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富血小板血浆与透明质酸治疗膝关节退行性病变的比较:一项随机对照试验的研究设计和初步结果。

Platelet-rich plasma vs hyaluronic acid to treat knee degenerative pathology: study design and preliminary results of a randomized controlled trial.

机构信息

Nano-Biotechnology Laboratory, Rizzoli Orthopaedic Institute, Via di Barbiano n. 1/10, Bologna 40136, Italy.

出版信息

BMC Musculoskelet Disord. 2012 Nov 23;13:229. doi: 10.1186/1471-2474-13-229.

Abstract

BACKGROUND

Platelet rich plasma (PRP), a blood-derived product rich in growth factors, is a promising treatment for cartilage defects but there is still a lack of clinical evidence. The aim of this study is to show, through a randomized double blind prospective trial, the efficacy of this procedure, by comparing PRP to Hyaluronic Acid (HA) injections for the treatment of knee chondropathy or osteoarthritis (OA).

METHODS

109 patients (55 treated with HA and 54 with PRP) were treated and evaluated at 12 months of follow-up. The patients were enrolled according to the following inclusion criteria: age > 18 years, history of chronic (at least 4 months) pain or swelling of the knee and imaging findings of degenerative changes of the joint (Kellgren-Lawrence Score up to 3). A cycle of 3 weekly injections was administered blindly. All patients were prospectively evaluated before and at 2, 6, and 12 months after the treatment by: IKDC, EQ-VAS, TEGNER, and KOOS scores. Range of motion and knee circumference changes were measured over time. Adverse events and patient satisfaction were also recorded.

RESULTS

Only minor adverse events were detected in some patients, such as mild pain and effusion after the injections, in particular in the PRP group, where a significantly higher post-injective pain reaction was observed (p=0.039). At the follow-up evaluations, both groups presented a clinical improvement but the comparison between the two groups showed a not statistically significant difference in all scores evaluated. A trend favorable for the PRP group was only found in patients with low grade articular degeneration (Kellgren-Lawrence score up to 2).

CONCLUSIONS

Results suggest that PRP injections offer a significant clinical improvement up to one year of follow-up. However, conversely to what was shown by the current literature, for middle-aged patients with moderate signs of OA, PRP results were not better than those obtained with HA injections, and thus it should not be considered as first line treatment. More promising results are shown for its use in low grade degeneration, but they still have to be confirmed.

摘要

背景

富含生长因子的富血小板血浆(PRP)是一种有前途的软骨缺损治疗方法,但目前仍缺乏临床证据。本研究旨在通过一项随机双盲前瞻性试验,通过比较 PRP 与透明质酸(HA)注射治疗膝关节软骨病或骨关节炎(OA),展示该方法的疗效。

方法

109 例患者(55 例接受 HA 治疗,54 例接受 PRP 治疗)在 12 个月的随访中进行了治疗和评估。根据以下纳入标准招募患者:年龄>18 岁,膝关节慢性(至少 4 个月)疼痛或肿胀史,影像学发现关节退行性改变(Kellgren-Lawrence 评分高达 3)。每周进行 3 次盲注治疗。所有患者在治疗前和治疗后 2、6 和 12 个月时均通过 IKDC、EQ-VAS、TEGNER 和 KOOS 评分进行前瞻性评估。测量了随时间变化的关节活动度和膝关节周长变化。还记录了不良事件和患者满意度。

结果

仅在一些患者中发现了轻微的不良事件,如注射后轻度疼痛和积液,尤其是在 PRP 组中,观察到注射后疼痛反应明显更高(p=0.039)。在随访评估中,两组均表现出临床改善,但两组间所有评分的比较均无统计学差异。仅在关节退变程度较低(Kellgren-Lawrence 评分最高为 2)的患者中,发现 PRP 组的结果有利。

结论

结果表明,PRP 注射可在 1 年随访时提供显著的临床改善。然而,与当前文献显示的情况相反,对于中度 OA 迹象的中年患者,PRP 的效果并不优于 HA 注射,因此不应将其视为一线治疗方法。在低等级退变中,其使用效果更有希望,但仍需进一步证实。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4298/3532098/5f3323327aeb/1471-2474-13-229-1.jpg

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