Clinical Evaluation Of Lingshao Zaoren Formula Granule Intervention Tio Deficiency Of Spleen And Kidney Of Female Patients With Overactive Bladder

Objective:To evaluate the clinical efficacy and safety of Lingshao Zaoren Formula granule in treating female bladder activity with two deficiency of spleen and kidney through randomized controlled clinical trial,meanwhile,analysing the differences of the therapeutic characteristics and symptom improvement between Lingshao Zaoren Formula granule and TolterodineMethods:From April 2018 to December 2019,128 female patients aged 18-60 who were diagnosed with overactive bladder in the outpatient department of urology in our hospital were divided into treatment group and control group by stratified randomization and double-blind method,each group of 64 patients.The patients in the treatment group were treated with Lingshao Zaoren Formula granule,take after mixing it with 250ml warm boiled water,one bag each morning and evening after meal,on this basis,Tolterodine Tartrate Sustained Release Tablets placebo was also be taken,4 mg,daily after breakfast;the patients in the control group were treated with Tolterodine Tartrate Sustained Release Tablets,4 mg,daily after breakfast,on this basis.Lingshao Zaoren Formula granule placebo was also be taken,mixing it with 250ml warm boiled water,one bag each morning and evening after meal.The treatment course of both groups were 4 weeks.The changes of overactive bladder symptom score(OABSS),TCM symptom score were observed before and after 2?4 weeks treatment,meanwhile,the urine NGF?BDNF levels in the two groups changes between before and after 4 weeks of treatment were also be observed.Resulats:1.There was no statistical difference in age,duration of disease,OABSS score,TCM symptom score,urine NGF?BDNF level between 64 patients in the treatment group and 64 patients in the control group(P>0.05).Balanced grouping and baseline is comparable.2.After 2 weeks of treatment,OABSS scores and TCM symptom scores of Lingshao Zaoren Formula granule treatment group and toterodine control group were significantly lower than those before treatment,and has showed statistical difference(P<0.001);Compared two groups,the OABSS score of treatment group was better than that of control group,the difference was statistically significant(P<0.05).The TCM symptom score of the treatment group was better than that of the control group,but the difference was not statistically significant(P>0.05).3.After 4 weeks of treatment,OABSS scores and TCM symptom scores of Lingshao Zaoren Formula granule treatment group and toterodine control group were also significantly lower than those before treatment,and has showed statistical difference(P<0.001);The comparison between the two groups showed that the improvement of OABSS score and TCM symptom score in treatment group was better than that in control group,and has showed significant statistical difference(P<0.001).4.In terms of efficacy evaluation,after 4 weeks of treatment,30 cases were markedly effective,29 cases were effective and 5 cases were ineffective in the Lingshao Zaoren formula granule treatment group,the total effective rate is 92.2%;5 cases were markedly effective,37 cases were effective and 22 cases were ineffective in the Tolterodine control group,the total effective rate is 65.6%.The comparison between the two groups has showed significant statistical difference(P<0.001).5.The urine NGF and BDNF levels in the treatment group were significantly lower after 4 weeks treatment,and has showed statistical difference(P<0.001).The urine NGF and BDNF levels in the control group after 4 weeks of treatment were lower than those before treatment,the difference was statistically significant(P<0.05).Compared two groups,the NGF level decreased in the treatment group was significantly better than that in the control group,and has showed statistical difference(P<0.001),the BDNF level decreased in the treatment group was better than that in the control group,the difference was statistically significant(P<0.05).6.In the aspect of safety evaluation,the observation results of safety indicators in the treatment group and the control group were normal before and after treatment.Conclusion:Lingshao Zaoren Formula granule can effectively improve the clinical symptoms of female overactive bladder patients with two deficiency of spleen and kidney,and the adverse reactions are less,it also could effectively improve the symptoms of patients OABSS and TCM symptom scores.It can significantly reduce the level of NGF and BDNF in urine of patients.