Objective: To clarify the clinical efficacy of retention of urine tablets in the treatment of urinary tract infection in type 2 diabetic patients, and also to explore the mechanism through objective physicochemical indexes. Methods 223 patients who met the diagnostic criteria were divided into observation group and control group, and the observation group took retention tablets orally while the control group took antibiotics orally. The main symptoms, signs, blood and urine routine, mid-stage urine culture, bladder residual urine, blood coagulation and other indexes of the patients before and after treatment were recorded, and the overall efficacy assessment and physicochemical analysis were conducted, followed by follow-up. Results The total effective rate was 87.72% in the observation group and 72% in the control group, and the observation group was better than the control group; the detection rate of drug-resistant bacteria in the urine of the observation group was significantly lower than that of the control group after medication; the prothrombin time of the observation group was prolonged than that of the control group, and there was a statistical difference; the fibrinogen quantification of the observation group was lower than that of the control group, but there was no statistical difference; the recurrence rate of the observation group was significantly lower than that of the control group. Conclusion Retention tablets can effectively treat urinary tract infection and reduce recurrence in type 2 diabetic patients, and the mechanism may be related to the antibacterial effect of high-dose heat-clearing and detoxifying traditional Chinese medicine, the diuretic effect of dampness-promoting traditional Chinese medicine and the antithrombotic effect of blood-stasis-activating drugs.
Type 2 diabetes mellitus is a common and frequent disease, and the prevention and treatment of its various chronic complications is a hot spot of clinical research. 10% to 40% of people with type 2 diabetes mellitus are combined with various urinary tract infections, most of which can be asymptomatic, and the current treatment is based on long-term use of antibiotics, and bacteriuria is not easily controlled and easily recurred. In this study, we used Chinese medicinal preparations to clear heat and detoxify the blood and promote dampness as the observation object, and confirmed that this method is better than using antibiotics alone in improving symptoms, reducing the production of pathogenic bacteria resistance, and slowing down recurrence, etc. In the study, we also improved the relevant physicochemical indexes to explore the mechanism of healing.
1.Clinical data
(1) General data
From September 2003 to May 2005, 223 patients with type 2 diabetes mellitus and urinary tract infection were selected, including 87 males and 136 females, aged 51-83 years old, 81 patients with the first attack and 142 patients with the second attack or more, 174 patients with different degrees of arteriosclerosis and 31 patients with sequelae of cerebrovascular disease. (The above two comorbidities are not relevant to this study, so can we consider deleting the part in red?) There were 50 cases of combined renal insufficiency and 88 cases of combined urinary retention and/or overflow incontinence of varying degrees. Patients were numbered according to the order of consultation and randomly divided into treatment and control groups according to a random number table, in which 113 cases were in the treatment group: 50 males and 63 females; age 51-83 years old, mean 66.2 years old; 42 cases with first episode and 71 cases with more than two episodes; 30 cases with combined renal insufficiency.
(2) Diagnostic criteria
Western medical diagnostic criteria: the diagnosis of diabetes mellitus was in accordance with the 1999 WHO recommended diagnostic criteria for diabetes mellitus. The diagnosis of urinary tract infection was in accordance with the diagnostic criteria for urinary tract infection established by the Second National Renal Symposium in 1985: quantitative bacterial culture with colony count ≥ 105/ml in clean mid-stage urine (requiring urine to have remained in the bladder for more than 4 h to 6 h); microscopic leukocytes > 10/HP in clean centrifugal mid-stage urine sediment; the diagnosis could be confirmed when both items were available, and if the second item was not available, the urine bacterial count should be rechecked The diagnosis can also be confirmed if it is still ≥105/ml and if the bacterial species is the same twice. Diagnostic criteria of TCM: The diagnostic criteria of “hot gonorrhea” in the “Industry Standard of Chinese Medicine of the People’s Republic of China – Diagnostic and Efficacy Criteria of Chinese Medicine Evidence”.
(3) Exclusion criteria
Cases that cannot adhere to insulin treatment during the observation period and cases that cannot complete the treatment and control during the specified observation period.
2. Treatment and observation methods
(1) Basic treatment
All patients were treated with subcutaneous insulin to control blood glucose, so that fasting blood glucose was controlled between 6 and 8 mmol/L. Those with medical comorbidities such as heart, brain, lung and kidney were treated with symptomatic treatment at the same time.
(2) Group treatment method
(1) The control group received oral levofloxacin mesylate tablets (lot 040723) 0.2g twice a day from Beijing Shuanghe Pharmaceutical Co.
②The treatment group should take urine retention tablets (batch number 0804497) manufactured by Tianjin Zhongxin Pharmaceutical Group Longshunrong Pharmaceutical Factory orally: the main ingredients are Jin Yinhua, Huang Lian, Huang Bai, Bai Hua She Tongue and Tongue, Severus, Dan Pi, Red Peony, Ze Xie Di, Che Qian Zi, Xian He Cao, etc. 6 capsules each time, 3 times a day.
(3) Observation index
The patients’ main symptoms and signs as well as blood routine, urine routine, clean middle urine culture plus drug sensitivity test, residual bladder urine, prothrombin time (PT) and fibrinogen quantification (FIB) before and after treatment on days 0 and 28 were recorded on days 0, 7, 14, 21 and 28, respectively, in the observation cycle of 28 days. Among them, routine blood and urine examination was used as an auxiliary reference index for diagnosis and guiding treatment, and was not treated as comparative statistics.
(4) Statistical methods
The t-test was used for measurement data, the corrected t-test was used for unequal measurement data, and the x2 test was used for counting data.
3.Efficacy observation
(1) Efficacy evaluation criteria
Refer to the efficacy assessment criteria of “hot gonorrhea” in the Chinese Medicine Industry Standard – Diagnostic Efficacy Criteria for Chinese Medicine Evidence of the People’s Republic of China.
(2) Treatment results
The total clinical efficacy of the two groups was compared: 83 cases were cured, 20 cases were improved, and 10 cases were not cured in the treatment group, with an overall effective rate of 91.15%; 69 cases were cured, 10 cases were improved, and 31 cases were not cured in the control group, with an overall effective rate of 71.82%. There was a statistical difference between the groups, and the treatment group was better than the control group.
In the first two weeks of treatment, the antibacterial effect of the control group (antibiotic group) was significantly better than that of the treatment group (urine retention tablet group), P < 0.01; in the third week, the two were similar and there was no statistical difference; in the fourth week, the antibacterial effect of the treatment group was better than that of the control group, P < 0.05. This indicates that in the early stage of treatment, the antibiotics had a better antibacterial effect, but With the extension of treatment time, the control of bacteriuria by traditional Chinese medicine was gradually better than antibiotics.
The results are shown in Table 2. During the treatment process, there was no significant change of drug-resistant strains in the treatment group; in the control group, drug resistance began to appear from the first week, and the number of drug-resistant strains increased significantly in the second, third and fourth weeks.
④ Assessment of fungal situation in urine: before and after treatment in the treatment group, there was no significant change in the number of fungal infection cases, due to the small number of cases, it could not be determined whether Chinese medicine had antifungal effect; in the control group, there was no significant change in the number of fungi in the first two weeks, and from the third week onwards, the number of fungal infection cases increased significantly, comparing between groups and before and after within the group, P < 0.01, indicating that with the prolongation of antibiotic use, especially after using more than 3 weeks, the the odds of fungal infection increased. The results of the cases with fungal infection in both groups are shown in Table 3.
⑤The improvement of the symptoms of chronic urinary retention was evaluated: the results of ultrasound examination of bladder residual urine before and after treatment are shown in Table 4. the amount of bladder residual urine improved in the control group before and after treatment, but there was no statistical difference; the amount of bladder residual urine decreased significantly in the observation group before and after treatment, and P < 0.01 in both before and after comparison within and between groups. It indicates that retention tablets have the effect of improving the symptoms of urinary retention in patients with DM combined with urinary tract infection.
(6) Effect on coagulation function of patients: There was no significant change of blood coagulation before and after treatment in the control group; FIB decreased before and after treatment in the treatment group, but there was no statistical difference; PT prolonged before and after treatment in the treatment group, which was statistically significant; the change of PT compared between groups after treatment was also statistically significant. It indicates that retention tablets have some effect on the anticoagulant-fibrinolytic system of diabetic urinary sensation patients. See Table 5.
(7) Assessment of relapse rate after treatment: Patients who were still positive for bacteriuria at the end of the first stage were not counted as follow-up cases. 52 cases were taken off during the follow-up period due to lost visits, death, hospitalization for other reasons, and inability to adhere to insulin therapy, etc. The remaining 148 patients were intermittently examined for urine culture during the 6-month follow-up period, without considering symptoms, and only bacteriuria was taken as a basis for diagnosis. The recurrence rate of the treatment group was significantly lower than that of the control group within six months after treatment. See Table 6.
4. Discussion
Diabetic patients are more prone to urinary tract infections than normal people, which include susceptibility factors due to hyperglycemia and high glucose environment of local tissues; there are also diabetic vasculopathy factors: diabetic patients are prone to macrovascular lesions such as atherosclerosis due to lipid metabolism disorders; due to the presence of insulin resistance and hyperinsulinemia, the fat and sugar metabolism is disturbed and many coagulation factors (II, V, VIII, X The narrowing of renal arteries and renal microangiopathy make the renal pelvis of diabetic patients less resistant to infection, thus inducing urinary sensation; autonomic neuropathy is one of the main chronic complications of diabetes mellitus, which affects the urinary system due to the slowing down of nerve conduction, mainly in the bladder The abnormal bladder function is mostly manifested by urinary retention and overflow incontinence, which are also reflected in this group of cases. These factors, in turn, contribute to the long duration and recurrence of urinary tract infections in diabetes mellitus. For these reasons, clinical researchers have been prompted to look for methods other than pure antibiotic therapy.
Diabetic patients have a weak qi and yin, and for urinary tract infections, the traditional Chinese medicine attaches more importance to the basic pathogenesis of yin deficiency and bladder dampness and heat as the symptoms. In addition, Zhu Danxi has proposed the theory of “blood subjected to damp-heat will be clotted for a long time”; Wang Qingren has also said that “prolonged illness enters the lobe as stasis”. Throughout the formula, the legislation of clearing heat, invigorating blood and promoting dampness is in line with the traditional theory of Chinese medicine, and the whole formula can be divided into three major parts: clearing heat and detoxifying drugs, promoting dampness and cooling blood and invigorating blood.
In the present study, it has been confirmed that retention of urine tablets is better than antibiotic treatment alone in treating urinary tract infections in diabetic patients, and can reduce the recurrence rate within six months, reduce the development of bacterial resistance, and reduce the chance of secondary infections such as fungal infections. However, the antibacterial effect of antibiotics in the early stage (within two weeks) still has obvious advantages, so the combination of antibiotics can be applied in the early stage, and the use of antibiotics should not exceed three weeks, otherwise the possibility of bacterial resistance and secondary infections will be greatly increased.
Prospecting on this basis, this method focuses on expelling evil, and there is no intervention for the nature of Qi-Yin deficiency in diabetic patients. Therefore, if the use of corrective drugs is continued after the first stage of treatment to improve the immunity of the body, the recurrence rate can be expected to be further reduced.