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首页> 外文期刊>The journal of sexual medicine >Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie’s Disease
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Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie’s Disease

机译：胶原酶梭菌组织术治疗急性期Peyronie病的安全性和有效性

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Abstract Background Peyronie’s disease (PD), defined as the abnormal formation of fibrous plaque(s) in the tunica albuginea of the penis, is a chronic condition that afflicts 3% to 13% of the US male population; there is no current research on the efficacy and safety of collagenase Clostridium histolyticum (CCH) in the treatment of acute phase PD. Aim To examine the efficacy and safety of CCH in the treatment of acute-phase PD. Methods We retrospectively reviewed the records for all patients treated with CCH for PD from April 2014 through April 2017. Patients who reported penile pain and duration of PD no longer than 12 months at presentation qualified as being in the acute phase of PD. The primary outcomes of interest were final changes in curvature after CCH treatment regardless of the number of CCH cycles received and frequency of treatment-related adverse events. Outcomes Parameters of efficacy and safety were compared between acute- and stable-phase PD. Results A total of 162 patients were included in the study, of which 36 (22%) qualified as having acute-phase PD (group 1) and the remaining 126 (78%) qualified as having stable-phase PD (group 2). Median duration of?PD was 8.5 months (range?= 1–12) for group 1 and 18 months (range?= 1–492) for group 2. There was no?significant difference in final change in curvature between the acute and stable phases of PD (16.7° vs 15.6°; P ?= .654). There was no statistically significant difference in frequency of treatment-related adverse events between the acute phase (4 patients, 11%) and the stable phase (12 patients, 10%; P ?= .778). Clinical Implications CCH therapy is as safe and efficacious in acute-phase PD as it is in stable-phase PD. Strengths and Limitations This is the first report that assesses the safety and efficacy of CCH therapy focusing on acute-phase PD. This study was composed of a large cohort of patients receiving CCH therapy in acute- and stable-phase PD. Limitations include bias associated with retrospective studies, a small sample, and a single-center setting. Conclusions Although CCH is not clearly indicated for treatment during the acute phase of PD, these results suggest that CCH use during this phase can be effective and safe. There was no statistically significant difference in final change in curvature or treatment-related adverse events after CCH therapy delivered between the acute and stable phases of PD. Nguyen HMT, Anaissie J, DeLay KJ, et?al. Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie’s Disease. J Sex Med 2017;14:1220–1225.
机译：摘要背景PEYRONIE疾病（PD）被定义为阴茎的苔藓植物中纤维斑块的异常形成，是一种慢性条件，占美国男性人口的3％至13％;胶原酶梭菌组织溶液（CCH）治疗急性相Pd的疗效和安全性没有目前研究。目的研究CCH治疗急性期PD的疗效和安全性。方法回顾性研究了2014年4月至2017年4月从2014年4月到2017年4月治疗CCH治疗的所有患者的记录。报告过度疼痛和持续时间不超过12个月的患者，呈现在PD的急性期。感兴趣的主要结果是CCH治疗后曲率的最终变化，无论收到的CCH循环数量和治疗相关不良事件的频率。在急性和稳定相Pd之间比较了疗效和安全性的结果。结果共有162名患者均涉及162名患者，其中36（22％）合格，具有急性相Pd（第1组）和符合稳定相Pd（第2组）的剩余126（78％）。中位数持续时间为8.5个月（范围？= 1-12）组，18个月（范围？= 1-492）组2.急性和稳定之间的曲率的最终变化差异Pd的阶段（16.7°Vs 15.6°; p？= .654）。急性期（4名患者，11％）和稳定相之间的治疗相关不良事件频率没有统计学显着差异（12例，10％; P？= .778）。临床影响CCH治疗在急性相Pd中是安全和有效的，因为它在稳定相Pd中。优势和局限性这是第一个评估CCH治疗的安全性和疗效关注急性期PD。本研究由急性和稳定相Pd中接受CCH治疗的大型患者组成。限制包括与回顾性研究，小样本和单中心设置相关的偏差。结论尽管在PD的急性期间没有清楚地表明CCH，但这些结果表明CCH在该阶段使用可以有效和安全。 CCH治疗在Pd的急性和稳定阶段之间的CCH治疗后，曲率或治疗相关不良事件的最终变化没有统计学意义。 Nguyen HMT，Anaissie J，Delay KJ，et？Al。胶原酶梭菌组织溶液在急性期Peyronie病治疗中的安全性和有效性。 2017年性别医学; 14：1220-1225。

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