两种强化联合治疗策略（包括初始高剂量泼尼松龙）治疗早期类风湿关节炎患者四年后对骨矿物质密度的长期影响：COBRA-light试验
Long-term effects on bone mineral density after four years of treatment with two intensive combination strategies, including initially high-dose prednisolone, in early rheumatoid arthritis patients: the COBRA-light trial.
作者信息
Lucassen M J J, Ter Wee M M, den Uyl D, Konijn N P C, Nurmohamed M T, Voskuyl A E, van Schaardenburg D, Kerstens P J S M, Bultink I E M, Boers M, Lems W F
机构信息
Department of Epidemiology and Data Science, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1089a, 1081 HV, Amsterdam, The Netherlands.
Department of Rheumatology and Clinical Immunology, Amsterdam Rheumatology and immunology Center, Amsterdam UMC, VU University Amsterdam, De Boelelaan, 1117, Amsterdam, Netherlands.
出版信息
Osteoporos Int. 2021 Jul;32(7):1441-1449. doi: 10.1007/s00198-020-05781-7. Epub 2021 Jan 19.
UNLABELLED
In this study, no difference in bone loss was observed between patients with early RA initially treated with COmbinatietherapie Bij Reumatoide Artritis (COBRA) (including initially 60 mg/day prednisolone) and patients treated with COBRA-light (including initially 30 mg/day prednisolone) during 4-year observation.
PURPOSE
To assess changes in bone mineral density (BMD) after 4 years in early rheumatoid arthritis (RA) patients initially treated with COBRA-light or COBRA therapy.
METHODS
In a 1 year, open-label, randomised, non-inferiority trial, patients were assigned to COBRA-light (methotrexate 25 mg/week plus initially prednisolone 30 mg/day) or COBRA (methotrexate 7.5 mg/week, sulfasalazine 2 g/day plus initially prednisolone 60 mg/day) therapy. After 1 year, antirheumatic treatment was at the discretion of treating rheumatologists. BMD was measured at baseline and after 1, 2 and 4 years at hips and lumbar spine with dual-energy X-ray absorptiometry. BMD changes between treatment strategies on average over time were compared with GEE analysis.
RESULTS
Data from 155 out of 162 patients could be analysed: 68% were female with a mean age of 52 (SD 13) years. Both COBRA-light and COBRA therapy showed declines in BMD at the total hip of -3.3% and -1.7%, respectively (p = 0.12), and the femoral neck, -3.7% and -3.0%, respectively (p = 0.95). At the lumbar spine, both treatment groups showed minor decline in BMD over 4 years: -0.5% and -1.0%, respectively (p = 0.10).
CONCLUSION
In a treat-to-target design in early RA, over 4 years, no differences between groups were found in change in BMD at total hip, femoral neck and the lumbar spine. At the hip, bone loss was around 3% in both groups, while mild bone loss was observed at lumbar spine, both in patients starting prednisolone 60 and 30 mg/day. These data suggest that the well-known negative effects of prednisolone can be modulated by modern treatment of RA.
未标注
在本研究中，对早期类风湿关节炎（RA）患者进行为期4年的观察，结果显示，初始接受类风湿关节炎联合治疗（COBRA）（初始使用泼尼松龙60mg/天）的患者与接受简化版COBRA治疗（COBRA-light）（初始使用泼尼松龙30mg/天）的患者在骨质流失方面没有差异。
目的
评估早期类风湿关节炎（RA）患者初始接受简化版COBRA治疗或COBRA治疗4年后骨矿物质密度（BMD）的变化。
方法
在一项为期1年的开放标签、随机、非劣效性试验中，患者被分配接受简化版COBRA治疗（甲氨蝶呤25mg/周加初始泼尼松龙30mg/天）或COBRA治疗（甲氨蝶呤7.5mg/周、柳氮磺胺吡啶2g/天加初始泼尼松龙60mg/天）。1年后，抗风湿治疗由主治风湿病医生决定。使用双能X线吸收法在基线时以及1年、2年和4年后测量髋部和腰椎的骨密度。通过广义估计方程（GEE）分析比较不同治疗策略随时间的平均骨密度变化。
结果
162例患者中的155例数据可进行分析：68%为女性，平均年龄52（标准差13）岁。简化版COBRA治疗组和COBRA治疗组全髋部骨密度分别下降了3.3%和1.7%（p = 0.12），股骨颈分别下降了3.7%和3.0%（p = 0.95）。在腰椎，两个治疗组在4年内骨密度均有轻微下降：分别为0.5%和1.0%（p = 0.10）。
结论
在早期RA的达标治疗设计中，4年期间，两组在全髋部、股骨颈和腰椎的骨密度变化方面未发现差异。在髋部，两组的骨质流失率均约为3%，而在初始使用泼尼松龙60mg/天和30mg/天的患者中，腰椎均观察到轻度骨质流失。这些数据表明，泼尼松龙的众所周知的负面影响可通过现代RA治疗得到调节。
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