Barnett D B, Hudson S A, McBurney A
Br J Clin Pharmacol. 1982 Aug;14(2):310-2. doi: 10.1111/j.1365-2125.1982.tb01985.x.
The plasma and breast milk were sampled from a woman who was breastfeeding whilst taking disopyramide (200 mg three times daily). Paired samples taken on the fifth to eighth day of treatment showed that disopyramide was present in breast milk in a similar concentration to plasma (mean +/- s.d. milk; plasma ratio 0.9 +/- 0.17). The estimated dose likely to be ingested by an infant is less than 2 mg kg-1 day-1. The active N-monodesalkyl metabolite of disopyramide (NMD) although present in plasma in much smaller concentrations than the parent compound, was excreted in breast milk (mean +/- s.d. milk: plasma ratio 5.6 +/2.9) in concentrations similar to those of disopyramide. The pharmacological and toxicological properties of the disopyramide metabolite need to be considered when assessing likely effects on the infant. No adverse effects were noted in the infant in this case. Maternal plasma and breast milk were sampled again along with infant plasma after 28 days. Disopyramide and NMD were undetectable in the infant's serum. No evidence was found to indicate that the concentrations of disopyramide or NMD in breast milk might be sufficient to pose a definite risk to the infant. Whenever disopyramide is prescribed in a breast feeding mother, close observation of the baby and measurement of both disopyramide and its active metabolite NMD in breast milk or infant plasma is recommended, pending further investigation.
从一名正在服用丙吡胺（每日三次，每次200毫克）的哺乳期妇女身上采集了血浆和母乳样本。在治疗的第五至八天采集的配对样本显示，母乳中丙吡胺的浓度与血浆相似（平均±标准差，母乳与血浆的比值为0.9±0.17）。估计婴儿可能摄入的剂量低于2毫克/千克/天。丙吡胺的活性N-单去烷基代谢物（NMD）虽然在血浆中的浓度比母体化合物小得多，但在母乳中的排泄浓度（平均±标准差，母乳与血浆的比值为5.6±2.9）与丙吡胺相似。在评估对婴儿可能的影响时，需要考虑丙吡胺代谢物的药理和毒理学特性。在这种情况下，未观察到婴儿有不良反应。28天后再次采集了母体血浆、母乳以及婴儿血浆样本。在婴儿血清中未检测到丙吡胺和NMD。没有证据表明母乳中丙吡胺或NMD的浓度可能足以对婴儿构成明确风险。每当给哺乳期母亲开丙吡胺处方时，建议密切观察婴儿，并测量母乳或婴儿血浆中丙吡胺及其活性代谢物NMD的含量，以待进一步研究。
