比较不同剂量舍尼通在防止良性前列腺增生疾病进程中的作用

目的:比较服用不同剂量舍尼通在防止BPH疾病进程的疗效和安全性。方法:将国际前列腺症状评分(IPSS)>7的用舍尼通治疗的BPH患者240例分成两组。试验组120例为口服舍尼通750mg/次,2次/d;对照组120例为口服舍尼通375mg/次,2次/d,疗程均为4年。观察2组治疗前后IPSS、前列腺体积、剩余尿、最大尿流率(Qmax)、血清前列腺特异性抗原(PSA)的变化,以及尿潴留和接受外科治疗的发生率。结果:试验组治疗前IP-SS为(20.1±4.1)分,前列腺体积为(37.8±12.5)ml,剩余尿为(42.5±6.6)ml,Qmax为(10.0±3.5)ml/s。试验组治疗4年后IPSS为(10.5±5.6)分,前列腺体积为(29.2±9.5)ml,剩余尿为(15.2±3.1)ml,Qmax为(16.2±4.5)ml/s。对照组治疗前IPSS为(19.2±3.8)分,前列腺体积为(37.1±11.9)ml,剩余尿为(41.8±6.1)ml,Qmax为(10.2±3.8)ml/s。对照组用药4年后IPSS为(14.9±4.3)分,前列腺体积为(34.7±9.8)ml,剩余尿为(25.6±4.6)ml,Qmax为(13.5±4.1)ml/s。试验组比对照组IPSS、前列腺体积、剩余尿、Qmax改善更明显(P<0.0001)。与治疗前比,IPSS试验组在治疗3个月后[(16.7±3.9)分,P<0.0001],对照组在6个月后[(17.6±3.3)分,P=0.0010)有改善。前列腺体积试验组在治疗1年后[(15.6±3.2)ml,P=0.0487]有改善,对照组4年时[(25.6±4.6)ml,P=0.1040]仍无改善。剩余尿试验组[(38.7±6.1)ml,P<0.0001]与对照组[(40.2±5.5)ml,P=0.0422]在治疗3个月后都有改善。Qmax试验组在治疗6个月后[(13.2±4.1)ml/s,P<0.0001],对照组在9个月后[(12.0±3.7)ml/s,P=0.0005]有改善。尿潴留发生数试验组(5人次)比对照组(16人次)低(P=0.0147)。接受外科治疗的发生数更低试验组(2人次)比对照组(8人次)低(P=0.0462)。试验组PSA治疗前为(4.5±3.3)ng/ml,治疗后为(4.1±2.9)ng/ml,二者无明显变化(P=0.3496)。对照组PSA治疗前为(4.6±2.9)ng/ml,治疗后为(4.3±2.1)ng/ml,二者无明显变化(P=0.3805)。试验组和对照组均无发生舍尼通引起药物不良反应。结论:长期采用舍尼通750mg/次剂量治疗比375mg/次剂量改善BPH所导致的症状更快、更显著,在防止良性前列腺增生疾病进展上也更好,且无明显不良反应。

A Comparative Study on Different Doses of Cernilton for Preventing the Clinical Progression of Benign Prostatic Hyperplasia

OBJECTIVE: To compare the efficacy and safety of different doses of cernilton in preventing the clinical progression of benign prostatic hyperplasia (BPH). METHODS: 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 (Prostat), 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. RESULTS: 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. CONCLUSION: 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.