Autologous conditioned serum (Orthokine) is an effective treatment for knee osteoarthritis
Autologous conditioned serum (Orthokine) is an effective treatment for knee osteoarthritis
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DOI：
10.1016/j.joca.2008.06.014
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发表时间：
2009-02-01
影响因子：
7
通讯作者：
Krauspe, R.
中科院分区：
文献类型：
--
作者：
Baltzer, A. W. A.;Moser, C.;Krauspe, R.
目的：骨关节炎（OA）发病率高，治疗难度大。自体条件血清（ACS），以商品名Orthokine上市，是一种从患者自身血液中提取的新型可注射抗关节炎药物。本研究是ACS首次进行对照临床试验。我们对376例膝关节OA患者进行了前瞻性、随机、患者和观察者双盲、安慰剂对照试验，采用意向治疗分析（ITT）。ACS的临床效果与透明质酸（HA）和生理盐水（安慰剂）进行比较，并在7周、13周和26周后通过患者给药的结果工具（西安大略省和麦克马斯特大学骨关节炎指数、总体患者评估、视觉模拟量表、Short-Form 8）进行评估。104周后进行盲法随访。不良事件发生频率和严重程度作为安全参数。结果：在所有治疗组中，关节内注射均减轻了症状并改善了生活质量。然而，在所有结果测量和时间点上，ACS的效果明显优于HA和生理盐水，并且改善具有临床相关性；透明质酸和生理盐水的效果没有差异。ACS组和生理盐水组的不良事件发生率相当，但HA组的不良事件发生率更高。结论：ACS注射液能明显改善OA患者的临床症状和体征。目前尚不清楚ACS是否具有疾病改善、软骨保护或软骨再生作用。(C) 2008国际骨关节炎研究学会。Elsevier Ltd.出版。版权所有。
Objective: Osteoarthritis (OA) is prevalent and difficult to treat. Autologous conditioned serum (ACS), marketed under the trade name Orthokine, is a novel, injectable antiarthritic derived from the patient's own blood. The present study is the first time ACS has undergone a controlled clinical trial.Method. We investigated 376 patients with knee OA in a prospective, randomized, patient- and observer-blinded, placebo-controlled trial using an intention-to-treat analysis (ITT). The clinical effects of ACS were compared to hyaluronan (HA) and saline (placebo) as assessed by patient-administered outcome instruments (Western Ontario and McMaster Universities osteoarthritis index, global patient assessment, visual analog scale, Short-Form 8) after 7, 13 and 26 weeks. After 104 weeks an observer-blinded follow-up was carried out. Frequency and severity of adverse events were used as safety parameters.Results: In all treatment groups, intra-articular injections produced a reduction in symptoms as well as an improvement in quality of life. However, the effects of ACS were significantly superior to those of HA and saline for all outcome measures and time points, and improvements were clinically relevant; there were no differences between the effects of HA and saline. The frequency of adverse events was comparable in the ACS and saline groups, but higher in the HA group.Conclusion: The data demonstrate that ACS injection considerably improves clinical signs and symptoms of OA. It remains to be determined whether ACS is disease-modifying, chondroprotective, or chondroregenerative. (C) 2008 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.