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首页> 外文期刊>The journal of sexual medicine >Treatment of Peyronie's Disease With Collagenase Clostridium histolyticum and Vacuum Therapy: A Randomized, Open-Label Pilot Study
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Treatment of Peyronie's Disease With Collagenase Clostridium histolyticum and Vacuum Therapy: A Randomized, Open-Label Pilot Study

机译：用胶原酶梭菌组织分层治疗PEYRONIE疾病和真空疗法：随机，开放标签试验研究

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Abstract Background Collagenase Clostridium histolyticum (CCH) is indicated for the treatment of penile curvature in adult men with Peyronie's disease (PD) with palpable plaque and curvature deformity of at least 30° at the start of therapy. Aim To evaluate the efficacy and safety of CCH plus vacuum-pump therapy with and without penile modeling for the management of PD. Methods Adult men with PD and penile curvature of at least 30° were randomly assigned to receive CCH 0.58 mg plus vacuum therapy alone (n?= 15) or with penile plaque modeling (n?= 15). Patients received no more than four treatment cycles (cycle?= ～6-week duration), each consisting of two intralesional injections of CCH administered 24 to 72 hours apart. Vacuum therapy was applied twice daily from 14 days after the second injection of each cycle until the following cycle. Modeling was performed 24 to 72 hours after the second injection of each cycle. Outcomes The primary end point was change in penile curvature from baseline to week 36; additional end points included changes in Peyronie's Disease Questionnaire (PDQ) domain scores, composite response (≥20% decrease in penile curvature and decrease in PDQ bother score ≥ 1 point), and global response (small but important, moderate, or much improvement in the Global Assessment of PD). Results At week 36, improvement in penile curvature from baseline was similar in the two groups (mean change from baseline?=??23.7° [SD?= 10.9] for CCH?+ vacuum?+ modeling and??23.3° [SD?= 7.2] for CCH?+ vacuum; between-group difference?= ?0.3°, 95% CI?=??7.3 to 6.6). Improvements in most PDQ domains, including bother, were observed from baseline to week 36 in the two groups. Most patients were composite (66.7% and 84.6% with CCH?+ vacuum?+ modeling and CCH?+ vacuum, respectively) and global (86.7% and 92.3%, respectively) responders. The most common adverse events were penile contusion, penile swelling, and penile pain. Clinical Implications Vacuum-pump therapy administered alone or in combination with modeling after CCH treatment could improve PD symptoms. Strengths and Limitations This was a pilot study with a small sample and limited follow-up duration. Conclusion CCH and vacuum-pump therapy (alone or combined with modeling) could be an appropriate consideration for men with PD and warrants further investigation. Ralph DJ, Abdel Raheem A, Liu G. Treatment of Peyronie's Disease With Collagenase Clostridium histolyticum and Vacuum Therapy: A Randomized, Open-Label Pilot Study. J Sex Med 2017;14:1430–1437.
机译：摘要背景胶原酶蛋白酶蛋白酶菌（CCH）被指示为在佩雷诺伊氏病（Pd）的成人男性中的阴茎曲率，在治疗开始时具有可明显的斑块和至少30°的曲率畸形。旨在评估CCH加真空泵治疗的疗效和安全性，无透明模拟PD的管理。方法对具有至少30°的Pd和阴茎曲率的成年男性被随机分配仅接受CCH 0.58mg加真空疗法（n？= 15）或用阴茎牙菌斑（n？= 15）。患者不超过四个治疗循环（循环？=〜6周持续时间），每个患者分开24至72小时的CCH施用24小时。每次循环后14天从14天施用真空疗法两次，直至下列循环。在第二次注射后24至72小时进行建模。结果是主要终点从基线到第36周的阴茎曲率变化;额外的终点包括PEYRONIE疾病调查问卷（PDQ）域分数的变化，复合响应（≥20％的阴茎曲率下降，PDQ麻烦得分≥1点的降低）和全球响应（小但重要，中等或更大的改进全球评估PD）。结果在第36周，两组中，基线的阴茎曲率的改善（来自基线的平均变化？= 23.7°[SD？= 10.9]用于CCH？+真空？+造型和?? 23.3°[SD吗？ CCH的= 7.2] +真空; - 组之间的差异？=？0.3°，95％CI？= ?? 7.3至6.6）。大多数PDQ领域的改进，包括麻烦，从两组的第36周从基线观察到。大多数患者是复合材料（66.7％和84.6％，CCH？+真空？+造型和CCH？+真空）和全球性（分别为86.7％和92.3％）响应者。最常见的不良事件是阴茎挫伤，阴茎肿胀和阴茎疼痛。临床暗示真空泵治疗单独施用或与CCH治疗后的建模组合可以改善PD症状。优势和局限性这是一个试点研究，采样小，随访持续时间有限。结论CCH和真空泵治疗（单独或与建模合并）可能是对具有PD的男性的适当考虑，并认证进一步调查。拉尔夫DJ，阿卜杜勒·雷格梅德，刘G.用胶原酶蛋白酶菌组织和真空疗法治疗PEYRONIE病：随机，开放式试点研究。 J SEX MED 2017; 14：1430-1437。

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