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富血小板血浆治疗腰椎间盘源性疼痛的安全性和有效性:一项前瞻性、多中心、随机、双盲研究。

Safety and Efficacy of Platelet Rich Plasma for Treatment of Lumbar Discogenic Pain: A Prospective, Multicenter, Randomized, Double-blind Study.

作者信息

Zielinski Margaret Anne, Evans Natalie Eleanor, Bae Hyun, Kamrava Evish, Calodney Aaron, Remley Kent, Benyamin Ramsin, Franc Daniel, Peterson Matthew R, Lovine Jessica, Barrows Hannah R, Mahdavi Kennedy, Kuhn Taylor P, Jordan Sheldon

机构信息

Neurological Associates - The Interventional Group, USA, Los Angeles, CA.

The Spine Institute Center for Spinal Restoration, Santa Monica, CA.

出版信息

Pain Physician. 2022 Jan;25(1):29-34.

Abstract

BACKGROUND

Interventions for chronic discogenic spine pain are currently insufficient in lowering individual patient suffering and global disease burden. A 2016 study of platelet rich plasma (PRP) for chronic discogenic pain previously demonstrated clinically significant response among active group patients compared with controls.

OBJECTIVES

To replicate the previous research to move this intervention forward as a viable option for patient care.

STUDY DESIGN

A double-blind, randomized, placebo-controlled study.

SETTING

Multicenter private practices.

METHODS

Twenty-six (12 men, 14 women) human patients, ages 25 to 71 with a diagnosis of chronic lumbar discogenic pain, were randomly assigned to active (PRP) or control (saline) groups in a ratio of 2 active to 1 control. Baseline and follow-up Oswestry Disability Index and Numeric Pain Rating Scale questionnaires were obtained to track patient outcomes at 8 weeks postoperatively.

RESULTS

Within group assessment showed clinically significant improvement in 17% of PRP patients and clinically significant decline in 5% (1 patient) of the active group. Clinically significant improvement was seen in 13% of placebo group patients and no placebo patients had clinically significant decline secondary to the procedure.

LIMITATIONS

Possible explanations may include a range of factors including differences in patient demographics, outcome-measure sensitivity, or misalignment of statistical analyses.

CONCLUSIONS

These findings are markedly different than the highly promising results of the 2016 PRP study. This study posits necessary caution for researchers who wish to administer PRP for therapeutic benefit and may ultimately point to necessary redirection of interventional research for discogenic pain populations.

摘要

背景

目前,针对慢性椎间盘源性脊柱疼痛的干预措施在减轻个体患者痛苦和全球疾病负担方面效果欠佳。2016年一项关于富血小板血浆(PRP)治疗慢性椎间盘源性疼痛的研究表明,与对照组相比,治疗组患者有显著的临床反应。

目的

重复之前的研究,使这种干预措施成为一种可行的患者护理选择。

研究设计

双盲、随机、安慰剂对照研究。

研究地点

多中心私人诊所。

方法

26名(12名男性,14名女性)年龄在25至71岁之间、诊断为慢性腰椎间盘源性疼痛的患者,按照2名治疗组(PRP)对1名对照组(生理盐水)的比例随机分组。通过术前、术后8周的Oswestry功能障碍指数和数字疼痛评分量表问卷来跟踪患者的治疗效果。

结果

组内评估显示,17%的PRP治疗组患者有显著的临床改善,治疗组中有5%(1名患者)有显著下降。安慰剂组中有13%的患者有显著改善,没有安慰剂组患者因手术出现显著下降。

局限性

可能的解释包括一系列因素,如患者人口统计学差异、结果测量敏感性或统计分析偏差。

结论

这些结果与2016年PRP研究的极有前景的结果明显不同。本研究为希望使用PRP获得治疗益处的研究人员提出了必要的警示,并可能最终指出椎间盘源性疼痛人群干预研究的必要方向。

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