Pande Satabdi, Hazra Avijit, Kundu Anup Kumar
Department of Pharmacology, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal, India.
Department of Urology, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal, India.
Indian J Pharmacol. 2014 Nov-Dec;46(6):601-7. doi: 10.4103/0253-7613.144912.
Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms in elderly men. Selective alfa1-adrenergic antagonists are now first-line drugs in the medical management of BPH. We conducted a single-blind, parallel group, randomized, controlled trial to compare the effectiveness and safety of the new alfa1-blocker silodosin versus the established drug tamsulosin in symptomatic BPH.
Ambulatory male BPH patients, aged above 50 years, were recruited on the basis of International Prostate Symptom Score (IPSS). Subjects were randomized in 1:1 ratio to receive either tamsulosin 0.4 mg controlled release or silodosin 8 mg once daily after dinner for 12 weeks. Primary outcome measure was reduction in IPSS. Proportion of subjects who achieved IPSS <8, change in prostate size as assessed by ultrasonography and changes in peak urine flow rate and allied uroflowmetry parameters, were secondary effectiveness variables. Treatment emergent adverse events were recorded.
Data of 53 subjects - 26 on silodosin and 27 on tamsulosin were analyzed. Final IPSS at 12-week was significantly less than baseline for both groups. However, groups remained comparable in terms of IPSS at all visits. There was a significant impact on sexual function (assessed by IPSS sexual function score) in silodosin arm compared with tamsulosin. Prostate size and uroflowmetry parameters did not change. Both treatments were well-tolerated. Retrograde ejaculation was encountered only with silodosin and postural hypotension only with tamsulosin.
Silodosin is comparable to tamsulosin in the treatment of BPH in Indian men. However, retrograde ejaculation may be troublesome for sexually active patients.
良性前列腺增生（BPH）是老年男性下尿路症状最常见的原因。选择性α1-肾上腺素能拮抗剂目前是BPH药物治疗的一线药物。我们进行了一项单盲、平行组、随机对照试验，以比较新型α1-阻滞剂西洛多辛与已上市药物坦索罗辛治疗有症状BPH的有效性和安全性。
根据国际前列腺症状评分（IPSS）招募年龄在50岁以上的门诊男性BPH患者。受试者按1:1比例随机分组，分别接受坦索罗辛0.4mg控释片或西洛多辛8mg，每日晚餐后服用12周。主要结局指标是IPSS的降低。达到IPSS<8的受试者比例、超声评估的前列腺大小变化以及最大尿流率和相关尿流率参数的变化是次要有效性变量。记录治疗中出现的不良事件。
分析了53名受试者的数据——26名服用西洛多辛，27名服用坦索罗辛。两组在12周时的最终IPSS均显著低于基线。然而，在所有访视中，两组在IPSS方面仍具有可比性。与坦索罗辛相比，西洛多辛组对性功能（通过IPSS性功能评分评估）有显著影响。前列腺大小和尿流率参数没有变化。两种治疗耐受性良好。仅西洛多辛组出现逆行射精，仅坦索罗辛组出现体位性低血压。
在治疗印度男性BPH方面，西洛多辛与坦索罗辛相当。然而，逆行射精可能会给性活跃患者带来困扰。
