Medical & Surgical Urology
Open Access

Observation of Clinical Effect of Tamsulosin Combined with Paishi Decoction on Postoperative Stone Removal in Patients with Upper Urinary Tract Stones

Mighu Qiu¹, Sun Zhang^2,3*, Jibing Chen^2,3 and Hongjun Gao^{2,3 *}Correspondence: Sun Zhang, Department of Neurology, Guangxi Traditional Chinese Medical University, Guangxi, China, Tel: 86+15296280721, Email:

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Introduction

Urinary stones are solid particles in the urinary system that can cause pain, nausea, vomiting, hematuria, and possibly chills and fever due to secondary infection. Urinary calculi can be divided into upper urinary tract calculi of kidney and ureter and lower urinary tract calculi located in bladder and urethra according to different anatomical locations. This paper mainly discusses upper urinary tract calculi [1]. Clinical calculus treatment is mainly divided into conservative treatment and surgical treatment, conservative treatment is mainly through self-exercise combined with oral drugs; For patients with upper urinary tract stones with surgical indications, conventional surgery or minimally invasive surgery can be selected. At present, postoperative residual stones in clinical patients greatly affect the stone discharge rate, and residual stones are very likely to cause stone recurrence, which will further lead to the risk of urinary obstruction, kidney colic, hematuria, urinary tract infection, etc., and also have serious effects on the kidney, such as cystine or uricate-related nephropathy [2]. After reviewing the literature and combining with the actual clinical situation, it was found that the postoperative residual stones could not be quickly and effectively discharged by western medicine alone, leaving a huge hidden danger for stone recurrence [3].

The use of Chinese and western medicine combined treatment of urinary calculi, not only play the role of western medicine to expand the ureter, spasmodic pain relief, but also according to the actual situation of patients dialectical use of Chinese medicine treatment. In this study, 87 patients with upper urinary tract calculi were selected to evaluate the effects of Tamsulosin combined with Paishi decoction on postoperative stone removal rate and recurrence rate of upper urinary tract calculi.

Materials and Methods

General information

A total of 87 cases of upper urinary calculi were selected from October 2021 to October 2022 in the inpatient Department of Urology, Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine. The patients were divided into three groups according to random number table method. In group A, there were 22 and 8 male and female patients, aged 20-65, with an average age of (45.33 ± 11.60) years, and the longest stone diameter was 1.80 (1.20, 2.00). Group B consisted of 19 male and 9 female patients, aged 14-65 years, with an average age of (44.04 ± 11.29) years, and the longest stone diameter was 1.60 (1.33, 2.00). In group C, there were 20 and 9 male and female patients, respectively, ranging in age from 14 to 65 years old, with an average age of (46.03 ± 10.74) years old, and the longest stone diameter was 2.0 (1.25, 2.00). There was no significant difference (p>0.05) was comparable between groups (Table 1).

Table 1: Comparison of the longest diameter of stones in the three groups.

The longest diameter of the stones in the three groups before surgery was between 0.6 cm and 2.5 cm, and there was no statistical difference after comparison (P>0.05). In group A, 18 cases were in kidney and 12 cases were in ureter. In group B, 13 patients were in kidney and 15 were in ureter. There were 14 cases in the kidney and 15 cases in the ureter in group C, and there was no statistical difference after examination (P>0.05), is comparable (Table 2).

Table 2: Comparison of stone location among the three groups.

Diagnosis, inclusion and exclusion criteria

Diagnostic criteria: The diagnosis of Western medicine is in accordance with the 2019 edition of the Chinese Guide for the Diagnosis and Treatment of Urology Diseases [4], and the diagnosis of Chinese medicine is in accordance with the 2008 edition of the Norms for the Diagnosis and Treatment of Urolithiasis of Integrated Chinese and Western Medicine and the 2012 edition of Chinese Internal Medicine [5,6].

Inclusion criteria: (1) Meet the above diagnostic criteria; (2) Aged 18-65, regardless of gender, resident in Guangxi; (3) Imaging examination confirmed the diagnosis of upper urinary tract stones, the longest diameter of the stones before surgery was between 0.6 cm-2.5 cm, and postoperative imaging data showed that there were still residual stones with the longest diameter within 0.6 cm; (4) TCM syndrome differentiation is dampness-heat syndrome; (5) No obvious drug allergy; (6) Stone removal was not performed by other means in the past six months; (7) Informed consent to voluntarily participate in and accept postoperative follow-up; All those who meet the above seven criteria are included in the statistical medical records (Table 3).

Table 3: Comparison of operation options among the three groups.

Exclusion and shedding criteria: (1) Stop taking the drug or use other drugs with similar efficacy midway; (2) Serious cardiovascular and cerebrovascular diseases and digestive tract diseases after taking the drugs used in this study; (3) Serious diseases of heart, brain, kidney and other related organs cannot continue to participate; (4) Withdrawal or loss of follow-up due to personal reasons during the follow-up.

Sample size estimation

In this study, the sample size was estimated by consulting literature, and the efficiency of stone removal was set as the main observation index. Class I error α=0.05, class II error β=0.2 were set as the cutoff value of freedom λ=k-1, K as the number of groups, Pmax and Pmin as the maximum efficiency of 90.00% and the minimum rate of 52.50% in the reference.

Ethical requirements

This study followed Chinese ethics norms, and the basic information of this clinical study was explained to the subjects before enrollment, and they were enrolled after their understanding and consent. The process respects the rights of the subject, allows withdrawal, respects and protects privacy. They were asked to contact the investigator for any changes in their condition during the course of the study. This research scheme has been submitted to the Ethics Committee of Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine for approval.

Research design

Case grouping: All patients signed the informed consent form and were numbered 1-87 according to their enrollment time. The patients were randomly divided into 3 groups by random number table method. There were no significant differences in gender, age, preoperative stone size and location among all groups.

Treatment plan: After improving preoperative examination and preparation, each group underwent urethral Flexible Ureteral Lithotripsy (FURL) or Per-Cutaneous Nephro-Lithotomy (PCNL). According to the needs of the condition. During the operation, double "J" tubes were routinely indurated. After operation, all patients were given symptomatic treatment such as antiinflammatory and pain relief, and patients were advised to drink more water (more than 2000 ml per day), urinate frequently, and deal with discomfort in time. The three groups were treated with oral drug-assisted stone removal starting from the first day after surgery, 2 weeks for 1 course, and a total of 2 courses were taken. The specific treatment plan is as follows: Group A: Tamsulosin hydrochloride sustained-release capsule (Zhejiang Haisheng Pharmaceutical Co., LTD.) 0.4 mg/ time, orally, once a day, for 4 weeks. Group B: Medicinal compositions of Paishi decoction were: Xianchao 3 g, Haijinsha 20 g, Jineijin 20 g, Shiwei 15 g, Psyllium 15 g, Achyranthes oxysanthes 12 g, Taoren 12 g, Delong 10 g, Dongquzi 15 g, Hongmaxiang 15 g, Astragalus 30 g, Licorice 6 g. Take one dose a day, decocted in water, decocted into 200 ml, divided into morning and evening 100 ml, orally for 4 weeks. Group C: Tamsulosin hydrochloride sustained release capsule plus paishi decoction, orally for 4 weeks.

Observation indicators: (1) Basic information: Gender, age and previous underlying diseases; (2) Safety outcome indicators: Blood, urine and stool routine, liver and kidney function before and 4 weeks after taking the drug. In case of discomfort, timely treatment and record; (3) Main outcome measures: Imaging, blood white blood cells, urinary occult blood, creatinine, uric acid and other indicators before and 4 weeks after taking the drug, and the excretion of residual stone fragments after taking the drug were analyzed. (4) Secondary outcome measures: TCM symptom score, pain VAS scale during stone discharge, adverse reactions (dizziness, abdominal pain, diarrhea, skin pruritus, etc.) and stone composition.

Statistical methods all the data collected in this study were recorded into excel tables and double-checked: SPSS26.0 statistical analysis software was used to compare before and after between groups and within groups. 1) The measurement data met the normal distribution and were expressed by mean ± standard deviation (x ± s) (Table 4). Univariate analysis of variance was used after the test variance was homogeneous. There were significant differences between groups. If the variance is not uniform, the Tamhani T2 method is used to make multiple comparisons after the event. Paired sample T test was used for intra-group comparison. When the measurement data did not meet the normal distribution, the median (interquartile distance), that is, M (Q3-Q1), was used, the Kruskal-Wallis test (H test) in the non-parametric test was used between groups, and the rank sum test of paired samples was used within groups. 2) Counting data is expressed in frequency or percentage and tested by chi-square (Table 5). 3) Set P<0.05 was statistically significant, P<0.01 was statistically significant.

Table 4: Comparison of serum creatinine before and after treatment in three groups (x ± s, umol/L).

Table 5: Comparison of serum uric acid changes between the three groups before and after treatment (x ± s, umol/L).

Results

Comparison of renal function before and after treatment among the three groups

The serum creatinine and serum uric acid data of the three groups before and after treatment were tested to be in line with normal distribution and the variance between the groups was homogeneous. The following results were obtained after corresponding statistical analysis: After 3 days of treatment, there was no statistically significant difference between the groups (P>0.05); There was no significant change compared with pre-operation (P>0.05). After 4 weeks of treatment, there were statistically significant differences between group C and groups A and B (P<0.05), there was no significant difference between group A and group B (P>0.05), indicating that group C was better than group A and group B; Serum creatinine decreased significantly after 4 weeks of treatment compared with 3 days of treatment, and the difference was statistically significant (P<0.05) (Table 6).

Table 6: Comparison of WBC changes in blood routine of the three groups before and after treatment (x ± s, 109/L).

Comparison of blood leukocytes before and after treatment in the three groups

The blood leukocyte data of the three groups were in line with normal distribution and homogeneous variance, and the following results were obtained after corresponding statistical analysis: After 3 days of treatment, there was no statistically significant difference between the groups (P>0.05); Compared with before operation, the WBC was significantly higher than that before treatment, and the difference was statistically significant (P<0.05), considered to be related to intraoperative or postoperative physiological stress. After 4 weeks of treatment, the difference between groups was significant (P<0.01), the difference between group C and group A and B was statistically significant (P<0.05), there was significant difference between group A and group B (P>0.05), indicating that the curative effect of group C was better than that of groups A and B; Compared with 3 days of treatment, the difference was significantly lower than before (P<0.05) (Table 7).

Table 7: Comparison of positive cases of urinary occult blood in the three groups after treatment.

Comparison of urinary occult blood in the three groups after treatment

The urinary occult blood values of the three groups after treatment were counted data, and the following results were obtained after corresponding statistical analysis: After 2 weeks of treatment, the positive rate of urinary occult blood in group A was 73.33%, group B was 39.29%, and group C was 34.48%, with significant differences between groups (P<0.05), there were significant differences between groups B and C and group A (P<0.05), there was no significant difference between groups B and C (P>0.05), indicating that after 2 weeks of treatment, the curative effect of group B and C was similar, and both were better than group A. After 4 weeks of treatment, the positive rate of urinary occult blood in group A was 16.67%, group B was 10.71%, and group C was 6.90%. There was no significant difference between groups (P>0.05).

Comparison of TCM symptom scores before and after treatment among the three groups

After testing, the statistical data did not conform to the normal distribution, and the following results were obtained after corresponding statistical analysis: After 2 weeks of treatment, there were significant differences between the groups (P<0.01), the curative effect between group B and C was comparable (P>0.05), the difference between group B and C and group A was statistically significant (P<0.05), indicating that the improvement of TCM syndrome scores in groups B and C was better than that in group A; There were statistically significant differences between the two groups before treatment (P<0.05). After 4 weeks of treatment, there were significant differences between groups (P<0.05), the curative effect between groups B and C was similar (P>0.05), the difference between group B and C and group A was statistically significant (P<0.05), indicating that group B and C were better than group A; There was a statistically significant difference between the two groups (P<0.05).

Comparison of pain scores after treatment among the three groups

After testing, the statistical data did not conform to the normal distribution, and the following results were obtained after corresponding statistical analysis: There was no statistical difference in pain scores between the groups after 3 days of treatment (P>0.05). After 2 weeks of treatment, the difference between groups was statistically significant (P<0.01), there was no significant difference between group B and group C (PV0.05), the difference between group B and C and group A was statistically significant (P<0.05), indicating that group B and C were better than group A; There was significant difference between 2 weeks’ treatment and 3 days’ treatment (P<0.05). After 4 weeks of treatment, the difference between groups was statistically significant (P<0.01), group C was compared in pairs. Group B Group A was lower than 0.05, indicating that the effect of group C was better than that of group A and B. There was significant difference between group A and group C compared with 2 weeks of treatment (P<0.05), there was no difference in group B (P>0.05).

Therapeutic indexes

Comparison of curative effects of TCM syndromes: The statistical information is hierarchical data, and the Kruskal-Wallis rank sum test for comparison of hierarchical data of multiple groups was used to analyze the difference in efficacy between groups. After 4 weeks of treatment, the effective rate of Chinese medicine symptoms in group A was 76.67%, 92.86% in group B and 93.10% in group C. The difference between the three groups was statistically significant (P<0.05). Comparing between two groups, there was a significant difference between groups B and C and group A (P<0.05), and the efficacy between groups B and C was comparable (P>0.05), which concluded that the overall improvement of Chinese medicine symptoms in groups B and C was better than that in group A.

Comparison of the efficacy of residual stone removal in Western medicine: This statistic is rank information, and the Kruskal-Wallis rank sum test for comparison of rank information in multiple groups was used to analyze the difference in efficacy between groups. The three groups of patients returned to the hospital for imaging examination after 4 weeks of medication, 15 people in group A had the residual stone completely discharged, 8 people had the position of the residual stone decreased or the longest diameter of the residual stone reduced compared with the previous one, and 7 people did not have any significant changes in the residual stone, with a total effective rate of 76.67%; 14 people in group B had the residual stone completely discharged, 8 people had the residual stone changed in position or size compared with the previous one, 6 people had the residual stone still in the original position, with a total effective rate of 78.57%; group C had 24 people had stones completely discharged, 3 people had changes in the location or size of residual stones compared with the previous one, and 2 people still had residual stones in the original position, with a total effective rate of 93.10%. The difference between the groups was statistically significant (P<0.05); comparing the two groups, group C compared with groups A and B⁽¹⁾P<0.05, and group A and B compared⁽²⁾P>0.05, indicating that group C had the best efficacy in stone expulsion (Tables 8 and 9 ).

Table 8: Comparison of TCM symptom scores before and after treatment among the three groups.

Table 9: Comparison of pain scores before and after treatment among the three groups.

Comparison of stone recurrence: The stone recurrence data of the three groups of patients were analyzed by the corresponding statistical methods and the following results were obtained: The three groups of patients were reviewed after 3 months of treatment (Table 10). 15 patients in group A had incompletely discharged their stones after 4 weeks of medication, and among the 15 patients with residual stones, 13 had completely discharged their residual stones, 1 patient's residual stone had increased in size, and 1 patient had found a new stone besides the residual stone; the remaining 15 cured patients had no new stones, and the recurrence rate of group A was 6.67%. In group A, the recurrence rate was 6.67%. In group B, 14 patients had stones that were not completely discharged after 4 weeks of medication, and in group C, the recurrence rate was 3.33%, and in group D, the recurrence rate was 3.33%. The recurrence rate of group B was 3.33%. 5 patients in group C had stones not completely discharged from the body after 4 weeks of medication, and all of them had been discharged from the body when they were rechecked 3 months later, and no neonatal stones were found in the remaining 24 cured patients, and the recurrence rate of group C was 0%. There was no significant difference in the comparison between groups (P>0.05) (Table 11).

Table 10: Efficacy of Chinese medicine symptoms after treatment in the three groups.

Table 11: Residual stone excretion after treatment in three groups of patients.

Security evaluation: The data belongs to the count data, after analyzing with the corresponding statistical methods, the following results were obtained among the 87 patients who completed the test, one case in group A had accelerated heart rate after the first dose of the drug, up to 134 beats/min, complained of discomfort in the precordial region, ECG examination did not indicate any abnormality, and improved after calm rest. 2 patients in group B and 1 patient in group C had diarrhea after the first dose of the lithopreparation broth, and it was transient, and the rest of the patients improved without treatment. The rest of the patients had no obvious discomfort. The general vital signs (respiration, pulse, heart rate and blood pressure, etc.), liver function, electrolytes and other indicators of the three groups of patients did not see obvious abnormalities, and there were no serious adverse reactions at the end of the two courses of treatment. Comparison of adverse reactions among the three groups showed no statistically significant difference at P>0.05, indicating that there was no significant difference in adverse reactions among the different drug treatment groups, and overall there were no obvious side effects, and the safety of clinical application was good (Tables 12 and 13 ).

Table 12: Comparison of stone recurrence rate after 3 months in three groups of patients.

Table 13: Comparison of the incidence of adverse reactions among the three groups of patients.

Discussion

Clinically, the special location of the stone, the limitation of lithotripsy equipment, the blurring of visual field caused by intraoperative bleeding or extravasation of irrigation fluid, and postoperative ureteral stimulation contracture and many other factors lead to the residual stone in the body cannot be removed at one time. The residual stone will provide the basis for the generation of new stones, which will easily cause stone recurrence. New stones will be dislodged and displaced in the process of formation, thus causing urinary obstruction, severe renal pain, hematuria, etc. [7]. Infection-related residual stones can harbor bacteria within them, and proliferation of bacteria remaining in the body for a long period of time can cause persistent bacteriuria that is difficult to control in the postoperative period. How to make the residual stone fragments quickly and safely discharged from the body, to improve the rate of residual stone discharge, and to reduce the complications is a hot spot of clinical research.

Urinary stones belong to the category of "gonorrhea" and "stone gonorrhea" in Chinese medicine. Modern people like to eat hot and spicy stimulation or fat, sweet and thick flavors, or excessive addiction to tobacco and alcohol, resulting in the spleen and stomach dysfunction, the spleen does not transport water and dampness, silt for a long time into heat, downstream injection of the bladder and eventually lead to gonorrhea. The pathogenesis of dampness and heat downward injection of fire and injury to the yin, frying urine to sand and stone stagnation of the watercourse [8]. Treatment requires clearing heat and removing dampness, clearing lymphatic drainage. After reviewing the literature, it is found that the symptomatic typing of stonorrhea has certain regionality, which is related to different regional environments and the dietary and living habits of the region, and the spleen deficiency and damp-heat type is predominant in Hunan region [9]. Our region is located in the southwest, for the subtropical monsoon climate, the summer climate is hot and lasts for a long time, spring and fall are hot and humid, winter is cold and humid, the diet is also partial to spicy and acidic stimulating food, and most of the people are hot and humid, phlegm-damp body, and the hot and humid injection type of stonorrhea is more crowded.

Tamsulosin is an adrenergic al receptor antagonist that inhibits intramuscular excitability in the area innervated by al receptors, which are more widely distributed in the urethra, bladder, and prostate. Of the entire urinary tract, the ureters are the longest and the most disruptive to residual stone expulsion. When the stone stimulates the smooth muscle in these areas, it will activate the a1 receptor, and then tamsulosin, as a sphincter of l receptor, will inhibit the activity of smooth muscle, reduce the spasm of smooth muscle to make it in a more relaxed state, and also reduce the pressure of the ureteral wall to achieve the purpose of promoting the discharge of the stone, and tamsulosin also reduces the pressure of prostate in the urethral pressure curve, relaxing the smooth muscle of the prostate to help the residual stone to be discharged into the bladder to be excreted out of the body [10,11]. A multicenter randomized controlled trial of tamsulosin showed that the drug has a more pronounced pro-excretory effect on distal ureteral stones, as well as reducing the frequency and degree of renal striae pain episodes, and patients with lower ureteral stones are recommended to prioritize the treatment of oral tamsulosin [12]. The results of a series of Meta-analysis of tamsulosin for promoting urinary stone excretion [13], tamsulosin not only improves the efficacy of stone treatment, but also shortens the time of stone excretion, reduces the probability of renal colic, and the excretion rate of high-dose (0.4 mg) tamsulosin is higher.

Chinese medicine has a long history in China, and has accumulated rich diagnostic and therapeutic experience in long-term clinical practice. In recent years, Chinese medicine has played an important role in improving surgical efficacy after urinary tract stone surgery, and at the same time effectively preventing postoperative stone recurrence, and thus has gradually been emphasized by clinical workers. Our region is a typical hot and humid climate, living here for a long time is susceptible to hot and humid evils, wet offenders in the middle jiao is most likely to injure the spleen, the spleen is the main transportation of water and dampness, like dry, not wet, water and dampness do not transport aggravate the growth of dampness. Spleen is the main qi and blood transportation, qi and blood transportation dysfunction will aggravate qi and blood stagnation, blocked in the veins and collaterals are not through the pain, lumbar and knee pain; spleen is the foundation of the day after tomorrow, eating spicy stimulation will hurt the spleen and stomach qi, long time the spleen qi weakness, resulting in deficiency and stasis. Dampness injection into the bladder, bladder qi unfavorable urination difficulties, dribbling astringent pain; dampness and heat stagnation for a long time, urine impurities refining liquid into. Combining the above stone generating process, the formula not only add heat and dampness medicines, but also add Gu protect the spleen and stomach qi, tonifying the nature of the original medicine. On the other hand, if the stone stays in the body for a long time, it will produce adhesion with the surrounding tissues, and minimally invasive lithotripsy is an invasive intracavitary operation, which will inevitably cause damage to the mucosa of the ureter, resulting in intermittent hematuria, so the patient needs to add the medicines for eliminating blood stasis and cooling the blood to stop bleeding. The patient is sick for a long time, the disease will be weak and damage the positive qi, combined with the postoperative damage to yang qi, the body becomes weaker and weaker, the qi is weak and powerless to agitate the urine discharge so that the water and dampness will stop gathering in the body, which will aggravate the risk of recurrence of the stone, and the appropriate addition of drugs to support and replenish the deficiency can promote the recovery of the positive qi, and promote the vitalization of the bladder.

Due to the many causes of stone formation, it is necessary to formulate stone-dispelling tonics according to the location of stones, etiology and mechanism of disease in detail and individually, thus leading to different ingredients in stone-dispelling tonics. Stone removing tonic is composed of a variety of herbs, in the formula, money grass is sweet, light and slightly cold, attributed to the kidney, bladder meridian, has the effect of clearing dampness and heat to clear the drenching effect, is the key to prevent and control stone drenching, stone drenching is one of the most frequent drugs in the formula. Hai Jin Sha is cold and sweet in nature, belonging to the small intestine and bladder meridian, it is the most important medicine for all gonorrhea and astringent pain, and it is especially good for urethral pain, and it is called "the king of all gonorrhea medicines, Hai Jin Sha" in the "Song of the King of Linzheng Medicines". Chicken Neijin is sweet in taste and flat in nature, belonging to spleen, stomach, small intestine and bladder meridian, and "Rihua Zi Materia Medica" said that it can "stop blood in urine", and Zhang et al,. [12] said that it is "the spleen and stomach of the chicken, in which the porcelain stone, copper, and iron can be digested", and it can facilitate urination, eliminate petrochemicals and firmness, and regulate the elevation of the qi of the spleen and stomach, based on softening and resolving stones. In addition, it can promote the stone outside on the basis of softening the stone [14]. Wang Hui et al., [15] found that the reuse of chicken Neijin can significantly improve the efficiency of stone excretion. The above three flavors are the king, referred to as "Sanjin", and are also an important part of "Sanjin Stone Drainage Soup" in "Ancient and Modern Famous Formulas", which play the role of clearing away heat and inducing dampness, clearing lymph and draining stones together. Shi Wei is slightly cold, sweet and bitter, belonging to the lung, bladder meridian, can diuretic, cool blood to stop bleeding, on the stone gonorrhea, blood gonorrhea, urinary incontinence and gonorrhea and astringent pain is indeed a curative effect. Psyllium is cold and sweet in nature, belonging to the liver, kidney and lung meridian, it can promote diuresis and lymphatic drainage, separate clearing and lowering turbidity so that water and dampness can be dissolved from the two stools, "Shennong's Classic of the Materia Medica" said that it can be used for "main gas retention of urine, and facilitate the passage of water for urination". Dong Quai Zi is sweet and cold in nature, and enters the large and small intestines and bladder meridians, which is diuretic, diuretic and stone-dispersing. Shen Nong's Classic of the Materia Medica states that it can treat "five retention of urine, and promote urination." It is also used in combination with Qian Cao, Hai Jin Sha, and Chicken Nei Jin to enhance stone-dispersing effects and relieve episodes of renal colic. The upper three flavors are ministers, assisting the monarch in inducing diuresis, clearing drench and removing stones. Long-term diseases will be stagnant when they enter the channels, and pain will result if they do not pass. Stone obstruction will cause pathological changes such as congestion, edema, inflammation and fibrous tissue proliferation. Stasis for a long time qi and chemical obstruction, aggravated qi stagnation blood stagnation and water stoppage, in clearing heat and diuresis at the same time with blood circulation products is particularly important, not only to improve the circulation, but also to play a role in pain relief [16]. After taking a large number of heat-clearing and dampness-dispelling medicines, it will damage the human body fundamentally, and there will be fatigue, weakness, lumbar and knee pain and gastrointestinal dysfunction, etc. Modern people's spleen and stomach function is generally lower and more vulnerable to damage. To sum up, we should add blood circulation and blood stasis, tonifying the kidney, spleen and qi drugs on the basis of clearing heat and dampness. Cow's Knee, which is flat in nature, sour and bitter in taste, belongs to the liver and kidney meridians, can activate blood circulation, remove blood stasis, tonify the liver and kidney, strengthen the muscles and bones, and lead the medicine downward to reach the place of disease. In ancient times, it was said that "hyssop is the holy medicine to relieve gonorrhea", which can cure hematuria and pain in the stem caused by five gonorrhea. The Ming Dynasty's "Pu Jifang" had used hyssop alone to make a thick decoction of the "medulla oblongata soup" to treat the five gonorrhea and urinary incontinence. Peach kernel is bitter and flat in nature, belonging to the heart, liver and large intestine meridians, and is known as an important medicine for stasis and blood stagnation, which can activate blood circulation and remove blood stasis.

Dilong is cold in nature and belongs to the liver, spleen and bladder meridians, which can activate blood circulation, move qi and relieve pain. It is used together with Niu Knee and Peach Kernel to dispel blood stasis and clear the channels. Stones obstructing the ureter will cause pain, and Dilong moves Qi to relieve pain. Red Hat Top is cold and slightly bitter in nature, belongs to the liver meridian, has the effect of clearing away heat and removing toxins, drying dampness and stopping itching, cooling blood and stopping bleeding, folk will be used in the treatment of urinary incontinence, hematuria, urinary tract stones, belonging to the characteristics of the drug in our region. The above four flavors are used as adjuvants to assist the ruler and minister to play the role of stone removal, and at the same time to remove blood stasis and clear the channels, and to move qi to relieve pain. Long-term illness and qi deficiency damage to the positive qi, Astragalus sweet warm and beneficial to the qi, has a "tonic qi holy medicine" reputation, can support the positive and solid foundation, there is a tonic qi and Yang, diuresis and swelling effect. Glycyrrhiza glabra is flat and sweet in nature, it can nourish the spleen and qi, relieve pain, clear heat and detoxification, nourish the spleen and benefit qi so that the evils of water and dampness can be transported and transformed, and Astragalus can be used to prevent too much damage to the spleen and yang by clearing the heat medicine, the two medicines are used together as a make medicine. The whole formula is based on clearing heat and removing dampness, clearing lymph and dissolving stones, while removing blood stasis and clearing collaterals, promoting qi and relieving pain, and taking care of the qi of the spleen and stomach. There are both attacking and tonifying drugs for clearing away dampness and heat, removing stasis, eliminating blood stasis and clearing up blood vessels, and tonifying drugs for replenishing qi and elevating yang, benefiting qi and strengthening the spleen to take care of the essence of the latter. Guided by the basic theories of traditional Chinese medicine, the formula is formulated to address the etiology and pathogenesis of stagnation of stasis under the influence of damp-heat in stonecrosis, so as to enhance the efficacy of stone-discharging treatment. It has been found that moneywort contains a large number of phenolic substances that can reduce oxidative stress, protect renal epithelial cells, and bring calcium and magnesium ions in the body to a homeostatic state [17]. Its antioxidant effect can reduce the generation of free radicals in the body, reduce lipid peroxidation in the body in order to reduce the formation of uric acid and lower the concentration of uric acid. With the increase in the dosage of moneywort, the ureteral smooth muscle tone increased, the frequency of ureteral peristalsis and urine volume increased simultaneously, and the efficiency of proelimination was significantly improved. Containing flavonoids, phenolic acids, glycosides and water-soluble crude polysaccharides and other substances, Hai Jin Sha is also an important drug for the prevention and treatment of stones, in which water-soluble crude polysaccharides can effectively inhibit Escherichia coli and Staphylococcus aureus, and has a variety of pharmacological activities such as stone prevention, antioxidant, antibacterial and other pharmacological activities [18]. Luhong et al., [19] studied the experiments related to the effect of Hai Jin Sha extract on the kidney of animals, and found that Hai Jin Sha extract plays an important role in reducing the oxalic acid and calcium content in the renal tissues of animal models, and also reduces the level of blood creatinine. Bai Yingtang et al., [20] pointed out that the polyphenol alkaloids contained in hen's gold can disintegrate the stones and expel them from the body after alkalinization reaction with the minerals on the surface of the stones. Various trace elements such as zinc, aluminum, molybdenum and manganese in the extract of chickpea can inhibit stone formation by competing for the core sites of stone growth, inhibiting enzyme activity and improving the urinary environment. Pang et al., [21] studied the antibacterial effect in the active ingredients of Shiwei, and the results showed that it had a good inhibitory effect on Pseudomonas aeruginosa, Escherichia coli and Staphylococcus aureus, etc. It was also found that its antibacterial substances were the same as those in Haijinsha, which were flavonoids, and had the active effects of lowering blood glucose, regulating immune system, and antiinflammation, etc. Rodgers et al., [22] proved that shiwei could inhibit the formation of calcium oxalate stone crystals, reducing the incidence of kidney stones. The decoction-free form of Shi Wei can reduce the degree of renal tubular dilatation in test rats, protect renal function and reduce renal injury. The polysaccharides and phenylethanol glycosides contained in psyllium have diuretic, antiinflammatory, antioxidant and nephroprotective effects, which can effectively promote the excretion of uric acid, urea and sodium chloride, and experiments have shown that psyllium extracts inhibit the release of inflammatory factors or reduce apoptosis of renal tissues through the down-regulation of expression of the relevant proteins [23]. Like chickweed, dong quai seed contains elements such as iron, zinc and manganese that can competitively bind to the core site of stone growth, inhibit enzyme activity, and affect stone formation. Cow's Knee can improve immunity, improve microcirculation by dilating blood vessels and increasing capillary permeability, promote inflammation absorption, and achieve the purpose of anti-inflammatory and decongestive. The total saponin contained in hyssop has analgesic effect, and there is a quantitative-effect relationship between the analgesic intensity and the dose of total saponin [24]. Peach kernel has antibacterial, antiinflammatory and antioxidant effects, as well as antithrombotic and analgesic [25]. Astragalus has the effect of enhancing immunity, anti-inflammatory diuretic inhibiting renal interstitial fibrosis. The methyl glycoside in Astragalus can significantly reduce the level of reactive oxygen species expression in glomerular mesangial cells under high glucose environment and inhibit oxidative stress [26]. The total saponin contained in licorice can directly counteract the inflammatory response, and the anti-inflammatory mechanism is to reduce macrophage inflammatory mediator production and release, reduce the expression of monocyte chemotactic proteins, and inhibit the renal inflammatory response [27]. Modern pharmacological research shows that heat-clearing herbs have antiinflammatory, antipyretic and detoxicating effects [28], and the combination of this formula with a variety of heat-clearing and dampness-inducing drugs can effectively reduce the probability of postoperative inflammatory reactions, protect the suprarenal cells, and restore renal function. The whole formula can not only promote ureteral peristalsis, increase urinary output to promote stone discharge, but also anti-inflammatory, swelling and pain relief. It plays an important role in promoting the discharge of residual stones, relieving pain and reducing hematuria after surgery.

Conclusion

The efficacy of stone-dispelling soup combined with tamsulosin in promoting the recovery of blood creatinine, improving postoperative lumbar and abdominal pain, dribbling and astringent urination, hematuria, and weakness of urination after upper urinary tract lithotripsy is better than that of Chinese herbal medicine treatment alone or Western medicine treatment alone, improving the postoperative Chinese medicine symptom score without obvious adverse reactions, and with a good safety, so it can be used in the clinic for promotion to improve the rate of stonedispelling and to reduce the rate of recurrence of stones.

Statements

None.

Acknowledgements

None.

Conflict of Interest Statement

The authors declare that they have no conflicts of interest, financial or otherwise.

Funding Sources

This work was supported by grants from the Construction of Clinical Key Specialties in 2023, Urology Department, Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, the Guangxi Chinese Medicine Administration Special Fund for Chinese Medicine Inheritance, Innovation and Development (Construction of Translational Medicine Center for Integrated Chinese and Western Medicine in 2023), and the Guangxi Science and Technology Base and Talent Project (grant number AD22035122).

Author Contributions

Minhua Qiu: Manuscript writing; Ting Zhang: Literature collection and review; Jibing Chen: Project development; Hongjun Gao: Literature collection.

Data availability statement

All data generated or analysed during this study are included in this article. Further enquiries can be directed to the corresponding author.

Ethics Statement

This study protocol was reviewed and approved by Ethics Committee of Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine, approval numberYJ2021-053. For studies using human subjects, written informed consent has been obtained from the subject (or their parent/legal guardian/ next of kin.

Statement of Consent to Participate

For studies using human subjects, written informed consent has been obtained from the subject (or their parent/legal guardian/ next of kin) to participate in the study, including consent from the Ethics Committee. The published studies met guidelines for human studies and were conducted in accordance with the World Medical Association's Declaration of Helsinki code of ethics.

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