摘要
目的观察吡罗昔康Patch剂型(透皮控释贴片)治疗骨关节炎的疗效和安全性。方法研究采用开放试验。试验病例数21例,完成病例数20例。治疗方法吡罗昔康2天一贴贴于患处,连续使用14d。主要疗效指标:靶部位休息痛VAS评分,靶部位活动痛VAS评分;次要疗效指标: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:血尿常规、肝肾功能、心电图等,用药部位皮肤的刺激性,全身不良事件。结果治疗前患者休息痛VAS评分为6.69,治疗后为3.88分,下降了2.81分,统计学分析有差异;治疗前患者活动痛VAS评分为6.89,治疗后为4.02分,下降了2.87分,统计学分析有差异。患者对疗效的综合评价有效为80%,显效为70%。首次给药后疼痛缓解时间平均为3.15天。无疼痛消失患者。所有受试者均未发现不良反应。结论吡罗昔康贴片治疗骨关节炎有良好的止痛效果,安全性好。
Efficacy and safety of piroxicam patch for the treatment of osteoarthritis<Author>Sun Yong-qing Tang Ya-juan Ma Xiao-wei Orthopaedics department, Beijing Electric Power HospitalObjective To evaluate the effect and security of the new drug -Piroxicam patch. Methods We use open clinical trail according to GCP. 20 patients were included into our study. Piroxicam patch was patched on painful joint, changed every other day, and continuously used for 14 days. Patients were followed up on one week and two weeks respectively. Final effect was evaluated with visual analog scale (VAS) for rest and act pain intensity, patients general evaluation, the effective time, the pain disappear time and security index, such as physical and laboratory examination. Result The rest pain VAS score was 6.69 and 3.88 before and after treatment. The act pain VAS score was 6.49 and 4.02 before and after treatment. The effective time was 3.25 days. 70% patients showed good response to Piroxicam patch. Conclusion Our clinical study of Piroxicam patch on osteoarthritis supports good pain releasing effect and good safety of it, and we recommend to use Piroxicam patch.<Keywords>osteoarthritis piroxicam patch
