| 烯丙孕素内服溶液的临床药效和靶动物安全性研究 |
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| 引用本文： | 杨海峰,§,李艳艳,§,陈晓兰,姚诗贇,黄亚奇,夏良友,李宇琛,卜仕金.烯丙孕素内服溶液的临床药效和靶动物安全性研究[J].中国农业科技导报,2020,22(1):78-86. |
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| 作者姓名： | 杨海峰 § 李艳艳 § 陈晓兰 姚诗贇 黄亚奇 夏良友 李宇琛 卜仕金 |
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| 作者单位： | 1.江苏农牧科技职业学院, 江苏 泰州 225300; 2.扬州大学兽医学院, 江苏 扬州 225009 |
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| 基金项目： | 江苏高校“青蓝工程”资助项目（苏教师\[2018\]12号）；江苏省大学生创新训练计划项目（201812806016Y）；江苏农牧科技职业学院科研项目（NSFPT201722）；江苏农牧科技职业学院大学生创新项目（201912806082Y）。 |
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| 摘 要： | 研究国产烯丙孕素内服溶液的临床药效和靶动物安全性，为其新兽药注册和临床合理应用提供依据。通过发情间隔、发情率、发情集中度、妊娠率等指标评价烯丙孕素内服溶液调控母猪同期发情的临床效果；通过比较给药前后的临床体征、血常规指标、血清生化指标及组织病理学变化，评价烯丙孕素内服溶液对靶动物母猪的安全性。实验性临床试验中，国产烯丙孕素内服溶液高（25 mg·d-1）、中（20 mg·d-1）、低（10 mg·d-1）剂量组以及空白对照组的母猪从停药到出现发情反应的间隔时间分别为（3.45±0.81）（3.35±0.66）（5.21±2.65）和（11.71±5.39）d，发情率分别为100%（20/20）、100%（20/20）、95%（19/20）、70%（7/10）。扩大临床试验中，国产烯丙孕素内服溶液组和进口药物对照组的母猪在药物调控下均表现出良好的同期发情效果，发情间隔分别为（3.59±1.07）d和（3.75±1.22）d，发情率分别为96.72%（59/61）和98.33%（59/60）。靶动物安全性试验中，国产烯丙孕素内服溶液在5倍推荐剂量（100 mg·d-1）范围内对母猪的血液生理生化功能和主要脏器未造成明显的不良影响。结果表明，国产烯丙孕素内服溶液调控母猪同期发情，一次量20 mg，连续给药18 d，临床应用安全、有效。
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| 关 键 词： | 烯丙孕素内服溶液 临床药效 靶动物安全性 同期发情 母猪 |
| 收稿时间： | 2018-10-17 |
Clinical Effect and Target Animal Safety of Altrenogest Oral Solution |
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| YANG Haifeng,§,LI Yanyan,§,CHEN Xiaolan,YAO Shiyun,HUANG Yaqi,XIA Liangyou,LI Yuchen,BU Shijin.Clinical Effect and Target Animal Safety of Altrenogest Oral Solution[J].Journal of Agricultural Science and Technology,2020,22(1):78-86. |
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| Authors: | YANG Haifeng § LI Yanyan § CHEN Xiaolan YAO Shiyun HUANG Yaqi XIA Liangyou LI Yuchen BU Shijin |
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| Institution: | 1.Jiangsu Agri-animal Husbandry Vocational College, Jiangsu Taizhou 225300, China; 2.College of Veterinary Medicine, Yangzhou University, Jiangsu Yangzhou 225009, China |
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| Abstract: | In order to provide basis for new veterinary drug registration and clinical rational application, the clinical effect and target animal safety of domestic altrenogest oral solution were investigated. The clinical effect of altrenogest oral solution in regulation of synchronous estrus in mature sows was evaluated by estrus interval, estrus rate, concentration ratio of estrus, pregnancy rate and etc. The target animal safety of altrenogest oral solution in mature sows was evaluated by comparison of clinical signs, blood routine and serum biochemical indexes and histopathology before and after administration. In experimental clinical trials, mature sows were divided into domestic altrenogest oral solution groups with the high (25 mg·d-1), middle (20 mg·d-1) and low (5 mg·d-1) dose and blank control group, estrus interval of above four groups were (3.45±0.81)(3.35±0.66)(5.21±2.65) and (11.71±5.39) d, and estrus rate were 100% (20/20), 100% (20/20), 95% (19/20) and 70% (7/10), respectively. In expanded clinical trials, domestic altrenogest oral solution group and imported drug control group both showed good clinical effect of synchronous estrus in mature sows, estrus interval were (3.45±0.81) and (3.35±0.66) d, oestrus rate were 96.72% (59/61) and 98.33% (59/60), respectively. In target ainimal safety test, within the oral administration at 5-fold recommended dose of 100 mg·d-1, domestic altrenogest oral solution was safe and had no adverse reactions to blood physiological and biochemical functions and main organs of mature sows. In conclusion，the results indicated that domestic altrenogest oral solution was safe and effective in regulation of synchronous estrus in mature sows at the recommended dose of 20 mg·d-1 for successive 18 d. |
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| Keywords: | altrenogest oral solution clinical effect target animal safety synchronous estrus mature sows |
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