Consoli G, Covelli M, Di Matteo L, Marcolongo R, Tirri G, La Montagna G, Pipitone V
Cattedra e Scuola di Specializzazione in Reumatologia, Università degli Studi di Chieti.
Minerva Med. 1994 Mar;85(3):89-96.
An open comparative study was carried out to evaluate the efficacy and safety of piroxicam FDDF, for sublingual administration, versus naproxen in the treatment of osteoarthritis. Sixty-one patients with acute-phase osteoarthritis involving various joints are reported. They were treated with 20 mg/day piroxicam FDDF or with 1000 mg/day naproxen for a total of 4 weeks. Drug efficacy was evaluated on the base of the variation of spontaneous pain, pain on motion, functional limitation and capacity to perform a specific activity. The intensity of spontaneous pain on the first day showed a statistically significant improvement with both drugs, but the onset of analgesia was only after 15 minutes with piroxicam and after 1 hour with naproxen. The improvement in pain intensity increased on the first day and until the 7th day with both drugs, but the comparative analysis between the analgesic efficacy of the two treatments proved to be favourable to piroxicam. On the 7th day, pain on motion and the capacity to perform a specific activity showed a statistically significant improvement with both drugs, but the comparative analysis between the two treatments proved to be favourable to piroxicam. The two drugs showed the same efficacy in functional restriction. The local and systemic tolerability of piroxicam was good. Only 5 patients experienced 6 systemic side-effects, and 1 patients showed local side-effects, but 11 patients of the naproxen group showed 12 systemic side-effects. Thus piroxicam showed a better analgesic and anti-inflammatory efficacy than naproxen. Piroxicam proved to have a better systemic tolerability than naproxen. The local tolerability of piroxicam FDDF was good.
开展了一项开放性对照研究，以评估用于舌下给药的吡罗昔康速释分散片（FDDF）与萘普生治疗骨关节炎的疗效和安全性。报告了61例涉及多个关节的急性期骨关节炎患者。他们分别接受20毫克/天的吡罗昔康FDDF或1000毫克/天的萘普生治疗，疗程共4周。根据自发痛、运动痛、功能受限及进行特定活动的能力变化来评估药物疗效。第一天自发痛的强度在两种药物治疗下均有统计学意义的改善，但吡罗昔康用药15分钟后即出现镇痛效果，而萘普生用药1小时后才出现。两种药物治疗下，疼痛强度在第一天至第7天均持续改善，但两种治疗的镇痛效果比较分析显示吡罗昔康更具优势。在第7天，两种药物治疗下运动痛及进行特定活动的能力均有统计学意义的改善，但两种治疗的比较分析显示吡罗昔康更具优势。两种药物在功能受限方面疗效相当。吡罗昔康的局部和全身耐受性良好。仅5例患者出现6次全身副作用，1例患者出现局部副作用，而萘普生组有11例患者出现12次全身副作用。因此，吡罗昔康的镇痛和抗炎疗效优于萘普生。吡罗昔康的全身耐受性优于萘普生。吡罗昔康FDDF的局部耐受性良好。
