Ishijima Muneaki, Nakamura Toshitaka, Shimizu Katsuji, Hayashi Kunihiko, Kikuchi Hiraku, Soen Satoshi, Omori Go, Yamashita Toshihiko, Uchio Yuji, Chiba Junji, Ideno Yuki, Kubota Mitsuaki, Kurosawa Hisashi, Kaneko Kazuo
Arthritis Res Ther. 2014 Jan 21;16(1):R18. doi: 10.1186/ar4446.
INTRODUCTION: While many of the commonly used conservative treatments for knee osteoarthritis (OA) have been recognized to be effective, there is still insufficient evidence available. Among the pharmacological treatments for knee OA, oral non-steroidal anti-inflammatory drugs (NSAIDs) act rapidly and are recommended for the management of OA. However, frequent and serious adverse effects of NSAIDs have been recognized. Intra-articular injections of hyaluronic acid (IA-HA) for the treatment of knee OA have been shown to reduce pain and improve joint function. However, there has been no qualified direct comparison study of the efficacy and safety between IA-HA and NSAIDs for patients with knee OA. The aim of this study was to clarify the efficacy and safety of early-phase IA-HA in comparison to those of NSAIDs for patients with knee OA. METHODS: This multicenter, randomized, open-label, parallel-group, non-inferiority comparison study with an oral NSAID involved a total of 200 patients with knee OA. An independent, computer-generated randomization sequence was used to randomly assign patients in a 1:1 ratio to NSAIDs three times per day for five weeks (n = 100) or IA-HA once a week for five weeks (n = 100). The primary endpoint was the percentage change in the patient-oriented outcome measure for knee OA, the Japanese Knee Osteoarthritis Measure (JKOM) score. All patients were questioned regarding any adverse events during treatment. The full analysis set (FAS) was used for analysis. The margin of non-inferiority was 10%. RESULTS: The analyses of primary endpoint included 98 patients in the IA-HA group and 86 patients in the NSAID group. The difference in the percentage changes of the JKOM score between the two intervention arms (IA-HA; -34.7% (P<0.001), NSAID; -32.2% (P<0.001)) was -2.5% (95% confidence interval (CI): -14.0 to 9.1), indicating IA-HA was not inferior to NSAID. The frequency of both withdrawal and adverse events in the IA-HA group were significantly lower than those in the NSAID group (P = 0.026 and 0.004, respectively). CONCLUSIONS: The early efficacy of IA-HA is suggested to be not inferior to that of NSAIDs, and that the safety of the early phase of IA-HA is superior to that of NSAIDs for patients with knee OA. TRIAL REGISTRATION: UMIN Clinical Trials Registry (UMIN-CTR), UMIN000001026.
引言：虽然许多常用于膝关节骨关节炎（OA）的保守治疗方法已被认为是有效的，但仍缺乏充分的证据。在膝关节OA的药物治疗中，口服非甾体抗炎药（NSAIDs）起效迅速，被推荐用于OA的管理。然而，NSAIDs频繁且严重的不良反应已被认识到。关节内注射透明质酸（IA-HA）治疗膝关节OA已显示可减轻疼痛并改善关节功能。然而，对于膝关节OA患者，尚无关于IA-HA与NSAIDs疗效和安全性的合格直接比较研究。本研究的目的是阐明早期IA-HA与NSAIDs相比，对膝关节OA患者的疗效和安全性。 方法：这项多中心、随机、开放标签、平行组、非劣效性比较研究涉及200例膝关节OA患者，并与一种口服NSAID进行比较。使用独立的计算机生成随机序列，以1:1的比例将患者随机分配至每天三次服用NSAIDs，共五周（n = 100）或每周一次注射IA-HA，共五周（n = 100）。主要终点是膝关节OA以患者为导向的结局指标的百分比变化，即日本膝关节骨关节炎测量（JKOM）评分。询问所有患者治疗期间的任何不良事件。使用全分析集（FAS）进行分析。非劣效性界值为10%。 结果：主要终点分析包括IA-HA组98例患者和NSAID组86例患者。两个干预组之间JKOM评分百分比变化的差异（IA-HA组为-34.7%（P<0.001），NSAID组为-32.2%（P<0.001））为-2.5%（95%置信区间（CI）：-14.0至9.1），表明IA-HA不劣于NSAID。IA-HA组的退出率和不良事件发生率均显著低于NSAID组（分别为P = 0.026和0.004）。 结论：提示IA-HA的早期疗效不劣于NSAIDs，且对于膝关节OA患者，IA-HA早期的安全性优于NSAIDs。 试验注册：UMIN临床试验注册中心（UMIN-CTR），UMIN000001026。
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