Evaluation of the symptomatic and structural efficacy of a new hyaluronic acid compound, NRD101, in comparison with diacerein and placebo in a 1 year randomised controlled study in symptomatic knee osteoarthritis
Evaluation of the symptomatic and structural efficacy of a new hyaluronic acid compound, NRD101, in comparison with diacerein and placebo in a 1 year randomised controlled study in symptomatic knee osteoarthritis
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DOI：
10.1136/ard.2003.019703
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发表时间：
2004-12-01
影响因子：
27.4
通讯作者：
Dougados, M
中科院分区：
文献类型：
--
作者：
Pham, T;Le Henanff, A;Dougados, M
目的：评估每周三周关节内 (IA) 注射 NRD101 的三个迭代疗程治疗有症状的膝骨关节炎 (OA) 的长期疗效。 患者和方法：一项为期 1 年的前瞻性、多中心、随机、双盲、安慰剂对照研究，纳入了 301 名年龄 > 50 岁的疼痛性和放射性内侧膝关节 OA 患者。患者被随机分为三组，接受：（1）透明质酸（HA）3次IA注射3个疗程+口服安慰剂； (2)IA注射盐水溶液+双醋瑞因100mg/天； (3)IA注射盐水溶液+口服安慰剂。研究期间获得了人口统计数据和症状标准——疼痛、莱克纳指数、患者对疾病活动的总体评估、疼痛天数的百分比；主要结构标准是JSW。疗效标准是疼痛 VAS、关节间隙狭窄 (JSN) 和进展百分比 (JSN >0.5 mm) 的变化。对症状变量使用意向治疗分析，对结构变量使用更完整的分析。结果：三组之间的基线特征相似。疼痛 VAS 的平均 (SD) 改善具有临床相关性 (-33.9 (27.3)，n = 301），但组间无差异 (p = 0.96)。 JSW 恶化（-0.09 (0.55) mm，n = 277，p = 0.01），但组间无差异（p = 0.82）。第 1、2 和 3 组中进展者的百分比分别为 17.7%、18.9% 和 20.3% (p = 0.90)。结论：在接受口服药物和反复 IA 注射的患者中，一年多以来出现了微弱但具有统计学意义的结构恶化，同时临床相关症状得到改善。这种新的 HA 化合物和双醋瑞因的症状和/或结构效应尚未得到证实。
Objective: To evaluate long term efficacy of three iterative courses of three weekly intra-articular (IA) injections of NRD101 in the treatment of symptomatic knee osteoarthritis (OA).Patients and methods: A 1 year prospective, multicentre, randomised, double blind, placebo controlled study of 301 patients aged >50 years with painful and radiological medial knee OA. Patients were randomly assigned into three groups receiving: (1) three courses of three IA injections of hyaluronic acid (HA) + oral placebo; (2) IA injections of saline solution + diacerein 100 mg/day; (3) IA injections of saline solution + oral placebo. Demographic data and symptomatic criteria-pain, Lequesne's index, patient's global assessment of disease activity, percentage of painful days-were obtained during the study; primary structural criterion was JSW. Efficacy criteria were changes in pain VAS, joint space narrowing (JSN), and percentage of progressors (JSN >0.5 mm). An intention to treat analysis was used for symptomatic variables, and completer analysis for structural variables.Results: Baseline characteristics were similar between the three groups. Mean (SD) improvement in pain VAS was clinically relevant (-33.9 (27.3), n = 301), but with no difference between the groups (p = 0.96). JSW deteriorated (-0.09 (0.55) mm, n = 277, p = 0.01), but with no difference between the groups (p = 0.82). Percentages of progressors were 17.7, 18.9, and 20.3% (p = 0.90), in groups 1, 2, and 3, respectively.Conclusion: A weak but statistically significant structural deterioration occurred over 1 year, together with clinically relevant symptomatic improvement in patients receiving oral drug and iterative IA injections. Symptomatic and/or structural effects for both this new HA compound and diacerein were not demonstrated.