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富含血小板血浆对治疗跟腱病有效吗?一项随机临床试验的荟萃分析。

Is Platelet-rich Plasma Effective in Treating Achilles Tendinopathy? A Meta-analysis of Randomized Clinical Trials.

作者信息

Barreto Eduardo Silva Reis, Antunes Júnior César Romero, Silva Israel Cardoso, Alencar Vinicius Borges, Faleiro Thiago Batista, Kraychete Durval Campos

机构信息

Federal University of Bahia, Salvador, Brazil.

Federal University of São Paulo, São Paulo, Brazil.

出版信息

Clin Orthop Relat Res. 2025 May 1;483(5):779-790. doi: 10.1097/CORR.0000000000003349. Epub 2024 Dec 19.

Abstract

BACKGROUND

Several meta-analyses have evaluated the use of platelet-rich plasma (PRP) in the treatment of Achilles tendinopathy. Although they generally did not find PRP to be effective, an updated meta-analysis containing all the available, high-quality randomized trial evidence that addresses the methodological shortcomings identified in earlier meta-analyses needs to be performed.

QUESTION/PURPOSES: This systematic review and meta-analysis aimed to evaluate the efficacy of PRP in improving (1) pain and function as assessed using the Victorian Institute of Sports Assessment-Achilles (VISA-A) score 3 months, 6 months, and 1 year after treatment and (2) VAS pain scores 3 months after treatment in patients with chronic Achilles tendinopathy.

METHODS

We conducted a systematic search of PubMed, Scopus, Embase, and Cochrane CENTRAL from their inception until June 2024, focusing on randomized clinical trials (RCTs) comparing PRP with placebo or other treatments for Achilles tendinopathy. Our search identified 1289 studies, of which 1262 were excluded after removing duplicates and screening titles and abstracts, leaving 27 studies for detailed review. Six RCTs met the inclusion criteria, encompassing 422 patients, with a predominance of participants who were men. Publication bias was suggested by funnel plot asymmetry, which suggested that, if anything, the results may have overstated the apparent benefit of PRP treatment. Risk of bias was evaluated using the Cochrane Risk of Bias tool for randomized trials, revealing an overall low or unclear risk of bias. The primary outcomes were pain relief and functional improvement, assessed using the VAS, scored 0 to 10, with higher scores representing more severe pain, and VISA-A score, scored 0 to 100, with higher scores representing better pain and function. Heterogeneity was assessed using the Cochran Q test and I 2 statistics, and a random-effects model was applied due to substantial heterogeneity. Statistical analyses were performed using Review Manager 5.4 and RStudio, version 764.

RESULTS

We found no benefit in terms of VISA-A scores favoring PRP over placebo at 3 months (mean difference 1.7 [95% confidence interval (CI) -1.8 to 5.2]; p = 0.34), 6 months (mean difference 0.5 [95% CI [-8.5 to 9.3]; p = 0.92), or 1 year (mean difference -7.9 [95% CI -27.3 to 11.6]; p = 0.43). PRP did not improve VAS pain scores at 3 months (mean difference -0.22 [95% CI -0.56 to 0.12]; p = 0.21). Sensitivity analyses confirmed these findings. PRP showed no difference compared with stromal vascular fraction and was less effective in the short term compared with high-volume injection.

CONCLUSION

Until future high-quality RCTs show a clear clinical benefit, PRP should not be used to treat Achilles tendinopathy. Our analysis found that PRP does not improve pain or function compared with placebo, and potential publication bias suggests that the apparent benefits may be inflated. Surgeons should be cautious when considering PRP for this condition, and future research should focus on larger trials with standardized protocols to provide more definitive guidance.

LEVEL OF EVIDENCE

Level II, therapeutic study.

摘要

背景

多项荟萃分析评估了富血小板血浆(PRP)在跟腱病治疗中的应用。尽管这些分析总体上未发现PRP有效,但仍需进行一项更新的荟萃分析,纳入所有可用的高质量随机试验证据,以解决早期荟萃分析中发现的方法学缺陷。

问题/目的:本系统评价和荟萃分析旨在评估PRP在改善以下方面的疗效:(1)治疗后3个月、6个月和1年时,使用维多利亚运动评估-跟腱(VISA-A)评分评估的疼痛和功能;(2)慢性跟腱病患者治疗后3个月时的视觉模拟评分(VAS)疼痛评分。

方法

我们对PubMed、Scopus、Embase和Cochrane CENTRAL进行了系统检索,检索时间从各数据库创建至2024年6月,重点关注比较PRP与安慰剂或其他治疗跟腱病方法的随机临床试验(RCT)。我们的检索共识别出1289项研究,在去除重复项并筛选标题和摘要后,排除了其中1262项研究,最终留下27项研究进行详细审查。六项RCT符合纳入标准,涉及422例患者,其中男性参与者居多。漏斗图不对称提示存在发表偏倚,这表明即便有偏倚,结果可能也高估了PRP治疗的明显益处。使用Cochrane随机试验偏倚风险工具评估偏倚风险,结果显示总体偏倚风险较低或不明确。主要结局为疼痛缓解和功能改善,分别使用VAS评分(0至10分,分数越高表示疼痛越严重)和VISA-A评分(0至100分,分数越高表示疼痛和功能越好)进行评估。使用Cochran Q检验和I²统计量评估异质性,由于存在显著异质性,应用随机效应模型。使用Review Manager 5.4和RStudio 764版本进行统计分析。

结果

我们发现,在3个月时(平均差值1.7 [95%置信区间(CI)-1.8至5.2];p = 0.34)、6个月时(平均差值0.5 [95% CI [-8.5至9.3];p = 0.92])或1年时(平均差值-7.9 [95% CI -27.3至11.6];p = 0.43),与安慰剂相比,PRP在VISA-A评分方面并无优势。PRP在3个月时并未改善VAS疼痛评分(平均差值-0.22 [95% CI -0.56至0.12];p = 0.21)。敏感性分析证实了这些结果。与基质血管成分相比,PRP未显示出差异,且与大容量注射相比,PRP在短期内效果较差。

结论

在未来高质量RCT显示出明确的临床益处之前,不应使用PRP治疗跟腱病。我们的分析发现,与安慰剂相比,PRP并未改善疼痛或功能,潜在的发表偏倚表明其明显益处可能被夸大。外科医生在考虑将PRP用于这种情况时应谨慎,未来的研究应侧重于采用标准化方案的更大规模试验,以提供更明确的指导。

证据级别

二级,治疗性研究。

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本文引用的文献

6
Platelet-rich plasma in chronic Achilles tendinopathy.富含血小板的血浆治疗慢性跟腱病。
Eur J Orthop Surg Traumatol. 2023 Dec;33(8):3255-3265. doi: 10.1007/s00590-023-03570-6. Epub 2023 May 24.

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