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皮质类固醇注射用于膝关节骨关节炎的症状性治疗:一项初步双盲随机试验

Corticosteroid Injections for Symptomatic Treatment of Osteoarthritis of the Knee: A Pilot Blinded Randomized Trial.

作者信息

Baker Joshua F, Olave Marianna, Leach William, Doherty Caleigh R, Gillcrist Rachel L, White Daniel K, Ogdie Alexis, England Bryant R, Wysham Katherine, Quinones Mercedes, Xiao Rui, Neogi Tuhina, Scanzello Carla R

机构信息

Corporal Michael J. Crescenz VA Medical Center, Philadelphia and Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.

出版信息

ACR Open Rheumatol. 2023 Oct;5(10):529-535. doi: 10.1002/acr2.11596. Epub 2023 Sep 22.

Abstract

OBJECTIVE

To quantify the effect of corticosteroids compared to lidocaine-only injections over 12 weeks among patients with knee osteoarthritis (KOA).

METHODS

Participants with KOA were randomized to receive a knee injection of methylprednisolone acetate 1 mL (40 mg) plus 2 mL lidocaine (1%) or 1 mL saline and 2 mL lidocaine. Participants and providers were blinded to treatment allocation using an opacified syringe. The outcome was the average change from baseline of the total Knee Injury and Osteoarthritis Outcome Score (KOOS) (range 0-100) assessed at 2-week intervals over 12 weeks. Participants received KOOS questionnaires on their smartphones through a web-based platform. We used linear mixed-effects regressions with robust variance estimators to evaluate the association between the intervention and change in KOOS total and subscales (ClinicalTrials.gov identifier NCT03835910; registered 2019-02-11).

RESULTS

Of the 33 randomized participants, 31 were included in the final analysis. The predicted mean (SE) change in total KOOS over the 12-week follow-up was 9.4 (3.2) in the corticosteroids arm versus -1.3 (1.4) in the control arm (P = 0.003). Of participants, 47% achieved change as large as the minimal clinically important difference (16 units) in the intervention arm compared to 6% of participants in the lidocaine arm. Further, there were greater improvements in the intervention arm for KOOS subscales and for Patient Reported Outcomes Measurement Information System (PROMIS) assessments of pain intensity, behavior, and interference.

CONCLUSION

Corticosteroid injections demonstrated clinically meaningful improvements in KOA symptoms over 12 weeks of follow-up. These data support larger studies to better quantify short-term benefits.

摘要

目的

量化在12周内,与仅注射利多卡因相比,皮质类固醇对膝关节骨关节炎(KOA)患者的疗效。

方法

KOA患者被随机分为两组,一组接受膝关节注射1 mL醋酸甲泼尼龙(40 mg)加2 mL利多卡因(1%),另一组接受1 mL生理盐水加2 mL利多卡因。使用遮光注射器使参与者和医护人员对治疗分配不知情。结局指标是在12周内每隔2周评估的膝关节损伤和骨关节炎结局评分(KOOS)总分(范围0 - 100)相对于基线的平均变化。参与者通过基于网络的平台在其智能手机上接收KOOS问卷。我们使用具有稳健方差估计器的线性混合效应回归来评估干预措施与KOOS总分及各子量表变化之间的关联(ClinicalTrials.gov标识符NCT03835910;注册于2019年2月11日)。

结果

33名随机分组的参与者中,31名被纳入最终分析。在12周的随访中,皮质类固醇组KOOS总分的预测平均(SE)变化为9.4(3.2),而对照组为 -1.3(1.4)(P = 0.003)。在干预组中,47%的参与者实现了相当于最小临床重要差异(16分)的变化,而利多卡因组为6%。此外,干预组在KOOS子量表以及患者报告结局测量信息系统(PROMIS)对疼痛强度、行为和干扰的评估方面有更大改善。

结论

在12周的随访中,皮质类固醇注射显示出KOA症状有临床意义的改善。这些数据支持开展更大规模的研究以更好地量化短期益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3188/10570668/2dd18c691d96/ACR2-5-529-g002.jpg

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