透明质酸（500 - 730kDa）超声引导注射治疗疼痛性肌腱病的疗效与安全性：一项前瞻性、开放标签的临床研究。
Efficacy and safety of hyaluronic acid (500-730kDa) Ultrasound-guided injections on painful tendinopathies: a prospective, open label, clinical study.
作者信息
Fogli Marco, Giordan Nicola, Mazzoni Gianni
机构信息
Department of Biomedical Sciences, University of Ferrara, Ferrara, Italy.
Clinical Research Department, Fidia Farmaceutici S.p.A., Abano Terme, Padua, Italy.
出版信息
Muscles Ligaments Tendons J. 2017 Sep 18;7(2):388-395. doi: 10.11138/mltj/2017.7.2.388. eCollection 2017 Apr-Jun.
BACKGROUND
Tendinopathies are conditions characterized by activity-induced pain, local tenderness and swelling for which a gold standard treatment is not established yet. Hyaluronic Acid (HA) is a key-molecule in several cellular activities and it is normally present in the extra-cellular matrix of tendons and ligaments. Amongst its properties, HA injections may reduce pain and determine disease-modifying effects. This study is an investigator-initiated open-label trial conducted to investigate the efficacy and safety of HA (500-730 kDa) peritendinous injections on pain reduction in patients affected by lateral elbow, Achilles or patellar tendinopathy.
METHODS
A total of 71 tendons (34 with Achilles tendinopathy, 26 with lateral elbow tendinopathy, 11 with patellar tendinopathy) of 62 patients with painful tendinopathy were treated with a cycle of ultrasound-guided peritendinous injections one injection per week for three consecutive weeks. Efficacy assessments included changes in pain intensity measured by Visual Analogue Scale (VAS) at follow-up evaluations were performed 7 (V2), 14 (V3) and 56 days aften first treatment. An Ultrasound (US) assessment was also performed to evaluate changes in tendon thickness and neovascularization. Adverse events were recorded for safety analysis throughout the study. All results were analyzed with descriptive statistics appropriate to the nature of the variables.
RESULTS
Significant reduction in VAS (p<0.001) from baseline was observed in Achilles (-6.16 ± 0.45 cm), patellar (-6.16 ± 0.72 cm) and lateral elbow (-5.33 ± 0.43 cm) tendinopathies. The sagittal thickness decreased significantly from baseline at each endpoint (V3 day 14 and V4 day 56) in each type of tendinopathy analyzed (p<0.05). Neovascularization decreased for each tendons at V3 and V4, except for patellar tendon at V3 V1 (p=0.125). Nevertheless, reduction at V4 compared to baseline remained significant (p=0.016).
CONCLUSIONS
US-guided HA (500-730 kDa) peritendinous injections determine significant pain relief and reduction in tendon thickness and neovascularization in US evaluations. The effect of HA did not show differences regarding the site of affected tendon. The treatment proved to be safe and very well tolerated.
LEVEL OF EVIDENCE
背景
肌腱病的特征是活动诱发的疼痛、局部压痛和肿胀，目前尚未确立金标准治疗方法。透明质酸（HA）是多种细胞活动中的关键分子，正常存在于肌腱和韧带的细胞外基质中。HA注射具有多种特性，可能减轻疼痛并产生疾病改善效果。本研究是一项由研究者发起的开放标签试验，旨在研究HA（500 - 730 kDa）腱鞘周围注射对外侧肘部、跟腱或髌腱肌腱病患者减轻疼痛的疗效和安全性。
方法
62例患有疼痛性肌腱病的患者共71条肌腱（34条跟腱肌腱病、26条外侧肘部肌腱病、11条髌腱肌腱病）接受了一个疗程的超声引导下腱鞘周围注射，每周注射一次，连续注射三周。疗效评估包括在首次治疗后7天（V2）、14天（V3）和56天进行随访评估时，通过视觉模拟量表（VAS）测量的疼痛强度变化。还进行了超声（US）评估，以评估肌腱厚度和新生血管形成的变化。在整个研究过程中记录不良事件以进行安全性分析。所有结果均采用适合变量性质的描述性统计方法进行分析。
结果
跟腱（-6.16 ± 0.45 cm）、髌腱（-6.16 ± 0.72 cm）和外侧肘部（-5.33 ± 0.43 cm）肌腱病患者的VAS评分较基线显著降低（p<0.001）。在每种分析的肌腱病类型中，在每个终点（V3第14天和V4第56天）矢状厚度均较基线显著降低（p<0.05）。除V3时髌腱（V1）外，各肌腱在V3和V4时新生血管形成均减少（p = 0.125）。然而，与基线相比，V4时的减少仍具有显著性（p = 0.016）。
结论
超声引导下HA（500 - 730 kDa）腱鞘周围注射可显著缓解疼痛，并在超声评估中减少肌腱厚度和新生血管形成。HA的效果在受影响肌腱的部位上未显示出差异。该治疗方法被证明是安全的，耐受性良好。
证据级别
4级。
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