Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study

Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study
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DOI:
10.1016/j.pmrj.2015.08.010
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发表时间:
2016-01-01
期刊:
影响因子:
2.1
通讯作者:
Lutz, Gregory E.
Lutz, Gregory E.
中科院分区:
医学4区
文献类型:
--
作者:
Tuakli-Wosornu, Yetsa A.;Terry, Alon;Lutz, Gregory E.

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目的:确定向有症状的退行性椎间盘单次注射自体富血小板血浆(PRP)是否会改善参与者报告的疼痛和功能。 设计:前瞻性、双盲、随机对照研究。 地点:门诊物理医学与康复脊柱诊所。 参与者:患有慢性(≥6个月)、中重度腰椎间盘源性疼痛且对保守治疗无反应的成年人。 方法:参与者在激发性椎间盘造影后被随机分配接受椎间盘内PRP或造影剂。在1周、4周、8周、6个月和1年时收集有关疼痛、身体功能和参与者满意度的数据。对照组中在8周时未改善的参与者可选择接受PRP并随后接受随访。 主要观察指标:使用功能评定指数(FRI)、疼痛数字评定量表(NRS)、36项简明健康调查问卷的疼痛和身体功能部分以及改良的北美脊柱协会(NASS)结果问卷。 结果:由一名独立观察者对47名参与者(治疗组29名,对照组18名)进行了分析,随访率为92%。在8周的随访期间,与对照组相比,接受椎间盘内PRP的参与者在疼痛(NRS最佳疼痛)(P = 0.02)、功能(FRI)(P = 0.03)和患者满意度(NASS结果问卷)(P = 0.01)方面有统计学上的显著改善。在注射PRP后,未报告有椎间盘间隙感染、神经损伤或进行性突出等不良事件。 结论:与对照组相比,接受椎间盘内PRP的参与者在8周内FRI、NRS最佳疼痛和NASS患者满意度评分方面有显著改善。接受PRP的参与者在至少1年的随访中FRI评分仍保持显著改善。尽管这些结果很有希望,但还需要进一步的研究来确定最有可能对生物椎间盘内治疗有反应的参与者亚群以及椎间盘内PRP注射物的理想细胞特征。
Objective: To determine whether single injections of autologous platelet-rich plasma (PRP) into symptomatic degenerative intervertebral disks will improve participant-reported pain and function.Design: Prospective, double-blind, randomized controlled study.Setting: Outpatient physiatric spine practice.Participants: Adults with chronic (>= 6 months), moderate-to-severe lumbar diskogenic pain that was unresponsive to conservative treatment.Methods: Participants were randomized to receive intradiskal PRP or contrast agent after provocative diskography. Data on pain, physical function, and participant satisfaction were collected at 1 week, 4 weeks, 8 weeks, 6 months, and 1 year. Participants in the control group who did not improve at 8 weeks were offered the option to receive PRP and subsequently followed.Main Outcome Measures: Functional Rating Index (FRI), Numeric Rating Scale (NRS) for pain, the pain and physical function domains of the 36-item Short Form Health Survey, and the modified North American Spine Society (NASS) Outcome Questionnaire were used.Results: Forty-seven participants (29 in the treatment group, 18 in the control group) were analyzed by an independent observer with a 92% follow-up rate. Over 8 weeks of follow-up, there were statistically significant improvements in participants who received intradiskal PRP with regards to pain (NRS Best Pain) (P = .02), function (FRI) (P = .03), and patient satisfaction (NASS Outcome Questionnaire) (P = .01) compared with controls. No adverse events of disk space infection, neurologic injury, or progressive herniation were reported following the injection of PRP.Conclusion: Participants who received intradiskal PRP showed significant improvements in FRI, NRS Best Pain, and NASS patient satisfaction scores over 8 weeks compared with controls. Those who received PRP maintained significant improvements in FRI scores through at least 1 year of follow-up. Although these results are promising, further studies are needed to define the subset of participants most likely to respond to biologic intradiskal treatment and the ideal cellular characteristics of the intradiskal PRP injectate.