Clinical Observation Of Benign Prostatic Hyperplasia By Yuanbei Mixture Decoration

Objective:The study aimed to explore the addictive effect and safety of Yuanbei Mixture Decoration for Benign Prostatic Hyperplasia(BPH)patients with Kidney Deficiency and Phlegm-heat Syndrome.Methods:70 case of Mild-to-moderate BPH patients from outpatient and ward of our hosipital,accord with Western medicine diagnostic criteria and TCM diagnostic criteria,were randomly divided into experimental group and control group.The experimental group was treated by Yuanbei Mixture Decoration.The control group was treated by Tamsulosin Hydrochloride Sustained Release Capsules.Both groups take medication consecutively for 12 weeks.I-PSS,QOL,Qmax,Qave,urinary bladder residual urine volume,prostate volume and the TCM syndrome scores were assessed between before treatment and after treatment.The changes of the two groups and the differences between the two groups were compared after treatment.Meanwhile,adverse reactions were recorded,and the three routine tests,liver and kidney function,PSA,electrocardiogram and blood pressure indexes were observed as safety evaluation,finally the related data were statistically analyzed.Results:1.A total of 70 cases of mild-to-moderate BPH were enrolled,with 9 cases shedding and 61 cases completing the study.The total expulsion rate was 12.8%.2.At baseline,the scores of I-PSS,QOL,Qmax,Qave,urinary bladder residual urine volume,prostate volume and TCM syndrome showed no significant differences between the two groups(P>0.05).3.After 12-week treatment,significant improvement in total scores of I-PSS,QOL,Qmax,Qave and urinary bladder residual urine volume were observed for both groups(P<0.05),there was no significant difference in I-PSS,QOL,Qmax and urinary bladder residual urine volume between the two goups after 12-week treatment(P>0.05).4.After 12-week treatment,improvement in total scores of prostate volume were observed for the experimental group(P<0.05),but the control group was no significant difference in prostate volume after 12-week treatment(P>0.05),and there was no significant difference in prostate volume between the two goups after 12-week treatment(P>0.05).5.Improvement in the scores of TCM syndromes was observed in the TCM group instead of western medicine group after 12-week treatment(P<0.05).6.No serious adverse events were observed in the two groups,and there was no significant difference in the treatment-related adverse reactions between the two groups(P>0.05).Conclusion:1.There was no difference in curative effect between Yuanbei Mixture Decoration and Tamsulosin Hydrochloride Sustained Release Capsules in reducing the I-PSS,raising BPH patients life quality,improving the Qmax and Qave,decreasing residual urine volume and reducing the prostate volume.2.Yuanbei Mixture Decoration has significant effect on improving the patients with TCM Syndromes of BPH with Kidney Deficiency and Phlegm-heat Syndrome.3.Yuanbei Mixture Decoration is safe with the clinical use.