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类固醇注射治疗髋关节骨关节炎:一项随机、双盲、安慰剂对照试验。

Steroid injection for osteoarthritis of the hip: a randomized, double-blind, placebo-controlled trial.

作者信息

Lambert Robert G W, Hutchings Edna J, Grace Michael G A, Jhangri Gian S, Conner-Spady Barbara, Maksymowych Walter P

机构信息

Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, Alberta, Canada.

出版信息

Arthritis Rheum. 2007 Jul;56(7):2278-87. doi: 10.1002/art.22739.

Abstract

OBJECTIVE

To determine the efficacy of fluoroscopically guided corticosteroid injection for hip osteoarthritis (OA) in a randomized, double-blind, placebo-controlled trial.

METHODS

Fifty-two patients with symptomatic hip OA were randomly allocated to receive placebo (10 mg bipuvicaine, 2 ml saline) (n = 21) or corticosteroid treatment (10 mg bipuvicaine, 40 mg triamcinolone hexacetonide) (n = 31). Patients were followed up for 1, 2, 3, and 6 months. The primary outcome measure was the pain improvement response, defined as a 20% decrease in the Western Ontario and McMaster Universities OA Index (WOMAC) pain score (on 5 100-mm visual analog scales [VAS]) (WOMAC20) from baseline to 2 months postinjection. Secondary outcomes were a 50% decrease in the WOMAC pain score (WOMAC50), changes in other WOMAC subscale scores, patient's global assessment of health (on a 100-mm VAS), and Short Form 36 (SF-36) quality of life indices. Analyses were based on the intent-to-treat principle.

RESULTS

The mean WOMAC pain score fell 49.2% (decreasing from 310.1 mm to 157.4 mm) at 2 months postinjection in patients receiving corticosteroid, compared with a decrease of 2.5% (from 314.3 mm to 306.5 mm) in the placebo group (P < 0.0001). The proportion of WOMAC20 responders at 2 months' followup was significantly higher in the corticosteroid group (67.7%) compared with the placebo group (23.8%) (P = 0.004); similar proportions of WOMAC50 responders were observed between groups (61.3% in the corticosteroid group versus 14.3% in the placebo group; P = 0.001). Response differences were maintained at 3 months' followup (58.1% responders in the corticosteroid group versus 9.5% responders in the placebo group; P = 0.004). Significant differences in the WOMAC stiffness and physical function scores (P < 0.0001), patient's global health scores (P = 0.005), and SF-36 physical component scores (P = 0.04) were observed, with patients in the corticosteroid group showing greater improvements. There were no differences in the frequency of adverse events between groups.

CONCLUSION

This placebo-controlled trial confirms that corticosteroid injection can be an effective treatment of pain in hip OA, with benefits lasting up to 3 months in many cases. Future studies should address questions related to the benefits of repeated steroid injection and the effects of this treatment on disease modification.

摘要

目的

在一项随机、双盲、安慰剂对照试验中确定荧光镜引导下皮质类固醇注射治疗髋骨关节炎(OA)的疗效。

方法

52例有症状的髋OA患者被随机分配接受安慰剂(10mg布比卡因,2ml生理盐水)(n = 21)或皮质类固醇治疗(10mg布比卡因,40mg曲安奈德己酸酯)(n = 31)。对患者进行1、2、3和6个月的随访。主要结局指标为疼痛改善反应,定义为从基线到注射后2个月,西安大略和麦克马斯特大学OA指数(WOMAC)疼痛评分(在5个100mm视觉模拟量表[VAS]上)(WOMAC20)降低20%。次要结局指标为WOMAC疼痛评分降低50%(WOMAC50)、其他WOMAC子量表评分的变化、患者对健康的整体评估(在100mm VAS上)以及简短健康调查问卷36(SF - 36)生活质量指数。分析基于意向性治疗原则。

结果

接受皮质类固醇治疗的患者在注射后2个月时,WOMAC疼痛评分平均下降49.2%(从310.1mm降至157.4mm),而安慰剂组下降2.5%(从314.3mm降至306.5mm)(P < 0.0001)。在2个月随访时,皮质类固醇组WOMAC20反应者的比例(67.7%)显著高于安慰剂组(23.8%)(P = 0.004);两组间WOMAC50反应者的比例相似(皮质类固醇组为61.3%,安慰剂组为14.3%;P = 0.001)。在3个月随访时反应差异依然存在(皮质类固醇组反应者为58.1%,安慰剂组为9.5%;P = 0.004)。观察到WOMAC僵硬和身体功能评分(P < 0.0001)、患者整体健康评分(P = 0.005)以及SF - 36身体成分评分(P = 0.04)存在显著差异,皮质类固醇组患者改善更明显。两组间不良事件发生频率无差异。

结论

这项安慰剂对照试验证实皮质类固醇注射可有效治疗髋OA疼痛,在许多情况下益处可持续长达3个月。未来研究应解决与重复类固醇注射的益处以及该治疗对疾病修饰的影响相关的问题。

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