Effect of Longbishu Capsule (癃闭舒胶囊) plus Doxazosin on Benign Prostatic Hyperplasia:A Randomized Controlled Trial

Objective：To investigate the effect of Longbishu Capsule（癃闭舒胶囊,LBS）,doxazosin,and combination therapy on benign prostatic hyperplasia（BPH）.Methods：A randomized,double-blind,multi-center parallel trial was conducted involving 360 patients in hospitals in Beijing（108 cases）,Heilongjiang（90 cases）,Sichuan（90 cases）,Shanghai（72 cases）,China.They were randomly assigned with central randomization method to group A（LBS placebo plus doxazosin）,group B（LBS plus doxazosin）or group C（LBS plus doxazosin placebo）,120 cases for each group.The international prostate symptom score,maximum urinary flow rate,postvoid residual urine volume and prostate volume were measured for evaluating the efficacy of the three treatments.Results：At baseline,there was no significant difference in the measured variables among the three groups.After 12-month treatment,the three groups showed significant improvements in IPSS and maximum urinary flow rate from baseline（P〈0.01）.Although postvoid residual urine volume was not significantly different from the baseline in group A（P〉0.05）,it significantly decreased in group B and C（P〈0.05）.The incidence of adverse events were similar among the three groups.Conclusions：The treatment of LBS alone or LBS plus doxazosin was able to significantly improve IPSS in patients with BPH.The treatments may reduce the increase in prostate volume and postvoid residual urine volume as well.

癃闭舒胶囊联合中药穴位贴敷治疗良性前列腺增生症临床研究

目的:观察癃闭舒胶囊联合中药穴位贴敷治疗良性前列腺增生症的临床疗效。方法:选取60例良性前列腺增生症患者作为研究对象,随机分为对照组和观察组各30例。对照组给予坦索罗辛缓释片联合非那雄胺片治疗,观察组在对照组基础上加用癃闭舒胶囊联合中药穴位贴敷治疗,2组疗程均为1月。对比分析2组临床疗效,观察治疗前后患者的前列腺体积(PV)、最大尿流率(Qmax)及残余尿量(PVR)的变化,记录不良反应情况。结果:观察组治疗总有效率93.33%,对照组治疗总有效率70.00%,2组比较,差异有统计学意义(P <0.05)。治疗后,2组PV均较治疗前缩小,Qmax均较治疗前提升,PVR均较治疗前减少,差异均有统计学意义(P <0.05);观察组PV小于对照组,Qmax大于对照组,PVR少于对照组,差异均有统计学意义(P <0.05)。结论:在常规西药治疗基础上加用癃闭舒胶囊联合中药穴位贴敷治疗良性前列腺增生症临床疗效显著,可明显改善患者的症状,无不良反应,值得临床推广应用。