背景：随机，失明,阳性对照,多中心,符合良好临床实践规范，进行了关键领域研究，以评估对自然感染肠道线虫的客户拥有的狗口服口服洛蒂兰纳+米尔贝霉素肟片（Credelio®Plus;ElancoAnimalHealth）的新组合的有效性和安全性。
方法：来自法国家庭的客户拥有的狗向兽医诊所展示，对匈牙利和德国进行了肠线虫筛查。最初粪便卵数呈阳性的狗，随后通过后续粪便检查得到证实，以证明存在自然发生的犬弓形虫混合或单一感染，弓形虫Leonina,在第0天,将寻常毛虫或犬囊虫纳入研究。家庭以约2:1的比例随机接受研究产品(IP;CredelioPlus片剂)或对照产品(CP;NexgardSpectra®片剂)作为治疗。在第0天以0.75-1.56mg/kg体重米尔贝霉素肟和20.0-41.5mg/kg体重lotilaner（IP）或推荐（CP）的剂量给狗一次IP（n=278）或CP（n=117）。IP和CP处理的有效性是基于处理后第8天(范围第7-10天)的几何平均粪便卵数与它们的处理前线虫粪便卵数相比的处理后减少。
结果：T.canis的几何平均值（GM）粪便卵数，CredelioPlus组的犬和T.vulpis减少≥97.2％，在afoxolaner米尔贝霉素肟组中减少≥95.3％。由于流行率低，因此没有足够的数据来计算在第0天和第8天之间，T.leonina的转基因粪便卵数减少的百分比。CredelioPlus在本领域研究中耐受性良好。在给药的355个总剂量中，IP组接受自由选择的比例为82.3%，CP组为80.8%。
结论：本研究显示有效性（降低≥97.2%），米伯霉素肟和lotilaner（CredelioPlus）的组合口服给犬T.canis自然肠道感染的狗的安全性和片剂接受度，A.犬和T.vulpis。
BACKGROUND: A randomised, blinded, positive controlled, multicentre, Good Clinical Practice-compliant, pivotal field
study was conducted to evaluate the effectiveness and safety of a new combination of lotilaner + milbemycin oxime tablets (Credelio® Plus; Elanco Animal Health) administered orally to client-owned dogs naturally infected with intestinal nematodes.
METHODS: Client-owned dogs presenting to veterinary clinics from households in France, Hungary and Germany were screened for intestinal nematodes. Dogs with an initial positive faecal egg count that was subsequently confirmed with a follow-up faecal examination to demonstrate the presence of naturally occurring mixed or mono-infections with Toxocara canis, Toxascaris leonina, Trichuris vulpis or Ancylostoma caninum were enrolled on Day 0 into the
study. Households were randomised in an approximately 2:1 ratio to receive either an investigational product (IP; Credelio Plus tablets) or control product (CP; Nexgard Spectra® tablets) as treatment. Dogs were administered the IP (n = 278) or CP (n = 117) once on Day 0 at a dose rate of 0.75-1.56 mg/kg bodyweight milbemycin oxime and 20.0-41.5 mg/kg bodyweight lotilaner (IP) or as recommended (CP). Effectiveness of the IP and CP treatments was based on the post-treatment reduction in geometric mean faecal egg counts on Day 8 (range Day 7-10) after treatment as compared to their pre-treatment nematode faecal egg counts.
RESULTS: Geometric mean (GM) faecal egg counts for T. canis, A caninum and T. vulpis were reduced by ≥ 97.2% in the Credelio Plus group and by ≥ 95.3% in the afoxolaner + milbemycin oxime group. There were insufficient data to calculate a percentage reduction in GM faecal egg counts between Day 0 and Day 8 for T. leonina due to low prevalence. Credelio Plus was well tolerated in this field
study. Of the 355 total doses administered, 82.3% were accepted free choice in the IP group compared to 80.8% in the CP group.
CONCLUSIONS: This
study demonstrated effectiveness (≥ 97.2% reduction), safety and tablet acceptance of a combination of milbemycin oxime and lotilaner (Credelio Plus) administered orally to dogs with natural intestinal infections of T. canis, A. caninum and T. vulpis.
PDF(Pubmed)