| 저자 |
Sung Hoon Kim1†, Sang Yeol Yong1*, Young-Hee Lee1, Jeong Mee Park1, Ji Hyun Kim1, Jun Young Park1, Ji sun Hong1, Min Woo Kim1 |
In this study, a total of 20 subjects provided their written consent and participated in the study, and of these, 8 subjects (40%) were confirmed ineligible at the screening test. Therefore, a total of 12 subjects were enrolled and treated with the intra-articular polynucleotide. Among those 12 subjects, 11 subjects were included in the full analysis set while 1 subject was excluded due to withdrawal. A total of 6 subjects were excluded from the per protocol set, including 3 subjects withdrawing their consent and 1 subject being declared early termination by investigator. The subjects were treated with the intra-articular polynucleotide injection for 5 times in total at an interval of 1 week. Synovial fluid was collected for analysis of interleukin 6, 10 and TNF-α immediately before all across trial of the polynucleotide injection. VAS (Viausl analogue scale) and KOOS (Knee injury and osteoarthritis outcome score) was checked at enrollment, the last 5th intra-articular injection, 8th weeks and 16th weeks follow up visit.
The result of efficacy in both analysis set showed decrease in pain for all categories (at rest, at weight bearing and during activities) of VAS. In full analysis set, the main population, VAS at rest at week 16 was 4.91(±5.22) mm, which reduced dramatically (p<0.0001) compared to the baseline of 49.45(±8.80) mm by -44.55±7.41 mm. VAS at weight bearing at week 16 was 10.27(±11.20) mm, which reduced dramatically (p<0.0001) compared to the baseline 62.09(±11.93) mm by -51.82±12.73 mm, and the VAS during activies decreased at week 16 from baseline of 62.55 (±8.48) mm to 8.45 (±13.72) mm by -54.09±16.65 mm (p=0.001).
The KOOS-Sport/Rec score at week 8 by -3.00(±4.40), indicating statistically significant improvement of function in sport and recreation. The result of synovial biomarker test of IL-6, IL-10, and TNF-α. showed no statistically significant difference.
The main ingredient of the injection material is polynucleotide which forms a three-dimensional gel when injected, resulting in reducing mechanical friction itself through the cushioning effect. It can also reduce the pain caused by mechanical friction by coating the synovium and thereby blocking the nociceptors that exist in the synovium. This study indirectly verified the efficacy in reducing mechanical friction through pain assessment based upon the principles described above. From the 12 subjects in this study, the decrease in pain after the treatment was confirmed, though there was no statistical significance in pro-inflammatory and anti-inflammatory marker levels. Based on this, intra-articular polynucleotide injection therapy identified to reduce mechanical friction in knee joint. |
