Serefoglu Ege C, Smith Ted M, Kaufman Gregory J, Liu Genzhou, Yafi Faysal A, Hellstrom Wayne J G
Bagcilar Training & Research Hospital, Department of Urology, Istanbul, Turkey.
Auxilium Pharmaceuticals, Chesterbrook, PA.
Urology. 2017 Sep;107:155-160. doi: 10.1016/j.urology.2017.05.029. Epub 2017 May 26.
To elucidate patient characteristics that impact symptom-related bother and erectile function in patients with Peyronie disease (PD).
A post hoc analysis used data from patients with PD (ie, had PD symptoms ≥12 months and penile curvature deformity of 30-90 degrees) who received ≥1 injection of study medication in 2 phase 3 trials of collagenase clostridium histolyticum (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Study I [n = 417] and Investigation for Maximal Peyronie's Reduction Efficacy and Safety Study II [n = 415]). The Covariance Analysis of Linear Structural Equations procedure was used to estimate the potential relationship of specified variables on the level of distress and erectile dysfunction associated with PD as measured by the Peyronie's Disease Questionnaire and the International Index of Erectile Function, erectile function domain.
Pain during intercourse (P = .02) and PD bother (P <.0001) had a significant impact on International Index of Erectile Function, erectile function scores. The Peyronie's Disease Questionnaire bother domain score was significantly affected by penile curvature deformity, penile shortening, pain during intercourse, and the presence of plaques (P ≤.0005 for all), with pain during intercourse having the greatest impact (maximum likelihood estimation ± standard error = .496 ± .030; P <.0001). Erectile function did not appear to be directly influenced by the presence of plaques, penile curvature deformity, or penile shortening but was associated with PD bother and penile pain.
This post hoc analysis provides a conceptual framework through which disease characteristics may impact PD-related bother and erectile function in patients with PD.
阐明影响佩罗尼氏病(PD)患者症状相关困扰和勃起功能的患者特征。
一项事后分析使用了来自PD患者(即有PD症状≥12个月且阴茎弯曲畸形30 - 90度)的数据,这些患者在两项溶组织梭状芽孢杆菌胶原酶3期试验(最大佩罗尼氏病缓解疗效和安全性研究I [n = 417]和最大佩罗尼氏病缓解疗效和安全性研究II [n = 415])中接受了≥1次研究药物注射。使用线性结构方程的协方差分析程序来估计特定变量与通过佩罗尼氏病问卷和国际勃起功能指数勃起功能领域测量的与PD相关的痛苦和勃起功能障碍水平之间的潜在关系。
性交时疼痛(P = .02)和PD困扰(P < .0001)对国际勃起功能指数、勃起功能评分有显著影响。佩罗尼氏病问卷困扰领域得分受阴茎弯曲畸形、阴茎缩短、性交时疼痛和斑块的存在显著影响(所有P≤.0005),性交时疼痛影响最大(最大似然估计±标准误 = .496±.030;P < .0001)。勃起功能似乎不受斑块、阴茎弯曲畸形或阴茎缩短的直接影响,但与PD困扰和阴茎疼痛有关。
这项事后分析提供了一个概念框架,通过该框架疾病特征可能影响PD患者与PD相关的困扰和勃起功能。