| Objective:1.To further evaluate the efficacy and safety of Sanjin tablets in the treatment of acute simple lower urinary tract infection(Xiajiao damp heat syndrome)and its impact on the recurrence rate of patients;2.To provide theoretical basis for the clinical research of partial substitution of traditional Chinese medicine for antibiotics.Methods:The randomized,double-blind,double dummy,parallel controlled trial was conducted to select 54 patients diagnosed as acute simple lower urinary tract infection(Xiajiao damp heat syndrome)in the urology outpatient department of Hubei Provincial Hospital of traditional Chinese medicine(Guanggu District)from October 2018 to December 2019,to conduct a prospective study.The patients were divided into a group(test group),group B(control group 1)and group C(control group 2)by the method of central system random distribution.The sample ratio was 1:1:1.Group A: Sanjin Tablets+ Levofloxacin Tablets simulation agent,oral for 7 days;Group B:Sanjin tablet simulation agent + levofloxacin tablet,oral for 7days;Group C: Levofloxacin tablets + Sanjin tablets were taken orally for 5 days,and Levofloxacin simulation agent + Sanjin tablets were taken orally for 2 days.Recorded before and after treatment in patients with symptoms of 7 days evaluation,lab routine inspection,bacteriology inspection,security check,the illness severity score,TCM symptom scores,OABSS score,adverse reactions and other related indicators,after 7 days later recovered patients treated for 4 weeks follow-up and record signs and symptoms,routine urine examination,bacteriology examination index,judge the recurrence;SPSS22.0 software was used for data analysis.Results:1.Symptom evaluation: 15 patients in group A were cured,with A cure rate of 88.2%;17 patients in group B were cured,and the cure rate was 100%.Sixteen patients in group C were cured,and the cure rate was 94.1%.There was no statistical significance among the three groups(P > 0.05).2.Routine urine examination showed that the cure rate of group A was 64.7%;The cure rate of group B was 94.1%.The cure rate of group C was 94.1%.There was statistically significant difference between group A and B and between group A and C(P < 0.05),while there was no statistically significant difference between group B and C(P > 0.05).3.Bacteriological examination showed that 1 of the 6 patients in group A was cleared,with A clearance rate of 16.7%;In group B,5 cases were cleared,and the clearance rate was 100%.Ten of the 10 patients in group C were cleared,and the clearance rate was100%.There was statistically significant difference between group A and B and between group A and C(P < 0.05),while there was no statistically significant difference between group B and C(P >0.05).4.The severity of the disease was 7.47±2.48,2.24±2.97 in group A,6.88±2.29,0.35±0.61 in group B and 6.53±1.74,1.29± 1.65 in group C before and after treatment.There was no statistical significance in the difference of severity scores between the three groups after treatment and before treatment(P=0.203,P > 0.05).5.TCM symptom scores of the three groups before and after treatment were 9.71±2.82,1.94±3.96,9.35±2.45,0.24±0.44,9.12±1.96,0.88±1.83,respectively.There was no significant difference in TCM symptom scores between the three groups after treatment and before treatment(P=0.343,P > 0.05).6.OABSS scores of the three groups before and after treatment were 2.65±1.37 and 0.82±1.67 in group A,2.77±1.52 and 0.12±0.49 in group B,and 2.18±1.24 and 0.24±0.56 in group C.There was no significant difference in OABSS scores between the three groups after treatment and before treatment(P=0.194,P > 0.05).7.The disappearance rates of frequent urination,urgent urination and dysuria in group A were 88.2%,88.2% and 76.5%,respectively;Group B patients were 100%,100%,100%;The patients in group C were 88.2%,100% and 82.4%,respectively.After treatment,there was no statistical significance in the disappearance rates of frequency of urination,urgency of urination and dysuria among the three groups(P > 0.05).8.Recurrence criteria: 0 of the 9 patients in group A had recurrence,and the recurrence rate was 0%;5 of the 15 patients in group B relapsed,and the recurrence rate was 33.3%.In group C,2 of the 15 patients relapsed,and the recurrence rate was 13.3%.There was statistically significant difference between group A and B,B and C(P < 0.05),while there was no statistically significant difference between group A and C(P > 0.05).Conclusion:In this study,Sanjin Tablets,Levofloxacin Tablets and Sanjin Tablets combined with Levofloxacin Tablets were compared to show the effectiveness and safety of Sanjin Tablets in the treatment of acute simple lower urinary tract infection(lower coke damp-heat syndrome).In terms of improving symptoms and signs,it was similar to levofloxacin tablet in terms of reducing the severity rating score,TCM symptom score and OABSS score.In addition,levofloxacin is better than levofloxacin in preventing recurrence of acute simple lower urinary tract infection.The combination of levofloxacin and levofloxacin can reduce the dosage of levofloxacin without decreasing efficacy.Therefore,in the antibiotic treatment of acute simple lower urinary tract infection,the early addition of Sanjin Tablet can accelerate the improvement of the symptoms and signs of patients,reduce the recurrence rate,improve the efficacy,improve the level of rational drug use,especially the rational application of antibiotics,to provide a reference for clinical drug use. |
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