BACKGROUND One randomized, controlled clinical field study was conducted in 18 general veterinary practices throughout the USA to evaluate the safety and efficacy of a novel oral chewable combination tablet, Simparica Trio™, containing sarolaner, moxidectin and pyrantel for the treatment and prevention of fleas on dogs. METHODS Client-owned dogs, from households of three or fewer dogs were eligible for enrollment. Four hundred and twenty-two dogs from 251 households were enrolled. Households were randomly assigned in a 2:1 ratio to treatment with either Simparica Trio™ at the minimum label dose of 1.2 mg/kg sarolaner, 24 µg/kg moxidectin and 5 mg/kg pyrantel (as pamoate salt) or afoxolaner (NexGard®, Boehringer-Ingelheim) at the label dose. One dog per household was selected as the primary dog for efficacy evaluations. Treatments were dispensed and dogs were dosed in their home environment on Day 0 and on approximately Day 30. Flea counts and examination for clinical signs of flea allergy dermatitis (FAD) were performed at the initial visit the day before or on Day 0 prior to treatment and on Days 30 and 60. Additionally, all dogs were examined for general health at each visit and blood and urine were collected for clinical pathology at screening and Day 60. RESULTS Simparica Trio™ reduced geometric mean live flea counts by 99.0% by Day 30 and by 99.7% by Day 60. As a result of the rapid reduction in flea infestations, clinical signs associated with FAD substantially improved following treatment. Simparica Trio™ was well-tolerated and a diverse range of concomitant medications were administered to dogs during the course of the study. Simparica Trio™ chewable tablets were well-accepted by dogs, with the majority of flavored chewable tablets (91.9%) voluntarily consumed by free choice without, or when offered in food. CONCLUSIONS Simparica Trio™ administered orally once monthly for two consecutive treatments was safe and effective against natural flea infestations and substantially improved clinical signs associated with FAD in client-owned dogs in a field study conducted in the USA.

中文翻译：

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含有沙罗那、莫昔克丁和噻嘧啶 (Simparica Trio™) 的新型口服咀嚼组合片剂 (Simparica Trio™) 对美国客户养的狗的自然跳蚤侵扰的安全性和有效性。


背景 一项随机、对照临床现场研究在美国 18 个普通兽医诊所进行，旨在评估一种新型口服咀嚼组合片 Simparica Trio™（含有 sarolaner、莫昔克丁和噻嘧啶）用于治疗和预防跳蚤的安全性和有效性。狗。方法 来自三只或更少狗的家庭的客户拥有的狗有资格参加。 251户422只狗被招募。家庭按 2:1 的比例随机分配接受 Simparica Trio™ 治疗，最低标签剂量为 1.2 mg/kg sarolaner、24 µg/kg 莫昔克丁和 5 mg/kg 噻嘧啶（双羟萘酸盐）或 afoxolaner (NexGard® ，勃林格殷格翰）在标签剂量。每户选择一只狗作为主要狗进行功效评估。第 0 天和大约第 30 天在家庭环境中对狗进行治疗和给药。在治疗前一天或治疗前第 0 天首次访视时进行跳蚤计数和跳蚤过敏性皮炎 (FAD) 临床症状检查以及第 30 天和第 60 天。此外，每次就诊时均检查所有狗的一般健康状况，并在筛查和第 60 天收集血液和尿液用于临床病理学。结果 Simparica Trio™ 在第 30 天将几何平均活跳蚤数量减少了 99.0%到第 60 天，减少了 99.7%。由于跳蚤感染迅速减少，与 FAD 相关的临床症状在治疗后显着改善。 Simparica Trio™ 具有良好的耐受性，并且在研究过程中给狗施用了多种伴随药物。 Simparica Trio™咀嚼片深受狗的欢迎，大多数调味咀嚼片（91.9%）通过自由选择自愿食用，不添加或在食物中提供。结论 在美国进行的一项实地研究中，每月一次口服 Simparica Trio™，连续两次治疗对自然跳蚤侵扰是安全有效的，并且显着改善了客户自养狗与 FAD 相关的临床症状。