Kuo H C
Department of Urology, Buddhist Tzu-Chi General Hospital, Hualien, Taiwan.
Urol Int. 1998;60(2):85-91. doi: 10.1159/000030217.
A prospective study was conducted in a community hospital in order to evaluate the therapeutic effect of dibenyline, finasteride, and a combination of the two drugs for symptomatic benign prostatic hyperplasia (BPH).
190 men suffering from severe prostatism entered this study. They were assessed by IPSS symptom score, digital rectal examination, transrectal sonography of the prostate, uroflowmetry and residual urine. The patients were randomly selected for medical treatment with dibenyline 10 mg b.i.d. (n = 71), finasteride 5 mg q.d. (n = 54), and a combination (n = 65). Clinical assessments were carried out before treatment and 3 and 6 months after starting treatment. Patients who could not complete the treatment and those with prostatic cancer were excluded from the final statistics. The quality of life after 6 months of treatment and side effects were also assessed.
A total of 172 patients completed the treatment course and 153 patients completed the periodic clinical assessments. Improvement in IPSS was noted in all 3 groups of patients both at 3 and 6 months. The prostatic volume was found to decrease in the finasteride group and the combination group at 6 months by 24.3 and 10.5%, respectively. Maximal flow rate (Qmax) was significantly improved in the dibenyline and combination groups but not in the finasteride group at 3 months. At 6 months a significant increase in Qmax was noted in all groups with a mean increase of 1.4-1.8 ml/s. The quality of life after treatment was satisfactory in 71.9% of the dibenyline group, 70.4% of the finasteride group and 83.1% of the combination group. Side effects were higher in the dibenyline than the finasteride or combination group. The dropout rate was higher in the dibenyline group (15.5%) than in the finasteride (7.5%) and combination (4.6%) groups. After 6 months of treatment, some of the patients discontinued medication and symptom relapse was noted in 92.6% of the dibenyline group, 57.6% of the finasteride group, and 71% of the combination group.
Medical treatment is effective in treating symptomatic BPH. Combination dibenyline and finasteride provides a weak synergistic clinical effect without additive side effects.
在一家社区医院进行了一项前瞻性研究,以评估酚苄明、非那雄胺及二者联合用药对有症状的良性前列腺增生(BPH)的治疗效果。
190名患有严重前列腺增生的男性进入本研究。通过国际前列腺症状评分(IPSS)、直肠指检、经直肠前列腺超声检查、尿流率测定和残余尿量对他们进行评估。患者被随机分为三组,分别接受酚苄明10毫克每日两次治疗(n = 71)、非那雄胺5毫克每日一次治疗(n = 54)以及联合治疗(n = 65)。在治疗前以及开始治疗后的3个月和6个月进行临床评估。无法完成治疗的患者以及患有前列腺癌的患者被排除在最终统计之外。还评估了治疗6个月后的生活质量和副作用。
共有172名患者完成了治疗疗程,153名患者完成了定期临床评估。所有三组患者在3个月和6个月时IPSS均有改善。非那雄胺组和联合治疗组在6个月时前列腺体积分别下降了24.3%和10.5%。3个月时,酚苄明组和联合治疗组的最大尿流率(Qmax)显著改善,而非那雄胺组未改善。6个月时,所有组的Qmax均显著增加,平均增加1.4 - 1.8毫升/秒。酚苄明组71.9%、非那雄胺组70.4%、联合治疗组83.1%的患者治疗后的生活质量令人满意。酚苄明组的副作用高于非那雄胺组或联合治疗组。酚苄明组的脱落率(15.5%)高于非那雄胺组(7.5%)和联合治疗组(4.6%)。治疗6个月后,一些患者停止用药,酚苄明组92.6%、非那雄胺组57.6%、联合治疗组71%的患者出现症状复发。
药物治疗对有症状的BPH有效。酚苄明和非那雄胺联合使用具有微弱的协同临床效果,且无附加副作用。