疼痛和活动度下降是骨关节炎(OA)的主要临床特征。透明质酸(HA)是治疗OA的浸润性疗法之一;然而,它的有效性是临床实践中正在进行的辩论。多核苷酸(PN),具有天然来源和营养活性的DNA衍生大分子,被发现有利于细胞生长和胶原蛋白的产生,关于软骨再生的临床前和临床研究。这项研究旨在评估注射PNs是否,结合HA[与HA相关的PN(PNHA)],可以改善受OA影响的膝关节疼痛和功能,不仅仅是HA。
随机,双盲,对照临床试验。
这项研究招募了100名患者,然后随机接受单独的PNHA或HA(每周3次膝关节I.A.注射)。
减轻疼痛,降低促炎滑液(SF)因子,膝关节功能的改善通过膝关节社会评分和WOMAC评分进行评估,在2、6和12个月后,通过治疗结束时SF的生化和免疫酶分析。
两组膝关节协会评分总分和疼痛项目均有显著改善,在PNHA-中显示比在HA处理组中更好的结果。观察到两组的WOMAC评分随时间显著降低。两组均未发生明显的不良事件。
这些发现表明,I.A.注射PNs,结合HA,更有效地改善膝关节功能和疼痛,在受OA影响的关节中,与单独的HA相比。
Pain and range of motion loss are the main clinical features of osteoarthritis (OA). Hyaluronic acid (HA) is one of the infiltrative therapies for OA treatment; however, its effectiveness is a matter of an ongoing debate in clinical practice.
Polynucleotides (PNs), a DNA-derived macromolecule with natural origin and trophic activity, were found to favor cell growth and collagen production, in preclinical and clinical studies regarding cartilage regeneration. This
study aimed at evaluating whether injection of PNs, in combination with HA [PNs associated with HA (PNHA)], can ameliorate pain and function of knees affected by OA, more than HA alone.
A randomized, double-blind, controlled clinical
trial.
The
study enrolled 100 patients, then randomized to receive PNHA or HA alone (3 weekly knee I.A. injections).
Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function were evaluated by Knee Society Score and WOMAC scores, after 2, 6, and 12 months and by biochemical and immunoenzymatic analyses of SF at the end of the treatment.
Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group. A significant reduction in the WOMAC score was observed over time for both groups. No significant adverse events were reported in either group.
These findings suggest that I.A. injection of PNs, in combination with HA, is more effective in improving knee function and pain, in a joint affected by OA, compared with HA alone.