Multiple concurrent collagenase clostridium histolyticum injections to dupuytren's cords: an exploratory study
Multiple concurrent collagenase clostridium histolyticum injections to dupuytren's cords: an exploratory study
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DOI：
10.1186/1471-2474-13-61
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发表时间：
2012-04-27
影响因子：
2.3
通讯作者：
Cohen, Brian
中科院分区：
文献类型：
--
作者：
Coleman, Stephen;Gilpin, David;Cohen, Brian
背景资料：掌腱膜挛缩症是一种进行性纤维增生性疾病，其特征是手部掌筋膜内出现结节和胶原索。胶原酶溶组织梭菌（CCH）目前已被批准用于成人DC，在30天的治疗周期内对单个可触及脊髓进行非手术治疗。这个开放标签的试点研究的目的是检查的安全性，有效性和多剂量的药代动力学注射两个索（受影响的关节）与多个剂量的CCH同时进入同一只手在受试者与DC和多发性contractures.Methods：12个受试者与DC入组，每个有>= 3挛缩引起的可触及的索。在治疗后30天进行疗效评估，并记录整个过程中的不良事件（AE）。在第一个治疗阶段，所有受试者均在单根脐带中注射单剂量CCH（0.58 mg）。30天后，相同的受试者进入第二个治疗期，在同一只手上同时注射两个不同的脊髓（受影响的关节）。一个手指伸展程序进行24小时后，每次管理CCH破坏酶弱化cord.Results：对于掌指（MP）关节，平均挛缩减少每个关节治疗后单次注射29.0 +/- 20.7度与30.3 +/- 10.9度，每个治疗后的关节多次注射。对于近端指间关节（PIP），两个阶段每个治疗关节的挛缩平均减少分别为30.7 ± 21.1和22.1 ± 4.9度。所有患者（100%）在任一治疗周期后均为“非常满意”或“非常满意”。最常见的治疗相关AE为外周水肿、挫伤和治疗肢体疼痛;治疗期间注射局部效应的严重程度差异极小。没有严重的治疗相关的不良事件或全身并发症reported.Conclusion：这些结果提供了初步证据，两个电源线（受影响的关节）可以同时与CCH治疗的疗效和安全性相似的电源线单独治疗在一个连续的方式。多次同时注射将消除单次治疗之间的30天等待，并允许快速有效地治疗患有多个受影响关节的患者，这对患者和医生都是一个显著的优势。
Background: Dupuytren's contracture (DC) is a progressive fibroproliferative disorder characterized by development of nodules and collagen cords within the palmar fascia of the hand. Collagenase clostridium histolyticum (CCH) is currently approved in adults with DC for the nonsurgical treatment of a single palpable cord during a 30-day treatment cycle. This open-label pilot study was designed to examine the safety, efficacy, and multiple-dose pharmacokinetics of injecting two cords (affected joints) with multiple doses of CCH concurrently into the same hand in subjects with DC and multiple contractures.Methods: Twelve subjects with DC were enrolled, each with >= 3 contractures caused by palpable cords. Efficacy assessments were taken 30 days after treatment and adverse events (AEs) were recorded throughout. In the first treatment period, all subjects were injected with a single dose of CCH (0.58 mg) into a single cord. The same subjects entered a second treatment period 30 days later, where two different cords (affected joints) were injected concurrently on the same hand. A finger extension procedure was performed 24 hours after each administration of CCH to disrupt the enzymatically weakened cord.Results: For metacarpophalangeal (MP) joints, mean contracture reduction per joint treated was 29.0 +/- 20.7 degrees following single injection vs 30.3 +/- 10.9 degrees per treated joint following multiple injections. For proximal interphalangeal (PIP) joints, mean reduction in contracture was 30.7 +/- 21.1 and 22.1 +/- 4.9 degrees per treated joint, respectively, for the two periods. All patients (100%) were either "quite satisfied" or "very satisfied" following either treatment cycle. The most common treatment-related AEs were edema peripheral, contusion, and pain in the treated extremity; the differences in severity for local effects of the injections were minimal between treatment periods. No serious treatment-related AEs or systemic complications were reported.Conclusion: These results provide preliminary evidence that two cords (affected joints) can be treated concurrently with CCH with similar efficacy and safety as cords treated individually in a sequential fashion. Multiple concurrent injections would eliminate the 30 day wait between single treatments and allow for rapid and effective treatment of patients with multiple affected joints, a significant advantage for both patient and physician.