用于治疗掌腱膜挛缩症的胶原酶疗法的研发
Development of Collagenase Treatment for Dupuytren Disease.
作者信息
Badalamente Marie A, Hurst Lawrence C
机构信息
Department of Orthopaedics, T-18 Health Science Center, Stony Brook University Medical Center, Room 052, 100 Nicolls Road, Stony Brook, NY 11794, USA.
Department of Orthopaedics, T-18 Health Science Center, Stony Brook University Medical Center, Room 080, Stony Brook, NY 11794, USA.
出版信息
Hand Clin. 2018 Aug;34(3):345-349. doi: 10.1016/j.hcl.2018.03.004.
Proof-of-principle, basic-science studies, using a rat-tail tendon model and surgically removed Dupuytren cords, began collagenase Clostridium histolyticum (CCH) development. Clinical studies in humans were then conducted, where the primary endpoint was reduction in contracture to within 0° to 5° of extension. Phase 2 studies, which confirmed the optimal dose of collagenase as 0.58 mg, showed injectable CCH reduced contractures in MP and PIP joints to within 0° to 5° in many joints and was well tolerated. Clinical results from phase 3 studies confirmed the efficacy and safety of injectable CCH as a viable nonsurgical intervention.
原理验证性基础科学研究使用大鼠尾腱模型和手术切除的杜普伊特伦挛缩索带，开启了溶组织梭状芽孢杆菌胶原酶（CCH）的研发。随后开展了人体临床研究，主要终点是将挛缩减少至伸展0°至5°范围内。2期研究证实胶原酶的最佳剂量为0.58毫克，结果显示可注射的CCH在许多关节中将掌指关节和近端指间关节的挛缩减少至0°至5°范围内，且耐受性良好。3期研究的临床结果证实了可注射CCH作为一种可行的非手术干预措施的有效性和安全性。
Zotero 插件