Baltzer A W A, Moser C, Jansen S A, Krauspe R
Centre for Molecular Orthopaedics, Düsseldorf, Germany.
Osteoarthritis Cartilage. 2009 Feb;17(2):152-60. doi: 10.1016/j.joca.2008.06.014. Epub 2008 Jul 31.
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.
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.
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.
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.
骨关节炎（OA）普遍存在且难以治疗。商品名为Orthokine的自体浓缩血清（ACS）是一种源自患者自身血液的新型可注射抗关节炎药物。本研究是ACS首次进行的对照临床试验。
我们在一项前瞻性、随机、患者和观察者双盲、安慰剂对照试验中，采用意向性分析（ITT）对376例膝骨关节炎患者进行了研究。在7周、13周和26周后，通过患者自我管理的结局指标（西安大略和麦克马斯特大学骨关节炎指数、整体患者评估、视觉模拟量表、简明健康状况调查量表8）评估ACS与透明质酸（HA）和生理盐水（安慰剂）的临床效果。在104周后进行了观察者盲法随访。不良事件的频率和严重程度用作安全性参数。
在所有治疗组中，关节内注射均使症状减轻，生活质量改善。然而，在所有结局指标和时间点上，ACS的效果均显著优于HA和生理盐水，且改善具有临床意义；HA和生理盐水的效果之间无差异。ACS组和生理盐水组不良事件的频率相当，但HA组更高。
数据表明，注射ACS可显著改善OA的临床体征和症状。ACS是否具有疾病修饰、软骨保护或软骨再生作用仍有待确定。
