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罗非昔布治疗猫慢性退行性关节疾病相关疼痛的疗效:一项随机和盲法的初步临床试验。

Robenacoxib shows efficacy for the treatment of chronic degenerative joint disease-associated pain in cats: a randomized and blinded pilot clinical trial.

机构信息

Translational Research in Pain (TRiP) Program, Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, NC, USA.

Elanco Animal Health, Greenfield, USA.

出版信息

Sci Rep. 2021 Apr 8;11(1):7721. doi: 10.1038/s41598-021-87023-2.

Abstract

The main objective of this pilot clinical trial was to evaluate outcome measures for the assessment of the nonsteroidal anti-inflammatory drug (NSAID) robenacoxib in cats with degenerative joint disease-associated pain (DJD-pain). Otherwise healthy cats (n = 109) with DJD-pain entered a parallel group, randomized, blinded clinical trial. Cats received placebo (P) or robenacoxib (R) for two consecutive 3-week periods. Treatment groups were PP, RR, and RP. Actimetry and owner-assessment data were collected. Data were analyzed using mixed-effects and generalized mixed-effects linear models. Activity data showed high within-cat and between-cat variability, and 82.4% of the values were zero. Compared to placebo, mean total activity was higher (5.7%) in robenacoxib-treated cats (p = 0.24); for the 80th percentile of activity, more robenacoxib-treated cats had a > 10% increase in activity after 3 (p = 0.046) and 6 weeks (p = 0.026). Robenacoxib treatment significantly decreased owner-assessed disability, (p = 0.01; 49% reduction in disability; effect size ~ 0.3), and improved temperament (p = 0.0039) and happiness (p = 0.021) after 6 weeks. More robenacoxib-treated cats were successes at 6 weeks (p = 0.018; NNT: 3.8). Adverse effect frequencies were similar across groups. Results identified suitable endpoints for confirmatory studies, while also indicating efficacy of robenacoxib in cats with DJD-pain.

摘要

本临床试验的主要目的是评估非甾体抗炎药(NSAID)罗非考昔治疗与退行性关节病相关疼痛(DJD-疼痛)的猫的疗效评估指标。 109 只健康状况良好的 DJD-疼痛猫进入平行组、随机、双盲临床试验。猫接受安慰剂(P)或罗非考昔(R)连续治疗 3 周。治疗组为 PP、RR 和 RP。收集活动计和主人评估数据。使用混合效应和广义混合效应线性模型进行数据分析。活动数据显示出高的个体内和个体间变异性,82.4%的数值为零。与安慰剂相比,罗非考昔治疗猫的总活动平均值更高(5.7%)(p=0.24);对于活动的第 80 个百分位数,更多罗非考昔治疗猫在 3 周(p=0.046)和 6 周(p=0.026)后活动增加超过 10%。罗非考昔治疗后,猫的主人评估残疾(p=0.01;残疾减少 49%;效应大小~0.3)、性情(p=0.0039)和幸福感(p=0.021)显著改善。6 周时,更多的罗非考昔治疗猫获得成功(p=0.018;NNH:3.8)。各组的不良反应频率相似。研究结果确定了适合验证性研究的终点,同时也表明罗非考昔治疗 DJD-疼痛猫的疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6ef7/8032665/2a7e897cbd6d/41598_2021_87023_Fig1_HTML.jpg

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