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在一项针对疑似急性起病胰腺炎犬的随机对照多中心盲法研究中应用福扎匹坦。

Fuzapladib in a randomized controlled multicenter masked study in dogs with presumptive acute onset pancreatitis.

机构信息

Gastrointestinal Laboratory, Department of Small Animal Clinical Sciences, School of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, Texas, USA.

IntegRxal Consulting Strategies, Inc., Saskatoon, Saskatchewan, Canada.

出版信息

J Vet Intern Med. 2023 Nov-Dec;37(6):2084-2092. doi: 10.1111/jvim.16897. Epub 2023 Oct 9.

DOI:10.1111/jvim.16897
PMID:37811705
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10658511/
Abstract

BACKGROUND

Currently, no specific treatment is available for acute onset pancreatitis (AP), and management relies on symptomatic and supportive standard of care (SOC). Fuzapladib is a novel leukocyte function-associated antigen type-1 (LFA-1) activation inhibitor, blocking activation and subsequent adhesion and migration of neutrophils, potentially decreasing the risk of pancreatitis progression and systemic inflammation.

OBJECTIVE

Evaluate the safety and clinical response of dogs with AP after 3 days of administration of fuzapladib.

ANIMALS

Sixty-one client-owned dogs with presumptive AP.

METHODS

Randomized, masked, and placebo controlled multicenter study. Sixty-one dogs with AP were included for safety assessment, whereas 35 evaluable cases (fuzapladib, n = 16; placebo, n = 19) were included for clinical evaluation. Clinical improvement was assessed based on the change in the modified clinical activity index (MCAI) score on Day 3 compared to Day 0. Secondary variables included canine acute pancreatitis clinical severity index (CAPCSI) scores and serum concentrations of canine pancreatic lipase immunoreactivity, cytokines, and C-reactive protein.

RESULTS

Fuzapladib was well tolerated by all treated dogs. Mean change in MCAI scores was significantly higher in the fuzapladib-treated (-7.75) than the placebo group (-5.68; P = .02, 95% confidence interval [CI] for the difference, -4.33, -0.35), suggesting clinical improvement in fuzapladib-treated dogs. No significant difference was found in any of the secondary variables between groups.

CONCLUSIONS AND CLINICAL RELEVANCE

Administration of fuzapladib to dogs was safe, and a favorable response was detected in 2 clinical activity scores. Effects of fuzapladib on survival and duration of hospitalization were not studied.

摘要

背景

目前,尚无针对急性胰腺炎(AP)的特定治疗方法,治疗主要依赖于对症和支持性的标准治疗(SOC)。富马酸氟普拉辛是一种新型白细胞功能相关抗原 1(LFA-1)激活抑制剂,可阻断中性粒细胞的激活及其随后的黏附和迁移,从而降低胰腺炎进展和全身炎症的风险。

目的

评估富马酸氟普拉辛给药 3 天后患有 AP 的犬的安全性和临床反应。

动物

61 只疑似 AP 的患犬。

方法

随机、双盲、安慰剂对照的多中心研究。纳入 61 只患有 AP 的犬进行安全性评估,而 35 例可评估病例(富马酸氟普拉辛组,n = 16;安慰剂组,n = 19)进行临床评估。根据第 3 天与第 0 天相比改良临床活动指数(MCAI)评分的变化评估临床改善。次要变量包括犬急性胰腺炎临床严重程度指数(CAPCSI)评分和犬胰脂肪酶免疫反应性、细胞因子和 C 反应蛋白的血清浓度。

结果

所有接受治疗的犬均耐受良好。富马酸氟普拉辛治疗组(-7.75)的 MCAI 评分变化均值明显高于安慰剂组(-5.68;P =.02,95%置信区间[CI]差值为-4.33,-0.35),提示富马酸氟普拉辛治疗组的临床改善。两组间的任何次要变量均无显著差异。

结论和临床相关性

富马酸氟普拉辛在犬中使用是安全的,两种临床活动评分均显示出良好的反应。未研究富马酸氟普拉辛对生存率和住院时间的影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e83a/10658511/40cac84e231a/JVIM-37-2084-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e83a/10658511/6f2115de3c76/JVIM-37-2084-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e83a/10658511/703cacc20097/JVIM-37-2084-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e83a/10658511/40cac84e231a/JVIM-37-2084-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e83a/10658511/6f2115de3c76/JVIM-37-2084-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e83a/10658511/703cacc20097/JVIM-37-2084-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e83a/10658511/40cac84e231a/JVIM-37-2084-g003.jpg

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