Application of traditional Chinese medicine composition in preparation of medicine for treating acute lower urinary tract infection

Abstract

The invention belongs to the technical field of traditional Chinese medicine application, and relates to application of a traditional Chinese medicine composition in preparation of a medicine for treating acute lower urinary tract infection. The traditional Chinese medicine composition is combined with western medicines to improve the lower urinary tract stimulation symptom score decline value, the traditional Chinese medicine symptom effective rate, the lower urinary tract stimulation symptom halving rate, the lower urinary tract stimulation symptom disappearance time and the application of the lower urinary tract stimulation single symptom to preparation of the medicine for treating acute lower urinary tract infection by improving the lower urinary tract stimulation symptom score decline value. The traditional Chinese medicine composition can improve the treatment effect on acute lower urinary tract infection in combination with western medicines, and is free of side effects and good in safety.

Description

Technical Field

[0001] The invention belongs to the technical field of application of traditional Chinese medicines, and relates to application of a traditional Chinese medicine composition in preparing a medicine for treating acute lower urinary tract infection. Background Art

[0002] Lower urinary tract infection refers to a urinary tract infection caused by the growth and reproduction of various pathogenic microorganisms in the urinary tract. It is common in women of childbearing age, the elderly, people with low immunity, etc. It is one of the more common infectious diseases in clinical practice, second only to respiratory tract infection. Cystitis and urethritis both belong to the category of lower urinary tract infection in urinary tract infection. Whether it is cystitis or urethritis, the main clinical manifestations are bladder irritation, that is, frequent urination, urgency, pain, discomfort in the bladder area or perineum, and burning sensation in the urethra. Cystitis is the most common disease of the urinary system. The main pathogens are Escherichia coli and Proteus, which are divided into acute and chronic types. Urethritis is a common disease, which refers to inflammation of the urethral mucosa. It is common in women. It can be clinically divided into acute, chronic, nonspecific urethritis and gonococcal urethritis. The latter two have similar clinical manifestations and must be differentiated based on medical history and bacteriological examinations, but they are mostly caused by retrograde invasion of pathogenic bacteria into the urethra. Acute cystitis is manifested by frequent urination, urgency, and pain when urinating, often accompanied by pain in the suprapubic area, and some patients have hematuria.

[0003] At present, since acute lower urinary tract infection (cystitis and urethritis) is mainly caused by pathogenic bacteria through ascending or bloodstream infection, its treatment is mainly based on antibiotics. Although the existing treatment methods can relieve or improve acute lower urinary tract symptoms to a certain extent, the abuse of antibiotics not only leads to an increasing number of drug-resistant strains that are insensitive, causing repeated attacks of the disease, leading to clinical treatment failure, and the disease cannot be effectively treated; and the excessive use of antibiotics can also cause side effects to the body.

[0004] Therefore, providing a drug that can effectively treat acute lower urinary tract infection is the focus of current research and development. Summary of the invention

[0005] In view of the technical problems that the abuse of antibiotics in the existing treatment of acute lower urinary tract infection has led to an increasing number of drug-resistant strains that are insensitive, repeated attacks of the disease, failure of clinical treatment, and side effects on the body, the present invention provides an application in the preparation of a drug for the treatment of acute lower urinary tract infection.

[0006] The present invention has found through research that the combination of a Chinese medicine composition and a Western medicine can enhance the therapeutic effect of acute lower urinary tract infection, has no side effects and is highly safe.

[0007] In order to achieve the above object, the technical solution adopted by the present invention is:

[0008] A use of a Chinese medicine composition combined with a Western medicine in preparing a medicine for treating acute lower urinary tract infection.

[0009] A Chinese medicine composition combined with a Western medicine is used in preparing a medicine for treating acute lower urinary tract infection by increasing the decrease value of the lower urinary tract irritation symptom score.

[0010] A Chinese medicine composition combined with a Western medicine is used in preparing a medicine for treating acute lower urinary tract infection by improving the effective rate of TCM syndromes.

[0011] A Chinese medicine composition combined with a Western medicine is used in preparing a medicine for treating acute lower urinary tract infection by improving the disappearance rate of lower urinary tract irritation symptoms.

[0012] A Chinese medicine composition combined with a Western medicine is used in preparing a medicine for treating acute lower urinary tract infection by increasing the halving rate of lower urinary tract irritation symptoms.

[0013] A Chinese medicine composition combined with a Western medicine is used in preparing a medicine for treating acute lower urinary tract infection by prolonging the disappearance time of lower urinary tract irritation symptoms.

[0014] A Chinese medicine composition combined with a Western medicine is used in preparing a medicine for treating acute lower urinary tract infection by improving the disappearance rate of a single symptom of lower urinary tract irritation.

[0015] Further limited, the single symptom of lower urinary tract irritation includes frequent urination, urgent urination, dripping after urination, painful urination, urethral burning sensation or incomplete urination.

[0016] It is further specified that the Chinese medicine composition includes main active ingredients; the main active ingredients include Herba Dioscoreae, Phellodendron chinense, Patrinia chinensis, Indigo naturalis, Talcum, Plantago seed, Acorus gramineus, Poria cocos, Atractylodes lancea and Salvia miltiorrhiza; the mass ratio of Herba Dioscoreae, Phellodendron chinense, Patrinia chinensis, Indigo naturalis, Talcum, Plantago seed, Acorus gramineus, Poria cocos, Atractylodes lancea and Salvia miltiorrhiza is 1:0.5:1:0.156:0.594:1:0.5:0.5:0.5:1.

[0017] It is further defined that the Chinese medicine composition also includes auxiliary active ingredients; the auxiliary active ingredients include Polygonum cuspidatum, Taraxacum officinale and Alisma orientale; the mass ratio of Phellodendron chinense, Polygonum cuspidatum, Taraxacum officinale and Alisma orientale is 16:1.5:1.5:1.

[0018] It is further defined that talc is replaced by tongcao; the mass ratio of the herb ophiopogon, phellodendron chinense, patrinia herb, indigo naturalis, tongcao, plantago seed, calamus tatarinowii, poria, atractylodes lancea and salvia miltiorrhiza is 1:0.5:1:0.156:0.03:1:0.5:0.5:0.5:1.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] 1. The research of the present invention shows that the Chinese medicine composition is effective in treating acute lower urinary tract infection, and the combination of drugs can greatly enhance the therapeutic effect of acute lower urinary tract infection, thereby expanding the scope of indications of the Chinese medicine composition; and the Chinese medicine composition is a Chinese medicinal material, has no side effects on the body, can slow down or avoid the adverse effects of Western medicine on the body, and has better safety.

[0021] 2. The present invention found in the study that compared with the baseline, the combination of Chinese medicine composition and Western medicine can increase the decrease value of the lower urinary tract irritation symptom score, and the combination of Chinese medicine composition and Western medicine can greatly improve the effective rate of TCM syndrome. It shows that the combination of Chinese medicine composition and Western medicine has excellent effects in improving the lower urinary tract irritation symptoms and TCM syndromes of acute lower urinary tract infection.

[0022] 3. The present invention has found in the study that the combination of Chinese medicine composition and Western medicine can increase the disappearance rate and halving rate of lower urinary tract irritation symptoms, and increase the disappearance time of lower urinary tract irritation symptoms, further verifying that the combination of Chinese medicine composition and Western medicine is the best in improving acute lower urinary tract infection and shortening the course of the disease.

[0023] 4. The present invention has found in the research that the Chinese medicine composition combined with Western medicine can improve the disappearance rate of single symptoms of lower urinary tract irritation, especially the disappearance rate of single symptoms of frequent urination, urgency, pain when urinating, burning sensation in the urethra, dripping after urination or incomplete urination.

[0024] 5. When the Chinese medicine composition of the present invention is combined with Western medicine to treat acute lower urinary tract infection, the symptoms of acute lower urinary tract infection in patients can be improved more quickly. In a 2-week course of treatment, only one week of treatment can show significant therapeutic effects, greatly shortening the course of the disease. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 To measure the changes in lower urinary tract irritation symptom scores in patients with acute lower urinary tract infection during the observation period;

[0026] Figure 2 The total score of TCM syndromes in patients with acute lower urinary tract infection during the observation period;

[0027] Figure 3 The effective rate of TCM syndromes in three groups of patients with acute lower urinary tract infection at different time points;

[0028] Figure 4 It is the disappearance rate of lower urinary tract irritation symptoms in patients with acute lower urinary tract infection during the observation period;

[0029] Figure 5 It is the halving rate of lower urinary tract irritation symptom score in patients with acute lower urinary tract infection during the observation period;

[0030] Figure 6 This is the survival curve of the disappearance time (days) of lower urinary tract irritation symptoms in acute lower urinary tract infection;

[0031] Figure 7 Changes in the irritation symptom scores of acute cystitis and acute urethritis treated with the Chinese medicine composition alone;

[0032] Figure 8 The halving rate of the irritation symptom score of acute cystitis and urethritis treated with the Chinese medicine composition alone;

[0033] Fig. 9 The disappearance rate of irritation symptoms of acute cystitis and urethritis treated with the Chinese medicine composition alone;

[0034] Fig.10 The total score of TCM syndromes in patients with acute cystitis and urethritis treated with TCM combination alone during the observation period;

[0035] Fig.11 The effective rate of the Chinese medicine composition in treating the TCM syndromes of patients with acute cystitis and acute urethritis at different time points. DETAILED DESCRIPTION

[0036] The technical solution of the present invention is now further described in conjunction with the accompanying drawings and embodiments, but the present invention is not limited to the following implementations.

[0037] Unless otherwise defined, technical or scientific terms used in the present invention shall have the common meanings understood by one having ordinary skills in the field to which the present invention belongs.

[0038] Technologies, methods, and equipment known to ordinary technicians in the relevant field may not be discussed in detail, but where appropriate, the technologies, methods, and equipment should be considered as part of the specification.

[0039] It should also be understood that the specific embodiments described above are only used to explain the present invention, and the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field, within the technical scope disclosed by the present invention, can make equivalent replacements or changes based on the technical solutions and inventive concepts of the present invention, which should be covered by the protection scope of the present invention / invention.

[0040] The Chinese medicine composition contains multiple Chinese medicines such as Radix Dioscoreae, Semen Plantaginis, Cortex Phellodendri, Poria, Indigo Naturalis, Salvia Miltiorrhiza, Herba Patriniae, Acorus Gramineus, Atractylodes, etc., which have the effects of clearing turbidity, relieving stranguria, clearing away heat and promoting diuresis. The prior art shows that the Chinese medicine composition is mainly used for the treatment of chronic prostatitis (CP). However, the scope of indications of the Chinese medicine composition is relatively single, therefore, expanding the scope of indications of the Chinese medicine composition is an urgent problem that the Chinese medicine composition needs to further solve.

[0041] The present invention mainly explores the therapeutic effect of a Chinese medicine composition combined with Western medicine on acute lower urinary tract infection, expands the indication range of the Chinese medicine composition, and provides a new use for the Chinese medicine composition.

[0042] The traditional Chinese medicine composition provided by the invention comprises main active ingredients; the main active ingredients comprise rhizoma schizonepetae, phellodendron chinense, herba patriniae, indigo naturalis, talc, seed of plantain, calamus tatarinowii, poria, atractylodes and salvia miltiorrhiza; the mass ratio of rhizoma schizonepetae, phellodendron chinense, herba patriniae, indigo naturalis, talc, seed of plantain, calamus tatarinowii, poria, atractylodes and salvia miltiorrhiza is 1:0.5:1:0.156:0.594:1:0.5:0.5:0.5:1.

[0043] The Chinese medicine composition provided by the present invention also includes auxiliary active ingredients; the auxiliary active ingredients include Polygonum cuspidatum, Taraxacum officinale and Alisma orientale; the mass ratio of Phellodendron chinense, Polygonum cuspidatum, Taraxacum officinale and Alisma orientale is 16:1.5:1.5:1. Polygonum cuspidatum can enhance the effect of clearing away heat and detoxification, Taraxacum officinale assists Patrinia chinensis in anti-inflammatory, and Alisma orientale cooperates with Talc and Plantago asiatica to promote diuresis and relieve stranguria.

[0044] In the Chinese medicine composition provided by the present invention, talc is replaced by tongcao; the mass ratio of fennel, phellodendron chinense, patrinia chinensis, indigo, tongcao, plantago, calamus, tuckahoe, atractylodes, and salvia miltiorrhiza is 1: 0.5: 1: 0.156: 0.03: 1: 0.5: 0.5: 0.5: 1. Talc is cold and can easily hurt the stomach, so people with gastrointestinal sensitivity can replace tongcao, which retains the diuretic effect and is more mild.

[0045] Example 1

[0046] This example mainly verifies the effectiveness and clinical effect of a Chinese medicine composition combined with Western medicine in treating acute lower urinary tract infection (cystitis, urethritis).

[0047] In this embodiment, the Chinese medicine composition includes main active ingredients; the main active ingredients include Radix Dipterocarpa, Phellodendron chinense, Patrinia chinensis, Indigo naturalis, Talcum, Seed of Plantago, Acorus gramineus, Poria cocos, Atractylodes lancea and Salvia miltiorrhiza; the mass ratio of Radix Dipterocarpa, Phellodendron chinense, Patrinia chinensis, Indigo naturalis, Talcum, Seed of Plantago, Acorus gramineus, Poria cocos, Atractylodes lancea and Salvia miltiorrhiza is 1:0.5:1:0.156:0.594:1:0.5:0.5:0.5:1.

[0048] The preparation method of the Chinese medicine composition provided in this embodiment comprises the following steps:

[0049] (1) Take Phellodendron chinense and boil it in water three times, adding 10-12 times the amount of water each time. Boil it for 1.5 hours for the first time, and 1 hour for the second and third times respectively. Combine the three decoctions and filter.

[0050] (2) Extracting volatile oil from Atractylodes lancea and Glechoma tatarinowii by distillation, encapsulating the volatile oil with B-cyclodextrin, drying and crushing the resulting inclusion compound into coarse powder for later use, and collecting the distilled aqueous solution in another container;

[0051] (3) Extracting Danshen twice with ethanol, adding 5.5 to 6.5 times the volume of 80% ethanol (volume fraction) each time, extracting for 1 hour each time, combining the extracts obtained twice, filtering, recovering ethanol until there is no alcohol taste, and setting aside;

[0052] (4) Mix the residue obtained in the above three steps with Radix Trichosanthis, Herba Patriniae, Semen Plantaginis, Talcum and Poria, add 10 to 12 times the amount of water and boil twice, each time for 1.5 hours, combine the decoctions and filter;

[0053] (5) combining the medicinal solutions in the above steps, concentrating them into a thick paste, adding indigo, drying, and crushing to obtain a powdery Chinese medicine composition;

[0054] (6) Adding an excipient to the above powdered Chinese medicine composition to obtain a Chinese medicine composition preparation.

[0055] During the above preparation, each raw material is weighed according to 160g of Phellodendron chinense. Preferably, an excipient is added to prepare a capsule-shaped Chinese medicine composition preparation.

[0056] 1. Research subjects

[0057] Among patients with acute lower urinary tract infection, there were 751 cases in the Chinese medicine composition treatment group (exposed group) and 369 cases in the pure Western medicine treatment group (non-exposed group). There were 17 and 6 patients in the exposed group and non-exposed group, respectively, who violated the study protocol. There were 734 cases in the exposed group (338 cases in the Chinese medicine composition alone treatment group and 396 cases in the Chinese medicine composition combined Chinese and Western medicine treatment group), and 363 cases in the non-exposed group (pure Western medicine treatment group). Therefore, in this embodiment, the effect analysis of the three groups of Chinese medicine composition alone treatment group, pure Western medicine treatment group and Chinese medicine composition combined Chinese and Western medicine treatment group was performed.

[0058] In this embodiment, the Chinese medicine combination therapy with Chinese and Western medicine refers to the combination therapy of Chinese medicine combination and Western medicine, i.e., Chinese and Western medicine combined therapy or combined medication. The Western medicines used in both pure Western medicine therapy and Chinese and Western medicine combined therapy include: (1) quinolones: levofloxacin, ciprofloxacin, moxifloxacin or norfloxacin; (2) cephalosporins: cefaclor, cefuroxime axetil, cefdinir or cefixime; (3) penicillins: amoxicillin or amoxicillin-clavulanate potassium.

[0059] 1.1. Conditions of the research subjects

[0060] In this embodiment, the research subjects meet the following conditions:

[0061] (1) People who are clinically diagnosed with acute cystitis or urethritis (excluding gonococcal urethritis);

[0062] (2) lower urinary tract irritation symptoms (frequent urination, urgency, dysuria, and / or urethral burning);

[0063] (3) TCM syndrome differentiation is consistent with "damp-heat obstruction syndrome";

[0064] (4) Age ≥18 years;

[0065] (5) Exclude urinary tract obstruction caused by stones, tumors, urethral stenosis / congenital malformation, and neurogenic cystitis.

[0066] 1.2 Characteristics of the research subjects

[0067] The demographic characteristics (age, height, weight) and vital signs (temperature, heart rate, blood pressure, respiration and physique) of the subjects are shown in Table 1 below.

[0068] Table 1 Characteristics of subjects with acute lower urinary tract infection

[0069]

[0070] As can be seen from the table above, the average age of the three groups of patients with acute lower urinary tract infection was around 45 years old. There were no clinically significant differences in age, gender, height, weight, etc. among the three groups of patients. The vital signs of the three groups of patients were mostly normal (average body temperature 36.4℃, heart rate about 76 times / min, respiration 19 times / min, etc.), and there were no clinically significant differences in body temperature, heart rate, blood pressure, respiration and physical examination among the three groups.

[0071] 1.3 Disease conditions of the three groups of patients

[0072] Table 2 is the results of the disease condition analysis of the three groups of patients with acute lower urinary tract infection. As can be seen from the table, for acute lower urinary tract infection, the baseline disease conditions of patients in each group are quite consistent and comparable, and there is no statistically significant difference in the inter-group comparison results (P>0.05). Table 3 is the results of the disease condition analysis of the three groups of patients with acute lower urinary tract infection. As can be seen from the table, there are no clinically significant differences in the TCM syndrome scores, TCM single symptom scores, lower urinary tract irritation symptom scores, and lower urinary tract irritation single symptom scores among the three groups when they visited the hospital for acute lower urinary tract infection.

[0073] Table 2 Analysis results of disease conditions in three groups of patients with acute lower urinary tract infection

[0074]

[0075]

[0076] Table 3 The total score of TCM syndrome and the severity of individual symptoms in the three groups of patients with acute lower urinary tract infection

[0077]

[0078]

[0079] 2. Medication status of the three groups of patients

[0080] Table 4 shows the drug treatment of patients during the observation period. From the perspective of drug treatment of patients with different indications during the observation period, there was no significant difference in drug dosage, number of days of medication, and concomitant medication between the acute lower urinary tract infection exposure group and the non-exposure group during the observation period, and the differences between the groups were not statistically significant (P>0.05).

[0081] In this embodiment, the non-exposed group is treated with pure western medicine, and the dosage of the western medicine is selected according to the patient's condition and the recommended dosage of the western medicine, so that it can be taken as needed.

[0082] The combined medication uses a Chinese medicine combination and Western medicine. The dosage of the Chinese medicine combination refers to the single medication, and the dosage of the Western medicine refers to the non-exposed group.

[0083] Table 4 Drug treatment of patients in each group during the observation period

[0084]

[0085] 3. Acute lower urinary tract infection

[0086] 3.1. Lower urinary tract irritation symptom score

[0087] Figure 1 The changes in lower urinary tract irritation symptom scores at different time points during the observation period in the three treatment groups of patients with acute lower urinary tract infection. Compared with the baseline, the lower urinary tract irritation symptom scores of the Chinese medicine combination alone treatment group, the pure Western medicine treatment group and the Chinese medicine combination combined Chinese and Western medicine treatment group gradually decreased after 1 week and 2 weeks of treatment, and the intra-group differences at each visit point of the three groups were statistically significant (P < 0.05). As can be seen from the figure, although the average lower urinary tract irritation symptom scores of the three groups of patients were very different in the second week (compared with the baseline, all decreased by more than 98%), in the first week, the Chinese medicine combination combined Chinese and Western medicine treatment group decreased by 90.5%, which was significantly greater than the pure Western medicine treatment group (80.23%) and the Chinese medicine combination alone treatment group (77.15%), and the difference between the latter two groups was not obvious.

[0088] Because the baseline differences among the three groups were statistically significant (P<0.05), covariance analysis was performed with the baseline as the covariate. The results of the decrease in the first week of treatment compared with the baseline showed that the least squares mean (95% confidence interval) was 9.8259 (9.4114, 10.2405) in the Chinese medicine combination combined Chinese and Western medicine treatment group, which was significantly greater than 8.5144 (8.1218, 8.9070) in the Chinese medicine combination alone treatment group and 8.6072 (8.3372, 8.8773) in the pure Western medicine treatment group. Further pairwise comparisons showed that the inter-group ratios between the pure Western medicine treatment group and the Chinese medicine combination combined Chinese and Western medicine treatment group, and between the Chinese medicine combination alone treatment group and the Chinese medicine combination combined Chinese and Western medicine treatment group were The differences were statistically significant {the least squares means (95% confidence interval) were -1.2187 (-1.7132, -0.7242) and -1.3116 (-1.8823, -0.7408)}; the results of the decrease from the baseline in the second week of treatment showed that the least squares means (95% confidence interval) of the Chinese medicine combination treatment group, the pure Western medicine treatment group and the Chinese medicine combination Chinese and Western medicine treatment group were 10.7061 (10.5704, 10.8417), 10.7313 (10.6312, 10.8313), and 10.8416 (10.7044, 10.9788), respectively. There was no statistically significant difference among the three groups. Specific data are shown in Tables 5 and 6.

[0089] It can be seen that treatment with the Chinese medicine combination alone, treatment with Western medicine alone, and treatment with the Chinese medicine combination combined with Western medicine can all effectively improve the lower urinary tract irritation symptoms of patients with acute lower urinary tract infection. The effect of treatment with the Chinese medicine combination combined with Western medicine is better than that with Western medicine alone and treatment with the Chinese medicine combination alone, and significant therapeutic effects are shown after one week of treatment.

[0090] Table 5 Analysis of lower urinary tract irritation symptoms in acute lower urinary tract infection

[0091]

[0092]

[0093] Table 6 Covariance analysis of changes in lower urinary tract irritation symptom scores in acute lower urinary tract infection

[0094]

[0095] 3.2 TCM Syndrome Scoring

[0096] Figure 2 The data are as follows: changes in the total score of TCM syndromes at different time points during the observation period in the three treatment groups of patients with acute lower urinary tract infection; the results are similar to those of the lower urinary tract irritation symptom scores.

[0097] Compared with the baseline, the total score of TCM syndrome in the TCM combination alone treatment group, the pure Western medicine treatment group, and the TCM combination combined Chinese and Western medicine treatment group gradually decreased after 1 and 2 weeks of treatment, and the intra-group differences in each visit point of the three groups were statistically significant (P < 0.05). Although the average total score of TCM syndrome in the three groups was very small in the second week (compared with the baseline, it was reduced by more than 98%), in the first week, the TCM combination combined Chinese and Western medicine treatment group decreased by 89.80%, which was significantly greater than the pure Western medicine treatment group (79.61%) and the TCM combination alone treatment group (77.78%), and the difference between the latter two groups was not obvious. Because the baseline differences among the three groups were statistically significant (P<0.05), covariance analysis was performed with the baseline as the covariate. The results of the decrease in the first week of treatment compared with the baseline showed that the least squares mean (95% confidence interval) was 12.6095 (12.0911, 13.1278) in the Chinese medicine combination combined Chinese and Western medicine treatment group, which was significantly greater than 11.1813 (10.6906, 11.6720) in the Chinese medicine combination alone treatment group and 11.0737 (10.7360, 11.4113) in the pure Western medicine treatment group. Further pairwise comparisons showed that the pure Western medicine treatment group and the Chinese medicine combination combined Chinese and Western medicine treatment group, the Chinese medicine combination alone treatment group and the Chinese medicine combination combined Chinese and Western medicine treatment group The differences among the three groups were statistically significant {the least squares means (95% confidence interval) were -1.5358 (-2.1546, -0.9170) and -1.4282 (-2.1421, -0.7143)}; the results of the decrease from the baseline in the second week of treatment showed that the least squares means (95% confidence interval) of the Chinese medicine combination treatment group, the pure Western medicine treatment group and the Chinese medicine combination Chinese and Western medicine treatment group were 13.8061 (13.6333, 13.9789), 13.8045 (13.6771, 13.9320), and 13.9488 (13.7739, 14.1237), respectively. There was no statistically significant difference among the three groups. Specific data are shown in Tables 7 and 8.

[0098] In the first week of treatment, the effective rates of TCM syndrome in the TCM combination treatment group, the pure Western medicine treatment group, and the TCM combination and Western medicine treatment group were 89.49%, 83.47%, and 93.92%, respectively. Figure 3 ), there were certain differences among the three groups, and the differences between the groups were statistically significant (P<0.05). Further pairwise comparisons showed that there was a statistically significant difference between the Chinese medicine combination and Western medicine treatment group and the pure Western medicine treatment group (P<0.0167), and there were no statistically significant differences in other pairwise comparisons (P>0.0167). In the second week of treatment, the effective rate of TCM syndrome in the three groups of patients was close to or reached 100%, and there was no statistically significant difference between the three groups (P>0.05).

[0099] It can be seen that the combined treatment of Chinese and Western medicine with the Chinese herbal composition is superior to Western medicine treatment alone in improving the Chinese medicine symptoms of patients with acute lower urinary tract infection, and shows significant therapeutic effects after one week of treatment.

[0100] Table 7 Analysis of TCM syndromes and therapeutic effects of acute lower urinary tract infection

[0101]

[0102]

[0103] Table 8 Covariance analysis of changes in TCM syndrome scores for acute lower urinary tract infection

[0104]

[0105] 3.3. Disappearance rate of lower urinary tract irritation symptoms

[0106] From the disappearance rate of lower urinary tract irritation symptoms ( Figure 4 ), at the end of the second week of treatment, most patients were asymptomatic, and the disappearance rate was not significantly different among the three groups, and there was no statistically significant difference between the groups (P>0.05). In the first week, the disappearance rates of lower urinary tract irritation symptoms in the Chinese medicine combination alone treatment group, the pure Western medicine treatment group, and the Chinese and Western medicine combined treatment group were 59.46%, 54.55%, and 72.41%, respectively. The Chinese and Western medicine combined treatment group was significantly higher than the other two groups, and the differences between the three groups were statistically significant (P<0.05). Further pairwise comparisons showed that the differences between the Chinese and Western medicine combined treatment group vs the pure Western medicine treatment group, and the Chinese and Western medicine combined treatment group vs the Chinese medicine combination alone treatment group were statistically significant (P<0.0167). Specific data are shown in Table 9.

[0107] It can be seen that the combined treatment of Chinese and Western medicine with the Chinese herbal composition is more effective than simple Western medicine treatment and treatment with the Chinese herbal composition alone in promoting the disappearance of lower urinary tract irritation symptoms in patients with acute lower urinary tract infection, and shows significant therapeutic effects after one week of treatment.

[0108] Table 9 Analysis of disappearance rate of lower urinary tract irritation symptoms in acute lower urinary tract infection

[0109]

[0110] 3.4. Lower urinary tract irritation symptom score halving rate

[0111] From the perspective of the halving rate of lower urinary tract irritation symptom scores ( Figure 5), and the results were similar to those of the disappearance rate of lower urinary tract irritation symptoms. At the end of the second week of treatment, the vast majority of patients were asymptomatic, and the halving rate was not significantly different among the three groups, and there was no statistically significant difference between the groups (P>0.05). However, in the first week, the halving rates of lower urinary tract irritation symptom scores in the Chinese medicine combination alone treatment group, the pure Western medicine treatment group, and the Chinese and Western medicine combined treatment group were 82.58%, 87.33%, and 95.95%, respectively. The Chinese and Western medicine combined treatment group was significantly higher than the other two groups, and the differences between the three groups were statistically significant (P<0.05). Further pairwise comparisons showed that the differences between the Chinese and Western medicine combined treatment group vs the pure Western medicine treatment group, and the Chinese and Western medicine combined treatment group vs the Chinese medicine combination alone treatment group were statistically significant (P<0.0167). Specific data are shown in Table 10.

[0112] It can be seen that the combined treatment of Chinese and Western medicine with a Chinese herbal composition is more effective than pure Western medicine treatment and treatment with a Chinese herbal composition alone in alleviating lower urinary tract irritation symptoms in patients with acute lower urinary tract infection, and shows significant therapeutic effects after one week of treatment.

[0113] Table 10 Analysis of halving rate of lower urinary tract irritation symptom score in acute lower urinary tract infection

[0114]

[0115] 3.5. Disappearance time of lower urinary tract irritation symptoms

[0116] The median disappearance time of lower urinary tract irritation symptoms in the group treated with Chinese medicine alone was 7.0 days, 7.0 days in the group treated with pure Western medicine, and 6.0 days in the group treated with combined Chinese and Western medicine. The difference between the groups was statistically significant (P<0.0001). Figure 6 and Table 11.

[0117] The results showed that combined Chinese and Western medicine treatment can shorten the course of lower urinary tract irritation symptoms in patients with acute lower urinary tract infection, and the effect is better than pure Western medicine treatment and treatment with a Chinese medicine combination alone.

[0118] Table 11 Survival analysis of the disappearance time of lower urinary tract irritation symptoms in acute lower urinary tract infection (days)

[0119] Observation indicators Individual treatment Pure Western medicine treatment Combination medication n(censoring) 335(12) 359(8) 392(16) Med 7.0 7.0 6.0

[0120] 3.6. Disappearance rate of single symptom of lower urinary tract irritation

[0121] The disappearance rate of single symptoms of lower urinary tract irritation in acute lower urinary tract infection. The results showed that in the first week of treatment, the disappearance rate of single symptoms of frequent urination, urgency, pain, burning sensation in the urethra, dripping after urination and incomplete urination in the combined Chinese and Western medicine treatment group was higher than that in the Chinese medicine combination treatment group and the pure Western medicine treatment group, and the difference between the two groups was statistically significant (P<0.0167); in the first week of treatment, the disappearance rate of single symptom of yellow and red urine in the combined Chinese and Western medicine treatment group was higher than that in the pure Western medicine treatment group, and the difference between the two groups was statistically significant (P<0.0167). In the second week of treatment, except for the disappearance rate of post-urinary dripping, there was no significant difference in the other single symptoms among the three groups (P>0.05) or in further pairwise comparison (P>0.05). There was a significant difference in the post-urinary dripping between the combined Chinese and Western medicine treatment group and the pure Western medicine treatment group, and between the Chinese medicine combination treatment group and the pure Western medicine treatment group (P<0.0167). Specific data are shown in Tables 12 and 13.

[0122] It can be seen that in terms of relieving the single symptom of lower urinary tract irritation, the combined treatment of Chinese and Western medicine has the best effect, which is better than the simple Western medicine treatment and the Chinese medicine combination alone. And the treatment shows significant therapeutic effect after one week.

[0123] Table 12 Disappearance rate of single symptom of lower urinary tract irritation at different time points in patients with acute lower urinary tract infection (%)

[0124]

[0125] Table 13 Disappearance rate of other TCM single symptoms at different time points in patients with acute lower urinary tract infection (%)

[0126]

[0127]

[0128] 3.7 Comparison of the efficacy of Chinese herbal medicine combination in treating acute cystitis and acute urethritis

[0129] Figure 7-Figure 9 The results are the comparison results of the lower urinary tract irritation symptom scores of two groups of people treated with the Chinese medicine composition alone for acute cystitis and acute urethritis. Whether it is the total score of lower urinary tract irritation symptoms, or the halving rate and disappearance rate of the total score, the results of the Chinese medicine composition alone in the treatment of acute cystitis and acute urethritis are basically the same.

[0130] Figure 10-11 The figures are the comparison results of the total score of TCM syndrome and the effective rate of TCM syndrome in two groups of people who were treated with TCM combination alone for acute cystitis and acute urethritis. As can be seen from the figure, whether it is the reduction of the total score of TCM syndrome or the effective rate of TCM syndrome, the results of the two groups are basically the same.

[0131] For acute cystitis and acute urethritis, the comparison results of three groups, namely the Chinese medicine combination treatment group, the pure Western medicine treatment group and the Chinese medicine combination combined Chinese and Western medicine treatment group, showed that the change value, disappearance rate and reduction rate of lower urinary tract irritation symptoms were the best in the Chinese medicine combination combined Chinese and Western medicine treatment group, which were better than the pure Western medicine treatment group and the Chinese medicine combination treatment group; in terms of the effective rate of Chinese medicine syndrome, the Chinese medicine combination combined Chinese and Western medicine treatment group was better than the pure Western medicine treatment group.

[0132] 3.8 Safety Analysis of Acute Lower Urinary Tract Infection

[0133] A safety analysis of acute lower urinary tract infection was also conducted during the study, and the results are shown in Table 14.

[0134] As can be seen from the table: a total of 85 adverse events occurred in 61 patients, of which 68 adverse events occurred in 47 patients in the exposure group with an incidence rate of 6.39%, and 17 adverse events occurred in 14 patients in the non-exposed group with an incidence rate of 3.85%.

[0135] Among the adverse events, 5 patients had 5 serious adverse events, including 4 serious adverse events in 4 patients in the exposure group with an incidence rate of 0.54%, and 1 serious adverse event in 1 patient in the non-exposed group with an incidence rate of 0.27%.

[0136] Among the adverse events, 7 patients experienced 9 adverse reactions, all of which were in the exposure group. The incidence rate was 0.95%.

[0137] Table 14 Safety data of acute lower urinary tract infection

[0138]

[0139] From the above results of this embodiment, it can be seen that: for the main effect indicator of the total score of lower urinary tract irritation symptoms, in the first week of treatment, the Chinese medicine combination combined with Western medicine treatment group decreased by 90.5%, and the reduction was significantly greater than that of the pure Western medicine treatment group (80.23%) and the Chinese medicine combination alone treatment group (77.15%); covariance analysis was performed with the baseline as a covariate to analyze the decrease in the first week of treatment compared with the baseline. The results showed that the Chinese medicine combination combined with Western medicine treatment was better than the pure Western medicine treatment and the Chinese medicine combination alone. At the end of the second week of treatment, the vast majority of patients were asymptomatic, and there was no statistically significant difference among the three groups. Regarding the main effect indicator of TCM syndrome effectiveness, the effectiveness rates of the TCM combination treatment group, the pure Western medicine treatment group and the TCM combination combined Chinese and Western medicine treatment group were 89.49%, 83.47% and 93.92% respectively. There were certain differences among the three groups, and the differences among the groups were statistically significant (P<0.05). In the second week of treatment, the effectiveness rates of TCM syndrome in the three groups of patients were close to or reached 100%, and there was no statistically significant difference among the three groups (P>0.05).

[0140] Among the secondary efficacy indicators, the disappearance rate of lower urinary tract irritation symptoms and the halving rate of scores were higher in the combined Chinese and Western medicine treatment group than in the other two groups after one week of treatment, and the differences between the two groups were statistically significant (P<0.0167). The combined Chinese and Western medicine treatment group was superior to the pure Western medicine treatment group and the Chinese medicine combination treatment group in terms of the disappearance of lower urinary tract irritation symptoms in the treatment of acute lower urinary tract infection (P<0.0167), and the symptom disappearance time could be shortened by 1 day. In the first week of treatment, the disappearance rates of single symptoms of frequent urination, urgency, dysuria, urethral burning sensation, post-urination dripping and incomplete urination in the combined Chinese and Western medicine treatment group were higher than those in the Chinese medicine combination treatment group and the pure Western medicine treatment group, and the differences between the two groups were statistically significant (P<0.0167). The disappearance rate of the single symptom of yellow and red urine in the combined Chinese and Western medicine treatment group was higher than that in the pure Western medicine treatment group, and the differences between the two groups were statistically significant (P<0.0167). At the end of the second week of treatment, most patients were asymptomatic.

[0141] It can be seen that the research results of acute cystitis and acute urethritis are basically consistent with those of acute lower urinary tract infection. The combined treatment group of Chinese and Western medicine with Chinese herbal medicine combination has the best effect, which is better than the pure Western medicine treatment group and the Chinese herbal medicine combination alone treatment group.

[0142] Example 2

[0143] This embodiment is different from Embodiment 1 in that the Chinese medicine composition further comprises auxiliary active ingredients; the auxiliary active ingredients comprise Polygonum cuspidatum, Taraxacum officinale and Alisma orientalis; the mass ratio of Phellodendron chinense, Polygonum cuspidatum, Taraxacum officinale and Alisma orientalis is 16:1.5:1.5:1.

[0144] The preparation method of the Chinese medicine composition provided in this embodiment comprises the following steps:

[0145] (1) Take Phellodendron chinense and boil it in water three times, adding 10-12 times the amount of water each time. Boil it for 1.5 hours for the first time, and 1 hour for the second and third times respectively. Combine the three decoctions and filter.

[0146] (2) Extracting volatile oil from Atractylodes lancea and Glechoma tatarinowii by distillation, encapsulating the volatile oil with B-cyclodextrin, drying and crushing the resulting inclusion compound into coarse powder for later use, and collecting the distilled aqueous solution in another container;

[0147] (3) Extracting Danshen twice with ethanol, adding 5.5 to 6.5 times the volume of 80% ethanol (volume fraction) each time, extracting for 1 hour each time, combining the extracts obtained twice, filtering, recovering ethanol until there is no alcohol taste, and setting aside;

[0148] (4) Mix the residue obtained in the above three steps with Radix Trichosanthis, Herba Patriniae, Semen Plantaginis, Talcum, Poria, Polygonum cuspidatum, Herba Taraxaci and Rhizoma Alismatis, add 10-12 times the amount of water respectively and boil twice, each time for 1.5 hours, combine the decoctions and filter;

[0149] (5) combining the medicinal solutions in the above steps, concentrating them into a thick paste, adding indigo, drying, and crushing to obtain a powdery Chinese medicine composition;

[0150] (6) Adding an excipient to the above powdered Chinese medicine composition to obtain a Chinese medicine composition preparation.

[0151] During the above preparation, each raw material is weighed according to 160g of Phellodendron chinense. Preferably, an excipient is added to prepare a capsule-shaped Chinese medicine composition preparation.

[0152] Example 3

[0153] The present embodiment is different from the embodiment 1 in that the talc is replaced by Tongcao in the Chinese medicine composition. The mass ratio of Psoralea corylifolia, Phellodendron chinense, Patrinia paniculata, Indigo naturalis, Tongcao, Plantago asiatica, Acorus calamus, Poria cocos, Atractylodes macrocephala, and Salvia miltiorrhiza is 1:0.5:1:0.156:0.03:1:0.5:0.5:0.5:1. Tongcao is suitable for people with gastrointestinal sensitivity, has a diuretic effect and is milder.

[0154] The preparation method of the Chinese medicine composition provided in this embodiment comprises the following steps:

[0155] (1) Take Phellodendron chinense and boil it in water three times, adding 10-12 times the amount of water each time. Boil it for 1.5 hours for the first time, and 1 hour for the second and third times respectively. Combine the three decoctions and filter.

[0156] (2) Extracting volatile oil from Atractylodes lancea and Glechoma tatarinowii by distillation, encapsulating the volatile oil with B-cyclodextrin, drying and crushing the resulting inclusion compound into coarse powder for later use, and collecting the distilled aqueous solution in another container;

[0157] (3) Extracting Danshen twice with ethanol, adding 5.5 to 6.5 times the volume of 80% ethanol (volume fraction) each time, extracting for 1 hour each time, combining the extracts obtained twice, filtering, recovering ethanol until there is no alcohol taste, and setting aside;

[0158] (4) Mix the residue obtained in the above three steps with Radix Trichosanthis, Herba Patriniae, Semen Plantaginis, Herba Cynanchum and Poria, add 10 to 12 times the amount of water and boil twice, each time for 1.5 hours, combine the decoctions and filter;

[0159] (5) combining the medicinal solutions in the above steps, concentrating them into a thick paste, adding indigo, drying, and crushing to obtain a powdery Chinese medicine composition;

[0160] (6) Adding an excipient to the above powdered Chinese medicine composition to obtain a Chinese medicine composition preparation.

[0161] During the above preparation, each raw material is weighed according to 160g of Phellodendron chinense. Preferably, an excipient is added to prepare a capsule-shaped Chinese medicine composition preparation.

[0162] For the Chinese medicine compositions of Examples 2 and 3 above, the therapeutic effects on acute lower urinary tract infection were tested with reference to the method of Example 1, and compared with pure Western medicine treatment and Chinese medicine composition alone. After testing, compared with pure Western medicine treatment and Chinese medicine composition alone, the Chinese medicine compositions provided in Examples 2 and 3 and Western medicine combined treatment both have therapeutic effects on acute lower urinary tract infection. In addition, compared with Example 1, the therapeutic effect of the Chinese medicine composition of Example 2 combined with Western medicine on acute lower urinary tract infection is slightly better than that of Example 1, indicating that the addition of Polygonum cuspidatum, Taraxacum officinale and Rhizoma Alismatis can improve the efficacy. The therapeutic effect of the Chinese medicine composition of Example 3 combined with Western medicine on acute lower urinary tract infection is basically the same as the therapeutic effect of Example 1, indicating that the Chinese medicine composition formed after replacing talc with Tongcao can also achieve the treatment of acute lower urinary tract infection.

[0163] Through the above research of the present invention, it can be seen that the three Chinese medicine compositions can effectively treat acute lower urinary tract infection, and each Chinese medicine composition has a better therapeutic effect than Western medicine in terms of the disappearance rate of lower urinary tract irritation symptoms and the effective rate of TCM syndrome of damp-heat obstruction syndrome, especially for relieving symptoms such as frequent urination, urgency and dripping after urination. The effect advantage of Western medicine treatment is also reflected in the faster improvement of lower urinary tract irritation symptoms in patients. However, the treatment effect of the combined treatment of Chinese and Western medicine for acute lower urinary tract infection is significantly better than that of the Chinese medicine composition alone and pure Western medicine treatment in terms of the disappearance rate of lower urinary tract irritation symptoms and the effective rate of TCM syndrome of damp-heat obstruction syndrome, and the symptoms of acute lower urinary tract infection in patients are improved faster. In the course of 2 weeks, only 1 week of treatment shows a significant therapeutic effect. At the same time, in the treatment of acute lower urinary tract infection with Chinese medicine composition, the incidence of adverse reactions is low, which is an occasional adverse reaction, indicating that the safety of the Chinese medicine composition is better. It can be seen that the Chinese medicine composition combined with Western medicine can be promoted and applied in the clinical treatment of acute lower urinary tract infection.

[0164] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention rather than to limit the present invention, although the present invention has been described in detail with reference to the preferred embodiments. It should be understood by those skilled in the art that the technical solutions of the present invention can still be modified or replaced by equivalents, and these modifications or equivalent replacements cannot cause the modified technical solutions to deviate from the spirit and scope of the technical solutions of the present invention.

Claims

1. Use of a Chinese medicine composition combined with a Western medicine in the preparation of a drug for treating acute lower urinary tract infection.

2. Use of a Chinese medicine composition combined with a Western medicine in the preparation of a drug for treating acute lower urinary tract infection by increasing the decrease in the lower urinary tract irritation symptom score.

3. Use of a Chinese medicine composition combined with Western medicine in the preparation of a drug for treating acute lower urinary tract infection by improving the effectiveness of Chinese medicine syndromes.

4. Use of a Chinese medicine composition combined with Western medicine in the preparation of a drug for treating acute lower urinary tract infection by increasing the disappearance rate of lower urinary tract irritation symptoms.

5. Use of a Chinese medicine composition combined with a Western medicine in the preparation of a drug for treating acute lower urinary tract infection by increasing the halving rate of lower urinary tract irritation symptoms.

6. Use of a Chinese medicine composition combined with a Western medicine in the preparation of a drug for treating acute lower urinary tract infection by prolonging the disappearance time of lower urinary tract irritation symptoms.

7. Use of a Chinese medicine composition combined with a Western medicine in the preparation of a drug for treating acute lower urinary tract infection by increasing the disappearance rate of a single symptom of lower urinary tract irritation.

8. The use according to claim 7, characterized in that: The individual symptoms of lower urinary tract irritation include frequent urination, urgent urination, dripping after urination, painful urination, burning sensation in the urethra or incomplete urination.

9. The use according to any one of claims 1 to 8, characterized in that: The traditional Chinese medicine composition includes main active ingredients; the main active ingredients include ophiopogon japonicus, phellodendron chinense, patrinia chinensis, indigo naturalis, talc, plantago seed, calamus tatarinowii, poria, atractylodes lancea and salvia miltiorrhiza; the mass ratio of ophiopogon japonicus, phellodendron chinense, patrinia chinensis, indigo naturalis, talc, plantago seed, calamus tatarinowii, poria, atractylodes lancea and salvia miltiorrhiza is 1:0.5:1:0.156:0.594:1:0.5:0.5:0.5:

1.

10. The use according to claim 9, characterized in that: The Chinese medicine composition also includes auxiliary active ingredients; the auxiliary active ingredients include Polygonum cuspidatum, Taraxacum officinale and Alisma orientale; the mass ratio of Phellodendron chinense, Polygonum cuspidatum, Taraxacum officinale and Alisma orientale is 16:1.5:1.5:

1.

11. The use according to claim 9, characterized in that: In the traditional Chinese medicine composition, talc is replaced by tongcao; the mass ratio of the herb scutellaria, phellodendron chinense, patrinia chinensis, indigo naturalis, tongcao, plantago seed, calamus tatarinowii, poria, atractylodes and salvia miltiorrhiza is 1:0.5:1:0.156:0.03:1:0.5:0.5:0.5:1.

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