Effect of risedronate on joint structure and symptoms of knee osteoarthritis: results of the BRISK randomized, controlled trial [ISRCTN01928173].
Effect of risedronate on joint structure and symptoms of knee osteoarthritis: results of the BRISK randomized, controlled trial [ISRCTN01928173].
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升压对关节结构和膝关节骨关节炎症状的影响：轻快的随机，对照试验的结果[ISRCTN01928173]。
DOI：
10.1186/ar1716
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发表时间：
2005
影响因子：
4.9
通讯作者：
Meyer, Joan M
中科院分区：
文献类型：
--
作者：
Spector, Tim D;Conaghan, Philip G;Buckland-Wright, J Christopher;Garnero, Patrick;Cline, Gary A;Beary, John F;Valent, David J;Meyer, Joan M
为了确定利塞膦酸钠在膝关节骨关节炎（OA）患者中的有效性和安全性，英国研究利塞膦酸钠在膝关节OA的结构和症状中的作用（BRISK），一项为期1年的前瞻性、双盲、安慰剂对照研究，招募了膝关节内侧间室轻度至中度OA患者（40-80岁）。主要目的是检测症状和功能的差异。患者被随机分配至每日一次的利塞膦酸盐（5 mg或15 mg）或安慰剂组。在基线和1年时拍摄X线片，使用标准化X线片方法和关节荧光定位评估关节间隙宽度。使用西安大略和麦克马斯特大学（WOMAC）OA指数评估疼痛、功能和僵硬。测量患者总体评估和使用助行器的情况，并评估骨和软骨标记物。意向治疗人群包括284例患者。与接受安慰剂的患者相比，接受15 mg利塞膦酸钠治疗的患者WOMAC指数改善，特别是身体功能，患者总体评估显著改善（P < 0.001），使用助行器的患者减少（P = 0.009）。在接受15 mg利塞膦酸钠的组中观察到关节间隙狭窄的衰减趋势。8%（n = 7）接受安慰剂的患者和4%（n = 4）接受5 mg利塞膦酸盐的患者显示出可检测的疾病进展（关节间隙宽度≥ 25%或≥ 0.75 mm），而15 mg利塞膦酸盐的患者为1%（n = 1）（P = 0.067）。利塞膦酸盐（15毫克）显着减少软骨降解和骨吸收的标志物。两种剂量的利塞膦酸盐均耐受良好。在这项研究中，观察到利塞膦酸钠治疗的原发性膝关节OA患者的关节结构和症状有明显的改善趋势。
To determine the efficacy and safety of risedronate in patients with knee osteoarthritis (OA), the British study of risedronate in structure and symptoms of knee OA (BRISK), a 1-year prospective, double-blind, placebo-controlled study, enrolled patients (40–80 years of age) with mild to moderate OA of the medial compartment of the knee. The primary aims were to detect differences in symptoms and function. Patients were randomized to once-daily risedronate (5 mg or 15 mg) or placebo. Radiographs were taken at baseline and 1 year for assessment of joint-space width using a standardized radiographic method with fluoroscopic positioning of the joint. Pain, function, and stiffness were assessed using the Western Ontario and McMaster Universities (WOMAC) OA index. The patient global assessment and use of walking aids were measured and bone and cartilage markers were assessed. The intention-to-treat population consisted of 284 patients. Those receiving risedronate at 15 mg showed improvement of the WOMAC index, particularly of physical function, significant improvement of the patient global assessment (P < 0.001), and decreased use of walking aids relative to patients receiving the placebo (P = 0.009). A trend towards attenuation of joint-space narrowing was observed in the group receiving 15 mg risedronate. Eight percent (n = 7) of patients receiving placebo and 4% (n = 4) of patients receiving 5 mg risedronate exhibited detectable progression of disease (joint-space width ≥ 25% or ≥ 0.75 mm) versus 1% (n = 1) of patients receiving 15 mg risedronate (P = 0.067). Risedronate (15 mg) significantly reduced markers of cartilage degradation and bone resorption. Both doses of risedronate were well tolerated. In this study, clear trends towards improvement were observed in both joint structure and symptoms in patients with primary knee OA treated with risedronate.