恩氟昔布治疗犬骨关节炎：一项与马昔康对照的随机、盲法、多中心、非劣效性临床试验。

BACKGROUND: This prospective, multisite, blinded, randomized, non-inferiority clinical study aimed to confirm the efficacy and safety of enflicoxib in the treatment of pain and inflammation associated with canine osteoarthritis. A total of 180 dogs were randomized to receive enflicoxib (n = 78), mavacoxib (n = 80) or placebo (n = 22). Dogs underwent veterinary assessments from day 0 to day 42 using a clinical sum score (CSS). Efficacy was also assessed by the owners using the Canine Brief Pain Inventory (CBPI). The primary efficacy endpoint was the overall CSS from day 0 to day 42. RESULTS: The overall CSS expressed as area under the curve demonstrated non-inferiority of enflicoxib compared to mavacoxib, and both showed superiority over placebo. At the end of the study, average CSS, and the percentage of CSS responders for enflicoxib (3.64 and 74%) and mavacoxib (4.49 and 68%), was superior to placebo (7.15 and 29%). A faster onset of action was observed for enflicoxib as superiority over placebo was evidenced from the first efficacy assessment (day 7) onwards for both parameters, whereas mavacoxib was only significantly different from day 14 onwards. According to the owner assessment, the percentage of CBPI responders was 90%, 79%, and 43% for dogs treated with enflicoxib, mavacoxib and placebo, respectively, and superiority over placebo was demonstrated for both active treatments. In all secondary parameters, non-inferiority of enflicoxib versus mavacoxib was confirmed. The dog's quality of life improved in all groups, but only enflicoxib showed superiority versus placebo. When assessing severely affected dogs only, results were similar, thus confirming the efficacy of enflicoxib in all stages of canine OA. There were no differences between groups in the frequency of adverse events, which were most frequently mild affecting the gastrointestinal tract and recovered without treatment. CONCLUSIONS: Enflicoxib is efficacious and safe for the treatment of pain and inflammation in any stage of canine osteoarthritis with a faster onset of action compared to mavacoxib.

背景：本项前瞻性、多中心、盲法、随机、非劣效性临床研究旨在确认恩氟昔布治疗犬骨关节炎相关疼痛和炎症的疗效和安全性。共 180 只犬随机分为恩氟昔布（n = 78）、马昔康（n = 80）或安慰剂（n = 22）组。犬从第 0 天到第 42 天接受兽医评估，采用临床综合评分（CSS）。疗效也由犬主人使用犬简明疼痛量表（CBPI）进行评估。主要疗效终点是从第 0 天到第 42 天的总 CSS。

结果：以曲线下面积表示的总 CSS 表明，与马昔康相比，恩氟昔布具有非劣效性，且均优于安慰剂。在研究结束时，恩氟昔布（平均 CSS 为 3.64，CSS 应答率为 74%）和马昔康（平均 CSS 为 4.49，CSS 应答率为 68%）的平均 CSS 以及 CSS 应答率均优于安慰剂（平均 CSS 为 7.15，CSS 应答率为 29%）。恩氟昔布起效更快，因为从第 7 天开始，与安慰剂相比，这两个参数均显示出优越性，而马昔康仅从第 14 天开始才有显著差异。根据犬主人的评估，接受恩氟昔布、马昔康和安慰剂治疗的犬的 CBPI 应答率分别为 90%、79%和 43%，且这两种治疗方法均优于安慰剂。在所有次要参数中，均确认了恩氟昔布与马昔康相比的非劣效性。所有组犬的生活质量均有所改善，但只有恩氟昔布与安慰剂相比具有优越性。仅评估严重受影响的犬时，结果相似，从而确认了恩氟昔布在犬骨关节炎的所有阶段的疗效。各组之间不良事件的频率无差异，这些不良事件最常发生在胃肠道，且未经治疗即可恢复。

结论：恩氟昔布治疗犬骨关节炎相关疼痛和炎症有效且安全，与马昔康相比起效更快。