毒理性
哺乳期使用概述：有限的信息表明青霉胺在母乳中不可检测，且在接受青霉胺治疗的哺乳期妇女中，未见对哺乳儿有不良影响的报告。一些接受青霉胺治疗的母亲乳汁中的铜和锌含量有所降低。在几个婴儿的哺乳期间使用青霉胺似乎安全。根据现有数据，青霉胺在哺乳期间使用似乎是可接受的。
对哺乳儿的影响：一位因胱氨酸尿症每天服用1500毫克青霉胺的妇女哺乳了3个月，她的婴儿未出现明显的不良反应。
一位因威尔逊病服用青霉胺（剂量未指明）的妇女哺乳了她的婴儿。婴儿的血清铜和锌水平正常，婴儿喂养良好，发育正常。
另一位妇女在两次怀孕后，因威尔逊病每天服用750毫克青霉胺治疗期间哺乳了2个婴儿。其中一个婴儿出现了持续性黄疸，但不太可能与青霉胺有关。
土耳其的一个中心报告，在20年期间，有23名婴儿出生给患有威尔逊病的母亲。其中21人接受了每天600毫克青霉胺和100毫克锌的治疗。所有婴儿都接受了哺乳（程度和持续时间未指明）。一名早产儿在3周龄时死亡（母亲的药物未指明），但其他婴儿在平均51个月（范围13至105个月）的随访期间未出现明显并发症。
德国的一个中心报告，32名威尔逊病患者怀孕。其中13名患者每天服用600至1200毫克青霉胺。在分娩活婴的31名妇女中，有27人哺乳了她们的婴儿（程度未陈述）。其中4名婴儿出现了新生儿黄疸，但其与青霉胺的关系无法确定。报告中不清楚具体有多少名妇女在服用青霉胺期间哺乳。
7名威尔逊病患者每天服用300至800毫克青霉胺。母亲报告显示所有婴儿表现出正常发育。
对泌乳和母乳的影响：在一些案例报告和研究中，用青霉胺治疗威尔逊病期间，乳汁中的铜和锌浓度有所降低。
最近的一项研究比较了7名服用青霉胺的母亲的乳汁中的铜浓度与25名未患威尔逊病的对照组母亲的乳汁。初乳（产后0-4天）中的铜浓度略高于正常。尽管母亲血清中的铜浓度较低，但所有接受青霉胺治疗的母亲成熟母乳（产后>14天）中的铜和锌浓度均正常。
◉ Summary of Use during Lactation:Limited information indicates that penicillamine is not detectable in breastmilk and no adverse effects have been reported among breastfed infants whose mothers were taking the drug. Copper and zinc levels in breastmilk are reduced in some mothers receiving penicillamine. Penicillamine has been used with apparent safety during nursing of several infants. Based on available data, it appears that penicillamine is acceptable to use during breastfeeding.
◉ Effects in Breastfed Infants:One woman taking penicillamine 1500 mg daily for cystinuria breastfed her infant for 3 months with no apparent adverse effects in her infant.
A woman taking penicillamine in an unspecified dosage for Wilson’s disease breastfed her infant. The infant’s serum copper and zinc levels were normal. The infant fed well and developed normally.
Another woman breastfed 2 infants after 2 pregnancies while being treated for Wilson's disease with penicillamine 750 mg daily. One infant had prolonged icterus that was unlikely to have been related to the penicillamine.
A center in Turkey reported 23 infants born to mothers with Wilson's disease over a 20-year period. Twenty-one were treated with penicillamine 600 mg and zinc 100 mg daily. All of the infants were breastfed (extent and duration not specified). One premature infant died at 3 weeks of age (maternal drug not specified), but the other infant had no apparent complications over a median of 51 months (range 13 to 105 months) of follow-up.
A center in Germany reports 32 patients with Wilson's disease who became pregnant. Thirteen of the patients were taking penicillamine in dosages of 600 to 1200 mg daily. Of the 31 women who delivered a live infant, 27 of them breastfed their infants (extent not stated). Four of the infants had neonatal jaundice, but its relationship to penicillamine cannot be determined. The exact number of women who breastfed while taking penicillamine is unclear in the report.
Seven patients with Wilson’s disease were taking penicillamine in dosages of 300 to 800 mg daily. Maternal reports indicate that all infants exhibited normal development.
◉ Effects on Lactation and Breastmilk:In some case reports and studies, milk concentrations of copper and zinc were reduced during therapy of Wilson's disease with penicillamine.
A more recent study compared copper concentration in the milk of 7 mothers taking penicillamine compared to 25 control mothers without Wilson’s disease. The copper concentration in the colostrum (0-4 days postpartum) was slightly higher than normal. Copper and zinc concentrations were normal in mature breastmilk (>14 days postpartum) from all mothers treated with penicillamine, despite lower copper concentrations in maternal serum.
来源:Drugs and Lactation Database (LactMed)
