| ForewordAcute uncomplicated lower urinary tract infection(AULUTI)is one of the most common conditions in renal and urological clinical practice and is prone to resistance with inappropriate use of antimicrobials as the drug of choice.Currently,increasing antimicrobial resistance and the lack of new oral antibiotics targeting resistant pathogens have become two major crises forcing clinicians and antibiotic stewardship programs to find innovative approaches.In light of the above,reducing antibiotic dependence and choosing effective alternative therapies have become hot issues that need to be addressed.Chinese patent medicine treatment of this disease can be based on the whole,specimen consideration,in the elimination of urinary tract irritation symptoms at the same time also has the advantages of tonic,less drug resistance.AULUTI is a type of "strangury" in Chinese medicine,with the pathogenesis of the disease being based on unfavorable bladder gasification,and the Chinese medical evidence classifying dampness-heat diffusing downward as the main syndrome.This formula embodies the TCM treatment of clearing heat,detoxifying toxins,and relieving dampness,and has shown antibacterial effects in clinical practice.Therefore,this study systematically evaluated the efficacy and safety of clearing heat and freeing strangury prescription for AULUTI treatment.Due to the low quality of the included literature,a multicenter randomized controlled trial was conducted to clarify the clinical efficacy of clearing heat and freeing strangury prescription for the intervention of AULUTI(syndrome of dampness-heat diffusing downward)using levofloxacin tablets as a control,which provides evidence-based evidence for the treatment of AULUTI with clearing heat and freeing strangury prescription and is important for the clinical search for alternative antibiotic therapy.This research is of great significance.ObjectiveTo evaluate the clinical efficacy and safety of clearing heat and freeing strangury prescription in the treatment of AULUTI(syndrome of dampness-heat diffusing downward).MethodsPart Ⅰ:Randomized controlled trials on the treatment of AULUTI with clearing heat and freeing strangury prescription were conducted by searching eight databases including SinoMed,Cochrane Library,and PubMed,built up to October 15,2021.The risk of bias of the included studies was assessed using the Cochrane Risk of Bias tool and the CONSORT randomized controlled trials reporting information checklist.RevMan 5.4 was used for Meta-analysis,and the ROB tool of the Cochrane Collaboration Network was used for literature quality assessment.Part Ⅱ:A stratified area,randomized,double-blind,positive-drug parallel-controlled,multicenter clinical trial design was used.A total of 160 AULUTI(syndrome of dampness-heat diffusing downward)patients from 5 hospitals were included and randomly divided into the experimental group and the control group in a 1:1 ratio.The experimental group was given clearing heat and freeing strangury prescription and levofloxacin tablets mimetic,while the control group was administered levofloxacin tablets and clearing heat and freeing strangury prescription mimetic,both with a treatment duration of 7 days,and the recurrence rate of cured patients was followed up after 1 month.ResultsPart Ⅰ:A total of 354 papers were retrieved and 12 were finally included,with a total sample size of 1596 cases,808 cases in the experimental group and 788 cases in the control group,and the overall quality of the included studies was low.Meta-analysis results showed that:in terms of therapeutic effect,compared with quinolone antibiotics group,clearing heat and freeing strangury prescription combined with quinolone antibiotics had a higher recovery rate of AULUTI(RR=1.20,95%CI[1.10,1.30],P<0.0001).And the recovery rate of clearing heat and freeing strangury prescription group was comparable to that of the quinolone antibiotics group(RR=0.87,95%CI[0.74,1.02],P=0.09);the total effective rate of clearing heat and freeing strangury prescription combined with quinolone antibiotics was higher than that of the quinolone antibiotics group(RR=1.13,95%CI[1.05,1.21],P=0.0005),and the total effective rate of clearing heat and freeing strangury prescription was comparable to that of the quinolone antibiotics group(RR=0.97,95%CI[0.86,1.09],P=0.60);the recurrence rate of clearing heat and freeing strangury prescription(combined with quinolone antibiotics)group was lower than that of the quinolone antibiotics group(RR=0.40,95%CI[0.19,0.80],P=0.010).In terms of bacteriological examination and clinical symptoms,the bacteriological clearance rate in the clearing heat and freeing strangury prescription combined with quinolone antibiotics group was higher than that in the quinolone antibiotics group(RR=1.28,95%CI[1.04,1.57],P=0.02),and the bacteriological clearance rate in the clearing heat and freeing strangury prescription group was comparable to that in the quinolone antibiotics group(RR=0.77,95%CI[0.09,6.80],P=0.81);the urinalysis recurrence rate in the clearing heat and freeing strangury prescription combined with quinolone antibiotics group was comparable to that in the quinolone antibiotics group(RR=1.06,95%CI[0.94,1.19],P=0.36);the urinalysis recurrence rate in the clearing heat and freeing strangury prescription alone group was lower than that in the quinolone antibiotics alone group(RR=0.68,95%CI[0.52,0.88],P=0.004);the disappearance rate of urinary frequency,urgency and pain after treatment in the clearing heat and freeing strangury prescription combined with quinolone antibiotics group was comparable to that in the quinolone antibiotics group(RRurinary frequency=1.01,95%Cl[0.75,1.34],P urinary frequency=0.97;RR urinary urgency=1.18,95%Cl[0.71,1.99],P urinary urgency=0.52;RR Urination pain=0.95,95%Cl[0.74,1.22],P Urination pain=0.70),and the disappearance rate of urinary frequency,urgency and pain after treatment in the clearing heat and freeing strangury prescription group and the quinolone antibiotic group were comparable(RR urinary frequency=0.98,95%Cl[0.82,1.17l,P dysuria=0.82;RR urinary urgency=0.28,95%Cl[0.00,52.12],P urinary urgency=0.63;RR Urination pain=0.91,95%Cl[0.69,1.18],P Urination pain=0.46),the intervention of clearing heat and freeing strangury prescription(combined with quinolone antibiotics)was able to shorten the time to eliminate the symptoms of urinary tract infection.In terms of adverse reactions,fewer adverse reactions occurred in the clearing heat and freeing strangury prescription combined with quinolone antibiotics group than in the quinolone antibiotics group(RR=0.48,95%CI[0.29,0.80],P=0.004).Adverse reactions in the clearing heat and freeing strangury prescription group were comparable to those in the quinolone antibiotics group(RR=0.75,95%CI[0.27,2.13],P=0.59).Part II:A total of 160 patients with clinical diagnosis were included,of which 159 entered FAS(79 in the experimental group and 80 in the control group),148 entered PPS(73 in the experimental group and 75 in the control group),and 159 entered SS(79 in the experimental group and 80 in the control group).The analysis results showed that the overall efficacy in the FAS(PPS):the comprehensive cure rate was 64.6%(69.9%)in the experimental group and 57.5%(61.3%)in the control group;the clinical symptom cure rate was 67.1%(72.6%)in the experimental group and 65.0%(69.3%)in the control group;the comprehensive recurrence rate was 17.6%in the experimental group and 10.9%in the control group.The efficacy and recurrence rates were balanced between the two groups(P>0.05),and the FAS and PPS analyses were consistent.In terms of laboratory tests,the recurrence rate of urinalysis in the FAS(PPS)was 73.4%(79.5%)in the experimental group and 66.3%(70.7%)in the control group;the clearance rate of bacteriological tests was 86.7%(92.9%)in the experimental group and 94.7%(100.0%)in the control group;the mean reduction of urinary WBC after treatment was 517.524ul in the experimental group and 335.971ul in the control group;the recurrence rate of urinalysis examination was 17.6%in the experimental group and 6.5%in the control group;the recurrence rate of bacteriological examination was 0%in the experimental group and 2.2%in the control group,and the laboratory examination results of the two groups improved significantly after treatment,and the efficacy was equally balanced(P>0.05),and FAS was consistent with the findings of PPS analysis.On the symptom and sign scale,the total score of severity of infection was reduced by 5.14±3.259 points in the experimental group and by 4.82±3.027 points in the control group after treatment;the total score of severity of infection was reduced by 7.66±3.798 points in the experimental group and by 7.79±4.350 points in the control group after treatment;the total score of OABSS in the experimental group The difference between before and after treatment was 1.92±2.197 points,and the difference in the control group was 1.77±2.486 points;the disappearance rate of each single symptom of urinary frequency,urinary urgency,and burning and stinging urethra was 55.7%(60.3%),63.3%(68.5%),and 64.6%(69.9%)in the experimental group,and 58.8%(62.7%)and 62.5%(66.7%)in the control group,respectively the recurrence rate of clinical symptoms was 9.8%in the experimental group and 8.7%in the control group.The total symptom scale score and individual symptoms in the two groups were significantly reduced(P<0.001)and disappeared after treatment,and the efficacy was balanced(P>0.05).The conclusions of the FAS and PPS analyses were consistent.Regarding safety,there was one adverse event in the control group,which was judged to be probably unrelated to the test drug;No adverse reactions occurred in the experimental group,and one adverse reaction occurred in the control group.ConclusionPart Ⅰ:The overall efficacy of clearing heat and freeing strangury prescription combined with quinolone antibiotics in the treatment of AULUTI was better than that of the quinolone antibiotics group,and the incidence of adverse reactions was significantly lower than that of the quinolone antibiotics group.However,there was some heterogeneity in the included studies,and given that the original studies were published over a large time span,were of low quality,and were mostly published in low-to mid-level journals,further validation using clinical trial protocols with large samples,rigorous designs,and in line with international norms is needed to provide more scientific and credible evidence-based clinical evidence.Part Ⅱ:The clinical cure rate,bacteriological clearance rate,urinalysis recurrence rate,recurrence rate,and improvement of clinical symptoms of patients with AULUTI(syndrome of dampness-heat diffusing downward)in the clearing heat and freeing strangury prescription group were equally balanced to those in the group that received sensitive antibiotics(levofloxacin),and no adverse reactions and adverse events occurred in the experimental group.It is of great significance in the clinical treatment of AULUTI(syndrome of dampness-heat diffusing downward)and in reducing the use of antibiotics,and is worthy of clinical application and promotion. |
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