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4.7毫克醋酸去甲雄三烯醇酮植入剂作为雄性猫绝育选择的有效性和安全性:一项大规模多中心随机对照研究

Efficacy and Safety of 4.7 mg Deslorelin Acetate Implants as a Neutering Option in Male Cats: A Large-Scale Multicentre Randomised Controlled Study.

作者信息

Amaral Joana, Briantais Philippe, Fontaine Christelle, Rigaut Delphine

机构信息

Research & Development, Licensing Department, Virbac, 06515 Carros, France.

Global Marketing & Market Development Department, Virbac, 06515 Carros, France.

出版信息

Animals (Basel). 2023 Jan 22;13(3):379. doi: 10.3390/ani13030379.

Abstract

This multicenter-controlled, double-masked randomized European study was conduc-ted to confirm both the efficacy and safety of a deslorelin implant in controlling fertility and sexual behavior in a large population of tom cats over a 12-month period. Among the 225 screened individuals, a total of 205 privately owned indoor intact male cats, aged 3 months of age or older, were randomly allocated to a deslorelin implant (n = 154) or to a negative control group (n = 51). After the screening visit performed between day (D)-14 and D-7, six additional visits were sche-duled on D0, D45, D93, D186, D279 and D372. Effects on testosterone, sexual behaviors, penile spines, testicular volume and intact male cat urine odor were assessed at every visit under masked conditions as regards to the treatment group. In addition, phone calls from the investigators to the owners were scheduled on D7 and then on a monthly basis whenever no visit was scheduled. Success was defined as an individual serum testosterone concentration below or equal to 0.10 ng/mL and was 77.9% at D45, 83.1% at D93, 84.4% at D186 and D279, and 61.7% at D372 in the deslorelin group, and 3.9% at D45, 5.9% at D93, 3.9% at D186, 7.8% at D279 and 3.9% at D372 in the negative control group. Testing for superiority was made stepwise from D45 to D372 upwards; the difference in success rates was significant from D45 to D372 ( < 0.001 for each time point). The mean testosterone concentration dropped from baseline in the deslorelin group, remaining below the set threshold of 0.1 ng/mL until D372. From D7 onwards, the mean sum score for sexual behaviors (including vocalization, urine marking, aggression and intact male cat urine odor) was significantly lower at each observation time point in the deslorelin group compared to the control group, where no decrease in scores was observed. The mean percent change to baseline of the testicular volume and the percentage of cats with a decreased visibility and adult appearance of penile spines were significantly lower in the deslorelin group as soon as D45. No relevant safety concerns were reported during the course of the study. The deslorelin implant Suprelorin 4.7 mg (Virbac, Carros, France) is a safe and effective neutering option, inducing infertility over a 12-month period when administered to intact male cats aged between 3 months of age and 11 years of age. The implants also successfully reduced sexual behaviors (i.e., vocalization, urine marking, aggression), intact male cat urine odor, testicular volume and penile spine score for 1 year (372 ± 5 days).

摘要

这项多中心对照、双盲随机欧洲研究旨在确认去甲舍林植入剂在12个月期间对大量雄性家猫控制生育能力和性行为的有效性和安全性。在225只接受筛查的个体中,共有205只年龄在3个月及以上的私人饲养室内未阉割雄性家猫被随机分配到去甲舍林植入剂组(n = 154)或阴性对照组(n = 51)。在第 -14天至第 -7天进行筛查访视后,另外安排了6次访视,分别在第0天、第45天、第93天、第186天、第279天和第372天。在对治疗组进行盲法处理的情况下,每次访视时评估对睾酮、性行为、阴茎棘、睾丸体积和未阉割雄性家猫尿液气味的影响。此外,研究人员在第7天给猫主人打电话,之后在没有安排访视的情况下每月打一次电话。成功定义为个体血清睾酮浓度低于或等于0.10 ng/mL,去甲舍林组在第45天的成功率为77.9%,第93天为83.1%,第186天和第279天为84.4%,第372天为61.7%;阴性对照组在第45天的成功率为3.9%,第93天为5.9%,第186天为3.9%,第279天为7.8%,第372天为3.9%。从第45天到第372天逐步进行优效性检验;从第45天到第372天成功率的差异具有显著性(每个时间点P < 0.001)。去甲舍林组的平均睾酮浓度从基线下降,直到第372天一直保持在设定的0.1 ng/mL阈值以下。从第7天起,去甲舍林组在每个观察时间点的性行为平均总分(包括鸣叫、尿液标记、攻击行为和未阉割雄性家猫尿液气味)显著低于对照组,对照组的分数没有下降。去甲舍林组在第45天睾丸体积相对于基线的平均百分比变化以及阴茎棘可见度降低和呈现成年外观的猫的百分比就显著低于对照组。在研究过程中未报告相关安全问题。去甲舍林植入剂Suprelorin 4.7 mg(法国卡罗斯维克拜克公司)是一种安全有效的绝育选择,当给予年龄在3个月至11岁之间的未阉割雄性家猫时,可在12个月内诱导不育。植入剂还成功减少了性行为(即鸣叫、尿液标记、攻击行为)、未阉割雄性家猫尿液气味、睾丸体积和阴茎棘评分,持续1年(372 ± 5天)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e1e/9913284/5344910a0a64/animals-13-00379-g001.jpg

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