Russu Octav Marius, Pop Tudor Sorin, Feier Andrei Marian, Trâmbițaș Cristian, Incze-Bartha Zsuzsanna, Borodi Paul Gabriel, Gergely István, Zuh Sándor-György
Department of Orthopaedics and Traumatology, Clinical County Hospital, 540139 Tîrgu Mureș, Romania.
Faculty of General Medicine, University of Medicine, Pharmacy, Sciences and Technology, 540139 Tîrgu Mureș, Romania.
J Pers Med. 2021 Apr 15;11(4):303. doi: 10.3390/jpm11040303.
: Prior trials investigating the treatment of symptomatic osteoarthritis (OA) with hyaluronic-acid-derived products injections have provided optimistic results. The study was directed to assess the effectiveness of an innovative hyaluronic-acid-based hydrogel (Hymovis) in the treatment of symptomatic knee OA. : A prospective, single-center, clinical trial was performed. Thirty-five patients with degenerative knee OA were included. Inclusion criteria were: age between 45-80, radiographic Kellgren grade II or III osteoarthritis, minimum 35 mm score on the Visual Analogue Scale (VAS), pain for at least 6 months and agreement to participate in the study. Patients received two injections at a one-week interval. The evaluator assessed the patients using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and VAS. Evaluation was performed before, at 2 and 6 months after the injections. : A significant improvement on the WOMAC Index pain subscale was observed at 6 months after the injection. At two months, pain subscale score decreased from 10.34 to 9.34. At six months, a significant decrement in pain parameters compared to baseline was observed (from 10.34 to 7.72; = 0.0004). Median points on VAS significantly ameliorated after 6 months (from 74.2 to 57.3 cm; < 0.0001). Regarding physical function, a statistically significant difference compared to baseline was observed at the end of the study (from 29.74 to 25.18; = 0.0025). WOMAC Index stiffness component did not differ from baseline at any time during follow-up. : Pain relief installed with a delayed on-set but had a prolonged duration. The novel hyaluronic acid-based hydrogel (Hymovis) had effective results, particularly after six months post-injections and offers a therapeutic advancement in the treatment of moderate to severe osteoarthritis.
此前关于使用透明质酸衍生产品注射治疗症状性骨关节炎(OA)的试验取得了乐观的结果。本研究旨在评估一种创新的基于透明质酸的水凝胶(Hymovis)治疗症状性膝关节OA的有效性。
进行了一项前瞻性、单中心临床试验。纳入了35例退行性膝关节OA患者。纳入标准为:年龄在45至80岁之间,放射学Kellgren分级为II级或III级骨关节炎,视觉模拟量表(VAS)评分至少35分,疼痛至少6个月且同意参与研究。患者每隔一周接受两次注射。评估者使用西安大略和麦克马斯特大学骨关节炎指数(WOMAC)和VAS对患者进行评估。在注射前、注射后2个月和6个月进行评估。
注射后6个月,WOMAC指数疼痛亚量表有显著改善。两个月时,疼痛亚量表评分从10.34降至9.34。六个月时,与基线相比疼痛参数有显著下降(从10.34降至7.72;P = 0.0004)。6个月后VAS中位数得分显著改善(从74.2降至57.3 cm;P < 0.0001)。关于身体功能,在研究结束时与基线相比有统计学显著差异(从29.74降至25.18;P = 0.0025)。WOMAC指数僵硬成分在随访期间的任何时候与基线均无差异。
疼痛缓解起效延迟但持续时间延长。新型基于透明质酸的水凝胶(Hymovis)取得了有效的结果,尤其是在注射后六个月后,为中重度骨关节炎的治疗提供了治疗进展。