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胶原酶注射治疗对阴茎硬结症手术治疗的影响:基于人群的分析。

Impact of the Advent of Collagenase Clostridium Histolyticum on the Surgical Management of Peyronie's Disease: A Population-Based Analysis.

机构信息

Department of Urology, Columbia University, New York, NY, USA.

Department of Urology, Department of Biostatistics, Columbia University, New York, NY, USA.

出版信息

J Sex Med. 2020 Jan;17(1):111-116. doi: 10.1016/j.jsxm.2019.09.022. Epub 2019 Nov 21.

DOI:10.1016/j.jsxm.2019.09.022
PMID:31759930
Abstract

INTRODUCTION

Penile plication or partial excision with grafting has traditionally been the first-line treatment for stable Peyronie's disease (PD). Numerous injection therapies (ITs) have been introduced over the last few decades. Intralesional collagenase clostridium histolyticum (CCH) was U.S. Food and Drug Administration approved in 2013 for patients with stable disease, curvature ≥30° and ≤90°, and intact erectile function. The impact of the advent of CCH on the surgical management of PD is unknown.

AIM

We studied the effect of IT on the surgical management of PD in a population-based analysis.

METHODS

The Statewide Planning and Research Cooperative System database, which provides statewide level of all-payer data on patients in the outpatient, inpatient, ambulatory, and emergency department setting in New York State was reviewed. Patients undergoing a penile prosthesis for concurrent erectile dysfunction were excluded.

MAIN OUTCOME MEASURE

Descriptive statistics and multivariable logistic regression modeling were used to assess factors influencing choice of injection therapy vs surgical therapy (penile plication or partial excision with grafting).

RESULTS

From 2003-2016, 547 patients with PD presented for management. Median age was 56 years and 57% were white. Over the study period, surgical management was used less often as the primary procedure with a concurrent increase in use of IT (P < .001). On multivariable modeling, patients more likely to receive IT as treatment for penile curvature were younger (odds ratio [OR]: 1.26; P = .002; CI: 1.09-1.46), of higher socioeconomic status (OR: 1.14; P = .037; CI: 1.01-1.29), presented in the post-CCH era (OR: 1.17; P = .018; CI: 1.03-1.33) and presented to a surgeon with a high volume practice (OR: 1.25; P = .007; CI: 1.07-1.48). Patients presenting in the post-CCH era were 17% significantly more likely to receive IT.

CLINICAL IMPLICATIONS

ITs like CCH are increasingly displacing surgical management as the primary treatment option of Peyronie's disease.

STRENGTHS & LIMITATIONS: The Statewide Planning and Research Cooperative System database is particularly useful for this analysis because it is an all-payer database that tracks patients longitudinally across various health care settings-outpatient and inpatient.

LIMITATIONS

It only includes patients in New York State limiting generalizability. The retrospective nature of the analysis makes it subject to the biases inherent in such reports. Specific disease level characteristics (eg, degree of curvature, duration of disease, and associated deformities) were not available.

CONCLUSION

Since the introduction of CCH, there has been a markedly decreasing trend in the utilization of surgery as the primary modality in the management of PD-associated penile curvature. Sukumar S, Pijush DB, Brandes S. Impact of the Advent of Collagenase Clostridium Histolyticum on the Surgical Management of Peyronie's Disease: A Population-Based Analysis. J Sex Med 2020;17:111-116.

摘要

简介

传统上,阴茎折叠术或部分切除术加移植物一直是稳定型 Peyronie 病(PD)的一线治疗方法。在过去几十年中,已经引入了许多注射疗法(IT)。2013 年,美国食品和药物管理局(FDA)批准了腔内胶原酶梭菌组织溶菌素(CCH)用于治疗稳定型疾病、曲率≥30°且≤90°和完整勃起功能的患者。CCH 的出现对 PD 的手术治疗的影响尚不清楚。

目的

我们在基于人群的分析中研究了 IT 对 PD 手术治疗的影响。

方法

审查了全州规划和研究合作系统数据库,该数据库提供了纽约州门诊、住院、门诊和急诊环境中所有患者的全州水平数据。同时排除了因并发勃起功能障碍而行阴茎假体植入术的患者。

主要观察指标

描述性统计和多变量逻辑回归模型用于评估影响注射治疗与手术治疗(阴茎折叠术或部分切除术加移植物)选择的因素。

结果

2003 年至 2016 年间,有 547 名 PD 患者接受了治疗。中位年龄为 56 岁,57%为白人。在研究期间,作为主要治疗方法,手术治疗的应用越来越少,而 IT 的应用同时增加(P<0.001)。多变量建模显示,更年轻的患者(优势比[OR]:1.26;P<0.001;95%置信区间[CI]:1.09-1.46)、社会经济地位较高的患者(OR:1.14;P=0.037;CI:1.01-1.29)、处于 CCH 时代的患者(OR:1.17;P=0.018;CI:1.03-1.33)和接受高容量手术的医生治疗的患者(OR:1.25;P=0.007;CI:1.07-1.48)更有可能接受 IT 治疗。处于 CCH 时代的患者接受 IT 的可能性显著增加 17%。

临床意义

像 CCH 这样的 IT 正在越来越多地取代手术作为 PD 的主要治疗选择。

优势与局限性

全州规划和研究合作系统数据库对于这种分析特别有用,因为它是一个涵盖所有支付者的数据库,可跟踪患者在各种医疗保健环境(门诊和住院)中的纵向情况。

局限性

它仅包括纽约州的患者,限制了其普遍性。分析的回顾性性质使其容易受到此类报告中固有的偏见的影响。特定的疾病水平特征(例如,曲率程度、疾病持续时间和相关畸形)不可用。

结论

自 CCH 问世以来,作为 PD 相关阴茎弯曲主要治疗方式的手术应用呈明显下降趋势。Sukumar S、Pijush DB、Brandes S. 胶原酶组织溶菌素的出现对 Peyronie 病手术治疗的影响:基于人群的分析。J 性医学 2020;17:111-116。

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