Hirata H, Tanaka K, Sakai A, Kakinoki R, Ikegami H, Tateishi N
1 Department of Hand Surgery, Graduate School of Nagoya University, Nagoya, Japan.
2 Department of Plastic and Reconstructive Surgery, Nagasaki University, Nagasaki, Japan.
J Hand Surg Eur Vol. 2017 Jan;42(1):30-38. doi: 10.1177/1753193416653249. Epub 2016 Sep 28.
To assess the efficacy, safety and pharmacokinetics of 0.58 mg collagenase Clostridium histolyticum injections for the treatment of Dupuytren's contracture in Japanese patients, we conducted a phase III, multicentre, uncontrolled, open-label clinical study in patients with Dupuytren's contracture. Of the 77 patients, 66 achieved clinical success in the primary treated joint (86%; 95% confidence interval: 76% to 93%), confirming the efficacy of collagenase Clostridium histolyticum injections. More improvement was seen in the metacarpophalangeal joints than in the proximal interphalangeal joints (94% versus 73%). The main adverse reaction was a local reaction in the injected hand. No tendon rupture or anaphylactic reactions were seen. The concentrations of collagenase Clostridium histolyticum were below the lower limit of quantification in plasma samples at all time points. As seen in global studies in Caucasian patients, a corrective effect on Dupuytren's contracture and good tolerance were observed in most non-Caucasian (Asian) Japanese patients.
Level 3.
为评估0.58毫克溶组织梭菌胶原酶注射剂治疗日本患者掌腱膜挛缩症的疗效、安全性和药代动力学，我们对掌腱膜挛缩症患者进行了一项III期、多中心、非对照、开放标签的临床研究。77例患者中，66例在初次治疗的关节取得临床成功（86%；95%置信区间：76%至93%），证实了溶组织梭菌胶原酶注射剂的疗效。掌指关节的改善比近端指间关节更明显（94%对73%）。主要不良反应是注射手部的局部反应。未观察到肌腱断裂或过敏反应。在所有时间点，血浆样本中溶组织梭菌胶原酶的浓度均低于定量下限。正如在白种人患者的全球研究中所见，在大多数非白种人（亚洲）日本患者中观察到对掌腱膜挛缩症的矫正作用和良好耐受性。
3级。
