Department of Public Health, Epidemiology and Health Economics, University of Liège, CHU Sart-Tilman, Liège, Belgium, School of Medicine, University of Queensland, Herston, Queensland, Australia, INSERM UMR 1033 and Université de Lyon, Service de Rhumatologie et Pathologie Osseuse, Hôpital Edouard Herriot, Lyon, France, Université Paris 7, UFR médicale, Assistance Publique-Hôpitaux de Paris, Hôpital Lariboisière, Fédération de Rhumatologie, Paris Cedex, France and MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, and NIHR Biomedical Research Unit, University of Oxford, Oxford, UK.
Rheumatology (Oxford). 2014 Aug;53(8):1457-64. doi: 10.1093/rheumatology/keu018. Epub 2014 Mar 25.
The aim of this study was to assess the efficacy of strontium ranelate in improving symptoms in knee OA.
Symptoms were assessed over 3 years in patients with primary knee OA receiving strontium ranelate 2 g/day (n = 454), 1 g/day (n = 445) or placebo (n = 472) in the Strontium Ranelate Efficacy in Knee Osteoarthritis Trial. Clinical response was evaluated using WOMAC subscores, minimal perceptible clinical improvement (MPCI), minimal clinically important improvement (MCII) and a modified OMERACT-Osteoarthritis Research Society International (OARSI) responder definition. Patients who withdrew prematurely from the study were considered non-responders.
There was no significant effect on symptoms for strontium ranelate 1 g/day. At the dosage of 2 g/day, strontium ranelate was associated with greater response than placebo in terms of ≥20% improvement in WOMAC pain from baseline to the last visit (58% vs 47%, P = 0.002) and ≥50% improvement in WOMAC pain (42% vs 36%, P = 0.083). Significant differences were found in MPCI response for WOMAC pain (52% vs 40%, P < 0.001), stiffness (47% vs 39%, P = 0.009) and physical function (46% vs 37%, P = 0.009) and in MCII response for WOMAC physical function (46% vs 37%, P = 0.013). There were also more OMERACT-OARSI-like responders with strontium ranelate (44% vs 35%, P = 0.004). The treatment-placebo difference in MPCI response for WOMAC pain was significant after 6 months (P = 0.024), while that in MPCI and MCII response for WOMAC physical function reached significance after 12 months (P = 0.027 and P = 0.019, respectively).
Treatment with strontium ranelate 2 g/day over 3 years is associated with a clinically meaningful improvement in pain from 6 months as well as physical function and stiffness as assessed by the number of responders above thresholds of clinical relevance.
Current Controlled Trials. http://www.controlled-trials.com/ (ISRCTN41323372).
本研究旨在评估雷奈酸锶在改善膝骨关节炎（OA）症状方面的疗效。
在 Strontium Ranelate Efficacy in Knee Osteoarthritis Trial 中，454 例原发性膝 OA 患者接受雷奈酸锶 2g/天（n=454）、1g/天（n=445）或安慰剂（n=472）治疗，为期 3 年评估症状。采用 WOMAC 亚量表、最小可察觉临床改善（MPCI）、最小临床重要改善（MCII）和改良 OMERACT-Osteoarthritis Research Society International（OARSI）应答定义评估临床应答。提前退出研究的患者被视为无应答者。
雷奈酸锶 1g/天对症状无显著影响。2g/天剂量时，与安慰剂相比，雷奈酸锶治疗组在 WOMAC 疼痛从基线到最后一次就诊时改善≥20%（58% vs 47%，P=0.002）和 WOMAC 疼痛改善≥50%（42% vs 36%，P=0.083）方面有更大的应答。在 WOMAC 疼痛（52% vs 40%，P<0.001）、僵硬（47% vs 39%，P=0.009）和身体功能（46% vs 37%，P=0.009）的 MPCI 应答以及 WOMAC 身体功能的 MCII 应答（46% vs 37%，P=0.013）方面，均发现 MPCI 应答存在显著差异。雷奈酸锶组 OMERACT-OARSI 样应答者也更多（44% vs 35%，P=0.004）。雷奈酸锶治疗组 WOMAC 疼痛的 MPCI 应答在 6 个月时（P=0.024）差异具有统计学意义，而 WOMAC 身体功能的 MPCI 和 MCII 应答在 12 个月时（P=0.027 和 P=0.019）差异具有统计学意义。
雷奈酸锶治疗 3 年，6 个月后疼痛明显改善，12 个月后身体功能和僵硬的 MPCI 和 MCII 应答也达到临床相关阈值以上，与疼痛、身体功能和僵硬的临床相关改善相关。
