吡罗昔康透皮控释贴片治疗急慢性疼痛多中心随机对照临床研究

目的:观察吡罗昔康贴片(透皮控释剂型)治疗急慢性疼痛的疗效和安全性。方法:采用多中心、随机、单盲、阳性药(双氯芬酸)平行对照试验。急慢性疼痛病人随机分为2组,试验组予吡罗昔康贴片2日1贴贴于患处,对照组予双氯芬酸乳胶1日3次涂于患处,均连续使用14 d。主要疗效指标为靶部位休息痛和活动痛视觉模拟量表(VAS)评分,次要疗效指标为疗效的综合评价、病人对疗效的总体评价、药物起效时间、疼痛消失时间、肿胀和压痛评分变化,并观察不良事件。结果:210例病人入选,试验组(吡罗昔康组)106例,对照组(双氯芬酸组)104例。2组治疗前基础情况,疼痛分类、程度等均具有可比性。治疗后按全分析集(FAS)人群分析,对照组和试验组休息痛VAS评分分别下降了(2．6±s 2．0)和(3．6±2．3)分,改善率分别为(50±47)％和(63±38)％(P<0．01);活动痛VAS评分分别下降了(3．0±2．3)和(4．0±2．4)分,改善率分别为(44±33)％和(61±32)％(P<0．01)。2组疗效综合评价总有效率分别为70．2％和82．1％(P<0．05),病人对疗效的总体评价有效率分别为81．4％和93．3％(P<0．05)。2组压痛和肿胀评分、首次给药后疼痛缓解率有显著差异,而2组疼痛消失时间、安全性指标无显著差异。按符合方案集(PP)人群分析结果与按FAS人群分析结果基本一致。结论:吡罗昔康贴片治疗急慢性疼痛多项疗效指标结果优于双氯芬酸乳胶,安全性与双氯芬酸乳胶相似。

Piroxicam patch in treatment of acute and chronic pain: a multicenter, randomized and controlled clinical study

AIM: To evaluate the efficacy and safety of piroxicam patch in the treatment of acute and chronic pain. METHODS: A randomized, single blind, positive-control, and multicenter clinical trail was conducted. The patients with acute or chronic pain were radomized divided into two groups. The patients in the trial group were treated with piroxicam patch once every other day, while the other patients in the control group with diclofenac emulsion three times per day, with 14 d for each group. The main indexes of efficacy were visual analougue scale (VAS) score of the pain at rest and in activity of the target region. The secondary indexes included general evaluation of therapeutic effect, total comment by patients, initial effective time, pain disappearing time, score changes of tumefaction, and tenderness. Safety was also under monitoring. RESULTS: A total of 210 patients with acute or chronic pain were enrolled in the study, including 106 patients completed the study in the trial (piroxicam) group and 104 patients in the control (diclofenac) group. Before treatment, there were no statistically significant differences between the two groups in the baseline data, classification, and degree of pain, etc. After treatment, according to full analysis set (FAS), the VAS scores at rest in control and trail groups reduced 2.6±s 2.0 vs 3.6±2.3 with the improve rates (50±47) % vs (63±38) % (P < 0.01), respectively. While the VAS scores in activity reduced 3.0±2.3 vs 4.0±2.4, with the improve rates (44±33) % vs (61±32) % (P < 0.01), respectively. General evaluations of therapeutic effect were 70.2 % vs 82.1 % (P < 0.05) and total comments by patients were 81.4 % vs 93.3 % in control and trail groups. Trial group showed better results than those of the control group in the initial effective time, score changes of tumefaction, and tenderness (P < 0.05) . The pain disappearing times were similar in two groups (P > 0.05). The incidences of adverse drug reaction have no significant difference between the two groups. The results of per protocol (PP) analysis were similar to those of FAS analysis. CONCLUSION: Piroxicam patch shows better efficacy and similar safety in the treatment of acute and chronic pain in comparing with diclofenac.