Xu Jun, Qian Wei-qing, Song Jian-da
Department of Urology, Huadong Hospital, Fudan University, Shanghai 200040, China.
Zhonghua Nan Ke Xue. 2008 Jun;14(6):533-7.
To compare the efficacy and safety of different doses of cernilton in preventing the clinical progression of benign prostatic hyperplasia (BPH).
A total of 240 BPH patients with the International Prostate Symptom Score (IPSS) >7 were equally allocated to an experimental and a control group and treated with oral cernilton (Prostate), the former at the dose of 750 mg, the latter at 375 mg, both twice a day for 4 years. Changes, of IPSS, prostate volume, postvoid residual urine, maximum flow rate (Qmax), prostate specific antigen (PSA), the incidence of urine retention and the rate of surgery were compared between the two groups after the treatment.
In the experimental group, the IPSS, prostate volume, postvoid residual urine and Qmax were 10.5 +/- 5.6, (29.2 +/- 9.5) ml, (15.2 +/- 3.1) ml and (16.2 +/- 4.5) ml/s after the treatment, as compared with 20.1 +/- 4.1, (37.8 +/- 12.5) ml, (42.5 +/- 6.6) ml and (10.0 +/- 3.5) mVs before the treatment, while in the control group, the four indexes were 14.9 +/- 4.3 vs 19.2 +/- 3.8, (34.7 +/- 9.8) ml vs (37.1 +/- 11.9) ml, (25.6 +/- 4.6) ml vs (41.8 +/- 6.1) ml and (13.5 +/- 4.1) ml/s vs (10.2 +/- 3.8) ml/s, with a more obvious improvement in the experimental group than in the control after the 4-year treatment (P < 0.0001). Compared with pre-treatment, the IPSS and Qmax were improved 3 months (16.7 +/- 3.9, P < 0. 000 1) and 6 months ([13.2 +/- 4.1] ml/s, P < 0. 0001) respectively after the treatment in the experimental group, compared with 6 months (17.6 +/- 3.3, P = 0.0010) and 9 months ([12.0 +/- 3.7] ml/s, P = 0.0005) in the control; the prostate volume was improved 1 year after the treatment in the former ( [ 15.6 +/- 3.2 ] ml,P = 0.0487) but not at 4 years in the latter ([25.6 +/- 4.6] ml,P = 0.1040). The postvoid residual urine was improved at 3 months in both the experimental ([38.7 +/- 6.1] ml, P < 0.000 1) and the control group ([40.2 +/- 5.5] ml, P = 0.0422). The incidence of urine retention was lower in the former than in the latter (5 vs 16 person-times, P = 0.0147), and so was the rate of surgery (2 vs 8 person-times, P = 0.046 2). There were no significant differences in PSA between the pre-and post-treatment either in the experimental (P = 0.349 6) or in the control group (P = 0.3805). No toxical and adverse effects were observed.
Long-term administration of cernilton at the dose of 750 mg may achieve faster and more obvious efficacy than at 375 mg in improving symptomatic BPH and preventing the clinical progression of BPH, with no adverse events.
比较不同剂量舍尼通在预防良性前列腺增生（BPH）临床进展方面的疗效和安全性。
将240例国际前列腺症状评分（IPSS）>7的BPH患者平均分为实验组和对照组，口服舍尼通（普适泰）治疗，前者剂量为750mg，后者为375mg，均每日2次，治疗4年。比较两组治疗后IPSS、前列腺体积、残余尿量、最大尿流率（Qmax）、前列腺特异抗原（PSA）、尿潴留发生率及手术率的变化。
治疗后实验组IPSS、前列腺体积、残余尿量及Qmax分别为10.5±5.6、（29.2±9.5）ml、（15.2±3.1）ml及（16.2±4.5）ml/s，治疗前分别为20.1±4.1、（37.8±12.5）ml、（42.5±6.6）ml及（10.0±3.5）ml/s；对照组上述四项指标治疗后分别为14.9±4.3对19.2±3.8、（34.7±9.8）ml对（37.1±11.9）ml、（25.6±4.6）ml对（41.8±6.1）ml及（13.5±4.1）ml/s对（10.
