Efficacy and Safety of Concurrent Collagenase Clostridium Histolyticum Injections for Multiple Dupuytren Contractures

被引:58
作者
Coleman, Stephen [1 ]
Gilpin, David
Kaplan, F. Thomas D.
Houston, Anthony
Kaufman, Gregory J.
Cohen, Brian M.
Jones, Nigel
Tursi, James P.
机构
[1] Brisbane Hand & Upper Limb Clin, Brisbane, Qld 4000, Australia
来源
JOURNAL OF HAND SURGERY-AMERICAN VOLUME | 2014年 / 39卷 / 01期
关键词
Collagenase clostridium histolyticum (CCH); Dupuytren contracture; Dupuytren disease; patient satisfaction; treatment outcome; DISEASE;
D O I
10.1016/j.jhsa.2013.10.002
中图分类号
R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学(修复外科学)];
学科分类号
摘要
Purpose To assess the safety and efficacy of 2 concurrent injections of collagenase clostridium histolyticum (CCH) in the same hand to treat multiple Dupuytren flexion contractures. Methods In a multicenter, open-label phase IIIb study, 60 patients received two 0.58-mg CCH doses injected into cords affecting 2 joints in the same hand during 1 visit, followed by finger extension approximately 24 hours later. Efficacy at postinjection day 30 (change in flexion contracture and active range of motion, patient satisfaction, physician-rated improvement, and rates of clinical success [flexion contracture 5 degrees or less]) and adverse events were summarized. Results The concurrent injections were most commonly administered in cords affecting metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints on the same finger (47%) or 2 MCP joints on different fingers of the same hand (37%). Mean total (sum of the 2 treated joints) flexion contracture decreased 76%, from 87 degrees to 24 degrees (MCP joints: 86%; PIP joints: 66%). Mean total range of motion increased from 100 degrees to 161 degrees. Clinical success was 76% for MCP joints and 33% for PIP joints. Most patients were very satisfied (60%) or quite satisfied (28%) with treatment. Most investigators rated treated joints as very much improved (55%) or much improved (37%). The most common treatment-related adverse events (> 75% of patients) were contusion, pain in extremity, and edema peripheral (local edema). Most adverse events were mild to moderate in severity. Serious complications included 1 pulley rupture related to study medication and 1 flexor tendon rupture (following conclusion of the study). There were no systemic complications. Conclusions Results suggest that 2 affected joints can be effectively and safely treated with concurrent CCH injections. There was an increased incidence of some adverse events with concurrent treatment (pruritus, lymphadenopathy, blood blister, and skin laceration) compared with treatment of a single joint. High degrees of patient satisfaction and physician-rated improvement were reported. (J Hand Surg Am. 2014;39(1):57-64. Copyright (C) 2014 by the American Society for Surgery of the Hand. All rights reserved.) Type of study/level of evidence Therapeutic IV.
引用
收藏
页码:57 / 64
页数:8
相关论文
共 14 条
[1]  
[Anonymous], 2009, AUX CC 859 CORD 2 CL
[2]  
[Anonymous], 2012, XIAFL COLL CLOSTR HI
[3]  
Bainbridge Christopher, 2012, Eur Orthop Traumatol, V3, P31
[4]   Multiple concurrent collagenase clostridium histolyticum injections to dupuytren's cords: an exploratory study [J].
Coleman, Stephen ;
Gilpin, David ;
Tursi, James ;
Kaufman, Greg ;
Jones, Nigel ;
Cohen, Brian .
BMC MUSCULOSKELETAL DISORDERS, 2012, 13
[5]   Collagenase clostridium histolyticum for Dupuytren's contracture [J].
Desai, Shaunak S. ;
Hentz, Vincent R. .
EXPERT OPINION ON BIOLOGICAL THERAPY, 2010, 10 (09) :1395-1404
[6]   Injectable Collagenase Clostridium Histolyticum: A New Nonsurgical Treatment for Dupuytren's Disease [J].
Gilpin, David ;
Coleman, Stephen ;
Hall, Stephen ;
Houston, Anthony ;
Karrasch, Jeff ;
Jones, Nigel .
JOURNAL OF HAND SURGERY-AMERICAN VOLUME, 2010, 35A (12) :2027-2038
[7]  
Hurst Larry, 2011, GREENS OPERATIVE HAN, P141
[8]   Injectable Collagenase Clostridium Histolyticum for Dupuytren's Contracture. [J].
Hurst, Lawrence C. ;
Badalamente, Marie A. ;
Hentz, Vincent R. ;
Hotchkiss, Robert N. ;
Kaplan, F. Thomas D. ;
Meals, Roy A. ;
Smith, Theodore M. ;
Rodzvilla, John .
NEW ENGLAND JOURNAL OF MEDICINE, 2009, 361 (10) :968-979
[9]  
McFarlane RM, 2009, DUPUYTRENS DIS, P377
[10]  
Peimer C A, 2012, Hand (N Y), V7, P143, DOI 10.1007/s11552-012-9407-3