胶原酶注射治疗急性期 Peyronie 病的安全性和疗效：多中心分析。

Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute Phase Peyronie's Disease: A Multi-institutional Analysis.

机构信息

Department of Urology, Tulane University School of Medicine, New Orleans, LA.

Department of Urology, Eastern Virginia Medical School, Norfolk, VA.

出版信息

Urology. 2020 Nov;145:147-151. doi: 10.1016/j.urology.2020.07.048. Epub 2020 Aug 7.

DOI:10.1016/j.urology.2020.07.048

PMID:32777367

Abstract

OBJECTIVE

To study, in a multi-institutional setting, the efficacy/safety outcomes in acute phase Peyronie's disease (PD) of multiple high-volume centers employing CCH to treat PD, which is defined as the abnormal formation of fibrous plaque(s) in the tunica albuginea of the penis. It is a chronic condition that afflicts 3%-13% of the US male population. There is no current multi-institutional research on the efficacy and safety of collagenase Clostridium histolyticum (CCH) in the treatment of acute phase PD.

METHODS

Retrospective data were collected for consecutive patients with PD who underwent treatment with CCH between April 2014 and March 2018 at 5 institutions. 918 patients were included. Patients with duration of PD no longer than 6 months at presentation qualified as being in the acute phase of PD. Main outcomes of interest include the change in curvature after receiving CCH therapy, and frequency of serious treatment-related adverse events. Successful improvement in curvature is defined as an at least 20% decrease in penile curvature from baseline after CCH therapy.

RESULTS

A total of 918 patients were included in the analysis, of which 134 (14.6%) qualified as acute phase PD (group 1) and the remaining 784 (85.4%) qualified as stable phase (group 2). Mean duration of PD was 4.44 ± 1.68 months for group 1, and 40.8 ± 61.2 months for group 2. There was no significant difference in final change in curvature between acute and stable phase of PD (13.5° vs 15.6°, P = .09). There was no statistically significant difference in frequency of treatment-related adverse events between the acute phase (16 patients, 11.9%) and the stable phase (77 patients, 9.8%; P = .44). In our multivariate analysis, only number of CCH cycles received was predictive of improvement of curvature.

CONCLUSION

This large multi-institutional analysis confirms that CCH therapy is as safe and efficacious in acute phase PD as it is in stable phase PD.

摘要

目的

在多机构环境中研究采用 CCH 治疗 PD 的多个大容量中心在急性 PD 中的疗效/安全性结果，PD 被定义为阴茎白膜中的纤维斑块异常形成。这是一种影响美国男性人口 3%-13%的慢性疾病。目前尚无关于胶原酶 C. histolyticum (CCH) 治疗急性 PD 的疗效和安全性的多机构研究。

方法

回顾性收集了 2014 年 4 月至 2018 年 3 月在 5 家机构接受 CCH 治疗的 PD 连续患者的数据。共纳入 918 例患者。发病时 PD 持续时间不超过 6 个月的患者符合急性 PD 标准。主要观察指标包括接受 CCH 治疗后曲率的变化，以及严重治疗相关不良事件的发生频率。成功改善曲率定义为 CCH 治疗后阴茎曲率至少比基线降低 20%。

结果

共纳入 918 例患者进行分析，其中 134 例（14.6%）符合急性 PD（第 1 组），其余 784 例（85.4%）符合稳定期（第 2 组）。第 1 组 PD 平均持续时间为 4.44±1.68 个月，第 2 组为 40.8±61.2 个月。急性和稳定期 PD 的最终曲率变化无显著差异（13.5°vs 15.6°，P=0.09）。急性期（16 例，11.9%）和稳定期（77 例，9.8%；P=0.44）治疗相关不良事件的发生率无统计学差异。在我们的多变量分析中，只有接受 CCH 周期的数量与曲率改善有关。