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肌肉内注射糖皮质激素与安慰剂治疗髋关节骨关节炎的 12 周双盲随机对照试验。

Intramuscular glucocorticoid injection versus placebo injection in hip osteoarthritis: a 12-week blinded randomised controlled trial.

机构信息

Department of General Practice, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands.

Department of Orthopaedics, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands.

出版信息

Ann Rheum Dis. 2018 Jun;77(6):875-882. doi: 10.1136/annrheumdis-2017-212628. Epub 2018 Mar 7.

DOI:10.1136/annrheumdis-2017-212628
PMID:29514801
Abstract

OBJECTIVES

Guidelines recommend intra-articular glucocorticoid injection in patients with painful hip osteoarthritis. However, intra-articular hip injection is an invasive procedure. The efficacy of systemic glucocorticoid treatment for pain reduction in hip osteoarthritis is unknown. This randomised, double-blind, trial assessed effectiveness in hip pain reduction of an intramuscular glucocorticoid injection compared with a placebo injection in patients with hip osteoarthritis.

METHODS

Patients with painful hip osteoarthritis were randomised to either 40 mg triamcinolone acetate or placebo with an intramuscular injection into the gluteus muscle. The primary outcomes were severity of hip pain at rest, during walking (0-10) and WOMAC pain at 2-week postinjection. We used linear mixed models for repeated measurements at 2, 4, 6 and 12 weeks for the intention-to-treat data analysis.

RESULTS

Of the 107 patients randomised, 106 could be analysed (52 in the glucocorticoid group, 54 in the placebo group). At 2-week follow-up, compared with placebo injection, the intramuscular glucocorticoid injection showed a significant and clinically relevant difference in hip pain reduction at rest (difference -1.3, 95% CI -2.3 to -0.3). This effect persisted for the entire 12-week follow-up. For hip pain during walking, the effect was present at 4-week, 6-week and 12-week follow-ups, and for WOMAC pain the effect was present at 6-week and 12-week follow-up.

CONCLUSIONS

An intramuscular glucocorticoid injection showed effectiveness in patients with hip osteoarthritis on one of the three primary outcomes at 2-week postinjection. All primary outcomes showed effectiveness from 4 to 6 weeks, up to a 12-week follow-up.

TRIAL REGISTRATION NUMBER

NTR2966.

摘要

目的

指南建议在患有疼痛性髋骨关节炎的患者中进行关节内糖皮质激素注射。然而,关节内髋部注射是一种有创性的操作。对于髋骨关节炎患者,全身糖皮质激素治疗减轻疼痛的效果尚不清楚。本随机、双盲试验评估了与安慰剂注射相比,肌肉内糖皮质激素注射在髋骨关节炎患者中减轻髋部疼痛的效果。

方法

患有疼痛性髋骨关节炎的患者被随机分配到 40mg 曲安奈德乙酸酯或安慰剂,肌肉内注射到臀肌中。主要结局是注射后 2 周时静息时、行走时(0-10)和 WOMAC 疼痛的髋部疼痛严重程度。我们使用线性混合模型对 2 周、4 周、6 周和 12 周的意向治疗数据进行重复测量分析。

结果

在随机分配的 107 名患者中,有 106 名可进行分析(糖皮质激素组 52 名,安慰剂组 54 名)。在 2 周随访时,与安慰剂注射相比,肌肉内糖皮质激素注射在静息时髋部疼痛减轻方面显示出显著且具有临床意义的差异(差异-1.3,95%CI-2.3 至-0.3)。这种效果在整个 12 周的随访中持续存在。对于行走时的髋部疼痛,在 4 周、6 周和 12 周随访时都有效果,对于 WOMAC 疼痛,在 6 周和 12 周随访时都有效果。

结论

肌肉内糖皮质激素注射在注射后 2 周的三个主要结局之一中显示出对髋骨关节炎患者的有效性。所有主要结局在 4 周到 6 周,直至 12 周随访时都显示出有效性。

试验注册号

NTR2966。

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