Gruet Philippe, Seewald Wolfgang, King Jonathan N
BMC Vet Res. 2013 May 2;9:92. doi: 10.1186/1746-6148-9-92.
Non-steroidal anti-inflammatory drugs (NSAIDs) are used routinely to control pain and inflammation after surgery in dogs. Robenacoxib is a new NSAID with high selectivity for the cyclo-oxygenase (COX)-2 isoform of COX. The objective of this study was to evaluate the efficacy and tolerability of robenacoxib for the management of peri-operative pain and inflammation associated with soft tissue surgery in dogs. The study was a prospective, randomized, blinded, positive-controlled, non-inferiority, multi-center clinical trial. A total of 174 dogs undergoing major soft tissue surgery were included and randomly allocated in a 2:1 ratio to receive either robenacoxib (n = 118) or the positive control, meloxicam (n = 56). Each dog received an initial dose subcutaneously prior to surgery (robenacoxib 2 mg/kg, meloxicam 0.2 mg/kg), followed by daily oral doses (robenacoxib 1-2 mg/kg, meloxicam 0.1 mg/kg) for 12 days (range 10-14) after surgery. Pain and inflammation were assessed subjectively using the Glasgow Composite Pain Scale (GCPS) by clinicians as the primary end point and additional evaluations by the clinicians and animal owners as secondary endpoints.
Both treatments provided similar pain control, with no significant differences between groups for any efficacy variable using non-parametric analyses (Mann-Whitney U test). In no dog was analgesic rescue therapy administered. Non-inferior efficacy of robenacoxib compared to meloxicam was demonstrated statistically for the primary and all secondary endpoints using parametric analysis of variance, although the data were not normally distributed even after log transformation. For the primary endpoint (reciprocal of the modified GCPS score), the relative efficacy of robenacoxib/meloxicam was 1.12 with a 95% confidence interval of 0.97-1.29.
A treatment regimen of robenacoxib by subcutaneous injection followed by oral tablets had good tolerability and non-inferior efficacy compared to meloxicam for the management of peri-operative pain and inflammation associated with soft tissue surgery in dogs.
非甾体抗炎药(NSAIDs)常用于控制犬类手术后的疼痛和炎症。罗贝考昔是一种对环氧化酶(COX)-2亚型具有高选择性的新型NSAID。本研究的目的是评估罗贝考昔对犬软组织手术围手术期疼痛和炎症的管理效果及耐受性。该研究是一项前瞻性、随机、双盲、阳性对照、非劣效性、多中心临床试验。共有174只接受大型软组织手术的犬被纳入,并以2:1的比例随机分配,分别接受罗贝考昔(n = 118)或阳性对照药美洛昔康(n = 56)。每只犬在手术前皮下注射初始剂量(罗贝考昔2 mg/kg,美洛昔康0.2 mg/kg),随后在手术后每天口服给药(罗贝考昔1 - 2 mg/kg,美洛昔康0.1 mg/kg),持续12天(范围10 - 14天)。临床医生使用格拉斯哥综合疼痛量表(GCPS)主观评估疼痛和炎症作为主要终点,临床医生和动物主人的额外评估作为次要终点。
两种治疗方法提供了相似的疼痛控制效果,使用非参数分析(曼-惠特尼U检验)时,各疗效变量在组间无显著差异。没有一只犬接受镇痛解救治疗。尽管数据即使经过对数转换后也不呈正态分布,但使用方差参数分析时,罗贝考昔相对于美洛昔康在主要和所有次要终点上的非劣效性疗效在统计学上得到了证实。对于主要终点(改良GCPS评分的倒数),罗贝考昔/美洛昔康的相对疗效为1.12,95%置信区间为0.97 - 1.29。
与美洛昔康相比,罗贝考昔皮下注射后口服片剂的治疗方案在管理犬软组织手术围手术期疼痛和炎症方面具有良好的耐受性和非劣效性疗效。