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Pilot Study to Evaluate the Efficacy of Polynucleotide Sodium Compared to Sodium Hyaluronate and Crosslinked Sodium Hyaluronate in Patients with Knee Osteoarthritis

机译:试点研究以评估膝关节骨关节炎患者透明质酸钠和交联透明质酸钠相比的多核苷酸钠的功效

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摘要

Degenerative arthritis of the knee joint has become a major social problem worldwide due to population aging. There are several treatment options for knee osteoarthritis, and the intraarticular injection of sodium hyaluronate is commonly selected by many clinicians as a nonsurgical treatment. However, the efficacy of the treatment is controversial. In this pilot study, we aimed to compare polynucleotide sodium (Conjuran®) with sodium hyaluronate (Hyruan Plus®) and 1,4-butanediol diglycidyl ether-crosslinked sodium hyaluronate (Synovian®) in terms of analgesic efficacy after intraarticular injection in patients with knee osteoarthritis. One of the three intraarticular agents was selected according to what agents were available for outpatients when each patient was enrolled in the study. The 15 enrolled patients were subdivided into 3 groups of 5 patients each. Three injections were performed under ultrasound guidance at a 1-week intervals over a total of 3 weeks. The visual analog scale (VAS) score, the Korean version of the Western Ontario and McMaster Universities Arthritis Index (K-WOMAC), the EuroQol five-dimension scale (EQ-5D) score, and the Korean version of the painDETECT Questionnaire (K-PDQ) score were evaluated before injection and at 1, 2, and 6 weeks after the start of the treatment protocol. The primary endpoint was the change in weight-bearing pain at 4 weeks after the last injection. Secondary endpoints included pain at rest and during walking and the K-WOMAC, EQ-5D, and K-PDQ scores. Weight-bearing pain decreased significantly more from pretreatment to 6 weeks after the start of the treatment protocol in the polynucleotide sodium-treated patients than in the patients who were treated with other agents (p = 0.006, one-way ANOVA). There were no significant between-group differences in the other secondary endpoints. No adverse events occurred. In conclusion, polynucleotide sodium could effectively reduce weight-bearing pain in the patients with knee osteoarthritis compared to standard hyaluronic acid viscosupplementation.
机译:由于人口老龄化,膝关节的退化性关节炎已成为全球主要的社会问题。膝关节骨关节炎有几种治疗方案,并且透明质酸钠的细胞内注射通常由许多临床医生选择作为非静电治疗。然而,治疗的疗效是有争议的。在该试点研究中,我们旨在将多核苷酸钠(Chancurean®)与透明质酸钠(Hyruan Plus)和1,4-丁二醇二缩水甘油醚 - 交联透明质酸钠(Synovian®)进行比较,以便在患者内注射后的镇痛药物后膝关节骨关节炎。根据在研究中纳入每种患者时,根据什么试剂选择三种细胞内剂。将15名注册的患者分为3组5名患者。在超声波引导下以1周的间隔进行三个时间进行三个注射。视觉模拟规模(VAS)得分,韩国版西部的安大略省和麦克马斯大学关节炎指数(K-WOMAC),欧元QOL五维规模(EQ-5D)得分,以及韩国版的痛苦调查问卷(k -PDQ)评分在注射前和治疗方案开始后的1,2和6周之前进行评分。主要终点是最后一次注射后4周内止动疼痛的变化。次要终点包括休息和步行期间的疼痛和K-Womac,EQ-5D和K-PDQ分数。在多核苷酸钠治疗患者的治疗方案开始后,对治疗方案开始的预处理至6周后,负载疼痛比在用其他代理处理的患者中,从预处理减少到6周(P = 0.006,单向ANOVA)。在其他次要终点中没有显着的差异。没有发生不良事件。总之,与标准透明质酸粘液相比,多核苷酸钠可以有效地减少膝关节骨关节炎患者的负重疼痛。

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