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特立帕肽对类风湿关节炎关节侵蚀的影响:一项随机对照试验。

Effects of Teriparatide on Joint Erosions in Rheumatoid Arthritis: A Randomized Controlled Trial.

机构信息

Brigham and Women's Hospital, Boston, Massachusetts.

University of Massachusetts Memorial Medical Center, Worcester.

出版信息

Arthritis Rheumatol. 2017 Sep;69(9):1741-1750. doi: 10.1002/art.40156. Epub 2017 Jul 14.

Abstract

OBJECTIVE

Articular erosions correlate with disability in rheumatoid arthritis (RA). Biologic agents reduce erosion progression in RA, but erosion healing occurs infrequently. This study was undertaken to assess the effects of the anabolic agent teriparatide on joint erosion volume in RA patients treated with a tumor necrosis factor inhibitor (TNFi).

METHODS

We conducted a randomized controlled trial in 24 patients with erosive RA, osteopenia, and disease activity controlled by TNFi treatment for at least 3 months. Half were randomized to receive teriparatide for 1 year and the others constituted a wait-list control group. Subjects and primary rheumatologists were not blinded with regard to treatment assignment, but all outcomes were assessed in a blinded manner. The primary outcome measure was change in erosion volume determined by computed tomography at 6 anatomic sites. Significance within each hand and anatomic site was based on a 2-tailed test, with P values less than 0.05 considered significant.

RESULTS

Baseline characteristics of the treatment groups were well balanced. After 52 weeks, the median change in erosion volume in the teriparatide group was -0.4 mm (interquartile range [IQR] -34.5, 29.6) and did not differ significantly from that in controls (median change +9.1 mm [IQR -29.6, 26.4]) (P = 0.28). No significant difference in change in erosion volume was noted at the radius, ulna, or metacarpophalangeal joints. Bone mineral density improved at the femoral neck and lumbar spine in the teriparatide group.

CONCLUSION

Our findings indicate that teriparatide treatment for 1 year does not significantly reduce erosion volume in the hands or wrists of patients with established RA with disease activity controlled by TNFi treatment.

摘要

目的

关节侵蚀与类风湿关节炎(RA)的残疾有关。生物制剂可减少 RA 的侵蚀进展,但侵蚀愈合很少发生。本研究旨在评估合成代谢剂特立帕肽对接受肿瘤坏死因子抑制剂(TNFi)治疗的 RA 患者关节侵蚀体积的影响。

方法

我们对 24 例患有侵蚀性 RA、骨质疏松症和疾病活动度经 TNFi 治疗至少 3 个月控制的患者进行了一项随机对照试验。一半患者随机接受特立帕肽治疗 1 年,其余患者为候补对照组。尽管患者和主要风湿病医生对治疗分配没有被蒙蔽,但所有结果都是以盲法评估的。主要观察指标是通过 CT 在 6 个解剖部位测量的侵蚀体积变化。每个手部和解剖部位的差异均基于双侧检验,P 值小于 0.05 被认为有统计学意义。

结果

治疗组的基线特征均衡良好。治疗 52 周后,特立帕肽组侵蚀体积的中位数变化为-0.4 毫米(四分位距[IQR] -34.5,29.6),与对照组(中位数变化+9.1 毫米[IQR -29.6,26.4])无显著差异(P=0.28)。在桡骨、尺骨或掌指关节,侵蚀体积变化无显著差异。特立帕肽组股骨颈和腰椎的骨密度改善。

结论

我们的研究结果表明,特立帕肽治疗 1 年不能显著减少 TNFi 治疗控制的活动性 RA 患者手部或腕部的侵蚀体积。

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