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自体肌腱细胞注射治疗慢性顽固性外侧上髁炎的疗效持久性证据:平均4.5年临床随访

Evidence for the Durability of Autologous Tenocyte Injection for Treatment of Chronic Resistant Lateral Epicondylitis: Mean 4.5-Year Clinical Follow-up.

作者信息

Wang Allan, Mackie Katherine, Breidahl William, Wang Tao, Zheng Ming H

机构信息

Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia Centre for Orthopaedic Research, School of Surgery, The University of Western Australia, Crawley, Western Australia, Australia.

Centre for Orthopaedic Research, School of Surgery, The University of Western Australia, Crawley, Western Australia, Australia.

出版信息

Am J Sports Med. 2015 Jul;43(7):1775-83. doi: 10.1177/0363546515579185. Epub 2015 Apr 23.

DOI:10.1177/0363546515579185
PMID:25908113
Abstract

BACKGROUND

Chronic lateral epicondylitis (LE) induces cell apoptosis and autophagy, which lead to the reduction of tendon-derived cells in the torn tendon. Our previous study has shown that ultrasound-guided autologous tenocyte injection (ATI) to the torn tendon in patients with chronic resistant LE significantly improves pain, function, and structural repair at 1 year. This report is the continued assessment of the clinical outcomes of these patients at mean 4.5-year follow-up.

HYPOTHESIS

Improvements in LE clinical function and structural repair after ATI will be maintained at mean 4.5-year follow-up.

STUDY DESIGN

Case series; Level of evidence, 4.

METHODS

Patients with severe refractory LE underwent clinical evaluation and MRI before intervention. A patellar tendon needle biopsy was performed under local anesthetic, and tendon cells were expanded by in vitro culture. Autologous tenocytes were injected into the central tendinopathy identified at the common extensor tendon origin under ultrasound guidance on a single occasion. Patients underwent serial clinical evaluations for up to 5 years after ATI, including the visual analog scale (VAS) for pain, Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH), Upper Extremity Functional Scale (UEFS), and grip strength. Post-ATI MRI scanning was performed at 1 year and final follow-up.

RESULTS

A total of 16 patients (9 male, 7 female), aged between 37 and 63 years, were included in the study. The mean duration of symptoms before study recruitment was 29.24 months (range, 6-240 months). One patient elected to proceed to surgery 3 months after ATI due to reinjury at work, and 1 patient died of prostate cancer with metastases during the follow-up period. The mean final follow-up time for the remaining 15 patients was 4.51 years (range, 3.08-5.17 years). No complications were observed at the patellar tendon biopsy site for any patient. No adverse events, infection, or excessive fibroblastic reactions were observed in any patient at the injection site. Clinical evaluation revealed significant (P < .001) improvement in mean VAS pain score from 5.73 at initial assessment to 1.21 (78% improvement) at final follow-up. Mean QuickDASH, UEFS, and grip strength scores also significantly (P < .001) improved from initial assessment to final follow-up (from 45.88 to 6.61 [84%], from 31.73 to 9.20 [64%], and from 19.85 to 46.60 [208%], respectively). There was no difference in mean QuickDASH and UEFS scores at 1 year and final follow-up (P > .05); however, grip strength continued to improve (P < .001). A validated MRI scoring system indicated that the mean grade of tendinopathy at the common extensor origin improved significantly (P < .001) from initial assessment (4.31) to 1 year (2.88) and was maintained (P > .05) at final follow-up (2.87). At final follow-up, 93% of patients were either highly satisfied or satisfied with their ATI treatment.

CONCLUSION

ATI significantly improved clinical function and MRI tendinopathy scores for up to 5 years in patients with chronic resistant LE who had previously undergone unsuccessful nonsurgical treatment. This study provides evidence for the midterm durability of ATI for treatment of LE tendinopathy.

摘要

背景

慢性外侧上髁炎(LE)会诱导细胞凋亡和自噬,导致撕裂肌腱中肌腱衍生细胞数量减少。我们之前的研究表明,对于慢性难治性LE患者,超声引导下将自体肌腱细胞注射(ATI)到撕裂的肌腱中,在1年时能显著改善疼痛、功能和结构修复。本报告是对这些患者平均4.5年随访期临床结果的持续评估。

假设

ATI后LE临床功能和结构修复的改善在平均4.5年随访期将得以维持。

研究设计

病例系列;证据等级,4级。

方法

重度难治性LE患者在干预前接受临床评估和磁共振成像(MRI)检查。在局部麻醉下进行髌腱针吸活检,通过体外培养扩增肌腱细胞。在超声引导下一次性将自体肌腱细胞注射到在伸肌总腱起点处确定的中央肌腱病变部位。ATI后患者接受长达5年的系列临床评估,包括疼痛视觉模拟评分(VAS)、上肢、肩部和手部快速残疾评定量表(QuickDASH)、上肢功能量表(UEFS)和握力。在1年时和最终随访时进行ATI后的MRI扫描。

结果

本研究共纳入16例患者(9例男性,7例女性),年龄在37至63岁之间。研究招募前症状的平均持续时间为29.24个月(范围6 - 240个月)。1例患者在ATI后3个月因工作中再次受伤选择进行手术,1例患者在随访期间死于前列腺癌伴转移。其余15例患者的平均最终随访时间为4.51年(范围3.08 - 5.17年)。所有患者在髌腱活检部位均未观察到并发症。在注射部位,所有患者均未观察到不良事件、感染或过度的成纤维细胞反应。临床评估显示,平均VAS疼痛评分从初始评估时的5.73显著改善(P <.001)至最终随访时的1.21(改善78%)。平均QuickDASH、UEFS和握力评分从初始评估到最终随访也显著改善(P <.001)(分别从45.88至6.61 [84%]、从31.73至9.20 [64%]、从19.85至46.60 [208%])。1年时和最终随访时的平均QuickDASH和UEFS评分无差异(P >.05);然而,握力持续改善(P <.001)。一个经过验证的MRI评分系统表明,伸肌总腱起点处肌腱病变的平均等级从初始评估时的4.31显著改善(P <.001)至1年时的2.88,并在最终随访时维持(P >.05)(2.87)。在最终随访时,93%的患者对其ATI治疗高度满意或满意。

结论

对于先前非手术治疗失败的慢性难治性LE患者,ATI在长达5年的时间里显著改善了临床功能和MRI肌腱病变评分。本研究为ATI治疗LE肌腱病变的中期持久性提供了证据。

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