爱普列特治疗良性前列腺增生的有效性及安全性

目的 评价爱普列特治疗BPH的有效性和安全性.方法 采用随机、双盲、双模拟及安慰剂对照的多中心临床试验方法.分3组:爱普列特组10例,平均年龄(72±10)岁;非那雄胺(商品名:保列治)组13例.平均年龄(70±10)岁;安慰剂组16例,平均年龄(70±7)岁.3组患者接受治疗时间均为6个月.每月随访1次,随访评估内容包括IPSS、困扰评分、前列腺体积、尿流率、残余尿量、PSA及国际勃起功能评分问卷(IIEF-5)等,治疗前所有评估指标3组间比较差异均无统计学意义(P值均＞0.05).采用SAS 9.0统计学软件,双侧检验,计量数据组间比较采用t检验,计数数据组间比较采用χ~2检验,a=0.05.结果 爱普列特组IPSS评分F降50.0%±10.3%,与保列治组(37.0%±11.2%)比较差异无统计学意义(P=0.94),但均高于安慰剂组(22.0%±7.6%,P＜0.05);爱普列特组前列腺体积缩小40.0%±12.1%,明显高于保列治组(19.1%±7.3%,P=0.041)及安慰剂组(4.3%±3.2%,P=0.004),保列治组前列腺体积缩小百分比与安慰剂组比较差异无统计学意义(P=0.348).爱普列特组患者Q_(max)改善70.2%±13.9%,与保列治组(50.0%±9.7%)比较差异无统计学意义(P=0.630),但均显著高于安慰剂组(0.5%±0.8%,P＜0.05).其他几项评估指标3组间比较差异无统计学意义.结论 爱普列特能安全有效地治疗BPH,与保列治比较,缩小前列腺体积的疗效更快且更显著.

A randomized,double blind,double imitation clinical trial to study the efficacy and safety of epristeride in the treatment of benign prostatic hyperplasia

Objective To clarify the efficacy and safety of epristeride for treatment of benign prostatic hyperplasia(BPH). Methods A 6-month,randomized,double blind,double imitation multicenter clinical trial was conducted.The trial involved 39 patients to compare the efficacy and safe- ty of epiristeride,proscar and placebo on measures of BPH. Results All patients completed the whole protocol of the trial.The baseline evaluation items including IPSS,bother score.volume of prostate,uroflowmetry,residual urine and serum PSA had no significant differences among the 3 groups of epristeride,proscar and placebo.The reduction percentage of IPSS in epristerede group (50.0±10.3)％had no significant differenc as compared to proscar group(37.0±11.2)％(P=0.94),but both groups had higher reduction percentages than that of placebo group(22.0±7.6)％ (P=0.017,0.008,respectively).The shrinkage percentage of prostate volume in epristeride group (40.O±12.1)％was higher than those of proscar(19.1±7.3)％(P=0.041)and placebo groups (4.3±3.2)％(P=0.004),but shrinkage percentage of prostate volume in proscar group had no sig- nificant difference as compared to that of placebo group(P=0.348).The improvement percentage of Q_(max) in epristeride group(70.2±1 3.9)％had no significant difference as compared to proscar (50.0±9.7)％(P=0.630),both groups had higher improvement percentage of Qmax than that of pla- cebo group(0.5±0.8)％(P=0.009,0.022,respectively).Other evalution items including residual urine,serum PSA and IIEF-5 had no significant differences among the 3 groups. Conclusion Epris- teride iS a patent non-competitive 5a-reductase inhibitor for treatment of BPH.and it had more obvious quickness and effectiveness on shrinkage of prostate volume as compared to proscar.