Urology Associates Medical Group, Burbank, California 91505, USA.
J Urol. 2012 Jun;187(6):2268-74. doi: 10.1016/j.juro.2012.01.032. Epub 2012 Apr 13.
Collagenase Clostridium histolyticum is an investigational nonsurgical treatment for Peyronie disease. In this phase 2b, double-blind, randomized, placebo controlled study we determined the safety and efficacy of collagenase C. histolyticum and assessed a patient reported outcome questionnaire.
A total of 147 subjects were randomized into 4 groups to receive collagenase C. histolyticum or placebo (3:1) with or without penile plaque modeling (1:1). Per treatment cycle 2 injections of collagenase C. histolyticum (0.58 mg) were given 24 to 72 hours apart. Subjects received up to 3 cycles at 6-week intervals. When designated, investigator modeling was done 24 to 72 hours after the second injection of each cycle. We evaluated penile curvature by goniometer measurement, patient reported outcomes and adverse event profiles.
After collagenase C. histolyticum treatment significant improvements in penile curvature (29.7% vs 11.0%, p=0.001) and patient reported outcome symptom bother scores (p=0.05) were observed compared to placebo. In modeled subjects 32.4% improvement in penile curvature was observed in those on collagenase C. histolyticum compared to 2.5% worsening of curvature in those on placebo (p<0.001). Those treated with collagenase C. histolyticum who underwent modeling also showed improved Peyronie disease symptom bother scores (p=0.004). In subjects without modeling there were minimal differences between the active and placebo cohorts. Most adverse events in the collagenase C. histolyticum group occurred at the injection site and were mild or moderate in severity. No treatment related serious adverse events were reported.
Collagenase C. histolyticum treatment was well tolerated. We noted significant improvement in penile curvature and patient reported outcome symptom bother scores, suggesting that this may be a safe, nonsurgical alternative for Peyronie disease.
胶原酶 C. 组织溶菌素是一种研究中的非手术治疗方法，用于治疗佩罗尼病。在这项 2b 期、双盲、随机、安慰剂对照研究中，我们确定了胶原酶 C. 组织溶菌素的安全性和有效性，并评估了患者报告的结局问卷。
共有 147 名受试者被随机分为 4 组，分别接受胶原酶 C. 组织溶菌素或安慰剂（3:1）治疗，并进行阴茎斑块模型制作（1:1）。每个治疗周期中，在 24 至 72 小时之间注射 2 次 0.58mg 的胶原酶 C. 组织溶菌素。受试者在 6 周的间隔内接受最多 3 个周期的治疗。在指定的情况下，在每个周期的第 2 次注射后 24 至 72 小时，由研究者进行模型制作。我们通过测角器测量评估阴茎弯曲度，患者报告的结局和不良事件情况。
与安慰剂相比，接受胶原酶 C. 组织溶菌素治疗后，阴茎弯曲度显著改善（29.7%对 11.0%，p=0.001），患者报告的结局症状困扰评分也显著改善（p=0.05）。在进行模型制作的受试者中，接受胶原酶 C. 组织溶菌素治疗的患者中，阴茎弯曲度改善了 32.4%，而接受安慰剂治疗的患者中，弯曲度恶化了 2.5%（p<0.001）。接受胶原酶 C. 组织溶菌素治疗并进行模型制作的患者，其佩罗尼病症状困扰评分也得到了改善（p=0.004）。在未进行模型制作的受试者中，活性组和安慰剂组之间的差异很小。胶原酶 C. 组织溶菌素组的大多数不良事件发生在注射部位，严重程度为轻度或中度。未报告与治疗相关的严重不良事件。
胶原酶 C. 组织溶菌素治疗耐受性良好。我们注意到阴茎弯曲度和患者报告的结局症状困扰评分显著改善，这表明胶原酶 C. 组织溶菌素可能是一种安全的、非手术治疗佩罗尼病的替代方法。
