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羟氯喹治疗手骨关节炎的疗效:一项随机、双盲、安慰剂对照试验。

Efficacy of Hydroxychloroquine in Hand Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial.

机构信息

Maasstad Hospital, Rotterdam, The Netherlands.

Franciscus Gasthuis and Vlietland, Rotterdam, The Netherlands.

出版信息

Arthritis Care Res (Hoboken). 2018 Sep;70(9):1320-1325. doi: 10.1002/acr.23471. Epub 2018 Aug 12.

Abstract

OBJECTIVE

To determine the symptom-modifying effect of hydroxychloroquine (HCQ) in hand osteoarthritis (OA).

METHODS

In this randomized, double-blind, multicenter trial, patients with symptomatic hand OA received either HCQ 400 mg once a day or placebo during 24 weeks. The primary outcome was change of pain measured on a 100-mm visual analog scale (VAS) at 24 weeks. Secondary outcomes included decrease of pain at weeks 6 and 12 and change in Australian Canadian Hand Osteoarthritis Index (AUSCAN) and Arthritis Impact Measurement Scale 2 short form (AIMS2-SF) total scores.

RESULTS

A total of 196 patients was included (placebo n = 98, HCQ n = 98). Mean ± SD age was 58.0 ± 7.6 years, and 86% were female. Baseline mean ± SD pain VAS was 44.9 ± 22.9 mm in the placebo group and 43.2 ± 22.3 mm in the HCQ group. At 24 weeks, change in pain VAS was not significantly different between both groups (imputed mean VAS 42.7 in the HCQ group versus 45.3 in the placebo group after 24 weeks), as was the case in pain VAS at weeks 6 and 12. Changes in AUSCAN total score and AIMS2-SF total score in both groups were similar between the groups. In total, 24 patients in the placebo group and 21 patients in the HCQ group reported ≥1 adverse event. In the HCQ group, 3 patients reported a severe allergic reaction. Fifteen patients withdrew from the study (5 placebo, 10 HCQ group) due to adverse events.

CONCLUSION

Treatment with HCQ at 24 weeks is not effective in reducing the symptoms of hand OA compared to placebo.

摘要

目的

确定羟氯喹(HCQ)对手骨性关节炎(OA)的症状改善作用。

方法

在这项随机、双盲、多中心试验中,患有症状性手 OA 的患者在 24 周内每天接受 HCQ 400mg 或安慰剂治疗。主要结局是 24 周时疼痛的变化,用 100mm 视觉模拟量表(VAS)测量。次要结局包括第 6 周和第 12 周疼痛的减轻以及澳大利亚加拿大手部骨关节炎指数(AUSCAN)和关节炎影响测量量表 2 短表(AIMS2-SF)总分的变化。

结果

共纳入 196 例患者(安慰剂组 98 例,HCQ 组 98 例)。平均年龄±标准差为 58.0±7.6 岁,86%为女性。安慰剂组基线平均±标准差疼痛 VAS 为 44.9±22.9mm,HCQ 组为 43.2±22.3mm。24 周时,两组间疼痛 VAS 的变化无显著差异(HCQ 组的估计平均 VAS 为 24 周时的 42.7mm,安慰剂组为 45.3mm),第 6 周和第 12 周的疼痛 VAS 也同样如此。两组的 AUSCAN 总分和 AIMS2-SF 总分的变化相似。安慰剂组共有 24 例和 HCQ 组共有 21 例患者报告了≥1 例不良事件。在 HCQ 组,有 3 例患者报告了严重过敏反应。共有 15 例患者因不良事件退出研究(5 例安慰剂,10 例 HCQ 组)。

结论

与安慰剂相比,HCQ 治疗 24 周对手 OA 的症状没有改善作用。

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