School of Medicine, Mayo Clinic Alix School of Medicine, Rochester, Minnesota, USA.
Department of Orthopaedics, Institute of Clinical Sciences, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Am J Sports Med. 2024 Oct;52(12):3147-3160. doi: 10.1177/03635465231224463. Epub 2024 Feb 29.
Based in part on the results of randomized controlled trials (RCTs) that suggest a beneficial effect over alternative treatment options, the use of platelet-rich plasma (PRP) for the management of knee osteoarthritis (OA) is widespread and increasing. However, the extent to which these studies are vulnerable to slight variations in the outcomes of patients remains unknown.
To evaluate the statistical fragility of conclusions from RCTs that reported outcomes of patients with knee OA who were treated with PRP versus alternative nonoperative management strategies.
Systematic review and meta-analysis; Level of evidence, 2.
All RCTs comparing PRP with alternative nonoperative treatment options for knee OA were identified. The fragility index (FI) and reverse FI were applied to assess the robustness of conclusions regarding the efficacy of PRP for knee OA. Meta-analyses were performed to determine the minimum number of patients from ≥1 trials included in the meta-analysis for which a modification on the event status would change the statistical significance of the pooled treatment effect.
In total, this analysis included outcomes from 1993 patients with a mean ± SD age of 58.0 ± 3.8 years. The mean number of events required to reverse significance of individual RCTs (FI) was 4.57 ± 5.85. Based on random-effects meta-analyses, PRP demonstrated a significantly higher rate of successful outcomes when compared with hyaluronic acid ( = .002; odds ratio [OR], 2.19; 95% CI, 1.33-3.62), as well as higher rates of patient-reported symptom relief ( = .019; OR, 1.55; 95% CI, 1.07-2.24), not requiring a reintervention after the initial injection treatment ( = .002; OR, 2.17; 95% CI, 1.33-3.53), and achieving the minimal clinically important difference (MCID) for pain improvement ( = .007; OR, 6.19; 95% CI, 1.63-23.42) when compared with all alternative nonoperative treatments. Overall, the mean number of events per meta-analysis required to change the statistical significance of the pooled treatment effect was 8.67 ± 4.50.
Conclusions drawn from individual RCTs evaluating PRP for knee OA demonstrated slight robustness. On meta-analysis, PRP demonstrated a significant advantage over hyaluronic acid as well as improved symptom relief, lower rates of reintervention, and more frequent achievement of the MCID for pain improvement when compared with alternative nonoperative treatment options. Statistically significant pooled treatment effects evaluating PRP for knee OA are more robust than approximately half of all comparable meta-analyses in medicine and health care. Future RCTs and meta-analyses should consider reporting FIs and fragility quotients to facilitate interpretation of results in their proper context.
部分基于随机对照试验（RCT）的结果表明，富血小板血浆（PRP）在治疗膝骨关节炎（OA）方面优于其他替代治疗方法，因此 PRP 在治疗膝 OA 方面的应用越来越广泛。然而，这些研究的结论在多大程度上容易受到患者结局的微小变化影响尚不清楚。
评估报道 PRP 治疗膝 OA 患者与替代非手术治疗策略相比的结局的 RCT 结论的统计学稳健性。
系统评价和荟萃分析；证据水平，2 级。
所有比较 PRP 与替代非手术治疗膝 OA 的 RCT 均被纳入。应用脆弱指数（FI）和反向 FI 评估 PRP 治疗膝 OA 疗效结论的稳健性。进行荟萃分析以确定在汇总治疗效果中，至少有 1 项试验的患者数量发生改变，会改变统计学意义。
共纳入 1993 例患者的结局数据，平均年龄为 58.0±3.8 岁。单个 RCT 中需要改变事件状态才能逆转统计学意义的最小所需事件数（FI）为 4.57±5.85。基于随机效应荟萃分析，与透明质酸相比，PRP 治疗后患者的结局更优（ =.002；比值比 [OR]，2.19；95%CI，1.33-3.62），患者报告的症状缓解率更高（ =.019；OR，1.55；95%CI，1.07-2.24），初始注射治疗后无需再次干预的比例更高（ =.002；OR，2.17；95%CI，1.33-3.53），且达到疼痛改善的最小临床重要差异（MCID）的比例更高（ =.007；OR，6.19；95%CI，1.63-23.42）。总体而言，需要改变每个荟萃分析中事件数量才能改变汇总治疗效果的统计学意义的平均事件数为 8.67±4.50。
评价 PRP 治疗膝 OA 的单个 RCT 得出的结论显示出一定的稳健性。荟萃分析显示，与透明质酸相比，PRP 在症状缓解、较低的再次干预率和更频繁地达到疼痛改善 MCID 方面具有显著优势，优于其他非手术治疗选择。评价 PRP 治疗膝 OA 的汇总治疗效果具有统计学意义，比大约一半的医学和保健领域的可比荟萃分析更为稳健。未来的 RCT 和荟萃分析应考虑报告 FI 和脆弱性比率，以便在适当的背景下解释结果。
