Rasmussen Allan D, Nelson Joyce K, Chellman Gary J, Golub Mari, McAnulty Peter A
Ferring Pharmaceuticals A/S, International PharmaScience Center, Kay Fiskers Plads 11, DK-2300 Copenhagen S, Denmark.
Reprod Toxicol. 2007 Jun;23(4):471-9. doi: 10.1016/j.reprotox.2006.12.007. Epub 2007 Jan 14.
The oxytocin receptor antagonist barusiban, currently being developed for treatment of preterm labour, was investigated in pregnant cynomolgus monkeys with a 9-month postnatal follow-up of their offspring. The nature of barusiban, its indication, and the potential exposure of pre- and postnatal infants entailed the design of a unique protocol to investigate all aspects of maternal and offspring well-being. Barusiban was administered to the mothers from gestation day 85 until delivery with daily subcutaneous dosages up to 2.5mg/kg body weight/day. There were no test article-related effects seen in the mothers at any time during the study. The postnatal examination of offspring included routine toxicological parameters, as well as specialised investigation of the immune, cardiovascular, renal and central nervous systems, including a full behavioural assessment. A full pathology examination of offspring was performed at the end of the 9-month postnatal period. No adverse infant findings occurred.
目前正在研发用于治疗早产的催产素受体拮抗剂巴芦米布，在怀孕的食蟹猴身上进行了研究，并对其后代进行了为期9个月的产后随访。巴芦米布的性质、适应症以及产前和产后婴儿的潜在暴露情况，需要设计一个独特的方案来研究母体和后代健康的各个方面。从妊娠第85天至分娩，每天以高达2.5mg/kg体重/天的皮下剂量给母亲施用巴芦米布。在研究期间的任何时候，母亲身上均未观察到与试验品相关的影响。对后代的产后检查包括常规毒理学参数，以及对免疫、心血管、肾脏和中枢神经系统的专门研究，包括全面的行为评估。在产后9个月结束时对后代进行了全面的病理学检查。未发现婴儿有不良情况。
