Badalamente Marie A, Hurst Lawrence C, Hentz Vincent R
Department of Orthopaedics, State University of New York at Stony Brook, Health Science Center, Stony Brook, NY 11794, USA.
J Hand Surg Am. 2002 Sep;27(5):788-98. doi: 10.1053/jhsu.2002.35299.
The cellular events leading to abnormal synthesis of collagen are important to our understanding of pathologic processes leading to impaired joint function. The contracture of Dupuytren's disease is a notable example. In a series of controlled phase-2 clinical trials, excessive collagen deposition in Dupuytren's disease has been targeted by a unique nonoperative method using enzyme (Clostridial collagenase) injection therapy to lyse and rupture finger cords causing metacarpophalangeal and/or proximal interphalangeal joint contractures. Forty-nine patients were treated in a random, placebo-controlled trial of one dose of collagenase versus placebo at one center. Subsequently 80 patients were treated in a random, placebo-controlled, dose-response study of collagenase at 2 test centers. The results of these studies indicate that nonoperative collagenase injection therapy for Dupuytren's disease is both a safe and effective method of treating this disorder in the majority of patients as an alternative to surgical fasciectomy. Phase-3 efficacy trials are now being planned to further develop and test this method under Food and Drug Administration regulatory guidelines. The findings of our study may lead to simpler and less invasive nonoperative treatments of joint limitation in which collagen plays a major pathologic role.
导致胶原蛋白异常合成的细胞事件，对于我们理解导致关节功能受损的病理过程至关重要。掌腱膜挛缩症就是一个显著的例子。在一系列对照的2期临床试验中，掌腱膜挛缩症中过量的胶原蛋白沉积已成为一种独特非手术方法的治疗靶点，该方法使用酶（梭菌胶原酶）注射疗法来溶解和断裂导致掌指关节和/或近端指间关节挛缩的手指条索。在一个中心，49名患者参与了单剂量胶原酶与安慰剂对比的随机、安慰剂对照试验。随后，80名患者在2个试验中心参与了胶原酶的随机、安慰剂对照、剂量反应研究。这些研究结果表明，对于掌腱膜挛缩症，非手术胶原酶注射疗法在大多数患者中是一种安全有效的治疗该疾病的方法，可替代手术筋膜切除术。目前正在计划进行3期疗效试验，以在食品药品监督管理局的监管指南下进一步开发和测试该方法。我们研究的结果可能会带来更简单、侵入性更小的非手术治疗方法，用于治疗胶原蛋白起主要病理作用的关节受限。
