...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Arthritis Research >Intra-articular hyaluronic acid injection versus oral non-steroidal anti-inflammatory drug for the treatment of knee osteoarthritis: a multi-center, randomized, open-label, non-inferiority trial
【24h】

Intra-articular hyaluronic acid injection versus oral non-steroidal anti-inflammatory drug for the treatment of knee osteoarthritis: a multi-center, randomized, open-label, non-inferiority trial

机译：关节内透明质酸注射液与口服非甾体类抗炎药治疗膝盖骨关节炎：一项多中心，随机，开放标签，非劣效性试验

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

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 .
机译：引言虽然许多公认的膝骨关节炎（OA）常用保守治疗方法是有效的，但仍然没有足够的证据。在膝盖OA的药物治疗中，口服非甾体类抗炎药（NSAIDs）起效快，建议用于OA的治疗。然而，已经认识到NSAID的频繁和严重的副作用。关节腔内注射透明质酸（IA-HA）治疗膝骨关节炎已显示出可减轻疼痛并改善关节功能。但是，目前尚无有关IA-HA和NSAIDs对膝OA患者的疗效和安全性的直接比较研究。这项研究的目的是阐明早期IA-HA与NSAIDs对膝OA患者的疗效和安全性。方法该多中心，随机，开放标签，平行组，非劣效性与口服NSAID的比较研究共涉及200例膝OA。使用独立的，计算机生成的随机序列将患者以1：1的比例随机分配给NSAIDs，连续三周，共五周（n？=？100），或IA-HA，一周一次，共五周（n？= 100）。主要终点是针对膝盖OA的以患者为导向的结果测量值（日本膝骨关节炎测量值（JKOM）得分）的百分比变化。对所有患者进行治疗期间的任何不良事件询问。完整的分析集（FAS）用于分析。非自卑的边缘是10％。结果主要终点分析包括IA-HA组98例和NSAID组86例。两个干预组（IA-HA; -34.7％（P <0.001），NSAID; -32.2％（P <0.001））之间的JKOM得分变化百分比差异为-2.5％（95％置信区间（ CI）：-14.0至9.1），表示IA-HA不劣于NSAID。 IA-HA组的戒断和不良事件发生频率均明显低于NSAID组（分别为P = 0.026和0.004）。结论IA-HA的早期疗效不亚于NSAIDs，对于膝骨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。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号