Hayes Brad, Schnitzler Beate, Wiseman Scott, Snyder Daniel E
Elanco Animal Health, Eli Lilly and Company Limited, Basingstoke, Hampshire, United Kingdom.
Elanco Animal Health Research and Development, a Division of Eli Lilly and Company, 2500 Innovation Way, Greenfield, IN, USA.
Vet Parasitol. 2015 Jan 15;207(1-2):99-106. doi: 10.1016/j.vetpar.2014.11.011. Epub 2014 Nov 18.
Two separate randomised, blinded, multicentre field trials were conducted to evaluate the efficacy and safety of a combination of spinosad and milbemycin oxime (MO) (Trifexis(®), Elanco Animal Health) in the treatment and prevention of naturally acquired flea infestations and intestinal nematode infections in European dogs. Treatments using Trifexis(®) and each control veterinary product (CVP) were administered once on Day 0 in both field studies. In the flea field trial, 11 veterinary clinics in France participated in the study. On Day 0, whole body flea comb counts were conducted on all dogs being evaluated for enrolment. Dogs with ≥7 fleas on Day 0 were enrolled, treated once on Day 0 with spinosad/MO or the CVP (Stronghold(®); selamectin) and then underwent post-treatment flea counts on Days 14 and 30. There were 150 spinosad/MO treated dogs and 71 CVP treated dogs included in the flea effectiveness population. Effectiveness against fleas (% reduction in geometric means; GM) was 98.97% and 97.37% for the spinosad/MO treated dogs, and 97.43% and 93.96% for the CVP dogs on Days 14 and 30, respectively, compared to the pre-treatment baseline flea counts. Of the spinosad/MO dogs, 89.3% and 80.0% had no live fleas on Days 14 and 30, compared to 77.5% and 70.4% of the CVP dogs, respectively. In the nematode field trial, data from 10 veterinary clinics in France and 19 in Ireland were pooled. Faecal samples from dogs at each clinic were analysed. A positive result at screening (parasite eggs from Toxocara canis, Toxascaris leonina, Trichuris vulpis or Ancylostoma caninum) allowed for enrolment. Dogs were randomised to spinosad/MO or the CVP (Milbemax(®); MO/praziquantel). On Day 8, a post-treatment faecal sample was taken and analysed. Of 2333 dogs screened for nematode eggs, 238 dogs were positive with one or more of these nematodes, and 229 were enrolled in the study. Of the 229 dogs, 151 were treated with a single dose of spinosad/MO, and 77 were treated with a single dose of CVP. Post-treatment effectiveness against all nematodes (% reduction GM) was achieved with reductions of 98.57% and 97.57% for the spinosad/MO treated dogs and CVP dogs, respectively, as compared to the pre-treatment baseline faecal egg counts. Trifexis(®) was shown to be safe and effective against natural infestations of fleas as well as mixed and single intestinal nematode infections in client owned dogs in Europe when administered as a single oral administration at the recommended dose.
进行了两项独立的随机、双盲、多中心现场试验，以评估多杀霉素和米尔贝肟（MO）（Trifexis®，美国礼蓝动物保健公司）联合用药在治疗和预防欧洲犬自然感染跳蚤及肠道线虫方面的疗效和安全性。在两项现场试验中，于第0天对Trifexis®和每种对照兽用产品（CVP）进行一次给药。在跳蚤现场试验中，法国的11家兽医诊所参与了研究。在第0天，对所有接受评估以确定是否符合入组条件的犬进行全身跳蚤梳检计数。第0天有≥7只跳蚤的犬被纳入研究，于第0天用多杀霉素/MO或CVP（Stronghold®；塞拉菌素）进行一次治疗，然后在第14天和第30天进行治疗后跳蚤计数。在跳蚤疗效评估群体中，有150只接受多杀霉素/MO治疗的犬和71只接受CVP治疗的犬。与治疗前基线跳蚤计数相比，在第14天和第30天，接受多杀霉素/MO治疗的犬对跳蚤的疗效（几何平均数降低百分比；GM）分别为98.97%和97.37%，接受CVP治疗的犬分别为97.43%和93.96%。在接受多杀霉素/MO治疗的犬中，第14天和第30天分别有89.3%和80.0%没有活跳蚤，而接受CVP治疗的犬分别为77.5%和70.4%。在肠道线虫现场试验中，汇总了来自法国10家兽医诊所和爱尔兰19家兽医诊所的数据。对每个诊所的犬粪便样本进行分析。筛查呈阳性结果（犬弓首蛔虫、狮弓蛔虫、狐毛首线虫或犬钩口线虫的寄生虫卵）的犬被纳入研究。犬被随机分为接受多杀霉素/MO或CVP（Milbemax®；MO/吡喹酮）治疗。在第8天，采集并分析治疗后的粪便样本。在2333只接受线虫卵筛查的犬中，238只对这些线虫中的一种或多种呈阳性，229只被纳入研究。在这229只犬中，151只用单剂量多杀霉素/MO治疗，77只用单剂量CVP治疗。与治疗前基线粪便虫卵计数相比，接受多杀霉素/MO治疗的犬和接受CVP治疗的犬对所有线虫的治疗后疗效（GM降低百分比）分别为98.57%和97.57%。在欧洲，当按照推荐剂量单次口服给药时，Trifexis®被证明对宠物犬自然感染的跳蚤以及混合和单一肠道线虫感染安全有效。
