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一项非劣效性研究评估了一种新的替米考星皮下注射长效制剂与头孢噻呋乳房内注射相比,作为荷斯坦弗里生奶牛干奶期治疗的效果。

A non-inferiority study evaluating a new extended-release preparation of tilmicosin injected subcutaneously vs. ceftiofur administered intramammary, as dry-cow therapy in Holstein Friesian cows.

机构信息

Department of Animal Production-Ruminants, School of Veterinary Medicine, National Autonomous University of Mexico, Mexico City 04510, Mexico.

Department of Microbiology and Immunology, School of Veterinary Medicine, National Autonomous University of Mexico, Mexico City 04510, Mexico.

出版信息

J Vet Sci. 2020 Nov;21(6):e87. doi: 10.4142/jvs.2020.21.e87.

DOI:10.4142/jvs.2020.21.e87
PMID:33263234
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7710465/
Abstract

BACKGROUND

A new, extended long-acting tilmicosin (TLAe) preparation was tested against intramammary ceftiofur (CEF) using a non-inferiority trial model during dry-cow therapy (DCT) in a farm with high bovine population density and deficient hygiene application.

OBJECTIVES

To evaluate the possibility that TLAe administered parenterally can achieve non-inferiority status compared to CEF administered intramammary for DCT.

METHODS

Cows were randomly assigned to TLAe (20 mg/kg subcutaneous; n = 53) or CEF (CEF-HCl, 125 mg/quarter; n = 38 cows) treatment groups. California mastitis testing, colony-forming unit assessment (CFU/mL), and number of cases positive for were quantified before DCT and 7 d after calving. A complete cure was defined as no bacteria isolated; partial cure when CFU/mL ranged from 150 to 700, and cure-failure when CFU/mL was above 700.

RESULTS

TLAe and CEF had overall cure rates of 57% and 53% ( > 0.05) and cure rates of 77.7% and 25%, respectively ( < 0.05). The pathogens detected at DCT and 7 days after calving were (62.71% and 35.55%), spp. (22.03% and 35.55%), (10.16% and 13.33%), and (5.08% and 15.55%). Non-inferiority and binary logistic regression analyses revealed a lack of difference in overall efficacies of TLAe and CEF. Apart from , was the predominant pathogen found in both groups.

CONCLUSIONS

This study is the first successful report of parenteral DCT showing comparable efficacy as CEF, the gold-standard. The extended long-term pharmacokinetic activity of TLAe explains these results.

摘要

背景

在一个奶牛密度高且卫生应用不足的农场,使用非劣效性试验模型,对干奶期治疗(DCT)中新型长效替米考星(TLAe)制剂与乳房内头孢噻呋(CEF)进行了比较。

目的

评估 TLAe 经皮给药相对于乳房内 CEF 给药用于 DCT 是否具有非劣效性。

方法

将奶牛随机分配到 TLAe(20mg/kg 皮下;n=53)或 CEF(CEF-HCl,125mg/乳房;n=38 头奶牛)治疗组。在 DCT 前和产后 7d 时,对加利福尼亚乳房炎检测、集落形成单位评估(CFU/mL)和 阳性病例数进行量化。完全治愈定义为未分离出细菌;部分治愈时 CFU/mL 范围为 150 至 700,治愈失败时 CFU/mL 高于 700。

结果

TLAe 和 CEF 的总体治愈率分别为 57%和 53%(>0.05)和 77.7%和 25%(<0.05)。在 DCT 和产后 7d 时检测到的病原体分别为 (62.71%和 35.55%)、 spp.(22.03%和 35.55%)、 (10.16%和 13.33%)和 (5.08%和 15.55%)。非劣效性和二项逻辑回归分析表明,TLAe 和 CEF 的总体疗效无差异。除 外, 是两组中主要的病原体。

结论

本研究首次成功报告了与金标准 CEF 相比,经皮 DCT 具有相似的疗效。TLAe 的延长长效药代动力学活性解释了这些结果。

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本文引用的文献

1
Impact of intramammary tilmicosin infusion as a dry cow therapy.乳房内注入替米考星作为干奶牛疗法的效果
J Vet Pharmacol Ther. 2018 Feb;41(1):22-27. doi: 10.1111/jvp.12427. Epub 2017 Jun 10.
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Concentrations of tilmicosin in mammary gland secretions of dairy cows following subcutaneous administration of one or two doses of an experimental preparation of tilmicosin and its efficacy against intramammary infections caused by Staphylococcus aureus.皮下注射一剂或两剂替米考星实验制剂后,奶牛乳腺分泌物中替米考星的浓度及其对金黄色葡萄球菌引起的乳房内感染的疗效。
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Interpretation of California mastitis test scores using Staphylococcus aureus culture results for screening of subclinical mastitis in low yielding smallholder dairy cows in the Dar es Salaam region of Tanzania.利用金黄色葡萄球菌培养结果解读加利福尼亚乳房炎检测分数,以筛查坦桑尼亚达累斯萨拉姆地区低产小农户奶牛的亚临床乳房炎
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