毒理性
哺乳期使用概要:泼尼松在母乳中的含量非常低。在哺乳期使用任何皮质类固醇的报告中,没有对母乳喂养婴儿产生不良影响的记录。尽管通常建议在服药后4小时内避免哺乳,但由于泼尼松在乳汁中的水平非常低,这种操作并非必要。高剂量可能会偶尔导致暂时性的乳汁供应减少。
对母乳喂养婴儿的影响:在使用泼尼松或任何其他皮质类固醇时,没有报告对婴儿产生不良影响。在一项前瞻性随访研究中,六位哺乳母亲报告服用泼尼松(剂量未指定),婴儿未出现不良反应。有多份报告显示,母亲在长期使用皮质类固醇期间哺乳,婴儿未出现不良反应:泼尼松每日10毫克(2名婴儿)和泼尼松龙每日5至7.5毫克(14名婴儿)。
一名患有克罗恩病的妇女在分娩后立即在哺乳期间按递减方案使用泼尼松60毫克/日(具体程度未说明)。她还接受了产前和产后每日4克的磺胺类药物和每8周5毫克/公斤的英夫利昔单抗治疗。婴儿在6个月大时无症状,体重正常增长。
国家移植妊娠登记处报告,截至2013年12月,124名移植妇女在哺乳期间服用了泼尼松,共哺乳了169名婴儿,最长达48个月,未发现明显的婴儿伤害。
对泌乳和母乳的影响:截至修订日期,未找到有关泼尼松对血清催乳素或哺乳母亲泌乳影响的信息。然而,有报告称,将中到大剂量的皮质类固醇注射液注入关节会导致暂时性的泌乳减少。
一项对46名在34周妊娠前分娩的妇女的研究发现,如果在分娩前3至9天内给予另一种皮质类固醇(倍他米松,两次肌肉注射,每次11.4毫克,间隔24小时),会导致第二阶段泌乳延迟,并且在分娩后10天内的平均乳汁量减少。如果婴儿在母亲接受皮质类固醇后不到3天或多于10天分娩,乳汁量不会受到影响。等效剂量的泼尼松可能产生相同的效果。
一项对87名孕妇的研究发现,在孕期给予上述剂量的倍他米松会导致孕期乳糖分泌的过早刺激。尽管增加在统计学上显著,但临床意义似乎很小。等效剂量的泼尼松可能产生相同的效果。
◉ Summary of Use during Lactation:Amounts of prednisone in breastmilk are very low. No adverse effect have been reported in breastfed infants with maternal use of any corticosteroid during breastfeeding. Although it is often recommended to avoid breastfeeding for 4 hours after a dose this maneuver is not necessary because prednisone milk levels are very low. High doses might occasionally cause temporary loss of milk supply.
◉ Effects in Breastfed Infants:None reported with prednisone or any other corticosteroid. In a prospective follow-up study, six nursing mothers reported taking prednisone (dosage unspecified) with no adverse infant effects. There are several reports of mothers breastfeeding during long-term use of corticosteroids with no adverse infant effects: prednisone 10 mg daily (2 infants) and prednisolone 5 to 7.5 mg daily (14 infants).
A woman with Crohn's disease used prednisone 60 mg daily in a tapering schedule immediately postpartum during breastfeeding (extent not stated). She also received sulfasalazine 4 grams daily and infliximab 5 mg/kg every 8 weeks during pregnancy and postpartum. At 6 months of age, the infant was asymptomatic with regular weight gain.
The National Transplantation Pregnancy Registry reports that as of December 2013, 124 women with transplants have taken prednisone while breastfeeding 169 infants for periods as long as 48 months, with no apparent infant harm.
◉ Effects on Lactation and Breastmilk:Published information on the effects of prednisone on serum prolactin or on lactation in nursing mothers was not found as of the revision date. However, medium to large doses of depot corticosteroids injected into joints have been reported to cause temporary reduction of lactation.
A study of 46 women who delivered an infant before 34 weeks of gestation found that a course of another corticosteroid (betamethasone, 2 intramuscular injections of 11.4 mg of betamethasone 24 hours apart) given between 3 and 9 days before delivery resulted in delayed lactogenesis II and lower average milk volumes during the 10 days after delivery. Milk volume was not affected if the infant was delivered less than 3 days or more than 10 days after the mother received the corticosteroid. An equivalent dosage regimen of prednisone might have the same effect.
A study of 87 pregnant women found that betamethasone given as above during pregnancy caused a premature stimulation of lactose secretion during pregnancy. Although the increase was statistically significant, the clinical importance appears to be minimal. An equivalent dosage regimen of prednisone might have the same effect.
来源:Drugs and Lactation Database (LactMed)