Efficacy of platelet-rich plasma and plasma for symptomatic treatment of knee osteoarthritis: a double-blinded placebo-controlled randomized clinical trial.
Efficacy of platelet-rich plasma and plasma for symptomatic treatment of knee osteoarthritis: a double-blinded placebo-controlled randomized clinical trial.
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DOI：
10.1186/s12891-021-04706-7
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发表时间：
2021-09-24
影响因子：
2.3
通讯作者：
Fuller R
中科院分区：
文献类型：
--
作者：
Dório M;Pereira RMR;Luz AGB;Deveza LA;de Oliveira RM;Fuller R
富血小板血浆（PRP）治疗膝关节骨关节炎（KOA）的疗效仍然存在矛盾，可能是一种微创和安全的治疗替代方案。从未研究过仅血浆（非富集）的潜在获益。我们的目的是评估关节内富血小板血浆（PRP）和血浆在24周内改善KOA参与者疼痛和功能的疗效。随机、双盲、安慰剂对照试验，3组（n = 62）：PRP（n = 20）、血浆（n = 21）和生理盐水（n = 21）。两次超声引导下膝关节注射，间隔2周。主要结局为第24周时总体疼痛的视觉模拟量表0-10 cm（VAS），以及第6周和第12周的中期评估。主要次要结局为：KOOS、OMERACT-OARSI标准和TUGT。基线时，92%的参与者为女性，平均年龄为65岁，平均BMI为28.0 Kg/m2，平均VAS疼痛为6.2 cm。对于PRP、血浆和生理盐水，第24周时疼痛相对于基线的变化分别为-2.9（SD 2.5）、-2.4（SD 2.5）和-3.5 cm（SD 3.3）（组间p = 0.499）。在第6周和第12周，三组之间没有差异。同样，两组之间的次要结局也无差异。PRP组不良事件发生率较高（血浆和生理盐水组分别为65%、24%和33%，p = 0.02），大多数为轻度一过性疼痛增加。PRP和血浆在24周内对KOA疼痛和功能改善方面并不上级安慰剂。PRP组疼痛轻度一过性增加的频率较高。ClinicalTrials.gov，NCT 03138317，03/05/2017.在线版本包含补充材料，可通过10.1186/s12891-021-04706-7获得。
Platelet-rich plasma (PRP) has a still conflicting efficacy for knee osteoarthritis (KOA) and might be a minimally invasive and safe treatment alternative. The potential benefit of only plasma (non-enriched) has never been investigated. Our aim was to evaluate the efficacy of intra-articular platelet-rich plasma (PRP) and plasma to improve pain and function in participants with KOA over 24 weeks. Randomized, double-blind, placebo-controlled trial with 3 groups (n = 62): PRP (n = 20), plasma (n = 21) and saline (n = 21). Two ultrasound-guided knee injections were performed with a 2-week interval. The primary outcome was visual analog scale 0-10 cm (VAS) for overall pain at week 24, with intermediate assessments at weeks 6 and 12. Main secondary outcomes were: KOOS, OMERACT-OARSI criteria and TUGT. At baseline, 92% of participants were female, with a mean age of 65 years, mean BMI of 28.0 Kg/m2and mean VAS pain of 6.2 cm. Change in pain from baseline at week 24 were -2.9 (SD 2.5), -2.4 (SD 2.5) and -3.5 cm (SD 3.3) for PRP, plasma and saline, respectively (p intergroup = 0.499). There were no differences between the three groups at weeks 6 and 12. Similarly, there were no differences between groups regarding secondary outcomes. The PRP group showed higher frequency of adverse events (65% versus 24% and 33% for plasma and saline, respectively, p = 0.02), mostly mild transitory increase in pain. PRP and plasma were not superior to placebo for pain and function improvement in KOA over 24 weeks. The PRP group had a higher frequency of mild transitory increase in pain. ClinicalTrials.gov, NCT03138317, 03/05/2017. The online version contains supplementary material available at 10.1186/s12891-021-04706-7.
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