Anz Adam W, Hubbard Ryan, Rendos Nicole K, Everts Peter A, Andrews James R, Hackel Joshua G
Andrews Research & Education Foundation, Gulf Breeze, Florida, USA.
Gulf Coast Biologics, Fort Myers, Florida, USA.
Orthop J Sports Med. 2020 Feb 18;8(2):2325967119900958. doi: 10.1177/2325967119900958. eCollection 2020 Feb.
Approximately 47 million people in the United States have been diagnosed with arthritis. Autologous platelet-rich plasma (PRP) injections have been documented to alleviate symptoms related to knee osteoarthritis (OA) in randomized controlled trials, systematic reviews, and meta-analyses. Autologous bone marrow aspirate concentrate (BMC) injections have also emerged as a treatment option for knee OA, with a limited clinical evidence base.
To compare the efficacy of BMC to PRP for the treatment of knee OA regarding pain and function at multiple time points up to 12 months after an injection. We hypothesized that BMC will be more effective in improving outcomes in patients with knee OA.
Randomized controlled trial; Level of evidence, 2.
A total of 90 participants aged between 18 and 80 years with symptomatic knee OA (Kellgren-Lawrence grades 1-3) were randomized into 2 study groups: PRP and BMC. Both groups completed the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and subjective International Knee Documentation Committee (IKDC) questionnaires before and 1, 3, 6, 9, and 12 months after a single intra-articular injection of leukocyte-rich PRP or BMC.
There were no statistically significant differences in baseline IKDC or WOMAC scores between the 2 groups. All IKDC and WOMAC scores for both the PRP and BMC groups significantly improved from baseline to 1 month after the injection ( < .001). These improvements were sustained for 12 months after the injection, with no difference between PRP and BMC at any time point.
Both PRP and BMC were effective in improving patient-reported outcomes in patients with mild to moderate knee OA for at least 12 months; neither treatment provided a superior clinical benefit. Autologous PRP and BMC showed promising clinical potential as therapeutic agents for the treatment of OA, and while PRP has strong clinical evidence to support its efficacy, BMC has limited support. This study did not prove BMC to be superior to PRP, providing guidance to clinicians treating OA. It is possible that the results were affected by patients knowing that there was no control group.
NCT03289416 (ClinicalTrials.gov identifier).
在美国,约有4700万人被诊断患有关节炎。在随机对照试验、系统评价和荟萃分析中,自体富血小板血浆(PRP)注射已被证明可缓解与膝关节骨关节炎(OA)相关的症状。自体骨髓抽吸浓缩物(BMC)注射也已成为膝关节OA的一种治疗选择,但临床证据有限。
比较BMC与PRP在注射后长达12个月的多个时间点治疗膝关节OA的疼痛和功能疗效。我们假设BMC在改善膝关节OA患者的预后方面将更有效。
随机对照试验;证据等级,2级。
共有90名年龄在18至80岁之间、有症状的膝关节OA(Kellgren-Lawrence分级1-3级)参与者被随机分为2个研究组:PRP组和BMC组。两组在单次关节内注射富含白细胞的PRP或BMC之前以及注射后1、3、6、9和12个月完成了西安大略和麦克马斯特大学骨关节炎指数(WOMAC)以及主观国际膝关节文献委员会(IKDC)问卷。
两组之间的基线IKDC或WOMAC评分无统计学显著差异。PRP组和BMC组的所有IKDC和WOMAC评分从基线到注射后1个月均显著改善(P <.001)。这些改善在注射后持续了12个月,PRP组和BMC组在任何时间点均无差异。
PRP和BMC在改善轻度至中度膝关节OA患者的患者报告结局方面均有效,至少持续12个月;两种治疗方法均未提供更优的临床益处。自体PRP和BMC作为OA治疗药物显示出有前景的临床潜力,虽然PRP有强有力的临床证据支持其疗效,但BMC的支持有限。本研究未证明BMC优于PRP,为治疗OA的临床医生提供了指导。结果可能受到患者知晓没有对照组的影响。
NCT03289416(ClinicalTrials.gov标识符)