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评估人工蛋白(丝素弹性蛋白)促进半月板损伤患者愈合的安全性、可行性和有效性的首次人体探索性试验。

First-in-human exploratory trial assessing safety, feasibility, and efficacy of artificial protein (silk-elastin) in promoting healing in patients with meniscus injuries.

作者信息

Ishikawa Masakazu, Tsuji Shunya, Kamei Goki, Nakata Kyohei, Nekomoto Akinori, Hashiguchi Naofumi, Nakasa Tomoyuki, Nakamae Atsuo, Kamei Naosuke, Inoue Keiichiro, Kawabata Shingo, Ueda Keiko, Adachi Nobuo

机构信息

Department of Orthopedic Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan.

Department of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.

出版信息

Sci Rep. 2025 Feb 7;15(1):4658. doi: 10.1038/s41598-025-88616-x.

Abstract

Meniscal tears, especially those in avascular regions, pose a significant risk for osteoarthritis if repair fails. While meniscal repair is the preferred method for preserving knee function, it often has a high failure rate in avascular zones. This study aimed to evaluate the safety and potential efficacy of silk-elastin (SE), an artificial protein with wound-healing properties, for enhancing meniscal repair. Eight patients with meniscal tears in avascular areas underwent arthroscopic repair followed by SE application, including cases of lateral and medial tears, discoid lateral meniscus, and bucket-handle tears. No adverse events or reactions were attributed to SE. At 3 months post-surgery, clinical outcomes and repair sites were evaluated using MRI and arthroscopy. Significant improvements were observed in Lysholm and visual analog scale scores (P < 0.05), with the knee injury and osteoarthritis outcome scores showing significant improvement in the symptom subscale. MRI findings indicated one patient with grade 1 healing, three with grade 2, and four with grade 3 (unhealed). Arthroscopically, six patients demonstrated completely healed menisci, while two showed incomplete healing; none were classified as "unhealed." These findings suggest that SE is safe and may support meniscal healing in avascular zones, indicating its potential to improve repair outcomes.

摘要

半月板撕裂,尤其是那些位于无血管区域的撕裂,如果修复失败,会对骨关节炎构成重大风险。虽然半月板修复是保留膝关节功能的首选方法,但在无血管区域其失败率往往很高。本研究旨在评估具有伤口愈合特性的人工蛋白丝素 - 弹性蛋白(SE)增强半月板修复的安全性和潜在疗效。8例无血管区域半月板撕裂患者接受了关节镜修复并应用SE,包括外侧和内侧撕裂、盘状外侧半月板以及桶柄状撕裂病例。未发现与SE相关的不良事件或反应。术后3个月,使用MRI和关节镜评估临床结果和修复部位。Lysholm评分和视觉模拟量表评分有显著改善(P < 0.05),膝关节损伤和骨关节炎疗效评分在症状子量表上有显著改善。MRI结果显示,1例患者为1级愈合,3例为2级,4例为3级(未愈合)。关节镜检查显示,6例患者半月板完全愈合,2例显示不完全愈合;无1例被归类为“未愈合”。这些发现表明,SE是安全的,可能有助于无血管区域的半月板愈合,显示出其改善修复结果的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/171c/11806047/4b809c451618/41598_2025_88616_Fig1_HTML.jpg

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本文引用的文献

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Development of a novel approach for restoration of the meniscus using silk-elastin in a rabbit meniscus injury model.
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