在 2 项大型、双盲、随机、安慰剂对照的 3 期研究中评估胶原酶注射治疗 Peyronie 病的临床疗效、安全性和耐受性。

Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies.

机构信息

Urology Associates Medical Group, Burbank, California 91505, USA.

出版信息

J Urol. 2013 Jul;190(1):199-207. doi: 10.1016/j.juro.2013.01.087. Epub 2013 Jan 31.

DOI:10.1016/j.juro.2013.01.087

PMID:23376148

Abstract

PURPOSE

IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) I and II examined the clinical efficacy and safety of collagenase Clostridium histolyticum intralesional injections in subjects with Peyronie disease. Co-primary outcomes in these identical phase 3 randomized, double-blind, placebo controlled studies included the percent change in the penile curvature abnormality and the change in the Peyronie disease questionnaire symptom bother score from baseline to 52 weeks.

MATERIALS AND METHODS

IMPRESS I and II examined collagenase C. histolyticum intralesional injections in 417 and 415 subjects, respectively, through a maximum of 4 treatment cycles, each separated by 6 weeks. Men received up to 8 injections of 0.58 mg collagenase C. histolyticum, that is 2 injections per cycle separated by approximately 24 to 72 hours with the second injection of each followed 24 to 72 hours later by penile plaque modeling. Men were stratified by baseline penile curvature (30 to 60 vs 61 to 90 degrees) and randomized to collagenase C. histolyticum or placebo 2:1 in favor of the former.

RESULTS

Post hoc meta-analysis of IMPRESS I and II data revealed that men treated with collagenase C. histolyticum showed a mean 34% improvement in penile curvature, representing a mean ± SD -17.0 ± 14.8 degree change per subject, compared with a mean 18.2% improvement in placebo treated men, representing a mean -9.3 ± 13.6 degree change per subject (p <0.0001). The mean change in Peyronie disease symptom bother score was significantly improved in treated men vs men on placebo (-2.8 ± 3.8 vs -1.8 ± 3.5, p = 0.0037). Three serious adverse events (corporeal rupture) were surgically repaired.

CONCLUSIONS

IMPRESS I and II support the clinical efficacy and safety of collagenase C. histolyticum for the physical and psychological aspects of Peyronie disease.

摘要

目的

IMPRESS（最大阴茎硬结症减少疗效和安全性研究）I 和 II 研究了胶原酶 Clostridium histolyticum 皮损内注射治疗阴茎硬结症患者的临床疗效和安全性。这两项相同的 3 期随机、双盲、安慰剂对照研究的主要疗效终点包括从基线到 52 周时阴茎弯曲畸形的百分比变化和阴茎硬结症问卷症状困扰评分的变化。

材料和方法

IMPRESS I 和 II 分别在 417 和 415 名受试者中检查了胶原酶 C. histolyticum 的皮损内注射，最多进行 4 个治疗周期，每个周期间隔 6 周。男性接受多达 8 次 0.58mg 胶原酶 C. histolyticum 的注射，每个周期注射 2 次，间隔约 24 至 72 小时，每个周期的第 2 次注射后 24 至 72 小时进行阴茎斑块成型。根据基线阴茎弯曲度（30 至 60 度与 61 至 90 度）对男性进行分层，并以 2:1 的比例随机分为胶原酶 C. histolyticum 或安慰剂组，前者占优势。

结果

IMPRESS I 和 II 数据的事后荟萃分析显示，接受胶原酶 C. histolyticum 治疗的男性阴茎弯曲度平均改善 34%，代表每个受试者平均±SD-17.0±14.8 度变化，而接受安慰剂治疗的男性平均改善 18.2%，代表每个受试者平均-9.3±13.6 度变化（p<0.0001）。与接受安慰剂治疗的男性相比，接受治疗的男性的阴茎硬结症症状困扰评分的平均变化显著改善（-2.8±3.8 与-1.8±3.5，p=0.0037）。3 例严重不良事件（阴茎破裂）接受了手术修复。