Department of Foot and Ankle Surgery, Beijing Tongren Hospital, Capital Medical University, No.1, Dong Jiao Min Lane, Dong Cheng District, Beijing, 100730, People's Republic of China.
Int Orthop. 2023 Aug;47(8):1963-1974. doi: 10.1007/s00264-023-05773-2. Epub 2023 Mar 21.
To evaluate the safety and efficacy of platelet-rich plasma (PRP) intra-articular injective treatments for ankle osteoarthritis (OA).
A systematic literature search was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines in PubMed, Scopus, Embase, Google Scholar, and the Cochrane library until May 2022. Both randomized and non-randomized studies were included with the assessment of the risk of bias. We recorded the participant's age, gender, type of PRP, injection volume, the kit used, and activating agent. We subsequently assessed the short-term and long-term efficacy of PRP using the functional scores and visual analog scale (VAS).
We included four studies with a total of 127 patients, with a mean age of 56.1 years. 47.2% were male (60/127), according to eligibility criteria. There were three cohort studies and one randomized controlled trial (RCT) study, and no study reported severe adverse events. All included studies used the Leukocyte-poor PRP. Short-term follow-up results suggested significant improvement of the American Orthopaedic Foot and Ankle Society (AOFAS) score in the PRP injection group compared to the control group (n = 87 patients; MD: 6.94 [95% CI: 3.59, 10.29]; P < 0.01). Consistently, there was a statistical difference in AOFAS score between PRP injection and control groups in the final follow-up (≥ 6 months) (n = 87 patients; MD: 9.63 [95% CI: 6.31, 12.94]; P < 0.01). Furthermore, we found a significant reduction in VAS scores in the PRP groups at both the short-term follow-up (n = 59 patients; MD, - 1.90 [95% CI, - 2.54, - 1.26]; P < 0.01) and the ≥ six months follow-up (n = 79 patients; MD, - 3.07 [95% CI, - 5.08, - 1.05]; P < 0.01). The improvement of AOFAS and VAS scores at ≥ six months follow-up reached the minimal clinically important difference (MCID). Nevertheless, the treatment effect of AOFAS and VAS scores offered by PRP at short-term follow-up did not exceed the MCID. Substantial heterogeneity was reported at the ≥ six months follow-up in VAS scores (I: 93%, P < 0.01).
This meta-analysis supports the safety of PRP intra-articular injection for ankle OA. The improvements of AOFAS and VAS scores in the PRP group at short-term follow-up do not exceed the MCID to be clinically significant. PRP injection provides significant improvement of AOFAS score and reduced pain at ≥ six months follow-up. The efficacy of PRP should be interpreted with caution regarding the high heterogeneity and the scarcity of available literature, which urges large-scale RCTs with longer follow-up to confirm the potential efficacy of PRP injection for ankle OA.
评估富含血小板的血浆(PRP)关节内注射治疗踝骨关节炎(OA)的安全性和疗效。
按照系统评价和荟萃分析的首选报告项目(PRISMA)指南,在 PubMed、Scopus、Embase、Google Scholar 和 Cochrane 图书馆进行了系统文献检索,截至 2022 年 5 月。纳入了随机和非随机研究,并评估了偏倚风险。我们记录了参与者的年龄、性别、PRP 类型、注射量、使用的试剂盒和激活剂。随后,我们使用功能评分和视觉模拟评分(VAS)评估 PRP 的短期和长期疗效。
我们纳入了四项研究,共 127 名患者,平均年龄为 56.1 岁。根据纳入标准,47.2%(60/127)为男性。有三项队列研究和一项随机对照试验(RCT)研究,没有研究报告严重不良事件。所有纳入的研究均使用白细胞减少的 PRP。短期随访结果表明,PRP 注射组的美国矫形足踝协会(AOFAS)评分较对照组显著改善(n=87 例;MD:6.94[95%CI:3.59,10.29];P<0.01)。同样,在最终随访(≥6 个月)时,PRP 注射组和对照组的 AOFAS 评分之间存在统计学差异(n=87 例;MD:9.63[95%CI:6.31,12.94];P<0.01)。此外,我们发现 PRP 组在短期随访(n=59 例;MD,-1.90[95%CI,-2.54,-1.26];P<0.01)和≥6 个月随访(n=79 例;MD,-3.07[95%CI,-5.08,-1.05];P<0.01)时 VAS 评分显著降低。AOFAS 和 VAS 评分在≥6 个月随访时的改善达到了最小临床重要差异(MCID)。然而,PRP 在短期随访时提供的 AOFAS 和 VAS 评分的治疗效果并未超过 MCID。在≥6 个月随访时,VAS 评分的异质性显著(I:93%,P<0.01)。
这项荟萃分析支持 PRP 关节内注射治疗踝骨关节炎的安全性。PRP 组在短期随访时 AOFAS 和 VAS 评分的改善未超过 MCID,不具有临床意义。PRP 注射可显著提高 AOFAS 评分,并在≥6 个月随访时减轻疼痛。鉴于异质性高和现有文献匮乏,PRP 注射治疗踝骨关节炎的潜在疗效应谨慎解释,需要进行更大规模的 RCT 并进行更长时间的随访以证实。