Application of traditional Chinese medicine composition in preparation of medicine for treating lower urinary tract stimulation symptom

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 lower urinary tract stimulation symptoms. The traditional Chinese medicine composition can improve the lower urinary tract stimulation symptom score decline value, the lower urinary tract stimulation symptom disappearance rate, the lower urinary tract stimulation symptom halving rate, the lower urinary tract stimulation symptom disappearance time and the lower urinary tract stimulation single symptom disappearance rate, has a good curative effect on the lower urinary tract stimulation symptom, and expands the indication range of the traditional Chinese medicine composition; no side effect exists, and the safety is good.

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 lower urinary tract irritation symptoms. Background Art

[0002] Lower urinary tract irritation signs (or urinary tract irritation symptoms) refer to a group of common clinical symptoms caused by lower urinary tract related diseases, including frequent urination, urgency, pain, incomplete urination, and burning sensation during urination, etc., which are caused by irritation of the bladder neck and bladder triangle. At present, for the treatment of lower urinary tract irritation symptoms, in addition to actively treating the primary disease, while controlling the infection or treating other causes, drugs are often needed to relieve the symptoms of lower urinary tract irritation and improve the patient's quality of life. However, in the current clinical evaluation, the type of disease is determined first, and then the treatment method is selected according to the cause; and the treatment method is mainly antibiotics. Although it can relieve or improve lower urinary tract irritation symptoms to a certain extent, the abuse of antibiotics has not only made the situation of drug-resistant strains insensitive to more and more cases, but also caused repeated attacks of the disease, leading to clinical treatment failure and the inability to effectively treat the disease; and the excessive use of antibiotics will also cause side effects on the body.

[0003] In addition, in the study of TCM disease-syndrome integration, the mainstream of TCM is still "unifying syndromes with diseases", but the diseases at this time are no longer "diseases" in traditional TCM; therefore, if we only unify TCM syndromes with Western medicine diseases, we cannot well reflect the common TCM pathogenesis of TCM diseases in the development process, thus ignoring the unity of homogeneity and heterogeneity between disease syndromes. Because for TCM, when the pathogenesis is similar but the condition is different, the traditional TCM principle of different diseases with different syndromes and similar diseases with similar treatments should be followed in the understanding and treatment. Therefore, in recent years, "unifying diseases with syndromes" has become a hot field in TCM theoretical research, and its role in TCM diagnosis, TCM treatment, TCM discipline classification and other fields is gradually attracting the attention of scholars.

[0004] Therefore, how to expand the scope of Chinese medicine products in improving or treating lower urinary tract irritation symptoms based on the traditional Chinese medicine idea of ​​"treating diseases by symptoms" is an issue that needs to be urgently addressed. Summary of the invention

[0005] In view of the technical problems that the abuse of antibiotics in the existing treatment of lower urinary tract irritation symptoms 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 of a Chinese medicine composition in the preparation of a drug for treating lower urinary tract irritation symptoms.

[0006] The present invention is based on the idea of ​​"treating diseases by syndrome" in traditional Chinese medicine, and through research, it is found that the Chinese medicine composition has a good therapeutic effect on lower urinary tract irritation symptoms, thereby expanding the scope of indications of the Chinese medicine composition, and has no side effects and good safety.

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

[0008] Application of a traditional Chinese medicine composition in preparing a medicine for treating lower urinary tract irritation symptoms.

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

[0010] A Chinese medicine composition is used in preparing a medicine for treating lower urinary tract irritation symptoms by improving the effective rate of Chinese medicine syndromes.

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

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

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

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

[0015] It is further defined that the lower urinary tract irritation symptoms include at least one of frequent urination, urgent urination, painful urination and urethral burning sensation.

[0016] 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.

[0017] It is further defined that in the Chinese medicine composition, talc is replaced with tongcao; the mass ratio of fennel, phellodendron chinense, patrinia scabra, indigo, tongcao, plantago, calamus, poria, atractylodes 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.

[0018] 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.

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

[0020] 1. The present invention studies the effectiveness of the Chinese medicine composition in treating lower urinary tract irritation symptoms, indicating that the Chinese medicine composition is effective in treating lower urinary tract irritation symptoms, thereby expanding the scope of indications of the Chinese medicine composition and providing a parallel idea and method for the Chinese medicine composition in the diagnosis and treatment of complex diseases; and the Chinese medicine composition is a Chinese medicinal material, has no side effects on the body, and has good safety.

[0021] 2. The present invention is based on the traditional Chinese medicine idea of ​​"treating diseases by syndrome", focusing on patients' lower urinary tract irritation symptoms such as frequent urination and urgency, rather than just treating specific diseases. It improves the targeted treatment and effect, expands the scope of indications of the Chinese medicine composition, and has clinical and therapeutic guiding significance for lower urinary tract irritation symptoms.

[0022] 3. The present invention adopts the prospective cohort study design with the highest level of evidence in real-world research, which is closer to clinical practice and has stronger extrapolation of research results; saw palmetto fruit extract soft capsules (Sabate) are selected as the positive control drug. As a botanical drug, the composition and effect of this drug are closer to traditional Chinese medicine. Both the composition of the present invention and Sabate can effectively treat lower urinary tract irritation symptoms, and the therapeutic effect of the composition of the present invention in terms of the disappearance rate of lower urinary tract irritation symptoms, the effective rate of TCM syndrome of damp-heat obstruction syndrome, and the decrease value of chronic prostatitis symptom score (NIH-CPSI) are better than Sabate, especially for relieving symptoms such as frequent urination, urgency and dripping after urination. The effect advantage over Sabate is also reflected in the ability to improve patients' lower urinary tract irritation symptoms faster (i.e., significantly shorten the course of the disease). The composition of the present invention and conventional Western medicine treatment can both effectively treat lower urinary tract irritation symptoms, and the composition of the present invention alone is equivalent to Western medicine treatment alone.

[0023] 4. The present invention found in the study that compared with the baseline, the Chinese medicine composition can increase the decrease value of the lower urinary tract irritation symptom score; the Chinese medicine composition can also improve the effective rate of TCM syndromes. This shows that the Chinese medicine composition has a good effect in improving lower urinary tract irritation symptoms and TCM syndromes.

[0024] 5. The present invention has found in the research that the Chinese medicine composition can increase the disappearance rate and the halving rate of lower urinary tract irritation symptoms, and increase the disappearance time of lower urinary tract irritation symptoms, which further verifies that the Chinese medicine composition has the best effect in improving lower urinary tract irritation symptoms and shortening the course of the disease.

[0025] 6. The present invention has found in research that the Chinese medicine composition can improve the disappearance rate of single symptoms of lower urinary tract irritation, especially the disappearance rate of lower urinary tract irritation symptoms such as frequent urination, urgent urination, dripping after urination, painful urination, urethral burning sensation, incomplete urination, yellow and red urine, wet scrotum and abdominal pain and refusal to press. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 is the change in the lower urinary tract irritation symptom score of the patient during the observation period in Example 1;

[0027] Figure 2 is the change in the total score of TCM syndromes of the two groups of patients during the observation period in Example 1;

[0028] Figure 3 The effective rate of TCM syndromes of the two groups of patients at different time points in Example 1;

[0029] Figure 4 is the disappearance rate of lower urinary tract irritation symptoms in the patients during the observation period in Example 1;

[0030] Figure 5 The halving rate of the lower urinary tract irritation symptom score of the patient in Example 1 during the observation period;

[0031] Figure 6 is the change in the total NIH-CPSI score of the two groups of patients in Example 1;

[0032] Figure 7 is the change in pain or discomfort score of NIH-CPSI of the two groups of patients in Example 1;

[0033] Figure 8 is the change in NIH-CPSI urination symptom scores of the two groups of patients in Example 1;

[0034] Fig. 9 is the change in NIH-CPSI symptom severity scores of the two groups of patients in Example 1;

[0035] Fig.10 The changes in the NIH-CPSI quality of life scores of the two groups of patients in Example 1;

[0036] Fig.11 The survival curve of the disappearance time (days) of lower urinary tract irritation symptoms in Example 1;

[0037] Fig.12 is the change in the lower urinary tract irritation symptom score of the patient during the observation period in Example 2;

[0038] Fig.13 is the change in the total score of TCM syndromes of the patient during the observation period in Example 2;

[0039] Fig.14The effective rate of TCM syndromes of the patients at different time points in Example 2;

[0040] Fig.15 is the disappearance rate of lower urinary tract irritation symptoms in the patients during the observation period in Example 2;

[0041] Fig.16 The halving rate of the lower urinary tract irritation symptom score of the patient during the observation period in Example 2;

[0042] Fig.17 The survival curve of the disappearance time (days) of lower urinary tract irritation symptoms in Example 2;

[0043] Fig.18 Changes in the irritation symptom scores of acute cystitis and acute urethritis treated with the Chinese medicine composition alone;

[0044] Fig.19 The halving rate of the irritation symptom score of acute cystitis and urethritis treated with the Chinese medicine composition alone;

[0045] Fig. 20 The disappearance rate of irritation symptoms of acute cystitis and urethritis treated with the Chinese medicine composition alone;

[0046] Fig.21 The total score of TCM syndromes in patients with acute cystitis and urethritis treated with TCM combination alone during the observation period;

[0047] Fig. 22 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

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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, and Atractylodes, which have the effects of clearing turbidity, relieving stranguria, clearing away heat and promoting diuresis. The prior art shows that the Chinese medicine composition can be used for the treatment of chronic prostatitis (CP). However, the scope of indications of the Chinese medicine composition is relatively single, so expanding the scope of indications of the Chinese medicine composition is an urgent problem that needs to be further solved by the Chinese medicine composition.

[0053] Most lower urinary tract irritation symptoms are caused by urinary tract infection, non-infectious inflammation and physical and chemical factors, including cystitis, urethritis, pyelonephritis, bladder stones / urethral stones, lower ureteral stones, urinary tuberculosis, interstitial cystitis, bladder cancer, urethral tumors, neurogenic bladder, vaginitis / cervicitis and other diseases. The research design idea of ​​the present invention is: adopt the concept of "unifying diseases by syndromes" to explore the therapeutic effect of Chinese medicine compositions on lower urinary tract irritation symptoms (frequent urination, urgency, urinary pain, urethral burning sensation), so as to expand the scope of indications of Chinese medicine compositions.

[0054] 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.

[0055] 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.

[0056] Example 1

[0057] This example mainly verifies the effectiveness of the Chinese medicine composition in treating chronic prostatitis with lower urinary tract irritation symptoms (frequent urination, urgent urination, painful urination and / or urethral burning).

[0058] 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.

[0059] The preparation method of the Chinese medicine composition provided in this embodiment comprises the following steps:

[0060] (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.

[0061] (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;

[0062] (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;

[0063] (4) Mix the residue obtained in the above three steps with Radix Psoraleae, Herba Patriniae, Semen Plantaginis, Talc, 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;

[0064] (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;

[0065] (6) Adding an excipient to the above powdered Chinese medicine composition to obtain a Chinese medicine composition preparation.

[0066] Preferably, excipients are added to prepare a capsule-shaped Chinese medicine composition preparation.

[0067] 1. Research subjects

[0068] A total of 480 patients were included, including 360 patients in the TCM combination treatment group and 120 patients in the Saw Palmetto Fruit Extract (Sabat) treatment group. There were 17 patients in the TCM combination treatment group and 7 patients in the Sabat treatment group who violated the study protocol. A total of 343 patients in the TCM combination treatment group and 113 patients in the Sabat treatment group were included in the efficacy analysis.

[0069] 1.1. Conditions of the research subjects

[0070] (1) Having lower urinary tract irritation symptoms (frequent urination, urgency, dysuria and / or urethral burning);

[0071] (2) People clinically diagnosed with chronic prostatitis;

[0072] (2) The TCM syndrome differentiation is consistent with the syndrome of “damp-heat obstruction”;

[0073] (3) Age ≥18 years;

[0074] (4) Exclude urinary tract obstruction caused by stones, tumors, urethral stenosis / congenital malformations, and neurogenic cystitis.

[0075] 1.2 Characteristics of the research subjects

[0076] 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 .

[0077] Table 1 Characteristics of the subjects in Example 1

[0078] Chinese medicine combination treatment cohort (n=343) Sabat treatment cohort (n=113) Age (years) 45.17±15.22 46.03±15.63 Height (cm) 172.51±5.99 171.97±5.82 Weight(kg) 71.49±9.62 72.61±9.59 Body temperature(℃) 36.40±0.21 36.38±0.20 Heart rate (beats / min) 74.17±8.90 72.37±9.19 Breathing (times / min) 19.24±1.24 19.34±1.07 Systolic blood pressure (mmHg) 123.58±8.53 124.17±9.24 Diastolic blood pressure (mmHg) 79.35±7.39 80.14±8.37

[0079] As can be seen from the above table: the average age of the patients is about 45 years old, and there are no statistically significant differences in age, height, weight, etc. between the two treatment cohorts of the Chinese medicine composition and Sabate. Most of the patients' vital signs were normal when they were treated. There was not much difference in body temperature, heart rate, blood pressure and respiration between the two groups, and the difference was not statistically significant (P>0.05). There was a statistically significant difference in the resting heart rate (beats / min) between the two groups (P<0.05). The physical examination of the whole body was normal except for the urinary system (19.53% and 17.70% of the Chinese medicine composition treatment cohort and Sabate treatment cohort were abnormal) or cardiovascular system of individual patients. There was no difference between the two groups, and the difference was not statistically significant (P>0.05).

[0080] 1.3 Disease conditions of the two groups of patients

[0081] Table 2 shows the analysis results of the disease conditions of the two groups of patients. The baseline disease conditions of the patients in each group were quite consistent and comparable, and there were no statistically significant differences in the inter-group comparison results (P>0.05).

[0082] Table 2 Conditions of two groups of patients in Example 1

[0083]

[0084] Tables 3 and 4 show the results of the efficacy index analysis of the two groups of patients. It can be seen from the table that the baseline TCM syndrome scores, TCM single symptom scores, NIH-CPSI scores and NIH-CPSI total scores of the two groups are quite consistent and comparable, and there is no statistically significant difference in the comparison results between the two groups (P>0.05).

[0085] Table 3 The total score of TCM syndrome and the severity of individual symptoms in the two groups of patients in Example 1

[0086]

[0087]

[0088] Table 4 NIH-CPSI scores of two groups of patients in Example 1

[0089] Observation indicators Chinese medicine combination treatment cohort (n=343) Sabat treatment cohort (n=113) Pain or discomfort symptom score 9.71±2.90 9.95±2.75 Voiding Symptom Score 4.85±1.87 4.88±1.90 Symptom severity score 14.56±4.04 14.83±3.74 Quality of life score 7.89±1.92 7.81±1.84 NIH-CPSI Overall Score 22.45±5.35 22.65±5.10

[0090] 2. Medication status of the two groups of patients

[0091] Table 5 shows the drug treatment of the two groups 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 the drug dosage, medication days, and combined medication between the two groups during the observation period, and the differences between the two groups were not statistically significant (P>0.05).

[0092] Table 5 Drug treatment of two groups of patients during the observation period in Example 1

[0093]

[0094] 3. Results

[0095] 3.1. Lower urinary tract irritation symptom score

[0096] Figure 1 The changes in the lower urinary tract irritation symptom scores of the two groups of patients at different time points during the observation period. In the second week of treatment, the lower urinary tract irritation symptom scores of the Chinese medicine combination treatment group and the Shabat treatment group were 6.98 points and 7.38 points, respectively, and there was no significant difference between the two groups (P>0.05). In the fourth week of treatment, the lower urinary tract irritation symptom scores of the Chinese medicine combination treatment group and the Shabat treatment group were 2.68 points and 3.54 points, respectively; in the eighth week of treatment, the lower urinary tract irritation symptom scores of the Chinese medicine combination treatment group and the Shabat treatment group were 0.57 points and 0.94 points, respectively, and there were significant differences between the two groups (P<0.05).

[0097] Compared with the baseline, the scores of lower urinary tract irritation symptoms in the Chinese medicine composition treatment group and the Sabat treatment group gradually decreased at the 2nd, 4th, and 8th week of treatment, and the differences before and after treatment at each visit point in the two groups were statistically significant (P<0.05). The changes in the scores of lower urinary tract irritation symptoms in the Chinese medicine composition treatment group at the 2nd, 4th, and 8th week of treatment were 3.82±2.85, 8.08±3.38, and 10.16±3.09 points, respectively, which were slightly higher than 3.38±2.85, 7.15±3.94, and 9.67±3.44 points in the Sabat treatment group, respectively. There was no statistically significant difference between the groups at each visit point (P>0.05). Specific data are shown in Tables 6 and 7.

[0098] It can be seen that both the Chinese herbal composition and Sabat are effective in improving patients' lower urinary tract irritation symptoms, and the Chinese herbal composition may have a better effect trend than Sabat.

[0099] Table 6 Analysis of lower urinary tract irritation symptoms in Example 1

[0100]

[0101] Table 7 Results of disappearance of lower urinary tract irritation symptoms in Example 1

[0102] Observation indicators Chinese medicine combination treatment cohort Sabat two treatment cohort n(Missing) 339(4) 113(0) Disappeared n(%) 280(82.60) 89(78.76) Not disappeared n (%) 59(17.40) 24(21.24)

[0103] 3.2 TCM Syndrome Scoring

[0104] Figure 2 and Figure 3 These are the changes in the average total score of TCM syndromes and the effective rate of TCM syndromes in the patients in the TCM combination treatment group and the Sabat treatment group at different time points.

[0105] Compared with the baseline, the total score of TCM syndrome in the TCM combination treatment group and the Shabat treatment group gradually decreased in the 2nd, 4th and 8th weeks of treatment, and the differences before and after treatment in each visit point of the two groups were statistically significant (P<0.05). In the 2nd week of treatment, the total score of TCM syndrome in the TCM combination treatment group and the Shabat treatment group was 9.68 points and 10.27 points, respectively, and there was no statistically significant difference between the two groups (P>0.05). In the 4th week of treatment, the total score of TCM syndrome in the TCM combination treatment group and the Shabat treatment group was 3.89 points and 5.39 points, respectively; in the 8th week of treatment, the total score of TCM syndrome in the TCM combination treatment group and the Shabat treatment group was 0.79 points and 1.20 points, respectively, and there was a statistically significant difference between the two groups (P<0.05).

[0106] In the second week of treatment, the effective rates of TCM syndrome in the Chinese medicine combination treatment group and the Shabat treatment group were 29.03% and 27.43%, respectively; in the eighth week of treatment, the effective rates of TCM syndrome in the Chinese medicine combination treatment group and the Shabat treatment group were 98.72% and 96.26%, respectively, and there was no significant difference between the two groups (P>0.05). In the fourth week of treatment, the effective rates of TCM syndrome in the Chinese medicine combination treatment group and the Shabat treatment group were 89.41% and 77.27%, respectively, and there was a significant difference between the two groups (P<0.05). See Tables 8 and 9 for specific data.

[0107] It can be seen that both the Chinese medicine combination and Sabat can effectively improve the patients' traditional Chinese medicine symptoms, especially in the fourth week, the effect of the Chinese medicine combination was better than Sabat.

[0108] Table 8 Analysis of TCM Syndrome Efficacy in Example 1

[0109]

[0110] Table 9 TCM syndrome effective rate of Example 1

[0111]

[0112]

[0113] 3.3. Disappearance rate of lower urinary tract irritation symptoms

[0114] In the second week of treatment, the disappearance rates of lower urinary tract irritation symptoms in the Chinese medicine combination treatment group and the Shabat treatment group were 0.88% and 0%, respectively; in the fourth week of treatment, the disappearance rates of lower urinary tract irritation symptoms in the Chinese medicine combination treatment group and the Shabat treatment group were 36.99% and 30.91%, respectively, and there was no significant difference between the groups (P>0.05). In the eighth week of treatment, the disappearance rates of lower urinary tract irritation symptoms in the Chinese medicine combination treatment group and the Shabat treatment group were 81.07% and 69.47%, respectively, and there was a significant difference between the groups (P<0.05). For specific data, see Figure 4 , Table 10.

[0115] It can be seen that both the Chinese herbal composition and Sabat can promote the disappearance of lower urinary tract irritation symptoms, and as the treatment time increases, the therapeutic effect of the Chinese herbal composition is better than that of Sabat.

[0116] Table 10 Analysis of the disappearance rate of lower urinary tract irritation symptoms in Example 1

[0117]

[0118] 3.4. Lower urinary tract irritation symptom score halving rate

[0119] In the second week of treatment, the halving rates of the lower urinary tract irritation symptom scores in the Chinese medicine combination treatment group and the Shabat treatment group were 37.54% and 33.93%, respectively; in the fourth week of treatment, the halving rates of the lower urinary tract irritation symptom scores in the Chinese medicine combination treatment group and the Shabat treatment group were 84.01% and 76.36%, respectively; in the eighth week of treatment, the halving rates of the lower urinary tract irritation symptom scores in the Chinese medicine combination treatment group and the Shabat treatment group were 97.50% and 95.79%, respectively. There was no significant difference between the groups (P>0.05). For specific data, see Figure 5 and Table 11.

[0120] It can be seen that both the Chinese medicine combination and Sabat can effectively relieve the symptoms of lower urinary tract irritation, and the effect of relieving symptoms becomes more obvious as the treatment time prolongs.

[0121] Table 11 Analysis of the halving rate of lower urinary tract irritation symptom scores in Example 1

[0122]

[0123] 3.5. Symptom Index (NIH-CPSI)

[0124] NIH-CPSI consists of three parts, which respectively evaluate the pain or discomfort caused by chronic prostatitis, urination symptoms, and the impact on quality of life, including pain or discomfort, urination symptoms, symptom severity and quality of life. Figure 6-Figure 10 They are the NIH-CPSI total score and the four parts of the score results.

[0125] NIH-CPSI total score: Compared with the baseline, the NIH-CPSI total scores of the Chinese medicine composition treatment group and the Sabat treatment group gradually decreased at the 2nd, 4th, and 8th week of treatment, and the differences before and after treatment at each visit point of the two groups were statistically significant (P<0.05). At the 2nd week of treatment, the NIH-CPSI total scores of the Chinese medicine composition treatment group and the Sabat treatment group were 17.26±5.62 and 17.96±4.71, respectively; at the 8th week of treatment, the NIH-CPSI total scores of the Chinese medicine composition treatment group and the Sabat treatment group were 4.27±4.90 and 5.73±5.70, respectively, and there was no statistically significant difference between the groups (P>0.05). At the 4th week of treatment, the NIH-CPSI total scores of the Chinese medicine composition treatment group and the Sabat treatment group were 10.61±5.71 and 12.66±6.05, respectively, and there was a statistically significant difference between the groups (P<0.05).

[0126] Pain or discomfort: Compared with the baseline, the NIH-CPSI pain or discomfort symptom scores of the Chinese medicine composition treatment group and the Sabat treatment group gradually decreased at the 2nd, 4th, and 8th week of treatment, and the differences before and after treatment at each visit point between the two groups were statistically significant (P<0.05). At the 2nd week of treatment, the NIH-CPSI pain or discomfort symptom scores of the Chinese medicine composition treatment group and the Sabat treatment group were 7.31±3.18 and 7.55±2.94, respectively; at the 4th week of treatment, the NIH-CPSI pain or discomfort symptom scores of the Chinese medicine composition treatment group and the Sabat treatment group were 4.16±3.01 and 4.67±3.01, respectively; at the 8th week of treatment, the NIH-CPSI pain or discomfort symptom scores of the Chinese medicine composition treatment group and the Sabat treatment group were 1.36±2.12 and 1.51±2.08, respectively, and there were no statistically significant differences between the groups (P>0.05).

[0127] Urinary symptoms: Compared with the baseline, the NIH-CPSI urination symptom scores of the Chinese medicine composition treatment group and the Sabat treatment group gradually decreased at the 2nd, 4th, and 8th week of treatment, and the differences before and after treatment at each visit point of the two groups were statistically significant (P<0.05). At the 2nd week of treatment, the NIH-CPSI urination symptom scores of the Chinese medicine composition treatment group and the Sabat treatment group were 3.55±1.77 and 3.99±1.69, respectively; at the 4th week of treatment, the NIH-CPSI urination symptom scores of the Chinese medicine composition treatment group and the Sabat treatment group were 2.19±1.53 and 2.92±1.75, respectively; at the 8th week of treatment, the NIH-CPSI urination symptom scores of the Chinese medicine composition treatment group and the Sabat treatment group were 0.98±1.28 and 1.55±1.83, respectively, and the differences between the groups were statistically significant (P<0.05).

[0128] Symptom severity: Compared with the baseline, the NIH-CPSI symptom severity scores of the Chinese medicine composition treatment group and the Sabat treatment group gradually decreased at the 2nd, 4th, and 8th week of treatment, and the differences before and after treatment at each visit point of the two groups were statistically significant (P<0.05). At the 2nd week of treatment, the NIH-CPSI symptom severity scores of the Chinese medicine composition treatment group and the Sabat treatment group were 10.87±4.29 and 11.54±3.65, respectively; at the 8th week of treatment, the NIH-CPSI symptom severity scores of the Chinese medicine composition treatment group and the Sabat treatment group were 2.34±3.08 and 3.07±3.40, respectively, and there was no statistically significant difference between the groups (P>0.05). At the 4th week of treatment, the NIH-CPSI symptom severity scores of the Chinese medicine composition treatment group and the Sabat treatment group were 6.35±4.02 and 7.59±4.29, respectively, and there were statistically significant differences between the groups (P<0.05).

[0129] Quality of life: Compared with the baseline, the NIH-CPSI quality of life impact scores of the Chinese medicine composition treatment group and the Sabat treatment group gradually decreased at the 2nd, 4th, and 8th week of treatment, and the differences before and after treatment at each visit point of the two groups were statistically significant (P<0.05). At the 2nd week of treatment, the NIH-CPSI quality of life impact scores of the Chinese medicine composition treatment group and the Sabat treatment group were 6.39±2.02 and 6.42±1.79, respectively, and there was no statistically significant difference between the two groups (P>0.05). At the 4th week of treatment, the NIH-CPSI quality of life impact scores of the Chinese medicine composition treatment group and the Sabat treatment group were 4.24±2.19 and 5.07±2.20, respectively; at the 8th week of treatment, the NIH-CPSI quality of life impact scores of the Chinese medicine composition treatment group and the Sabat treatment group were 1.93±2.17 and 2.66±2.55, respectively, and there was a statistically significant difference between the two groups (P<0.05). Specific data are shown in Table 12.

[0130] It can be seen that both the Chinese medicine composition and Sabat can effectively improve the lower urinary tract irritation symptoms of chronic prostatitis. Compared with Sabat, the Chinese medicine composition is more effective in relieving the lower urinary tract irritation symptoms, which is mainly reflected in the improvement of urination symptoms and quality of life.

[0131] Table 12 Analysis of scores of lower urinary tract irritation symptoms in Example 1

[0132]

[0133]

[0134]

[0135] 3.6. Time for lower urinary tract irritation symptoms to disappear

[0136] The median disappearance time of lower urinary tract irritation symptoms in the Chinese medicine combination treatment group and the Sabat treatment group was 40 days and 43 days, respectively. The Chinese medicine combination treatment group could shorten the course of disease by 3 days. The difference between the two groups was statistically significant (P<0.05). For specific data, see Fig.11 and Table 13.

[0137] The results showed that both the Chinese herbal composition and Sabat could effectively shorten the course of lower urinary tract irritation symptoms, and the Chinese herbal composition was faster than Sabat.

[0138] Table 13 Survival analysis of the disappearance time (days) of lower urinary tract irritation symptoms in Example 1

[0139] Observation indicators Chinese medicine combination treatment cohort Sabat treatment cohort n(Missing) 339(57) 113(26) Time (day) 40 43

[0140] 3.7. Disappearance rate of single symptom of lower urinary tract irritation

[0141] From the disappearance rate of different lower urinary tract irritation symptoms in patients with chronic prostatitis, the disappearance rate of each lower urinary tract irritation symptom in the second week was not much different between the two groups (P>0.05); by the fourth week, the disappearance rates of frequent urination, urgency and post-urination dripping in the Chinese medicine combination group reached 52.34%, 58.26% and 54.95%, respectively, which were more than 10 percentage points higher than those in the Sabat treatment group, and the difference between the groups was statistically significant (P<0.05); by the eighth week, the disappearance rates of frequent urination and urgency were statistically significant between the groups (P<0.05), and there was no statistically significant difference between the other symptoms (P>0.05). Specific data are shown in Tables 14 and 15.

[0142] It can be seen that the Chinese herbal composition and Shabat can both play a role in relieving lower urinary tract irritation symptoms such as frequent urination, urgency, pain when urinating and urethral burning sensation in patients with chronic prostatitis, and compared with Shabat, the Chinese herbal composition may be more effective in improving the single symptoms of frequent urination, urgency and dripping after urination.

[0143] Table 14 Disappearance rate of single symptom of lower urinary tract irritation at different time points in Example 1 (%)

[0144]

[0145] Table 15 Disappearance rate of other TCM single symptoms at different time points in Example 1 (%)

[0146]

[0147] 3.8 Security Analysis

[0148] During the study, a safety analysis of patient treatment was also conducted, and the results are shown in Table 16.

[0149] A total of 86 patients experienced 128 adverse events, including 99 events in 66 patients in the Chinese medicine combination cohort, with an adverse event incidence of 18.86%, and 29 events in 20 patients in the Sabat cohort, with an adverse event incidence of 17.09%. There was no significant difference between the two groups.

[0150] Among the adverse events, 9 patients suffered from 10 serious adverse events, including 8 serious adverse events in 7 patients in the Chinese medicine combination cohort with an incidence rate of 2.00%, and 2 serious adverse events in 2 patients in the Sabat cohort with an incidence rate of 1.71%. There was no statistically significant difference between the groups.

[0151] Among the adverse events, 17 patients experienced 20 adverse reactions. Among them, 16 adverse reactions occurred in 13 patients in the Chinese medicine combination cohort, with an incidence rate of 3.71%, and 4 adverse reactions occurred in 4 patients in the Sabat cohort, with an incidence rate of 3.42%. There was no statistically significant difference between the groups.

[0152] Table 16 Safety analysis data in Example 1

[0153]

[0154] In summary, when the Chinese medicine composition of this embodiment is used to treat patients with chronic prostatitis with lower urinary tract irritation symptoms, it can be seen from the two main efficacy indicators of lower urinary tract irritation symptom score and TCM syndrome effectiveness that with the extension of treatment time, the lower urinary tract irritation symptom scores of the Chinese medicine composition treatment group and the Sabat treatment group both showed a gradual downward trend. The decrease values ​​of the scores compared with the baseline at the 2nd, 4th, and 8th weeks of treatment were 3.82±2.85, 8.08±3.38, and 10.16±3.09 points in the Chinese medicine composition treatment group, respectively, which were slightly higher than 3.38±2.85, 7.15±3.94, and 9.67±3.44 points in the Sabat treatment group, respectively. At the 4th week, the difference between the two groups was most obvious, and there was no statistically significant difference between the groups at each visit point (P>0.05). The effective rate of TCM syndrome was 89.41% in the Chinese medicine combination treatment group at the 4th week of treatment, which was significantly higher than the 77.27% in the Sabat treatment group. The difference between the two groups was statistically significant (P<0.05).

[0155] Secondary efficacy indicators: the disappearance rate of lower urinary tract irritation symptoms at the 8th week of treatment was 81.07% in the Chinese medicine combination treatment group, which was significantly higher than 69.47% in the Sabat treatment group, and the difference between the groups was statistically significant (P<0.05); the halving rate of lower urinary tract irritation symptoms in the Chinese medicine combination treatment group was slightly higher than that in the Sabat treatment group at the 2nd, 4th and 8th weeks of treatment. The difference between the two groups was most obvious at the 4th week, and there was no statistically significant difference between the groups at each visit point (P>0.05); the decrease in the average NIH-CPSI total score in the Chinese medicine combination treatment group was better than that in the Sabat treatment group (P<0.05), which was mainly reflected in the improvement of urination symptoms and quality of life; the Chinese medicine combination is superior to Sabat in the disappearance of lower urinary tract irritation symptoms in the treatment of chronic prostatitis, and can shorten the course of the disease by 3 days, and the difference between the groups was statistically significant (P<0.05). In the fourth week of treatment, the disappearance rates of frequent urination, urgency and post-micturition dripping in the Chinese medicine combination treatment group were significantly higher than those in the Sabat treatment group, and the differences between the groups were statistically significant (P<0.05).

[0156] It can be seen that both the Chinese herbal composition and Shabat have effective therapeutic effects on lower urinary tract irritation symptoms, and the Chinese herbal composition is superior to Shabat in terms of the disappearance rate of lower urinary tract irritation symptoms, the effective rate of TCM syndrome of damp-heat obstruction syndrome, and the decrease value of chronic prostatitis symptom score (NIH-CPSI), especially for relieving lower urinary tract irritation symptoms such as frequent urination, urgency and dripping after urination. At the same time, compared with the Shabat group, the Chinese herbal composition can shorten the treatment time and improve the patient's lower urinary tract irritation symptoms more quickly.

[0157] Example 2

[0158] This example mainly verifies the effectiveness and clinical effect of the Chinese medicine composition in treating acute lower urinary tract infection (cystitis, urethritis) with lower urinary tract irritation symptoms (frequent urination, urgency, urination pain and / or urethral burning).

[0159] In this embodiment, the Chinese medicine composition is composed of Radix Trichosanthis, Phellodendron chinense, Herba Patriniae, Indigo Naturalis, Talcum, Semen Plantaginis, Acorus Graminus, Poria, Atractylodes and Salvia miltiorrhiza in a mass ratio of 1:0.5:1:0.156:0.594:1:0.5:0.5:0.5:1.

[0160] The preparation method of the Chinese medicine composition provided in this embodiment comprises the following steps:

[0161] (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.

[0162] (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;

[0163] (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;

[0164] (4) Mix the residue obtained in the above three steps with Radix Psoraleae, Herba Patriniae, Semen Plantaginis, Talc, 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;

[0165] (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;

[0166] (6) Adding an excipient to the above powdered Chinese medicine composition to obtain a Chinese medicine composition preparation.

[0167] Preferably, excipients are added to prepare a capsule-shaped Chinese medicine composition preparation.

[0168] 1. Research subjects

[0169] Patients with acute lower urinary tract infection were selected and then divided into two groups: a Chinese medicine combination treatment group (exposed group) with 338 cases and a pure Western medicine treatment group (non-exposed group) with 363 cases.

[0170] In this example, the effects of the two groups, a Chinese medicine composition treatment group and a pure Western medicine treatment group, were analyzed.

[0171] In this embodiment, the drugs used in pure western medicine treatment include: (1) quinolones: levofloxacin, ciprofloxacin, moxifloxacin or norfloxacin; (2) cephalosporins: cefaclor, cefuroxime axetil, cefdinir or cefixime; (3) penicillins: amoxicillin or amoxicillin-clavulanate potassium.

[0172] 1.1. Conditions of the research subjects

[0173] In this embodiment, the research subjects meet the following conditions:

[0174] (2) lower urinary tract irritation symptoms (frequent urination, urgency, dysuria, and / or urethral burning);

[0175] (2) People who are clinically diagnosed with acute cystitis or urethritis (excluding gonococcal urethritis);

[0176] (3) TCM syndrome differentiation is consistent with "damp-heat obstruction syndrome";

[0177] (4) Age ≥18 years;

[0178] (5) Exclude urinary tract obstruction caused by stones, tumors, urethral stenosis / congenital malformation, and neurogenic cystitis.

[0179] 1.2 Characteristics of the research subjects

[0180] The demographic characteristics (age, height, weight) and vital signs (temperature, heart rate, blood pressure, respiration and physique) of the study subjects are shown in Table 17 below.

[0181] Table 17 Characteristics of the subjects in Example 2

[0182]

[0183] As can be seen from the table above, the average age of the two groups of patients was around 45 years old. There was no clinical significance in the differences in age, gender, height, weight, etc. between the two groups of patients. Most of the vital signs of the two groups of patients were normal (average body temperature 36.4℃, heart rate about 76 times / min, respiration 19 times / min, etc.), and there was no clinical significance in the differences in body temperature, heart rate, blood pressure, respiration and physical examination between the two groups.

[0184] 1.3 Disease conditions of the two groups of patients

[0185] Table 18 is the analysis results of the disease conditions of the two groups of patients. As can be seen from the table, the baseline disease conditions of the patients in each group are quite consistent and comparable, and there is no statistically significant difference between the groups (P>0.05). Table 19 is the analysis results of the disease conditions of the two groups of patients. As can be seen from the table, there is no clinical significance in the differences in the TCM syndrome scores, TCM single symptom scores, lower urinary tract irritation symptom scores and lower urinary tract irritation single symptom scores between the two groups of patients at the time of consultation.

[0186] Table 18 Analysis results of disease conditions of two groups of patients in Example 2

[0187]

[0188]

[0189] Table 19 The total score of TCM syndrome and the severity of individual symptoms in the two groups of patients in Example 2

[0190]

[0191]

[0192] 2. Medication status of the two groups of patients

[0193] Table 20 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 little difference in the amount of medication taken and the number of days of medication between the two groups during the observation period, and there was no statistically significant difference in the results of the inter-group comparison (P>0.05).

[0194] In this embodiment, the non-exposed group is treated with pure Western medicine, and the dosage is selected according to the patient's condition and the recommended dosage of Western medicine, so that it can be taken as needed.

[0195] Table 20 Drug treatment of patients in each group during the observation period

[0196]

[0197] 3. Treatment results

[0198] 3.1. Lower urinary tract irritation symptom score

[0199] Fig.12 The changes in the lower urinary tract irritation symptom scores of the two groups of patients at different time points during the observation period. Compared with the baseline, the lower urinary tract irritation symptom scores of the Chinese medicine combination treatment group and the pure Western medicine treatment group gradually decreased after 1 and 2 weeks of treatment, and the intra-group differences at each visit point in the two 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 two groups of patients were very different in the second week (compared with the baseline, both decreased by more than 98%), in the first week, the pure Western medicine treatment group decreased by 80.23%, and the Chinese medicine combination treatment group decreased by 77.15%, and the difference between the two groups was not obvious.

[0200] Because the difference between the baselines of the two groups was 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 8.5144 (8.1218, 8.9070) for the Chinese medicine combination treatment group and 8.6072 (8.3372, 8.8773) for the pure western medicine treatment group; the results of the decrease in the second week of treatment compared with the baseline showed that the least squares mean (95% confidence interval) was 10.7061 (10.5704, 10.8417) for the Chinese medicine combination treatment group and 10.7313 (10.6312, 10.8313) for the pure western medicine treatment group, respectively. Specific data are shown in Tables 21 and 22.

[0201] It can be seen that both the Chinese medicine combination treatment and the simple Western medicine treatment can effectively improve the patient's lower urinary tract irritation symptoms, and the treatment shows significant therapeutic effects after one week.

[0202] Table 21 Analysis of lower urinary tract irritation symptoms in Example 2

[0203]

[0204] Table 22 Covariance analysis of the change values ​​of lower urinary tract irritation symptom scores in Example 2

[0205]

[0206]

[0207] 3.2 TCM Syndrome Scoring

[0208] Fig.13 Figure 3 shows the changes in the total score of TCM syndromes in the two groups of patients at different time points during the observation period. The results were similar to the scores of lower urinary tract irritation symptoms.

[0209] Compared with the baseline, after 1 and 2 weeks of treatment, the total score of TCM syndrome in the TCM combination treatment group and the pure Western medicine treatment group gradually decreased, and the intra-group differences at each visit point of the two groups were statistically significant (P < 0.05). Although the average total score of TCM syndrome in the two groups was very small in the second week (compared with the baseline, both decreased by more than 98%), in the first week, the pure Western medicine treatment group decreased by 79.61%, and the TCM combination treatment group decreased by 77.78%, and the difference between the two groups was not obvious. Because the difference in baseline between the two groups was statistically significant (P<0.05), covariance analysis was performed with the baseline as the covariate. The results of the decrease in the value compared with the baseline in the first week of treatment showed that the least squares mean (95% confidence interval) was 11.1813 (10.6906, 11.6720) in the Chinese medicine combination treatment group and 11.0737 (10.7360, 11.4113) in the pure western medicine treatment group. Further comparison results showed that there were statistically significant differences between the pure western medicine treatment group and the Chinese medicine combination treatment group; the results of the decrease in the value compared with the baseline in the second week of treatment showed that the least squares mean (95% confidence interval) was 13.8061 (13.6333, 13.9789) in the Chinese medicine combination treatment group and 13.8045 (13.6771, 13.9320) in the pure western medicine treatment group, respectively. There was no statistically significant difference between the groups. See Table 23 and Table 24 for specific data.

[0210] In the first week of treatment, the effective rates of TCM syndrome in the TCM combination treatment group and the pure Western medicine treatment group were 89.49% and 83.47%, respectively ( Fig.14 ), there were some differences between the two groups, and the difference between the two groups was statistically significant (P<0.05). Further comparison results showed that there was no statistically significant difference between the Chinese medicine combination treatment group and the pure Western medicine treatment group (P>0.0167). In the second week of treatment, the effective rate of TCM syndrome in both groups of patients was close to or reached 100%, and there was no statistically significant difference between the two groups (P>0.05).

[0211] It can be seen that the Chinese medicine combination treatment is not much different from the simple Western medicine treatment in improving the traditional Chinese medicine symptoms of patients with lower urinary tract irritation symptoms, and the treatment shows significant therapeutic effects after two weeks.

[0212] Table 23 TCM syndrome efficacy analysis of Example 2

[0213]

[0214]

[0215] Table 24 Covariance analysis of the changes in the TCM syndrome scores of Example 2

[0216]

[0217] 3.3. Disappearance rate of lower urinary tract irritation symptoms

[0218] From the disappearance rate of lower urinary tract irritation symptoms ( Fig.15 ), at the end of the second week of treatment, most patients were asymptomatic, and the disappearance rate was not significantly different between the two groups, and there was no statistically significant difference between the two groups (P>0.05). In the first week, the disappearance rates of lower urinary tract irritation symptoms in the Chinese medicine combination treatment group and the pure Western medicine treatment group were 59.46% and 54.55%, respectively. Specific data are shown in Table 25.

[0219] It can be seen that the effect of the Chinese medicine combination treatment group in promoting the disappearance of patients' lower urinary tract irritation symptoms is equivalent to that of the simple Western medicine treatment group, and the treatment shows significant therapeutic effect after two weeks.

[0220] Table 25 Analysis of lower urinary tract irritation symptoms in Example 2

[0221]

[0222] 3.4. Lower urinary tract irritation symptom score halving rate

[0223] From the perspective of the halving rate of lower urinary tract irritation symptom scores ( Fig.16 ), 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 between the two groups, and there was no statistically significant difference between the two groups (P>0.05). In the first week, the halving rates of the lower urinary tract irritation symptom scores in the Chinese medicine combination treatment group and the pure Western medicine treatment group were 82.58% and 87.33%, respectively. In the second week, the halving rates of the lower urinary tract irritation symptom scores in the Chinese medicine combination treatment group and the pure Western medicine treatment group were 99.40% and 99.33%, respectively. See Table 26 for specific data.

[0224] It can be seen that the effect of the Chinese medicine combination treatment group in alleviating patients' lower urinary tract irritation symptoms is not much different from that of the pure Western medicine treatment group, and obvious therapeutic effects are shown after one week of treatment.

[0225] Table 26 Analysis of lower urinary tract irritation symptoms in Example 2

[0226]

[0227] 3.5. Disappearance time of lower urinary tract irritation symptoms

[0228] The median disappearance time of lower urinary tract irritation symptoms in the Chinese medicine combination treatment group was 7.0 days, and that in the pure Western medicine treatment group was 7.0 days. The difference between the two groups was statistically significant (P<0.0001). Fig.17 and Table 27.

[0229] Table 27 Survival analysis of the disappearance time of lower urinary tract irritation symptoms in Example 2 (days)

[0230] Observation indicators Treatment with Chinese herbal medicine combination Pure Western medicine treatment n(censoring) 335(12) 359(8) Med 7.0 7.0

[0231] 3.6. Disappearance rate of single symptom of lower urinary tract irritation

[0232] The results of the disappearance rate of single symptoms of lower urinary tract irritation showed that in the first week of treatment, the disappearance rate of single lower urinary tract irritation symptoms such as frequent urination, dysuria, urethral burning sensation, dripping after urination, discomfort or pain in the perineum / anus, incomplete urination, wet scrotum (male), yellow and red urine, and abdominal pain and refusal to press (female) in the Chinese medicine combination treatment group was better than that in the pure Western medicine treatment group, and the differences between the groups were statistically significant (P<0.0167); in the second week of treatment, the disappearance rate of single lower urinary tract irritation symptoms such as dripping after urination, discomfort or pain in the perineum / anus, incomplete urination, yellow and red urine, and abdominal pain and refusal to press (female) in the Chinese medicine combination treatment group was also better than that in the pure Western medicine treatment group. Specific data are shown in Tables 28 and 29.

[0233] It can be seen that in terms of relieving the single symptom of lower urinary tract irritation, the Chinese medicine combination treatment group was mostly superior to pure Western medicine treatment and showed obvious therapeutic effect after one week of treatment.

[0234] Table 28 Disappearance rate of single symptom of lower urinary tract irritation at different time points in Example 2 (%)

[0235]

[0236] Table 29 Disappearance rate of other TCM single symptoms at different time points in Example 2 (%)

[0237]

[0238]

[0239] 3.7 Comparison of the efficacy of Chinese herbal medicine combination in treating acute cystitis and acute urethritis

[0240] Figure 18-Figure 20 The results are the comparison results of the lower urinary tract irritation symptom scores of two groups of people treated with Chinese medicine combination 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 treatment results of the Chinese medicine combination treatment group for acute cystitis and acute urethritis are basically the same.

[0241] Figure 21-22 These are the comparison results of the total score of TCM syndrome and the effective rate of TCM syndrome in two groups of people treated with TCM combination 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.

[0242] The results of the comparison between the Chinese medicine combination treatment group and the pure Western medicine treatment group for acute cystitis and acute urethritis showed that the change value, disappearance rate and reduction rate of lower urinary tract irritation symptoms in the pure Western medicine treatment group and the Chinese medicine combination treatment group were not much different. The effective rate of TCM syndrome was better in the Chinese medicine combination treatment group than in the pure Western medicine treatment group.

[0243] 3.8 Security Analysis

[0244] Safety analysis was also conducted during the study, and the results are shown in Table 30.

[0245] Table 30 Safety analysis data of Example 2

[0246]

[0247] As can be seen from the table: A total of 33 patients had 44 adverse events, of which 19 patients in the exposure group had 27 events, with an adverse event rate of 5.62%; 14 patients in the non-exposed group had 17 events, with an adverse event rate of 3.85%. Three patients had 3 serious adverse events, of which 2 patients in the exposure group had 2 events, with a serious adverse event rate of 0.59%; 1 patient in the non-exposed group had 1 event, with a serious adverse event rate of 0.27%. Three patients had 4 adverse reactions, all in the exposure group, with an adverse reaction rate of 0.89%. Therefore, it can be seen that the incidence of adverse reactions in the Chinese medicine combination cohort (exposed group) is low, which is an occasional adverse reaction and has good safety.

[0248] From the above results of this embodiment, it can be seen that for the main effect index of the total score of lower urinary tract irritation symptoms, in the first week of treatment, the pure Western medicine treatment group decreased by 80.23%, and the Chinese medicine combination treatment group decreased by 77.15%; at the end of the second week of treatment, the vast majority of patients were asymptomatic, and there was no statistically significant difference between the groups. For the main effect index of TCM syndrome effectiveness, the Chinese medicine combination group and the pure Western medicine treatment group were 89.49% and 83.47%, respectively, and there were certain differences between the two groups; in the second week of treatment, the TCM syndrome effectiveness of both groups of patients was close to or reached 100%.

[0249] Among the secondary effect indicators, the disappearance rate of lower urinary tract irritation symptoms and the halving rate of the score, the effect of the Chinese medicine combination treatment group on the disappearance of lower urinary tract irritation symptoms was not much different from that of the pure Western medicine treatment group; after one week of treatment, the halving rate of the score of lower urinary tract irritation symptoms was obvious, which could shorten the time for symptom disappearance by 1 day.

[0250] In the first week of treatment, the disappearance rates of single symptoms such as frequent urination, dysuria, burning sensation in the urethra, dripping after urination, discomfort or pain in the perineum / anus, incomplete urination, wet scrotum (male), yellow and red urine, and abdominal pain and refusal to press (female) in the Chinese medicine combination treatment group were better than those in the pure Western medicine treatment group; in the second week of treatment, the disappearance rates of single symptoms such as dripping after urination, discomfort or pain in the perineum / anus, incomplete urination, yellow and red urine, and abdominal pain and refusal to press (female) in the Chinese medicine combination treatment group were better than those in the pure Western medicine treatment group. At the end of the second week of treatment, the vast majority of patients were asymptomatic. In addition, the research results of acute cystitis and acute urethritis are basically consistent with the lower urinary tract irritation symptoms of acute lower urinary tract infection.

[0251] Example 3

[0252] 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.

[0253] The preparation method of the Chinese medicine composition provided in this embodiment comprises the following steps:

[0254] (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.

[0255] (2) Extracting volatile oil from Atractylodes lancea and Glechoma tatarinowii by distillation, encapsulating the volatile oil with β-cyclodextrin, drying and crushing the resulting inclusion complex into coarse powder for later use, and collecting the distilled aqueous solution in another container;

[0256] (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;

[0257] (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;

[0258] (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;

[0259] (6) Adding an excipient to the above powdered Chinese medicine composition to obtain a Chinese medicine composition preparation.

[0260] 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.

[0261] The therapeutic effect of the Chinese medicine composition provided in this embodiment on lower urinary tract irritation symptoms was tested by referring to the method of Example 1. The results showed that compared with the treatment with Sabate, the therapeutic effect of the Chinese medicine composition provided in Example 3 on lower urinary tract irritation symptoms was improved. In addition, the therapeutic effect of the Chinese medicine composition of Example 3 on lower urinary tract irritation symptoms was equivalent to that of Example 1.

[0262] Example 4

[0263] This embodiment is different from Embodiment 2 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.

[0264] The preparation method of the Chinese medicine composition provided in this embodiment comprises the following steps:

[0265] (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.

[0266] (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;

[0267] (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;

[0268] (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;

[0269] (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;

[0270] (6) Adding an excipient to the above powdered Chinese medicine composition to obtain a Chinese medicine composition preparation.

[0271] 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.

[0272] According to the test method of Example 2, the therapeutic effect of the Chinese medicine composition provided in this example on lower urinary tract irritation symptoms was tested. The results showed that compared with pure Western medicine treatment, the therapeutic effect of the Chinese medicine composition provided in Example 4 on lower urinary tract irritation symptoms was improved. In addition, the therapeutic effect of the Chinese medicine composition in Example 4 on lower urinary tract irritation symptoms was slightly better than that in Example 2, indicating that the addition of Polygonum cuspidatum, Taraxacum officinale and Alisma orientalis can improve the therapeutic effect.

[0273] Through the study of the above embodiments of the present invention, it can be seen that both the Chinese medicine composition and Shabat can effectively treat diseases with lower urinary tract irritation symptoms, and the Chinese medicine composition is better than Shabat in the disappearance rate of lower urinary tract irritation symptoms, the effective rate of TCM syndrome of damp-heat obstruction syndrome, and the decrease value of chronic prostatitis symptom score (NIH-CPSI), especially for relieving symptoms such as frequent urination, urgency and dripping after urination. The effect advantage of Shabat is also reflected in the ability to improve the lower urinary tract irritation symptoms of patients faster; the incidence of adverse reactions during treatment with the Chinese medicine composition (Example 1) is no different from that of the Shabat treatment group. At the same time, compared with pure Western medicine treatment, the Chinese medicine composition of the present invention is used for single treatment, and the therapeutic effect of lower urinary tract irritation symptoms is improved, and the incidence of adverse reactions is low (Example 2), which is an occasional adverse reaction. It shows that the Chinese medicine composition of the present invention is not only safer, but also has an excellent therapeutic effect on lower urinary tract irritation symptoms, and can be promoted and applied in the clinical treatment of lower urinary tract irritation symptoms of frequent urination, urgency, urinary pain and / or urethral burning sensation.

[0274] 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 in the preparation of a medicine for treating lower urinary tract irritation symptoms.

2. A Chinese medicine composition is used in the preparation of a drug for treating lower urinary tract irritation symptoms by increasing the decrease value of the lower urinary tract irritation symptom score.

3. Use of a Chinese medicine composition in the preparation of a drug for treating lower urinary tract irritation symptoms by improving the effectiveness of Chinese medicine syndromes.

4. Use of a Chinese medicine composition in preparing a drug for treating lower urinary tract irritation symptoms by increasing the disappearance rate of lower urinary tract irritation symptoms.

5. Use of a Chinese medicine composition in preparing a drug for treating lower urinary tract irritation symptoms by increasing the halving rate of lower urinary tract irritation symptoms.

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

7. Use of a Chinese medicine composition in preparing a drug for treating lower urinary tract irritation symptoms by increasing the disappearance rate of a single symptom of lower urinary tract irritation.

8. The use according to any one of claims 1 to 7, characterized in that: The lower urinary tract irritation symptoms include at least one of frequent urination, urgent urination, painful urination and urethral burning sensation.

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: In the Chinese medicine composition, talc is replaced by tongcao; the mass ratio of the herb scutellaria, phellodendron chinense, patrinia chinensis, indigo, tongcao, plantago, calamus, poria, atractylodes and salvia miltiorrhiza is 1:0.5:1:0.156:0.03:1:0.5:0.5:0.5:

1.

11. 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.

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