A traditional Chinese medicine composition for treating recurrent vulvovaginal candidiasis and application thereof

Abstract

The present application relates to a kind of traditional Chinese medicine composition for treating recurrent vulvovaginal candidiasis, the traditional Chinese medicine composition is made of the following weight parts of raw medicinal materials: 28-32 parts of smilax glabra, 13-17 parts of root bark of ailanthus, 28-32 parts of raw rice, 13-17 parts of tuckahoe, 7-11 parts of poria cocos, 13-17 parts of plantago, 7-11 parts of phellodendron, 7-11 parts of red root, 28-32 parts of raw milk. The present application also provides the use of traditional Chinese medicine composition. The present application clears heat and soothes the kidney drink to clear heat and detoxify, tonify qi and invigorate the spleen, and the core compatibility is used for treating recurrent vulvovaginal candidiasis, and the local treatment of oral combined with clotrimazole suppository can synergistically improve the fungal clearance rate, significantly improve the pruritus of vulva, abnormal leucorrhea and other dampness syndrome, while down-regulating pro-inflammatory factor TNF-α, IL-8, reducing the chronic inflammation of genital tract, repairing the immune barrier of organism, and significantly reducing the recurrence rate within 3 months. The present application is safe and has no obvious toxic side effects, and is a safe and effective combination of traditional Chinese and western medicine for treating dampness-down type recurrent vulvovaginal candidiasis, and is worthy of clinical popularization and application.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating recurrent vulvovaginal candidiasis and its application. Background Technology

[0002] Vulvovaginal candidiasis (VVC) is a common vulvovaginal inflammation caused by Candida albicans, predominantly affecting women of reproductive age. Its main symptoms include vulvovaginal itching, burning, increased vaginal discharge, lower abdominal pain, and a feeling of heaviness or pressure. 70%–75% of women will experience VVC at least once in their lifetime, with about 10% developing recurrent vulvovaginal candidiasis (RVVC). RVVC is defined as four or more symptomatic and mycologically confirmed episodes of VVC within a year. Clinical studies show that VVC recurrence and the development of fungal resistance are the main reasons for the persistent nature of RVVC, severely impacting patients' reproductive health and quality of life, and even affecting other organs or systems, resulting in a lasting adverse effect on women's health.

[0003] Currently, the treatment of recurrent vulvovaginal candidiasis (RVVC) employs an antifungal regimen consisting of intensive and consolidation therapy. After achieving mycological cure with intensive therapy, consolidation therapy is administered for six months. Intensive therapy extends the treatment duration by 1-2 courses beyond the initial VVC treatment. There is currently no established consolidation therapy regimen domestically or internationally. Oral fluconazole 150mg once weekly for 6 months can be used, but its clinical efficacy remains unclear. Furthermore, fluconazole has a high resistance rate and numerous adverse reactions. Common adverse reactions include allergic reactions and abnormal liver and kidney function, possibly related to fluconazole accumulation and toxicity. Long-term use requires regular monitoring of liver and kidney function; therefore, long-term oral fluconazole treatment for RVVC is rarely used clinically.

[0004] Based on the clinical manifestations of recurrent vulvovaginal candidiasis (RVVC), it can be categorized under the traditional Chinese medicine (TCM) categories of "leukorrhea" and "vaginal pruritus." In TCM, RVVC is most commonly associated with the syndrome of damp-heat accumulation in the lower body, often caused by various factors leading to the accumulation of damp-heat within the body, coupled with external pathogenic factors. Damp-heat is the internal cause, while pathogenic factors are the external cause; the interaction between these two factors makes the condition persistent, recurring, and difficult to cure.

[0005] Chinese patent document CN102485244A discloses the application of a traditional Chinese medicine composition in the preparation of a gel for treating gynecological inflammation. The composition is made from the following raw materials in parts by weight: 2000 parts of *Toona sinensis* bark, 1500 parts of *Sophora flavescens* root, 1500 parts of frankincense, 50 parts of borneol, and 1500 parts of *Paeonia suffruticosa* bark. The gel prepared from this traditional Chinese medicine composition overcomes many shortcomings of chemical drugs and can exert a wide range of therapeutic effects that chemical drugs cannot match (such as clearing heat and dampness, stopping leukorrhea and itching, removing necrotic tissue and promoting tissue regeneration, astringing and stopping bleeding, etc.). It can be widely used for gynecological inflammations caused by pathogens such as bacteria, fungi, protozoa, chlamydia, and mycoplasma (such as leukorrhea of ​​the damp-heat type, including bacterial vaginosis and vulvovaginal candidiasis).

[0006] Chinese patent document CN105194450A discloses a traditional Chinese medicine composition for treating vulvovaginal candidiasis and its preparation method. To overcome the shortcomings of existing technologies, this invention provides a traditional Chinese medicine composition that clears heat and dampness, and enhances the body's resistance. It is prepared from the following raw materials: Coix seed, Achyranthes bidentata, Phellodendron chinense, Paeonia lactiflora, Cercis chinensis bark, Polyporus umbellatus, Plantago asiatica seed, and Coptis chinensis. Clinical trials have confirmed its significant therapeutic effect on vulvovaginal candidiasis.

[0007] Traditional Chinese medicine compositions for treating vulvovaginal candidiasis 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 senile heart failure, has fewer ingredients, is practical to use, has high compliance, is safe and effective, and has a low recurrence rate. Summary of the Invention

[0008] The purpose of this invention is to address the shortcomings of existing technologies by providing a traditional Chinese medicine composition for treating recurrent vulvovaginal candidiasis and its application.

[0009] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating recurrent vulvovaginal candidiasis, which is made from the following raw materials in parts by weight: 28-32 parts of Smilax glabra, 13-17 parts of Toona sinensis root bark, 28-32 parts of raw Coix lacryma-jobi, 13-17 parts of Poria cocos, 7-11 parts of Polyporus umbellatus, 13-17 parts of Plantago asiatica, 7-11 parts of Phellodendron chinense, 7-11 parts of Paeonia lactiflora, and 28-32 parts of raw Astragalus membranaceus.

[0010] As a preferred example, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 29-31 parts of Smilax glabra, 14-16 parts of Toona sinensis root bark, 29-31 parts of raw Coix lacryma-jobi, 14-16 parts of Poria cocos, 8-10 parts of Polyporus umbellatus, 14-16 parts of Plantago asiatica, 8-10 parts of Phellodendron chinense, 8-10 parts of Paeonia lactiflora, and 29-31 parts of raw Astragalus membranaceus.

[0011] As a preferred example, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 30 parts of Smilax glabra, 15 parts of Toona sinensis root bark, 30 parts of raw Coix lacryma-jobi, 15 parts of Poria cocos, 9 parts of Polyporus umbellatus, 15 parts of Plantago asiatica, 9 parts of Phellodendron chinense, 9 parts of Paeonia lactiflora, and 30 parts of raw Astragalus membranaceus.

[0012] As a preferred example, the Chinese medicine composition is in the form of granules, tablets, capsules, oral liquid, or syrup.

[0013] As a preferred example, the traditional Chinese medicine composition further includes pharmaceutically acceptable excipients.

[0014] Secondly, this invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for treating recurrent vulvovaginal candidiasis.

[0015] Thirdly, the present invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for treating recurrent vulvovaginal candidiasis of the damp-heat type.

[0016] Fourthly, the present invention provides a pharmaceutical composition for treating recurrent vulvovaginal candidiasis, the pharmaceutical composition comprising a traditional Chinese medicine composition and clotrimazole.

[0017] Fifthly, the present invention provides the use of the pharmaceutical composition in the preparation of a medicament for treating recurrent vulvovaginal candidiasis.

[0018] In a sixth aspect, the present invention provides the use of the pharmaceutical composition in the preparation of a medicament for treating recurrent vulvovaginal candidiasis of the moist-heat type.

[0019] The advantages of this invention are:

[0020] 1. Antifungal effect: The ingredients in this formula, including Smilax glabra, Phellodendron chinense, Toona sinensis root bark, and Coix lacryma-jobi, all possess in vitro antifungal activity against Candida albicans, inhibiting the proliferation of fungal hyphae and spores. Combined with clotrimazole suppositories, they form a synergistic antifungal effect, increasing the fungal clearance rate within the month. The clearance rate in the observation group was 95.2%, higher than the 88.1% in the control group, demonstrating the advantage of combining oral Chinese medicine with topical Western medicine in synergistic fungal eradication.

[0021] 2. Regulating inflammatory pathways and reducing pro-inflammatory factors: Red peony root and phellodendron bark can inhibit the activation of the TLR4 / NF-κB signaling pathway and reduce the release of TNF-α and IL-8. Data from this study showed that TNF-α levels significantly decreased (P < 0.01) and IL-8 levels significantly decreased (P < 0.05) in the observation group after treatment, with a greater degree of improvement than the control group. This indicates that Qingre Ankun Decoction can reduce chronic inflammation of the reproductive tract by downregulating circulating pro-inflammatory factors through systemic administration.

[0022] 3. Regulating the body's immunity and reducing recurrence: Astragalus membranaceus can enhance the body's innate immune function and strengthen the immune cells' ability to clear fungi; Poria cocos and Coix lacryma-jobi regulate systemic metabolism and improve the vaginal microecological environment. In terms of long-term efficacy, the recurrence rate in the observation group was only 26.2% after 3 months, far lower than the 47.6% in the control group (P<0.05), confirming that traditional Chinese medicine, by strengthening the body's resistance and regulating systemic immunity, compensates for the shortcomings of simple local Western medicine in improving systemic immune deficiencies.

[0023] 4. Safety advantages: The formula contains no herbs with obvious hepatotoxicity or nephrotoxicity. There are no abnormal changes in blood routine tests, liver and kidney function before and after treatment. There are no serious allergies or gastrointestinal adverse reactions. Compared with the risk of liver and kidney damage from long-term oral fluconazole, it is more suitable for long-term consolidation and conditioning of RVVC.

[0024] The pathogenesis of RVVC (recurrent vulvovaginal candidiasis) due to damp-heat is rooted in endogenous damp-heat and deficiency of vital energy, while external damp-toxins are the superficial manifestation. Simple local antifungal treatment only addresses the symptoms and cannot correct the systemic damp-heat constitution and immune-inflammatory imbalance, hence the high recurrence rate. This invention, Qingre Ankun Decoction, uses a core formula of clearing heat, resolving dampness, detoxifying, and tonifying qi and spleen to strengthen the body's foundation. Oral administration combined with local clotrimazole suppositories synergistically enhances fungal clearance, significantly improves damp-heat symptoms such as vulvar itching and abnormal vaginal discharge, and simultaneously downregulates pro-inflammatory factors TNF-α and IL-8, reducing chronic inflammation of the reproductive tract, repairing the body's immune barrier, and significantly reducing the recurrence rate within 3 months. This invention is safe with no obvious toxic side effects, overcoming the shortcomings of long-term antifungal treatment in Western medicine, such as drug resistance, significant adverse reactions, and high long-term recurrence rates. It is a safe and effective integrated traditional Chinese and Western medicine treatment for recurrent vulvovaginal candidiasis due to damp-heat, and is worthy of clinical promotion and application. Detailed Implementation

[0025] 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.

[0026] Example 1: A Traditional Chinese Medicine Composition for Treating Recurrent Vulvovaginal Candidiasis (Part 1)

[0027] 30 parts of Smilax glabra, 15 parts of Toona sinensis root bark, 30 parts of raw Coix lacryma-jobi, 15 parts of Poria cocos, 9 parts of Polyporus umbellatus, 15 parts of Plantago asiatica, 9 parts of Phellodendron chinense, 9 parts of Paeonia lactiflora, and 30 parts of raw Astragalus membranaceus.

[0028] Example 2: A Traditional Chinese Medicine Composition for Treating Recurrent Vulvovaginal Candidiasis (Part Two)

[0029] 28 parts of Smilax glabra, 13 parts of Toona sinensis root bark, 28 parts of raw Coix lacryma-jobi, 13 parts of Poria cocos, 7 parts of Polyporus umbellatus, 13 parts of Plantago asiatica, 7 parts of Phellodendron chinense, 7 parts of Paeonia lactiflora, and 28 parts of raw Astragalus membranaceus.

[0030] Example 3: A Traditional Chinese Medicine Composition for Treating Recurrent Vulvovaginal Candidiasis (Part Three)

[0031] 32 parts of Smilax glabra, 17 parts of Toona sinensis root bark, 32 parts of raw Coix lacryma-jobi, 17 parts of Poria cocos, 11 parts of Polyporus umbellatus, 17 parts of Plantago asiatica, 11 parts of Phellodendron chinense, 11 parts of Paeonia lactiflora, and 32 parts of raw Astragalus membranaceus.

[0032] Example 4: A Traditional Chinese Medicine Composition for Treating Recurrent Vulvovaginal Candidiasis (Part Four)

[0033] 29 parts of Smilax glabra, 14 parts of Toona sinensis root bark, 29 parts of raw Coix lacryma-jobi, 14 parts of Poria cocos, 8 parts of Polyporus umbellatus, 14 parts of Plantago asiatica, 8 parts of Phellodendron chinense, 8 parts of Paeonia lactiflora, and 29 parts of raw Astragalus membranaceus.

[0034] Example 5: A Traditional Chinese Medicine Composition for Treating Recurrent Vulvovaginal Candidiasis (Part 5)

[0035] 31 parts of Smilax glabra, 16 parts of Toona sinensis root bark, 31 parts of raw Coix lacryma-jobi, 16 parts of Poria cocos, 10 parts of Polyporus umbellatus, 16 parts of Plantago asiatica, 10 parts of Phellodendron chinense, 10 parts of Paeonia lactiflora, and 31 parts of raw Astragalus membranaceus.

[0036] Example 6: A Traditional Chinese Medicine Composition for Treating Recurrent Vulvovaginal Candidiasis (VI)

[0037] 30 parts of Smilax glabra, 15 parts of Toona sinensis root bark, 28 parts of raw Coix lacryma-jobi, 13 parts of Poria cocos, 7 parts of Polyporus umbellatus, 13 parts of Plantago asiatica, 7 parts of Phellodendron chinense, 7 parts of Paeonia lactiflora, and 28 parts of raw Astragalus membranaceus.

[0038] Example 7: A Traditional Chinese Medicine Composition for Treating Recurrent Vulvovaginal Candidiasis (VII)

[0039] 32 parts of Smilax glabra, 17 parts of Toona sinensis root bark, 30 parts of raw Coix lacryma-jobi, 15 parts of Poria cocos, 11 parts of Polyporus umbellatus, 17 parts of Plantago asiatica, 11 parts of Phellodendron chinense, 11 parts of Paeonia lactiflora, and 32 parts of raw Astragalus membranaceus.

[0040] Example 8: A Traditional Chinese Medicine Composition for Treating Recurrent Vulvovaginal Candidiasis (VIII)

[0041] 29 parts of Smilax glabra, 14 parts of Toona sinensis root bark, 29 parts of raw Coix lacryma-jobi, 14 parts of Poria cocos, 9 parts of Polyporus umbellatus, 15 parts of Plantago asiatica, 8 parts of Phellodendron chinense, 8 parts of Paeonia lactiflora, and 29 parts of raw Astragalus membranaceus.

[0042] Example 9: A Traditional Chinese Medicine Composition for Treating Recurrent Vulvovaginal Candidiasis (IX)

[0043] 31 parts of Smilax glabra, 16 parts of Toona sinensis root bark, 31 parts of raw Coix lacryma-jobi, 16 parts of Poria cocos, 10 parts of Polyporus umbellatus, 16 parts of Plantago asiatica, 9 parts of Phellodendron chinense, 9 parts of Paeonia lactiflora, and 30 parts of raw Astragalus membranaceus.

[0044] Example 10 Clinical Trial

[0045] Research Content

[0046] Patients with recurrent vulvovaginal candidiasis were randomly assigned to two groups: a combined traditional Chinese and Western medicine treatment group (using Qingre Ankun Decoction and clotrimazole suppositories) and a control group (using clotrimazole suppositories). The recurrence rate after 3 months of treatment, the fungal clearance rate of vaginal secretions in the month following treatment, the TCM syndrome scores before and after treatment, and serum TNF-α and IL-8 levels were observed and statistically analyzed to evaluate the clinical efficacy of Qingre Ankun Decoction in treating recurrent vulvovaginal candidiasis.

[0047] Research Methods

[0048] 1. Research Subjects

[0049] 1.1 Source of Cases

[0050] Female patients who visited the Department of Gynecology of our hospital from July 2024 to March 2026 and met the criteria for RVVC damp-heat syndrome were selected.

[0051] 1.2 Diagnostic Criteria

[0052] 1.2.1 Western Medicine Diagnostic Criteria: Refer to *Obstetrics and Gynecology (9th Edition)*, published by People's Medical Publishing House. Patients present with symptoms such as vulvar itching, burning, dyspareunia, increased vaginal discharge, urinary urgency, and dysuria. Gynecological examination reveals vulvar erythema and edema, vaginal mucosal redness and swelling, and white lumps adhering to the inner labia minora and vaginal mucosa; after wiping, the red and swollen mucosal surface is visible. Budding spores or pseudohyphae of *Candida* are found in the vaginal discharge. Patients with 4 or more symptomatic episodes within one year, confirmed by mycology, are also considered to have vulvar VC.

[0053] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria: Refer to the syndrome differentiation criteria for leukorrhea with damp-heat accumulation in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs".

[0054] Main symptoms: ① Vulvar itching or pain; ② Increased vaginal discharge, yellow or yellowish-white in color; ③ Thick, cottage cheese-like discharge; ④ Foul-smelling discharge.

[0055] Secondary symptoms: ① Lower abdominal distension or pain, tenderness upon touch; ② Bitter taste in the mouth and dry throat; ③ Scanty, painful urination, and dark yellow urine. Tongue and pulse characteristics: Red tongue with a thick or yellow coating, and a slippery or rapid pulse.

[0056] A diagnosis can be made by referring to the tongue and pulse if two or more main symptoms are present, or one or more main symptoms plus two secondary symptoms.

[0057] 1.3 Inclusion Criteria

[0058] ① Age between 18 and 65 years old.

[0059] ② Meets the diagnostic criteria for recurrent vulvovaginal candidiasis and leukorrhea with damp-heat syndrome.

[0060] ③ Voluntarily participate in this study and sign an informed consent form.

[0061] 1.4 Exclusion Criteria

[0062] Antifungal medications have been used within the past week.

[0063] ②Those who are suspected or confirmed to be pregnant.

[0064] Patients with other infections besides vaginal infection who require or are currently undergoing anti-inflammatory treatment.

[0065] Individuals with a history of allergies to relevant drugs, or those with a known allergy to any component of the investigational drug.

[0066] Those with severe mental illness or severe liver or kidney dysfunction.

[0067] Patients who are participating in other clinical trials or who declined to participate in this study.

[0068] 1.5 Criteria for Rejection or Dropout

[0069] Those who were mistakenly included but did not meet the inclusion criteria.

[0070] Subjects had poor compliance, failing to take medication as prescribed or failing to attend follow-up appointments regularly.

[0071] Participants withdrew or were lost to follow-up for personal reasons.

[0072] The clinical data is incomplete, making it impossible to determine the efficacy.

[0073] 1.6. Handling of cases after exclusion or dropout

[0074] Those who withdraw from the trial due to adverse reactions should complete the "Adverse Event / Reaction Record Form".

[0075] If a case is confirmed as a dropout or exclusion case, and the patient requests continued treatment, the researcher should continue to provide the relevant treatment, but the patient should no longer be recorded as an observational case.

[0076] 2. Research Methods

[0077] 2.1 Randomization Methods and Grouping

[0078] This was a prospective randomized controlled trial. The sample was randomly divided into an observation group and a control group at a 1:1 ratio. A simple randomization method was used, employing the RAND() function in Excel to generate random numbers. Subjects were strictly grouped according to the random numbers.

[0079] 2.2 Sample Size Calculation

[0080] This study used clotrimazole suppositories as the control group and a combination of Qingre Ankun Decoction and clotrimazole suppositories as the observation group. The superiority test was used to calculate the sample size. The formula for estimating the sample size is as follows:

[0081]

[0082] The sample size ratio (k) of the observation group and the control group was 1:1. The Type I error α was set at 0.05, and the Type II error β at 0.2. =1.64, =0.84, The sample size of the observation group was 33, and the sample size of the control group was 33. Assuming a loss to follow-up rate of 20%, the observation group needs at least 42 samples, and the control group needs at least 42 samples. That is, a total of 84 cases are needed as research subjects, and each group needs to complete 42 valid cases, so that the superiority conclusion can be verified at a significance level of 0.05 (one-sided).

[0083] 2.3 Treatment methods

[0084] 2.3.1 Control Group

[0085] Treatment involved administering clotrimazole suppositories (0.15g / suppository; manufacturer: Harbin Oute Pharmaceutical Co., Ltd.; National Drug Approval Number: H23022432). The method was as follows: after vaginal cleansing each night, insert the suppository into the vaginal fornix using a disposable glove before bedtime, one suppository per application, once daily, for 7 days as one course of treatment. Three consecutive courses of treatment were administered, totaling 21 days.

[0086] 2.3.2, Observation Group

[0087] The observation group received Qingre Ankun Decoction in addition to the treatment given to the control group. The prescription for Qingre Ankun Decoction is as follows: 30g Smilax glabra, 15g Toona sinensis root bark, 30g Coix lacryma-jobi, 15g Poria cocos, 9g Polyporus umbellatus, 15g Plantago asiatica, 9g Phellodendron chinense, 9g Paeonia lactiflora, and 30g Astragalus membranaceus. In accordance with the "Management Standards for Traditional Chinese Medicine Decoction Rooms in Medical Institutions," the hospital's pharmacy prepared the decoction. Each dose of Qingre Ankun Decoction was concentrated and filtered into two bags of 180ml each. One bag was taken twice daily, half an hour after meals, for 21 consecutive days.

[0088] 2.3.3 Treatment course and follow-up

[0089] Treatment lasts for 21 consecutive days. Sexual intercourse is prohibited during treatment. Change underwear frequently, maintain vaginal hygiene, eat a light diet, and get adequate rest.

[0090] Follow-up was conducted after treatment, with vaginal secretions examined for fungi monthly within one week after menstruation ended for three consecutive months to observe for any recurrence, in order to more accurately understand the efficacy. Patients with menstrual disorders were examined every four weeks after the end of the treatment course, when there was no vaginal bleeding.

[0091] 3. Evaluation of therapeutic effect

[0092] 3.1 Efficacy indicators and evaluation criteria

[0093] 3.1.1. Main therapeutic indicators

[0094] Recurrence rate 3 months after treatment:

[0095] Vaginal secretion fungal examination was performed one week after menstruation ended in the first, second, and third months after treatment. The examination method was as follows: Secretions from the posterior fornix of the vagina were collected using a sterile cotton swab and placed in a test tube containing physiological saline. After thorough mixing, the mixture was evenly spread onto a glass slide and allowed to stand for 2 minutes. The presence of spores or hyphae was observed under a low-power microscope, followed by confirmation under a high-power microscope. The presence of spores or hyphae indicated a positive diagnosis and a recurrence. Conversely, the absence of spores or hyphae indicated a negative diagnosis and no recurrence.

[0096] 3.1.2 Secondary therapeutic indicators

[0097] Negative conversion rate in the month treatment ends:

[0098] A fungal examination of vaginal secretions should be performed in the month following the completion of treatment. A positive result is indicated by the observation of spores or hyphae, while a negative result is indicated by the absence of these.

[0099] Traditional Chinese Medicine Syndrome Scoring Table (see Table 1): Based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" regarding the primary and secondary symptoms of leukorrhea due to damp-heat accumulation, the following were scored before treatment and after 21 days of treatment: Vulvar itching, distending burning, foul-smelling and sticky leukorrhea, cottage cheese-like discharge, vaginal tenderness, vaginal mucosal redness and swelling, bitter taste in the mouth, dry throat, and poor appetite; Secondary symptoms: red / yellow greasy tongue, lower abdominal distension and pain, frequent and dark urination, etc. Each item was scored from 0 to 4 points, with higher scores indicating more severe symptoms.

[0100] The TCM syndrome scoring table is shown in Table 1.

[0101] Table 1: Traditional Chinese Medicine Syndrome Scoring Table

[0102]

[0103] The efficacy of TCM syndrome scores was calculated using the nimodipine method: E = [(Pre-treatment score - Post-treatment score) / Pre-treatment score] × 100%

[0104] The clinical efficacy of the two groups was compared and categorized into cured, significantly effective, effective, and ineffective. Efficacy assessment criteria:

[0105] Cured: The symptom score decreased by 100% after treatment;

[0106] Significant effect: Symptom scores decreased by 80%–99% after treatment;

[0107] Effective: Symptom scores decreased by 60%–79% after treatment;

[0108] Ineffective: The symptom score decreased by less than 60% after treatment.

[0109] Overall effective rate = cure rate + significant efficacy rate + effective rate.

[0110] Serum TNF-α and IL-8 levels before and after treatment: 3 ml of blood was drawn from the elbow vein of all patients before treatment and within 1 week after treatment. After centrifugation, the upper serum layer was collected and the levels of TNF-α and IL-8 were detected by enzyme-linked immunosorbent assay.

[0111] 3.2 Safety Indicators

[0112] Complete blood count, urinalysis, and liver and kidney function tests were performed. All indicators were checked before and after treatment. During treatment, any allergic reactions or adverse reactions were monitored.

[0113] 4. Statistical Analysis

[0114] This study used SPSS 27.0 statistical software to analyze and process the data. Quantitative data were expressed as mean ± standard deviation. Data are expressed as mean ± standard deviation (±s), and t-tests are used. Count data are expressed as percentages (%). Ranked data are compared using the rank-sum test, and unordered data are compared using the chi-square test. 2 Test. A p-value < 0.05 is considered statistically significant.

[0115] Research Results

[0116] 1. General Information

[0117] There were no statistically significant differences in age, pre-treatment TCM syndrome scores, and TNF-α and IL-8 levels between the control and treatment groups (P>0.05). The quantitative data for TNF-α and IL-8 levels did not conform to a normal distribution and had homogeneous variances.

[0118] 2. Comparison of negative conversion rates between the two groups after treatment

[0119] There were 42 cases in each group. After treatment, 37 cases in the control group and 42 cases in the treatment group became negative. There was no difference in recurrence rate between the treatment group and the control group (P > 0.05). See Table 2.

[0120] Table 2 Comparison of negative conversion rates between the two treatment groups

[0121]

[0122] 3. Recurrence rate 3 months after treatment in both groups

[0123] Both groups underwent follow-up examinations for vaginal discharge pathogens at 1, 2, and 3 months after treatment. In the control group, a total of 20 cases relapsed at the 3 follow-up visits after treatment, while in the treatment group, a total of 11 cases relapsed during the same period. The relapse rate in the treatment group was lower than that in the control group (P < 0.05) (Table 3).

[0124] Table 3 Comparison of recurrence rates between the two groups 3 months after treatment

[0125]

[0126] 4. Traditional Chinese Medicine Symptom Scoring Scale

[0127] Comparison of TCM symptom scores before and after treatment in the two groups: In the control group, 0 cases were cured, 1 case showed significant improvement, 31 cases showed improvement, and 10 cases showed no improvement; in the treatment group, 0 cases were cured, 7 cases showed significant improvement, 29 cases showed improvement, and 6 cases showed no improvement. The treatment group showed better efficacy than the control group (P < 0.05) (Table 4).

[0128] Table 4 Comparison of TCM syndrome scores before and after treatment in the two groups

[0129]

[0130] 5. Comparison of serum TNF-α and IL-8 levels before and after treatment

[0131] There were no statistically significant differences in serum TNF-α and IL-8 levels before and after treatment in the control group (P>0.05). In the treatment group, serum TNF-α levels decreased significantly after treatment compared to before treatment (P<0.01), and the therapeutic effect was significantly better than that in the control group (P<0.01) (Table 4). Serum IL-8 levels decreased significantly after treatment in the treatment group compared to before treatment (P<0.05), and the therapeutic effect was better than that in the control group (P<0.05) (Tables 5 and 6).

[0132] Table 5 Comparison of TNF-α before and after treatment in the two groups

[0133]

[0134] Table 6 Comparison of IL-8 levels before and after treatment in the two groups

[0135]

[0136] in conclusion

[0137] The treatment group had a higher rate of pathogen conversion to negative after treatment than the control group, and a lower recurrence rate.

[0138] The treatment group showed better efficacy than the control group in reducing TCM symptom scores.

[0139] The treatment group effectively reduced serum TNF-α and IL-8 levels in patients, and the efficacy was better than that in the control group.

[0140] Innovation and Clinical Value of This Invention

[0141] 1. Expanding the scope of application of empirical formulas and providing evidence for treating different diseases with the same method: Based on the common damp-heat pathogenesis and similar clinical manifestations of leukorrhea, the Qingre Ankun Decoction is extended from HPV infection and chronic cervicitis to RVVC, improving the clinical application system of Cai's gynecological empirical formulas, providing oral Chinese medicine solutions for similar recurrent gynecological damp-heat inflammations, and providing reliable evidence-based medicine for the application of hospital preparations.

[0142] 2. Multi-dimensional objective evaluation system: This study simultaneously included long-term recurrence rate (core outcome indicator), fungal clearance rate, TCM syndrome score, serum TNF-α, IL-8 inflammatory factors and other multi-level indicators to study the clinical efficacy of TCM from the dual levels of clinical efficacy and systemic inflammatory immune mechanism.

[0143] 3. The advantages of the combined Chinese and Western medicine approach are clear. This study adopted a combined approach of oral Qingre Ankun Decoction and external clotrimazole suppositories. In the short term, it synergistically improves the fungal clearance rate. In the long term, it reduces recurrence by clearing heat and strengthening the body's resistance and downregulating inflammatory factors through Chinese medicine. It addresses both the symptoms and the root cause, avoids the risks of oral fluconazole resistance and liver and kidney damage, and is suitable for patients of childbearing age with recurrent RVVC and damp-heat accumulation. It has strong clinical applicability.

Claims

1. A traditional Chinese medicine composition for treating recurrent vulvovaginal candidiasis, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 28-32 parts of Smilax glabra, 13-17 parts of Toona sinensis root bark, 28-32 parts of raw Coix lacryma-jobi, 13-17 parts of Poria cocos, 7-11 parts of Polyporus umbellatus, 13-17 parts of Plantago asiatica, 7-11 parts of Phellodendron chinense, 7-11 parts of Paeonia lactiflora, and 28-32 parts of raw Astragalus membranaceus.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The aforementioned traditional Chinese medicine composition is made from the following raw materials in parts by weight: 29-31 parts of Smilax glabra, 14-16 parts of Toona sinensis root bark, 29-31 parts of raw Coix lacryma-jobi, 14-16 parts of Poria cocos, 8-10 parts of Polyporus umbellatus, 14-16 parts of Plantago asiatica, 8-10 parts of Phellodendron chinense, 8-10 parts of Paeonia lactiflora, and 29-31 parts of raw Astragalus membranaceus.

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 of Smilax glabra, 15 parts of Toona sinensis root bark, 30 parts of raw Coix lacryma-jobi, 15 parts of Poria cocos, 9 parts of Polyporus umbellatus, 15 parts of Plantago asiatica, 9 parts of Phellodendron chinense, 9 parts of Paeonia lactiflora, and 30 parts of raw Astragalus membranaceus.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The traditional Chinese medicine composition is in the form of granules, tablets, capsules, oral liquids, or syrups.

5. The traditional Chinese medicine composition according to claim 4, characterized in that, The traditional Chinese medicine composition also includes pharmaceutically acceptable excipients.

6. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a drug for treating recurrent vulvovaginal candidiasis.

7. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a drug for treating recurrent vulvovaginal candidiasis of the damp-heat type.

8. A pharmaceutical composition for treating recurrent vulvovaginal candidiasis, characterized in that, The pharmaceutical composition comprises the traditional Chinese medicine composition according to any one of claims 1-3 and clotrimazole.

9. The use of the pharmaceutical composition according to claim 8 in the preparation of a medicament for treating recurrent vulvovaginal candidiasis.

10. The use of the pharmaceutical composition according to claim 8 in the preparation of a medicament for treating recurrent vulvovaginal candidiasis of the damp-heat type.

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