Alberton F, Corain M, Garofano A, Pangallo L, Valore A, Zanella V, Adani R
Department of Hand Surgery, University Hospital of Verona, Policlinico GB Rossi, Piazzale LA Scuro 10, Verona, Italy.
Musculoskelet Surg. 2014 Dec;98(3):225-32. doi: 10.1007/s12306-013-0304-x. Epub 2013 Nov 20.
Dupuytren's disease (DD) is a fibroproliferative pathology that affects the palmar aponeurosis causing the development of nodules and collagen cords and the progressive flexion of the fingers. The standard procedure is surgical fasciectomy, followed by high recurrence rates. Collagenase Clostridium histolyticum (CCH) injection represents an innovative noninvasive approach to the treatment of DD. This prospective study was designed to examine the efficacy and safety of CCH injection performed in the outpatient, using local anesthesia.
Forty patients [32 metacarpophalangeal (MP), 8 proximal interphalangeal (PIP)] with Dupuytren's contracture of at least 20° for MP joint and any degree for PIP joint were included. The mean age was 66. All joints were treated with a single vial of collagenase injection and manual breaking of the cord 24 h after. All adverse effects (AEs) were monitored. Patients were checked 7, 30, 90, and 180 days after the injection. Primary endpoint was a reduction in digit contracture within 0°-5° of normal extension. Secondary endpoints were the improvement of range of motion, the evaluation of AEs incidence, and cost-effectiveness of collagenase treatment.
About 67.5 % of patients obtained a clinical success. At 6 months, a further 7.5% attained the same result. The mean contracture of treated joints was 5.3º for MP and 6.8° for PIP joints. Twenty-three patients had one or more mild-to-moderate side effects.
The use of collagenase appears to be an effective and safe method for the treatment of Dupuytren's contracture. Therapeutic success was achieved in a significant percentage of patients. The incidence of side effects was higher, but they were local reactions of short duration. The use of a single collagenase vial in patients treated in day surgery appears more cost-effective than surgery.
杜普伊特伦挛缩病（DD）是一种纤维增生性病变，影响掌腱膜，导致结节和胶原索形成以及手指逐渐屈曲。标准治疗方法是手术筋膜切除术，但复发率很高。注射溶组织梭状芽孢杆菌胶原酶（CCH）是一种创新的无创治疗DD的方法。本前瞻性研究旨在探讨在门诊使用局部麻醉进行CCH注射的疗效和安全性。
纳入40例患有杜普伊特伦挛缩的患者[32例掌指关节（MP），8例近端指间关节（PIP）]，MP关节挛缩至少20°，PIP关节挛缩任意程度。平均年龄为66岁。所有关节均用单瓶胶原酶注射治疗，并在24小时后手动松解条索。监测所有不良反应（AE）。在注射后7、30、90和180天对患者进行检查。主要终点是手指挛缩减少至正常伸展0°-5°以内。次要终点是活动范围的改善、AE发生率的评估以及胶原酶治疗的成本效益。
约67.5%的患者取得了临床成功。在6个月时，另有7.5%的患者达到了相同结果。治疗关节的平均挛缩度MP关节为5.3°，PIP关节为6.8°。23例患者出现一种或多种轻度至中度副作用。
使用胶原酶似乎是治疗杜普伊特伦挛缩的一种有效且安全的方法。相当比例的患者取得了治疗成功。副作用发生率较高，但均为短期局部反应。在日间手术中治疗的患者使用单瓶胶原酶似乎比手术更具成本效益。
