A traditional Chinese medicine composition for treating AIDS combined with pneumocystis pneumonia

Abstract

The application provides a traditional Chinese medicine composition for treating AIDS combined with pneumocystis pneumonia, and belongs to the technical field of traditional Chinese medicines.The traditional Chinese medicine composition is prepared from the following raw medicinal materials in a proportion by weight: lily 10-16 parts, raw rehmannia 5-12 parts, prepared rehmannia 5-12 parts, ophiopogon 5-12 parts, licorice 2-6 parts, fried white peony root 2-6 parts, scrophularia 5-12 parts, platycodon 2-6 parts, angelica 5-12 parts, radix pseudostellariae 10-16 parts, astragalus 10-16 parts, and atractylodes 10-16 parts.It has been verified that the traditional Chinese medicine composition can obviously improve the effective treatment rate; when treating patients with AIDS combined with pneumocystis pneumonia, in addition to the conventional application of compound sulfamethoxazole (SMZ-TMP) and / or combined with lily solid gold soup oral treatment, the application of SMZ-TMP combined with the traditional Chinese medicine composition can effectively improve the symptoms, chest CT performance and other conditions of the patients, and can shorten the time of the uncomfortable symptoms of the patients.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and specifically relates to a traditional Chinese medicine composition for treating AIDS complicated with Pneumocystis pneumonia. Background Technology

[0002] AIDS, or Acquired Immunodeficiency Syndrome, is caused by the Human Immunodeficiency Virus (HIV). It is one of the most important public health problems affecting public health. When the disease progresses to stage III, i.e. the AIDS stage, various opportunistic infections often occur, and Pneumocystis pneumonia (PCP) is one of the most common opportunistic infections. Its main characteristics are: (1) subacute onset, with dyspnea gradually worsening, accompanied by fever, dry cough, and chest tightness. The symptoms gradually worsen, and in severe cases, respiratory distress occurs; (2) few positive signs in the lungs, or a small number of scattered dry and wet rales may be heard. The signs are often disproportionate to the severity of the disease symptoms; (3) chest X-ray examination shows diffuse reticular nodular interstitial infiltration in both lungs starting from the hilum, and lung CT shows ground-glass opacities in both lungs; (4) blood gas analysis shows hypoxemia. In severe cases, the arterial blood oxygen partial pressure (PaO2) is significantly reduced, often below 60 mmH part (1 mmH part = 0.133 kPa); (5) blood lactate dehydrogenase is often >500 mg / dL.

[0003] In terms of treatment, in addition to symptomatic treatments such as bed rest and oxygen therapy, the primary treatment for pathogen infection is oral sulfamethoxazole-trimethoprim (SMZ-TMP). For moderate to severe patients (PaO2 or alveolar-arterial oxygen partial pressure difference >35 mmH2), hormone therapy can be used in the early stage (within 72 hours). If the patient has significant progressive respiratory distress, assisted ventilation can be provided. Specific implementation follows the treatment guidelines for HIV / AIDS patients with PCP in the "Chinese Guidelines for the Diagnosis and Treatment of HIV / AIDS (2021 Edition)". For mild to moderate patients, oral TMP 15-20 mg / (k mg / day) and SMZ 75-100 mg / (k mg / day) are administered in 3-4 divided doses for a 21-day course. The course of treatment can be extended if necessary. Hormone therapy: For moderate to severe patients (PaO2 or alveolar-arterial oxygen partial pressure difference >35 mmH2), hormone therapy can be used in the early stage (within 72 hours). Prednisone 40 mg twice a day orally for 5 days, then 20 mg twice a day for 5 days, then 20 mg once a day until the end of the course of treatment; the intravenous dose of methylprednisolone is 75% of the above prednisone dosage.

[0004] From the perspective of Traditional Chinese Medicine (TCM), AIDS is a chronic infectious disease with a long course, complex symptoms, wide range of locations affected, and diverse clinical manifestations. Based on its etiology, clinical manifestations, and prognosis, it falls under the TCM categories of "epidemic disease" and "asthenia." Patients with concurrent Pneumocystis pneumonia primarily present with fever, dry cough, shortness of breath, and fatigue, falling under the TCM category of "cough." Cough refers to a condition characterized by a cough sound or phlegm production caused by external or internal factors leading to impaired lung function, upward flow of lung qi, and impact on the airways. Historically, cough without phlegm was called "cough," phlegm without sound was called "sou," and both phlegm and sound were called "cough." Clinically, cough and phlegm are often seen together, making them difficult to distinguish, hence the combined term "cough." Cough is divided into exogenous cough and endogenous cough. Exogenous cough is caused by external pathogenic factors (the six pathogenic factors); endogenous cough is caused by internal factors such as diet and emotional distress leading to dysfunction of the internal organs and the generation of pathogenic factors. Both external and internal coughs are caused by pathogenic factors that impair the lung qi's function of dispersing and descending, forcing the qi upwards and causing coughing.

[0005] In clinical practice, the most common symptom in AIDS patients complicated with Pneumocystis pneumonia is internal injury cough with deficiency of both Qi and Yin. The main manifestations include fatigue, spontaneous sweating, palpitations, shortness of breath, cough with wheezing, dry mouth and thirst, indigestion, loss of appetite, night sweats, hot palms and soles, pale complexion, red tongue with little coating, and a thready and rapid pulse. The treatment principle is "tonifying the kidneys and replenishing Qi, nourishing Yin and moistening the lungs, and generating essence and replenishing marrow," often using "Baihe Gujin Tang" (Lily Bulb Decoction for Strengthening Metal). Baihe Gujin Tang originates from *Shenzhai Yishu* (Shenzhai's Posthumous Writings). In the Five Elements theory, the lungs belong to Metal. When the Lung Metal is not strengthened, various symptoms arise. This formula calms the Lung Metal and strengthens the Lung Qi, thus alleviating the symptoms; hence the name "Baihe Gujin Tang." The formula primarily uses lily bulbs and other lung-moistening and fluid-generating herbs. The combined effects of these herbs nourish the lungs and kidneys, replenish Yin fluids, clear deficiency fire, and stop phlegm and cough.

[0006] However, the traditional "Lily Bulb Decoction for Strengthening Metal" is less effective for patients with underlying HIV / AIDS who experience internal injuries, coughs, qi deficiency, and general weakness. It is slow to take effect and lacks specificity. Finding a more suitable formula for HIV / AIDS patients with Pneumocystis pneumonia to further improve treatment outcomes and efficiency is a problem that needs to be addressed. Summary of the Invention

[0007] In view of the problems existing in the prior art, the purpose of this invention is to provide a traditional Chinese medicine composition for treating AIDS complicated with Pneumocystis pneumonia. It is an improvement on the traditional "Baihe Gujin Tang" formula, which can further improve the treatment effect, increase the treatment effectiveness rate, and relieve the patient's discomfort symptoms as soon as possible.

[0008] The objective of this invention is achieved through the following technical solution:

[0009] The first aspect of this invention provides a traditional Chinese medicine composition for treating AIDS complicated with Pneumocystis pneumonia, prepared from the following raw materials in the indicated weight ratios:

[0010] Lily bulb 10-16 parts, raw rehmannia root 5-12 parts, prepared rehmannia root 5-12 parts, ophiopogon root 5-12 parts, licorice root 2-6 parts, stir-fried white peony root 2-6 parts, scrophularia root 5-12 parts, platycodon root 2-6 parts, angelica root 5-12 parts, codonopsis root 10-16 parts, astragalus root 10-16 parts, atractylodes rhizome 10-16 parts.

[0011] Furthermore, the traditional Chinese medicine composition is prepared from the following raw materials in the indicated weight ratios:

[0012] Lily bulb 15 parts, raw rehmannia root 10 parts, prepared rehmannia root 10 parts, ophiopogon root 10 parts, licorice root 5 parts, stir-fried white peony root 5 parts, scrophularia root 10 parts, platycodon root 5 parts, angelica root 10 parts, codonopsis root 15 parts, astragalus root 15 parts, atractylodes rhizome 15 parts.

[0013] Furthermore, the traditional Chinese medicine composition is a pharmaceutical preparation made by adding pharmaceutically acceptable excipients or auxiliary ingredients to raw drug powders, water extracts or organic solvent extracts in various weight proportions.

[0014] Furthermore, the traditional Chinese medicine composition is an oral preparation.

[0015] A second aspect of the present invention provides a method for preparing the traditional Chinese medicine composition, comprising the following steps:

[0016] Take the raw materials in the specified weight ratios, grind them directly into powder, or extract them with water or organic solvents, and then add pharmaceutically acceptable excipients or auxiliary ingredients to obtain the Chinese medicine composition.

[0017] A third aspect of the present invention provides the use of the traditional Chinese medicine composition in the preparation of a medicament for treating AIDS complicated with Pneumocystis pneumonia.

[0018] The advantages of this invention compared to the prior art are as follows:

[0019] 1. Compared to oral treatment with compound sulfamethoxazole (SMZ-TMP) alone, combination therapy and integrated traditional Chinese and Western medicine treatments are possible, offering a wider range of treatment options.

[0020] 2. Based on the traditional "Lily Bulb Decoction for Strengthening Metal" formula, this version is more tailored to the constitution of patients with underlying HIV / AIDS, especially enhancing its effects of invigorating Qi, strengthening the spleen, promoting body fluid production, and moistening the lungs. Therefore, it is more suitable for patients with HIV / AIDS complicated by Pneumocystis pneumonia, effectively improving treatment outcomes and increasing treatment efficiency. Detailed Implementation

[0021] The raw materials and equipment used in the specific embodiments of the present invention are all known products, obtained by purchasing commercially available products.

[0022] Example

[0023] In clinical practice, to further improve treatment efficacy, increase treatment effectiveness, and alleviate patients' symptoms as quickly as possible, we have modified and adjusted the representative herbs in the "Baihe Gujin Tang" formula, combining modern pharmacological research of traditional Chinese medicine with clinical experience, to create a new combination of herbs. The original formula of Baihe Gujin Tang consists of lily bulb, raw rehmannia root, prepared rehmannia root, ophiopogon root, licorice root, stir-fried white peony root, scrophularia root, platycodon root, angelica root, and fritillaria bulb. When treating patients with AIDS complicated by Pneumocystis pneumonia, considering that the patients have an underlying AIDS condition known as "asthenia," mainly manifested as dry cough without phlegm, we removed fritillaria bulb and added codonopsis root, astragalus root, and atractylodes rhizome to enhance the effects of qi and generating fluids.

[0024] This embodiment provides a traditional Chinese medicine composition for treating AIDS complicated with Pneumocystis pneumonia, which is prepared from the following raw materials in the indicated weight ratios: 15g of lily bulb, 10g of raw rehmannia root, 10g of prepared rehmannia root, 10g of ophiopogon root, 5g of licorice root, 5g of stir-fried white peony root, 10g of scrophularia root, 5g of platycodon root, 10g of angelica root, 15g of codonopsis root, 15g of astragalus root, and 15g of atractylodes rhizome.

[0025] In this formula, lily bulb is sweet, bitter, and slightly cold, nourishing yin, clearing heat, moistening the lungs, and relieving cough. Rehmannia root (raw and prepared) is used together to nourish the kidneys and strengthen yin. These three herbs together nourish the yin fluids of the lungs and kidneys, forming a common combination for moistening the lungs and kidneys, and tonifying both metal and water elements; these three herbs are the principal herbs. Ophiopogon root (sweet and cold) assists lily bulb in nourishing lung yin and clearing lung heat; Scrophularia root (salty and cold) assists raw and prepared rehmannia root in benefiting kidney yin and reducing deficiency fire; these are the assistant herbs. Angelica root and peony root nourish blood and regulate qi; Platycodon root promotes lung function, soothes the throat, resolves phlegm, and relieves cough; Codonopsis root, Astragalus root, and Atractylodes rhizome tonify qi, strengthen the spleen, generate fluids, and moisten the lungs; these are the adjuvant herbs. Licorice root harmonizes all the herbs and acts as the guiding herb. The combined effects of these herbs restore yin fluids and strengthen lung metal, thus curing cough symptoms. The main characteristics of this formula are: first, it nourishes the kidneys and protects the lungs, harmonizing metal and water elements, especially focusing on moistening the lungs and relieving cough; second, it nourishes while also cooling the blood, tonifying qi, promoting lung function, and resolving phlegm, addressing both the root cause and the symptoms, but prioritizing the root cause. In clinical application, if the phlegm is copious and yellow, add Trichosanthes peel, mulberry bark, and Arisaema cum Bile to clear the lungs and resolve phlegm; if the cough and wheezing are severe, add apricot kernel, coltsfoot flower, and schisandra fruit to stop cough and relieve wheezing; if the hemoptysis is severe, remove Platycodon grandiflorus to lift the qi, or add Bletilla striata, Imperata cylindrica root, and Agrimonia pilosa to enhance the hemostatic effect; if the patient also has poor appetite, add Amomum villosum, Amomum cardamomum, and Citrus reticulata peel to regulate qi, invigorate the spleen, and harmonize the stomach.

[0026] The preparation method of the traditional Chinese medicine composition is as follows:

[0027] Weigh the following herbs according to the formula for preparing a Chinese herbal composition for daily use: 15g lily bulb, 10g raw rehmannia root, 10g prepared rehmannia root, 10g ophiopogon root, 5g licorice root, 5g stir-fried white peony root, 10g scrophularia root, 5g platycodon root, 10g angelica root, 15g codonopsis root, 15g astragalus root, and 15g atractylodes rhizome. Mix all herbs together and soak them in clean, cold water for 30-40 minutes, adding enough water to cover the herbs by 1-2 cm to ensure complete saturation. Bring to a boil over high heat, then reduce to a simmer and cook for 20-30 minutes. Strain the liquid. Add an appropriate amount of water again, bring to a boil, then simmer for 15-20 minutes. Strain the liquid again. Combine the two liquids (approximately 200ml) and divide into two doses, taken in the morning and evening.

[0028] Test case

[0029] To verify the therapeutic effect of the traditional Chinese medicine composition described in the examples on AIDS complicated with Pneumocystis pneumonia, the following study was conducted in this test case:

[0030] 1. General Information: This test case included 49 patients with HIV complicated by Pneumocystis pneumonia who were hospitalized in our hospital from August 1, 2019 to November 30, 2023. The treatment group consisted of 24 patients, and the control group consisted of 25 patients. There were no statistically significant differences in the basic information (gender, age) between the two groups (P > 0.05).

[0031] 2. Research Methods: Both groups of patients received high-protein diets, non-invasive assisted ventilation, and highly effective antiretroviral therapy. The treatment group received oral administration of the traditional Chinese medicine composition described in the examples combined with compound sulfamethoxazole (SMZ-TMP) tablets, while the control group received oral administration of Baihe Gujin Decoction combined with compound sulfamethoxazole (SMZ-TMP) tablets. The compound sulfamethoxazole tablets were produced by Shandong Xinhua Pharmaceutical Co., Ltd., with the national drug approval number H37020649, specification: sulfamethoxazole 0.4g, trimethoprim 80mg), 3 tablets / time, 3 times / day. Patients in the treatment group also received oral administration of the traditional Chinese medicine composition prepared in the examples (200ml of decoction was obtained from the traditional Chinese medicine preparation room of our hospital, 100ml each time, divided into two warm doses after meals, morning and evening). Both groups were treated for 10 days.

[0032] 3. Efficacy evaluation criteria:

[0033] Clinical efficacy was evaluated according to the relevant criteria in "Diagnosis and Treatment of Pneumocystis pneumonia". Marked effect: multiple clinical symptoms (cough, fever, etc.) completely disappeared, and chest CT showed lesion absorption >50%; Effective: multiple clinical symptoms (cough, fever, etc.) were relieved, and chest CT showed lesion absorption ≤50% (25% < lesion absorption); Ineffective: multiple clinical symptoms (cough, fever, etc.) did not improve, and chest CT showed lesion absorption ≤25%. The total effective rate = (number of markedly effective + number of effective cases) / total number of cases × 100%.

[0034] 4. Statistical methods: SPSS 26.0 statistical software was used to analyze the data. For count data, the χ2 test was used; for measurement data, the t test was used. P was used to indicate that the difference was statistically significant.

[0035] 5. Results: Comparison of clinical efficacy between the two groups of patients. After 10 days of treatment, the total effective rate of the treatment group was significantly higher than that of the control group, and the difference was statistically significant (P<0.05), as shown in Table 1.

[0036] Table 1 Comparison of clinical efficacy between the two groups of patients

[0037]

[0038] III. Research Conclusions:

[0039] Therefore, it can be seen that the traditional Chinese medicine composition described in the embodiments of the present invention can significantly improve the treatment efficacy. When treating patients with AIDS complicated with Pneumocystis pneumonia, in addition to the conventional use of compound sulfamethoxazole (SMZ-TMP) combined with Baihe Gujin Decoction for oral treatment, switching to SMZ-TMP combined with the traditional Chinese medicine composition described in the embodiments of the present invention can effectively improve the patient's symptoms, chest CT findings, etc., and can shorten the duration of the patient's discomfort symptoms.

[0040] Finally, it should be noted that the above description is only used to illustrate the technical solutions of the present invention and is not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating AIDS complicated with Pneumocystis pneumonia, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials in the indicated weight ratios: Lily bulb 15 parts, raw rehmannia root 10 parts, prepared rehmannia root 10 parts, ophiopogon root 10 parts, licorice root 5 parts, stir-fried white peony root 5 parts, scrophularia root 10 parts, platycodon root 5 parts, angelica root 10 parts, codonopsis root 15 parts, astragalus root 15 parts, atractylodes rhizome 15 parts. The preparation method of the traditional Chinese medicine composition includes the following steps: Take the raw materials in the specified weight ratios, grind them directly into powder, or extract them with water or organic solvents, and then add pharmaceutically acceptable excipients or auxiliary ingredients to obtain the Chinese medicine composition.

2. The use of the traditional Chinese medicine composition according to claim 1 in the preparation of a drug for treating AIDS complicated with Pneumocystis pneumonia.

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