毒理性
◉ 母乳喂养期间使用总结:有限的信息表明,母亲每天服用乙胺丁醇的剂量高达15毫克/千克,在乳汁中产生的水平较低,预计不会对哺乳的婴儿产生任何不良影响,尤其是如果婴儿年龄超过2个月。乳汁中的乙胺丁醇量不足以治疗母乳喂养婴儿的结核病。疾病控制与预防中心和其他专业组织表示,不应劝阻服用乙胺丁醇的女性进行母乳喂养。
◉ 对哺乳婴儿的影响:在一项非对照研究中,测量了10名男性婴儿的6-β-羟基皮质醇水平,这些婴儿的母亲患有结核病,每天服用乙胺丁醇1克加异烟肼300毫克,以及那些没有结核病迹象的母亲(显然没有结核病)没有长期药物治疗。在90至195天大的8次,每隔15天测量一次,服用抗结核药的母亲的婴儿的6-β-羟基皮质醇水平始终较低,但仅在120天和195天时差异具有统计学意义。作者将较低的水平归因于抗结核药在乳汁中对肝脏将皮质醇代谢为6-β-羟基皮质醇的抑制作用。然而,乙胺丁醇并不已知会抑制药物代谢,因此如果出现这种效果,更有可能是由异烟肼引起的。
乙胺丁醇作为七药方案的一部分,用于治疗一名孕妇在孕中晚期和产后患有多重耐药结核病。婴儿进行了母乳喂养(喂养的程度和持续时间未说明)。在4.6岁时,除了轻微的言语延迟外,孩子发育正常。
土耳其有两名孕妇在第30周和第34周被诊断出患有结核病。她们立即开始服用异烟肼300毫克、利福平600毫克、吡哆醇50毫克,每天服用6个月,以及吡嗪酰胺25毫克/千克和乙胺丁醇25毫克/千克,每天服用2个月。两名母亲都对自己的婴儿进行了母乳喂养(喂养程度未说明)。他们的婴儿每天服用异烟肼5毫克/千克,预防性服用3个月。3个月后结核菌素皮肤测试阴性,1岁时婴儿都没有结核病。没有提到药物的副作用。
◉ 对哺乳和母乳的影响:截至修订日期,没有找到相关的已发布信息。
◉ Summary of Use during Lactation:Limited information indicates that maternal doses of ethambutol up to 15 mg/kg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. The amount of ethambutol in milk is insufficient to treat tuberculosis in the breastfed infant. The Centers for Disease Control and Prevention and other professional organizations state that breastfeeding should not be discouraged in women taking ethambutol.
◉ Effects in Breastfed Infants:In one uncontrolled study, 6-beta-hydroxycortisol levels were measured in 10 male infants whose mothers had tuberculosis and took ethambutol 1 gram daily plus isoniazid 300 mg daily and the infants of mothers (apparently without tuberculosis) who took no chronic drug therapy. The infants of mothers taking the antituberculars had consistently lower 6-beta-hydroxycortisol levels on 8 occasions at 15-day intervals from 90 to 195 days of age, but these differences were statistically significant on days 120 and 195 only. The authors attributed the lower levels to inhibition of hepatic metabolism of cortisol to 6-beta-hydroxycortisol by the antitubercular drugs in milk. However, ethambutol is not known to inhibit drug metabolism, so if the effect occurs it is more likely caused by isoniazid.
Ethambutol was used as part of a seven-drug regimen to treat a pregnant woman with multidrug-resistant tuberculosis during the second and third trimesters of pregnancy and postpartum. The infant was breastfed (extent and duration not stated). At age 4.6 years, the child was developing normally except for a mild speech delay.
Two mothers in Turkey were diagnosed with tuberculosis at the 30th and 34th weeks of pregnancy. They immediately started isoniazid 300 mg, rifampin 600 mg, pyridoxine 50 mg daily for 6 months, plus pyrazinamide 25 mg/kg and ethambutol 25 mg/kg daily for 2 months. Both mothers breastfed their infants (extent not stated). Their infants were given isoniazid 5 mg/kg daily for 3 months prophylactically. Tuberculin skin tests were negative after 3 months and neither infant had tuberculosis at 1 year of age. No adverse effects of the drugs were mentioned.
◉ Effects on Lactation and Breastmilk:Relevant published information was not found as of the revision date.
来源:Drugs and Lactation Database (LactMed)