富血小板血浆(PRP)治疗肩袖撕裂的益处仍不确定,因为它既可以作为手术修复的佐剂,也可以作为不针对索引病变的原发性浸润,这可能会削弱其效果。
为了确定PRP浸润在改善愈合方面是否优于盐溶液浸润(安慰剂),疼痛,在超声引导下在孤立的冈上肌间质泪液中注射时的功能。
随机对照试验;证据水平,1.
在这个单中心,双盲,随机对照试验,80例成人有症状的孤立性冈上肌间质撕裂,磁共振关节造影证实,被随机分配到PRP或盐水注射。每个患者接受2次注射,间隔1个月。主要结果是病变体积的变化,根据磁共振关节造影计算,在7个月。次要结果是在>12个月时肩痛和单一评估数值评估(SANE)评分的改善。
两组之间的术前患者特征没有差异。7个月时,PRP组和对照组在病变大小减小方面没有显着差异(分别为-0.3±23.6mm3和-8.1±84.7mm3;P=.175);视觉模拟量表(VAS)疼痛减轻(分别为-2.3±3.0和-2.0±3.0;P=.586);SANE改善(分别为16.7±20.0和14.9±29.650);P=.常数(分别为8.6±13.0和10.7±19.0;P=.596),美国肩肘外科医师(19.5±20.0vs21.9±28.0;P=.665)得分。在>12个月时,PRP组和对照组在VAS疼痛减轻(分别为-3.3±2.6vs-2.3±3.2;P=.087)或SANE评分改善(分别为24.4±27.5vs23.4±24.9;P=.846)方面无显著差异.在19.5±5.3个月时,不良反应的发生率(疼痛>48小时,冻结肩,PRP组的病变扩展)明显高于对照组(54%vs26%,分别为;P=.020)。
与注射生理盐水相比,在冈上间质泪液中注射PRP并不能改善肌腱愈合或临床评分,并且与更多的不良事件相关。
NCT02672085(ClinicalTrials.gov标识符)。
The benefits of platelet-rich plasma (PRP) for the treatment of rotator cuff tears remain inconclusive, as it is administered either as an adjuvant to surgical repair or as a primary infiltration without targeting the index lesion, which could dilute its effect.
To determine whether PRP infiltrations are superior to saline solution infiltrations (placebo) at improving healing, pain, and function when injected under ultrasound guidance within isolated interstitial supraspinatus tears.
Randomized controlled
trial; Level of evidence, 1.
In this single-center, double-blinded, randomized controlled
trial, 80 adults with symptomatic isolated interstitial tears of the supraspinatus, confirmed by magnetic resonance arthrography, were randomized to PRP or saline injections. Each patient received 2 injections with a 1-month interval. The primary outcome was the change in lesion volume, calculated on magnetic resonance arthrography, at 7 months. The secondary outcomes were improvements in shoulder pain and the Single Assessment Numerical Evaluation (SANE) score at >12 months.
Preoperative patient characteristics did not differ between the 2 groups. At 7 months, there were no significant differences between the PRP and control groups in terms of a decrease in lesion size (-0.3 ± 23.6 mm3 vs -8.1 ± 84.7 mm3, respectively; P = .175); reduction of pain on a visual analog scale (VAS) (-2.3 ± 3.0 vs -2.0 ± 3.0, respectively; P = .586); and improvement in SANE (16.7 ± 20.0 vs 14.9 ± 29.0, respectively; P = .650), Constant (8.6 ± 13.0 vs 10.7 ± 19.0, respectively; P = .596), and American Shoulder and Elbow Surgeons (19.5 ± 20.0 vs 21.9 ± 28.0, respectively; P = .665) scores. At >12 months, there were no significant differences between the PRP and control groups in terms of a reduction of pain on a VAS (-3.3 ± 2.6 vs -2.3 ± 3.2, respectively; P = .087) or improvement in the SANE score (24.4 ± 27.5 vs 23.4 ± 24.9, respectively; P = .846). At 19.5 ± 5.3 months, the incidence of adverse effects (pain >48 hours, frozen shoulder, extension of lesion) was significantly higher in the PRP group than the control group (54% vs 26%, respectively; P = .020).
PRP injections within interstitial supraspinatus tears did not improve tendon healing or clinical scores compared with saline injections and were associated with more adverse events.
NCT02672085 (ClinicalTrials.gov identifier).