Wang Yuanyuan, Estee Mahnuma Mahfuz, Gan Desmond, Lim Yuan Z, Heritier Stephane, Wluka Anita E, Hussain Sultana Monira, Trevaskis Natalie L, Cicuttini Flavia M
School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC 3004, Australia.
Department of Dermatology, Alfred Hospital, Melbourne, VIC 3004, Australia.
Osteoarthr Cartil Open. 2023 Jun 16;5(3):100382. doi: 10.1016/j.ocarto.2023.100382. eCollection 2023 Sep.
To examine the efficacy and safety of topical corticosteroid over 6 weeks in patients with symptomatic hand osteoarthritis.
In a randomized, double-blind, placebo-controlled trial, community-based participants with hand osteoarthritis were randomly assigned (1:1) to topical Diprosone OV (betamethasone dipropionate 0.5 mg/g in optimised vehicle, n=54) or placebo (plain paraffin, n=52) ointment to painful joints 3 times daily for 6 weeks. Primary outcome was pain reduction [assessed by 100 mm visual analogue scale (VAS)] at 6 weeks. Secondary outcomes included changes in pain and function using the Australian Canadian Osteoarthritis Hand Index (AUSCAN), Functional Index for Hand Osteoarthritis (FIHOA), and Michigan Hand Outcomes Questionnaire (MHQ) at 6 weeks. Adverse events were recorded.
Of 106 participants (mean age 64.2 years, 85.9% female), 103 (97.2%) completed the study. Change in VAS at 6 weeks was similar in the Diprosone OV and placebo groups (-19.9 vs. -20.9, adjusted difference 0.6, 95% CI -8.9 to 10.2). There were no significant between-group differences in change in AUSCAN pain [adjusted difference 25.8 (-16.0 to 67.5)], AUSCAN function [21.2 (-55.0 to 97.4)], FIHOA [-0.1 (-1.7 to 1.5)], or MHQ [-1.2 (-6.0 to 3.6)]. Incidence of adverse events was 16.7% in Diprosone OV and 19.2% in placebo group.
Topical Diprosone OV ointment, although well-tolerated, was no better than placebo in improving pain or function over 6 weeks in patient with symptomatic hand osteoarthritis. Future studies should consider examining joints with synovitis and whether delivery approaches enhancing transdermal penetration of corticosteroids into joints are effective in hand osteoarthritis.
ACTRN 12620000599976. Registered May 22, 2020.
研究外用皮质类固醇治疗症状性手部骨关节炎6周的疗效和安全性。
在一项随机、双盲、安慰剂对照试验中，将社区中患有手部骨关节炎的参与者随机分配（1:1）至外用得宝松OV（丙酸倍他米松0.5mg/g，赋形剂优化，n = 54）或安慰剂（纯石蜡，n = 52）软膏组，每天3次涂抹于疼痛关节，持续6周。主要结局为6周时的疼痛减轻情况[通过100mm视觉模拟量表（VAS）评估]。次要结局包括6周时使用澳大利亚-加拿大骨关节炎手部指数（AUSCAN）、手部骨关节炎功能指数（FIHOA）和密歇根手部结局问卷（MHQ）评估的疼痛和功能变化。记录不良事件。
106名参与者（平均年龄64.2岁，85.9%为女性）中，103名（97.2%）完成了研究。得宝松OV组和安慰剂组6周时VAS的变化相似（-19.9对-20.9，调整后差异0.6，95%CI -8.9至10.2）。AUSCAN疼痛变化[调整后差异25.8（-16.0至67.5）]、AUSCAN功能变化[21.2（-55.0至97.4）]、FIHOA变化[-0.1（-1.7至1.5）]或MHQ变化[-1.2（-6.0至3.6）]在组间均无显著差异。得宝松OV组不良事件发生率为16.7%，安慰剂组为19.2%。
外用得宝松OV软膏尽管耐受性良好，但在改善症状性手部骨关节炎患者6周的疼痛或功能方面并不优于安慰剂。未来研究应考虑检查患有滑膜炎的关节，以及增强皮质类固醇经皮渗透至关节的给药方法在手部骨关节炎中是否有效。
ACTRN 12620000599976。于2020年5月22日注册。
