Gijón Baños J
Servicio de Reumatología, Hospital La Paz, Madrid.
Med Clin (Barc). 1997 Jun 21;109(4):130-4.
Non-steroidal antiinflammatory drugs are extensively prescribed for the symptomatic treatment of osteoarthritis (OA). This study compared the efficacy and safety of nabumetone with aceclofenac in patients with active knee osteoarthritis.
Phase IV, multicentre, prospective, open-label, parallel-group, randomized, three-month treatment, clinical trial, of nabumetone (1-2 g once a day) vs aceclofenac (100 mg two times each day). The main efficacy variable was intensity of pain, evaluated on a Visual Analogic Scale (VAS). In addition: Gonarthrosis Severity Index (GSI)-baseline score > 5 and < 17-, patient and physician Global Assessment of OA Activity, patient and physician Global Assessment of OA progression were assessed. Adverse events incidence and severity were assessed. Three study visits were made on a monthly basis. The main statistical analysis was by intention to treat (ITT).
In 12 centres 274 patients were recruited (137/group), aged 62.5 +/- 8.4 years, of whom 189 completed the trial (97 nabumetone and 92 aceclofenac). 90% were female, and 83% of the patients had both knees affected. In both groups the intensity of pain at month 3 improved significantly (p < 0.001) with respect to baseline: VAS of the nabumetone group: 6.1 +/- 1.9 to 4.3 +/- 2.8 cm; VAS of the aceclofenac group: 6.1 +/- 1.9 to 4.4 +/- 2.7 cm. There were no significant differences in any of the intergroup comparisons made. 15 nabumetone-treated and 23 aceclofenac-treated patients withdrew from the study due to moderate to severe adverse events. Gastrointestinal adverse events were the reason for withdrawal in 7 nabumetone and 14 aceclofenac-treated patients.
The efficacy and safety of nabumetone are similar to those of aceclofenac in the treatment of knee osteoarthritis.
非甾体类抗炎药被广泛用于骨关节炎（OA）的症状性治疗。本研究比较了萘丁美酮与醋氯芬酸治疗活动性膝骨关节炎患者的疗效和安全性。
一项IV期、多中心、前瞻性、开放标签、平行组、随机、为期三个月治疗的临床试验，比较萘丁美酮（每日1 - 2 g一次）与醋氯芬酸（每日100 mg两次）。主要疗效变量为疼痛强度，采用视觉模拟评分法（VAS）进行评估。此外，还评估了膝关节病严重程度指数（GSI）（基线评分> 5且< 17）、患者和医生对OA活动度的整体评估、患者和医生对OA进展的整体评估。评估不良事件的发生率和严重程度。每月进行三次研究访视。主要统计分析采用意向性分析（ITT）。
在12个中心招募了274例患者（每组137例），年龄为62.5±8.4岁，其中189例完成试验（97例萘丁美酮组和92例醋氯芬酸组）。90%为女性，83%的患者双膝受累。两组在第3个月时疼痛强度相对于基线均有显著改善（p < 0.001）：萘丁美酮组VAS从6.1±1.9降至4.3±2.8 cm；醋氯芬酸组VAS从6.1±1.9降至4.4±2.7 cm。组间比较均无显著差异。15例接受萘丁美酮治疗和23例接受醋氯芬酸治疗的患者因中度至重度不良事件退出研究。7例接受萘丁美酮治疗和14例接受醋氯芬酸治疗的患者因胃肠道不良事件而退出。
萘丁美酮在治疗膝骨关节炎方面的疗效和安全性与醋氯芬酸相似。
