Guzmán Raúl, Fernández Julio C, Pedroso Manuel, Fernández Lilia, Illnait José, Mendoza Sarahí, Quiala Ana T, Rodríguez Zunilda, Mena Jilma, Rodíguez Aylim, Campos Marbelis, Sánchez Carlos, Alvarez Yanet, Jiménez Gladys
Salvador Allende Hospital, Havana, Cuba.
National Center for Scientific Research, 25 Avenue and 158 st, Cubanacan, Playa, Havana, 113000, Cuba.
Ther Adv Urol. 2019 Jun 11;11:1756287219854923. doi: 10.1177/1756287219854923. eCollection 2019 Jan-Dec.
Benign prostatic hyperplasia (BPH), a common urological disease in aging men, frequently produces lower urinary tract symptoms (LUTS). Clinical studies have shown that terazosin relaxes the smooth muscle of the prostate and bladder, facilitates bladder emptying, improves LUTS, increases maximum urinary flow, and reduces the residual volume of urine. D-004, a lipid extract of the fruit of the Cuban royal palm (), presents a similar efficacy to Saw palmetto. Clinical studies have demonstrated its efficacy and safety in short- and medium-term trials in patients with BPH. The objective of this study was to compare the efficacy and tolerability of D-004 with terazosin for 6 months on LUTS in patients with BPH.
The present phase III study had an open, randomized, comparative design, with two parallel groups who received D-004 (320 mg/day) or terazosin (5 mg/day) for 6 months. The study included men at least 50 years of age, with evidence of the LUTS of moderate intensity according to the International Symptoms of the Prostate (IPSS). The effects on the IPSS Scale was the primary efficacy variable. The effects on the size of the prostate and the residual volume were secondary variables. The subjective self-perception of symptom relief at trial completion was a collateral outcome. Analysis was done by intention-to-treat.
The study included 100 men with a diagnosis of BPH, confirmed by digital rectal examination and ultrasonography, and moderate LUTS (IPSS score >7, <19). Baseline characteristics were similar in both groups. Nine patients did not continue the study: one from group D-004 (due to protocol violation) and eight from the terazosin group (six due to adverse events and two due to protocol violation; < 0.01). D-004 and terazosin significantly reduced the IPSS scores at the end of the 6 months of therapy by 74.2% and 66.1%, respectively, with respect to baseline values. Comparisons between groups performed showed that, at the end of the treatment, D-004 was more effective ( < 0.05) than terazosin in reducing the IPSS score. Although the average size of the prostate was reduced in both groups, this reduction reached statistical significance only for D-004. On the other hand, postvoid residual volume was significantly and similarly reduced in both groups. Both treatments were safe, while D-004 was better tolerated than terazosin.
D-004 administered at a dose of 320 mg/day for 6 months showed comparable efficacy with terazosin (5 mg/day) in reducing the LUTS (IPSS score), producing a significant decrease in prostate volume and postvoid residual volume. Both treatments were safe, with better tolerability for D-004 as compared with terazosin.
良性前列腺增生（BPH）是老年男性常见的泌尿系统疾病，常导致下尿路症状（LUTS）。临床研究表明，特拉唑嗪可松弛前列腺和膀胱的平滑肌，促进膀胱排空，改善LUTS，增加最大尿流率，并减少残余尿量。D-004是古巴王棕果实的脂质提取物，其疗效与锯叶棕相似。临床研究已证实其在BPH患者短期和中期试验中的疗效及安全性。本研究的目的是比较D-004与特拉唑嗪治疗6个月对BPH患者LUTS的疗效和耐受性。
本III期研究采用开放、随机、对照设计，分为两个平行组，分别接受D-004（320mg/天）或特拉唑嗪（5mg/天）治疗6个月。研究纳入年龄至少50岁、根据国际前列腺症状评分（IPSS）有中度强度LUTS证据的男性。对IPSS量表的影响是主要疗效变量。对前列腺大小和残余尿量的影响是次要变量。试验结束时症状缓解的主观自我感觉是一个附带结果。分析采用意向性分析。
该研究纳入100例经直肠指检和超声检查确诊为BPH且有中度LUTS（IPSS评分>7，<19）的男性。两组基线特征相似。9例患者未继续研究：1例来自D-004组（因违反方案），8例来自特拉唑嗪组（6例因不良事件，2例因违反方案；P<0.01）。治疗6个月结束时，D-004和特拉唑嗪使IPSS评分相对于基线值分别显著降低74.2%和66.1%。组间比较显示，治疗结束时，D-004在降低IPSS评分方面比特拉唑嗪更有效（P<0.05）。虽然两组前列腺平均大小均减小，但仅D-004组的减小具有统计学意义。另一方面，两组的排尿后残余尿量均显著且相似地减少。两种治疗均安全，而D-004的耐受性优于特拉唑嗪。
每天服用320mg D-004，持续6个月，在降低LUTS（IPSS评分）方面显示出与特拉唑嗪（5mg/天）相当的疗效，可使前列腺体积和排尿后残余尿量显著减少。两种治疗均安全，与特拉唑嗪相比，D-004的耐受性更好。
