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唑来膦酸可减少膝关节疼痛和骨髓病变,持续 1 年:一项随机对照试验。

Zoledronic acid reduces knee pain and bone marrow lesions over 1 year: a randomised controlled trial.

机构信息

Menzies Research Institute Tasmania, University of Tasmania, Hobart, Tasmania, Australia.

出版信息

Ann Rheum Dis. 2012 Aug;71(8):1322-8. doi: 10.1136/annrheumdis-2011-200970. Epub 2012 Feb 21.

Abstract

OBJECTIVES

To compare the effect of a single infusion of zoledronic acid (ZA) with placebo on knee pain and bone marrow lesions (BMLs).

METHODS

Adults aged 50-80 years (n=59) with clinical knee osteoarthritis and knee BMLs were randomised to receive either ZA (5 mg/100 ml) or placebo. BMLs were determined using proton density-weighted fat saturation MR images at baseline, 6 and 12 months. Pain and function were measured using a visual analogue scale (VAS) and the knee injury and osteoarthritis outcome score (KOOS) scale.

RESULTS

At baseline, mean VAS score was 54 mm and mean total BML area was 468 mm(2). VAS pain scores were significantly reduced in the ZA group compared with placebo after 6 months (-14.5 mm, 95% CI -28.1 to -0.9) but not after 3 or 12 months. Changes on the KOOS scales were not significant at any time point. Reduction in total BML area was greater in the ZA group compared with placebo after 6 months (-175.7 mm(2), 95% CI -327.2 to -24.3) with a trend after 12 months (-146.5 mm(2), 95% CI -307.5 to +14.5). A greater proportion of those in the ZA group achieved a clinically significant reduction in BML size at 6 months (39% vs 18%, p=0.044). Toxicity was as expected apart from a high rate of acute phase reactions in treatment and placebo arms.

CONCLUSIONS

ZA reduces knee pain and areal BML size and increases the proportion improving over 6 months. Treatment of osteoarthritis may benefit from a lesion specific therapeutic approach.

CLINICAL TRIAL REGISTRATION NUMBER

ACTRN 12609000399291.

摘要

目的

比较唑来膦酸(ZA)单次输注与安慰剂对膝关节疼痛和骨髓病变(BML)的影响。

方法

纳入年龄在 50-80 岁之间的 59 例有临床膝关节骨关节炎和膝关节 BML 的成年人,随机接受 ZA(5mg/100ml)或安慰剂治疗。基线时、6 个月和 12 个月时使用质子密度加权脂肪饱和磁共振成像确定 BML。使用视觉模拟量表(VAS)和膝关节损伤和骨关节炎结局评分(KOOS)量表评估疼痛和功能。

结果

基线时,VAS 评分的平均值为 54mm,总 BML 面积的平均值为 468mm²。ZA 组的 VAS 疼痛评分在 6 个月时较安慰剂组显著降低(-14.5mm,95%CI-28.1 至-0.9),但在 3 个月和 12 个月时没有显著变化。在任何时间点,KOOS 评分的变化均不显著。与安慰剂组相比,ZA 组在 6 个月时总 BML 面积的减少更显著(-175.7mm²,95%CI-327.2 至-24.3),12 个月时也有减少的趋势(-146.5mm²,95%CI-307.5 至+14.5)。ZA 组在 6 个月时有更大比例的患者达到 BML 大小的临床显著减少(39%比 18%,p=0.044)。除治疗和安慰剂组中出现高比例的急性期反应外,毒性与预期一致。

结论

ZA 可减轻膝关节疼痛和 BML 面积,并增加 6 个月时改善的比例。骨关节炎的治疗可能受益于针对病变的治疗方法。

临床试验注册号

ACTRN 12609000399291。

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