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一项针对犬骨关节炎两种治疗方法的随机对照盲法临床试验。

A randomised controlled masked clinical trial of two treatments for osteoarthritis in dogs.

机构信息

Translational Research and Animal Clinical Trials (TRACTs) group, Melbourne Veterinary School, Faculty of Veterinary and Agricultural Sciences, The University of Melbourne, Melbourne, Victoria, Australia.

出版信息

Aust Vet J. 2021 Jul;99(7):267-272. doi: 10.1111/avj.13066. Epub 2021 Apr 26.

DOI:10.1111/avj.13066
PMID:33904159
Abstract

The product 4CYTE™ Canine (Interpath Pty Ltd., Ballarat, Victoria, Australia) contains four active ingredients: three marine-derived ingredients and Epiitalis®, which is extracted from the seed of the plant Biota orientalis. Carprofen is a non-steroidal anti-inflammatory drug (NSAID) licensed for the treatment of osteoarthritis in dogs and is the active ingredient in several licensed products. This study aimed to compare the efficacy of 4CYTE Canine with carprofen for the treatment of pain from osteoarthritis. The trial was a randomised, masked, parallel group trial in dogs with naturally occurring osteoarthritis. Sixty-nine dogs with body weight of between 10 and 50 kg were enrolled in the study, of which 66 (95.7%) completed the study. The 4CYTE Canine was administered at 60 mg active/kg daily and carprofen at 2-4 mg/kg daily, with a loading dose of up to 4 mg/kg on the first day. The trial duration was 28 days. The primary outcome was defined as improvement in Owner Lameness Score at Day 28 compared with Day 0. Other outcomes measured included Veterinary Lameness Scores and the Owner Mobility Scores. At Day 28, 14 of 29 (48.3%) dogs that received 4CYTE Canine and 13 of 37 (35.1%) dogs that received carprofen had improved. The 4CYTE Canine was found to be non-inferior to carprofen at Day 14 for the Owner Mobility Score and at Day 28 for all three outcomes. This response pattern suggests that improvement in response to 4CYTE Canine continued between Days 14 and 28. These results support the conclusion that 4CYTE Canine is not inferior to carprofen by end-point clinical efficacy.

摘要

4CYTE™犬用配方(Interpath Pty Ltd.,维多利亚州巴拉瑞特)包含四种活性成分:三种来自海洋的成分和 Epiitalis®,它是从植物 Biota orientalis 的种子中提取的。卡洛芬是一种非甾体抗炎药(NSAID),用于治疗犬骨关节炎,也是几种许可产品的活性成分。本研究旨在比较 4CYTE 犬用配方和卡洛芬治疗骨关节炎疼痛的疗效。该试验是一项在患有自发性骨关节炎的犬中进行的随机、盲法、平行组试验。共纳入 69 只体重在 10 至 50 公斤之间的犬,其中 66 只(95.7%)完成了研究。4CYTE 犬用配方的剂量为 60mg 活性成分/千克/天,卡洛芬的剂量为 2-4mg/千克/天,第 1 天的最大剂量可达 4mg/千克。试验持续 28 天。主要终点是与第 0 天相比,第 28 天的主人跛行评分的改善。其他测量的结果包括兽医跛行评分和主人活动能力评分。第 28 天,接受 4CYTE 犬用配方的 29 只犬中有 14 只(48.3%)和接受卡洛芬的 37 只犬中有 13 只(35.1%)得到改善。在第 14 天的主人活动能力评分和第 28 天的所有三个结果方面,4CYTE 犬用配方被发现非劣效于卡洛芬。这种反应模式表明,对 4CYTE 犬用配方的反应在第 14 天和第 28 天之间持续改善。这些结果支持 4CYTE 犬用配方在终点临床疗效上不劣于卡洛芬的结论。

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