Department of Urology, Shaheed Modarress Hospital, Shahid Beheshti University, Tehran, Iran.
BJU Int. 2010 Jul;106(2):240-8. doi: 10.1111/j.1464-410X.2009.09041.x. Epub 2009 Oct 26.
To analyse the safety and efficacy of pentoxifylline sustained-release (PTX-SR) treatment in patients with early chronic Peyronie's disease (PD).
In all, 228 patients with a mean (sd) age of 51 (9) years who had early chronic PD were randomized to receive 400 mg PTX-SR (Apo-Pentoxifylline, Apotex Inc., Toronto, Canada) twice daily (group 1, 114) or similar regimen of placebo (group 2, 114) for 6 months. A medical history was taken and the men had a complete physical examination. The following variables were assessed before and after therapy: penile curvature and penile artery spectral traces (end-diastolic velocity, EDV, peak systolic velocity, PSV, and resistivity index, RI, of the right and left cavernous arteries assessed with dynamic penile duplex ultrasonography), plaque characteristics (assessed by penile X-ray and penile ultrasonography), pain (assessed by visual analogue scale), erectile function (assessed by the International Index of Erectile Function, IIEF questionnaire), treatment satisfaction (assessed by Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire), and side-effects. Patient perception of penile curvature and plaque size, and mean weekly intercourse attempts were also assessed.
Overall, 36.9% of patients who received PTX-SR reported a positive response, vs only 4.5% in the placebo group. Of patients in PTX-SR group, 12 (11%) had disease progression, vs 46 (42%) in placebo group (P = 0.01). Improvement in penile curvature (P = 0.01), and plaque volume (P = 0.001) was significantly greater in patients treated with PTX-SR than placebo. The increase in IIEF total score was significantly higher in the PTX-SR group (P = 0.02). Mean PSV changes after therapy compared to baseline were statistically significant between PTX-SR (right, +11.4%, left, +11.7%) and placebo-treated (+0.2% and -4.2%, respectively) patients (both P = 0.04).
PTX-R was moderately effective in reducing penile curvature and plaque volume in patients with early chronic PD. Further studies with different treatment regimens are needed to better elucidate the beneficial effects of PTX-SR in PD.
分析己酮可可碱持续释放（PTX-SR）治疗早期慢性佩罗尼氏病（PD）患者的安全性和疗效。
共纳入 228 例平均年龄（标准差）为 51（9）岁的早期慢性 PD 患者，随机分为两组，每日 2 次口服 400mgPTX-SR（Apo-己酮可可碱，Apotex Inc.，多伦多，加拿大）（组 1，114 例）或相似剂量安慰剂（组 2，114 例），疗程 6 个月。记录患者病史并进行全面体格检查。治疗前后评估以下变量：阴茎弯曲度和阴茎动脉频谱痕迹（右、左海绵体动脉舒张末期速度[EDV]、收缩期峰值速度[PSV]和阻力指数[RI]，采用动态阴茎双功能超声评估）、斑块特征（通过阴茎 X 射线和超声评估）、疼痛（采用视觉模拟评分评估）、勃起功能（采用国际勃起功能指数问卷[IIEF]评估）、治疗满意度（采用勃起功能障碍治疗满意度问卷[EDD]评估）和副作用。还评估了患者对阴茎弯曲度和斑块大小的感知以及每周尝试性交的平均次数。
总体而言，接受 PTX-SR 治疗的患者中，36.9%报告有阳性反应，而安慰剂组仅为 4.5%。PTX-SR 组中有 12 例（11%）患者疾病进展，而安慰剂组中有 46 例（42%）（P = 0.01）。与安慰剂组相比，PTX-SR 组的阴茎弯曲度（P = 0.01）和斑块体积（P = 0.001）改善更明显。PTX-SR 组 IIEF 总评分的增加明显更高（P = 0.02）。与基线相比，治疗后平均 PSV 的变化在 PTX-SR 组（右侧，+11.4%，左侧，+11.7%）和安慰剂治疗组（分别为+0.2%和-4.2%）之间具有统计学意义（均 P = 0.04）。
PTX-R 可有效降低早期慢性 PD 患者的阴茎弯曲度和斑块体积。需要进一步研究不同的治疗方案，以更好地阐明 PTX-SR 在 PD 中的有益作用。
