McAlindon Timothy, Bartnik Eckart, S Ried Janina, Teichert Lenore, Herrmann Matthias, Flechsenhar Klaus
Tufts Medical Center, Chief, Division of Rheumatology, Boston, MA 02111, USA.
Sanofi-Aventis Deutschland GmbH, Frankfurt am Main D-65926, Germany.
J Biomed Res. 2016 Oct 17;31(1):25-30. doi: 10.7555/JBR.31.20150167.
To evaluate in an interventional trial on knee osteoarthritis (OA) the level and change of two serum biomarkers and their correlation with imaging parameters. The previously reported interventional OA study (ClinicalTrials.gov: NCT00536302) identified a positive effect of collagen hydrolysate (CH) on cartilage morphology in patients with knee OA using delayed gadolinium enhanced magnetic resonance imaging (dGEMRIC). It was the objective in this research project to evaluate in an interventional clinical trial on knee OA the level and change of two serum biomarkers and their correlation with imaging parameters. In blood samples of study participants, we determined the concentration of procollagen type II N-terminal propeptide (PIIANP) and aggrecan chondroitin sulfate 846 epitope (CS846) at baseline (BL) and at the follow-up (FU) visits at 24 and 48 weeks. We measured the level and change of biomarker concentrations in both study groups, and the correlation of those changes with changes in dGEMRIC. For the biomarker PIIANP, we observed a significantly greater increase in the CH group (29.9% vs. 1.2% at week 24, P= 0.001). For CS846, the mean concentration was lower among the CH treated participants at 24 weeks (78% vs. 96%, P= 0.045). Consistent correlations of changes in biomarkers PIIANP and CS846 with changes of the dGEMRIC score could not be observed. In this study, different changes per treatment group, CH and placebo were seen for dGEMRIC and PIIANP BL to 24 weeks FU, but only weak correlations between changes in dGEMRIC and biochemical markers.
在一项关于膝关节骨关节炎（OA）的干预性试验中，评估两种血清生物标志物的水平及变化，以及它们与影像学参数的相关性。先前报道的干预性OA研究（ClinicalTrials.gov：NCT00536302）使用延迟钆增强磁共振成像（dGEMRIC）确定了胶原蛋白水解物（CH）对膝关节OA患者软骨形态的积极作用。本研究项目的目的是在一项关于膝关节OA的干预性临床试验中，评估两种血清生物标志物的水平及变化，以及它们与影像学参数的相关性。在研究参与者的血液样本中，我们在基线（BL）以及随访（FU）的第24周和第48周测定了II型前胶原N端前肽（PIIANP）和聚集蛋白聚糖硫酸软骨素846表位（CS846）的浓度。我们测量了两个研究组中生物标志物浓度的水平及变化，以及这些变化与dGEMRIC变化的相关性。对于生物标志物PIIANP，我们观察到CH组的增加显著更大（第24周时为29.9%对1.2%，P = 0.001）。对于CS846，在第24周接受CH治疗的参与者中平均浓度较低（78%对96%，P = 0.045）。未观察到生物标志物PIIANP和CS846的变化与dGEMRIC评分变化之间存在一致的相关性。在本研究中，从BL到24周FU，CH组和安慰剂组在dGEMRIC和PIIANP方面出现了不同的变化，但dGEMRIC变化与生化标志物之间只有微弱的相关性。
