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关节内注射多核苷酸治疗膝关节骨关节炎:一项具有中期随访的初步研究。

Intrarticular treatment of osteoartropaty knee with polynucleotides: a pilot study with medium-term follow-up.

机构信息

Department of Neuroscience and Imaging, University of Chieti, Italy.

出版信息

J Biol Regul Homeost Agents. 2013 Apr-Jun;27(2):543-9.

Abstract

Knee osteoarthritis is a major cause of disability in the elderly. Many therapies are nowadays available, ranging from non-pharmacologic to pharmacological approaches like visco-supplementation, oral supplements or topical treatments, but a flawless treatment is still to be found. Visco-supplementation represents a valid treatment option for reducing pain associated with knee osteoarthritis and improving function in the affected joint. Many literature data report on the efficacy and safety profiles of hyaluronic acid in knee osteoarthritis, however the efficacy of intra-articular hyaluronic acid remains controversial, in fact while several clinical trials claimed a disease-modifying effect for hyaluronic acid, subsequent meta-analyses have cast doubts on this fact. The ideal intra-articular treatment for osteoarthritis should not only provide a mechanical protection of the cartilage surface, but also restore condrocytes’ homeostasis by restoring the physiological articular micro-environment and supplying nutrients. In this perspective an innovative medical product made up of polynucleotides (Condrotide) has been developed. The aim of this study is to test the 2-months efficacy in pain relief and improving function of intra-articular injections of Condrotide in patients with knee osteoarthritis or with grade III or IV chondropathy. Ninety-five subjects (33 men, 62 women), aged between 53 and 80, were included between May 2011 to July 2012. All subjects received intra-articular injections of Condrotide and were evaluated with the Knee injury and Osteoarthritis Outcome Score (KOOS), the NRS scale for pain assessment, the measurement of the range of motion (R.O.M.). In all subjects a significant improvement was found in KOOS score after 60 days. The mean global NRS pain decreased in both groups and there was also a R.O.M. improvement. These results show that the intra-articular administration of nucleotides in subjects with both severe knee arthritis and chondropathy can be recommended since is able to reverse in the short and medium term symptoms and function with a significant improvement in quality of life.

摘要

膝骨关节炎是老年人残疾的主要原因。目前有许多治疗方法,包括非药物治疗和药物治疗,如粘弹性补充剂、口服补充剂或局部治疗,但仍未找到完美的治疗方法。粘弹性补充剂是一种有效的治疗方法,可减轻与膝骨关节炎相关的疼痛并改善受影响关节的功能。许多文献资料报告了透明质酸在膝骨关节炎中的疗效和安全性概况,但是关节内透明质酸的疗效仍存在争议,事实上,虽然几项临床试验声称透明质酸具有疾病修饰作用,但随后的荟萃分析对这一事实提出了质疑。理想的关节内治疗方法不仅应提供对软骨表面的机械保护,还应通过恢复生理关节微环境和提供营养来恢复软骨细胞的体内平衡。在这方面,已经开发出一种由多核苷酸(Condrotide)组成的创新医疗产品。本研究旨在测试 Condrotide 关节内注射在膝骨关节炎或 3 或 4 级软骨病患者中缓解疼痛和改善功能的 2 个月疗效。95 名受试者(33 名男性,62 名女性)年龄在 53 至 80 岁之间,于 2011 年 5 月至 2012 年 7 月间纳入研究。所有受试者均接受 Condrotide 关节内注射,并采用膝关节损伤和骨关节炎结果评分(KOOS)、疼痛评估的 NRS 量表、关节活动范围(ROM)测量进行评估。所有受试者在 60 天后 KOOS 评分均显著提高。两组的全球 NRS 疼痛平均值均降低,ROM 也得到改善。这些结果表明,在患有严重膝关节炎和软骨病的患者中,关节内给予核苷酸是可行的,因为它能够在短期内和中期缓解症状和功能,同时显著提高生活质量。

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