Li Ning-chen, Wu Shi-liang, Jin Jie, Qiu Shao-peng, Kong Chui-ze, Song Yong-sheng, Ye Zhang-qun, Sun Guang, Sun Ying-hao, Sun Yu-cheng, Wang Xiao-feng, Na Yan-qun
Department of Urology, Peking University First Hospital, Institute of Urology, Beijing 100034, China.
Zhonghua Wai Ke Za Zhi. 2007 Jul 15;45(14):947-50.
To compare the differences of the efficacy and different therapeutic drugs on the treatment of benign prostatic hyperplasia (BPH) in order to ensure the optimal indication for different BPH patients.
A randomized, parallel-controlled, multicenter clinical trial was conducted. From September 2002 to December 2003 906 BPH patients were enrolled into 7 therapeutic groups, including selective-adrenoceptor antagonist (terazosin, doxazosin tamsulosin and naftopidil), 5 alpha-reductase inhibitor (finasteride and epristeride) and natural product (cernilton). International Prostate Symptom Score (IPSS) and Quality of Life (QOL), uroflowmetry, total prostatic volume (TPV) and transitional zone volume and residual urine were used as efficacy criteria.
According to the baseline, the IPSS and Qmax were significantly correlated to the prostatic volume and transitional zone volume (P < 0.01). At average follow-up of 6 months, significant improvements in IPSS, QOL, Qmax and residual urine volume were observed in each therapeutic group, and no difference in IPSS improvement was found among the groups. Prostatic volume and transitional zone volume were significant decreased in 5alpha-reductase inhibitor groups (P < 0.05). In patients with baseline TPV greater than 35.5 cm3, the improvement of Qmax was more significant than that in patients with TPV less than 35.5 cm3 in finasteride group (P < 0.01) (5.7 ml/s and 2.2 ml/s respectively), and more significant symptomatic improvements were also found in cernilton, doxazosin and naftopidil group. In each group, the improvement of symptom were more significant in patients with IPSS higher than 20 points (P < 0.01).
Each drug observed in this study can improve the subjective and objective symptoms significantly for BPH patients, especially for patients with higher IPSS baseline. When using 5alpha-reductase inhibitor, prostatic volume can be decreased significantly and more obviously subjective and objective improvement can be found in the patients with TPV greater than 35.5 cm3.
比较治疗良性前列腺增生（BPH）的疗效差异及不同治疗药物，以确定不同BPH患者的最佳适应证。
进行一项随机、平行对照、多中心临床试验。2002年9月至2003年12月，906例BPH患者被纳入7个治疗组，包括选择性肾上腺素能受体拮抗剂（特拉唑嗪、多沙唑嗪、坦索罗辛和萘哌地尔）、5α-还原酶抑制剂（非那雄胺和依立雄胺）和天然产物（舍尼通）。采用国际前列腺症状评分（IPSS）、生活质量（QOL）、尿流率、前列腺总体积（TPV）、移行区体积和残余尿量作为疗效指标。
根据基线情况，IPSS和最大尿流率（Qmax）与前列腺体积和移行区体积显著相关（P<0.01）。平均随访6个月时，各治疗组的IPSS、QOL、Qmax和残余尿量均有显著改善，各治疗组间IPSS改善情况无差异。5α-还原酶抑制剂组的前列腺体积和移行区体积显著减小（P<0.05）。在非那雄胺组中，基线TPV大于35.5 cm³的患者Qmax改善比TPV小于35.5 cm³的患者更显著（P<0.01）（分别为5.7 ml/s和2.2 ml/s），舍尼通、多沙唑嗪和萘哌地尔组的症状改善也更显著。在每组中，IPSS高于20分的患者症状改善更显著（P<0.01）。
本研究中观察到的每种药物均可显著改善BPH患者的主观和客观症状, 尤其是基线IPSS较高的患者。使用5α-还原酶抑制剂时，前列腺体积可显著减小，TPV大于35.5 cm³的患者主观和客观改善更明显。
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