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

Zoledronic acid reduces knee pain and bone marrow lesions over 1 year: a randomised controlled trial
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DOI:
10.1136/annrheumdis-2011-200970
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发表时间:
2012-08-01
影响因子:
27.4
通讯作者:
Jones, Graeme
Jones, Graeme
中科院分区:
医学1区
文献类型:
--
作者:
Laslett, Laura Louise;Dore, Dawn A.;Jones, Graeme

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目的 比较单次输注唑来膦酸 (ZA) 与安慰剂对膝关节疼痛和骨髓病变 (BML) 的影响。方法 患有临床膝骨关节炎和膝关节 BML 的 50-80 岁成人 (n=59) 被随机分配接受 ZA (5 mg/100 ml) 或安慰剂。使用基线、6 个月和 12 个月时的质子密度加权脂肪饱和 MR 图像确定 BML。使用视觉模拟评分 (VAS) 以及膝关节损伤和骨关节炎结果评分 (KOOS) 评分 (KOOS) 来测量疼痛和功能。结果 基线时,平均 VAS 评分为 54 mm,平均总 BML 面积为 468 mm(2)。与安慰剂相比,6 个月后 ZA 组的 VAS 疼痛评分显着降低(-14.5 mm,95% CI -28.1 至 -0.9),但 3 个月或 12 个月后则没有显着降低。 KOOS 量表的变化在任何时间点都不显着。与安慰剂相比,6 个月后 ZA 组 BML 总面积减少幅度更大(-175.7 mm(2),95% CI -327.2 至 -24.3),12 个月后呈趋势(-146.5 mm(2),95% CI -307.5 至 +14.5)。 ZA 组中有较大比例的患者在 6 个月时 BML 大小实现了临床显着减小(39% vs 18%,p=0.044)。除了治疗组和安慰剂组的急性期反应发生率较高之外,毒性符合预期。结论 ZA 减少了膝盖疼痛和面积 BML 大小,并增加了 6 个月内改善的比例。骨关节炎的治疗可能受益于针对病变的治疗方法。
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.