Osumi Takafumi, Shimada Takashi, Sakaguchi Masahiro, Tsujimoto Hajime
Laboratory of Veterinary Internal Medicine, Division of Animal Life Science, Graduate School, Tokyo University of Agriculture and Technology, 3-5-8 Saiwai-cho, Fuchu, Tokyo, 183-8509, Japan.
NichiNichi Pharmaceutical Co., Ltd., 239-1 Tominaga, Iga, Mie, 518-1417, Japan.
Vet Dermatol. 2019 Apr;30(2):127-e36. doi: 10.1111/vde.12725. Epub 2019 Jan 20.
Gastrointestinal microbiome modulation is reported to be an effective therapy to reduce the clinical signs of canine atopic dermatitis (cAD). The killed strain of Enterococcus faecalis FK-23 has been shown to reduce allergic responses in mice and people.
HYPOTHESIS/OBJECTIVE: The aim of this multicentre, double-blinded, placebo-controlled study was to evaluate the safety and efficacy of an orally administered heat-killed E. faecalis FK-23 preparation (FK-23p) for the control of cAD.
Thirty-nine client-owned dogs with clinical signs of nonseasonal cAD were enrolled by 10 veterinarians at 15 hospitals.
Dogs were randomized to either FK-23p at a dose of ≥100 mg/kg/day or placebo. Owner-assessed pruritus Visual Analog Scale (pVAS), clinician-assessed Canine Atopic Dermatitis Extent and Severity Index, 4 iteration (CADESI-4) and daily medication scoring (DMS) were evaluated on days 0, 28, 56 and 84. Owners and clinicians were interviewed about the overall response to treatment (RTT), after the study.
The CADESI-4 significantly decreased in the FK-23p group compared to the placebo group, by Day 84 (P = 0.035; Wilcoxon-Mann-Whitney U-test). There was no significant difference in pVAS and DMS between the groups. Owners and clinicians reported significantly better RTT in the FK-23p group than the placebo group (P = 0.043 and 0.002, respectively; Wilcoxon-Mann-Whitney U-test). There were no adverse events associated with FK-23p.
Oral administration of FK-23p provided a small, but measurable benefit when used as an adjunct treatment, in reducing clinical signs of atopic dogs.
据报道，调节胃肠道微生物群是减轻犬特应性皮炎（cAD）临床症状的有效疗法。粪肠球菌FK - 23的灭活菌株已被证明可减轻小鼠和人类的过敏反应。
假设/目的：这项多中心、双盲、安慰剂对照研究的目的是评估口服热灭活粪肠球菌FK - 23制剂（FK - 23p）控制cAD的安全性和有效性。
15家医院的10名兽医招募了39只出现非季节性cAD临床症状的客户拥有的犬。
将犬随机分为接受剂量≥100 mg/kg/天的FK - 23p组或安慰剂组。在第0、28、56和84天评估主人评估的瘙痒视觉模拟量表（pVAS）、临床医生评估的犬特应性皮炎范围和严重程度指数第4版（CADESI - 4）以及每日用药评分（DMS）。研究结束后，就治疗总体反应（RTT）对主人和临床医生进行访谈。
到第84天，FK - 23p组的CADESI - 4与安慰剂组相比显著降低（P = 0.035；Wilcoxon - Mann - Whitney U检验）。两组之间的pVAS和DMS无显著差异。主人和临床医生报告FK - 23p组的RTT明显优于安慰剂组（分别为P = 0.043和0.002；Wilcoxon - Mann - Whitney U检验）。没有与FK - 23p相关的不良事件。
口服FK - 23p作为辅助治疗使用时，在减轻特应性犬的临床症状方面提供了微小但可测量的益处。
