Jordan Gerald H
Department of Urology, Eastern Virginia Medical School, Norfolk, VA, USA.
J Sex Med. 2008 Jan;5(1):180-7. doi: 10.1111/j.1743-6109.2007.00651.x.
Peyronie's disease afflicts at least 3% of sexually active men over the age of 30. Many pharmacologic therapies have been tried, but to date, no systemic or local therapy has been proven to provide predictable and lasting results.
This study was designed to assess the efficacy and safety of intralesional clostridial collagenase injection therapy in a series of patients with Peyronie's disease.
Twenty-five patients aged 21-75 years who were referred to a single institution with a well-defined Peyronie's disease plaque were treated with three intralesional injections of clostridial collagenase 10,000 units in a small volume (0.25 cm(3) per injection) administered over 7-10 days, with a repeat treatment (i.e., three injections of collagenase 10,000 units/25 cm(3) injection over 7-10 days) at 3 months. Primary efficacy measures were changes from baseline in the deviation angle and plaque size. Secondary efficacy end points were patient responses to a Peyronie's disease questionnaire and improvement according to the investigators' global evaluation of change.
The primary efficacy measures were change in deviation angle and change in plaque size. Secondary end points were patient questionnaire responses and improvement according to the investigators' global evaluation of change.
Significant decreases from baseline were achieved in the mean deviation angle at months 3 (P = 0.0001) and 6 (P = 0.0012), plaque width at months 3 (P = 0.0052), 6 (P = 0.0239), and 9 (P = 0.0484), and plaque length at months 3 (P = 0.0018) and 6 (P = 0.0483). More than 50% of patients in this series considered themselves "very much improved" or "much improved" at all time points in the study, and the drug was generally well tolerated.
The benefits of intralesional clostridial collagenase injections in this trial lend support to prior studies supporting its use in the management of Peyronie's disease. A double-blind, placebo-controlled study is currently under development.
佩罗尼氏病困扰着至少3%的30岁以上性活跃男性。人们尝试了多种药物治疗方法，但迄今为止，尚无全身或局部治疗被证明能提供可预测且持久的效果。
本研究旨在评估病灶内注射梭菌胶原酶治疗一系列佩罗尼氏病患者的疗效和安全性。
25名年龄在21至75岁之间、因明确的佩罗尼氏病斑块被转诊至单一机构的患者，接受了三次病灶内注射10000单位梭菌胶原酶，每次注射量小（每次0.25立方厘米），在7至10天内完成，3个月后重复治疗（即7至10天内三次注射10000单位/25立方厘米胶原酶）。主要疗效指标为与基线相比的偏差角度和斑块大小的变化。次要疗效终点为患者对佩罗尼氏病问卷的反应以及根据研究者对变化的整体评估得出的改善情况。
主要疗效指标为偏差角度的变化和斑块大小的变化。次要终点为患者问卷反应以及根据研究者对变化的整体评估得出的改善情况。
与基线相比，在第3个月（P = 0.0001）和第6个月（P = 0.0012）时平均偏差角度显著降低，在第3个月（P = 0.0052）、第6个月（P = 0.0239）和第9个月（P = 0.0484）时斑块宽度显著降低，在第3个月（P = 0.0018）和第6个月（P = 0.0483）时斑块长度显著降低。该系列中超过50%的患者在研究的所有时间点都认为自己“非常改善”或“大有改善”，且该药物总体耐受性良好。
本试验中病灶内注射梭菌胶原酶的益处支持了先前支持其用于治疗佩罗尼氏病的研究。一项双盲、安慰剂对照研究目前正在开展。
