吡罗昔康透皮控释贴片治疗骨关节炎多中心对照临床研究

目的：观察吡罗昔康透皮控释贴片治疗骨关节炎的疗效和安全性.方法：研究采用多中心、随机、单盲、阳性药（双氯芬酸乳胶）平行对照.230例膝骨关节炎患者分为两组,吡罗昔康贴片组116例,双氯芬酸乳胶组114例.吡罗昔康贴片2日一贴,贴于患处,双氯芬酸乳胶涂于患处,tid,连续使用14 d.主要疗效指标为靶部位休息痛和活动痛VAS评分.次要疗效指标为疗效的综合评价,患者对疗效的总体评价,药物起效时间,疼痛消失时间,肿胀和压痛评分变化.安全性指标为血尿常规、肝肾功能、心电图等和用药部位皮肤的刺激性及全身不良反应.结果：（FAS人群）试验组和对照组的休息痛VAS评分分别下降了2.43和1.14分（P＜0.05）.两组活动痛VAS评分分别下降了3.41和1.99分（P＜0.05）.疗效综合评价两组的有效率分别为71.55%和51.75%（P＜0.05）.患者对疗效的综合评价两组分别为92.24%和77.88%（P＜0.05）.两组首次给药后疼痛缓解率、压痛评分和肿胀评分的变化有统计学差异.两组疼痛消失时间无统计学差异.安全性指标两组无统计学差异.PP分析结果和FAS结果一致.结论：吡罗昔康贴片治疗骨关节炎在多项疗效指标结果优于双氯芬酸乳胶剂,安全性与双氯芬酸乳胶剂相似.

Efficacy and safety of piroxicam patch for the treatment of osteoarthritis

Objective: To evaluate efficacy and safety of piroxicam patch for the treatment of os-teoarthritis. Methods: A random, single blind, positive-control and multi-center clinical trial recruited 230 patients with osteoarthritis, who were randomly applied onto the affected area with either piroxicam patch (n = 116) once every other day or diclofenac emulsion (n = 114) three times per day for 14 days. The primary endpoint was to measure the changes of VAS score of pain at rest and at activity. The secondary endpoints included general therapeutic impressions by physician and subjects, onset time of drug initial response and pain full relief, changes of tumefaction and tenderness scores. The safety endpoints were evaluated based on blood and urinary tests, renal and hepatic functions, ECG and incidence of adverse events. Result: The VAS score at rest vs. at activity with the patch and the emulsion reduced 2. 43 vs. 1. 14 and 3. 41 vs. 1. 99 (P <0. 05) , respectively; general therapeutic impression of the patch and the emulsions by physician was 71. 55% vs. 51.75% (P<0. 05) and by subjects 92. 24% vs. 77.88% (P < 0. 05). The onset time of drug initial response and changes of tumefaction and tenderness scores were improved better in the patch group than in the emulsion group (P < 0. 05). No statistical differences in the pain full relief and incidence of adverse events were shown between two groups (P > 0. 05). Conclusion: Piroxicam patch offered better options in the treatment of osteoarthritis.