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CeCORD-J 研究:胶原酶注射与腱膜切除术治疗掌腱膜挛缩的比较,从手部功能和成本效益方面评估。

The CeCORD-J study on collagenase injection versus aponeurectomy for Dupuytren's contracture compared by hand function and cost effectiveness.

机构信息

Department of Hand Surgery, Nagoya University, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.

Department of Clinical Epidemiology and Health Economics, Tokyo University, Tokyo, Japan.

出版信息

Sci Rep. 2022 May 31;12(1):9094. doi: 10.1038/s41598-022-12966-z.

DOI:10.1038/s41598-022-12966-z
PMID:35641603
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9156707/
Abstract

This study compared hand function and the cost-effectiveness of treatment between collagenase Clostridium histolyticum (CCH) injection and limited fasciectomy for patients with Dupuytren's contracture (DC). The CeCORD-J study is a prospective, multicenter, non-randomized controlled, observational study of two parallel groups. Participants were DC patients with multiple affected fingers, including flexion contracture of the proximal interphalangeal (PIP) joint. The primary outcome was the Hand10 score, as a patient-reported outcome measure (PROM). We set secondary outcomes of EQ-5D-5L (QOL) score, degree of extension deficit, and direct cost. Propensity score adjustment was used to balance differences in patient characteristics between groups. Participants comprised 52 patients in the Collagenase group and 26 patients in the Surgery group. There were no significant differences in the Hand10 and QOL scores between the two groups at 26 weeks. Mean direct cost was 248,000 yen higher in the Surgery group than in the Collagenase group. Extension deficit angle of the PIP joint was significantly larger in the Collagenase group at 26 weeks. Although the Collagenase group showed dominance in cost-effectiveness, there was no significant difference between the two groups in hand function at 26 weeks.

摘要

这项研究比较了胶原酶 C. _histolyticum(CCH)注射与局限性掌腱膜切开术治疗杜普伊特伦挛缩(DC)患者的手部功能和成本效益。CeCORD-J 研究是一项前瞻性、多中心、非随机对照、观察性研究,分为两个平行组。参与者为患有 DC 的患者,其多个手指受累,包括近端指间关节(PIP)关节的屈曲挛缩。主要结局是 Hand10 评分,作为患者报告的结局测量(PROM)。我们设定了 EQ-5D-5L(QOL)评分、伸展不足程度和直接成本的次要结局。采用倾向评分调整来平衡两组患者特征之间的差异。Collagenase 组有 52 名患者,Surgery 组有 26 名患者。两组患者在 26 周时的 Hand10 和 QOL 评分均无显著差异。Surgery 组的直接成本平均比 Collagenase 组高 248,000 日元。26 周时,Collagenase 组 PIP 关节的伸展不足角度明显大于 Surgery 组。尽管 Collagenase 组在成本效益方面表现出优势,但两组患者在 26 周时的手部功能无显著差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d01d/9156707/bf58993d3788/41598_2022_12966_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d01d/9156707/1e413f82245c/41598_2022_12966_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d01d/9156707/bf58993d3788/41598_2022_12966_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d01d/9156707/1e413f82245c/41598_2022_12966_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d01d/9156707/bf58993d3788/41598_2022_12966_Fig2_HTML.jpg

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Cost-effectiveness of Recurrent Dupuytren Contracture Treatment.复发性掌腱膜挛缩治疗的成本效益。
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英国成年患者中胶原酶注射与有限筋膜切除术治疗掌腱膜挛缩症的比较:DISC,一项非劣效性随机对照试验及经济学评估
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针刺腱膜切开术、胶原酶注射及筋膜切除术治疗掌腱膜挛缩症的疗效及直接成本
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Efficacy and safety of collagenase Clostridium histolyticum injection for Dupuytren's contracture in non-Caucasian Japanese patients (CORD-J Study): the first clinical trial in a non-Caucasian population.组织型胶原酶注射治疗非白种日本患者掌腱膜挛缩症的疗效与安全性(CORD-J研究):非白种人群中的首个临床试验
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Dupuytren's contracture in Ethiopia.埃塞俄比亚的杜普伊特伦挛缩症
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