Aginko Research AG, Marly, Switzerland.
IBSA Institut Biochimique SA, Pambio-Noranco, Switzerland.
Cartilage. 2021 Dec;13(2_suppl):185S-195S. doi: 10.1177/1947603520905363. Epub 2020 Feb 18.
This study aimed to test the hypothesis that administration of increasing doses of Sinovial (hyaluronic acid [HA]), would exhibit a dose-dependent effect on the prevention of cartilage degradation, without local and systemic toxicity.
Twenty-seven adult rabbits were subjected to anterior cruciate ligament transection (ACLT). Two Sinovial products containing HA concentrations of 1.6% and 2.4% were used as active treatment, and 0.9% saline was used as control and injected intra-articularly 7 days post ACLT. Radiographs were taken prior to surgery, at injection and sacrifice times. After euthanasia, 8 weeks postsurgery, knee joints were observed macroscopically using India ink staining with OARSI (Osteoarthritis Research Society International) scoring and histologically using modified Mankin scoring. The synovial membranes were analyzed using Cake classification.
No intraoperative complications were observed. One week postinjection, 4 animals in the HA 2.4% group developed subcutaneous nodules that disappeared spontaneously. No inflammation of the synovial membrane was ever observed. The control group exhibited the maximum uptake of India ink 2.22 ± 0.14. HA groups exhibited a dose-dependent ( = 0.02) reduction in India ink uptake: 1.75 ± 0.17 for HA 1.6% and 1.58 ± 0.14 for HA 2.4%. The most marked dose-dependent effect of this study was a reduction of modified Mankin score for HA groups, with the 2.4% treatment achieving a statistically significant improvement as compared with the control group (7.19 ± 0.85 for saline, 4.65 ± 0.66 for HA 1.6%, and 3.53 ± 0.59 for HA 2.4%; = 0.005).
A dose-dependent protective effect on cartilage was observed after injection of both HA solutions.
本研究旨在验证以下假设，即给予递增剂量的欣维可（透明质酸[HA]）将表现出剂量依赖性预防软骨降解的作用，而无局部和全身毒性。
27 只成年兔接受前交叉韧带切断（ACL）。两种含有 1.6%和 2.4%HA 浓度的欣维可产品作为活性治疗药物，0.9%生理盐水作为对照，在 ACL 后 7 天关节内注射。在手术前、注射时和牺牲时拍摄 X 光片。在手术后 8 周安乐死后，使用 OARSI（骨关节炎研究协会国际）评分进行印度墨水染色的大体观察和改良 Mankin 评分进行组织学观察来观察膝关节。使用 Cake 分类法分析滑膜膜。
术中未观察到并发症。注射后 1 周，2.4%HA 组的 4 只动物出现自发性消退的皮下结节。从未观察到滑膜膜炎症。对照组的印度墨水摄取量最大，为 2.22 ± 0.14。HA 组印度墨水摄取量呈剂量依赖性（= 0.02）减少：1.6%HA 组为 1.75 ± 0.17，2.4%HA 组为 1.58 ± 0.14。本研究最显著的剂量依赖性作用是减少 HA 组的改良 Mankin 评分，2.4%治疗与对照组相比具有统计学显著改善（盐水为 7.19 ± 0.85，1.6%HA 为 4.65 ± 0.66，2.4%HA 为 3.53 ± 0.59；= 0.005）。
两种 HA 溶液注射后均观察到对软骨的剂量依赖性保护作用。
