毒理性
哺乳期间使用的总结：由于红霉素在母乳中的含量较低，且直接给婴儿服用安全，因此在哺乳期母亲中是可以接受的。乳中的小量不太可能在婴儿中引起不良反应。监测婴儿是否出现烦躁不安以及可能对胃肠道菌群的影响，例如腹泻、念珠菌病（鹅口疮、尿布疹）。一份病例报告和未经证实的流行病学证据表明，在哺乳期头两周使用红霉素的母亲，婴儿可能会出现肥厚性幽门狭窄；然而，如果发生这种情况，其发生率非常低，其他人对此关系表示怀疑。
对于痤疮的局部应用，婴儿不太可能出现副作用，尽管乳头上的局部应用可能会增加婴儿腹泻的风险。应该只用水性乳膏或凝胶产品涂抹乳房，因为软膏可能会使婴儿通过舔食接触到高水平的矿物石蜡。[1]
对哺乳婴儿的影响：在3周大的婴儿中报告了可能与母乳中的红霉素有关的肥厚性幽门狭窄、呕吐、镇静、吸吮困难以及体重增长不良的情况。[4]
一项对诊断为婴儿肥厚性幽门狭窄的婴儿的队列研究发现，受影响的婴儿在分娩后90天内服用大环内酯类抗生素的母亲的可能性是未受影响婴儿的2.3至3倍。对婴儿进行分层发现，女性婴儿的比值比为10，男性婴儿为2。所有受影响婴儿的母亲都哺乳了她们的婴儿。72%的大环内酯类处方是红霉素。然而，作者没有说明受影响婴儿的母亲服用了哪种大环内酯类抗生素。[5]
一项比较服用氨苄青霉素的母亲和服用大环内酯类抗生素的母亲的哺乳婴儿的研究发现，没有出现肥厚性幽门狭窄的实例。然而，大多数暴露于母乳中大环内酯类的婴儿暴露于罗红霉素。在暴露于大环内酯类的55名婴儿中，只有2名暴露于红霉素。暴露于大环内酯类的婴儿中有12.7%出现了不良反应，这与暴露于氨苄青霉素的婴儿的不良反应率相似。反应包括皮疹、腹泻、食欲不振和嗜睡。[6]
丹麦的一项为期15年的回顾性数据库研究发现，在分娩后头13天内服用大环内酯类的母亲的婴儿患婴儿肥厚性幽门狭窄的风险增加了3.5倍，但在之后的暴露中没有发现这种情况。不清楚其中有多少婴儿是被哺乳的，但可能比例很高。也没有报告服用每种大环内酯类的妇女的比例。[7]
在一项电话随访研究中，母亲报告说，在哺乳期间服用红霉素的17名婴儿中，有2名婴儿出现腹泻，2名婴儿出现烦躁不安。所有这些反应都没有需要医疗关注。[8]
两项荟萃分析未能证明哺乳期间母亲使用大环内酯类与婴儿肥厚性幽门狭窄之间的关系。[9][10]
对泌乳和母乳的影响：截至修订日期，没有找到相关的已发布信息。
◉ Summary of Use during Lactation:Because of the low levels of erythromycin in breastmilk and safe administration directly to infants, it is acceptable in nursing mothers. The small amounts in milk are unlikely to cause adverse effects in the infant. Monitor the infant for irritability and possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash). One case report and unconfirmed epidemiologic evidence indicates that hypertrophic pyloric stenosis in infants might occur with maternal use of erythromycin during the first two weeks of breastfeeding; however, if it occurs, the frequency is very low and others have questioned this relationship.
Infant side effects are unlikely with topical application for acne, although topical application to the nipple may increase the risk of diarrhea in the infant. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[1]
◉ Effects in Breastfed Infants:Pyloric stenosis, vomiting, sedation, poor sucking and poor weight gain probably related to erythromycin in breastmilk was reported in a 3-week-old infant.[4]
A cohort study of infants diagnosed with infantile hypertrophic pyloric stenosis found that affected infants were 2.3 to 3 times more likely to have a mother taking a macrolide antibiotic during the 90 days after delivery. Stratification of the infants found the odds ratio to be 10 for female infants and 2 for male infants. All of the mothers of affected infants nursed their infants. Seventy-two percent of the macrolide prescriptions were for erythromycin. However, the authors did not state which macrolide was taken by the mothers of the affected infants.[5]
A study comparing the breastfed infants of mothers taking amoxicillin to those taking a macrolide antibiotic found no instances of pyloric stenosis. However, most of the infants exposed to a macrolide in breastmilk were exposed to roxithromycin. Only 2 of the 55 infants exposed to a macrolide were exposed to erythromycin. Adverse reactions occurred in 12.7% of the infants exposed to macrolides which was similar to the rate in amoxicillin-exposed infants. Reactions included rash, diarrhea, loss of appetite, and somnolence.[6]
A retrospective database study in Denmark of 15 years of data found a 3.5-fold increased risk of infantile hypertrophic pyloric stenosis in the infants of mothers who took a macrolide during the first 13 days postpartum, but not with later exposure. The proportion of infants who were breastfed was not known, but probably high. The proportion of women who took each macrolide was also not reported.[7]
In one telephone follow-up study, mothers reported diarrhea 2 infants and irritability in 2 infants out of 17 infants whose mothers were taking erythromycin during breastfeeding. None of the reactions required medical attention.[8]
Two meta-analyses failed to demonstrate a relationship between maternal macrolide use during breastfeeding and infantile hypertrophic pyloric stenosis.[9][10]
◉ Effects on Lactation and Breastmilk:Relevant published information was not found as of the revision date.
来源:Drugs and Lactation Database (LactMed)
