首页> 外文期刊>Journal of Veterinary Internal Medicine >Randomized placebo controlled clinical trial of an enteric coated micro‐pelleted formulation of a pancreatic enzyme supplement in dogs with exocrine pancreatic insufficiency
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Randomized placebo controlled clinical trial of an enteric coated micro‐pelleted formulation of a pancreatic enzyme supplement in dogs with exocrine pancreatic insufficiency

机译:肠外用胰腺功能不全犬肠溶微丸肠溶酶制剂的随机安慰剂对照临床试验

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Background Pancreatic enzyme supplements for the treatment of exocrine pancreatic insufficiency (EPI) in dogs can be uncoated or enteric coated. Enteric coated supplements might be advantageous. Hypothesis/Objectives Enteric coated enzyme supplements are superior to uncoated supplements in dogs with clinical EPI. Animals Eleven dogs with naturally occurring EPI that were apparently free from other diseases. Methods Randomized, blinded, controlled cross‐over clinical trial comparing a novel micro‐encapsulated enteric coated enzyme supplement to a commercially available uncoated product in dogs with clinical EPI. Search of serum canine serum trypsin‐like immunoreactivity concentration ≤?2.5 μg/L in the Gastrointestinal Laboratory database was used to identify dogs with EPI. Results There was no difference ?4.46% (95% CI: ?7.97%‐–0.96%; P =?.15) in the % acid hydrolysis fecal fat (primary outcome) between the enteric coated formulation (median: 11.8%; range 6.4%‐17.0%) and the uncoated pancreatic enzyme replacement product (median: 17.5%; range: 5.2%‐24.9%) in the 11 dogs that completed the study. Other variables did not differ between treatments. Conclusions and Clinical Importance This study, which had low statistical power, did not detect a difference between formulations.
机译:背景技术用于治疗狗的外分泌性胰腺功能不全(EPI)的胰酶补充剂可以是未包衣的或肠溶衣的。肠溶补充剂可能是有利的。假设/目标肠溶酶补充剂在具有临床EPI的犬中优于未包被的补充剂。动物十一只具有自然产生的EPI的狗,显然没有其他疾病。方法在具有临床EPI的犬中,将新型微囊肠溶酶补充剂与市售未包衣产品进行比较的随机,盲法,对照交叉临床试验。在胃肠实验室数据库中搜索血清犬类胰蛋白酶样免疫反应性浓度≤2.5μg/ L的狗,以鉴定患有EPI的狗。结果肠溶包衣制剂之间的酸水解粪便脂肪百分比(主要结局)之间没有差异约为4.44%(95%CI:7.97%-0.96%; P = 0.15)(中位数:11.8%;范围)在完成研究的11只狗中,有6.4%-17.0%)和未包被的胰酶替代产品(中位数:17.5%;范围:5.2%-24.9%)。其他变量在治疗之间没有差异。结论和临床重要性这项研究的统计功效很低,没有发现制剂之间的差异。

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