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预测胶原酶注射治疗 Peyronie 病的疗效:多中心单臂非安慰剂对照临床研究中建立列线图。

Predictors of treatment success after collagenase Clostridium histolyticum injection for Peyronie's disease: development of a nomogram from a multicentre single-arm, non-placebo controlled clinical study.

机构信息

Department of Urology, Careggi Hospital, University of Florence, Florence, Italy.

Urology Section, Department of Surgery, University of Catania, Catania, Italy.

出版信息

BJU Int. 2018 Oct;122(4):680-687. doi: 10.1111/bju.14410. Epub 2018 Jun 20.

DOI:10.1111/bju.14410
PMID:29791971
Abstract

OBJECTIVE

To build a nomogram able to predict treatment success after collagenase Clostridium histolyticum (CCH) for Peyronie's disease (PD).

MATERIALS AND METHODS

Between November 2016 and November 2017, we enrolled 135 patients with PD into a multicentre single-arm prospective study. All patients enrolled received CCH treatment. Success of therapy was defined as a decrease in penile curvature (PC) of ≥20° from baseline. Treatment satisfaction was assessed using a scale from 1 to 10, and high satisfaction was arbitrarily defined as a score of ≥8. Calcification level was classified as: absence of calcification; low perilesional calcification; and high calcification.

RESULTS

The median (interquartile range [IQR]) patient age was 56.0 (45.0-65.0) years and the median (IQR) was PC was 30 (30.0-60.0)°. After the treatment protocol, we observed a significant median change in PC of -20.0° (P < 0.01). The median (IQR) PC improvement was 44 (28.0-67.0)%. Overall median (IQR) satisfaction score was 8.0 (7.0-9.0). Treatment efficacy was reported in a total of 77 patients (57.04%). When analysing factors associated with PC improvement after treatment, we found that baseline PC (odds ratio [OR] 1.14; P < 0.01), basal plaque (OR 64.27; P < 0.01), low calcification (OR 0.06; P < 0.01) and high calcification (OR 0.03; P < 0.01) were significant predictors of PC improvement. The c-index for the model was 0.93.

CONCLUSIONS

Patients with longer PD duration, greater baseline PC and basal plaque location had a greater chance of treatment success. These results could be applied to clinical practice before external validation of our nomogram.

摘要

目的

建立预测胶原酶溶组织梭菌(CCH)治疗阴茎硬结症(PD)后治疗成功的列线图。

材料与方法

2016 年 11 月至 2017 年 11 月,我们纳入了 135 名 PD 患者进行一项多中心单臂前瞻性研究。所有纳入的患者均接受 CCH 治疗。治疗成功定义为从基线开始阴茎弯曲(PC)下降≥20°。采用 1 到 10 的量表评估治疗满意度,任意定义高满意度为评分≥8。钙化程度分为:无钙化;低旁皮质钙化;高钙化。

结果

患者年龄中位数(四分位距 [IQR])为 56.0(45.0-65.0)岁,PC 中位数(IQR)为 30(30.0-60.0)°。在治疗方案后,我们观察到 PC 有显著的中位数变化-20.0°(P < 0.01)。PC 改善的中位数(IQR)为 44(28.0-67.0)%。总体满意度中位数(IQR)为 8.0(7.0-9.0)。共有 77 名患者(57.04%)报告了治疗效果。在分析与治疗后 PC 改善相关的因素时,我们发现基线 PC(比值比 [OR] 1.14;P < 0.01)、基础斑块(OR 64.27;P < 0.01)、低钙化(OR 0.06;P < 0.01)和高钙化(OR 0.03;P < 0.01)是 PC 改善的显著预测因素。该模型的 C 指数为 0.93。

结论

PD 持续时间较长、基线 PC 较高和斑块位于基底的患者有更大的治疗成功机会。这些结果可以在我们的列线图外部验证之前应用于临床实践。

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