Autologous interleukin-1 receptor antagonist improves function and symptoms in osteoarthritis when compared to placebo in a prospective randomized controlled trial
Autologous interleukin-1 receptor antagonist improves function and symptoms in osteoarthritis when compared to placebo in a prospective randomized controlled trial
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DOI：
10.1016/j.joca.2007.07.008
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发表时间：
2008-04-01
影响因子：
7
通讯作者：
Saris, D. B. F.
中科院分区：
文献类型：
--
作者：
Yang, K. G. Auw;Raijmakers, N. J. H.;Saris, D. B. F.
简介：将血液与CRSO4涂层玻璃珠一起孵育刺激抗炎细胞因子的合成，例如白介素-1受体拮抗剂（IL-1RA），IL-4，IL-4，IL-10和IL-13。由于IL-1β被认为在骨关节炎（OA）的发展中起关键作用，因此该产品（也称为Orthokin）可能是有症状的膝关节OA的可行治疗方法。当前研究的目的是评估正交动物在随机，多中心，双盲，安慰剂对照试验中治疗有症状的膝关节的功效。患者和方法：一百六十七名患者接受了六个关节内。注射正向或生理盐水。主要疗效目标包括在3、6、9、9和12个月的治疗后3、6、9和12个月的骨关节炎指数（WOMAC）上的骨关节炎指数（WOMAC）组成30％。此外，患者完成了视觉模拟量表的疼痛，膝关节损伤和骨关节炎结局评分（KOOS）和膝关节社会临床评级系统。反应：Orthokin和安慰剂治疗对WOMAC有类似的改善（分别为16.8％和16.5％，分别为16.5％ ;与安慰剂治疗相比，Orthokin导致KOOS症状（P = 0.002）和Koos Sport（P = 0.042）参数的改善明显更大。对于大多数其他结局参数，与安慰剂治疗的患者相比，基于原生物治疗的患者始终显示出更高的改善，尽管这些差异都没有统计学意义。在正金蛋白组中观察到了两个严重的不良事件：注射后几个小时内膝关节重复发生严重炎症反应的患者，一名败血性关节炎患者归因于注射程序，而不是产物。改善KOOS症状和运动参数以及始终如一（尽管具有非统计意义）的始终如一的其他参数的改进表明Orthokin明显引起与安慰剂治疗不同的生物学反应，并保证对正金可能的软骨保护作用的未来研究。但是，在当前的研究中，未达到主要疗效目标，因此，目前不建议使用Orthokin来治疗OA。 （c）2007年国际骨关节炎研究协会。由Elsevier Ltd.出版。保留所有权利。
Introduction: Incubation of blood with CrSO4-coated glass beads stimulates the synthesis of anti-inflammatory cytokines, such as interleukin-1 receptor antagonist (IL-1ra), IL-4, IL-10, and IL-13. As IL-1 beta is thought to play a key role in the development of osteoarthritis (OA), this product, also known as Orthokin, might be a viable treatment for symptomatic knee OA. The aim of the current study was to evaluate the efficacy of Orthokin for treatment of symptomatic knee CA in a randomized, multicentre, double-blind, placebo-controlled trial.Patients and methods: One hundred and sixty-seven patients received six intra-articular injections either with Orthokin or physiological saline. The primary efficacy objective consisted of 30% superiority on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 3, 6, 9, and 12 months post-treatment. Additionally, the patients completed the visual analogue scale for pain, the Knee injury and Osteoarthritis Outcome Score (KOOS) and Knee Society Clinical Rating System.Results: Orthokin and placebo treatment resulted in similar improvements on the WOMAC (16.8% vs 16.5%, respectively; n.s.). Orthokin resulted in significantly more improvement for KOOS symptom (P = 0.002) and KOOS sport (P = 0.042) parameters as compared to placebo treatment. For most other outcome parameters, Orthokin-treated patients consistently showed higher improvement compared to placebo-treated patients, although none of these differences were statistically significant. Two serious adverse events were observed in the Orthokin group: one patient with repeated severe inflammatory reactions of the knee joint within hours after the injection and one patient with septic arthritis which was attributed to the injection procedure rather than the product.Conclusion: The statistically significant improvement of KOOS symptom and sport parameters together with the consistently higher, though non-statistically significant, improvement of most other parameters demonstrates that Orthokin clearly induces a biological response different from placebo treatment and warrant future investigations into the possible chondroprotective effect of Orthokin. However, in the current study the primary efficacy objective was not met and, therefore, the use of Orthokin currently cannot yet be recommended for the treatment of OA. (C) 2007 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.