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抗神经生长因子(NGF)研究中潜在髋关节不良事件的入选资格及研究期间安全性影像学图谱(第2部分)

Imaging atlas for eligibility and on-study safety of potential hip adverse events in anti-NGF studies (Part 2).

作者信息

Roemer F W, Hayes C W, Miller C G, Hoover K, Guermazi A

机构信息

Quantitative Imaging Center (QIC), Department of Radiology, Boston University School of Medicine, Boston, MA, USA; Department of Radiology, University of Erlangen-Nuremberg, Erlangen, Germany.

Department of Radiology, Virginia Commonwealth University School of Medicine, Richmond, VA, USA.

出版信息

Osteoarthritis Cartilage. 2015 Jan;23 Suppl 1:S43-58. doi: 10.1016/j.joca.2014.09.014.

DOI:10.1016/j.joca.2014.09.014
PMID:25527219
Abstract

Recently, nerve growth factor (NGF) inhibitors have been introduced for treatment of osteoarthritis (OA) symptoms, and have shown good analgesic efficacy and improvement in function in patients with OA. However, anti- (a-)NGF trials in OA had been suspended by the U.S. Food and Drug Administration (FDA) due to concerns over accelerated rates of OA progression and osteonecrosis. Since a-NGF therapies offer potential as the first new class of analgesics for many years, future studies assessing a-NGF compounds will have to follow stringent eligibility criteria and will require a rigorous safety monitoring. Imaging is paramount to identify potential negative outcomes as early as possible. These imaging findings include atrophic OA, osteonecrosis and others at eligibility and especially rapid progressive OA (RPOA) during the course of treatment. This second part of the a-NGF imaging atlas will present specific hip joint imaging findings that are relevant for eligibility and safety and represent potential adverse joint events on radiography and magnetic resonance imaging (MRI) in studies investigating a-NGF compounds. Researchers and clinicians should become familiar with several of these entities, and especially osteonecrosis of the hip and insufficiency fractures are relatively common findings in such a patient population. As several of these diagnoses may only be detected at late stages using radiographic methods, MRI plays an important role in identifying such pathologies early and at potentially still reversible stages before irreversible joint destruction has occurred.

摘要

最近,神经生长因子(NGF)抑制剂已被用于治疗骨关节炎(OA)症状,并在OA患者中显示出良好的镇痛效果和功能改善。然而,由于担心OA进展加速和骨坏死,美国食品药品监督管理局(FDA)暂停了OA的抗(α)-NGF试验。由于α-NGF疗法多年来有望成为首个新型镇痛药物类别,未来评估α-NGF化合物的研究将必须遵循严格的入选标准,并需要进行严格的安全监测。影像学对于尽早识别潜在的负面结果至关重要。这些影像学表现包括入选时的萎缩性OA、骨坏死及其他表现,尤其是治疗过程中的快速进展性OA(RPOA)。α-NGF影像学图谱的第二部分将展示与入选标准和安全性相关的特定髋关节影像学表现,这些表现代表了在研究α-NGF化合物的研究中,X线摄影和磁共振成像(MRI)上潜在的不良关节事件。研究人员和临床医生应熟悉其中一些情况,尤其是髋关节骨坏死和不全骨折在这类患者群体中是相对常见的表现。由于其中一些诊断使用X线摄影方法可能只能在晚期检测到,MRI在早期识别此类病变以及在不可逆的关节破坏发生之前的潜在可逆阶段发挥着重要作用。

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