Hu Ming-Yeah Y, Sigalos John T, Walker Dyvon T, Li Michelle K, Yoffe Dar A, Modiri Neilufar, Gaither Thomas W, Santamaria Alvaro J, Regets Keith V, Eleswarapu Sriram V, Mills Jesse N
Division of Andrology, Department of Urology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Division of Urology, Department of Surgery, University of Colorado School of Medicine, Aurora, CO, USA.
Transl Androl Urol. 2022 Aug;11(8):1074-1082. doi: 10.21037/tau-22-188.
Peyronie's disease (PD) can be subdivided into acute and chronic phases. Intralesional collagenase has been shown to improve curvature in the chronic phase. Initial clinical trials excluded patients in the acute phase from treatment. Recent studies show comparable results among men in the acute phase. The definition of acute phase varies among existing studies, but it is generally understood to last 12-18 months and is accompanied by penile pain and progression of deformity. We sought to evaluate the safety and efficacy of intralesional collagenase injection therapy during the acute phase of PD using multiple definitions of the acute phase.
All men receiving intralesional collagenase for PD from October 2015 through December 2020 at a single academic institution were retrospectively assessed for patient demographics and comorbidities, pre- and post-treatment curvature, and adverse events. Two definitions of acute phase were used: (I) acute phase duration ≤6 months, chronic phase duration >6 months; and (II) acute phase duration ≤12 months with penile pain, chronic phase duration >12 or no penile pain.
Of 330 patients identified, 229 underwent intralesional collagenase treatment with pre- and post-treatment erect penile goniometry. 65 (28%) met criteria for definition 1 of acute phase, 37 (16%) met criteria for definition 2, and 76 (33%) met criteria for either. Percent change in penile curvature was not significantly different between acute and chronic phases using definition 1 (16.0% 16.6%, P=0.89), definition 2 (19.9% 15.7%, P=0.43), or either (16.5% 16.3%, P=0.96). The rates of development of bruising, swelling, hematoma, or corporal rupture were not significantly different between the acute and chronic phases under either definition (all P>0.05).
This single-center, retrospective cohort analysis suggests that intralesional collagenase is both safe and effective for the treatment of men with acute phase PD. Limitations exist inherent to retrospective review, since many men did not return for post-treatment goniometry, possibly skewing our cohort toward incomplete responders. Prospective, randomized studies will be required to confirm these findings.
佩罗尼氏病(PD)可分为急性期和慢性期。病灶内注射胶原酶已被证明可改善慢性期的阴茎弯曲度。最初的临床试验将急性期患者排除在治疗之外。最近的研究表明,急性期男性患者的治疗效果相当。现有研究中急性期的定义各不相同,但一般认为急性期持续12 - 18个月,伴有阴茎疼痛和畸形进展。我们试图使用多种急性期定义来评估病灶内注射胶原酶治疗PD急性期的安全性和有效性。
回顾性评估2015年10月至2020年12月在单一学术机构接受病灶内注射胶原酶治疗PD的所有男性患者的人口统计学和合并症、治疗前后的阴茎弯曲度以及不良事件。使用了两种急性期定义:(I)急性期持续时间≤6个月,慢性期持续时间>6个月;(II)急性期持续时间≤12个月且伴有阴茎疼痛,慢性期持续时间>12个月或无阴茎疼痛。
在330名确诊患者中,229名接受了病灶内胶原酶治疗,并进行了治疗前后的阴茎勃起角度测量。65名(28%)符合急性期定义1的标准,37名(16%)符合定义2的标准,76名(33%)符合任一标准。使用定义1(16.0%对16.6%,P = 0.89)、定义2(19.9%对15.7%,P = 0.43)或任一标准(16.5%对16.3%,P = 0.96)时,急性期和慢性期阴茎弯曲度的百分比变化无显著差异。在两种定义下,急性期和慢性期出现瘀斑、肿胀、血肿或阴茎海绵体破裂的发生率均无显著差异(所有P>0.05)。
这项单中心回顾性队列分析表明,病灶内注射胶原酶治疗PD急性期男性患者既安全又有效。回顾性研究存在固有的局限性,因为许多男性患者未返回进行治疗后的角度测量,这可能使我们的队列偏向于未完全缓解的患者。需要进行前瞻性随机研究来证实这些发现。