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超声引导下单独及联合注射富血小板血浆和透明质酸治疗髋骨关节炎:一项随机对照研究

Ultrasound-Guided Injection of Platelet-Rich Plasma and Hyaluronic Acid, Separately and in Combination, for Hip Osteoarthritis: A Randomized Controlled Study.

作者信息

Dallari Dante, Stagni Cesare, Rani Nicola, Sabbioni Giacomo, Pelotti Patrizia, Torricelli Paola, Tschon Matilde, Giavaresi Gianluca

机构信息

Conservative Orthopedic Surgery and Innovative Techniques Ward, Rizzoli Orthopedic Institute, Bologna, Italy

Conservative Orthopedic Surgery and Innovative Techniques Ward, Rizzoli Orthopedic Institute, Bologna, Italy.

出版信息

Am J Sports Med. 2016 Mar;44(3):664-71. doi: 10.1177/0363546515620383. Epub 2016 Jan 21.

DOI:10.1177/0363546515620383
PMID:26797697
Abstract

BACKGROUND

The effectiveness of intra-articular platelet-rich plasma (PRP) injections has been evaluated in knee chondroplasty and osteoarthritis (OA); however, little evidence of its efficacy in hip OA exists.

PURPOSE

To compare the therapeutic efficacy of autologous PRP, hyaluronic acid (HA), or a combination of both (PRP+HA) in hip OA.

STUDY DESIGN

Randomized controlled trial; Level of evidence, 1.

METHODS

Patients aged between 18 and 65 years who were treated with outpatient surgery and who had hip OA and pain intensity at baseline of >20 on a 100-mm visual analog scale (VAS) were recruited for this study. Exclusion criteria were extensive surgery; presence of excessive deformities; or rheumatic, infective, cardiovascular, or immune system disorders. The primary outcome measure was a change in pain intensity as assessed by the VAS at 2, 6, and 12 months after treatment. Secondary outcome measures were the Harris Hip Score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and concentration of growth factors in PRP and their correlation with clinical outcomes. Clinical outcomes were evaluated by assessors and collectors blinded to the type of treatment administered.

RESULTS

A total of 111 patients were randomly assigned to 3 groups and received 3 weekly injections of either PRP (44 patients), PRP+HA (31 patients), or HA (36 patients). At all follow-ups, the PRP group had the lowest VAS scores. In particular, at 6-month follow-up, the mean VAS score was 21 (95% CI, 15-28) in the PRP group, 35 (95% CI, 26-45) in the PRP+HA group, and 44 (95% CI, 36-52) in the HA group (P < .0005 [PRP vs HA] and P = .007 [PRP vs PRP+HA]; F = 0.663). The WOMAC score of the PRP group was significantly better at 2-month follow-up (mean, 73; 95% CI, 68-78) and 6-month follow-up (mean, 72; 95% CI, 67-76) but not at 12-month follow-up. A significant, "moderate" correlation was found between interleukin-10 and variations of the VAS score (r = 0.392; P = .040). Significant improvements were achieved in reducing pain and ameliorating quality of life and functional recovery.

CONCLUSION

Results indicated that intra-articular PRP injections offer a significant clinical improvement in patients with hip OA without relevant side effects. The benefit was significantly more stable up to 12 months as compared with the other tested treatments. The addition of PRP+HA did not lead to a significant improvement in pain symptoms.

摘要

背景

关节腔内注射富血小板血浆(PRP)在膝关节成形术和骨关节炎(OA)中的有效性已得到评估;然而,关于其在髋关节OA中疗效的证据很少。

目的

比较自体PRP、透明质酸(HA)或两者联合使用(PRP+HA)在髋关节OA中的治疗效果。

研究设计

随机对照试验;证据等级,1级。

方法

本研究招募了年龄在18至65岁之间、接受门诊手术治疗、患有髋关节OA且基线时疼痛强度在100毫米视觉模拟量表(VAS)上大于20的患者。排除标准为广泛手术;存在过度畸形;或患有风湿性、感染性、心血管或免疫系统疾病。主要结局指标是治疗后2个月、6个月和12个月时通过VAS评估的疼痛强度变化。次要结局指标包括Harris髋关节评分、西安大略和麦克马斯特大学骨关节炎指数(WOMAC)以及PRP中生长因子的浓度及其与临床结局的相关性。临床结局由对所给予治疗类型不知情的评估者和收集者进行评估。

结果

总共111名患者被随机分为3组,每周接受3次注射,分别为PRP组(44例患者)、PRP+HA组(31例患者)或HA组(36例患者)。在所有随访中,PRP组的VAS评分最低。特别是在6个月随访时,PRP组的平均VAS评分为21(95%CI,15-28),PRP+HA组为35(95%CI,26-45),HA组为44(95%CI,36-52)(PRP组与HA组比较,P<.0005;PRP组与PRP+HA组比较,P=.007;F=0.663)。PRP组的WOMAC评分在2个月随访时(平均,73;95%CI,68-78)和6个月随访时(平均,72;95%CI,67-76)显著更好,但在12个月随访时并非如此。发现白细胞介素-10与VAS评分变化之间存在显著的“中度”相关性(r=0.392;P=.040)。在减轻疼痛、改善生活质量和功能恢复方面取得了显著改善。

结论

结果表明,关节腔内注射PRP可使髋关节OA患者的临床症状得到显著改善,且无相关副作用。与其他测试治疗相比,这种益处直至12个月时都显著更稳定。添加PRP+HA并未导致疼痛症状的显著改善。

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