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胶原酶溶组织梭状芽孢杆菌与手术治疗佩罗尼氏病的治疗模式及医疗结局:一项回顾性索赔数据库分析

Treatment Patterns and Healthcare Outcomes with Collagenase Clostridium Histolyticum vs Surgery in Peyronie's Disease: A Retrospective Claims Database Analysis.

作者信息

Trost Landon, Huang Huan, Han Xu, Burudpakdee Chakkarin, Hu Yiqun

机构信息

Department of Urology, Mayo Clinic, Rochester, MN, USA; Male Fertility and Peyronie's Clinic, Orem, UT, USA.

IQVIA, Falls Church, VA, USA.

出版信息

Sex Med. 2021 Apr;9(2):100321. doi: 10.1016/j.esxm.2021.100321. Epub 2021 Mar 5.

Abstract

INTRODUCTION

Treatments for Peyronie's disease (PD) include surgical management and collagenase clostridium histolyticum (CCH).

AIMS

To evaluate PD treatment trends after CCH approval and compare clinical outcomes in CCH- and surgery-treated cohorts.

METHODS

Patients newly diagnosed with PD between January 2011 and December 2017 were identified in a U.S. claims database. Cohorts initiating treatment with CCH or surgery between January 2014 and June 2017 were included. Patients were continuously enrolled ≥6 months before and ≥12 months after index date. Post-treatment penile complications and analgesic use were compared 1 year after procedure in propensity score-matched cohorts.

MAIN OUTCOME MEASURES

The main outcome measures of this study were treatment patterns, penile complications, and analgesic use.

RESULTS

In the newly diagnosed PD cohort, 1,609 patients received CCH and 1,555 patients had surgery. Overall CCH or surgery treatment rate/year increased from 9.8% in 2014 to 15.5% in 2017, with <1% receiving verapamil or interferon. Initial treatment ratios of CCH to surgery increased from approximately 1:1 (2014) to 2:1 (2017). In the unmatched CCH (n = 1,227) and surgery (n = 620) cohorts, more (P < .05) surgery-treated patients received analgesics (particularly opioids), oral PD therapies, vacuum erection devices, and phosphodiesterase-5 inhibitors before the index date. After propensity score matching (n = 620/cohort), newly occurring postprocedural complications during the follow-up period were higher in the surgery cohort (25.3% vs 18.4%, P = .003). The surgery cohort had significantly (P < .05) higher rates of erectile dysfunction (65.0% vs 44.8%), penile pain (17.9% vs 8.9%), and penile swelling (8.1% vs 5.2%) and was more likely to be prescribed opioids (93.3% vs 38.9%; P < .0001) or non-steroidal anti-inflammatory drugs (27.0% vs 20.3%; P = .006).

CONCLUSION

CCH demonstrated fewer complications and less analgesic use than surgery and was used as the initial therapy for PD twice as often as surgery. L Trost, H Huang, X Han, et al. Treatment Patterns and Healthcare Outcomes with Collagenase Clostridium Histolyticum vs Surgery in Peyronie's Disease: A Retrospective Claims Database Analysis. Sex Med 2021;9:100321.

摘要

引言

佩罗尼氏病(PD)的治疗方法包括手术治疗和注射溶组织梭菌胶原酶(CCH)。

目的

评估CCH获批后PD的治疗趋势,并比较CCH治疗组和手术治疗组的临床结果。

方法

在美国索赔数据库中识别出2011年1月至2017年12月期间新诊断为PD的患者。纳入2014年1月至2017年6月期间开始使用CCH或手术治疗的队列。患者在索引日期前连续入组≥6个月,索引日期后连续入组≥12个月。在倾向评分匹配队列中,比较术后1年的治疗后阴茎并发症和镇痛药使用情况。

主要观察指标

本研究的主要观察指标为治疗模式、阴茎并发症和镇痛药使用情况。

结果

在新诊断的PD队列中,1609例患者接受了CCH治疗,1555例患者接受了手术治疗。总体CCH或手术治疗率/年从2014年的9.8%增至2017年的15.5%,接受维拉帕米或干扰素治疗的患者不到1%。CCH与手术的初始治疗比例从约1:1(2014年)增至2:1(2017年)。在未匹配的CCH组(n = 1227)和手术组(n = 620)中,更多(P <.05)接受手术治疗的患者在索引日期前接受了镇痛药(尤其是阿片类药物)、口服PD疗法、真空勃起装置和5型磷酸二酯酶抑制剂治疗。倾向评分匹配后(每组n = 620),随访期间手术组新出现的术后并发症更高(25.3%对18.4%,P =.003)。手术组的勃起功能障碍(65.0%对44.8%)、阴茎疼痛(17.9%对8.9%)和阴茎肿胀(8.1%对5.2%)发生率显著更高(P <.05),且更可能被开具阿片类药物(93.3%对38.9%;P <.0001)或非甾体抗炎药(27.0%对20.3%;P =.006)。

结论

与手术相比,CCH的并发症更少,镇痛药使用更少,且作为PD的初始治疗的频率是手术的两倍。L·特罗斯特、H·黄、X·韩等。注射溶组织梭菌胶原酶与手术治疗佩罗尼氏病的治疗模式和医疗结果:一项回顾性索赔数据库分析。性医学2021;9:100321。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4ab/8072160/2fb1d9ddc107/gr1.jpg

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