三金片治疗下焦湿热证急性单纯性下尿路感染的随机对照双盲多中心临床研究

Sanjin Tablets for acute uncomplicated lower urinary tract infection in syndrome of dampness-heat in the lower jiao:A randomized,controlled,double-blind,multicenter clinical trial

目的:评价三金片治疗下焦湿热证急性单纯性下尿路感染的有效性和安全性,及其对复发率的影响,旨在为中医药治疗感染性疾病和临床减少抗生素应用提供高质量的循证依据。方法:本研究采用随机、双盲双模拟、阳性药平行对照的多中心临床试验设计,将252例受试者随机均分为3组。试验组给予三金片加左氧氟沙星片模拟剂治疗,对照1组给予左氧氟沙星片加三金片模拟剂治疗,对照2组前5天给予三金片加左氧氟沙星片,后2天给予三金片加左氧氟沙星片模拟剂治疗,每组治疗7 d。对临床症状治愈率、尿液分析检查复常率、细菌学检查清除率、综合疗效治愈率、症状量表及等级改善情况、单项症状消失率、复发率及抗生素用药频率(DDDs)等主要指标随访1~2次。结果:试验组在临床症状治愈率、尿液分析检查复常率、细菌学检查清除率、综合疗效治愈率、降低膀胱过度活动度总分、改善中医症状等级、中医尿急症状消失率方面优于对照2组(P<0.01,P<0.05),且与对照1组疗效相当;与对照2组比较,试验组可显著降低DDDs值(P<0.01)。安全性研究结果显示,对照1组发生1例不良事件,对照2组发生2例不良反应,但其临床症状停药或对症治疗后皆消失,无明显因药物而导致的实验室指标异常。结论:三金片治疗急性单纯性下尿路感染与左氧氟沙星片的疗效相当,可显著减少抗生素临床使用,有良好的临床应用价值。

Objective:To evaluate the efficacy and safety of Sanjin Tablets in the treatment of acute uncomplicated lower urinary tract infection in syndrome of dampness-heat in the lower jiao and its efficacy on recurrence rate,so as to provide highquality evidence-based basis for the treatment of infectious diseases with traditional Chinese medicine and clinical reduction of antibiotic application.Methods:The study was conducted in a randomized,double-blind,double-simulated,multi-center clinical trial design.A total of 252 cases were divided into 3 groups,treatment group(Sanjin Tablets combined with Levofloxacin Tablets simulator),control group 1(Sanjin Tablets simulator combined with Levofloxacin Tablets)and control group 2(The first 5 days were given Sanjin Tablets plus Levofloxacin Tablets,and the last 2 days were given Sanjin Tablets plus Levofloxacin Tablets simulator)averagelly.Each group was treated for 7 days.Major indicators such as cure rate of clinical symptoms,urinalysis recurrence rate,bacteriological clearance rate,comprehensive efficacy cure rate,symptom scale and grade improvement,disappearance rate of individual symptoms,recurrence rate and frequency of antibiotic use(DDDs)were followed up for 1 to 2 times.Results:The clinical cure rate,recovery rate of urine routine,clearance rate of bacteriological test,comprehensive efficacy of cure rate,reduce OABSS total score,the improvement of TCM symptoms grades,urgency symptoms disappear rate of traditional Chinese medicine in the treatment group were better than that of control group 2(P<0.01,P<0.05).And the efficacy was similar to that of control group 1.Compared with the control group 2,the treatment group could significantly reduce the DDDs value of antibiotic use frequency(P<0.01).The results of the safety showed that 1 case of AE occurred in the control group 1 and 2 cases of ADR in the control group 2,but their clinical symptoms disappeared after drug withdrawal or symptomatic treatment,and there was no obvious abnormal laboratory indicators caused by drugs.Conclusion:Sanjin Tablets has the same efficacy as levofloxacin tablet in the treatment of acute uncomplicated lower urinary tract infection,which can significantly reduce the clinical use of antibiotics and has good clinical application value.