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秋水仙碱治疗骨关节炎手部疼痛与安慰剂相比无效:一项随机、安慰剂对照试验(COLAH)。

Colchicine is not effective for reducing osteoarthritic hand pain compared to placebo: a randomised, placebo-controlled trial (COLAH).

机构信息

Discipline of Medicine, University of Adelaide, Adelaide, South Australia 5000, Australia; Rheumatology Department, Queen Elizabeth Hospital, Woodville South, South Australia 5000, Australia.

Rheumatology Department, Queen Elizabeth Hospital, Woodville South, South Australia 5000, Australia.

出版信息

Osteoarthritis Cartilage. 2021 Feb;29(2):208-214. doi: 10.1016/j.joca.2020.11.002. Epub 2020 Nov 21.

DOI:10.1016/j.joca.2020.11.002
PMID:33232804
Abstract

BACKGROUND

Colchicine may offer relief in osteoarthritis. This has never been investigated for hand osteoarthritis.

OBJECTIVES

To investigate the effect of 1 mg daily colchicine vs placebo on hand pain and function over 12 weeks in older adults with hand osteoarthritis.

METHODS

Community-dwelling adults with diagnosed osteoarthritis of the hand aged 40-80 years were randomised to receive colchicine (0.5 mg twice daily) or matching placebo. Primary outcome measure was VAS hand pain score (0-100 mm). Secondary outcome measures included tender and swollen joint count, grip strength, C-reactive protein, and Michigan Hand Questionnaire total, function and pain scores. In an exploratory assessment, we compared synovial grade and power Doppler. All outcome measures were obtained at baseline and week 12. Stata v16 was used to perform constrained longitudinal data analysis models.

RESULTS

64 adults (54 females, 10 males) aged 48-79 years of age were enrolled. 59 participants completed the study (N = 28 colchicine, N = 31 placebo) (withdrawal rate 8%). Adverse reactions to the study medication occurred in nine patients. VAS score was not significantly different at baseline (61 ± 17 mm in the colchicine, 64 ± 17 mm in the placebo group). Between-group difference for VAS score at week 12 was 7.6 mm (95% CI -3.5-18.7, p-value 0.18). There were no significant differences between groups for any secondary outcomes at baseline or week 12.

CONCLUSIONS

1 mg colchicine daily for 12 weeks was not effective for reducing pain, tender and swollen joint count or increasing grip strength in symptomatic hand osteoarthritis. Our results do not support the use of colchicine in hand osteoarthritis.

摘要

背景

秋水仙碱可能对骨关节炎有缓解作用。但它对手部骨关节炎的疗效从未被研究过。

目的

探究 1mg 秋水仙碱每日治疗与安慰剂相比,对 40-80 岁手部骨关节炎老年患者手部疼痛和功能的 12 周影响。

方法

诊断为手部骨关节炎的社区居住成年人,年龄在 40-80 岁之间,随机分为秋水仙碱(0.5mg 每日两次)或匹配安慰剂组。主要结局测量指标是视觉模拟量表(VAS)手部疼痛评分(0-100mm)。次要结局指标包括压痛和肿胀关节计数、握力、C 反应蛋白和密歇根手部问卷总评分、功能和疼痛评分。在探索性评估中,我们比较了滑膜分级和功率多普勒。所有结局指标均在基线和 12 周时获得。使用 Stata v16 执行约束性纵向数据分析模型。

结果

纳入了 64 名成年人(54 名女性,10 名男性),年龄 48-79 岁。59 名参与者完成了研究(n=28 名秋水仙碱,n=31 名安慰剂)(退出率为 8%)。9 名患者出现了与研究药物相关的不良反应。基线时 VAS 评分无显著差异(秋水仙碱组 61±17mm,安慰剂组 64±17mm)。治疗 12 周时两组间 VAS 评分的差异为 7.6mm(95%CI -3.5-18.7,p 值 0.18)。基线和 12 周时两组间任何次要结局均无显著差异。

结论

12 周内每天服用 1mg 秋水仙碱不能有效减轻手部骨关节炎的疼痛、压痛和肿胀关节计数,也不能增加握力。我们的结果不支持在手部骨关节炎中使用秋水仙碱。

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