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富血小板血浆注射治疗慢性跟腱病的有效性:一项荟萃分析。

Is Platelet-rich Plasma Injection Effective for Chronic Achilles Tendinopathy? A Meta-analysis.

机构信息

Yi-Jun Zhang, San-Zhong Xu, Peng-Cheng Gu, Jing-Yu Du, You-Zhi Cai, Chi Zhang, Xiang-Jin Lin, Department of Orthopedics, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, PR China.

出版信息

Clin Orthop Relat Res. 2018 Aug;476(8):1633-1641. doi: 10.1007/s11999.0000000000000258.

Abstract

BACKGROUND

Chronic Achilles tendinopathy is common in the general population, and platelet-rich plasma (PRP) is seeing increased use to treat this problem. However, studies disagree as to whether PRP confers a beneficial effect for chronic Achilles tendinopathy, and no one to our knowledge has pooled the available randomized trials in a formal meta-analysis to try to reconcile those differences.

QUESTIONS/PURPOSES: In the setting of a systematic review and meta-analysis of randomized controlled trials (RCTs), we asked: Does PRP plus eccentric strength training result in (1) greater improvements in Victorian Institute of Sports Assessment-Achilles (VISA-A) scores; (2) differences in tendon thickness; or (3) differences in color Doppler activity compared with placebo (saline) injections plus eccentric strength training in patients with chronic Achilles tendinopathy?

METHODS

A search of peer-reviewed articles was conducted to identify all RCTs using PRP injection with eccentric training for chronic Achilles tendinopathy in the electronic databases of PubMed, Web of Science (SCI-E/SSCI/A&HCI), and EMBASE from January 1981 to August 2017. Results were limited to human RCTs and published in all languages. Two reviewers assessed study quality using the Cochrane Collaboration risk-of-bias tool. All the included studies had low risk of bias. The primary endpoint was improvement in the VISA-A score, which ranges from 0 to 100 points, with higher scores representing increased activity and less pain; we considered the minimum clinically important difference on the VISA-A to be 12 points. Secondary outcomes were tendon thickness change (with a thicker tendon representing more severe disease), color Doppler activity (with more activity representing a poorer result), and other functional measures (such as pain and return to sports activity). Four RCTs involving 170 participants were eligible and included 85 participants treated with PRP injection and eccentric training and 85 treated with saline injection and eccentric training. The patients in both PRP and placebo (saline) groups seemed comparable at baseline. We assessed for publication bias using a funnel plot and saw no evidence of publication bias. Based on previous studies, we had 80% power to detect a 12-point difference on the VISA-A score with the available sample size in each group.

RESULTS

With the numbers available, there was no difference between the PRP and saline groups regarding the primary outcome (VISA-A score: mean difference [MD], 5.3; 95% confidence interval [CI], -0.7 to 11.3; p = 0.085). Likewise, we found no difference between the PRP and saline groups in terms of our secondary outcomes of tendon thickness change (MD, 0.2 mm; 95% CI, 0.6-1.0 mm; p = 0.663) and color Doppler activity (MD, 0.1; 95% CI, -0.7 to 0.4; p = 0.695).

CONCLUSIONS

PRP injection with eccentric training did not improve VISA-A scores, reduce tendon thickness, or reduce color Doppler activity in patients with chronic Achilles tendinopathy compared with saline injection. Larger randomized trials are needed to confirm these results, but until or unless a clear benefit has been demonstrated in favor of the new treatment, we cannot recommend it for general use.

LEVEL OF EVIDENCE

Level I, therapeutic study.

摘要

背景

慢性跟腱病在普通人群中很常见,富血小板血浆(PRP)的使用越来越多,以治疗这种疾病。然而,研究结果并不一致,PRP 是否对慢性跟腱病有有益的影响,据我们所知,没有人将现有的随机试验汇总到正式的荟萃分析中,以试图调和这些差异。

问题/目的:在对随机对照试验(RCT)进行系统评价和荟萃分析的背景下,我们提出了以下问题:在慢性跟腱病患者中,与安慰剂(生理盐水)注射加离心力训练相比,PRP 加离心力训练是否(1)在维多利亚运动评估-跟腱(VISA-A)评分方面有更大的改善;(2)在跟腱厚度方面有差异;或(3)在彩色多普勒活动方面有差异?

方法

对PubMed、Web of Science(SCI-E/SSCI/A&HCI)和 EMBASE 等电子数据库中的同行评审文章进行了搜索,以确定所有使用 PRP 注射加离心训练治疗慢性跟腱病的 RCT。结果仅限于人类 RCT,并以所有语言出版。两位评审员使用 Cochrane 协作风险偏倚工具评估研究质量。所有纳入的研究都有低风险偏倚。主要终点是 VISA-A 评分的改善,评分范围为 0 到 100 分,得分越高代表活动度越高,疼痛越少;我们认为 VISA-A 的最小临床重要差异为 12 分。次要结局是跟腱厚度变化(跟腱越厚代表疾病越严重)、彩色多普勒活动(活动越多代表结果越差)和其他功能指标(如疼痛和重返运动活动)。有四项 RCT 涉及 170 名参与者,其中 85 名参与者接受 PRP 注射和离心力训练治疗,85 名参与者接受生理盐水注射和离心力训练治疗。两组 PRP 和安慰剂(生理盐水)组的患者在基线时似乎具有可比性。我们使用漏斗图评估发表偏倚,未发现发表偏倚的证据。根据以往的研究,我们在每组现有的样本量下有 80%的能力检测到 VISA-A 评分 12 分的差异。

结果

根据现有的数据,PRP 组和生理盐水组在主要结局(VISA-A 评分:平均差异[MD],5.3;95%置信区间[CI],-0.7 至 11.3;p = 0.085)方面没有差异。同样,我们发现 PRP 组和生理盐水组在次要结局(跟腱厚度变化 MD,0.2 毫米;95%CI,0.6-1.0 毫米;p = 0.663)和彩色多普勒活动 MD,0.1;95%CI,-0.7 至 0.4;p = 0.695)方面也没有差异。

结论

与生理盐水注射相比,PRP 注射加离心训练并不能改善慢性跟腱病患者的 VISA-A 评分、减少跟腱厚度或减少彩色多普勒活动。需要更大规模的随机试验来证实这些结果,但在新治疗方法的益处得到明确证明之前,我们不能推荐其常规使用。

证据等级

一级,治疗性研究。

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