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患者对佩罗尼病的看法:在 2 期临床试验中对胶原酶梭菌的研究后访谈结果。

Patient perspectives on Peyronie's disease: results of poststudy interviews from a phase 2 trial of collagenase clostridium histolyticum.

机构信息

Manhattan Medical Research, New York, NY, USA.

21st Century Oncology/UroMedix-Aventura Division, Aventura, FL, USA.

出版信息

Int J Impot Res. 2019 Jul;31(4):263-268. doi: 10.1038/s41443-018-0027-5. Epub 2018 Sep 20.

Abstract

Intralesional injection of collagenase clostridium histolyticum (CCH) improves Peyronie's disease (PD) symptoms; however, patient perspectives regarding PD and CCH treatment have not been fully elucidated. This cross-sectional qualitative study included heterosexual men with PD who received ≥1 injection of study medication and had ≥1 posttreatment Peyronie's Disease Questionnaire (PDQ) assessment during a prior phase 2b clinical trial. These patients were "responders" if they reported (as part of the Global Assessment of the PDQ) that overall symptoms and effects of PD had at least "improved in a small but important way" after CCH therapy. Among 45 patients interviewed, penile bending or curvature was the most common and bothersome PD symptom reported (by 97.8% and 48.9% of patients, respectively). Patients indicated that multiple alterations were necessary in their sex lives because of penile symptoms and specified that these changes impacted their emotional health and partner relationship. Treatment with CCH improved PD symptoms (44.4%), frequency of or ability to have vaginal intercourse (22.2%) and partner relationship (22.2%), particularly among responders. Given that physical, psychologic and sexual function are impacted by PD, clinical trials that evaluate treatments for PD should include patient-reported outcome measures (e.g., the PDQ) to assess overall well-being after treatment.

摘要

胶原酶注射治疗阴茎硬结症(CCH)可改善阴茎硬结症(PD)症状;然而,患者对 PD 和 CCH 治疗的看法尚未完全阐明。本横断面定性研究纳入了在先前的 2b 期临床试验中接受了至少 1 次研究药物注射且至少有 1 次 PDQ 评估的 PD 患者。如果患者报告(作为 PDQ 整体评估的一部分)在 CCH 治疗后 PD 的总体症状和影响至少“以较小但重要的方式有所改善”,则这些患者被认为是“应答者”。在接受采访的 45 名患者中,阴茎弯曲或弯曲是报告最常见和最困扰的 PD 症状(分别为 97.8%和 48.9%的患者)。患者表示,由于阴茎症状,他们的性生活需要多次改变,并具体指出这些变化会影响他们的心理健康和伴侣关系。CCH 治疗可改善 PD 症状(44.4%)、阴道性交的频率或能力(22.2%)和伴侣关系(22.2%),尤其是在应答者中。鉴于 PD 会影响身体、心理和性功能,评估 PD 治疗方法的临床试验应包括患者报告的结果测量指标(例如 PDQ),以评估治疗后的整体健康状况。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b0d/6760640/44f7b7fb4399/41443_2018_27_Fig1_HTML.jpg

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