毒理性
◉ 母乳喂养期间使用的总结：贯叶连翘（Hypericum perforatum）含有金丝桃素和金丝桃苷以及类黄酮如槲皮素。它常被助产士推荐用于产后抑郁症。金丝桃素和金丝桃苷都很少排泄到母乳中；其他成分在乳汁中尚未被测量。一项研究发现，服用贯叶连翘的哺乳期母亲所哺乳的婴儿出现绞痛、嗜睡和乏力的情况略有增加，但没有一种效果是严重或需要治疗的。大多数报告都与哺乳较大的婴儿有关，而不是在产后的前两个月，这时婴儿更容易出现不良反应。关于贯叶连翘是否能够降低血清催乳素水平或母亲的乳汁供应，存在相互矛盾的信息，尽管土耳其的一些母亲据报道使用它来增加她们的乳汁供应。催乳剂永远不应替代评估和咨询影响乳汁生产的可修改因素。贯叶连翘通过与许多药物代谢的增加而与之发生不利相互作用，并且偶尔会导致光毒性。在美国市场上销售的产品的标签通常缺乏这些已知的安全问题。由于对贯叶连翘在哺乳期间的公开发表经验很少，可能更倾向于使用另一种药物，特别是在哺乳新生儿或早产儿时。
◉ 对哺乳婴儿的影响：一名妇女在怀孕期间每天服用贯叶连翘300毫克（产品细节未指定），在足月时停用，然后在产后20天重新开始服用。她的哺乳婴儿（程度未说明）在出生后第4天和第33天进行的正常行为评估中未发现异常。
一名产后抑郁症的妇女在产后5个月开始服用贯叶连翘（Jarsin品牌）300毫克，一天三次。在产后7个月时，她的哺乳婴儿（程度未说明）未发现副作用，婴儿的发展评分正常。
一项匹配队列研究比较了33位报告在哺乳期间服用贯叶连翘的妇女，与两组对照，一组是疾病匹配（主要是抑郁症），另一组是年龄和生育次数匹配。所有组的哺乳持续时间相似，平均为10.8至12.1个月。平均在4.3至6.3个月时引入配方奶，各组之间没有统计学差异。使用的贯叶连翘品牌未报告。平均每日剂量为705毫克（范围为225至2150毫克/天），平均治疗持续时间为1.5个月，从产后4.2个月（范围为0至11个月）开始。通过母乳接触贯叶连翘的婴儿的平均暴露时间为2.1个月。服用贯叶连翘的母亲比其他组的母亲更频繁地报告婴儿绞痛（n = 2）、嗜睡（n = 2）和乏力（n = 1），而其他组中每组只报告了1例绞痛。治疗组和疾病匹配对照组之间的差异具有统计学意义。在这两组之间，服用传统抗抑郁药的母亲比例或受影响婴儿的母亲，或母亲服用的剂量没有差异。受影响的婴儿中没有需要特定医疗治疗的，两组中能够获得体重的婴儿在15至16个月大时的体重增长没有差异。
五名产后10至22周的妇女至少连续4周每天三次服用贯叶连翘（Jarsin品牌）300毫克，并完全哺乳她们的婴儿。询问母亲是否注意到任何胃肠道症状、乏力、皮疹、光敏感或睡眠模式的变化。没有任何母亲观察到她们的婴儿出现不良反应或不寻常的行为，婴儿在母亲治疗期间正常成长。
◉ 对泌乳和母乳的影响：在一项匹配队列研究中，33位报告在哺乳期间服用贯叶连翘的妇女（上文“对哺乳婴儿的报道副作用”中描述得更详细）中没有发现服用贯叶连翘的母亲在哺乳期间乳汁产量降低的证据。
36名患有轻度经前期综合症的妇女接受了贯叶连翘450毫克，一天两次，作为包衣片剂（Jarsin品牌）或安慰剂，持续两个月经周期。随机接受积极治疗的妇女（n = 19）的血清催乳素水平与接受安慰剂治疗的妇女（n = 17）在月经周期的卵泡期或黄体期没有统计学差异。
在一项对12名健康男性志愿者单次给予2700毫克贯叶连翘（Jarsin品牌）的研究中，血清催乳素在给药后150至210分钟之间有统计学意义上的下降。
已建立泌乳的母亲催乳素水平可能不会影响她的哺乳能力。
◉ Summary of Use during Lactation:St. John's wort (Hypericum perforatum) contains hypericin and hyperforin as well as flavonoids such as quercetin. It is often recommended by midwives for postpartum depression. Both hypericin and hyperforin are poorly excreted into breastmilk; no other components have been measured in milk. One study found a slightly increased frequency of colic, drowsiness and lethargy among breastfed infants whose mothers were taking St. John's wort, but none of the effects were severe or required treatment. Most reports have related to breastfeeding older infants, rather than during the first 2 months postpartum when infants are more susceptible to adverse reactions. Conflicting information exists on whether St. John's wort can reduce serum prolactin levels or the maternal milk supply, although some mothers in Turkey reportedly use it to increase their milk supply. Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production. St. John's wort adversely interacts with many drugs by increasing their metabolism, and it can occasionally cause phototoxicity. Labeling of commercially available products in the United States is often deficient with respect to these known safety issues. Because there is little published experience with St. John's wort during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
Dietary supplements do not require extensive pre-marketing approval from the U.S. Food and Drug Administration. Manufacturers are responsible to ensure the safety, but do not need to prove the safety and effectiveness of dietary supplements before they are marketed. Dietary supplements may contain multiple ingredients, and differences are often found between labeled and actual ingredients or their amounts. A manufacturer may contract with an independent organization to verify the quality of a product or its ingredients, but that does not certify the safety or effectiveness of a product. Because of the above issues, clinical testing results on one product may not be applicable to other products. More detailed information about dietary supplements is available elsewhere on the LactMed Web site.
◉ Effects in Breastfed Infants:A woman took St. John's wort 300 mg daily (product details not specified) during pregnancy, discontinued it at term and then reinstituted it at 20 days postpartum. Her breastfed (extent not stated) infant was found to have a normal behavioral assessment on days 4 and 33.
A postpartum woman with depression began taking St. John's wort (Jarsin brand) 300 mg 3 times daily starting at 5 months postpartum. At 7 months postpartum, no side effects were noted in her breastfed (extent not stated) infant and the infant's developmental score was normal.
A matched cohort study compared 33 women who reported that they had taken St. John's wort during breastfeeding to 2 control groups who were either disease matched (primarily depression), or age and parity matched. The duration of breastfeeding was similar across all groups and ranged from a mean of 10.8 to 12.1 months. Formula was introduced on average between 4.3 and 6.3 months, with no statistical differences between groups. The brands of St. John's wort used were not reported. The average daily dosage was 705 mg (range 225 to 2150 mg daily), and the average duration of therapy was 1.5 months, beginning at 4.2 months (range 0 to 11 months) postpartum. The average duration of St. John's wort exposure in the infants via breastmilk was 2.1 months. Mothers who were taking St. John's wort more frequently reported infant colic (n = 2), drowsiness (n = 2) and lethargy (n = 1) than mothers in the other groups in which only 1 case of colic was reported in each group. The difference was statistically significant between the treatment and disease-matched control groups. Between these 2 groups, there were no differences in the proportion of women taking conventional antidepressants overall or among mothers of affected infants, or in the dosages the mothers took. None of the affected infants required specific medical treatment and there was no difference in weight gain between subsets of the groups in whom weight could be obtained between 15 and 16 months of age.
Five women who were 10 to 22 weeks postpartum had been taking St. John's wort (Jarsin brand) 300 mg 3 times daily for at least 4 weeks and exclusively breastfeeding their infants. Mothers were asked if they had noticed any gastrointestinal symptoms, lethargy, rashes, photosensitivity, or changes in sleep pattern. None of the mothers observed any adverse effects or unusual behavior in their infants, and the infants grew normally during maternal therapy.
◉ Effects on Lactation and Breastmilk:In a matched cohort study of 33 women who reported that they had taken St. John's wort during breastfeeding (described in more detail above in "Reported Side Effects In Breastfed Infants"), no evidence was found of lower milk production among mothers taking St. John's wort during breastfeeding.
Thirty-six women with mild premenstrual syndrome received St. John's wort 450 mg twice daily as coated tablets (Jarsin brand) or placebo for two menstrual cycles. Serum prolactin levels of the women randomized to active treatment (n = 19) were not statistically different from those of the women who received placebo (n = 17) in either the follicular or luteal phase of their menstrual cycles.
Studies in healthy volunteer males (n = 12) given single doses of 2700 mg of St. John's wort (Jarsin brand) had a drop in serum prolactin that was statistically significant between 150 and 210 minutes after administration.
The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
来源:Drugs and Lactation Database (LactMed)
