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髋关节骨关节炎患者玻璃酸钠补充治疗反应的预测因素:一项前瞻性、观察性、多中心、开放标签的试点研究结果

Predictors of response to viscosupplementation in patients with hip osteoarthritis: results of a prospective, observational, multicentre, open-label, pilot study.

作者信息

Eymard Florent, Maillet Bernard, Lellouche Henri, Mellac-Ducamp Sylvie, Brocq Olivier, Loeuille Damien, Chevalier Xavier, Conrozier Thierry

机构信息

Department of rheumatology, AP-HP Henri Mondor Hospital, 51 avenue du Maréchal de Lattre de Tassigny, Créteil, 94000, France.

Clinique Saint Odilon, Moulins, 03000, France.

出版信息

BMC Musculoskelet Disord. 2017 Jan 6;18(1):3. doi: 10.1186/s12891-016-1359-2.

Abstract

BACKGROUND

To identify predictive factors of response to viscosupplementation (VS) in patients with hip osteoarthritis (HOA).

METHODS

Prospective, multicentre, open-label trial, achieved in daily practice conditions. Patients with HOA were treated with a single intra-articular injection of a cross-linked hyaluronic acid combined with mannitol (HAnox-M-XL), using imaging guidance. WOMAC pain and function scores and patient global assessment (PGA) were assessed at baseline and day 90. Improvement, satisfaction and efficacy were self-assessed at day 90. Hip radiographs at baseline were scored using Kellgren-Lawrence grade and Osteoarthritis Research Society International (OARSI) score. Associations between clinical and radiological features and response to VS (pain improvement > 50% at day 90) were assessed in univariate analysis, and then using logistic regression, adjusted for confounding factors.

RESULTS

The intent-to-treat (ITT) population included 97 patients (57 females, mean age 63). Ninety completed the follow-up and 80 had full clinical and radiological data. Response to VS was achieved in 47.8% of patients. In univariate analysis, the only clinical outcome statistically and negatively related to response was PGA at baseline (p = 0.047). Radiologically, response to VS was negatively correlated with joint space narrowing (JSN) score (JSN < 2 vs. JSN ≥ 2, p = 0.01) and was related to the patterns of femoral head migration (p = 0.008). In multivariate analysis, only JSN grade (p = 0.03) remained significantly related to a poor response.

CONCLUSION

This pilot study, which needs further confirmation by larger scale trials, suggests that radiological features might be of importance for the decision of VS in patients with HOA.

TRIAL REGISTRATION NUMBER

ID RCB N°2013-A00165-40. Registered 31 January 2013.

摘要

背景

确定髋关节骨关节炎(HOA)患者对黏弹性补充疗法(VS)反应的预测因素。

方法

在日常实践条件下进行的前瞻性、多中心、开放标签试验。HOA患者在影像引导下接受单次关节内注射交联透明质酸联合甘露醇(HAnox-M-XL)治疗。在基线和第90天评估WOMAC疼痛和功能评分以及患者整体评估(PGA)。在第90天进行自我评估改善情况、满意度和疗效。使用Kellgren-Lawrence分级和国际骨关节炎研究学会(OARSI)评分对基线时的髋关节X线片进行评分。在单因素分析中评估临床和放射学特征与VS反应(第90天疼痛改善>50%)之间的关联,然后使用逻辑回归,并对混杂因素进行校正。

结果

意向性治疗(ITT)人群包括97例患者(57例女性,平均年龄63岁)。90例完成随访,80例有完整的临床和放射学数据。47.8%的患者对VS有反应。在单因素分析中,唯一与反应在统计学上呈负相关的临床结果是基线时的PGA(p = 0.047)。在放射学方面,VS反应与关节间隙变窄(JSN)评分呈负相关(JSN < 2与JSN≥2,p = 0.01),并与股骨头移位模式有关(p = 0.008)。在多因素分析中,只有JSN分级(p = 0.03)与反应不佳仍有显著相关性。

结论

这项需要更大规模试验进一步证实的初步研究表明,放射学特征可能对HOA患者VS治疗决策具有重要意义。

试验注册号

ID RCB N°2013-A00165-40。2013年1月31日注册。

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