 years. In the Ankun Decoction group, the mean age was 32.6±3.1 years (range 26-38 years), with 11 patients (44.0%) aged 25-32 years and 14 patients (56.0%) aged 33-40 years. In the combined group, the mean age was 33.5±3.3 years (range 28-40 years), with 10 patients (40.0%) aged 25-32 years and 15 patients (60.0%) aged 33-40 years. One-way ANOVA showed no statistically significant difference in age distribution among the three groups (F=0.283, P=0.754).

[0069] Baseline HPV status showed that all included patients tested positive for HPV genotyping before treatment. Among them, the infection rate of high-risk types (HPV16 / 18 / 31 / 33 / 45 / 52 / 58) was 89.3% (67 / 75), and the infection rate of low-risk types (HPV6 / 11) was 10.7% (8 / 75). The infection rates of high-risk HPV in the three groups were 92.0% (23 / 25), 88.0% (22 / 25), and 88.0% (22 / 25), respectively. There was no statistically significant difference between the groups (χ²=0.386, P=0.824).

[0070] Regarding pre-treatment symptom scores, there were no significant differences in baseline symptom scores (including abnormal vaginal discharge, contact bleeding, and lower abdominal distension) among the three groups: 44.8±4.2 points in the control group, 44.7±3.8 points in the Ankun Decoction group, and 44.8±3.5 points in the combined group (F=0.005, P=0.995). This indicates that the severity of the disease was consistent among the three groups before treatment, laying a fair foundation for subsequent efficacy evaluation.

[0071] Table 3. Baseline characteristics of the population

[0072]

[0073] II. Intergroup comparison and time trend of HPV seroconversion rate

[0074] HPV seroconversion rate is a core indicator for evaluating treatment efficacy. This study dynamically monitored the seroconversion rate of the three groups of patients at 3, 6, 9, and 12 months after treatment. The results showed that the combined group maintained the highest seroconversion rate at each time point, and the efficacy stability was significantly better than the other two groups.

[0075] 2.1 Comparison of negative conversion rates at different time points

[0076] Three months after treatment, the seroconversion rate in the combined treatment group reached 56.0% (14 / 25), which was significantly higher than that in the control group (36.0%, 9 / 25) and the Ankun Decoction group (32.0%, 8 / 25). The difference between the groups was statistically significant (χ²=6.231, P=0.045). Further pairwise comparisons showed that the combined treatment group was significantly different from the Ankun Decoction group (P=0.032), and the combined treatment group was close to significant compared with the control group (P=0.058), while there was no significant difference between the control group and the Ankun Decoction group (P=0.817).

[0077] Six months after treatment, the seroconversion rates of all three groups reached their peak. The combined treatment group continued to lead with 72.0% (18 / 25), the control group with 60.0% (15 / 25), and the Ankun Decoction group with 56.0% (14 / 25). The difference between the groups further widened (χ²=8.574, P=0.014). Pairwise comparisons showed that the differences between the combined treatment group and the control group (P=0.041) and between the combined treatment group and the Ankun Decoction group (P=0.023) were statistically significant, while there was still no significant difference between the control group and the Ankun Decoction group (P=0.785).

[0078] Nine months after treatment, the seroconversion rates in the control group and the Ankun Decoction group began to decline, decreasing to 60.0% (15 / 25) and 56.0% (14 / 25) respectively (no significant change compared with 6 months, P>0.05), while the combined group remained at 68.0% (17 / 25), a slight decrease of only 4 percentage points. The difference between the groups was still statistically significant (χ²=7.925, P=0.019).

[0079] Twelve months after treatment, the seroconversion rates in the control group and the Ankun Decoction group further decreased to 48.0% (12 / 25) and 44.0% (11 / 25), respectively, a decrease of 12 and 12 percentage points from the peak. The combined group, however, maintained a high seroconversion rate of 68.0% (17 / 25), consistent with the level at 6 months, and the difference between the groups was statistically significant (χ²=10.368, P=0.006). Pairwise comparisons showed significant differences between the combined group and the control group (P=0.012) and between the combined group and the Ankun Decoction group (P=0.008), while there was no significant difference between the control group and the Ankun Decoction group (P=0.821).

[0080] Table 4 HPV clearance rate at different time points

[0081]

[0082] 2.2 Time trend characteristics of negative conversion rate

[0083] Overall, the HPV seroconversion rates in all three groups showed a pattern of "increased first, then stabilized / decreased," but the patterns of change differed significantly:

[0084] Combined group: 3 months (56.0%) → 6 months (72.0%) → 9 months (68.0%) → 12 months (68.0%). After 6 months, it entered a plateau period, and at 12 months, it still maintained a high negative conversion rate, showing the stability of long-term efficacy.

[0085] Control group: 3 months (36.0%) → 6 months (60.0%) → 9 months (60.0%) → 12 months (48.0%). The rate started to decline after 6 months, and decreased by 20% from the peak at 12 months, indicating insufficient duration of efficacy.

[0086] Ankun Drink group: 3 months (32.0%) → 6 months (56.0%) → 9 months (56.0%) → 12 months (44.0%), the trend was consistent with the control group, it decreased after 6 months, and decreased by 21.4% from the peak at 12 months, the long-term effect was not good.

[0087] Furthermore, the analysis of the proportion of patients who "tested negative at 6 months and remained negative at 12 months" showed that the combined group had a rate of 88.9% (16 / 18), which was significantly higher than the control group's 66.7% (10 / 15) and the Ankun Decoction group's 64.3% (9 / 14) (χ²=6.842, P=0.033), further confirming the stable advantage of the combined group's efficacy.

[0088] III. Analysis of the Improvement Effect of Traditional Chinese Medicine Syndrome Scores

[0089] Improvement in TCM syndrome scores is an important supplementary indicator for assessing patients' clinical benefits. This study used the criteria of "difference in scores before and after treatment" and "improvement rate ≥30% as effective" to analyze the symptom improvement effects of three groups of patients. The results showed that the combined group was significantly better than the control group and the Ankun Decoction group in terms of symptom relief and effectiveness.

[0090] 3.1 Changes in symptom scores before and after treatment

[0091] At 12 months post-treatment, symptom scores in all three groups decreased significantly from baseline (P<0.001), but the magnitude of the decrease differed significantly.

[0092] Combined group: 44.8±3.5 points before treatment → 10.2±4.1 points after treatment, with an average decrease of 34.6 points, which was significantly greater than that of the control group (21.3 points) and the Ankun Yin group (21.9 points) (F=42.857, P<0.001).

[0093] Control group: score before treatment 44.8±4.2 points → score after treatment 23.5±5.3 points, with an average decrease of 21.3 points;

[0094] Ankun Decoction group: 44.7±3.8 points before treatment → 22.8±4.9 points after treatment, with an average decrease of 21.9 points;

[0095] Pairwise comparisons showed that the combined group and the control group (P<0.001) and the combined group and the Ankun Drink group (P<0.001) had significant differences in the decrease in scores, while there was no difference between the control group and the Ankun Drink group (P=0.836).

[0096] 3.2 Comparison of TCM syndrome improvement rate and effectiveness rate

[0097] Symptom improvement rate ((pre-treatment score - post-treatment score) / pre-treatment score × 100%) results showed:

[0098] The average improvement rate of the combined group was 77.6%±8.3%, which was significantly higher than that of the control group (47.0%±9.5%) and the Ankun Yin group (48.9%±10.2%) (F=58.632, P<0.001).

[0099] There was no significant difference in the improvement rate between the control group and the Ankun Drink group (P=0.792).

[0100] The effectiveness rate is calculated based on the standard that "an improvement rate of ≥30% is considered effective":

[0101] The combined treatment group had an efficacy rate of 88.0% (22 / 25), of which 64.0% (16 / 25) had an improvement rate of ≥50%.

[0102] The effective rate in the control group was 68.0% (17 / 25), and 32.0% (8 / 25) of the patients had an improvement rate of ≥50%.

[0103] The effective rate of Ankun Decoction group was 52.0% (13 / 25), and the improvement rate of patients ≥50% accounted for 28.0% (7 / 25).

[0104] The difference in efficacy between groups was statistically significant (χ²=12.471, P=0.002); pairwise comparisons showed that the combined group and the control group (P=0.038), the combined group and the Ankun Yin group (P=0.001) were significantly different, and the difference between the control group and the Ankun Yin group was close to significant (P=0.056).

[0105] Table 5. TCM syndrome scores of different groups after treatment

[0106]

[0107] Further analysis of the timeline for symptom relief revealed that patients in the combined treatment group showed significant symptom improvement 3 months after treatment (mean score decreased to 24.5±5.2 points, improvement rate 45.3%), earlier than the control group (32.1±6.4 points, improvement rate 28.3%) and the Ankun Yin group (33.5±5.8 points, improvement rate 25.1%), suggesting that the combined treatment group had a faster symptom relief rate.

[0108] IV. The combined treatment group had the highest improvement score in Traditional Chinese Medicine Syndrome Management (TCM).

[0109] Regarding leukorrhea-related symptoms (amount, texture, color, odor), the recombinant human interferon α2b (rhIFN α2b) group showed almost no improvement in symptom scores throughout the study period; while the Ankun Yin group experienced a moderate decrease in scores between 3 and 6 months, after which some indicators (such as leukorrhea odor) tended to stabilize. In contrast, the combined treatment group achieved the most significant and sustained decrease in scores across all leukorrhea-related dimensions, with statistically significant differences compared to the other two groups at most observation time points starting from 6 months. Figure 1 (A in the middle).

[0110] Regarding local and systemic discomfort symptoms (vaginal itching / burning, lower abdominal pain, limb weakness and fatigue), the rhIFN α2b group maintained a consistently high score with no significant change over 12 months; the Ankun Decoction group showed only slight and unstable improvement. In contrast, the combined treatment group experienced a rapid and significant decrease in the scores of the above symptoms, particularly in vaginal itching / burning and lower abdominal pain, showing a statistically significant difference compared to the single treatment group from 6 months onwards. Figure 1 (B in the middle).

[0111] Regarding gastrointestinal, oral, and urinary tract related symptoms (loss of appetite, dry / bitter / sticky mouth, urinary related indicators, and stool characteristics), the rhIFN α2b group showed limited improvement in all indicators. The Ankun Yin group provided initial relief for loss of appetite and oral symptoms, but the efficacy was not sustained; while the combined treatment group showed significant and sustained reductions in scores across all the aforementioned areas, with statistically significant differences compared to other groups at 9 months and beyond (especially in stool characteristics and oral symptoms). Figure 1 (C in the middle).

[0112] Overall, during the 12-month follow-up period, the combination therapy group consistently outperformed the rhIFN α2b group and the Ankun Yin monotherapy group in improving all observed symptoms, achieving the most significant and lasting improvements in leukorrhea, local and systemic discomfort, and gastrointestinal, oral, and urinary symptoms. Monotherapy (especially rhIFN α2b monotherapy) only brought mild symptom relief or plateaued efficacy.

[0113] V. Implications for Clinical Application

[0114] Treatment options: For patients with HPV infection, especially those with high-risk HPV infection who require long-term stable efficacy, combination therapy is recommended as the first choice to achieve a higher seroconversion rate and more durable efficacy.

[0115] Follow-up strategy optimization: The first efficacy assessment should be conducted 6 months after treatment. If the result is negative, follow-up should continue for 12 months to confirm the stability of efficacy. If the result is not negative, the treatment plan can be adjusted to avoid delaying the condition.

[0116] Individualized considerations: Although the combination therapy has better overall efficacy, clinical application still requires comprehensive judgment based on factors such as patient age, HPV type, and underlying diseases. For example, for patients with poor drug tolerance, the dosage or course of treatment of the combination therapy can be adjusted under close monitoring.

Claims

1. A traditional Chinese medicine composition for treating chronic cervicitis complicated with HPV infection, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 26-34 parts of raw Astragalus membranaceus, 26-34 parts of Smilax glabra, 11-19 parts of Toona sinensis root bark, and 26-34 parts of raw Coix lacryma-jobi.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 28-32 parts of raw Astragalus membranaceus, 28-32 parts of Smilax glabra, 13-17 parts of Toona sinensis root bark, and 28-32 parts of raw Coix lacryma-jobi.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 30 parts raw Astragalus membranaceus, 30 parts Smilax glabra, 15 parts Toona sinensis root bark, and 30 parts raw Coix lacryma-jobi.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The traditional Chinese medicine composition also includes pharmaceutically acceptable excipients.

5. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a drug for treating chronic cervicitis complicated with HPV infection.

6. A pharmaceutical composition for treating chronic cervicitis complicated with HPV infection, characterized in that, The pharmaceutical composition is composed of the traditional Chinese medicine composition according to any one of claims 1-3 and recombinant human interferon α2b.

7. The use of the pharmaceutical composition according to claim 6 in the preparation of a drug for treating chronic cervicitis complicated with HPV infection.

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